Supreme Court Creates New Food Labeling Battleground, plus GMO Labeling Primer

My colleague Anne Glazer recently co-authored an article with Connie Kirby of Northwest Food Processors Association titled “Summary of Regulatory Intersection between the Federal Trade Commission and the Food and Drug Administration over the Labeling and Advertising of Food Products: Implication for Genetically Engineered Foods.”

Prepared for Oregon Governor Kitzhaber’s Task Force on Genetically-Engineered Agriculture, of which Connie is a member, the article provides a helpful summary of the jurisdictional arrangements and regulatory approach to GMO labeling by the federal agencies charged with regulating food product manufacturing. It also provides an excellent breakdown of the recent U.S. Supreme Court decision in POM Wonderful, LLC v. The Coca-Cola Company, which paved the way for a new battleground in food and beverage labeling litigation: competitor-to-competitor lawsuits.

Readers can download a PDF copy of the article here.

Also a quick shout-out to Connie Kirby and her fellow bloggers on their new “NWFPA Issues Blog.” NWFPA members can follow their commentary on the recent decision in POM Wonderful and other current topics relevant to the food industry at http://www.nwfpa.org/resources/issues-blog.

Constitutionality of Vermont's Recently Enacted GMO Labeling Law Challenged

In a lawsuit filed yesterday, June 12, 2014, in United States District Court for the District of Vermont, four national trade associations representing food producers and manufacturers sued the state of Vermont claiming that the state’s recently passed Act 120, which would require certain food containing ingredients derived from genetically engineered crops to be labeled as such, violates the United States Constitution.

Enacted on May 8, 2014, Act 120 amends Title 9 of the Vermont Statutes to include a new chapter 82A, “Labeling of Food Produced with Genetic Engineering.” The new law requires food that is intended for human consumption and that is offered for sale on or after July 1, 2016 to be labeled as produced from genetic engineering if the food was entirely or partially produced with genetic engineering.

The act also prohibits a manufacturer of a food produced entirely or in part from genetic engineering from labeling the product on the package, in signage, or in advertising as “natural,” “naturally made,” “naturally grown,” “all natural,” or any other similar words. Most importantly, though, unlike other recently passed GMO labeling laws in Connecticut and Maine, Vermont’s law does not require passage of similar laws by other states in order to take effect. It is the first “no-strings-attached” GMO labeling bill to pass in any state.

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POM Finds Class Decertification Wonderful

In a recent decision, Judge Dean Pregerson of the U.S. District Court for the Central District of California decertified the class in an action against POM Wonderful over health claims about its pomegranate juice. You know the juice, it’s the one in the cooler section of the grocery store in the glass jar that looks like a purple snowman. Judge Pregerson had previously certified the class, but after discovery, particularly after plaintiffs’ expert’s testimony on damages, POM Wonderful had moved to decertify and, as the headline tells you, the court agreed. 

The decision to decertify was rooted in a recent U.S. Supreme Court case, Comcast Corp. v. Behrend, which dealt with the relationship between class certification and claimed damages. The court followed the Ninth Circuit’s interpretation of Comcast, which held that, in determining whether class certification was appropriate, “Plaintiffs must be able to show that their damages stemmed from the defendant’s actions that created the legal liability.” When applied to something that costs only a few bucks, this proposition is not easy to demonstrate.

 

Plaintiffs here offered two different theories, neither of which came close to persuading Judge Pregerson. First, the “Full Refund Model”: as plaintiffs’ expert testified: “[I]f the health benefits were what caused the purchase, at least predominantly, then a [full] refund would be appropriate”.   As the Church Lady might say, isn’t that special? And under the Full Refund Model, damages would be $450 million, an amount that would support some really nice legal fees for class counsel. POM argued, and that court agreed, that that model took no account of the benefits class plaintiffs would have received, such as hydration, calories and vitamins, even if the allegations about the untrue health benefits were proven. Heck, someone might simply want the bottle to use to make a snowman for a school project. There is no damages model that gets a plaintiff class those benefits for free.

 

More after the jump . . .

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New Wave of Prop 65 Notices Target Rice Industry

This week, Consumer Advocacy Group (CAG), a non-profit organization that files numerous Proposition 65 (Prop 65) lawsuits each year, issued notices of violation alleging that 15 companies violated California law by selling rice containing arsenic (and in some instances, lead) without a Prop 65 warning. The notices targeted a wide a range of companies, from small family-owned rice producers, to regional grocery chains and cooperatives. The same organization, CAG, issued a handful of similar notices to other companies in late 2013, also alleging the presence of arsenic in rice products sold in California without a Prop 65 warning.

For more information on these notices, including potential defenses that may apply, see my extended blog post at: http://www.californiaenvironmentallawblog.com/agribusiness/new-wave-of-prop-65-notices-target-rice-industry/

Alternative Product Labeling: Will "Simply" Changing Your Brand Protect Your Company From False Advertising Claims?

For the past few years, there has been a steady, if not increasing, stream of class action lawsuits filed against various food and beverage manufacturers and retailers alleging misbranding and false advertising due to the presence of “All Natural” claims. The companies sued in these cases range from major manufacturers and retailers to small private label suppliers. Typically, these consumer class actions typically allege that the products are falsely marketed as “natural” because they contain synthetic, artificial or processed ingredients. Products that bear an “All Natural” claim but contain ingredients anywhere from ascorbic acid (vitamin C) to zinc oxide have been challenged on false advertising grounds.

In light of the risk of litigation around the use of “All Natural” claims, some companies have begun reassessing statements and claims on their product labels and are taking a new approach to their marketing and advertising. One such company is PepsiCo. Recently, the company changed its “Simply Natural” line of Frito-Lay chips to just “Simply,” and its “Natural Quaker Granola” is now marketed as “Simply Quaker Granola.” Other large food companies, like Ben & Jerry’s, Breyers, and Campbell Soup Company, have also dropped the word “natural” from its new packaging.

However, replacing the word “natural” with a word like “simply” may not necessarily be a safe harbor. In 2003, the Center for Science in the Public Interest (CSPI) petitioned the Food and Drug Administration (FDA) to take regulatory action to prohibit The J.M. Smucker Company from making deceptive and misleading labeling claims that misrepresent the amount of fruit in Smucker’s “Simply 100% Fruit” spreadable fruit products. CSPI argued that the products contained more fruit syrup than fruit and that the syrups were actually made from apple and pineapple juice rather than the fruit named on the principal display panel.

In order to stave off litigation, food and beverage companies should carefully evaluate the claims of their product labels. For instance, is it worth the risk to use the work “natural” in product labeling and advertising? According to Stoel Rives attorney Melissa Jones, a trial lawyer who frequently counsels food and beverage companies faced with “All Natural” false advertising claims, it might not be. Melissa writes:

Although a few of the “All Natural” class action lawsuits have been dismissed at an early stage of the litigation, most courts have been unwilling to grant motions to dismiss entire cases and at least some of the claims usually proceed to further litigation or are resolved through settlement. The expense to companies that are sued in these cases is, not surprisingly, substantial, with settlements requiring payments of several million dollars.

That said, the alternative to “natural” labeling, such as the use of a word like “simply,” might not be litigation-proof either. Companies should conduct an intensive review of product ingredients to ensure compliance with labeling regulations and determine whether the ingredients and labeling claims are likely to result in an unwanted lawsuit.

Is Soy Milk to Milk as E-Books are to Books?

I don't think we need a lot of scientific research to determine why people drink soy milk, almond milk and coconut milk.  I'll save some time and list them, not in any particular order:

  • They are lactose-intolerant
  • They are living a vegan lifestyle
  • They prefer the taste to cow's milk
  • They prefer the nutritional profile to cow's milk

All four of these reasons have one thing in common:  they depend on the consumer understanding that soy milk, almond milk and coconut milk are not cow's milk.  So why on God's green earth did someone sue claiming that by labeling the products as soy milk, almond milk and coconut milk, they were confused into thinking the products contained cow's milk?

I will not cast aspersions, because I don't need to.  U.S. District Judge Samuel Conti of the Northern District of California took care of this for me. 

The case was Ang v. Whitewaves Food Co., and it involved two issues, one of which we won't get into at all:  the question of whether evaporated cane juice is "sugar".  The other was the claim that by labelling products as soy milk, almond milk and coconut milk, the producers of these products violated the "standard of identity" for milk.  The problem is that the regulation they claim "defines" milk is not its standad of identity at all. 

The regulation the point to, 21 CFR 131.110(a), provides, "Milk is the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows."  But since we actually are capable of reasoning and using language in a non-mechanical way, we can readily understand that this is not the definition of "milk."  This is a definition of milk, what you might call the default definition.  When we say "milk" without an adjective, in a food context, we mean cow's milk.  Milk in a dairy case that says only "milk" is assumed to be cow's milk, and indeed it had better be, or it is likely mislabeled. 

But within the same set of regulations that include this definition are a whole bunch of definitions that make it clear that the FDA is not telling anyone that the word "milk" must only apply to cow's milk, despite the plaintiffs' contentions.  For example, in the definition of "roquefort cheese", a cheese that cannot be made from cow's milk, the milk must be "of sheep origin", despite a cross-reference to a regulation that refers only to cow's milk. 

The court, without looking at my little roquefort definition, reaches the same conclusion:

Moreover, it is simply implausible that a reasonable consumer would mistake a product like soymilk or almond milk with dairy milk from a cow. The first words in the products' names should be obvious enough to even the least discerning of consumers. And adopting Plaintiffs' position might lead to more confusion, not less, especially with respect to other non-dairy alternatives such as goat milk or sheep milk.

On that basis, the court found that the claims under state law were preempted, because federal law generally prohibits states from imposing labeling requirements inconsistent with federal regulations. 

The court wasn't done with the plaintiffs, however.  Even if not preempted, the court held, citing the famous Crunchberry case we blogged about here, the plaintiffs' claims were simply not plausible. 

Plaintiffs essentially allege that a reasonable consumer would view the terms "soymilk" and "almond milk," disregard the first words in the names, and assume that the beverages came from cows. The claim stretches the bounds of credulity. Under Plaintiffs' logic, a reasonable consumer might also believe that veggie bacon contains pork, that flourless chocolate cake contains flour, or that e-books are made out of paper.

As I said at the outset, these products exist as a substitute for cow's milk for various reasons that give consumers a choice of beverage.  No one seeks out these products assuming they are getting cow's milk; they seek them out because they are seeking alternatives to cow's milk.  Judge Conti, who is a 91-year old senior U.S. District Judge appointed by Richard Nixon, deserves credit for so efficiently seeing through the plaintiffs' claims. 

Plaintiffs Seek New Targets in "All Natural" Class Actions

Recently, there have been both positive and negative developments in California regarding "All Natural" consumer class action litigation. By way of background, these cases are typically brought under California's Unfair Competition Law (Bus. & Prof. Code §17200), False Advertising Law (Bus. & Prof. Code § 17500) and Consumer Legal Remedies Act (Civ. Code §1750) regarding alleged false and misleading labels on food and beverage products.

Plaintiffs have begun to expand the focus of this litigation into new industries, including cosmetics, personal care products, and home cleaning supplies. The list of challenged ingredients also continues to expand. Additionally, some plaintiffs are pursuing claims simply where the product label contains the term "natural," even if it did not state "100% Natural” or "All Natural.”

On the other hand, there have been a handful of recent court decisions demonstrating that a motion to dismiss these consumer class actions can succeed, including under the “reasonable consumer” test, the primary jurisdiction doctrine and standing. This is a positive trend in California, given that in many earlier cases courts routinely denied motions to dismiss, leaving defendants with two bad options—further litigation or costly settlement.

For more information on this topic, including a list of the ingredients often challenged in these lawsuits, see my article, "All Natural: Label Making: Are You a Class Action Target in California."

Stoel Rives Attending the Women in Agribusiness Summit #womeninagri

Our firm is really excited to send a team of women food law lawyers to participate in the Women in Agribusiness Summit taking place in Minneapolis this year. We're currently on day 2 of the program, with great presentations on the schedule from representatives of Land O'Lakes, General Mills, Dow AgroScience, Zoetis, Monsanto, Cargill, Syngenta and many more.

Our Nicole Hancock presented yesterday along with Jacque Palmer, general counsel at Syngenta, on the topic of agribusiness litigation trends and best practices. The program concludes this evening with an executive roundtable moderated by Carol Kitchen, Senior Vice President/General Manager of Global Ingredients at Land O'Lakes, Inc.

Stay tuned to this blog for a follow-up report on the key food law issues discussed at the conference.

 

Joe Canada!

When innovation meets the law, the results are often surprising. 

We in Seattle are confronting this as ride services like Lyft compete with a regulated taxi industry.

Now consider Pirate Joe's, a business located in the upscale Kitsilano neighborhood of Vancouver, B.C..  I will let them describe their business model in their own words:

Pirate Joe's is an unaffiliated unauthorized re-seller of Trader Joe's products (we are being sued). We stock what we are asked to stock by Trader Joe's lovers who don't always have the time (or a car or a passport) to head south to Bellingham (the nearest Trader Joe's). We buy retail from Trader Joe's then import everything legally and add Canadian compliant ingredient and nutrition facts labels. We have to pay the rent and the help (and the label supplier) so prices are higher than at Trader Joe's. We have no set markup - every product we carry has different import and transport issues so we kinda just wing it until it seems fair to you and also makes business sense to us. If something seems overpriced, please tell us - we're sensitive about it. ;-)

Trader Joe's has no locations in Canada.  Canadians who live in British Columbia's Lower Mainland can access the store at 2410 James Street, Bellingham, Washington or the many located further south in the Seattle metropolitan area.  But this requires them to travel, to have a passport, to brave the line at customs, to use American money, etc.  Pirate Joe's will do all that for them, and allow them to buy in comfort using Canadian money in Kitsilano. 

One way Trader Joe's could look at this is they were getting a free ride into the Canadian market.  Pirate Joe's paid them exactly what they would have been paid had the same customers all driven down to Bellingham and bought the products there.  If Trader Joe's wanted to enter Canada, it would have to deal with export and import issues, Canadian labeling issues, Canadian taxes, Canadian employment law, the foreign exchange issue, and the price of Vancouver real estate, to name just a few.  Instead, they just make sales at retail to Pirate Joe's, owe him nothing for the service of advertising their products in Canada in the best possible way, or for affixing Canadian labels to the goods, handling the taxes, leasing space, putting up a website or anything else. 

Instead, Trader Joe's sued Pirate Joe's in federal court in Seattle.

And, so far, has lost

Pirate Joe's is actually just an assumed name of Michael Norman Hallatt, who is a Canadian citizen with permanent residency in the United States.  Thus, Trader Joe's could sue him in the United States and in federal court. 

The basic claim was a Lanham Act claim.  This is the main trademark act in the United States, but the question that Judge Marsha Pechman had to answer was whether it has extraterritorial impact.  In other words, in these circumstances, did the purchase of these goods in the United States at full retail price and importation, legally according to Canadian customs, into Canada violate American law? 

Under Ninth Circuit precedent, a Lanham Act claim can have extraterritorial effect under a three prong test:

  1. The defendant's action creates some effect on American foreign commerce
  2. The effect is sufficiently great to present a cognizable injury to plaintiff under the Lanham Act
  3. The interests of and links to American foreign commerce are sufficiently strong in relation to those of other nations to justify an assertion of extraterritorial authority.

The court determined, on a motion to dismiss, that Trader Joe's could not meet these tests.  The court relied on a Ninth Circuit decision involving a fight between Mike Love and Brian Wilson, both former Beach Boys.  Wilson had had a CD that included covers of old Beach Boys hits distributed with the Daily Mail in England to promote his "Smile" album and concerts.  Love, who had the right to the Beach Boys trademarks, sued.  But the Ninth Circuit found that any injury to him was not in the American market.  Similarly, Trader Joe's could not show that it was injured at all in the American market, since it had received literally as much money as it would have if Pirate Joe's customers had crossed the border and bought the goods in Bellingham. 

A far more interesting question would be what would happen if Trader Joe's wanted to open stores in Canada.  But that would represent issues of Canadian law that should be decided by Canadian courts.  Here, Judge Pechman's decision that Pirate Joe's is not damaging Trader Joe's in the United States seems correct. 

How can Pirate Joe's survive, given that it obviously has to mark up Trader Joe's prices significantly to cover its costs and some profit?  The answer lies in the price differential between the United States and Canada.  A decade ago, I spent a month in Canada when the Canadian dollar was at about 62 cents U.S.  Now it is essentially par, but Canadian prices have risen, not fallen, as the value of their dollar has increased.  So Canadians are just used to paying one-third or more higher prices for the same goods in the U.S.  Add in the convenience and cachet of the Trader Joe's goods available on a store shelf in Kitsilano, and the business model makes some sense.

Federal Judge Orders FDA to Address "All Natural" Labeling on GMO Foods

Coauthored by Claire Mitchell and Thomas Woods:

California federal courts now appear positioned to lead the way nationally on the issue of whether food products containing genetically modified ingredients, commonly referred to as “GMOs” can be labeled “All Natural.” Just last week a federal judge in Colorado stayed the case of Nicole Van Atta v. General Mills, Inc. (Case No. 12-cv-02815-MSK-MJW) (PDF), pending the Food and Drug Administration’s (FDA) input on this very issue recently sought from the agency by a California judge in the case of Cox v. Gruma Corp. (Case No. 12-CV-6502 YGR) (PDF).  

California, a hotbed of consumer litigation activity due to the state’s expansive consumer protection laws, has become a particularly common venue for consumer class actions alleging misbranding and false advertising regarding the use of “All Natural” claims. In particular, many cases have been filed challenging a manufacturer or retailer’s use of “All Natural” labels on products containing GMOs. These lawsuits are typically brought under California’s unfair competition and false advertising laws (referred to as the “UCL” and “FAL” or §§ 17200 and 17500 of the California Business and Professions Code).

Cox v. Gruma Corp. (“Cox”), the case that lead to the Colorado court’s stay, is a class action lawsuit filed in December 2012 in U.S. District Court for the Northern District of California against Gruma Corporation, the manufacturer of Mission® Tortilla chips. The complaint in Cox alleges that the product’s labeling is false and misleading because it claims to be “All Natural” when it is not in fact natural due to the involvement of genetically modified corn seed in the product’s manufacture.

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Driving a Stake Into State Obesity Litigation

Everyone from the First Lady to the Mayor of New York to my own personal physician is on an anti-obesity campaign these days.  Michelle Obama generally operates by trying to instill healthy habits; my doctor simply says I will lose weight if I use more calories than I consume (which is why you'll find my name here).  Mayor Bloomberg tried to limit some options he considers unhealthy.  

(Parenthetically, in the course of doing some research for this blog entry, I found the entry in the Urban Dictionary under my own surname.  One definition is "To maintain the proper diet in association with the physical activity."  What a nice way to refer to "Goldfarb".  I wish I could take credit, but it apparently comes from a Marc Goldfarb about whom I have been able to find out nothing more; ignore that first definition, please). 

Then there are lawyers.  One suggested way for combating obesity has been for attorneys general to take the initiative and sue the "food industry" for causing obesity.  This is a patently bad idea.

Happily, there is a well-written and well-argued law review article that suggests that the attorneys general would be wasting their time.  In Parens Patriae:  A Flawed Strategy for State-Initiated Obesity Litigation, published in the William & Mary Law Review, John B. Hoke makes the case that the case cannot be made for such litigation.  The argument is actually quite simple:  for a state attorney general to bring a claim, he or she ordinarily must operate under the parens patriae doctrine.  But, while this was asserted in the tobacco litigation that was generally settled between attorneys general and that industry, there are significant and important differences between the claims in those cases and the likely claims in obesity cases.  And those differences are enough to sink the idea.

Of these, the most important one is the basic causal link, without which any tort suit is bound to fail.

Because someone's overall lifestyle contributes to obesity, and food consumption is only one cause of obesity, establishing sufficient causation between the conduct of the food industry and the obesity epidemic may be an insurmountable burden for parens patriae obesity suits.

Moreover, as Hoke points out, "no food, if consumed in moderation, is entirely harmful."  Finally, and to me most importantly, "The sheer number of food companies and food manufacturers further weakens the causal connection between the conduct of the food industry and obesity."  I'd actually go farther:  in this context, there is no "food industry."  Unlike what Hoke called an "oligopoly," where five settling defendants essentially covered all the tobacco purveyors in the United States, a significant portion of food in the United States is produced and consumed outside of any "industry" as the term could be applied to any potential defendant in a lawsuit.  Mothers produce breast milk; I think we can assume that no attorney general and no plaintiffs' lawyer is going to go after mom.  People grow their own food; neighbors share the produce from their gardens.  People also actually cook food themselves, from raw ingredients whose quantities and proportions are up to them.  We are not slaves even to our cookbooks. 

Hoke similarly destroys the use of the "public nuisance" cause of action as a grounds for obesity litigation.  His strongest argument is that, under this doctrine, "the defendant must be in control of the product that actually causes the harm."  Other than a farm-to-table restaurant, this is a hard element to prove in connection with food, and that's not exactly the kind of defendant these cases are likely to want to target.

Combating obesity is a worthy goal.  Educating people about healthy choices and healthy lifestyles, providing valuable and germane information about the food they eat is a laudable means to that goal.  If I may be so vain, Goldfarbing is a laudable goal.  Using the blunt hammer of the litigation system, on the other hand, can lead to uncontrollable and not necessarily benign results. 

The Case That Makes You Go "Ewww"

You've heard about this case.  It's the story of the cop whose burger was spat on in Vancouver, Washington. 

The Washington Supreme Court's decision in Bylsma v. Burger King Corp., which covers a tiny but critical part of the policeman's lawsuit, has gotten a lot of publicity.  Let me give you three quick points that most of the reporting misses:

  • The guy who spat on the burger pled guilty to assault and was sentenced to 90 days in jail, was fired, and is not a defendant in the lawsuit.
  • The lawsuit, as it currently stands, has nothing to do with respondeat superior or whether the restaurant was negligent in hiring the guy who spat.
  • The case was decided under Washington law, and the real impact will be under Washington's Products Liability Act, which gives restaurants like the Burger King franchise here, and Burger King itself, few defenses to this action. 

Much more after the jump. 

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Battle Over Labeling Genetically Modified Food Continues

Our colleague Claire Mitchell recently published an article in Law360 that discusses a recent class action lawsuit filed against Pepperidge Farm, Inc. in Colorado on November 6, 2012. The complaint alleges that Pepperidge Farm misrepresented its Cheddar Goldfish crackers as “natural” when, in fact, they contain Genetically Modified Organisms (GMOs). The lawsuit is one of many class action suits that have been brought against food and beverage companies over the past few years claiming that the marketing of certain products as “natural” is false and misleading.

Claire explains possible ways for companies to avoid this type of litigation as well as the importance of being prepared for a lawsuit. She writes:

“Natural” labeling and advertising litigation has been both costly to food and beverage companies and damaging to their reputation. In order to avoid litigation, companies should take preventative measures such as reviewing their products’ ingredients for the presence of synthetic preservatives or other artificial or “unnatural” ingredients; examining product labeling, advertising, marketing and other promotional materials to ensure that all claims being made are accurate and compliant; and perhaps even considering whether the use of the term “natural” is worth the potential exposure to litigation.

It is also important for food and beverage companies to be prepared to defend against such lawsuits. Several possible defenses — such as removal to federal court under the Class Action Fairness Act (CAFA), forceful challenges to class certification and challenges to the pleadings under Rule 12(b)(6) — can be effective in defeating this type of class action lawsuit early in the process.

You can read the full text of her article here.

Pepperidge Farm Facing Potential Class Action Lawsuit Over All Natural Claims

Although California’s Right to Know Genetically Engineered Food Act, better known as Proposition 37, failed earlier this month when put to a vote, food companies still remain vulnerable to attacks over the use of genetically engineered ingredients in their products.

Specifically, it appears that marketing a food as “all natural” when it contains a genetically engineered (GE) ingredient continues to generate class action litigation. The latest lawsuit challenging the use of the word “natural” on a product label was filed by plaintiff Sonya Bolerjack on November 6, 2012 in U.S. District Court for the District of Colorado against Pepperidge Farm, Inc. The class action complaint alleges that the company “mistakenly or misleadingly represented that its Cheddar Goldfish crackers are ‘Natural,’ when in fact, they are not, because they contain Genetically Modified Organisms (GMOs) in the form of soy and/or soy derivatives.” In particular, the plaintiff asserts that the product is not natural due to the presence of soybean oil.

The plaintiff claims that Pepperidge Farm violated Colorado’s Consumer Protection Act by engaging in deceptive trade practices; breached express warranties including that the product is natural even though it contains GMOs; and negligently misrepresented to the public through its packaging and labeling that the product is natural even though it contains GMOs.

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ABC Files Motion to Dismiss BPI's Defamation Lawsuit

A few months ago, I wrote about a $1.2 billion defamation lawsuit filed by Beef Products, Inc. (BPI), a South Dakota-based meat processor, against ABC News Inc. found here. The most recent development in the case occurred on October 31 when lawyers for ABC filed a motion to dismiss.

In September, BPI, along with Technology, Inc. and Freezing Machines, Inc., collectively filed suit against American Broadcasting Companies Inc., ABC News Inc., ABC news anchor Diane Sawyer and ABC correspondents Jim Avila and David Kerley in Circuit Court in Union County, South Dakota claiming that ABC’s news coverage of lean finely textured beef (LFTB), or what became infamously known by the nickname “pink slime,” was defamatory and ultimately devastating for the company’s reputation and business. Since being filed, the case has been removed (PDF) to the U.S. District Court for the District of South Dakota. The complaint also named as defendants Gerald Zirnstein, the U.S. Department of Agriculture (USDA) microbiologist who called the product “pink slime,” Carl Custer, former federal food scientist, and Kit Foshee, a former BPI quality assurance manager who was interviewed by ABC.

Earlier this year, on March 7, 2012, ABC began reporting during its World News program that much of the ground beef we buy at the supermarket contains the product that the industry calls LFTB and others call “pink slime.” Over the next month, ABC continued to report on the story, both online and on its television news programs.

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Beef Products, Inc. Files Defamation Suit Against ABC

Just yesterday, Beef Products, Inc. (BPI), along with Technology, Inc. and Freezing Machines, Inc., collectively filed suit against ABC in Circuit Court in Union County, South Dakota claiming that ABC’s news coverage of lean finely textured beef (LFTB), or what became infamously known by the nickname “pink slime,” was defamatory and ultimately devastating for the company’s reputation and business.

LFTB is known in the meat industry as beef that has undergone a mechanical process to separate the fat from the meat in beef trimmings. The resulting product is then exposed to ammonia or citric acid in order to kill bacteria. The ABC investigation of LFTB that began earlier this year brought widespread attention to the product and the process by which it is produced.

The 256-page complaint filed by BPI specifically alleges that on March 7, 2012, ABC began a month long campaign during which the news agency knowingly and intentionally published false and disparaging statements regarding BPI and its LFTB product and improperly interfered with BPI’s business relationships. BPI argues that the statements made by ABC were not only inconsistent with information provided to them by BPI but were also contradictory to the findings of the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS), the Food and Drug Administration, food safety organizations, and many beef industry experts.

The company asserts that ABC’s reports caused grocery stores to stop selling products that contained the LFTB and misled consumers to believe that LFTB was unwholesome and unsafe. BPI is now seeking compensatory and statutory damages of more than $1 billion as well as punitive damages for what BPI alleges was ABC’s reckless disregard for the truth.

The complaint points out that prior to ABC’s broadcasts and online reports on LFTB, BPI was selling approximately five million pounds of LFTB per week. Afterwards, the company’s sales took a significant plunge declining to less than two million pounds per week. As we previously reported in an earlier blog post here, the drop in sales forced BPI to file for bankruptcy, close three processing facilities, and let go about 700 employees.

Accident in Search of a Cause of Action: the Alaska Supreme Court Strikes Out

The 20th century dramatist George S. Kaufman told the story, presumably apocryphal, of receiving a bill from his lawyer with the entry “For crossing the street to speak to you and discovering it was not you.”  A recent Alaska Supreme Court case, Estate of Mickelsen v. North-Wend Foods, Inc., indicates that Kaufman may have been an optimist. 

The case involves facts that wouldn't seem to implicate any issues we discuss on this blog.  Simply put, a motorist made an illegal left turn across traffic mid-block in Anchorage and killed a motorcyclist heading in the opposite direction. The motorcyclist crashed into the car, so presumably he didn’t have enough time to swerve or stop.  The unstated but obvious subtext, of course, is that the motorist did not have the resources to fulfill the damages caused. 

 

So whom did the estate sue?  The franchisee and owner of the land on which a fast food restaurant sits.   Their alleged mistake:  not taking sufficient steps to warn the motorist not to make an illegal left turn into the exit to their drive-through. 

 

Understand, the case had been dismissed on a Rule 12(b)(6) motion, which presents a pretty high standard, "failure to state a claim on which relief can be granted."  But it's hard to see where the claim is here. 

  

  

Mickelsen’s complaint alleges that [defendants] created an entry and exit system that had the effect of enticing . . . patrons to enter the premises by making an illegal turn across two lanes of traffic, that . . . customers in fact regularly used the short-cut, that [defendants] w[ere] or should have been aware of such use, and that this dangerous condition led to the fatal accident.

This is notwithstanding that the left turn involved illegally turning across a double yellow line and that there are, not surprisingly, traffic laws that impose on a driver making any kind of left turn the duty to do so only when no oncoming driver might smash into your car. Neither of those traffic laws relate to whether there is a driveway the illegal and negligent driver is turning into or the identity of the business that driver may be trying to patronize. And just to make it clear, “[b]ecause the width of the curb-cut accommodates only one vehicle at a time, drivers must often roll one tire over the raised curb in completing the short-cut maneuver.” So drivers would need to violate two important traffic laws and roll over a raised curb to undertake this “short-cut.” This, in Alaska, is “enticement” that is sufficient to create a cause of action that must be defended at great cost.  (more after the jump)

 

 

Continue Reading...

Nationwide Beef Processor, AFA, to Sell All Assets in Bankruptcy

AFA Investment Inc., and its affiliates, including AFA Foods, American Foodservice Corporation, United Food Group, LLC, and American Fresh Foods (together “AFA”) have requested that the Bankruptcy Court overseeing their Chapter 11 cases approve procedures for a sale of all of their assets. The sale process was a condition required by AFA’s lenders to continue financing the companies in bankruptcy.

AFA reports that 98 potential buyers have surfaced so far and that 36 have executed nondisclosure agreements. However, none have yet been chosen by AFA as a “stalking horse” bidder, so the sale process is being conducted, at least for now, as an open or “naked” auction.

 

A hearing on the requested procedures is set for May 8, 2012. AFA’s proposed procedures include: 

·         AFA will have until May 29, 2012 to obtain one or more letters of intent. 

·         Potential bidders would have until noon on June 11, 2012 to submit “qualified bids.”

·         If more than one qualified bid is received, an auction will be held at 10:00 a.m. on June 12, 2012, at the office of AFA’s counsel in Delaware.

·         AFA would have until 24 hours before the auction to choose a stalking horse against which other bidders would compete at the auction. If a stalking horse is chosen, a copy of the proposed asset purchase agreement will be filed with the Bankruptcy Court. A stalking horse may be provided with certain “bid protections” if approved by the Bankruptcy Court, including topping fees, asset mix requirements (to deter piecemeal purchases), and minimum overbids.

·         Qualified bids must include, among other things:  (a) a list of assets to be purchased, (b) the purchase terms, (c) a form of asset purchase agreement (or a redline against any stalking horse agreement), (d) a waiver of financing and due diligence contingencies, (e) an irrevocable offer until the earlier of July 25, 2012 or two business days following a sale; (f) a commitment to close by June 22, 2012; (g) a commitment to prepare evidence necessary to prove good faith under the Bankruptcy Code; (h) evidence of the buyer’s ability to provide adequate assurance of performance of any contracts to be assumed as part of the sale; and (i) a deposit of 10% of the proposed purchase price.

·         Due diligence is available upon execution of an acceptable nondisclosure agreement and proof of financial ability to close.

 

Parties have until April 30, 2012 to file any objections to the procedures.

 

If you are interested in participating in the sale process or would like a full copy of the proposed bidding procedures, please contact Brandy Sargent at (503) 294-9888 or David Levant at (206) 386-7601.

UCL Class Actions in California Expand Beyond "All Natural" Claims

The “All Natural” class action litigation in California has continued into 2012, as expected.  The claims in California are being filed under California’s consumer-friendly unfair competition law (or UCL), which is codified in sections 17200 and 17500 of the California Business & Professions Code, and the Consumer Legal Remedies Act (CLRA).

Given the costs and risks associated with UCL and CLRA class actions, many companies are getting pro-active and are carefully analyzing their labels.  The challenge for such companies, however, is that these lawsuits are not limited to labels that contain the words “All Natural.”  They fall into several broad categories.

 

First, there has been litigation over products that are marketed as being healthy but contain allegedly unhealthy ingredients, such as trans fat, saturated fat, high-fructose corn syrup or sugar.  Consumer protection class actions may also arise like a claim for a defective product-- where an otherwise healthy product experiences a manufacturing, packaging or storage deviation that takes its ingredients outside of the representations made on the label and subjects the manufacturer to litigation over “deceptive labeling” practices.

   

Second, there has been litigation over products that claim to be “All Natural” or “100% Natural” that allegedly contain GMOs or other synthetic or artificial ingredients.  The types of ingredients that have been challenged by plaintiffs include:

 

alkalized cocoa

ascorbic acid (vitamin C)

beta-carotene (vitamin A)

calcium pantothenate (vitamin B5)

cyanocobalamin

dutch cocoa

folic acid (a B vitamin)

glycerine

GMOs

inulin

niacinamide

potassium carbonate

pyridoxine hydrochloride

riboflavin

sodium benzoate

sodium citrate

soy proteins (from hexane)

xanthan gum

zinc oxide

        

Of course, many of these ingredients are used frequently in products and there is no evidence that they are harmful.  But given the California Supreme Court’s recent finding that “labels matter” (as opposed to product quality), plaintiffs are seizing on the opportunity to claim that something that has been processed or contains any “artificial” ingredient cannot possibly be “All Natural.” 

 

Third, there has been litigation over claims about the quality of ingredients, such as “100% Pure” claims on orange juice or coconut water labels.

 

Finally, there has been litigation over products that have unsubstantiated health benefit claims, such as “proven to reduce cholesterol,” “supports digestion, . . . metabolism, . . .[and] liver function,” “supports immunity,” “reduces risk of chronic diseases,” “promotes healthy joints,” or otherwise.

 

In the current environment (with the lack of guidance from FDA and various court rulings that have struck down motions to dismiss), companies cannot afford to ignore the risk of litigation.  The important thing for companies to take away from the morphing UCL class action litigation in California is that a cursory review of product labels is no longer enough to help ensure loss prevention.  The product, whether labeled “All Natural” or not, should be reviewed carefully as the litigation theories in California broaden.  Indeed, as noted above, many of the class action lawsuits in California involve claims other than “All Natural.”  Companies should conduct an intensive review of product ingredients (and consider testing) to ensure compliance with labeling regulations and to assess whether the ingredients and labeling claims are likely to result in unwanted attraction from the plaintiffs’ bar.   

 

For more information on this topic, contact Melissa Jones and Tom Woods in the litigation department of the firm’s Sacramento office.

Proposition 65 case involving 4-MEI in soda

For news on the first alleged Proposition 65 violation concerning 4-Methylimidazole (4-MEI) in soda, see my blog posting in the environmental law blog.  4-MEI exists in some food and beverage products, including certain sodas, beers, soy sauces, breads, and coffees, among others. 

http://www.californiaenvironmentallawblog.com/first-prop-65-notice-of-violation-issued-regarding-4-mei-in-soft-drinks/

 

"All Natural" Class Action Litigation in California: What's in Store for 2012?

California litigators Tom Woods and Melissa Jones have prepared a Litigation Legal Alert on "All Natural" class action litigation in California and what to expect in 2012. 

The Alert, which is linked above, provides background information regarding "All Natural" class action litigation in California.  It also discusses why the authors believe that class action litigation in this area will persist in 2012.  Finally, the Alert concludes with suggestions for companies that have litigation risks regarding "All Natural" claims associated with their products.

 

 

 

 

No Slow Down to Class Action Lawsuits in California Regarding Food Labeling and Marketing

By California litigators Tom Woods and Melissa Jones

Consumer class action plaintiffs remain very active in California, with cases continuing to be filed against food manufacturers and suppliers regarding alleged misleading labeling and marketing claims. Just this week, plaintiffs filed a class action lawsuit against Trader Joe’s alleging that it falsely advertised and sold cookies and apple juice as “All-Natural” even though the products contained synthetic ingredients. In the past few months alone, several other large companies have been sued over allegedly false “All Natural” claims in lawsuits involving ice cream, juice, granolas, energy bars, and cereal. In the same time period, other class actions have been filed in California regarding the marketing of products that are made from genetically modified plants and grains, such as cooking oil.

These actions are most commonly brought under California’s unfair competition law (referred to as the “UCL” or § 17200 of the California Business and Professions Code). The problem for companies sued under California’s UCL is that it is difficult to get claims dismissed at an early stage. Lawsuits frequently survive the pleading stage because claims are evaluated from a subjective, and not objective, standard. Cases are allowed to proceed even though only one plaintiff establishes standing to sue by showing they actually relied on a company’s statement. Finally, preemption defenses are frequently inapplicable.

Companies should get proactive in light of this litigation trend, which isn’t going away, and examine their labels to minimize the risk of litigation. Those that have been sued should consider creative ways to address these class actions by developing and preserving constitutional challenges. Despite recent California cases making it easier for plaintiffs to maintain their lawsuits at an early stage, aggressive discovery may prevent plaintiffs from certifying the proposed class.

FDA's Right To Photograph In Your Plant

The FDA asserts in its inspection manual its right to photograph in your plant. Yet the FDA does not have statutory authority to photograph. The manual cites the following cases as authority for its right to photograph the inside of a plant: Dow Chem. Co. v. United States, 476 U.S. 227 (1986), and United States v. Acri Wholesale Grocery Co., 409 F. Supp. 529 (S.D. Iowa 1976). But these cases rely on the theory of implied consent or a minimal expectation of privacy. These cases do not hold that FDA has the right to photograph the interior of a food facility when the facility has a strict policy against photography and does not consent to the photography.

So, should you resist FDA's request to photograph?

The first thing you need to do is to ask yourself the following two questions:

  1. Do you have a policy against photography in your plant?
  2. If you do, is the policy strictly enforced?

If the answer to either question is no, then you're on shaky footing in resisting the FDA's request. By not having a policy or by not strictly enforcing the policy, FDA's legal authority based on implied consent is that much stronger.

Assuming your plant does have a no-photography policy that is strictly enforced, you need to assess whether the photography is worth the fight. It may be. Resisting the request for photos may be worthwhile to protect potential disclosure of trade secrets and to prevent out-of-context photographs from being used adversely by FDA. The problem is that the harder you push against FDA, the more likely that it will seek more information and the more likely that it will seek enforcement action.

In a future entry, we'll explore what legal remedies might be available to prevent the FDA from photographing the inside of  your plant.

Learn How to Prepare for an FDA Inspection

Next Wednesday at the ACI Food Regulatory Summit in Chicago I'll be presenting a talk entitled "Curtailing Downstream Liability Arising Out of On-Site Inspections: How to Prepare and What to Do Should Government Come Knocking." My slide-deck can be linked here.

Topics that I plan to cover include:

  • FDA's plan to increase frequency of inspections and how it plans to do it
  • How to be prepared for FDA's greatly expanded records access authority
  • How to avoid new fees that will be imposed by FDA
  • Developing an appropriate strategy to deal with FDA
  • Preparing a privileged FDA inspection plan and training

More information about the ACI conference and registration can be found here.

3 New Ways FDA Will Access Your Records and 5 Things You Can Do About It

The Food Safety Modernization Act ("FSMA") significantly expands the FDA's ability to access a food company’s records.

The expanded authority is found in three places in the statute:

  1. FSMA § 101 amends 31 USC § 350c(a) and allows the FDA to obtain records related not only to a product that the FDA believes "will cause serious adverse health consequences or death to humans or animals" but also those related to "any other article of food" that the FDA believes is "likely to be affected in a similar manner."

This statute may allow FDA to "access and copy" all records in any format and at any location of products that are not known to be contaminated but that might share similar ingredients or be produced in a shared facility or that could otherwise be affected in a "similar manner" as products thought to be contaminated.

Section 101 was effective immediately on FSMA becoming law in January 2011.

  1. FSMA § 103 requires that FDA facilities (with certain exceptions) implement "Hazard Analysis and Risk-Based Preventative Controls." As part of this section, Congress requires the affected FDA facilities to keep "records documenting the monitoring of the preventative controls" and to keep a "written plan that documents and describes the procedures used by the facility to comply with the requirements of this section." Congress requires that these records "be made promptly available" to the FDA upon "oral or written request." The statute also requires that records be kept for at least two years.

Note that unlike in section 101, Congress did not use the term "copy" in section 103. This section instead says that records must "be made promptly available."

The question remains open whether the FDA interprets "be made promptly available" to mean copy and whether such a broad interpretation will be held up by the courts. Section 103 is effective in July 2012.

  1. FSMA § 202 requires the FDA by January 2013 to create a "program for the testing of food by accredited laboratories." By July 2013, section 202 will require testing by an "owner or consignee (i) in response to a specific testing requirement under this Act or implementing regulations, when applied to address an identified or suspected food safety problem; and (ii) as required by the Secretary, as the Secretary deems appropriate, to address an identified or suspected food safety problem.“

Test results from the FDA-accredited lab "shall be sent directly to the [FDA]" unless exempted by regulation.

The big questions under section 202 are whether:

a. Routine product and environmental testing accomplished for the purpose of a food safety plan under section 103 will be considered "in response to a specific testing requirement . . . when applied to address an identified or suspected food safety problem" and

b. The FDA will exempt certain testing records under this provision.

So, what should you do to prepare for the FDA's considerable expansion of its ability to access your records?

Here are five things that a food company should consider:

  1. Understand what records the FDA does not have the right to access (recipes, financial, pricing, research, personnel or certain sales data), and maintain these separate from records the FDA can access.
  2. Create and enforce a document destruction policy that conforms with FSMA.
  3. Create a standard FOIA letter to present to the FDA when it requests letters explaining that it considers information provided to be trade secrets, confidential and proprietary.
  4. Create and train employees on a confidential FDA inspection policy that involves legal counsel and therefore can be cloaked in the attorney-client privilege.
  5. Understand what finished product and environmental testing is needed and not needed for a section 103 food safety plan.

More on FSMA and Food Safety Risk Avoidance

Thank you to Parker Smith & Feek for inviting me to speak to about FSMA and how it’s changing the status quo. My slide-deck can be viewed here.

Following my talk, Marty Bask from Parker Smith & Feek led a very interesting discussion about the pros and cons of product recall and contamination coverage. A link to our recent discussion on this blog on what to ask when purchasing this kind of coverage is here.

Coffee Brewers and Servers Sued Under Prop 65

As we foreshadowed with our blog regarding 60 day notices, the Committee for Education and Research on Toxics (CERT) filed a Proposition 65 enforcement action alleging that ready-to-brew coffee exposes coffee drinkers to acrylamide (a chemical known to the state of California to cause cancer). CERT v. Brad Berry Co., Ltd., No. BC461182 (Cal. Sup. Ct., Los Angeles County, filed on May 9, 2011). Included as defendants are a number of high profile coffee roasters and retailers.

According to the suit, a single 12 oz. cup of coffee "contains anywhere from four to 100 times the No Significant Risk Level for acrylamide established by California's Office of Environmental Health Hazard Assessment." We look forward to seeing how this case plays out.

The FDA's Reportable Food Registry: Four Burning Questions

I authored the following article that appeared in the April 29, 2011 issue of Food Chemical News:

As the clock ticks on the FDA’s 24-hour deadline to report to the FDA’s Reportable Food Registry, a food retailer, manufacturer or supplier is forced to make snap decisions that can profoundly impact business and litigation.

Once a report is submitted, the FDA promptly alerts customers and suppliers of the "reasonable probability" that the product will result in "adverse health consequences or death." Even if a recall has not yet been issued, an RFR report often has the consequences of a Class I recall. While RFR reports can be amended or withdrawn based on new information, in the world of food products, the bell almost never can be unrung, food companies are now painfully aware.

But some burning questions regarding FDA’s RFR remain for the food industry, including if and how the agency will:

(1) use the RFR as an enforcement tool;
(2) move toward the concept of "control" and away from "possession" in interpreting one of the key exceptions to the RFR;
(3) address what it perceives as "out of control" undeclared allergen problems; and
(4) use the information obtained through the RFR to shape coming regulations on required preventive controls.

Let’s take a stab at answering some of these questions and a few others.

Will FDA Use RFR as an Enforcement Tool?
The RFR was created by Congress as part of the Food and Drug Administration Amendments Act of 2007 and is codified at 21 U.S.C. §350f. The RFR requires that "as soon as practicable, but in no case later than 24 hours after a responsible party determines that an article of food is a reportable food, the responsible party shall [] (A) submit a report to [FDA] ... and (B) investigate the cause of the adulteration if the adulteration of the article of food may have originated with the responsible party." 21 U.S.C. §350f(d)(1).

The reporting includes a "one step up and one step back" requirement. Food companies must identify their suppliers and customers to FDA through the web portal.

The FDA Food Safety Modernization Act (FSMA) tweaks the RFR and requires the FDA to promulgate new regulations requiring submission of "consumer-orientated information," including a description, product ID codes, contact information and anything else FDA deems necessary to enable consumers to accurately identify whether they are in possession of the reportable food.

The congressional intent behind the RFR is to provide the FDA with a mechanism to track patterns of adulterated product, essentially as an information gathering tool. Many in the industry fear that the FDA also will use the RFR as an enforcement tool. Even an unintentional failure to report in compliance with 21 U.S.C. §350f constitutes a criminal violation of the Food, Drug, and Cosmetic Act (FD&C Act).

It’s not clear if the FDA has initiated any enforcement action based on the RFR yet, but this should be monitored closely by the food industry.

Can You Take Advantage of Intra-Company Transfer Exception to Reporting Obligation?
21 U.S.C. § 350f(d)(2) provides an exception to the reporting obligation if:

 

The challenge with interpreting this exception centers on the term "transfer." The FDA's current draft guidance says: "A transfer to another person occurs when the responsible person releases the food to another person. 'Person' is defined in section 201(e) of the FD&C Act as including individuals, partnerships, corporations and associations. FDA does not consider an intra-company transfer in a vertically integrated company to be a 'transfer to another person,' where the company maintains continuous possession of the article of food."

The rub is that if the product is shipped to a third-party warehouse, but the responsible party maintains ownership and direct control over distribution, the product is reportable. The FDA’s draft guidance rationalizes that "'[p]erson is defined in section 201(e) of the FD&C Act (21 U.S.C. 321(e)) as including individuals, partnerships, corporations, and associations," and a "warehouse operator is a distinct legal person."

Another scenario under the 21 U.S.C. § 350f(d)(2) exception that is not addressed by the FDA's draft guidance arises if the product is subject to an intra-company transfer but the company uses a common carrier to transport the product. Under the FDA's rationale that use of a third-party warehouse takes a company out of the exception, a common carrier also could be considered a "distinct legal person" to which the product is transferred, eliminating the exception and requiring the company to report.

Many believe that the FDA (and the statute) could not intend that an otherwise unreportable food under 21 U.S.C. §350f(d)(2) become reportable for no reason other than that a company uses a third-party trucking company in an intra-company transfer. Many also question whether the FDA's current position on third-party warehouses is correct if the food company retains complete control over the product.

Neither of these policies reflects the reality of how many food companies operate. From a food safety policy perspective, many believe that food companies should not be forced into the business of trucking and warehousing.

Some believe that the FDA might be moving away from interpreting "transfer" through the lens of possession and broadening its view toward an interpretation based on issues of control. Control might reflect more accurately the reality of food production and promote more effectively food safety and the intent of the RFR. Whether the FDA will move toward a notion of control should be revealed in the FDA's expected amendments to its draft guidance and should be monitored closely by the industry.

In January 2011, the FDA issued its first annual report on the RFR, which provides statistics on the first full year of the RFR (2,240 entries, 229 "primary reports," a breakdown by hazards, etc.) (see FCN Jan. 28, Page 8). Beyond the statistics, companies should take particular note of the FDA’s focus on both allergen controls and creation of food safety plans.

The FDA reported that undeclared allergens/intolerances accounted for 34.9% of its primary reports. Industry experts assert that the FDA believes that the industry does not have good control over the issue of undeclared allergens. These experts believe that the FDA will give special attention to this issue in promulgating regulations under the FSMA's requirements for hazard analysis and preventive controls. In anticipation, manufacturers should consider now how they can change manufacturing processes to address the undeclared allergen issue.

Do You Have A Food Safety Plan? If So, Will It Be Sufficient Under FSMA?
In FDA’s report on its RFR results , FDA Deputy Commissioner for Foods Michael Taylor says “[s]everal key U.S. industries are already re-evaluating their hazard and preventive controls, core principles of the Food Safety Modernization Act recently passed by Congress. We also anticipate improved reporting as we continue our vigorous outreach to food facilities through federal, state, local and foreign agencies, to help us expand the positive effect of the RFR on the safety of the U.S. food supply.”

The RFR will be a guide for the FDA in risk assessment and writing regulations for preventive controls and what companies must include in their food safety plans. The new hazard analysis and preventive controls requirements in FSMA are not required to go into effect until July 4, 2012, 18 months from the date of enactment.

Deputy Commissioner Taylor's comments suggest that industry standards already might be moving in the same direction. To mitigate the risk of FDA enforcement actions, product liability claims, supply chain contract claims and recalls, food manufacturers should anticipate the FDA's eventual rule making, and update or create food safety plans that address the hazard analysis and preventive controls prescribed by the FSMA. One way to anticipate FDA's direction is to mine the information FDA has collected (and continues to collect) as part of the RFR.

(A) the adulteration originated with the responsible party;

(B) the responsible party detected the adulteration prior to any transfer to another person of such article of food; and

(C) the responsible party –

(i) corrected such adulteration; or

(ii) destroyed or caused the destruction of such article of food.

What to Ask About Recall or Product Contamination Insurance Coverage

If they don’t already have it, I advise my clients to talk with their insurance broker about purchasing recall insurance (otherwise known as product contamination insurance) . For clients who have recall insurance, I advise them to make sure the policy provides the coverage they expect. Recall insurance is a different animal than other policies like Commercial General Liability or Products Liability coverage. Food companies purchasing recall polices should consider the cost-benefit carefully and consider asking the underwriter to amend the policy where necessary.

The facts of a recall are often fluid and every company’s business is different. The facts known on the day a recall, a market withdrawal or another event involving product contamination occurs may be different than the facts known in the days, weeks or months that follow. In the event of a claim, the insurer is more likely to contest coverage under a recall policy than with other types of coverage.

So what should a food company should look at when purchasing, negotiating or renewing a recall or product contamination policy? The answer depends at least in part on the nature of the business and the exposure and expenditures that the business expects in the event of a recall or product contamination event.

Based on the various forms of coverage I've seen, here is a non-exhaustive list of issues to consider discussing with your broker:

o Class II or III Recall: Will the policy cover recalls where the likelihood of bodily injury is remote or non-existent, such as class II or class III recalls? What if the recall is requested (as opposed to ordered) by the FDA or other appropriate governmental agency?

o New Administrative Detention Rules: Will the policy cover loss from an FDA administrative detention? The new food safety laws lower the standard by which the FDA can administratively detain foods. Just last week the FDA released its proposed rule on administrative detention: it no longer needs evidence of serious adverse health consequences or death to detain foods.

o Mistaken Recall: What happens if loss is incurred due to a recall or other event and it turns out that the facts underlying the recall or other event turn out later to be incorrect? For example, a company issues a recall due to information that its product is contaminated and it later turns out that the information was incorrect and the product was not contaminated.

o Exclusion for Competitor's Product: Some policy forms exclude coverage if the recall or other loss was due to a problem with a competitor's product. This exclusion could be particularly problematic for those involved with selling commodities.

o Warranty of Fitness Exclusion: Some policy forms will exclude loss if the product breaches a warranty of fitness. The insurer may be trying to exclude manufacturing defects or other reasons for a product recall or market withdrawal other than accidental contamination. The problem is that the insurer could later argue that loss from a contaminated product or a product with an undeclared allergen is excluded because such a product would also breach a warranty of fitness.

o Third-Party Coverage: Does the policy provide coverage for claims by third parties (e.g., your customers)? If not, do you need that coverage and is it available?

o Lost Profits/Revenue: Does the policy cover your lost profits or lost revenue? If so, how is your loss calculated? Will you have sufficient documentation and evidence to prove loss in the event of a claim?

Listen on Demand to April 29, 2011 AON Webinar on the FSMA

A 60-minute webinar broadcast on April 29 on the Food Safety Modernization Act (and a short discussion of implications of the Japanese earthquake, tsunami and resulting nuclear disaster on food safety) is available for replay at this link. The webinar was sponsored by AON. My gratitude to AON for inviting me to participate. As always, I'm interested in your feedback and questions.

FDA's Reportable Food Registry Makes a Profound Impact

Here is a link to my article, "FDA's Reportable Food Registry Profoundly Impacts Litigation and the Food Industry," posted this week by the American Bar Association's Litigation Section (Products Liability). The article is a follow-on to lively discussions over the litigation impacts of the federal Reportable Food Registry ("RFR") at the ABA’s recent Food & Supplements CLE at Coca-Cola World Headquarters in Atlanta. The RFR was created by Congress as part of the Food and Drug Administration ("FDA") Amendments Act of 2007 and requires that a company submit a report to the FDA within 24 hours of discovering reportable adulterated food.

Two hot-button issues discussed at the ABA CLE (and in the ABA article) were whether the FDA (1) intends to use the RFR as an enforcement as well as an informational tool, and (2) will move toward the concept of "control" and away from "possession" in interpreting one of the key exceptions to the reporting requirement.

Health Claims Class Actions Set to Explode

Stoel Rives food liability attorney Ken Odza discussed with NutraIngredients-USA.com the significance of a rise in activism from consumer lobby groups combined with food manufacturers pushing the envelope with more aggressive health claims. General Mills recently lost its bid to invalidate class action certification at the Eleventh Circuit of Appeals in a Florida lawsuit involving digestive claims for Yo-Plus, a probiotic yoghurt product.

Odza said that plaintiff attorneys who have made fortunes out of asbestos and pharmaceutical lawsuits are now turning their attention to the food industry, and predicted that “these kind of [health claims] are going to explode.” He added that the Yo-Plus case was “pretty unusual” in that it wasn’t prompted by an investigation by the FDA (Food and Drug Administration) or the FTC (Federal Trade Commission). “Usually you see a warning letter rapidly followed by a class action piggy-backing off of that.”

Class Action Lawsuits Set to Explode in Health Claims Arena” was published by NutraIngredients-USA.com, April 1, 2011.

Defeating a Consumer Fraud Putative Class Case Early

Last week at the DRI products liability conference in New Orleans, Lara White from Adams and Reese and I presented "Regulatory Compliance Alone Is Not Enough: Understanding and Mitigating Consumer Fraud Claims." Our presentation dealt with putative class claims aimed at the marketing and labeling of food products. A link to the slide-deck can be found here. A link to the paper we submitted at the conference can be found here.

In our presentation we discussed the kinds of consumer fraud claims that have been litigated recently against the food industry and what can be expected going forward.

We also discussed effective strategies for defeating putative class claims at the earliest possible stage. While some preemption arguments in a limited number of cases may still be viable, lawyers and clients should be aware that preemption defenses are eroding. Even when a preemption argument appears to be on ”all fours” it may be worth focusing instead on a challenge to the plausibility of the pleadings.

The U.S. Supreme Court in its Iqbal and Twombly decisions said that a court must disregard conclusory allegations and scrutinize the complaint’s factual allegations to determine whether it nudges the alleged wrong-doing “across the line from conceivable to plausible.” In other words, the complaint must have meat on its bones. In the case of a consumer fraud class complaint, the plaintiffs’ counsel, to survive a motion to dismiss, must include references to evidence or other substantiation for the claim such as consumer surveys or perhaps a government finding. Bare allegations of consumer behavior, nutrition, or damages may be subject to challenge in a Rule 12 motion to dismiss.

Looking for Information and Presentations on FSMA, Recalls and The RFR? Look No Further.

I’ll be speaking at several events over the next two months on the Food Safety Modernization Act (FSMA) and how this comprehensive and far reaching legislation affects the status quo for food companies. Two of these events are free, and all promise to address relevant and critical issues for those involved in the food industry.

a. May 24 at Parker Smith Feek's offices in Bellevue for a discussion of the new FSMA, the Reportable Food Registry and how to survive a food product recall (event was rescheduled from March 22). Registration is free and coming soon. Contact me if you’re interested and I’ll get a spot reserved.

b. April 29 webinar sponsored by AON on FSMA. Link to the free registration is here.

c. May 12-14 Northwest Food Processors Association’s Executive Business Retreat in Coeur d'Alene, Idaho.

d. June 15-16 ACI Food Safety Regulatory Compliance Summit in Chicago. I'll be speaking specifically on "Curtailing Downstream Liability Arising Out of On-Site Inspections: How to Prepare and What to Do Should the Government Come Knocking." If you register by April 15, I can arrange for a discount. Just let me know.

If you can't make these events or would like a customized in-house presentation on FSMA, the Reportable Food Registry, recalls or other food liability topics, please let me know. Also, stay tuned for new blog entries addressing such topics as the Reportable Food Registry (RFR), restaurant menu labeling, and strategies to defeat food marketing/labeling putative class claims.

RAISED RIGHT Trademark Blocks BRASSTOWN BEEF Logo

Note: The following post is authored by guest blogger Anne Glazer.

The Trademark Trial and Appeal Board (“TTAB”) recently affirmed a USPTO refusal to register the following mark for use with beef:



The TTAB said the BRASSTOWN BEEF logo is likely to cause confusion in relation to the word mark RAISED RIGHT, which was already registered for use with poultry, meat and game. It didn’t help that the words “RAISED RIGHT” appear across the top of the BRASSTOWN BEEF logo.

This is yet another case that shows the importance of doing careful trademark clearance work before adopting a new mark or trying to register it.

Thanks to The TTABlog® for reporting this decision. In re Ridgefield Farm LLC, Serial No. 77758560 (February 25, 2011) [not precedential].

Prop 65 Targets Cooked Food, Coffee and Vitamin Supplements

This blog entry was originally written by Lee Smith from the California Environmental Law Blog.

The Industry Acrylamide Coalition (Coalition) filed suit against the State of California Office of Environmental Health  Hazard Assessment (OEHHA), the agency that manages and revised the Prop 65 list to include 4-metheylimidazole (4-MEI), as a carcinogen.  4-MEI is often found in cooked foods. The Coalition argues that the third party report on which the listing was based, from the National Toxicity Program (NTP), is insufficient to support a valid Prop 65 listing.  The complaint, which was filed in Sacramento, alleges that OEHHA failed to consider the entire file of evidence before making its decision.  The Coalition’s complaint also indicates that 4-MEI is created during normal cooking of food and ingredients and cannot easily be removed.  The Coalition includes the American Beverage Association, the California League of Food Processors, and the Grocery Manufacturers Association of USA.

Acrylamide – In Your Coffee?

In a similar manner, the National Coffee Association is coordinating the joint defense of a number of coffee roasters and retailers with respect to a 60-day notice served on 40 roasters.  The chemical at issue is acrylamide, which is formed when certain proteins are heated.  Original scrutiny for this chemical concentrated on potato products such as french fries, but apparently the same chemical reaction occurs in coffee when it is roasted.  In addition, other beverages that also contain caffeine, such as soft and energy drinks, have also received 60-day notices.

Dietary Supplements and Prop. 65

A dietary supplement company has been ordered to pay 2.65 million as part of a joint settlement with district attorneys in California.  This is one of the larger suits filed and settled by a public enforcement entity, other than the California Attorney General.  People v. Irwin Naturals, Inc., Orange County Superior Court, Case No. 30-2011-00445453.

Irwin Naturals was alleged to have made false and misleading representations with respect to the marketing and sales of its products.  The products were advertised as having Hoodia Gordonii, an alleged appetite suppressant; however, lab results found that the chemical was not present and triggered a mislabeling suit.  Additionally, the suit alleged that many of the products also exceeded the Prop. 65 level of  proposed Maximum Allowable Dose Level (“MADL”) of .5 micrograms/dA1.  Most of the indicated products were green tea products, sold without the Prop. 65 warning as required.

As part of the settlement, 1.95M in penalties were paid to help enforce state consumer protection laws, $100,000 in restitution, and $600,000 in set aside for investigation costs.  Reportedly, prosecutors felt that this prosecution was necessary in part because the FDA does not regulate dietary supplements.

How Regulatory Changes Affect Litigation Risks

On February 24, 2011, Lee Smith and I presented "How Regulatory Changes Affect Litigation Risks" to the Grocery Manufacturers Association's food litigation conference. A link to the slide-deck can be found here.

We discussed ways that the Reportable Food Registry (RFR) and the Food Safety Modernization Act (FSMA) are affecting litigation now and can be expected to affect litigation in the near term.

In particular, we discussed:

  • Ongoing and pending changes to the RFR
  • FSMA’s grant of records access to FDA
  • Mandatory recall authority and how this may delay certain recalls
  • Suspension of FDA registration
  • Hazard analysis and preventative controls: What are they? How do they differ from HAACP? How they will be effective with or without FDA rulemaking
  • Regulation of chemicals under FSMA (and under proposed changes to TSCA and Proposition 65 in California)
  • Specific things that food sellers should consider now to reduce risk

Let me know if your business is interested in an in-house, customized presentation or training on the RFR and FSMA.

Bad Guys Disguised As Good Guys: Labeling and Sourcing Issues at Farmers Markets

One of the first scenes in IFC’s comedy “Portlandia’ involves a couple asking their waitress for the provenance of the chicken they are considering ordering. She comes back with a photograph of “Colin”, the actual chicken, and describes the conditions under which he lived before he died for their meal. Unsatisfied with her answer, they ask her to hold their table while they drive 30 miles to the farm where Colin was raised. Five years later, they reappear (their waitress still holding their table) and decide they’d prefer not to have the chicken.

I thought of that as I read Jim Prevor’s report for The Perishable Pundit on “Farmers Market Fraud”, which included a follow-up as well.  Without question, farmers markets are opening rapidly all over, and it is not particularly surprising that some of the participants are not following the rules, leaving the honest participants with a bad name and consumers with legitimate concern that they are not getting what they bargained for in their farmers market experience. Apparently, similar research in Detroit indicated the same pattern as in Los Angeles.

 

In the spirit of the kind of people parodied on “Portlandia,” weren’t these supposed to be the good guys?

 

As it happens, I am related (by marriage, but we are far closer friends than the degree of relation) to Jennie Schacht, the author of the award-winning “Farmers Market Desserts.” In researching her book, Jennie visited farmers markets all over the country, and, she tells me, “I never had a producer refuse a visit to their farm and what I saw every place I visited, around the country, appeared authentic. (I didn't verify pesticide levels or other claims.).” For her work, of course, she needed to take the steps that Fred and Carrie parodied on “Portlandia.” What is the ordinary, non-cookbook author, non-obsessed consumer to do?

 

California is considering steps to deal with this issue, including raising the fees charged to farmers market participants from 60 cents to four dollars per market day, in order to increase the number of inspectors. One critic of the raised fee contends that dollars will not necessarily increase expertise. While Jennie Schacht suggests getting to know your producer can help, one of the letter writers to the Perishable Pundit notes that Bernie Madoff looked all his victims in the eye as well. 

 

In the end, I think the best regulation would occur by self-policing. This is not some free market solution, but rather a recognition that every honest seller in the marketplace has an incentive to weed out the bad apples, in this case sometimes literally. I recognize that farmers who attend farmers markets have a lot to do in the course of a day, and policing their neighbors’ stalls isn’t on their agendas. Market managers have a lot of work to do as well. But it is the honest farmer who will lose most if the reputation of farmers markets in general are diminished. 

 

Other, of course, than someone like me, who is already in mourning because the last of the year’s organic carrots have disappeared from the Ballard Farmers Market.

Why CSPI's Loyalty Card Suit Has No Merit and Does Not Promote Food Safety

Following the playbook it has followed in the past with sodium and other issues, the Center for Science in the Public Interest (CSPI) has filed yet another complaint of very questionable legal merit to promote a policy agenda. This time CSPI seeks to compel all retailers to use loyalty cards as a recall alert system.

Some retailers use their loyalty card systems to alert customers of product recalls. Other retailers do not. Retailers who don't use loyalty cards as a recall alert system may have a variety of legitimate reasons why they don't or can't create the technology that CSPI wants a court to order retailers to implement. For example, some may lack the technological ability, have privacy agreements with customers that do not allow loyalty cards to be used as a recall alert system, or have other legitimate privacy concerns.

Like CSPI's sodium litigation, this complaint has serious flaws. It seeks broad certification of a "nationwide class" of customers who bought recalled products and whom the retailer "did not advise that they had bought Recalled Products." Even supposing that the claims had some legal merit, few "common issues of fact and law" are apparent. State law varies on the type of consumer fraud claims asserted. Some putative class members surely did get notice of the recall (through means other than loyalty cards).

On the merits, the claims are problematic because we suspect that many (and perhaps most) jurisdictions do not recognize a retailer’s affirmative duty to create some technology to alert customers of manufacturers’ recalls. The complaint utterly fails to acknowledge that retailers employ mechanisms other than loyalty cards to assure customers are aware of recalls.

On its face, a claim for breach of the warranty of merchantability is completely incongruent with a request that the court order retailers to employ new technologies. And, a loyalty card is not a good subject to the warranty of merchantability.

What might be most shameful about CSPI's complaint is its conflict with the Food Safety Modernization Act (FSMA), which CSPI purports to support. Section 211 of the FSMA modifies the Reportable Food Registry to enhance consumer notification of Class I recalls by grocery stores. FDA is tasked to, "[n]ot more than 1 year after the date of enactment of the [FSMA,] . . . develop and publish a list of acceptable conspicuous locations and manners" for grocery stores to notify customers of Class I recalls. CSPI (as well as anyone else) will have the opportunity to submit comments to FDA as part of the rule-making process.

Even if CSPI were somehow successful in its litigation, the outcome of the litigation may be supplanted or even in direct conflict with the FDA's rulemaking and the FSMA. Litigation is rarely a productive, efficient or useful way to create industry regulation. Litigation in the wake of legislation creating the actual policy that CSPI seeks to promote seems utterly wasteful and counterproductive.

Beyond Statistics: What the FDA's RFR Report Means for Food Manufacturers

Last week, the FDA issued its first annual report on the Reportable Food Registry (RFR). The report provides statistics on the first year of the RFR (2240 entries, 229 "primary reports," a breakdown of the report by hazards, etc.).

Beyond the statistics, the FDA report should be noted by food companies for two reasons:

  1. Food Safety Plans

FDA Deputy Commissioner for Foods Michael Taylor says that “[s]everal key U.S. industries are already re-evaluating their hazard and preventive controls, core principles of the Food Safety Modernization Act recently passed by Congress. We also anticipate improved reporting as we continue our vigorous outreach to food facilities through federal, state, local and foreign agencies, to help us expand the positive effect of the RFR on the safety of the U.S. food supply.”

The new hazard analysis and preventative controls requirements in the Food Safety Modernization Act (FSMA) are not effective for 18 months following passage. Deputy Commissioner Taylor's comments suggest that industry standards may already be moving in that direction . To mitigate exposure and risk, FDA enforcement actions, product liability claims, supply chain contract claims and recalls, food manufacturers may want to consider updating and/or creating food safety plans that address the hazard analysis and preventative controls prescribed by the FSMA.

  1. Allergen Controls

The FDA reports undeclared allergens/intolerances accounted for 34.9 percent of the primary reports. Industry experts assert that the FDA believes that the industry does not in general have good control over the issue of undeclared allergens. These experts believe that the FDA will give special attention to the issue of undeclared allergens/intolerances in promulgating regulations under the FSMA's requirements for hazard analysis and preventative controls (see point 1 above). In anticipation of the FDA's concern, manufacturers should consider now how they can change manufacturing processes to address the undeclared allergen issue.

Strategies to Defeat Putative Class Claims Challenging Labeling and Marketing of Food Products

April 8, 2011 – Scott Rickman from Del Monte, Lara White from Adams and Reese, and I will be talking at the Defense Research Institute (DRI) food law break-out. This event is held in conjunction with the DRI annual product liability conference in New Orleans.

Click here for the complete manuscript that we’ve prepared to accompany our presentation. The manuscript summarizes some of the most significant and recent rulings concerning putative class claims arising from labeling and marketing of food products. The manuscript also offers suggestions on possible strategies to defeat these claims.

The type of claims discussed involves small-dollar state law “fraud” claims aggregated over millions of products sold. The common fact pattern is this: plaintiffs challenge the labeling or marketing of a food product, alleging that consumers would not have purchased the product or paid the price they did had they known the “truth” behind the representations made. Often, the plaintiffs’ strategy is to achieve class certification and then leverage the threat of a judgment into a settlement that involves a handsome payment of attorneys’ fees.

Recently, we’ve seen a trend toward legal action for labeling and/or marketing claims of products in the “natural” area and those touting health benefits. In many of these cases, preemption has not been successful to knock out claims in their entirety. State law varies considerably, and this can often work to the advantage of a food company. When that doesn’t work and when a jurisdiction doesn’t require an individualized showing of causation or reliance, here’s an alternative strategy to dismiss claims at an early stage:

  • In states where plaintiffs need not show individualized reliance/causation, they may still have to demonstrate that an objectively reasonable consumer would have been damaged by the marketing/advertising campaign. 
  • The Supreme Court in Iqbal/Twombly said that a court must disregard conclusory allegations and scrutinize the complaint’s factual allegations to determine whether it nudges the alleged wrong-doing “across the line from conceivable to plausible.” The complaint must have meat on its bones. In the case of a consumer fraud class complaint, the plaintiffs’ counsel, to survive a motion to dismiss, must include references to evidence or other substantiation for the claim such as consumer surveys or perhaps a government finding.
  • Without a strong factual basis as to how an “objectively reasonable consumer” might behave, consumer fraud/unfair trade practices putative class claims concerning the marketing of a food product may be in jeopardy.

How the Food Safety Modernization Act Changes the Status Quo

Yesterday (while taking a break from the Sustainable Food Summit in San Francisco), I traveled to Modesto, California to speak to the Manufacturer's Council of the Central Valley. I spoke about the new Food Safety Modernization Act (FSMA).

The focus of my talk was how the FSMA changes the status quo for food businesses. And when I mean changes the status quo, I mean not only what a food company needs to do to comply with the FSMA, but also how the FSMA is likely to affect exposure from recalls and product liability. I also discussed in some detail the dilemmas faced by food businesses and the FDA by the Reportable Food Registry (RFR) and its fallout. Here is a link to my slide deck.

I'm willing to tailor this talk to your company or trade association; just let me know.

Please also consider attending the ABA's Food and Supplements CLE at Coke World Headquarters in Atlanta on February 17. I'll be moderating with Ricardo Carvajal a panel of experts on the FSMA including Robert Brackett (formerly head of CFSAN), Art Liang from CDC, Miriam Guggenheim and Fred Degnan.

At the upcoming GMA food litigation conference in Scottsdale, Arizona, I'll be speaking with my law partner Lee Smith about specific strategies and action steps to take to reduce the increased risks from FDA compliance, and recalls and product liability exposures created by the FSMA and the RFR. We'll also touch on strategies to deal with some current trends in marketing and labeling putative class claims.

Plaintiffs Question "Carbon Negative" Water

The Fiji Water Company has attracted the attention of plaintiffs lawyers with its “carbon negative” bottled water.  The Newport Trial Group, a law firm representing California consumers, sued Fiji Water last month, arguing that Fiji’s carbon offset claims are deceptive and misleading.  The complaint against Fiji Water argues that the product is not necessarily carbon negative because Fiji’s offsets are premised on a speculative carbon offset method that “may or may not happen in the future.” 

According to the California consumers, Fiji’s carbon offsets are misleading because they  rely on “forward crediting,” a method of accounting for carbon offsets based on future offsetting activities.  The complaint explains that this method of carbon offsetting is unreliable and speculative according to the Stockholm Environment Institute, an independent scientific think tank.  

Fiji claims that its products are “carbon negative,” based on the purchase of carbon offsets equal to 120% of the company’s carbon emissions.  Even if Fiji can prove that its carbon offsets will ultimately meet that goal, expect the plaintiffs to argue that the carbon negative claim is still deceiving, on the theory that consumers were not apprised of the fact that offsets will occur in the future.  If Fiji’s future carbon offsets are found to be mismanaged, disorganized, or even false, consumers may succeed in obtaining a substantial judgment at trial, or a cash settlement.

The question of whether Fiji Water has actually deceived consumers will certainly be the focus of litigation in the California proceeding for at least a couple years.  In the meantime, while the Federal Trade Commission’s proposed new Green Guides, released last fall signal increasing federal enforcement against greenwashing, the Fiji Water case is an important reminder that environmental marketing claims may also be challenged by private parties.   

Another interesting aspect of this case is that while the California Consumers do not make reference to the FTC’s new Green Guides, the theory of their case is consistent with FTC policy.  The proposed new Guides tell marketers that they should “clearly and prominently disclose if [their] carbon offset represents emission reductions that will not occur for two years or longer.”  FTC regulations are not California law, but California’s consumer protection statute actually makes reference to the Green Guides, establishing a legal defense for companies if they can prove that their marketing claims comply with the Guides.  

Finally, regardless of how the Fiji water case proceeds, it teaches another valuable lesson.  Whether the claim is for carbon offsets, renewable energy, or another type of green claim, marketers must follow the key principles of clarity and disclosure.  A bare claim is risky –  but clear, concise disclosure can reduce and potentially eliminate that risk.
 

It's Official: The Food Safety Modernization Act Is Law. What Food Companies Need to Do Right Now

President Obama signed into law today the Food Safety Modernization Act (FSMA).

Companies with facilities subject to FDA jurisdiction should  take immediate steps to review and, where necessary, modify SOPs, policies and procedures.

For example, given the FDA's expanded access to business records, companies should set SOPs that anticipate (before a crisis occurs) what records they may have to turn over and what they may not. Food companies should take steps to protect confidential and proprietary information.

Companies also should anticipate now how they need to change their policies and approaches to mandatory recalls and whistleblower protections.

These parts of the legislation take effect today:

  • Stronger records access authority by FDA (FSMA § 101)
    • When FDA determines a "reasonable probability" of "serious adverse health consequences"
    • FDA can access records of other food affected in a similar manner
    • But FDA must show proper credentials and provide written notice
  • Mandatory recall authority (FSMA § 206)
    • FDA can order a recall if it finds a "reasonable probability" that
      1. food is adulterated or misbranded; and
      2. there may be serious adverse health consequences
    • FDA has to provide an opportunity for a voluntary recall
    • FDA will provide an informal hearing within two days of the order’s issuance
       
  • Increased frequency of inspections (FSMA § 201)
    • FDA will immediately increase the frequency of inspections
    • FDA will apply a risk-based approach to determine priorities
       
  • Whistleblower protection (FSMA § 402)
    • Protects employees who:
      • Provide information re violation of FDC Act ,
      • Testify, assist or participate in a proceeding re a violation, and/or
      • Object to "activity, policy, practice or assigned task" they "reasonably believe to be a violation"
         
  • Refused admission of imports if foreign facility refuses inspection (FSMA § 306)
    • Foreign establishments must allow entry to U.S. inspectors within 24 hours of requesting entry
    • Or imported food will be refused admission.

Future blog entries will discuss compliance with other provisions of the FSMA scheduled to be phased-in. If you are interested in a more detailed in-house discussion of the FSMA and its effect on your company, please let us know.

Dannon Forced to Open Wallet and Change Advertising (Again)

Note: The following is posted by David Pacheco from the Essential Nutrition Law Blog.

The multinational food company Dannon agreed to a 45 million dollar class action settlement earlier this year based on consumer complaints about advertising claims regarding the health benefits of its probiotic line of dairy products. Now the company has entered into a $21 million dollar settlement with the attorneys general from 39 states. The L.A. Times reports that this is the largest-ever multistate attorney general consumer protection settlement with a food producer. The attorneys general alleged that Dannon made deceptive and unlawful claims in advertising which were not substantiated by competent and reliable scientific evidence at the time the claims were made. According to the allegations, the majority of scientific studies showed improvement in intestinal transit time when an individual consumed three servings of the probiotic products per day for two weeks, and did not support Dannon's advertised claims that one serving per day for two weeks improved digestive health. In addition, the attorneys general alleged that Dannon could not substantiate claims regarding improved immunity against the flu and common cold.

Dannon also agreed with the FTC to drop claims that the probiotic foods help prevent irregularity and offer protection against the flu and common cold. The FTC found no substantiation of these claims. This isn’t the first time Dannon has had to alter its advertising; the March settlement required Dannon to remove specific language about the health benefits of the products from labels and advertising.

 

Between this and the March settlement, Dannon has now agreed to pay $66 million as restitution for the misleading health claims, which comes out to about 1.3% of Dannon reported $5 billion in worldwide net sales of the probiotic line in 2009. This latest settlement should remind companies to keep state governments on the list of watchful eyes monitoring health claims related to food and supplement products.

FDA Issues Warning on Alcoholic Energy Drinks; States Move to Ban "Blackout in a Can"

Note: The following is authored by guest blogger Jake Storms, from the Alcoholic Beverages Law Blog.

Amidst rising incidences of hospitalizations in college and teenage drinkers linked to consumption of alcoholic energy drinks, the Washington State Liquor Control Board banned their sale effective tomorrow, November 18, 2010. The move came on the heels of a request by Washington Governor Christine Gregoire, whose office stated in a November 10 press release that they were “…particularly concerned that these drinks tend to target young people.”

The Liquor Control Board placed the ban in an emergency ruling which will last for 120 days. During that time, the Liquor Control Board will move to make the ban permanent. Liquor Control Board Chairperson Sharon Foster stated, “[t]he Board is acting in the public safety…the Board is acting now to ensure these products do not contribute to a tragedy before the Food and Drug Administration or Legislature can act.” Earlier this year, the Liquor Control Board had lobbied for State legislative action to ban the sale of caffeinated malt beverages in Washington but those efforts were unsuccessful. A list of particular products affected by the Liquor Control Board’s ruling can be seen here.

Washington’s ban is merely the most recent action in an ever increasing movement by states to control the sale of caffeinated alcoholic beverages. The Oregon Liquor Control Commission Chairman stated in an October press release that, “…alcoholic energy drinks should be removed from the market until further research isdone.” The OLCC also stated that it is currently looking into possible regulatory efforts with the state legislature and is reaching out to community organizations to warn them of the dangers of the beverages.

While California’s Department of Alcoholic Beverage Control has not yet made a statement regarding the drinks, Connecticut announced Monday that it had reached agreements with state distributors to voluntarily stop shipments of caffeinated alcoholic beverages starting December 10, 2010. Michigan has banned one particular brand of caffeinated alcoholic beverage, Four Loko. New York has reached an agreement with Phusion Projects LLC, the manufacturer of Four Loko, to stop sales in the state until “…emerging science, regulatory developments or other relevant changes in circumstances arise." Utah and Oklahoma have followed Washington’s lead in banning the sale of any brands altogether. Massachusetts’ Alcoholic Beverage Control Commission stated that it will file an emergency ruling, similar to Washington’s, on Monday, November 22, 2010.

At the federal level, the Food and Drug Administration (“FDA”) is currently reviewing whether caffeine is a safe additive to alcoholic beverages. A negative finding would essentially ban the sale of caffeinated alcoholic beverages nationwide. It is widely assumed the FDA will, in fact, reach a negative finding. NY Senator Chuck Schumer, who has been lobbying for a ban on the drinks, stated that the FDA decision “…should be the nail in the coffin of these dangerous and toxic drinks.” The FDA decision is expected within the week.

More on FOP Labeling

Here's a link to an article that appeared recently in Inside Washington's FDA Week concerning the issue of front-of-package labeling (FOP). The article takes aim at the debate about state vs. federal regulation of FOP labeling. Here's a link to a recent post in this blog on the FOP issue.

Food Safety Tools and Defenses for Cheesemakers

Cheesemakers have endured a string of bad publicity recently over food safety. Cheesemakers, especially raw milk cheesemakers, are in the cross hairs of the FDA, the media, retailers and plaintiffs’ lawyers such as Bill Marler. I was interviewed last week on FDA seizure issues by the Pacific Northwest Cheese Project. Click here for the PowerPoint slides from my presentation to the American Cheese Society's annual meeting last August entitled "Product Liability - Protect Yourself and Protect Your Business."

Can Business Lawyers Afford to Practice "Defensively"?

I appreciate why lawyers practice defensively. We are risk adverse as a profession. But is this what our clients want from us? After all, our clients are usually in a risk-taking position when they seek our advice in the first place. In today's business climate, competition in almost ever sector is fierce to say the least. Our business clients are often in the position where they need to innovate, stay ahead of the competition or go extinct. For them, a "blue ocean" strategy is often the only pathway for survival.

Here's a common scenario in the practice of business law: client asks a question or poses a problem to his lawyer. Lawyer responds with a menu of options to solve problem. Lawyer goes through pros and cons of each but backs away from making a strong recommendation (or recommends the most risk-adverse solution). Lawyer feels that it’s the client's choice (which it is) and also wants to avoid blame if the recommendation is wrong (lawyer will be blamed anyway). Client feels dissatisfied because:

a. Client may not share the expertise/experience of his lawyer and wants a stronger recommendation; or
b. Client feels that lawyer may not be interested in really understanding the problem and/or the client's business; or
c. Client feels that lawyer is unwilling to put "skin in the game" and share the risk with the client; or
d. All of the above.

In litigation, defensive practice of law often comes in the form of "scorched earth" discovery and unnecessary motion practice. Attorneys tell their clients that they can't leave a stone unturned to prepare the case for trial (though they might not have a clue as to their trial strategy). Lawyers tell their clients that they can forgo the deposition but it's "risky." Although the lawyer advises the client that failure to conduct expensive discovery practice is "risky," the lawyer may be reluctant to help quantify the risk for the client. And if the lawyer is paid hourly, little incentive exists for the lawyer to make hard decisions in litigation as to what's necessary to try the case and what may not be. So the end result may be bloated fees and a disgruntled client (and often a bad result).

As outside counsel, we need to ask why clients hire us. Do they hire us to prescribe multiple choice solutions without a real recommendation or a path of scorched-earth litigation? Or do our clients hire us because (1) we have expertise, creativity and time that the client may not have in house and (2) the client expects us to solve its problem? With the legal monopoly threatened (look no further than the dramatic changes in professional rules in Great Britain), don't we have to provide clients the service they want? Your comments and thoughts are most welcome.

Multiple Occurrences in a Single E.Coli Outbreak: Double-Edged Sword for Insureds?

Marler Clark clients and the owners of the restaurant that sold MarlerClark's clients food they claim was contaminated with E.coli O111 joined forces against the restaurant's insurer. In the end, the peronsal injury plaintiffs and the restaurant insured convinced the United States District Court for the Northern District of Oklahoma  on a Rule 56 summary judgment motion that a single E.coli outbreak constituted at least two separate "occurrences" under a commercial general liability insurance policy ("CGL") issued to the restaurant. The result was another $1 million in coverage available to pay claims. A copy of the court's opinion can be linked here.

The primary policy at issue limited the amount of insurance available to $1 million per occurrence ($2 million products-completed operations aggregrate). According to the court, the policy defined an "occurrence" as “an accident, including continuous or repeated exposure to substantially the same general harmful conditions.” According to court's summary of the state health department's findings, the outbreak at issue included 341 persons, 60 confirmed, and 94 probable. The "point source outbreak" was from the Country Cottage restaurant. Though 21 persons did not dine at the restaurant, they were believed to be exposed at a church tea catered by the restaurant.

The court concluded that under Oklahoma law there are "two distinct places of injury and thus, two separate occurrences." The court explained that:

Looking for “the same temporal and spatial parameters” of an occurrence, the Court finds that the undisputed facts at least establish two separate occurrences of E. coli-induced illness covered under the policies: that resulting from the negligent contamination of food prepared and served at the Country Cottage restaurant and that resulting from the negligent contamination of food prepared and served at the Church Tea. Regardless of any temporal overlap between these two occurrences, the geographical distinction between the physical location of Country Cottage restaurant in Locust Grove, Oklahoma, and that of the Free Will Baptist Church in Broken Arrow, Oklahoma where the Church Tea took place is appreciable and, appreciatively, concrete.

For MarlerClark clients and the injured plaintiffs, the end result is another $1 million available to settle their claims. But is this a good result for the restaurant owners? The answer is maybe. Insureds should understand that the result may be a double-edged sword. On the one hand, another $1 million in indemnity is available to protect the owners' personal assets. On the other hand, if the insured had a large deductible or self-insured retention ("SIR"), two occurrences could mean two deductibles or two SIRs that need to be paid by the insured.

So why would an insured ever have a high deductible or SIR? The answer is that many food manufacturers and retailers maintain a high deductible or SIR in order to control the defense and settlement of the case and not hand over control to the insurer at the outset. Often, the insured's objective is to resolve the case in a way that best protects the client’s business and brand going forward. A conflict with the insurer arises because the insurer's objective is to resolve the case for the fewest dollars possible (combined payment of defense costs plus indemnity paid to the allegedly injured consumer).

Listeria Recall Toolkit

The FDA recently took the relatively unusual step of obtaining a court-issued warrant to seize all cheese products at Estrella Family Creamery, a small, family-owned artisan cheese maker in Washington State. According to the United States Attorney's Office for the Western District of Washington, "the FDA asked Estrella to recall all cheese products. The company refused." The FDA requested the recall after both products and the manufacturing environment at Estrella tested positive for Listeria. A copy of the FDA form 483 report immediately pre-dating the recall request is here.

As the Estrella situation illustrates, the FDA is not just focused on large-scale manufacturing. As the FDA and USDA move to more risk-based allocation of resources, they are increasingly concerned about smaller operations and retail. Below are issues any food manufacturer must tackle when it comes to Listeria (much of this also applies to other food-borne pathogens).

What is Listeria?

Listeria monocytogenes is a bacterium that causes listeriosis, which primarily affects persons of advanced age, pregnant women, newborns, and adults with weakened immune systems. Though it affects only a small portion of the population, Listeria is the most deadly food-borne pathogen in the United States, killing 20-30% of all those who become seriously ill.

What should you do if your product tests positive for Listeria?

Assemble your well-rehearsed crisis management team immediately if a product tests positive (or if a regulator believes that your product may be contaminated). Members of the crisis management team; food safety personnel; company executives; and representatives from accounting, legal, supply chain, sales and customer service all are essential in the decision making process below.

Can you trace back and isolate contamination?

Quality assurance and food safety personnel need to answer trace-back issues as soon as possible. Can you determine the source of the contamination? Is it limited to one lot or a single day of production? How often are production facilities sanitized? How often are production surfaces swabbed for Listeria? Does the production facility re-use contaminated product from shift to shift?

Will you have to issue a recall?

Both the FDA and USDA lack mandatory recall authority. Though, as Estrella learned, the agencies do have the bully pulpit and the ability to get a court order to seize products. Because of the high mortality rate, regulators (federal and state) take any positive Listeria test result in food products extremely seriously.

If the food is considered a ready-to-eat product (RTE), a positive Listeria test will almost invariably lead to the FDA or USDA requesting a class I recall.

Even for a non-RTE food, a positive Listeria test will lead to a requested recall. If the agencies believe that the cooking instructions are clear, are easily followed by consumers and, if followed, will kill the bacterium, then the recall may be considered class II.

A primary difference between class I and II is that the class I recall will result in much greater publicity. For FDA-regulated facilities, a class I recall also triggers reporting and notification requirements under the Reportable Food Registry (RFR).

What does the Reportable Food Registry require?

RFR requires FDA-registered facilities to report to the FDA portal within 24 hours when there is a "reasonable probability that an article of food will cause serious adverse health consequences." As part of the report, information must be submitted "one step back and one step forward" in the supply chain. Once a report is submitted, the FDA will promptly alert your customers of the "reasonable probability" that your product will result in "adverse health consequences or death." If suppliers and customers are also FDA facilities, the FDA will also pressure those companies to report to the portal.

The ticking of the RFR's 24-hour reporting deadline forces a company to make snap decisions that might affect its entire business. While RFR reports can be amended or withdrawn based on new information, in the world of food products, the bell can almost never be unrung. A more lengthy discussion of the RFR can be found here.

How do you marshal your case with the regulators?

Assuming that you have information showing that contamination is limited (or non-existent), how do you convince the regulators? The FDA and USDA’s concern is public health (and politics). The regulators’ concern is not for your business.

Providing information to the regulators in a manner they perceive as credible, prompt and transparent is critical. Once the regulators lose confidence in your company's credibility and competence, the game may be over. In most cases, the most effective way to marshal your evidence is a well-prepared and credentialed crisis management team (e.g., food safety, quality assurance, supply chain, accounting, sales, legal, media, etc.).

Front of Package Labeling Claims Survive Motion to Dismiss

A recent decision held that Front of Package (”FOP”) labeling claims may not (yet) be subject to federal preemption. The decision in a putative class action, Chacanaca v. The Quaker Oats Company, involves what has become a common fact pattern: The FDA says an issue is complex and subject to industry guidance and possibly rule-making (for example, use of the terms “natural,” “wholesome,” and “smart choices”), while a court says the issue may not be complex and may be perfectly within the expertise of the judiciary and jury system.

Federal District Court Judge Richard Seeborg of the Northern District of California dismissed plaintiffs’ state law claims targeting the “0 grams trans fat,” “good source,” “made with whole grain oats,” and “no high fructose corn syrup” declarations on preemption grounds. Yet, insofar as Quaker Oats "seeks a favorable judgment at this juncture on all state claims that focus on the term 'wholesome'; on images of children, nuts, or oats; or the 'smart choices made easy' language or decal," the court denied the motion to dismiss.

The plaintiffs’ challenges to Quaker Oats’ use of the term ”wholesome” and images of the children seem targeted exactly at the claims that were preempted: the trans-fat issue. The court concedes that the FDA has recently indicated its intent to explore rule-making in the area of FOP labeling claims and that the FDA already “has extensively regulated food labeling in the context of a labyrinthine regulatory scheme.” “Nonetheless,” according to the court, ”plaintiffs advance a relatively straightforward claim: they assert that defendant has violated FDA regulations and marketed a product that could mislead a reasonable consumer. As courts faced with state-law challenges in the food labeling arena have reasoned, this is a question ’courts are well-equipped to handle.’”

Are the plaintiffs’ claims really that straightforward? How is a court "well-equipped" to determine the meaning of ”wholesome,” ”natural,” or other FOP claims? Is a court able to fully consider comments and information from all corners of the food manufacturing world? Isn’t this really in the wheelhouse of the regulators (or possibly the legislators)? Can the food business in the United States function effectively with individual courts and states determining their own common law (or even statutory) rules for product labeling?

FTC Green Guides, Sustainability & Third Party Certification

Our previous blog entry discusses last week's release of the Federal Trade Commission's ("FTC") revised, proposed "Green Guides" generally, discussing how the FTC is focused on "deception" and is not taking a radical departure from the 1998 version (the last version) of the Green Guides. But under the new Guides what are the consequences of the FTC's position on sustainability and third-party certification, especially as it relates to food products? The bottom line is that marketers of sustainable food products should re-evaluate (1) what sustainability claims are made and (2) the benefits of proper third-party certification.

The FTC, in its commentary to the revised, proposed Green Guides, reports that it "is unable to provide specific advice on sustainable as an environmental marketing claim. Unlike other claims we tested, the term contains no cue alerting consumers that it refers to the environment."

Yet the FTC acknowledges that sellers of food (and non-food) products are using the term “sustainable,” and consumer awareness of sustainability issues is growing rapidly. The FTC seems to be leaving itself room for action against marketers of "sustainable" products if it’s clear that consumers are meant to believe that “sustainable” is an environmental marketing claim. And, as discussed in our previous entry, marketers need to be wary of compliance with not only the FTC but also state consumer protection laws, which often reach further than federal law on the marketing of food products.

FTC has also chosen for the first time to address in the Green Guides what it calls "Certifications and Seals of Approval." FTC makes clear that "It is deceptive to misrepresent, directly or by implication, that a product, package, or service has been endorsed or certified by an independent third-party." And, even
"third-party certification does not eliminate a marketer’s obligation to ensure that it has
substantiation for all claims reasonably communicated by the certification."

Food manufacturers and retailers who use a seal or logo to designate sustainability should evaluate whether the seal or logo could be read by the FTC, a consumer or a plaintiff’s lawyer to imply third-party certification or endorsement. In other words, if independent third-party certification isn't used, you should ask yourself the following questions:

  1. Is it clear to anybody reading your label (FTC, consumers, plaintiffs, bar, etc.) that the claim is only your claim and not a third-party claim?
  2. Do you have substantiation (i.e., science) to back up any claims of environmental sustainability (whether yours or a third party’s)?

If you as a food manufacturer or seller can't answer both questions affirmatively, your marketing may be a liability. The SC Johnson Company, for example, is the subject of a consumer class action alleging that the company's own "greenlist" certification program was deceptive. Often, the realistic choice may be a) not to market the product as environmentally sustainable or b) to switch to a substantiated third-party certification.

For food, your best choice may be Food Alliance certification, which is now the most comprehensive certification for sustainable food and the gold standard.*

*In the interests of full disclosure, I serve on the non-profit Board of Directors for Food Alliance and am a staunch advocate of the organization.

Juicy Jurisprudence: FTC and POM Wonderful File Suits

Over the last several weeks, the Federal Trade Commission (the “FTC”) and POM Wonderful LLC (“POM”), the makers of POM Wonderful 100% Pomegranate Juice and POMx supplements, have been engaged in a battle over the scope of the FTC’s authority to regulate advertisements and the propriety of claims POM has made in marketing its products.

After initially being placed on the defensive by a warning letter from the Food and Drug Administration (the “FDA”) in February, POM has taken an offensive approach by suing the FTC for declaratory relief, asking that the FTC’s standard for non-deceptive advertising be held invalid. Further, POM has asked the Washington D.C. District Court to find that the FTC overstepped its authority in defining what constitutes “substantiation” of health-related claims in recent consent agreements with Nestle Healthcare Nutrition, Inc. and Iovate Health Sciences, Inc. In those cases, the FTC alleged that Nestle and Iovate had engaged in deceptive trade practices in contravention of the FTC Act by falsely advertising the health benefits of their various products. As we have blogged previously (here and here), POM has been fairly active in the past year in pursuing its legal remedies, the two prior instances being Lanham Act claims.

On September 27, the FTC responded, alleging in its suit against POM that the advertisements for the company’s 100% Pomegranate Juice and POMx supplements contain false and unsubstantiated claims regarding the ability of the products to treat or prevent heart disease, prostate cancer, and erectile dysfunction. Interestingly, the FTC has proposed a settlement to POM, with one of the conditions being that POM receive FDA approval for any advertisements that claim its product “cures, prevents, treats, or reduces the risk of any disease.” Thus far, POM has stood by its research behind its health claims, making this an interesting set of cases to follow moving forward.

Litigation Strategies for Responding to Significant Consumer Threats

I've been invited to speak this Friday at the University of Oregon School of Law's symposium entitled "Cultivating Our Future: New Landscapes in Food and Agricultural Law and Policy" as a part of the "Food for Thought - Strategies for Advocacy" panel.

I'll outline a series of tools food lawyers can and should use to assist their clients in responding to significant consumer claims. I'll explain:

1. How a client can determine whether a claim has merit,

2. What should be done the moment any significant claim is received,

3. The importance of determining a trial strategy at the earliest possible moment, and

4. The three types of consumer claims seen most often and how to respond to each.

An advance copy of my slide-deck can be found here.

Aurora Dairy Organic Milk Case: Eighth Circuit Preempts Some Claims And Remands Others

As we reported some time ago, a class action suit was pending in the Eastern District of Missouri against Aurora Dairy, its organic certifier and certain retailers for violation of state consumer protection laws. The district court had dismissed the case on the grounds that all claims were preempted by the Organic Foods Production Act of 1990 (OFPA), and the plaintiffs appealed to the court of appeals for the Eighth Circuit. On September 15, the Eighth Circuit affirmed the dismissal of some of the claims and remanded the remaining claims to the district court.

Nineteen class action suits across the nation had been consolidated into a single action in the Eastern District of Missouri. In a consolidated class action, the plaintiffs made claims against Aurora Dairy Corporation, a certified organic dairy located in Boulder, Colorado, QAI, Inc., a certifying agent under the National Organic Program administered by the USDA, which had certified Aurora’s milk as organic, and certain retailers who had sold Aurora’s milk under Aurora’s brand as well as under their own store brands. A total of 57 counts were brought against the several defendants, on theories ranging from violation of state consumer protection laws to violation of implied warranties under the Uniform Commercial Code to unjust enrichment and negligence per se. The district court dismissed all the claims on the grounds of so-called “conflict preemption”, where allowing states to regulate an area would conflict with Congress’s regulation scheme.

The Eighth Circuit agreed with the conflict preemption analysis as it related to QAI, the certifying agent, which was dismissed from the case in full, and as it related to the labeling of the products as “organic” based on the certification by QAI.

To the extent the class plaintiffs, relying on state consumer protection or tort law, seek to set aside Aurora’s certification, or seek damages from any party for Aurora’s milk being labeled as organic in accordance with the certification, we hold that state law conflicts with federal law and should be preempted.

The court of appeals disagreed, however, with the district court on other claims, stating,

Preempting state law claims unrelated to the decision to certify, and certification compliance, does not advance the purpose of establishing national standards for organic foods. Nor does preemption of the facts underlying certification advance the goals of assuring consumers that organics meet a consistent standard, or in facilitating interstate commerce in organics.

The court remanded the case to the district court to determine, based on the standards in its decision, which claims would survive against Aurora and the retailers. This was due in part to the district court having not decided, on the grounds that it was moot, motions by the defendants to strike the consolidated complaint and by the plaintiffs’ motion to the amend it. Thus, the district court’s first task would be to decide those motions before it can determine what claims, if any survive.

Peeled, Inc. Seeks Injunction, Damages in Trademark Infringement Suit Against Peeled Fruit LLC

Originally posted on the Essential Nutrition Law Blog by Jonathan Stagg

Peeled, Inc. (“Peeled”) www.peeledsnacks.com, a company specializing in healthy, natural snack foods including dried fruits and dry roasted nuts, recently filed a trademark infringement suit in the United States District Court for the Southern District of New York against Peeled Fruit LLC (“Peeled Fruit”) www.simplypeeled.com.  Peeled Fruit sells frozen soft-serve fruit, with fresh fruit toppings. Peeled alleges that Peeled Fruit is attempting to cash in on the brand awareness and goodwill associated with Peeled’s marks.  

Peeled began marketing its products under the marks “Peeled,” “Peeled Fruit,” and “Peeled Snacks” as early as 2004. Since that time, Peeled’s marks have received extensive coverage in television and print media, including receiving a coveted spot on Oprah’s O List as one of Oprah’s favorite afternoon snacks, and receiving the 2008 “Best of Food” award from Health Magazine. Peeled registered the mark “PEELED SNACKS” on January 10, 2006 with the United States Patent and Trademark Office.
 
Peeled alleges in its complaint that long after it began marketing its products with the Peeled marks, Peeled Fruit began infringing on the marks by using the words “Peeled” and “Simply Peeled” in its marketing materials. Peeled argues that Peeled Fruit sells similar products with similar ingredients, and that as a result the products are confusingly similar. Peeled claims that Peeled Fruit had full knowledge of Peeled’s prior use of the marks, and that in spite of Peeled’s requests, Peeled Fruit has refused to cease its use of the marks.
 
231Peeled alleges that Peeled Fruit not only knew about Peeled’s use of the marks, Peeled Fruit “adopted the trademarks with the intent to trade and capitalize on the goodwill generated by Peeled, Inc.’s extensive and widespread use of its trademarks, as well as its extensive sales, advertising and consumer acceptance and recognition.” Peeled argues that the similarities between the products sold by both companies make the shared use of the marks likely to cause confusion, mistake and deception among consumers.
 
As a result, Peeled is seeking an injunction against Peeled Fruit, which would restrict Peeled Fruit from further use of the marks. Peeled is also seeking a monetary damage award, under federal trademark law (15 U.S.C. § 1117), in an amount equal to either 1) three times the amount by which Peeled was damaged by the alleged infringement, or 2) three times the total profits Peeled Fruit obtained from the use of the allegedly infringing marks.  Finally, Peeled is seeking an order from the court, under 15 U.S.C. § 1118, requiring Peeled Fruit to destroy all materials that display the allegedly infringing marks.

A Tale of Two Orders

Two recent court orders in motions to dismiss consumer fraud class actions illustrate the fine lines that exist in the analytical process courts engage in when determining whether or not a claim may continue forward.

In Zeisel v. Diamond Foods, Inc., the U.S. District Court for the Northern District of California denied Diamond Foods' motion for dismissal of the plaintiff’s claims. The complaint alleged that the plaintiff and other consumers in the class purchased the company’s shelled walnut products based on false claims of health benefits that consumption of the omega-3 fatty acids in walnuts provides. The complaint alleged (1) unfair competition, (2) false advertising, (3) violation of California’s Consumers Legal Remedies Act and (4) unjust enrichment.

Diamond Foods moved for dismissal on the basis that the plaintiff’s claims were preempted by the Federal Food, Drug and Cosmetic Act (the “FDCA”), as amended by the Nutrition Labeling and Education Act (the “NLEA”). The court found that the plaintiff’s claims were not expressly preempted on the plain language of the NLEA’s preemption clause, and further that the plaintiff’s unfair competition claims were based on California’s Sherman Food, Drug and Cosmetic Law, not the FDCA. The court also held that the plaintiff’s claims were not impliedly preempted, as Congress expressly stated its intent that the NLEA was not to be construed to preempt any provision of state law, unless such provision is expressly preempted under section 403A of the FDCA. As such, the plaintiff’s claims were allowed to move forward.

However, in Loreto v. Procter & Gamble, the background and core issues of which we blogged about here and here, the U.S. District Court for the Southern District of Ohio granted Procter & Gamble’s motion for dismissal, and dismissed the plaintiffs’ claims with prejudice. The plaintiffs alleged that Procter & Gamble violated consumer fraud statutes in New Jersey and all other states and the District of Columbia through false and misleading advertising practices involving Vick’s DayQuil Cold and Flu Symptom Relief Plus Vitamin C and Vick’s NyQuil Cold and Flu Symptom Relief Plus Vitamin C.

The court initially held that the plaintiffs, residents of New Jersey, lacked standing to pursue any claims under any state consumer protection statute other than that of New Jersey. Next, the court agreed with Procter & Gamble’s contention that despite presenting their cause of action in the form of a claim under the consumer protection statutes of New Jersey and other states, the plaintiffs’ cause of action was in actuality an improper attempt to assert a private right of action under the FDCA. Finally, the court held that even if it were to assume the plaintiff’s claims were not an improper attempt to assert a private right of action under the FDCA, the plaintiff’s claims merited dismissal as the alleged no actual injury, failed to allege causation, and otherwise failed to assert other essential elements of the individual state consumer law causes of action. The court, holding that the plaintiffs had ample opportunity to amend their complaint on notice of Procter & Gamble’s positions and failed to address the pleading deficiencies in their amended complaint, ultimately found that dismissal with prejudice was warranted.

"I Can't Believe It's Not Implausible" - Iqbal/Twombly Doctrine Does Not Result in Dismissal of Yumul Claims

As our own Ken Odza recently blogged, the plausibility pleading standard articulated by the Supreme Court in the Iqbal and Twombly cases resulted recently in the FRCP 12(b)(6) dismissal of misrepresentation claims against Unilever. That ruling seemed to indicate that consumer fraud claims would be vulnerable to motions for dismissal. However, in an order granting in part and denying in part the defendant’s motion for dismissal in Yumul v. Smart Balance, Inc., the U.S. District Court for the Central District of California did not apply the plausibility pleading standard as stringently as the court in the Unilever decision, lending some question as to precisely how far Iqbal and Twombly will reach.

In Yumul, the plaintiffs alleged Smart Balance violated the California Unfair Competition Law, False Advertising Law, and Consumers Legal Remedies Act. These exact same violations were alleged in the Unilever case. In Yumul, the plaintiffs alleged that Smart Balance misled consumers with its marketing of Nucoa margarine as “cholesterol free” and “healthy,” despite the presence of artificial trans fat in the product.

In addressing Smart Balance’s motion for dismissal, the court noted the plaintiffs’ reliance on the delayed discovery exception in support of its assertion that tolling of the statute of limitations was appropriate. Stating the applicable law, the court offered that:

A plaintiff whose complaint shows on its face that his claim would be barred without the benefit of the discovery rule must specifically plead facts to show (1) the time and manner of discovery and (2) the inability to have made earlier discovery despite reasonable diligence. The burden is on the plaintiff to show diligence, and conclusory allegations will not withstand demurrer.

In its order, the court directed the plaintiffs to specify the manner of discovery (how and when the plaintiffs actually discovered the fraud or mistake) within 14 days of the July 30 order in an amended complaint. The court denied Smart Balance’s motion to dismiss on all other grounds. While this is no guarantee of success for the plaintiffs by any means, the decision of the court not to dismiss the allegations in Yumul on the basis of the plausibility pleading standard under Iqbal and Twombly stands as an example of the type of inconsistency we may see as courts attempt to apply the standard. We will continue to closely follow this case.

Product Liability - Protect Yourself and Your Business

This is the title of a presentation I'll be giving at the American Cheese Society's (ACS) annual meeting in Seattle. I'll be speaking along with Marc Baker and Jill Perucca from the Elliott, Powell, Baden & Baker insurance agency at 3:30 p.m. on August 27. The slide deck I intend to use can be found here.

Michael Pollan and Laurie Demeritt keynote the ACS event that unites the nation's cheese makers in the Emerald City for four days (August 25-28).

Equally as compelling as the keynotes (and our presentation on product liability avoidance) will be presentations by other Stoel Rives lawyers:

Anne Glazer on Trademarks: The Legal Perspective on the Care and Feeding of Your Brand (1:30 p.m. on August 27); and

Peter Serrurier and Ryan Steen on Water, Water, Waste Water Everywhere (10 a.m. on August 27)

If you are at the ACS conference and can pull yourself away from the concurrent presentations on various cheese making topics, stop by and meet  the best food business lawyers in the Pacific Northwest.

The Show Goes On: USDC Allows Vitaminwater Lawsuit to Proceed

In an opinion issued on July 21, 2010, Judge John Gleason of the United States District Court for the Eastern District of New York largely denied the defendant’s motion for dismissal and held that 10 of the 13 claims in a class action suit brought against Coca-Cola for alleged unlawful health claims on its Vitaminwater drinks could proceed. The claims that still must be examined in court include allegations of misleading advertising, fraudulent business acts, and unfair methods of competition.

The plaintiffs in the class action, which include the health advocacy group Center for Science in the Public Interest (“CSPI”) as co-counsel, contended that Vitaminwater’s labeling and marketing is misleading because it (1) communicates a number of purported health benefits (including healthy joints, optimal immune function, and reduced risk of chronic disease), drawing consumer attention away from the significant amount of sugar (33 grams per bottle) in the product; (2) portrays Vitaminwater as healthy when it is essentially a snack food that provides nutritional benefits because it has been specifically fortified to do so; and (3) suggests that Vitaminwater contains nothing but vitamins and water.

While the court concluded, citing applicable Food and Drug Administration (“FDA”) rules and commentary, that sugar was not a “disqualifying nutrient” under applicable FDA regulations, the plaintiffs’ latter two claims were found to accurately describe violations of FDA regulations, and accordingly may serve as a non-preempted basis of state law liability.

The FDA regulations restricting health claims or implied claims of healthiness related to foods that meet certain minimum nutrient levels, colloquially termed “the jelly bean rule,” were developed in an effort to prevent food producers from encouraging the consumption by consumers of junk food by fortifying the food in question with nutrients. The “jelly bean rule” is applicable only to (1) health claims, and (2) nutrient content claims that use the word “healthy” to suggest that a food may help consumers maintain healthy dietary practices because of its nutrient content. Finding that Vitaminwater’s labeling contains claims in each of these two categories, the court ruled the plaintiffs could proceed with this claim.

The plaintiffs alleged Vitaminwater’s labeling is misleading because it uses a product name that includes two of the product’s ingredients (vitamins and water), but fails to mention another notable ingredient (sugar). FDA regulations on this subject recognize that such product names have the potential to mislead consumers. Thus, the court held that the plaintiffs were allowed to pursue this claim. In the aftermath of this ruling, Coca-Cola released a statement expressing their confidence that the plaintiffs’ claims are without merit and will ultimately be rejected. Given that the implications this case could carry into the growing functional food and beverage segments of the market, we will continue to track it closely.

Regulatory Compliance Alone Is Not Enough: Understanding and Mitigating Consumer Fraud Claims

Click on the image below to view the slide-deck from the presentation that I recently gave with Scott Rickman from Del Monte at ACI’s summit on Food Safety and Regulatory Compliance in Chicago. The ACI summit was a nice introduction to food regulation byFDA, USDA, FTC, EPA and DHS. Our presentation was intended to start from the premise that the job of a food lawyer (whether inside or outside counsel) does not end at ensuring regulatory compliance. Products that are regulatory-compliant may still be subject to putative class claims.



Please feel free to contact me if you have any trouble finding the cases or other references in the slide-deck.

Strategy to Defeat Consumer Class Claims

As we've discussed previously in this blog, the Supreme Court's plausibility pleading standard, as articulated in the Iqbal and Twombly cases often provides a rapid (and relatively inexpensive) pathway to defeat consumer fraud claims.

At the ACI food regulatory conference last week, we discussed a strategy to take advantage of the plausibility pleading standard in jurisdictions that have liberal class certification standards.
In states where individualized reliance or causation is required to make out consumer fraud or unfair trade practices claims, defendants’ first line of attack may be class certification. But where individualized reliance and/or causation is not required, courts will often deny class certification under Rule 23(b) because common issues of law or fact do not predominate over individual issues.

So here's a strategy in jurisdictions where a defeat of class certification may not work:

  • In states where plaintiffs need not show individualized reliance/causation, they may still have to demonstrate that an objectively reasonable consumer would have been damaged by the marketing/advertising campaign. 
  • The Supreme Court in Iqbal/Twombly said that a court must disregard conclusory allegations and scrutinize the complaint's factual allegations to determine whether it nudges the alleged wrong-doing "across the line from conceivable to plausible." The complaint must have meat on its bones. In the case of a consumer fraud class complaint, plaintiffs’ counsel, to survive a motion to dismiss, should need to include references to evidence or other substantiation for the claim such as consumer surveys or perhaps a government finding.
  • Without a strong factual basis as to how an "objectively reasonable consumer" might behave, consumer fraud/unfair trade practices putative class claims concerning the marketing of a food product may be in jeopardy. Defendants should take advantage and seek dismissal at the outset of the case.

Denial of Insurance for Consumer Fraud/Lanham Act Claims: Blaming the Product, Not the Advertising?

UPDATE: For those interested in reviewing the Axis policy discussed in the motion, it can be linked here. 

I'm often asked in my practice about the availability of insurance coverage for claims by consumers or competitors that products are deceptively labeled, marketed or advertised. Those interested in the topic should follow the litigation between Welch Foods, Inc. and its insurers regarding coverage for the putative consumer fraud and the Lanham Act claims asserted against Welch’s over the marketing of its pomegranate-containing juice products.

No rulings have been issued as of yet. But one of Welch's insurers, AXIS Surplus Insurance Company, has taken the interesting position that the "Media Wrongful Act" coverage in its policy provides no coverage. According to Axis's Motion for Summary Judgment, "[i]n a covered Media Wrongful Act claim, the Loss arises from, and is actionable based on, the creation or dissemination of the advertising."

Axis argues that the underlying claims that Welch's marketing of its product created "confusion, deception and mistake in the pomegranate juice market" are not covered under the Media Wrongful Act coverage because "the POM Complaint does not allege that Welch’s liability results from a media liability — i.e., a harm created by the creation or dissemination of Welch’s advertising — but from a liability resulting from the sale of juice which does not live up to such advertising." Axis explains further that "if the product conformed to the standards set forth in the advertisements, the putative class would not have a claim against Welch’s."

How is Axis's reasoning not circular? Can't Welch's argue the reverse in an equally compelling way: That had the putative class or competition believed that the advertising conformed to the product, there would be no claims against Welch's?

Indeed, isn't the counter to Axis's "blame the product argument" more compelling because claims against the labeling of the product itself are subject to federal preemption, and, therefore, they could not be brought by the putative class or the competition? The putative class and competition can ONLY bring claims related to the advertising and marketing.

Dismissal of "I Can't Believe It's Not Butter" Claims: Another Example of Iqbal/Twombly Succeeding Where Preemption Cannot

Judge James Ware dismissed on an FRCP 12(b)(6) motion putative class claims against Unilever alleging violations of the California Consumers Legal Remedies Act , Unfair Competition Law, and False Advertising Law . Judge Ware's decision can be found here. Plaintiff alleged that Unilever misrepresented the ingredients of its butter-substitute product through its advertising and product labeling.

The heart of plaintiff's complaint was Unilever's marketing of the product as "Made with a Blend of Nutritious Oils." Plaintiff alleged that "[t]his message . . . is misleading and deceptive because Defendant's Product contains a highly unhealthy, non-nutritious oil known as partially hydrogenated oil."

Unilever's preemption argument was rejected. The court followed what's becoming a familiar line of reasoning that while federal law governs the labeling of the product, state advertising and marketing claims are not preempted: 

Although the "oils" referred to in the advertisement on the label are the same oils that are subject to the NLEA labeling requirement, the Court finds that there is no inherent conflict in allowing relief under state law with respect to what is said in the advertisement on a label about characteristics of those oils that are not regulated by the NLEA.

Judge Ware dismissed the claims against Unilever on the basis of the plausibility pleading standards articulated by the Supreme Court in the Iqbal and Twombly cases. He ruled that plaintiff's claims concerning the oils were "conclusory" and explained that the "implausibility of Plaintiff's allegations can more readily be seen if the allegations are expressed as a categorical syllogism:"

For the representation "blend of nutritious oils" to be true, all constituent oils
must be nutritious. One of the constituent oils in the product [partially hydrogenated oil] is not nutritious. Therefore, the product representation is false.

The court went on to explain why plaintiff's claims, even if accepted as true, were implausible. The court found faulty the logic underlying plaintiff's complaint about the use of partially hydrogenated oil in the "blend of nutritious oils." The court found that plaintiff's argument suffered from (1) “petitio principii (begging the question)”, (2) the "fallacy of composition" and (3) the "fallacy of division." In short, the Unilever case demonstrates that without a solid scientific and factual basis, consumer fraud claims are frequently vulnerable to attack on an early motion to dismiss (though maybe not for preemption).

Froot Loops Litigation: An Endless Loop for Kellogg's?

Just over forty years ago, Crosby, Stills, Nash & Young came out with their Déja Vu album. Attorneys at Kellogg USA are undoubtedly thinking, “We have all been here before.” 

Froot Loops pre-dated Crosby, Stills, Nash & Young.  I remember taking the Kellogg's factory tour in Battle Creek and being handed an individual-sized packet at the end of the tour, even before they hit the market.  I was seven years old, but I knew they were cereal not fruit.  Apparently, some other people think otherwise.

 

Ken has already blogged about the related, and dismissed, Crunchberry lawsuit.  At the ABA Business Law Section Spring Meeting last weekend, my friend Teresa Harmon Wilton mentioned the Crunchberry case in her annual round-up of commercial law cases, and mentioned that the decision was based on the prior Froot Loops case.  I looked down at my Blackberry, and that's when I realized there was an old Froot Loops case but I had just got notice of a new one. 

 

Two old ones, actually.

 

In 2007, the United States District Court for the Central District of California dismissed a claim against Kellogg USA for violations of various California statutes and common law causes of action based on the claim that Froot Loops do not contain fruit. 

 

In 2009, the United States District Court for the Eastern District of California dismissed a claim against Kellogg USA for violations of various California statutes and common law causes of action based on the claim that Froot Loops do not contain fruit.

 

On April 19, a complaint was filed in the United States District Court for the Northern District of California against Kellogg USA for violations of various California statutes and common law causes of action based on the claim that Froot Loops do not contain fruit.
 

There is clearly a pattern here. I would note that there is only one other federal court district in California, the Southern District in San Diego. Unless I missed a case there.

 

In the McKinniss case, the court dismissed claims for:

In the Videtto case, the court dismissed claims for:

  • Violation of the California Unfair Competition Law
  • Violation of the California False Advertising Law
  • Violation of the California Consumer Legal Remedies Act
  • Intentional Misrepresentation
  • Breach of Implied Warranties

In the Werbel complaint, plaintiff seeks damages for:

  • Violation of the California Unfair Competition Law
  • Violation of the California False Advertising Law
  • Violation of the California Consumer Legal Remedies Act
  • Intentional Misrepresentation
  • Breach of Implied Warranties

Each complaint referenced a study by the Strategic Alliance for Healthy Food and Activity Environments that found that foods it claimed suggested the presence of fruit did not in fact contain fruit. The courts have so far not cared much for this study, which doesn’t in any way demonstrate that anyone could be misled by the actual advertising on the package.

 

Raise your hand if you’re surprised at the fact that the same attorneys brought all three cases. Under our justice system, a plaintiff is not bound by the decision of a court to which he or she was not a party. An attorney is held to a different standard under Rule 11 of the Federal Rules of Civil Procedure.  It will be interesting to see if there is anything that comes from expecting the same conditions to lead to a different outcome.

 

District Court to CSPI: No Standing Any Time

Standing is one of those basic concepts they teach everyone in law school.  Courts, law students are told, are for the resolution of disputes between parties with a real stake in the outcome, not for the delivery of advisory opinions.  Then, it being law school after all, you are taught a number of ways in which you can legally obtain standing and essentially get an advisory opinion.  A single plaintiff with a small stake can bring a class action.  A public official may agree that he or she will not sign a required document, and so be sued for a writ of mandamus; when the court decides whether the official can be forced to sign, it is also deciding on the constitutionality of the law the parties seek to have determined. 

Although these and other methods of obtaining standing are recognized, it is not always possible to obtain a proper plaintiff.  Two renowned securities fraud plaintiffs' lawyers spent time in prison for paying people to act as plaintiffs in their cases. 

It would be so much easier, of course, for certain organizational plaintiffs if they could turn their organization's mission into standing.  The Sierra Club, most notoriously, tried this in the seventies, and the Supreme Court smacked them down in Sierra Club v. Morton, a case notable for Justice Douglas claiming in dissent that the valley itself should have standing. 

The Center for Science in the Public Interest appears to have tried it again, with, so far, the same result.  The case was a drug case, not a food case, but the elements of the claim were not all that different from ones we've seen in the past.  Bayer had made claims for its One-a-Day "Men's Health Formula" Vitamins that selenium in the vitamins would reduce the risk of prostate cancer.  CSPI made public demand on Bayer to withdraw the ads and, failing that, sued, which brought it a lot of publicity.  Only the case wasn't "John Smith who bought Bayer and was shocked that he wasn't getting prostate cancer protection v. Bayer," it was CSPI against Bayer.  Like the plaintiffs in Sierra Club v. Morton, they made no claim of any injury to themselves or their members.  Rather, they claimed standing under the California's Unfair Competition Law.  But that statute contains its own express standing requirement, conferring standing on

a person who has suffered injury in fact and has lost money or property as a result of the unfair competition

CSPI didn't get within a mile of that standard, according to the District Court.  In an opinion dismissing the case, federal district court Judge Jefrrey S. White held that CSPI was benefited, not harmed, by Bayer's alleged conduct.  Citing to Sierra Club v. Morton, the court said,

An organization's mere interest in a problem is insufficient to demonstrate a cognizable injury sufficient to confer standing.  Rather, the allegations as currently pled indicate that, in reaction to Bayer's alleged misrepresentations, CSPI as an organization reacted by disseminating information about nutritional science and by educating its members.  This conduct, rather than causing CSPI to incur injury, fulfilled the espoused mission of the organization. 

In other words, CSPI's mission was enhanced by Bayer's alleged actions.  Thus, the action under the Unfair Competition Law was dismissed with prejudice.  A similar claim under the Consumer Legal Remedies Act, which has a lesser standing requirement, was dismissed with leave to amend, but with the court expressing skepticism that CSPI would be able to meet the standing requirement there as well. 

Denny's Sodium Claims in Illinois Tossed on FRCP 12(b)(6) Motion

As anticipated, the "sodium" claims against Denny’s asserted in federal district court in Illinois have been dismissed on a Federal Rule of Civil Procedure (FRCP) 12(b)(6) motion. A copy of the court’s order is here. As discussed previously in this blog, the Illinois action alleges claims of consumer fraud, breach of implied warranty of merchantability, unjust enrichment, accounting and breach of contract implied in fact.

State consumer fraud claims based on “deceptive conduct” were tossed because they require under FRCP 9(b)’s “heightened pleadings requirement” allegations of a specific “communication containing a deceptive misrepresentation or one with a deceptive omission.” Denny's made no deceptive misrepresentations or deceptive omissions (nor were any alleged). To the contrary, as discussed previously in this blog, Denny's discloses clearly on its website and in its restaurants sodium content of its meals.  

Unjust enrichment and accounting claims were dismissed for largely the same reason as the consumer fraud claims.

The breach of contract claim was based upon the novel theory that the “bargained for” contract between class members and Denny’s required Denny’s to provide “a meal fit for human consumption.” The food sold, according to the plaintiff, “contained excessive amounts of sodium, such that it was not fit for human consumption.”

The contract claims were dismissed because there were no allegations that (1) a single meal that contains sodium in excess of the recommended daily maximum “is by itself unsafe” or (2) “Denny’s enters into an implied contract to sell only meals that contain less than a particular amount of sodium.”

 

Ninth Circuit Approves California Ban on Slaughtering Nonambulatory Animals Against Preemption Challenge

Chief Judge Alex Kozinski of the Ninth Circuit Court of Appeals may be the best-known lower court judge in the United States.  He has wide-ranging tastes and accomplishments.  Nearly every lawyer has a favorite Judge Kozinski quote, such as the opening line in Mattel, Inc. v. MCA Records, Inc.:  "If this were a sci-fi melodrama, it might be called Speech-Zilla meets Trademark Kong." 

Today, Chief Judge Kozinski authored the opinion in National Meat Ass'n v. Brown, upholding California's statute rendering it illegal to slaughter non-ambulatory ("downer") animals against the claim the statute was preempted by the Federal Meat Inspection Act.  The case specifically involved pigs, apparently because cattle in that condition must be labeled "U.S. Condemned" and disposed of outside the food supply. 

The plaintiffs made two claims, one for express preemption and one for preemption by implication.  The court was having none of it.  With regard to express preemption, the statute expressly preempts state laws relating to "premises, facilities and operations."  On the other hand, the statute expressly permitted state regulation of slaughterhouses.  Two other circuit courts had reached the conclusion that regulating the kind of animal that may be slaughtered was not preempted.  In his typical fashion, Chief Judge Kozinski said that the analysis in one case involving horse flesh "made horse sense."  Then, in dealing with the district court's analysis about how a pig turns into pig meat no matter what its condition before slaughter, he wrote this one word rebuttal:  "Hogwash." 

In dealing with the implied preemption argument, the court concluded that it was physically possible to comply with both the FMIA and the California statute.  Wrote Chief Judge Kozinski,

But these regulations don't require the slaughter of downer animals; no slaughterhouse operator would be fined by federal authorities if he gave nonambulatory animals medical care and put them up for adoption as pets. 

And less flippantly:

Federal regulations require inspection if downer animals are to be slaughtered . . . .  Whether they may be slaughtered is up to the states. 

(emphasis original).  The court similarly dismissed an argument that release of the animals to be euthanized would require permission from federal officials, because there was nothing in the record to suggest that this permission would not be routinely granted.  Similarly, the claim that euthanized downer animals would need to be inspected by federal officials for disease was met with the fact that the California statute did not prohibit such inspection so long as the animals were not slaughtered for food.

One part of the California statute, Section 599f(e), which deals with the transportation of nonambultaory animals, was found to be preempted.  This was because the federal statute expressly authorized certain means of moving downer animals that were prohibited under the California law.  The court found, however, that no showing of irreparable harm had been demonstrated in the lower court, which was necessary to a preliminary injunction, and thus vacated the injunction in full, without prejudice to a later showing before the lower court of such irreparable harm on this one issue.

Difficult Week for the Food Industry (Good Week for the Plaintiffs' Bar): HVP Salmonella and FDA Warning Letters

The week of March 1 saw a double whammy hit food manufacturers.

I. Open Letter to Industry on Marketing Claims

First, on March 3, FDA sent warning letters to 16 food manufacturers concerning their labeling practices. FDA also issued an Open Letter to Industry warning against certain practices. For example, FDA warned that:

o Nutrient content claims that FDA has authorized for use on foods for adults are not permitted on foods for children under two. Such claims are highly inappropriate when they appear on food for infants and toddlers because it is well known that the nutritional needs of the very young are different than those of adults.
o Claims that a product is free of trans fats, which imply that the product is a better choice than products without the claim, can be misleading when a product is high in saturated fat, and especially so when the claim is not accompanied by the required statement referring consumers to the more complete information on the Nutrition Facts panel.
o Products that claim to treat or mitigate disease are considered to be drugs and must meet the regulatory requirements for drugs, including the requirement to prove that the product is safe and effective for its intended use.
o Misleading “healthy” claims continue to appear on foods that do not meet the long- and well-established definition for use of that term.
o Juice products that mislead consumers into believing they consist entirely of a single juice are still on the market. Despite numerous admonitions from FDA over the years, we continue to see juice blends being inaccurately labeled as single-juice products.

II. HVP Recall

A day later, on March 4, FDA announced a recall of hydrolyzed vegetable protein (HVP). As of noon on March 4, 56 products containing HVP have been recalled. Some have suggested that HVP is the "Next Peanut Butter.”

III. What Food Companies Can Do in the Wake of FDA's Warning Letters and HVP Recall

What do last week's FDA warning letters and HVP recall have in common? The answer is, of course, litigation and exposure of brand value.

The first thing any affected food seller should do is engage its crisis management team. While lawyers and public relations staff are critical in crisis response, management of the crisis should not be left solely in the hands of either. Decisions should be made holistically, examining legal, public relations, business, financial and public health implications.

As discussed previously in this blog, companies faced with putative class claims filed as a result of the FDA warning letters on labeling should develop strategies to challenge the merits of the claims and class certification at the earliest possible stage. The end game for the plaintiffs' class action law firms is to obtain class certification and use that "litigation blackmail" to enter into a settlement with a handsome payout of attorneys’ fees.

For those companies with products that include recalled HVP, the good news is that there are few, if any, reported illnesses. The bad news is that recalls are very expensive and, for some companies without recall coverage or sufficient resources, financially devastating. Many food manufacturers were driven out of business in 2009 after being overwhelmed with the expenses of recalling products that included ingredients manufactured by Peanut Corporation of America (PCA).

For those affected companies with recall coverage or financial means, proactive measures can pay dividends. For example, offering refunds to consumers mitigates against putative class claims. Setting up consumer hotlines and payment of medical expenses for persons with illnesses linked to recalled products mitigates against personal injury suits.

 

Takeaways from 2010 GMA Food Litigation Conference

Stoel Rives was a sponsor of this year's GMA food litigation conference in Austin from February 22 to 25. The slide deck from Ken Odza's presentation on consumer fraud class claims can be viewed by clicking on the image to the left.

Some of the takeaways from my presentation and those by others at the conference include:

  • Assure Marketing Is in Sync with R&D (to Avoid Exposure from Consumer Fraud Class Claims) (Ken Odza, Paul Benson, Richard Fama)

    The point was underscored in several presentations that exposure on consumer fraud class claims often comes from unsupported marketing claims (health claims in particular). Marketing departments should make sure not only that claims are supported but that the supporting research is not contradicted by other credible internal or external research. 

  • Iqbal/Twombly Makes FRCP 12(b)(6) Motions More Attractive (Ken Odza, Richard Famas)

    The Supreme Court has overruled the Conley standard on Rule 8 notice pleading. "Plausibility" is the new pleading standard on a Rule 12(b)(6) motion to dismiss. If the operative allegations are not factually specific and the complained-of-conduct can be explained by another obvious reason, the complaint may be dismissed.

  • Class Certification in Consumer Fraud Cases Not Likely If Individualized Reliance/Causation Need to Be Proven (Ken Odza)

    A court should deny class certification in a consumer fraud case under the FRCP 23(b) "predominance" standard (1) when the proposed class includes multiple states with materially different statutes or (2) where the applicable state law requires an individualized showing of reliance/causation for each class member.

As technology improves and chemicals can be detected at lower and lower levels, regulators are looking at stricter standards and lower thresholds. EPA, for example, has a renewed emphasis on risk assessments that will inevitably affect food regulation.

  • FALCPA Does Not Apply to Restaurants, but "Allergen-Free" and "Gluten-Free" Claims Must Be Supported (Joseph Bottiglieri)
     
  • Pros and Cons Of MDLs (Paul LaScala)

Paul La Scala provided a thorough and thoughtful analysis of the pros and cons of Multi-District Litigation (MDL) from a defendant's perspective.

  • FDA Recall Procedures Manual Is a Great Resource and Can Be Found Online (Tom Mazziotti)

The FDA's regulatory procedures manual (or at least the chapters related to recalls) should be mandatory reading as part of any company’s recall preparedness program.

  • Class Actions and Mass Torts on the Rise Internationally with More Countries Passing Plaintiff-Friendly Laws (Greg Fowler)

American companies selling products abroad need to be aware of and prepared for litigation abroad with rules that are increasingly unfriendly to business.

One Lesson From Fitzpatrick v. General Mills: Class Cert. Tough To Oppose In Consumer Fraud Cases When Plaintiffs Don't Have To Demonstrate Individualized Reliance/Causation

Last month Judge Paul Huck of the U.S. District Court for the Southern District of Florida granted in part and denied in part class certification on claims brought in Fitzpatrick v. General Mills. Judge Huck granted class certification on claims asserted under Florida’s Deceptive and Unfair Trade Practices Act (FDUTPA) but denied class certification for claims of breach of express warranty.

The named plaintiff asserted violations of FDUTPA and express warranties for purchases of Yo-Plus yogurt. Plaintiff "alleges that eating Yo-Plus does not provide any digestive health benefits that cannot be obtained from eating normal yogurt."

Judge Huck ruled that in Florida, unlike in many other jurisdictions, consumer fraud claims do not require a showing of actual causation and reliance. Rather, in Florida "each plaintiff is required to prove only that the deceptive practice would—in theory—deceive an objective reasonable consumer." And for that reason, the court found that causation under the FDUTPA does not defeat the predominance requirement of class certification.

While FDUTPA does not require individualized causation and reliance, claims of UCC breach of express warranty do require individualized showing of "the particular promise that created the express warranty," according to the court. For that reason, the court held that "individual issues would predominate as to the breach of express warranty claims."

The Fitzpatrick ruling illustrates the difficulties defendants have in resisting class certification for consumer fraud claims in jurisdictions where the court finds no requirement of individualized reliance or causation.

Court's Decision on CR 12(b)(6) Motion In Zupnik: FFDCA Preemption Under Further Attack and Twombly Ignored

We previously cited the motion to dismiss in Zupnik, et al. v. Tropicana Products, Inc. as an example of good pleading practice in a putative consumer fraud class case. United States District Judge Dale S. Fischer apparently disagreed with our assessment, this week issuing an order denying the motion.

Tropicana’s lead argument was a failure of pleading. Tropicana attacked the complaint both on the basis of Rule 9(b), and under the Supreme Court’s recent decision in Twombly. The Twombly decision requires the federal court on a Rule 12(b)(6) motion to determine whether operative factual allegations are “plausible” and more than simply “conclusory.”

Judge Fischer rejected summarily Rule 9(b) arguments. She completely disregarded Tropicana’s Twombly arguments, failing even to mention the Supreme Court’s decision.

Tropicana also moved to dismiss based on federal preemption. Most of Judge Fischer’s decision is devoted to the preemption argument. She ruled that since California’s Sherman Law is substantively identical to 21 U.S.C. § 343(a) of the FFDCA, the preemption argument fails.

Judge Fischer theorized that even though plaintiffs could not point to anything on Tropicana’s label that violated any FDA regulation, the FDA could bring an enforcement action “to target specific false or misleading labels.” If the FDA can bring that kind of action under 21 U.S.C. § 343(a), plaintiffs, according to Judge Fischer, should also be able to bring a private right of action under the identical California law. Query whether Judge Fischer’s reasoning negates any FFDCA preemption defense to a claim brought under California’s Sherman Act? 

Third Circuit Rules that Food Service Management Companies and Distributors are Not Competitors for Robinson-Patman Act Analysis

If a manufacturer is selling the exact same goods to someone else for 59% less than it will sell to you, it would seem natural that you'd pick up the phone and call your lawyer and sue someone, wouldn't it?  In particular, this would seem to be a classic violation of the Robinson-Patman Act,15 U.S.C. Section 13Feesers, Inc., a food distributor, found itself in just that situation in buying liquid eggs from Michael Foods, Inc.  It sued Michael Foods and Sodexo, Inc., the food service management company that was getting that huge discount, in federal court.  Both sides brought high-priced legal talent to bear and the case marched up and down the federal courts until, on January 7, the U.S,. Court of Appeals for the Third Circuit ruled that Feesers was wrong.  Because Sodexo was not, in its opinion, a competitor of Feesers, the Robinson-Patman Act was not violated.

The case is complex, as is much Robinson-Patman litigation, but essentially it hinges on when the actual sales to Feesers or Sodexo might occur.  Feesers is a classic food distributor.  In connection with liquid eggs, that means that it sells to what are called "self-ops", or businesses that run their own food services, such as a college dorm or a retirement home.  Sodexo, on the other hand, is a food service management company, which provides essentially turnkey services to businesses that are not interested in running their own food services.  The critical fact, to the Third Circuit, is this:  while Feesers and Sodexo may compete for the same customers, the competition between them is over when the customer decides to be a self-op or to use a food service management company.  And, critically, that competition takes place before as single liquid egg is sold to the winner by Michael. 

The Third Circuit relied on a recent U.S. Supreme Court case, Volvo Trucks North America, Inc. v. Reeder-Simco GMC, Inc. and its own decision in Toledo Mack Sales & Service, Inc. v. Mack Trucks, Inc., both of which had held that the question of whether two entities were in competition was to be construed both narrowly and formally. 

In sum, because any competition between Feesers and Sodexo occurred at the time an institution was deciding whether to self-operate or hire a food service management company, and any resulting sale of Michaels’s products would have to occur after that competition, Feesers cannot show that it was a competing purchaser of Sodexo. The evidence produced by Feesers only further confirms the futility of its RPA claims, because such evidence—evidence showing consistent favoring of another purchaser over the plaintiff over time by a manufacturer in a bid market—was rejected in Toledo Mack.  Such evidence cannot support an inference of competitive injury in a bid market. Finally, the Supreme Court’s instructions to narrowly construe the RPA also compel us to reject Feesers’s RPA claims.

Future plaintiffs faced with what seems to be a price differential for what they consider at first glance to be their competitiors will be well-served to engage in a deeper analysis prior to suit.  Where you stand in the food chain will need to be pretty much exactly where your price-advantaged competitor stands or the benefit of Robinson-Patman may be denied you.

Consumer Fraud Claims: Examples of Good and Bad Motion Practices

The Good: Tropicana recently brought a motion to dismiss the Zupnik putative consumer fraud class claims pending against it. Zupnik alleges that Tropicana misled consumers in the promotion of its “Pure 100% Juice Pomegranate Blueberry Flavored Blend of 5 Juices from Concentrate with other Natural Flavors” because its front label did not include pictures of fruits other than pomegranates and blueberries.

Tropicana’s motion, brought under both FRCP 9(b) and 12(b)(6), appears as a good example of how putative consumer class claims can be challenged at the outset of the case. Though we don’t yet know whether Tropicana will be successful, its pleading is a sharp attack on the plaintiff’s complaint and takes advantage of the heightened pleading requirements announced recently by the Supreme Court.

Tropicana moved on the basis that the complaint lacks particularity required under Rule 9(b) (the rule requires pleading of the “particularity of the fraud”). It also challenged whether the plaintiff had any injury in fact or alleged any reliance on particular advertising. Finally, Tropicana argued that Zupnik’s claims were expressly preempted by federal law.

Tropicana cites to Twombly to urge the court to disregard “plaintiffs legal conclusions . . . even when made, as here, in the guise of factual allegations.”

Tropicana also attacks Zupnik’s complaint on the basis that “she got what she paid for.” Tropicana points out that its product sold for far less than juice with a higher level of pomegranate or blueberry juices. Because she got what she paid for (presumably regardless of whether she understood it at the time of purchase), she lacks standing to bring a claim for consumer fraud.

The Bad: Coincidently, in another case involving a putative consumer fraud class claim over depictions of fruits on a label, Judge Gorton of the United States District Court for the District of Massachusetts in Wiley v. Gerber Products Company granted Gerber’s motion to transfer to the Southern District of California for consolidation with the Williams case pending in California. (The Williams case was previously discussed in this blog.)

The lesson from Wiley v Gerber: if your strategy is to avoid transfer of venue, think about this when pleading. For example, do not include allegations in the complaint about a nationwide class and the application of different states’ consumer protection laws.

Wiley argued against transfer, contending that the “Court’s familiarity with Massachusetts law, under which several claims are brought weights against transfer.” The problem is that “in her amended complaint, Wiley added several claims under New Jersey state law which only undermines her contention that this Court is especially competent to adjudicate the state laws at issue in this dispute.” Wiley also alleged a nationwide class. The court found that the plaintiff’s choice of forum mattered little when she alleged a nationwide class.

Who Ordered the Christmas Pudding? Please Sign Here

Christmas pudding is an English delicacy with a long tradition.  One of those traditions is that small coins or little silver charms are baked into the pudding, which are supposed to be sources of good luck for the coming year.  Small coins and little silver charms, of course, can be swallowed or can crack teeth.  This has, presumably, been going on for a long time without anyone bringing lawyers into it.

Until, that is, some lawyers started talking to the owner of High Timber Restaurant in London.  High Timber is "the only restaurant in the City of London with tables on the banks of the Thames," which means that it is likely to attract a lot of lawyers as clientele, since the Inns of Court are just steps away.  And some of those lawyers started advising owner Neleen Strauss about the risk of chipped tooth lawsuits.  And what, in their opinion, to do about it. 

So, before your server brought you Christmas Pudding at High Timber on Christmas, you were first asked to sign a waiver.  The Huffington Post (or whomever they collected the article from) points out that other restaurants in the UK apparently require you to sign a waiver before eating rare meat, and that a restaurant in Chicago required waivers before serving chicken wings made from Red Savina Habanero peppers, which come in at a whopping 577,000 Scoville heat units.  In some cases, it may be the waiver is used to generate publicity rather than necessarily providing legal protection.

I can't imagine anything more offputting than to be presented with a waiver to sign before being served dessert in a fine dining restaurant.  This is a restaurant that doesn't have a wine list but instead suggests you make an appointment to view the cellar.  Based on their online menu prices, the Christmas pudding probably cost about $12 US.  For that, I'd expect a dining experience unmarred by the need to sign anything other than a credit card receipt.  Would the other diners mind if I made a cell phone call to my English solicitor to have her interpret the waiver for me?

Food isn't the only place where the movement to turn every transaction into a legal confrontation is evident.  Some years ago, consumer groups advocated that there be a required explanation for the fine print in every consumer lease transaction.  Rental car companies pointed out that, in order to comply with such a requirement, they would have to show a fifteen minute video before allowing you to leave with your rental car.  That quashed that movement pretty quickly.

One of J.R.R. Tolkien's lesser-known but quite delightful works is Smith of Wooton Major.  In the town of Wooton Major, the Master Baker, as the culmination of his career, makes a "Great Cake" to be shared by 24 children.  In each slice of cake is baked a surprise, one for each child.  One child, Smith, does not find a surprise in his slice; instead he swallows it.  The surprise, though, is a special star that, having been swallowed, appears on Smith's forehead, and that star is his passport to meeting the king and queen of Faery.

I worry that if this trend keeps up, and I read this story to my as yet unborn grandchilden, one of them will ask, "Did the children have to sign a waiver before they could eat the cake?" 

New Reporting Requirements For Companies That Make Payments to Medicare Recipients in Personal Injury Lawsuits or Workers' Compensation Claims

By Guest Blogger Emily Grande

A few weeks ago, I attended the Grocery Manufacturer Association’s webinar on Consumer Complaint Management – Current Issues and Effective Procedures. One important topic covered was the new Medicare reporting requirements for self-insured companies that are defendants in personal injury lawsuits or that are paying workers’ compensation claims. If a company satisfies a judgment or settles with a personal injury plaintiff who is a Medicare recipient, the company must report the payment to Medicare, as required by Section 111 of the Medicare, Medicaid, and SCHIP Extension Act of 2007. These new reporting requirements were enacted to save the government’s health care programs money by arming them with the information needed to recover payments made to Medicare recipients for medical expenses in personal injury and workers’ compensation cases. In such cases, the defendant, not Medicare, is responsible for the plaintiff’s health care bills. The eye-popping penalty for a company’s failure to report payments to Medicare recipients is $1,000 per day per claim. In addition, Medicare can pursue legal action against the settling company if it fails to ensure that Medicare is reimbursed regardless of whether the company has already paid the plaintiff. As if that weren’t enough, Medicare can pursue double damages.

The registration deadline for the program was September 30, 2009, but there do not appear to be penalties for failing to register on time. The first required reporting period is the second quarter of 2010. All personal injury settlements made after January 1, 2010 must be reported, and all workers’ compensation claims considered “open” on January 1, 2009 must be reported.

A guide for responsible reporting entities can be found at the Centers for Medicare & Medicaid Services website.

The presenter at the GMA’s webinar was attorney Thomas S. Thornton III and his presentation slides are available here.

The Wall Street Journal on "Bagel-Related Injuries"

Where I grew up, there was a bagel bakery, or "bagel factory" as we called them, in every strip mall.  One of them was owned by the husband of my high school English teacher, and one day in class she demonstrated to us proper bagel sliciing technique.  It must have made an impression, because I remember it--and use it--to this day.  What you do is to slice halfway into the bagel toward you, and then turn the bagel around to slice outward from the middle.  I don't recall ever cutting myself while cutting a bagel.

According to the Wall Street Journal, I'm in the minority, and "bagel-related injuries" are a prime source of danger, with 1,979 people showing up in emergency rooms in 2008 because of improper bagel slicing technique.  This obviously does not include those who cut themselves but did not require a visit to the emergency room. 

There is a small industry of bagel-slicing devices intended to help you avoid bagel-related injuries.  The Journal article has a whole video on them.  Because I make my own bagels, I've been given many of them as gifts over the years, including the Brooklyn Bagel Slicer featured in the article.  I still just prefer to slice the bagel with a knife however.

According to the article, there are more "chicken-related injuries" than any other food injuries.  These are compiled by the National Electronic Injury Survey System, an arm of the U.S. Consumer Products Safety Commission.  As far as I can tell, the chicken-related injuries must have been injuries from the use of some kind of tool when cooking chicken, not, say, getting a bone caught in one's throat, because the NEISS Coding Manual says not to code injuries from food.

New York Times on the Rise in Unfair Competition Claims: Challenging Competitors' Advertising Is Increasingly an Important Part of an Overall Marketing Strategy

Stephanie Clifford wrote over the weekend in the New York Times about what’s behind the increase in unfair competition claims. Ms. Clifford reports:

The number of complaints over ads from competitors filed with the National Advertising Division of the Council of Better Business Bureaus, the industry’s main self-regulatory program for national ads, is on track to set a record this year. There have been 82 formal complaints so far in 2009, after last year’s record of 84 challenges, a sharp increase from 62 in 2007 and 52 in 2006.

Among a discussion of what it means to file an NAD complaint versus court action and why both seem to be increasing is this salient quote from Linda A. Goldstein at Manatt, Phelps & Phillips, LLP: “How brands will deal with their competitors’ advertisements is an increasingly important component of the overall marketing strategy.”

Take-Aways from November 17 Webinar: Sustainable Foods Increase Litigation Risks: Developing Strategies to Minimize Exposure

On November 17, we held our final webinar in a three-part series on bringing sustainable food products to market. Take-aways from the third webinar include:

• Be aware that "natural" is a hot button when advertising and labeling sustainable food products.

• "Sustainable" is not addressed in FTC Green Guides so it is imperative to be specific with your claim and/or use third-party certification.

• Truitt Brothers packaging/labels depict the source of their ingredients.

• Food-borne illness issues affect all food producers. Large producers have made significant investments in prevention in recent years; small producers of sustainable products without capital to improve farming or manufacturing practices are at a competitive disadvantage and possibly more susceptible to legal exposure from food borne illness claims.

• Food sellers should identify a crisis management team, review supplier agreements and understand insurance coverage to mitigate risk.

• Food sellers should understand that product recall coverage is excluded on most Commercial General Liability coverage forms.

Thanks again to our presenters and attendees. The recorded webcast was archived and is accessible here. Click here to access a PDF copy of the presentation slides.

Stay tuned for a possible new webinar series on food traceability. We're tracking the latest regulatory and legislative developments.

Delio v. McDonald's Corp.: The Connecticut Grilled Chicken Case

It took our intrepid docket clerk a few weeks of digging, and finally contacting the plaintiffs' counsel directly, to get a copy of the complaint in Delio v. McDonald's Corp., a case filed in Superior Court in Hartford County, Connecticut on October 6.  Plaintiff's counsel is Robert Solomon, a clinical professor at a small New Haven law school called Yale, along with Daniel Kinburn of The Cancer Project. 

Unlike the Denny's suit on which both Ken and I have blogged previously, the Conneciticut Grilled Chicken case is remarkably streamlined in its allegations and the remedies sought.  The named plaintiffs in the class action suit are two Connecticut residents who consumed grilled chicken products at McDonald's, Burger King and Friendly's stores in Connecticut between October 21, 2006, the date on which the complaint claims McDonald's and Burger King were warned their grilled chicken products were tested to show they contained PhIP, or 2-Amino-1-methyl-6-phenylimidazo[4,5-b]pyridine, a carcinogen, and October 17, 2008, when the plaintiffs allegedly became aware of the cancer-causing effects of grilled chicken.  The remedy claimed, beyond what would be nominal damages for the named plaintffis' purchase of grilled chicken products, is an injunction under the Connecticut Unfair Trade Practices Act which would require warning labels to sell these defendants' grilled chicken products.   They also seek punitive damages and attorneys' fees, although the complaint's allegations on those points appear thin.

The complaint is quite readable.  Missing are claims of violations of a warranty of merchantibility, or similar claims.  The plainitffs appear more willing, instead, to focus solely on their judicial attempt to require a warning label, and then only in Connecticut.  Without getting into the validity of their claims, or their motives (which have been questioned by others), this is at least a style of litigation that focuses solely on the issue of food safety and an appropriate remedy. 

There are some interesting questions in the case, however.  One is why Friendly's was added as a defendant.  It is not for the usual reason, an attempt to keep the case from being removed to federal court, because Friendly's is incorporated and headquartered in Massachusetts.  But the allegations about testing of products relate only to McDonald's and Burger King; there is just an allegation that Friendly's "is assumed to be aware of health issues pertinent to restaurants anywhere in the United States" and and even more conclusory, "Upon information and belief, Defendants' grilled chicken products are prepared in the same manner throughout the United States."  What is missing, though, is any direct allegation that anyone has tested Friendly's grilled chicken products and found they contain PhIP. 

The broader question is why this claim is appropriate for judicial resolution, as opposed to legislative or agency action.  If the plaintiffs are right, one presumes the issue is not limited to McDonald's, Burger King and Friendly's, yet the relief requested, if granted, would apply only to them, and only in Connecticut.  One assumes the plaintiffs desire that if granted their relief, at least every restaurant grilling chicken in Connecticut would follow suit in putting their desired warnings in place, but enforcement would only be by additional separate suits that would require proof in each instance.  That is cumbersome and inefficient and does not protect the public if the public needs to be protected. 

KFC just came out with a huge ad campaign for Grilled Chicken; they are not defendants.  TV chefs promote grilled chicken all over television; they are not defendants.  Barbecue manufacturers encourage their customers to use their grills to grill chicken; they are not defendants.  Chicken producers encourage their customers to grill their chicken products; they are not defendants.  I have no idea whether any of these products contain PhIP, but if there is to be a conversation about the health impacts of grilled chicken, I would think they should all be at the table.  And with all due respect to the Hartford County Superior Court, I'm not sure one of its judges is the right person to have at the head of the table. 

Hurdles Faced By Plaintiffs In Class Action Lawsuit for Sale and Marketing of Cold and Flu Medications Containing Vitamin C

By Guest Blogger Tyler Anderson

On November 2, we blogged about the FDA warning letter issued to Procter and Gamble for its unlawful marketing of Vicks cold and flu medications containing Vitamin C. On November 4, 2009, a putative class action lawsuit was filed against Procter and Gamble in the U.S. District Court for the Southern District of Ohio (Sixth Circuit) alleging Procter and Gamble violated federal and state consumer protection laws through false and misleading advertising practices regarding the two Vicks products mentioned in the FDA warning letter.

Regardless of the merits of their case, the plaintiffs in this action may have a hard time obtaining their desired relief. In Count 1 of the complaint, the plaintiffs allege Proctor and Gamble violated the consumer protection laws of 43 separate states. The Seventh Circuit’s holding in its Bridgestone/Firestone decision (J. Easterbrook) and its progeny, suggests that under FRCP 23(b)(3), such a class action is unmanageable. Courts point to the impracticability of one court applying the divergent laws of differing jurisdictions in circumstances such as those at bar.

“Plausibility” pleading standards (see recent discussion of Wright v. General Mills) present additional hurdles. Applying Twombly as the court did in the Wright case, to survive a motion to dismiss the plaintiffs would need to make plausible, non-conclusory allegations that the plaintiffs purchased the Vicks products because they contained Vitamin C and the cost of the product with the Vitamin C was greater than it would have been without. No such allegations exist here, so applying the holdings of Twombly and Wright to this claim indicates that it may be subject to dismissal.

“Reliance” may be yet another avenue to dismiss the action (at least in part). Many state consumer fraud statutes require reliance. This means that the plaintiffs would be required to show that each plaintiff in the action bought the product in reliance on the purported fraudulent statement. Because purchasing decisions are individual decisions, proving reliance on a class-wide basis would be an individual inquiry that would predominate over issues of fact common to the class, which would negate class treatment.

Take-Aways from November 3 Webinar: Making Good Marketing Claims: Product Labeling Pitfalls, Third-Party Certification and "Green Washing"

Tuesday, November 3, we held our second webinar in a three-part series on bringing sustainable food products to market. Thanks again to our presenters and attendees. The recorded webcast was archived and is accessible at this link. Click here to access a PDF copy of the presentation slides.

Take-aways from the second webinar include:

• With the exception of the FDA’s policy on “natural” claims, it has been silent on “green claims.”

• “Natural” could be hottest claim on the market but is becoming controversial. Food companies should continually monitor the marketplace to see which claims are drawing challenges.

• Food companies should pay attention to consumers union findings regarding eco-label credibility.

• While third-party certification may not help every food business, certification is a tool that supports your brand and your marketing/sales strategy.

• Retail leaders in sustainability, such as Burgerville, aspire for continuity of sustainability in each link in its supply chain.

• To understand the FTC green guidelines companies need to appreciate three key points: substantiation, specificity and qualification.

• To avoid “green washing” issues, food companies need to understand the complex matrix of federal, state, local and foreign statutes, regulations and guidelines governing “green” advertising.

I hope you can join me, Steve Marinkovich from Propel Insurance, my colleague at Stoel Rives, Anne Glazer, and Peter Truitt from Truitt Bros., Inc. on November 17, at 9 am PST, noon EST, (live Twitter feed at #sustainlaw) for the last webinar in the series as we discuss the following:

• Preventing and Dealing with Consumer Fraud, Unfair Trade and False Advertising Claims from Consumers and Competitors

• Real-Life Businesses Approaches to Sustainability, Product Labeling and Marketing

• Coping with Increased Risks of Food-Borne Illness from Local or Small Farm Products

• Insurance Coverage You Need, Think You May Have but Don’t Have or Think You May Want but Shouldn’t Get

Continue Reading...

Some Take-Aways from ACI's 3rd National Forum on Food-Borne Illness Litigation

American Conference Institute (ACI) recently held its latest conference on food-borne illness litigation. The conference has been a fairly intimate gathering of the nation’s lawyers, insurers and experts involved with food-borne illness litigation.

This year, I had the privilege of moderating an in-house counsel “think tank.” The panel was composed of lawyers from a nice cross-section of food businesses: Yum Brands, Hormel, Fresh Express and SUPERVALU (though for each, food-borne illness litigation is a rare event)  A slide-deck from the panel can be found here.

Also among the presenters at this year’s conference were Center for Disease Control’s (CDC) Dr. Arthur Liang and USDA/FSIS representative Dr. Dan Engeljohn. Both presentations provided fascinating insight into changes afoot in food safety enforcement and policy at the federal level. Here are some of the take-aways:

“Outbreaks Waiting to Be Discovered” – Dr. Liang opined that, based on surveilled illnesses, most food-borne illness outbreaks are not presently discovered. He believes that recent data shows that there are perhaps 2-3 times more outbreaks nationally than what’s been uncovered over the last few years.

• Food Safety Progress Being Undone by Retail Deli Operations – FSIS says there has been a “steady increase in risky behavior at the retail level.” According to Dr. Engeljohn, budget authority is being sought to intervene with retailers, particularly smaller supermarket deli operations.

Negative Tested Product Can Be Considered Adulterated - FSIS will be issuing a policy soon that for the first time will consider a “negative tested product to be determined adulterated” under circumstances where an associated product tested positive for pathogens.

Non-0157 STECs - FSIS will be finalizing methodology to detect non-0157 Shiga Toxin-Producing Escherichia coli (STEC).

The Table Is Set For Class Action Litigation Over the Use of Smart Choices Labeling

By Guest Blogger Troy Hutchinson

In response to recent consumer complaints and state attorney general investigations that the use of the Smart Choices label is misleading and deceptive, food companies now face the threat of consumer class action litigation under state fraud and deceptive practices statutes.

Adding to the uproar, the Food and Drug Administration (FDA) announced that it will consider using its regulatory tools if front of pack nutrition labeling is not used in a common, credible way, it said in a letter to industry on October 20, 2009.

In a conference call with journalists, Margaret Hamburg of the FDA said that the FDA wants to work with industry, but that over time it “will take enforcement action for egregious examples.” Hamburg did not pinpoint specific products, but mentioned claims of “zero trans fats” on the front of packaging for products that have high levels of saturated fat, and said: “There are products that have got the Smart Choices check mark that are almost 50 percent sugar.”

At least one member of Congress has also weighed in on the issue. U.S. Rep. Rosa DeLauro announced that she is “very encouraged by FDA’s commitment to proceed with enforcement actions” against unauthorized claims. She went on to state that “[c]learly something is wrong when foods such as Froot Loops cereal, Cookie Crisp cereal, and Uncle Ben’s Instant Rice are designated as ‘healthy’ by these labeling systems.”

Responding to the FDA’s letter, president of the Grocery Manufacturers Association Pamela Bailey said in a statement that the organization is looking forward to working with the FDA “to determine what nutrition information is most useful in providing consumers with the tools they need to help them build a healthful diet.”

While companies who are using the Smart Choices program to promote legitimately healthy options should encourage FDA enforcement, that enforcement brings with it the risk of class action litigation. Whenever there are attorney general investigations or other regulatory enforcement action taken, class action litigation often follows. Food companies using the Smart Choices labeling should be strategizing on how best to defend these actions. Some private litigation may be preempted if the FDA has used its rule making authority. Where companies are legitimately using the Smart Choices label to promote healthier food options, those companies should encourage the FDA to use its rule making function to give clear rules on how companies can use the Smart Choices label.

Preemption v. Plausibility: Will There Be More or Fewer Successful Consumer Fraud Suits?

Products Liability Law360 ran a piece this week entitled “Suits Over Deceptive Food Marketing Likely To Increase” (unfortunately, this is a subscription-only site) authored by Liz McKenzie. The article discusses rightly how increased FDA enforcement action may lead plaintiffs attorneys to file “piggy-back” putative class actions. For example, it took just 13 days following the FDA’s warning letter to General Mills concerning Cheerios for the first putative class suit to be filed.

Compounding increased FDA enforcement,  recent rulings from the Supreme Court and the Third Circuit, like the Snapple Decision, have made it more difficult to assert a preemption defense in food cases in the absence of formal FDA rulemaking. 

But, what one hand giveth the other taketh away. The hope for food companies is that that the Supreme Court’s recent decisions in Twombly and Iqbal will negate the preemption decisions and effectively heighten the bar for consumer fraud claims related to product marketing. Dismissal for failure to meet the new “plausibility” pleading standard and not preemption is exactly how the District Court ruled in Wright v. General Mills. Wright involved a putative class complaint involving Nature’s Valley products sold as “100% Natural” “even though the products contained one or more non-natural or artificial ingredients such as high-fructose corn syrup (’HFCS’).”

In Wright, the court found defective, under the Iqbal/Twombly “plausibility” standard, the plaintiffs’ injury-in-fact allegation. The Wright court ruled that the injury-in-fact allegation “conclusory,” “sparse” and “defective.” The plaintiff alleged only that “Defendant caused Plaintiff and other members of the Class to purchase, purchase more of, or pay more for, these Nature Valley products.”

Following the Supreme Court's new standard of notice pleading and its application in the Wright case, query how any putative consumer fraud class complaint can survive a Rule 12 motion without having first completed market surveys or gathering of other evidence of consumer injury.

Hungry for Change: ABA Journal on Food Safety Reform and Its History

Kristin Choo has written a piece for the ABA Journal tracking the history of food safety regulation, recent outbreaks and current legislation pending in Congress. I am grateful to be mentioned in the piece. The article can be found at this link.

 Ms. Choo writes:

Litigation is likely to increase as a pumped-up FDA, an arm of the Department of Health and Human Services, identifies more outbreaks of food-borne illness and collects more evidence about their causes. Meanwhile, many companies are likely to struggle, at least initially, with stricter requirements to develop safety plans, disclose business records when outbreaks occur and improve procedures for tracing products, according to Kenneth M. Odza, a member of Stoel Rives in Seattle, who litigates food safety cases and writes a blog on the subject.

Ms. Choo also includes a summary of information (see below) derived from CDC documented outbreaks (two or more people with the same illness after eating the same contaminated food) from 1990 to 2006 broken down by category of food. Note that nearly 50% of illnesses documented are from produce or "multi-ingredient."  Produce and "multi-ingredient" account for about twice the number of illnesses as beef and poultry combined.
 

Category Outbreaks Illnesses
Beef 518 14,191
Beverages 101 3,640
Breads and Bakery 179 4,904
Dairy 221 6,364
Eggs 351 11,143
Game 28 193
Luncheon and Other Meats 196 7,108
Multi-Ingredient 1,054 30,254
Pork 233 6,954
Poultry 620 18,906
Produce 768 35,060
Seafood 1,140 11,809
Other 369

183

 

Macaroni Grill Changes Its Menu for the Right Reasons

While Denny's appears to be subject to a growing trend of people suing it to change its menu, Romano's Macaroni Grill is lowering the calories in its menu for another reason:  to stem losses in sales.  According to an article in the Wall Street Journal, Macaroni Grill is increasing sales while at the same time lowering food costs, prep time and the calories in its menu items.  Criticism on The Today Show of a menu item with 1270 calories has caused it to be trimmed down to just 390 calories and 4 grams of fat. 

As the debate over labeling caloric and other information in restaurants continues, this is an example of the market making its own correction without intervention from the legal system.  According to Macaroni Grill, the new cherry tomatoes and small leaf basil in their tomato bruschetta makes the food taste better, too. 

Sodium Putative Class Action Suits to Become Epidemic?

Following the putative class suit filed last month in New Jersey by the Center for Science in the Public Interest (CSPI) against Denny’s, a similar suit was filed in Illinois (apparently CSPI is not directly involved in this action). The Illinois complaint can be found here.

Like the New Jersey complaint, the Illinois action alleges claims of consumer fraud and breach of implied warranty of merchantability. Previous posts on this site have explained why both consumer fraud and implied warranty of merchantability claims should fail on their face.

The Illinois action adds claims for unjust enrichment, accounting and ”breach of contract implied in fact.” Claims for unjust enrichment and accounting seem intertwined and not all that different from consumer fraud and breach of implied warranty claims.

Breach of contract implied in fact is more creative. Instead of directly attacking Denny's representations (which as discussed in previous posts are not really alleged to be inaccurate), this claim asserts something that looks more like a products liability claim. The claim turns not so much on “fraud” but on whether the meals sold “contained excessive amounts of sodium, such that it was not fit for human consumption.” This cause of action alleges that the “bargained for” contract between class members and Denny’s required Denny’s to provide “a meal fit for human consumption.”

While creative, the breach of contract implied in fact claim may be more problematic than the fraud and implied warranty of merchantability claims. First, as discussed previously, Denny’s discloses on its website (and according to CSPI, at its restaurants) sodium content of menu items. Like the fraud claims, proof that plaintiffs could have reasonably bargained for something different seems problematic.

Second, plaintiffs are asking the court to use its equitable powers and step into the shoes of local, state and federal health departments and regulatory agencies to pass on appropriate sodium levels in restaurant food. As a rule, courts use their equitable powers only in extraordinary circumstances (e.g., a building falls down, assets leave the country, an individual’s life or liberties at stake, etc.). If regulators and legislators have not reached consensus on regulating sodium, odds are that most judges will avoid weighing in on the issue.

Despite their problems (and probable lack of merit), best guess is that the plaintiffs' class action bar will continue copy-catting these suits across the country.  Doubtful that Denny's will be the only victim.

Before the Outbreak, Preapprove Defense Counsel with Insurer

When a food-borne illness outbreak happens, few food companies (especially those whose brand is at stake) want an unfamiliar defense lawyer who has little knowledge about food-borne illness responding to claims asserted against them. Unless a food company maintains a high, self-insured retention or has the lawyer of its choosing preselected, its insurer might appoint on the food company’s behalf low-cost defense counsel ill-equipped to respond to the claims and protect the brand.

Commercial General Liability insurance and Products liability insurance commonly maintained by food companies to protect them from the risks of food-borne illness outbreak usually will not cover the damage an outbreak can have on a company’s brand, stock value or sales. Lawyers appointed by insurers may have little understanding of the insured’s business or the impact the outbreak can have on its brand. Unlike in other areas, such as securities litigation, insurers are not as likely to have a panel or preapproved list of experienced food liability lawyers ready to deploy.

What a food company should consider before a food-borne illness outbreak happens:

1. Identify lawyers who are:

A. Familiar with (or will pledge on their dime to learn) the food company's business and brands;

B. Experienced in responding to consumer claims and food-borne illness; and

C. Knowledgeable about potential expert witnesses (about both those that the company will hire and those that plaintiffs will hire).

For companies with active crisis management plans , these lawyers likely have already been identified and included on the crisis management team.

2. Work with your broker, insurance coverage lawyer and preselected defense lawyer(s) to get preapproval of your chosen lawyers and agreement on their fees

For the sake of the business relationship (and self-interest), many insurers may agree to preapproval. Consider seeking preapproval at the time of renewal when a commercial insured may have the most leverage with an insurer.

For those with preapproved defense counsel, please consider sharing your experiences and insights. Comment or email.

Challenges of a Lanham Act Injunction in Food Cases: Lessons from an Advertising Battle Between Two Major Consumer Products Companies

The recent decision in Stokely-Van Camp, Inc. v. Coca-Cola Co. (i.e., Gatorade vs. Powerade) illustrates the hurdles a company has to overcome to convince a court to stop a competitor from using arguably false advertising. Stokely-Van Camp, Inc. (“SVM”) was challenging advertising that compared Powerade ION4 to Gatorade Thirst Quencher.

Judge John G. Koeltl of the Southern District of New York characterized the case as “an advertising battle between two major consumer products companies over one company’s comparison of its beverage to human sweat.”

Following a two-day preliminary injunction hearing, the court denied a request to enjoin various advertising claims about Powerade ION4. Ultimately, to succeed, SVM, makers of Gatorade, had to show (1) likelihood of irreparable harm and (2) either a likelihood of success on the merits or serious questions going to the merits that were sufficient to make them fair grounds for litigation, with a balance of hardships tipping decidedly in its favor.

As with any request for a preliminary injunction, this is a difficult standard to meet. Personal experience is that no matter the legal standards, judges often revert to the “is a building going to collapse?” gut-check approach.

“Unclean hands” are also a big deal when it comes to injunctions. Courts are very reluctant to grant injunctive relief if they get a sense that the moving party is itself guilty of the acts it complains of.

In the SVM case, the court came down against SVM on the second prong concerning the merits of its Lanham Act false advertising and trademark dilution claims. The court ruled that the claims were moot (because Coca-Cola already dropped the aggrieved advertising campaign), nonactionable puffery or, for the implied falsity claims, not supported by extrinsic evidence.

The court went further in addressing irreparable harm. Even if SVM’s claims were merited, the court did not believe SVM was entitled to a presumption of irreparable harm, because Coca-Cola discontinued the comparison ads. The court also found SVM’s arguments of a public health risk unconvincing.

Perhaps the most interesting lesson is the court’s final conclusion of law that SVM had “unclean hands.” Even if SVM’s injunction motion had met the legal standard, fatal to its motion would have been that “SVC complains about Coca-Cola’s claims regarding the presence of calcium and magnesium in Powerade ION4, but it has made virtually identical claims about calcium and magnesium in its own Gatorade Endurance Formula.”

The court concluded by saying, “SVC cannot, having jumped on the bandwagon of calcium and magnesium first, now jump off and claim that Coca-Cola must get off too.”

Facts Alleged in CSPI Sodium Suit Incongruent with Claims Asserted

Thought to be the first putative class action against a restaurant chain related to disclosure of sodium content on menus, Center for Science in the Public Interest (CSPI) has filed what appears to be a test case against Denny’s. Best guess is the case will fail on its merits (though for CSPI, success in litigation may not be the point).

The case, DeBenedetto v. Denny’s Corporation, asserts claims under New Jersey law for consumer fraud, N.J.S.A. 56:8-1, et seq., and breach of the implied warranty of merchantability under the New Jersey U.C.C., N.J.S.A. 12A:2-314(1)-(2). The theory advanced in CSPI’s complaint is that consumers have been “duped” about sodium content and that the “ordinary consumer, unschooled in nutrition and perhaps preoccupied with other matters, would not reasonably expect to encounter these high levels of sodium in one meal.”

Big incongruency in the complaint is that Denny’s does disclose sodium content in its meals. CSPI admits that Denny’s provides this information both online and in store pamphlets, but it complains that the information is “incomprehensible.” A review of Denny’s online disclosures shows a detailed nutritional chart, including sodium levels for every item on its menu. Here's an excerpt of Denny's online disclosures:

But, CSPI's complaint does not really seem to be that disclosures are not clear enough. Indeed,  CSPI argues that regardless of such disclosures by restaurants, studies show that “almost no one reads the nutrition information . . . .”

What CSPI is really saying is that sellers of salty foods (not unlike foods contaminated with E. coli) are strictly liable no matter the disclosures.  If this were the law (which as of now, it is not), few restaurants (or food manufacturers) would be exempt from paying the medical bills of their customers who develop heart disease. No doubt CSPI's real goal is "regulation through litigation" and the jury is still out whether CSPI's penchant for the court system will affect change.

Snapple Decision - FDA's Policy Concerning Use of "Natural" Not Entitled to Preemptive Effect

High Fructose Corn Syrup Labeling: Opening the Floodgates For Consumer HFCS Claims?

The Third Circuit ruled this week in Holk v. Snapple Beverage Corp., reversing the district court and reinstating the state law putative class claims for consumer fraud and breach of warranty for use of the term “all natural” despite the inclusion of high fructose corn syrup (HFCS) (though the court noted that the manufacturer no longer uses HFCS in its products).

The case is significant and is getting attention because the Third Circuit concluded that “FDA’s policy statement regarding the term ‘natural’ is not entitled to preemptive effect.” The court was persuaded because “the FDA declined to adopt a formal definition of the term ‘natural’ choosing instead to simply enforce its long standing ‘informal policy’”:

[T]he agency has considered “natural” to mean that nothing artificial or synthetic (including colors regardless of source) is included in, or has been added to, the product that would not normally be expected to be there. For example, the addition of beet juice to lemonade to make it pink would preclude the product being called “natural.”

As expected, the court followed its previous ruling in Fellner v. Tri-Union Seafood, LLC (our blog entry about it is here), ruling that neither the FDA’s “informal policy” nor their enforcement letters were entitled to any preemptive weight.

Practice Tip: For the next HFCS case, preemption may not be a dead issue. The Third Circuit did not rule (though it expressed its skepticism) on the “express preemption” argument based on 21 U.S.C. § 343-1(a)(3). The court ducked the issue by concluding that Snapple waived the argument by not “advancing it” in the district court.

Opening the Door to More Litigation Between Food Companies? See POM v. Ocean Spray Decision

False advertising claims under the Lanham Act and corresponding state law claims for food companies can be tough going. Many intersect issues regulated by the FDA under the Federal Food, Drug, and Cosmetic Act (FFDCA). No private right of enforcement of the FDA regulations exists. Only the FDA is allowed to bring a legal action to enforce its regulations. Lanham Act claims are generally barred where private litigants ask the court to determine preemptively how the FDA will interpret its own regulations.

Now comes the recent decision in POM Wonderful LLC v. Ocean Spray Cranberries, Inc. POM is aggrieved because Ocean Spray markets pomegranate and cranberry blended juices though, according to POM, the juices are “almost entirely comprised of apple and grape juice.” POM is alleging Lanham Act false advertising claims and California state law false advertising and unfair competition claims.

The court denied a Rule 12(b)(6) motion to dismiss. Threading the needle, the Court found that the claims were not seeking FFDCA enforcement. According the Court, POM’s claims are not for “mislabeling,” but for false advertising and promotion. The court determined it would not have to interpret FDA regulations and that “POM’s Lanham Act claim ‘extend beyond the packaging and name . . . to its advertising and marketing including . . . website.” Applying similar logic, the court found that the FFDCA did not preempt POM’s state law claims.

Lesson from the POM court: Whether one food company can bring false advertising claims against another depends in part on whether a court believes that the claims are focused on non-FFDCA-regulated issues such as advertising,  websites, social media or other marketing efforts.

Tool For Food Companies and Litigators - New Guidelines for Foodborne Disease Outbreak Response

Council to Improve Foodborne Outbreak Response (“CIFOR”) has published new guidelines designed to help local, state and federal agencies to improve their response to outbreaks. I became aware of this (again) through Ricardo Carvajal, who was a reviewer for the guidelines, and his firm’s FDA Law Blog. I agree with Ricardo that while the guidelines are designed for public agencies they have value for food businesses.

According to CIFOR, “[t]he guidelines are intended to give all agencies a common foundation from which to work and to provide examples of the key activities that should occur during the response to outbreaks of foodborne disease.”

Anticipating how the public health agency will behave will not only assist in crisis management, but it may also prevent the crisis. As discussed previously in this blog, one of the benefits of good crisis management is the ability to reach out and offer assistance to the investigating public health agencies. Keeping current on protocols that we can expect agencies to follow is a good practice.

The guidelines are also of some value to litigators. In the face of an outbreak investigation, they provide tools to assess the merits of the agency investigation. While it is always difficult to challenge a public health agency’s findings (no matter how flawed), the guidelines may help.

Bottled Water Association Sues Over Water Bottle Ads

The International Bottled Water Association (IBWA) is taking aim at an advertising campaign for Eco Canteen stainless steel water bottles, claiming the ads wrongly suggest that plastic water bottles are unhealthy and unsafe.

In a lawsuit filed in the U.S. District Court for the Western District of North Carolina, IBWA claims that Eco Canteen’s television ads and content on various Eco Canteen websites deceive the public into believing that single-serve and reusable plastic water bottles constitute a safety and health risk to consumers. Among other things, IBWA’s lawsuit alleges that some of Eco Canteen’s ads have:

  • Improperly linked plastic water bottles to breast and prostate cancer and stated that plastic water bottles “could be poisoning you and your family”;
     
  • Matched images of single-serve plastic water bottles with Eco Canteen’s claims “relating to an organic compound called Bisphenol A (BPA) with the intent to confuse consumers into believing that single-serve bottles also contain BPA even though they do not”;
     
  • Conveyed false and misleading information regarding the alleged health risks of BPA; and
     
  • Suggested that exposing certain water bottles to warm temperatures can lead to leaching of chemicals.
     

IBWA brings two claims against Eco Canteen: (i) a false advertising claim under the Lanham Act, 15 U.S.C. § 1125; and (ii) an unfair competition claim under North Carolina law. A copy of the complaint (including exhibits showing some of the Eco Canteen ads about which IBWA complains) is available here.

Preventing "Piercing of The Veil" - Practical Tips For Food Companies - Introduction (part I of III)

By guest blogger Jerry Chiang

In starting any business enterprise, especially in the food industry, incorporating the business as a corporation or limited liability company is as important as having a good product or solid business plan. Incorporation is essential because it shields owners from the liabilities of their business. A lawsuit against the business will not impact the personal assets of the business owners because the law recognizes the corporation or limited liability company as a distinct and separate entity.

Incorporation by itself, however, is not enough. In order for the liability shield to remain in place, or for the law to continue to recognize the corporation or limited liability company as a separate entity, the entity’s owners need to observe certain formalities. If the owners are not careful, the law may treat the entity and the owners as one and the same and disregard the corporate entity. This is commonly referred to as “piercing the corporate veil.”

Over the next few days, this blog will give you an overview of what the courts look at when they decide whether to disregard a business entity and find its owners liable. We’ll also provide a list of dos and don’ts to help you avoid losing your liability shield. 

For more in-depth discussion of the latest case developments on piercing the corporate veil, especially as it relates to LLCs, keep up with Doug Batey's blog, LLC Monitor.

Settlements and Implied Warranties

Article 2 of the Uniform Commercial Code contains powerful tools for buyers and sellers of food and other goods.  A recent case out of the Georgia Supreme Court emphasizes the critical gatekeeper function of the scope section of Article 2, Section 2-102.  This section provides:

Unless the context otherwise requires, this Article applies to transactions in goods;  it does not apply to any transaction which although in the form of an unconditional contract to sell or present sale is intended to operate only as a security transaction nor does this Article impair or repeal any statute regulating sales to consumers, farmers or other specified classes of buyers.

Prior case law has generally distinguished between contracts whose primary purpose is the sale of goods or services.  For instance, when you deal with a roofing contractor, are you buying the shingles or the installation services?

In Olé Mexican Foods, Inc. v. Hanson Staple Co. (Ga. April 28, 2009), the parties disputed whether certain packaging had met contract specifications.  Without lawyers present, they negoiated a handwritten settlement agreement.  The agreement included a provision whereby the buyer

would “purchase a minimum of $130,000 worth of current inventory from” [seller] and would “test the remainder of inventory and ... purchase additional inventory if it meets quality expectations.”

On a motion to enforce the settlement agreement, buyer got the court to agree that "that such purchases would “be governed by the Georgia Uniform Commercial Code [UCC], and [buyer] shall retain the right to reject [seller's product pursuant to the Georgia [UCC].”

The Georgia Court of Appeals reversed and the Georgia Supreme Court upheld the intermediate appellate court's decision.  The reasoning was that the purpose of the settlement agreement was not the sale of goods, but the settlement of a dispute over the sale of goods. 

The fact that the document at issue is labeled “agreement reached in settlement” “is a good barometer of the parties’ intentions. Though the label that contracting parties affix to an agreement is not necessarily determinative of the agreement’s predominant purpose, it can constitute potent evidence of that purpose.”

Citing a number of cases, the court held that where the purpose was settlement, it would be wrong to treat the case instead as a sale of goods, bringing in the implied warranties that the language of the parties' settlement indicated should not apply to the mandatory purchase of goods pursuant to the settlement.

As a UCC matter, the case is undoubtedly correct.  Kristen David Adams, a professor at Stetson Law School and one of the few others who possess the cap that illustrates this entry, has written:

one reason why the court’s holding is so clearly correct is that a contrary holding would essentially eviscerate the purpose of this particular settlement: since one of the central disputes in the underlying litigation was whether Hanson’s goods were merchantable within the meaning of the Uniform Commercial Code, and since the case was settled rather than having this issue decided by the court, applying the implied warranty of merchantability to the settlement agreement would almost certainly require the parties to relitigate the question of merchantability.

When settling a case involving goods that are alleged not to conform to the contract, then, it is often the case that the terms of the settlement might involve future shipments.  It is therefore critical to recognize that the question of whether implied warranties and other Article 2 default terms should be addressed by the parties directly in the contract, and not left for later interpretation by a court.  In this case, the parties settled without the benefit of counsel, and it is not inconceivable that each had a different take on whether the default warranties would apply.  It is also conceivable that neither gave the question a moment's thought until their respective lawyers looked over their handiwork

Which is another reason to have the advice of counsel when settling a case.

 

Video From Governor's Conference on Ensuring Food Safety

University of Nebraska has posted video on its website from the entire three days of the 2009 Governor’s Conference on Ensuring Food Safety. You can view my presentation on Defending Liability in Foodborne Illness Outbreaks. More important, you view the presentations of Dr. Andrew Benson and the other scientists who offer fascinating insights into the latest developments driving the science of food safety.

Tort Damages Not the Only Exposure from Food-Borne Illness Outbreaks

For lawyers and insurance adjustors, compartmentalizing food-borne illness claims is easy. They often see their jobs solely as minimizing the tort liability and legal fees. In my experience, attorneys and adjustors often fail to appreciate how outbreaks can affect a client’s (or even a whole industry’s) business going forward. Often, the long-term business losses of a food-borne illness outbreak, recall, or government alert are not insured.

There is no better example of how a nationally reported food-borne illness outbreak can affect an entire industry (or even an entire category of food products) than the 2006 E. coli spinach outbreak. Two new studies published by the Agriculture & Applied Economics Association (AAEA) in its Choices magazine analyze consumer information and studies in the wake of the spinach outbreak. 

Among the highlights from the first study, “Public Response to Large-Scale Produce Contamination” by Carra Cuite and William K. Hallman, were findings that Americans were more aware of advisories beginning than ending. For example, 87% of spinach consumers knew about the outbreak, but more than six weeks after the FDA had lifted its spinach warnings “almost half (45%) of people who were aware of the spinach recall were not confident that the recall had ended.”

A second study entitled “E. coli Outbreaks Affect Demand for Salad Vegetables” was authored by Faysal Fahs, Ron C. Mittelhammer, and Jill J. McCluskey. It examines the cumulative effects that sequential outbreaks can have on consumer demand and concludes that “the empirical results suggest that the subsequent outbreaks had a greater impact on the consumption of salad vegetables than the first.”

For food companies the lesson is this:

A lawyer’s role in responding to a food product crisis is important. But the roles of others, such as public relations experts, may be as important or more important in preserving the business. Make sure your lawyer (and your insurer) understands that the world may not revolve around simply resolving the tort claims as economically as possible.

Future of Food Litigation and Obama's Food Safety Working Group

President Obama’s Food Safety Working Group announced its Key Findings on July 7. Three groups of initiatives were announced: 1) Salmonella, 2) National Traceback and Response System, and 3) Improved Organization of Federal Food Safety Responsibilities. All of these represent major shifts in food policy. Coming changes will impact nearly every part of the nation’s food supply.

Despite Obama’s stepped-up food safety agenda, the question of how these changes will affect food-borne illness litigation remains. Bill Marler in a recent blog post reacting to the July 7 Key Findings says, “I really may live to see the government ‘put me out of business.’” No doubt that many of Obama’s initiatives will improve food safety. But will it eliminate food-borne illness and accompanying litigation? Not likely.

Many food companies today follow food safety precautions that exceed anything proposed by the Obama administration or Congress. Yet those same companies continue to experience food-borne illness outbreaks and are targets of the plaintiffs’ bar. E. coli, Salmonella, and other pathogens are persistent in the environment and successful at Darwinian evolution. In some sense, the pathogens that are the source of food-borne illness always seem at least one step ahead of the law.

Crystal ball: Obama’s initiatives will lead to a safer food supply but will also help the government detect more outbreaks that previously went undetected. Undetected outbreaks rarely lead to litigation; detected outbreaks almost always lead to litigation. Growth in food-borne illness litigation, therefore, should continue to accelerate.

HFCS Labeling Case: Opening The Floodgates For New Consumer Claims?

The Third Circuit may be close to opening the floodgates of claims against food and beverage manufacturers who use high-fructose corn syrup (“HFCS”) in products labeled “all natural.” Shannon Duffy at the Legal Intelligencer reported recently on a “lively hour-long” oral argument in the Third Circuit about reversing a District Court’s dismissal of state consumer claims against Snapple for use of HFSC.

The District Court dismissed the consumer claims in 2007 on the basis of field preemption. The dismissal predated the Third Circuit’s decision in Fellner v. Tri-Union Seafood, LLC. See our previous blog on the Fellner case. Despite the FDA’s position in Fellner that a state law failure-to-warn claim is preempted by federal law, the Third Circuit ruled to the contrary.

In Fellner, a claim by a person who suffered from mercury poisoning after eating canned tuna literally for breakfast, lunch and dinner for five years may have been an outlier. But reversal of the District Court’s decision in the Snapple case will open the floodgates to consumer class action claims against a whole slew of food sellers and manufacturers.

Why Are Food-borne Organisms Associated with Beef?

 USDA’s Be Food Safe Twitter Feed circulated its Fact Sheet titled “Beef . . . from Farm to Table.” First published a few years ago, this might be of interest to businesses involved in the sale, marketing, labeling, and/or packaging of beef. The article is a helpful primer on the history of beef, current industry practices, USDA’s role in inspection, consumer trends, cooking times, storage times, and food-borne illnesses associated with beef.

Captain Crunch Suit Dismissed: Court Finds No "Actual Fruit Referred to as Crunchberry"

Yes, someone has actually filed a putative class action on the basis that she was “mislead by the packaging and marketing, which she argues convey the message that the Product contains real, nutritious fruit.” U.S. District Judge England in the Eastern District of California dismissed the complaint captioned as Sugawara v. Pepsico, Inc.

Though Sugawara seems purely frivolous, the claim follows predictably from the Ninth Circuit’s decision in Williams v. Gerber discussed previously on this blog. In Williams, the Ninth Circuit reinstated a putative class action that alleged labeling on “fruit juice snacks” (1) constituted misrepresentation and breach of warranty under California common law and (2) violated California’s statutes on unfair competition and consumer law. The district court had granted a motion to dismiss under Rule 12(b)(6), finding that statements on the label “were not likely to deceive a reasonable consumer, particularly given that the ingredient list was printed on the side of the box.”

Judge England distinguished Sugawara from Williams, writing that

while the challenged packaging contains the word “berries” it does so only in
conjunction with the descriptive term “crunch.” This Court is not aware of, nor has Plaintiff alleged the existence of, any actual fruit referred to as a “crunchberry.” Furthermore, the “Crunchberries” depicted on the PDP are round, crunchy, brightly- colored cereal balls, and the PDP clearly states both that the Product contains “sweetened corn & oat cereal” and that the cereal is “enlarged to show texture.” Thus, a reasonable consumer would not be deceived into believing that the Product in the instant case contained a fruit that does not exist.

Even lawsuits as unmerited as alleging that consumers believe Crunchberries grow on trees are expensive to deal with. As we said following the Williams decision, the sad state of affairs is that the only way manufacturers can mitigate against these types of putative class actions is to directly involve lawyers in the marketing and labeling process.

Avoid Unnecessary Labeling Claims - Ensure That Cooking Instructions Are Adequate

Bill Marler funded independent research at the University of Idaho to study the adequacy of cooking instructions found on the packaging on various retail brands of frozen ground beef patties. The research was published this month in Food Protection Trends.

The study found that three of the packages included cooking instructions that “would be inadequate to produce a safely cooked patty.” Most of the issues raised in the article center on the variability in cooking techniques, e.g., pan frying, using a propane grill, or preheating, and variability in cooking temperatures. Suggested solutions for improved cooking instructions are included in the study.

For food sellers trying to minimize or avoid claims, adequate cooking instructions are a good thing. Even if food-borne illness claims cannot be avoided, the scope of the claims and damages can be limited by providing adequate, "bullet-proof", cooking instructions.

Kudos to Bill Marler for “putting skin in the game” and funding this study.

Energy Drink Maker Sued Over Alleged Health Risks

The maker of Redline energy drinks has been sued in federal court in California.  The plaintiff, Zack Aaronson, is seeking class action status for his lawsuit against Vital Pharmaceuticals, Inc. (operating under the trademark VPX).

The plaintiff claims that VPX failed to adequately warn consumers of potential side effects and health risks associated with consuming VPX’s Redline energy products.  Among other things, the plaintiff alleges that consumers have reported adverse side effects including chills, excessive sweating, vomiting, convulsions, chest pains, and rapid heartbeat.

According to VPX’s website, Redline is available as energy drinks and gel caps.  The company touts the products as “the first physique-transforming matrix to coax your body to burn fat through the ‘shivering response.’”

The case is Aaronson v. Vital Pharmacetucals, Inc., S.D. Cal. Case No. 09-1333.  A copy of the complaint is available here.

Trademarking Green/Eco-Friendly Food - What You Need To Know

By Guest Blogger Jere Webb

It is evident that virtually every business now is trying to position itself as being “green”. For a discussion of restrictions on “green advertising”, particularly the FTC’s green ad guidelines (the “Green Guides”), and similar efforts at the state level, see “Green Claims Advertising – What You Can Say and What You Can’t”. The FTC is reviewing the Green Guides and likely will amend them in the near future. For comments submitted in the review process and additional information, see Green Guides.

The newer arena is green trademarks. The United States Patent and Trademark Office is now routinely rejecting, based on descriptiveness, multiword trademarks, that start with or contain the word GREEN. An example is the mark GREEN JOURNEY for hybrid cars. But in the same application, the applicant sought to register for clothing, and the Trademark Office accepted the mark, but with a disclaimer of the word GREEN. It found that the two word mark was merely “suggestive” of clothing, not “descriptive”. See "Green" Trademarks Face Hostile Climate in USPTO.

For an example of a green mark that passed muster, the Trademark Trial and Appeal Board (TTAB) recently reversed an examining attorney’s descriptiveness refusal for the mark GREEN INDIGO for clothing, finding it to be an “incongruous” term for clothing and therefore merely suggestive and not descriptive. The case is In re Jones Investment, Inc. (TTAB Jan. 21, 2009.)

The lesson is: If you want to include the word “GREEN” in a trademark, some careful review and advice from a trademark lawyer is in order.

Want to read more? See “Eco-Friendly Claims Go Unchecked” (USA Today June 22, 2009). The FTC’s brochure “Sorting Out Green Advertising Claims” can be found here.

Sustainability and Consumer Confidence in Food Safety

For food sellers interested in promoting a “sustainable” brand and inspiring food safety confidence in their consumers, meet Food Alliance. Food Alliance “is a nonprofit organization that certifies farms, ranches and food handlers for sustainable agricultural and facility management practices.” It bills itself as “the most comprehensive certification program for sustainably produced food in North America.”

I’ve recently joined the Food Alliance Board of Directors (in fact, I’m headed to Portland today for a board meeting). My hope is to assist Food Alliance in becoming more widely accepted and mainstream. Credible third-party certification, such as Food Alliance provides, offers a transparent pathway to sustainability of our food supply and consumer confidence in food safety.

Food Alliance takes a holistic approach that is broader and more dynamic than organic certification, which does nothing to address food contamination from pathogens such as Salmonella, E. coli, and Listeria (in fact, many experts believe that organically grown food may be more likely to be contaminated by these pathogens). By way of example, Food Alliance certification standards, among other things, address “soil and water quality,” “ensure the health and humane treatment of animals,” “conserve energy and water,” and “ensure quality control and food handling safety.”

For more on why a holistic, independent third-party certification correlates with food safety (and accompanying consumer confidence), I’d suggest reading this op-ed piece co-authored by Food Alliance Executive Director Scott Exo, which was written earlier this year in the wake of the PCA peanut recall.

Nolan v. Ocean Spray Verdict: The PACA Angle

Jim Prevor, the author of the Perishable Pundit blog and a man who has probably forgotten more about the produce industry and its practices than many will learn in a lifetime, has been blogging constantly about the lawsuit brought by Theresa Nolan, her company The Nolan Network and her late husband Jim against Ocean Spray Cranberries, Inc.  On May 30, he reported that a jury in Plymouth, Massachusetts, home of Ocean Spray, had brought in a $1 million verdict against Ocean Spray and in favor of the Nolans. 

The lawsuit involved marketing practices with fresh cranberries, a minor part of Ocean Spray's business compared to, say, cranberry juice cocktail.  The background to the case is discussed at length in an article by Bill Martin in Jim Prevor's other publication, Produce Business.  As far as I can tell from the news reports, the actual allegation in the lawsuit was a violation of Chapter 93A of the Massachusetts General Laws, This broadly prohibits unfair or deceptive acts or practices in trade or commerce.  I'm not a Massachusetts lawyer, but I did a stint as a law clerk for the Massachusetts Appeals Court and my recollection is that Chapter 93A was considerably stronger in application and interpretation than many other states' mini-FTC Acts, particularly since a private right of action is included essentially without limit. 

The core of the allegations related to alleged differential pricing afforded by Ocean Spray to Costco and H.E. Butt in 2000 and 2002, respectively.  How this eventually led to the Nolans' claim is too complicated to discuss here.  I am more interested, however, in a suggestion Jim Prevor makes in some of his columns on the case, that the alleged differential pricing and the way it was dealt with might have violated PACA, the Perishable Agricultural Commodities Act,.

A key allegation is that C&S Wholesale Grocers, which supplied fresh cranberries to BJ's Wholesale Club, a competitor of Costco, was told by Ocean Spray, upon complaining about the price advantage allegedly given Costco, "to claim some cranberries it would receive from Ocean Spray were of poor quality and to take a discount from the Ocean Spray invoice." 

If true, there are ways that such treatment could violate PACA or violate the duties that Ocean Spray owed to its growers. 

PACA is best-known for creating a statutory trust in favor of unpaid growers of perishable agricultural commodities.  It also, however, requires people who deal in those commodities to account accurately for all transactions in those commodities.  Thus, the allegation that a buyer was told, in essence, to make a claim that certain cranberries were of lesser quality than they actually were raises the issue of whether some of Ocean Spray's growers were provided reports on their cranberries that inaccurately represented their quality (if not, one wonders how the auditors would have missed it, since they would have presumably had to match the returns from the pools that included the sales to C&S against the payments from C&S).  It's a reasonable question, though nothing that has occurred to date appears to have answered it. 

It is conceivable, of course, that the matter was settled internally without publicity, or that the growers involved considered the issue too small to litigate.  Anyone handling fruit or vegetables within PACA's ambit, though, must be aware that any form of inaccurate reporting can violate the statute.

More on Reducing the Risk of Failure - Focus on Shifting Liability For Consumer Claims

Food Safety Magazine ran an interesting piece by Aaron Krauss titled “Reducing the Risk of Failure.”  The article was part of the magazine’s focus on limiting liability for food companies.  Mr. Krauss includes a good discussion of the pros and cons of indemnities and disclaimers of warranty and liability as ways to shift or reduce liability for claims within the supply chain.  Yet, the article does not discuss how to shift liability for claims from outside the supply chain, i.e., consumer claims.

For example, Mr. Krauss advocates that if members of the supply chain limited liability between themselves to the purchase price of the product, this might reduce or eliminate litigation.  Mr. Krauss points out that “if everyone in the ‘peanut butter food chain’ had limited their liability, a store might not bother suing, since it could only recover its purchase price.”

Limitation of liability clauses, while effective to reduce exposure between members of the supply chain, will have no limiting effect on consumer claims.  Unless a food seller can invoke a “passive retailer” defense,  each member of the supply chain will be strictly liable for injuries to consumers caused by the food product.

The only ways for a food seller to shift consumer liability is through either supplier indemnity or insurance.  Mr. Krauss is correct that indemnities by suppliers may be hard to secure and harder to enforce. And, claims defended by the seller’s own carrier will invariably result in higher premiums.

Because insureds will generally be penalized through premiums for invoking their own insurance, the best insurance is somebody else’s insurance.  Even a food seller that might not have the leverage with its supplier to receive indemnification may be able to secure “additional insurance.”  Naming a vendor as an additional insured frequently costs the supplier nothing in added premiums.  If seller specifies that this insurance is to be “primary and noncontributory,” the supplier’s insurance may be the first line of defense for claims involving the supplier’s products. 

If a supplier will provide additional insurance, follow-through is essential. The seller needs to (1) verify that the supplier has, in fact, named the seller as an additional insured and (2) review the operative language of the additional insured endorsement and/or policy language to ensure that it does not include unacceptable conditions or exclusions.

 

Tips For Successful Multiparty Food Liability Mediation

Mediation has become a critical process for resolving large, multi-party consumer claims. Settlement of these claims is often complicated by insurance and third-party recovery. Often a brokered process is the only practical way to get to a meeting of the minds. Yet, in my experience mediations that can succeed fail because of the lawyers and mediators. Having been through a number of multiparty mediations (sometimes with more than 20 separately represented interests) and having been trained as a mediator, here are my top five tips entering into a multiparty mediation:

1.            Bargain from Strength—Be Prepared to Try the Case. Go into the mediation with well-developed trial themes, a trial plan, an opening statement, prepared expert witnesses, and, if possible, jury research. Whether the mediation occurs early on in the case or on the eve of trial, your opponents will know whether you are prepared to try the case. If you are not prepared, settlement will be harder and your client will be asked to compromise more. While trial preparation is critical in any case, it is most critical where the liability and damages claims against your client are the strongest and your client is in a difficult position (i.e., those cases your client would least like to try). For these cases, any leverage your client can bring to the table is important. Creating the perception that your client is ready to go to trial will create leverage.

2.            Make Sure the Right Players Are Present and Educated. Mediation cannot succeed unless each party includes a client/insurer representative with full settlement authority (or easy access to full settlement authority). For large multiparty claims, having those representatives physically present is critical. Perhaps more important is that those with authority be prepared in advance of mediation to exercise authority. It should go without mention that a lawyer should prepare his or her own client for mediation by providing a complete and honest assessment of the settlement value.

As or more important may be educating the opposing party, though this is easier said than done. Communicating your adversary’s weaknesses to your adversary is tricky. In most situations, a lawyer’s assessment of the opponent’s weaknesses is not considered credible and is written off as “chest-beating.” The only way a lawyer can succeed in communicating with an opponent about the opponent’s weaknesses is if the lawyer has worked in advance at building a relationship and credibility with the adversary.

3.            Select the Right Mediator. For difficult multiparty cases, mediator selection is an important, though often overlooked, key to success. Look for a mediator who will work hard in advance of the mediation to understand the barriers to settlement (see number 4 below). Look also for a mediator who (1) has the ability to quickly grasp complex issues impeding settlement; (2) is not afraid to confront parties with difficult questions; and (3) understands the mediation process, possesses good people skills, and is creative. Avoid at all costs a mediator whose primary tool is to brow-beat, make rulings, or intimidate the parties (this never works unless the mediator also happens to be your trial judge).

4.            Educate the Mediator (Well in Advance of the Mediation if Possible). If a mediator has waited until the morning of mediation to first meet with the parties, it may be too late. If there are more than a few interests represented, the entire mediation session may be consumed in educating the mediator about the relevant issues. Worse, the mediator may feel a need to take “short-cuts” and end up alienating the parties before negotiations have really begun. At minimum, the mediator should spend time well in advance of the mediation date, preferably in person, talking with counsel from each side. In advance of mediation, parties should also consider setting up a session for the mediator to hear directly from key expert witnesses. On the morning of the mediation, the mediator should have learned enough to understand the major settlement impediments and should come with a plan of action.

5.            Diffuse Personality Conflicts and Emotions. If your client’s goal is to settle the case if at all possible, a trial lawyer must do what he or she can to set aside the skirmishes, grudges, or ill will that might have built up during discovery, motion practice, pretrial preparation, etc. While I’m a big proponent of setting aside ego and of building relationships in litigation, this may not always be possible. But mediation/settlement negotiations are the one time in the litigation process where consensus building is the objective. Lawyers should do what they can (swallow pride, move on, etc.) to extricate personality conflicts from the mediation.

Similarly, lawyers should assess during the mediation the degree to which personality conflicts and emotions among the parties are inhibiting consensus. When practical, lawyers should consider counseling their clients on setting aside ego and emotions. If a heart-felt apology or another message can bridge the difference between the parties, the client should be told and given the opportunity to make the apology or to communicate.

Court Rules That Retailers Have No Duty to Investigate Suppliers Compliance with Organic Regulations

An important ruling was issued last week dismissing claims that milk produced by an organically certified dairy and labeled as organic was not really organic. Plaintiffs in the action asserted violations of various states’ laws because they claimed that they paid more for the milk because it was labeled as "organic.”

A federal judge in the Eastern District of Missouri granted a Rule 12(b)(6) motion to dismiss on a multitude of cases pending against the dairy, various retailers selling the dairy products and others (originally these suits were filed in various federal courts around the country but were consolidated for pretrial purposes by the United States Judicial Panel on Multi-District Litigation or MDL).

The judge ruled that claims against the dairy were preempted because a “conflict exists between federal and state law” (otherwise known as “conflict preemption”). As explained in the opinion, conflict preemption exists where “a party’s compliance with both federal and state law would be impossible or where state law would pose an obstacle to the accomplishment of congressional objectives.” Here, the court found that for “plaintiff’s claims to succeed, the Court would have to invalidate the regulatory scheme established under the OFPA [Organic Foods Production Act] and NOP [National Organic Program].” The court concluded that if plaintiffs were to prevail “producers would be liable even where fully certified and authorized to use these terms and seals.”

For the retailer defendants, the judge ruled that because plaintiffs’ claims against the dairy are preempted, “the retailer Defendants cannot be liable.” But the court went further and dealt explicitly with the plaintiffs’ claims that the retailers “should have investigated” the dairy’s activities to ensure compliance with the OFPA and NOP. The court rejected these arguments:

The Retailer Defendants did not have any duty to inspect [the dairy’s] facilities, or the facilities of any of their other organic producers. Imposing such a requirement “would place an undue burden on the distributor who is least likely to have access to such information.”

This should be good news for organic retailers. Hopefully, this decision will reduce their legal exposure to consumer labeling claims going forward.

Tracking the Food Safety Working Group - More or Less Legal Exposure For Food Sellers?

This week the Obama administration announced the launch of a new website for the recently formed food safety working group. Obama announced the formation of this group in March in the wake of the high-profile food safety issues surrounding PCA peanut products

This website will assist in tracking the efforts of the working group. As discussed previously on this blog, this group is expected to make recommendations aimed at detection, awareness and government reorganization. Possible examples include increasing funding to states to monitor food-borne illness, combining FDA and USDA food safety efforts, reexamining mandatory recall authority, increasing retail enforcement and implementing more aggressive consumer warnings.

What is not clear is whether the working group will look beyond just detection, awareness and reorganization to bolder initiatives that may result in less consumer illness and less legal exposure for food sellers. Bolder initiatives could include funding for irradiation, consumer food safety education, and fast-track development and implementation of technology that can sample food products for whole colonies of microorganisms

 

Defending Liability in Foodborne Illness Outbreaks

I’m asked frequently about the “anatomy of litigation.” I plan to write more in this space on the topic. For now, some may find useful the slides from a presentation I gave recently on “Defending Liability in Foodborne Illness Outbreaks.” I discussed what I see as three prototypes of consumer claims and possible strategies to respond to each.

Judge Denies Class Action Status in McDonald's French Fry and Hash Brown Litigation

A lawsuit claiming that McDonald’s deceived the public about ingredients in its french fries and hash browns will not proceed as a class action. A federal judge in Chicago has denied the plaintiffs’ motion for class certification, characterizing the proposed class and subclasses as “too indefinite and overbroad.”

According to the court’s opinion, the potato suppliers who provide McDonald’s with its french fries and hash browns par-fry the potatoes in oil made of 99 percent vegetable oil and one percent natural beef flavor. The beef flavor is partly made from wheat bran and casein (a dairy product). McDonald’s restaurants then fry the potatoes in 100% vegetable oil prior to serving the products to customers. Plaintiffs allege that McDonald’s falsely claimed its french fries and hash browns were gluten, wheat, and dairy-free. They say that they never would have purchased the potato products if they knew that the fries and hash browns were partially fried in oil containing wheat bran and casein. McDonald’s corrected its disclosure in 2006.

The plaintiffs proposed a class consisting of all persons residing in the United States who purchased McDonald’s french fries or hash browns between February 2002 and February 2006 and who, at the time of purchase, had been diagnosed with celiac disease, galactosemia, autism, and/or wheat, gluten, or dairy allergies.

In rejecting class certification, U.S. District Judge Elaine Bucklo noted that none of the plaintiffs has suffered any physical injury from eating the potato products; indeed, she noted that “plaintiffs testified in their depositions that they were quite satisfied with the Potato Products they consumed.” Additionally, Judge Bucklo noted that proving economic damage would be an “evidentiary headache” because the court would be required to review potentially millions of letters proving plaintiffs’ medical diagnoses and the damage to each potential class member would be nominal: between $1.00 and $1.50. Finally, the court ruled a nationwide class action would be unmanageable because state laws at issue in the case vary too much to apply to plaintiffs from across the country.

The case is In re McDonald’s French Fries Litigation, MDL No. 1784.

Kellogg Co. Agrees to Settle False Advertising Claims

Cereal maker Kellogg Company has entered into a consent agreement with the U.S. Federal Trade Commission to settle charges that certain Kellogg advertisements contain false or misleading statements.

At issue in the FTC’s complaint are statements from Kellogg’s advertising that eating a bowl of Kellogg’s Frosted Mini-Wheats cereal for breakfast is clinically shown to improve kids’ attentiveness by nearly 20 percent. The complaint also challenges a separate advertising claim that eating Frosted Mini-Wheats for breakfast was clinically shown to improve children’s attentiveness by nearly 20 percent when compared to children who ate no breakfast. The complaint alleges that both of the challenged claims are false and violate the Federal Trade Commission Act.

The proposed settlement would, among other things, bar Kellogg from making comparable claims about Frosted Mini-Wheats unless the claims are true and not misleading. The consent agreement will be subject to public comment through May 19, 2009. The FTC will then decide whether to make the agreement final.

Update: Supreme Court Declines Review of Methylmercury Case With Potential Preemption Implications

An update to a case we’ve been following: the U.S. Supreme Court has refused to review a decision by the U.S. Court of Appeals for the Third Circuit involving state-law claims over methylmercury content in canned tuna.

The Supreme Court’s order in Tri-Union Seafoods, LLC v. Fellner leaves in place the Third Circuit’s ruling that allowed the plaintiff to sue the maker of Chicken of the Sea products over methylmercury poisoning she allegedly suffered after consuming canned tuna almost exclusively for five years.

In its petition for a writ of certiorari, Tri-Union Seafoods argued that the Supreme Court should review the case to determine, among other things, whether regulatory actions by the U.S. Food and Drug Administration and the Federal Food, Drug, and Cosmetics Act preempt state-law claims based on a failure to warn of the risks of methylmercury in tuna products. The Supreme Court declined to review the case without comment.

Nestle's Makes the Very Best Peanut Decision

On Thursday, March 19, the Oversight and Investigations Subcommittee of the House Energy and Commerce Committee held another hearing on Peanut Corporation of America and the Salmonella outbreak.  A focus of the hearing was the different choices made by Nestle USA, which had refused to buy PCA peanuts, and the companies testifying at the hearing, including Kellogg and King Nut, which had. 

Nestle, when considering buying peanuts from PCA, had sent its own inspectors to PCA's plants.  They found, according to a report of the hearing in the Washington Post, some rather damaging items:

rat droppings, live beetles, dead insects and the potential for microbial contamination

Nestle, not surprisingly, declined to buy from PCA. 

At the hearing, witnesses from Kellogg and King Nut were questioned as to why they had not done their own inspections, instead relying on inspections by AIB, the American Institute of Baking, which were paid for by PCA, and which apparently tipped PCA about when it was coming

The question nobody seemed to ask--and no one from Nestle was at the hearing--was why Nestle could not have made the results of its inspection public at the time?  If there are "rodent droppings in the break room cabinets", and the company is selling peanuts to other members of the general public, just not through Nestle, isn't this something that should be made known to someone?

One answer lies in the fear of the various torts that come under the heading of "trade libel."  Nestle is a big company, and even though it presumably trusts its inspectors (and makes important business decisions based on their reports), it must recognize that it is a potential "deep pocket" for lawsuits.  Thus, to report publicly what its inspectors found, or even to make that information avaiable to others in the food industry, is to risk a major lawsuit. 

The flip side should also be considered.  If you are PCA, and someone broadcasts to the world that you have rat droppings in your break room cabinets, you are likely to experience significant losses, regardless of whether the report is true, and whether the presence of rat droppings in your cabinets affects the actual safety of your food.  What we do know is that in 2008 PCA began shipping peanuts that killed people.  The rat droppings found in the 2002 Nestle inspection presumably had nothing to do with those deaths, nor are we aware of any deaths or illnesses from PCA peanuts in the interim.  Finally, we do not of course know whether there are other suppliers Nestle or others who conducted their own inspections rejected, and what they did with the news of rejection.  Nestle, for instance, didn't write off PCA when it rejected it in 2002; it checked out another PCA facility in 2006 (and came to similar conclusions). 

Then there is the question of what contractual rights and obligations existed between PCA and Nestle.  Did PCA require Nestle to sign a non-disclosure agreement when it allowed it into the plants?  Any well-advised company would require such an agreement at the very least to protect proprietary technology.  Thus, Nestle may have been contractually bound not to reveal the results of its inspections.

As food safety legislation is being considered, the issue of tort liability and the right to use contracts to silence someone who knows about your dirty facility should be faced.  It is not as simple as "all inspections should be public", but it is also unlikely to remain as business as usual.  We publicize the results of government restaurant inspections without putting all restaurants that fail to pass inspection out of business.   

California Appeals Court: No Mercury Warnings Required on Canned Tuna

The California Court of Appeal for the First Appellate District has upheld a trial court ruling that canned tuna sold in California need not warn consumers about methylmercury.

 

In 2004, the State of California sued three tuna companies: Tri-Union Seafoods, LLC; Del Monte Corporation; and Bumble Bee Foods, LLC. The state argued, among other things, that California’s Proposition 65 requires the companies to provide warnings to pregnant women and women of childbearing age that the canned tuna the companies distribute and sell contains trace amounts of methylmercury, a chemical that can cause harm to a developing fetus. After a six-week trial in 2006, the lower court ruled against the state, holding that (i) Proposition 65 was preempted because it conflicts with federal law, (ii) the amount of methylmercury in canned tuna does not rise to the threshold level that would require a warning on the product, and (iii) the tuna companies are exempt from Proposition 65’s warning requirements because virtually all methylmercury is “naturally occurring.”

 

The state appealed, and the appellate court recently issued a decision upholding the tuna companies’ victory on the sole basis that substantial evidence supported the trial court’s finding that methylmercury is naturally occurring in canned tuna. Proposition 65 contains several exemptions to its warning requirements, one of which provides that there is no duty to warn if a chemical is naturally occurring in food. Significantly, the appellate court did not address the preemption or threshold level findings of the trial court. The court also posited scenarios that could lead to a renewed Proposition 65 claim against the tuna companies (see page 28 of the decision).

 

No word yet on whether the state plans to appeal to the California Supreme Court.

Alaska Unfair Trade Practices and Consumer Protection Statute

As discussed previously on this blog, the ABA Section of Litigation, Products Liability Committee will soon publish its 50-state survey on consumer protection statutes. In addition to the chapter on Washington, Bryan Anderson and I also coauthored the Alaska chapter.  

As with Washington, the Alaska statute is quite broad. See AS § 45.50.471-.561. A recent development in Alaska law extends the act to permit claims between commercial entities. See W. Star Trucks v. Big Iron Equip. Serv., Inc., 101 P.3d 1047 (Alaska 2004).  

A unique aspect of Alaska law is that it follows the English Rule awarding attorneys’ fees to the prevailing party. An interesting issue arises in the class context when a defendant “prevails” in a class suit. Who is responsible for paying prevailing party fees under Alaska Civil Rule 82 or AS § 45.50.537? The Alaska Supreme Court has resolved this issue by deciding that “named” class members may be liable for a prevailing defendant’s attorneys’ fees but that “absent” class members who are passive and have “relatively small claims” may not. See Turner v. Alaska Commc’ns Sys. Long Distance, Inc., 78 P.3d 264, 266-70 (Alaska 2003).

Washington Consumer Protection Law

The ABA Section of Litigation, Products Liability Committee will soon publish its 50-state survey on consumer protection statutes. Bryan Anderson and I coauthored the chapter for the state of Washington. As described in our article, Washington’s Consumer Protection Act, RCW 19.86.010, et seq., is quite broad:  

The Act is modeled after federal statutes, primarily the Federal Trade Commission Act, the Sherman Act, and sections of the Clayton Act. The purpose of the CPA is “to protect the public and foster fair and honest competition.” RCW 19.86.910. The CPA is “a carefully drafted attempt to bring within its reaches every person who conducts unfair or deceptive acts or practices in any trade or commerce.” Short v. Demopolis, 691 P.2d 163 (Wash. 1984) (emphasis in original). It is to be “liberally construed that its beneficial purposes may be served.” RCW 19.86.920.

Standing is also quite broad, allowing a party without monetary damages to bring suit:   

The Washington Supreme Court has recognized that the use of the term “injured” in this statutory provision “makes clear that no monetary damages need be proven” to have a cognizable claim under the CPA, and that “nonquantifiable injuries, such as loss of goodwill[,] would suffice. . . .” Nordstrom, Inc. v. Tampourlos, 733 P.2d 208, 211 (Wash. 1987).  

In fact, the Washington Supreme Court held that “a physician whose reputation is injured has standing to sue a drug company which engaged in an unfair or deceptive trade practice by failing to warn the physician of the dangers of its drug about which it had knowledge.” Wash. State Physicians Ins. Exch. & Ass’n v. Fisons Corp., 858 P.2d 1054, 1060 (Wash. 1993).

Another interesting development discussed in the article is that the “Supreme Court of Washington recently invalidated a class-action waiver in an arbitration clause of a contract for cellular telephone service, explaining that ‘without class actions, consumers would have far less ability to vindicate the CPA.’” Scott v. Cingular Wireless, 161 P.3d 1000 (Wash. 2007)

Another High-Profile California Labeling Case

Center for Science in the Public Interest (CSPI) recently filed a putative class action in federal court in the Northern District of California claiming that Glacéau’s VitaminWater is mislabeled under California law. This suit comes on the heels of the recent Ninth Circuit decision that remanded the Gerber foods case. We previously discussed the Gerber case on this blog and how it presents “serious questions as to whether there are any clearly defined legal standards as to when a food label is misleading and when it’s not.”

The VitaminWater case appears to raise similar issues. CSPI fails to point to anything directly in VitaminWater’s labeling or advertising that is actually incorrect. Instead, CSPI asserts that “the central message” of VitaminWater’s labeling “is that drinking VitaminWater is good for one’s health.” CSPI asserts this is misleading because “VitaminWater is loaded with sugar” and as a result “may actually harm consumers’ health.” CSPI also faults the product labeling because it fails to disclose that Glacéau, the company that manufactures VitaminWater, was purchased by a soft drink manufacturer.

Supreme Court Asked to Hear Preemption Case Involving Methylmercury; FDA Issues Draft Documents Regarding Consuming Commercial Fish

By Guest Blogger Bryan Anderson

The maker of Chicken of the Sea products has asked the U.S. Supreme Court to grant certiorari in a case we reported on involving preemption of state-law tort claims. In August 2008, the Third Circuit in Fellner v. Tri-Union Seafoods, LLC reversed the district court and held that Food and Drug Administration (FDA) actions regarding methylmercury content in tuna did not preempt the plaintiff’s claims under the New Jersey Product Liability Act. Tri-Union Seafoods’ certiorari petition presents two questions for the Supreme Court’s consideration:

1. Whether state-law tort claims based upon failure to warn of the risks of methylmercury in tuna fish products are preempted by the Federal Food, Drug, and Cosmetics Act and regulatory actions of the FDA, including a written determination that state-law warning requirements concerning methylmercury in tuna products are preempted by federal law and denial of a petition to require such warnings; and

2. Whether a “presumption against preemption” applies in conflict preemption cases.

If the Court grants the petition and hears the case, it certainly will have implications concerning local and state labeling requirements vis-à-vis federal agency action. Stay tuned; we will update you on this case as the plaintiff/respondent submits her brief opposing the petition.

Also related to methylmercury, the FDA yesterday published a notice in the Federal Register announcing the availability of two draft documents assessing the benefits and risks of consuming commercial fish.

The first document attempts to quantify the impact of eating commercial fish on three health endpoints: (i) fetal neurodevelopment, (ii) risk of fatal coronary heart disease, and (iii) risk of fatal stroke. The FDA notes that “[e]ach of these health endpoints has been associated in the scientific literature both with adverse effects of methylmercury exposure (including through fish consumption) and beneficial effects of regular fish consumption.”

The second document provides an overview of published scientific literature regarding beneficial effects of fish consumption and Omega-3 fatty acids for neurodevelopmental and cardiovascular endpoints.

Supreme Court Denies Certiorari on Salmon Labeling Case

UPDATE to previous blog entries about the California salmon labeling case (Albertsons v. Kanter) -

Just yesterday, the U.S. Supreme Court denied certiorari.  The Supreme Court's ruling followed briefing submitted by the Solicitor General (aka Bush Administration). The Bush Administration  argued in support of the California Supreme Court's  opinion that claims under state law for alleged mislabeling of salmon are not preempted by federal law. The ruling of the California Supreme Court denying federal preemption will stand. The case will be sent back to the trial court to proceed as a putative class action.

When Is Labeling Misleading and Actionable Under State Law? Is There Any Clearly Understood Standard?

A recent Ninth Circuit case again raises serious questions as to whether there are any clearly defined legal standards as to when a food label is misleading and when it’s not. Manufacturers who are in compliance with federal standards for labeling may still be liable under state law.

In Williams v. Gerber, the Ninth Circuit, reversing the district court, reinstated a putative class action that alleged labeling on “fruit juice snacks” (1) constituted misrepresentation and breach of warranty under California common law and (2) violated California’s statutes on unfair competition and consumer law. The district court had granted a motion to dismiss under Rule 12(b)(6), finding that statements on the label “were not likely to deceive a reasonable consumer, particularly given that the ingredient list was printed on the side of the box.”

Here’s the label in question:

In particular, the appellate court did not approve that the product, made of white grape juice, featured photographs of a variety of fruit on the label. The court also found misleading the statement that the product was made with “fruit juice and other all natural ingredients.” The product contained in addition to all-natural ingredients some ingredients the Ninth Circuit believed may not be “all natural.” The court believed that the statement, though not untruthful, should have disclosed more information.

Troubling in the court’s decision is that full nutritional and ingredient information was printed in similar size print on the same label. Even the court acknowledged that “reasonable consumers expect that the ingredient list contains more detailed information about the product . . . .” As a practical matter, the only way manufacturers can mitigate against these types of putative class actions is to involve lawyers directly in the marketing and labeling process. Under the world imagined in the Williams case, legal training seems to be a prerequisite to understanding which labels may give rise to litigation and which may not.

Happy New Year and Thank You

Happy New Year. Thank you for your support, readership and feedback for this site. Since we launched the blog in late February of 2008, the growth in readership has been extraordinary. I'm overwhelmed at the response. My hope is that the blog has provided some measure of assistance to those in the food industry. As always, I welcome your feedback, suggestions and critiques.

In the coming year, I hope to spend more time on the blog exploring trends in liability, insurance coverage and consumer claims related to the food industry. I also hope to discuss more deeply the anatomy of consumer-based food borne illness and labeling litigation.

You may notice a drop-off in the frequency of postings between February and April as I will be spending more time on the road. I apologize in advance. One of the things I will be doing (and posting about) is visiting with students and faculty at the Cornell Food Science program in Ithaca, New York. I hope to learn more about emerging technologies related to food production and safety.

The Latest On The Battle Over Federal Preemption of State Salmon Labeling Claims. . .

 

The Supreme Court signaled last fall it may review a California Supreme Court decision finding that federal law does not preempt claims for violations of state consumer protection laws concerning “selling artificially colored farmed salmon without disclosing to . . . customers the use of color additive.” It invited the justice department to comment on the petition for certiorari.

                                                   

Not surprisingly, the Bush Administration through its solicitor general took the side of those who seek to uphold the California Supreme Court’s decision finding no federal preemption. The petitioners filed a brief responsive to the government. Their argument is in part that:

In its brief, the United States never explains thequestion at the heart of this case: why Congresswould expressly prohibit private actions and even unsupervised state government actions to enforce the FDCA, but allow unregulable private actions toenforce state laws identical to the FDCA. Permitting private litigants to enforce state laws that admittedly“mirror” FDCA requirements cannot be squared with Congress’ intent that such requirements be enforced by government entities alone andthat control over such litigation be federally centralized.

It appears that the Supreme Court’s decision whether to accept review of this case will come earlier in the new year. Most Supreme Court watchers give this case a strong chance of receiving review. The decision could change the landscape of food liability law dramatically.

Practical Advice for Litigating the Food Case

Click here for the slides from a presentation I gave recently with Shawn Stevens entitled "Practical Advice for Litigating the Case: Retaining Experts, Assessing Damages and Planing Trial Strategy." Two threads of my part of the presentation were organization and relationships (I believe that these were also central to Obama's campaign hence the campaign log).

In the coming months, I intend to use this blog to continue my series on the anatomy of complex, multi-party consumer based claims. Building organization and relationships will be discussed heavily as central to positioning a case succussfully for trial (and settlement).

Is It Really A Food-Borne Illness?

At a recent presentation, Dr. Alan Melnick, a public health officer in both Oregon and Washington, provided a useful list of alternative causes of symptoms to consider when someone claims a food-borne illness. Other causes of symptoms that might be confused for food-borne illness include (but may not be limited to):

Another practical piece of advice offered by Dr. Melnick: When assessing a food-borne illness claim, determine whether the incubation period is compatible with the illness. Incubation periods (along with other useful information) were provided by Dr. Melnick (relying upon the CDC) as follows:

Pathogen

Incubation

Symptoms

Duration

Source

Bacillus cereus

1-6 hours (vomiting); 6-24 hours (diarrhea)

Nausea and vomiting or colic and diarrhea 24 hours (short form); 24-48 hours (long form) Soil organism found in raw, dry and processed foods, e.d. rice
Campylobacter 2-10 days; usually 2-5 days Diarrhea, cramps, fever and vomiting; diarrhea may be bloody 2-10 days Raw and undercooked poultry, unpasteurized milk, water
Clostridium botulinum (botulism) 2 hours to 8 days; usually 12-48 hours Vomiting, diarrhea, blurred vision, double vision, difficulty swallowing, descending muscle weakness Variable (days to months) Home-canned food, improperly canned commercial foods
Clostridium perfringens 6-24 hours Cramps, diarrhea 24-48 hours Meats, poultry, gravy; foods kept warm
Enterro-hemorrhagic E. coli, including E. coli O157:H7 and other Shiga toxin-producing E. coli (STEC) 1-10 days; usually 3-4 days Diarrhea, frequently bloody; abdominal cramps (often severe); little or no fever; 5-10% develop Hemolytic-uremic syndrome (HUS) and average of 7 days after onset, when diarrhea is improving (more common in children, elderly and immune-compromised) 5-10 days Ground beef, unpasteurized milk and juice, raw fruits and vegetables, contaminated water, sprouts, person to person
Listeria 9-48 hours for GI symptoms; 2-6 weeks for invasive disease Fever, muscle aches and nausea or diarrhea; pregnant women may have flu-like illness and stillbirth; elderly, immune-compromised and infants infected from mother can get sepsis and meningitis Variable Fresh soft cheeses, unpasteurized or inadequately pasteurized milk, ready-to eat deli meats and hot dogs
Salmonella 6 hours to 10 days; usually 5-48 hours Nausea, diarrhea, cramps, fever 4-7 days Poultry, eggs, meat, unpasteurized milk or juice, raw fruits and vegetables (e.g., sprouts), person to person
Shigella 12 hours to 6 days; usually 2-4 days Abdominal cramps, fever and diarrhea; stool may contain blood and mucus 4-7 days Contaminated food or water, raw foods touched by food workers, raw vegetables, egg salads, person to person
Staph (toxin) 30 minutes to 8 hours; usually 2-4 hours Nausea, cramps, vomiting, diarrhea  24-48 hours Custards, cream fillings, potato or egg salad, sliced meats
Vibrio cholerae 1-5 days Profuse watery diarrhea and vomiting, severe dehydration 3-7 days Contaminated water and shellfish, street vended food 
Vibrio parahaemolyticus 4-30 hours Watery diarrhea, abdominal cramps, nausea, vomiting  2-5 days Undercooked or raw seafood (fish and shellfish) 
Vibrio vulnificus 1-7 days Vomiting, diarrhea, abdominal pain; more severe in patients with liver disease or who are immune-compromised; can cause invasive infection (sepsis) 2-8 days Raw seafood, particularly oysters, harvested from warm coastal waters 
Yersinia 1-10 days; usually 4-6 days Appendicitis-like symptoms (diarrhea and vomiting, abdominal pain)  1-3 weeks  Undercooked pork, unpasteurized milk, contaminated water

 

2009 Priorities for USDA in Food Safety

I just returned from ACI’s Second National Forum on Food-Borne Illness, which included several interesting presentations and discussions. One was by Dan Engeljohn, Deputy Assistant Administrator of the Office of Policy and Program Development at the Food Safety and Inspection Service (“FSIS”). Mr. Engeljohn spoke about FSIS’s priorities for “2009 and beyond.” Takeaways from this presentation include:

Non-O157 STECs

FSIS is increasingly concerned with strains of E. coli other than O157:H7. Non-O157:H7 strains such as E.coli O121:H19 and O111 are growing more prevalent in the environment. FSIS is putting additional resources into developing methodology for detection of non-O157 STECs.

As FSIS, CDC, FDA and local health departments develop this methodology, the industry can expect more reported outbreaks and more liability exposure. Most experts believe that many non- O157:H7 outbreaks go undetected. Increased focus on detection of non-O157 E. coli strains is yet another reason to examine the sufficiency of your companies' insurance limits.

Frozen, Not Ready to Eat Meals


According to Mr. Engeljohn, because of recent salmonella scares, FSIS remains concerned about “frozen, not ready to eat” meals and specifically “frozen, not ready to eat” poultry meals. He explained that “evidence is mounting that these products cannot be safely prepared unless salmonella is controlled in the source materials.” In other words, FSIS now believes that no amount of package labeling or consumer education can prevent consumers from undercooking these meals.

FSIS jurisdiction over salmonella in poultry is limited. FSIS attempts restrict the sale of “frozen, not ready to eat” meals or impose more stringent standards against salmonella in poultry may be a reach for the agency. As discussed in Supreme Beef Processors v. USDA Salmonella, "is not an adulterant per se, meaning its presence does not require the USDA to refuse to stamp such meat 'inspected and passed.'" Absent statutory reform, FSIS action in this area may be challenged.

Listeria


Mr. Engeljohn stated that FSIS is “deeply concerned” about listeria. It believes that gains made in recent years at meatpacking plants may be undone by problems at supermarket deli counters. FSIS believes that little is being done to address critical control points at the retail level, such as proper cleaning and sanitizing of meat slicers. FSIS may be exploring ways to exercise more jurisdiction to regulate supermarket delis.

Dramatic Shift in Plaintiffs' Burden of Proof for Food-Borne Illness Claims?

A California Court of Appeal panel recently issued a lengthy decision in Sarti v. Salt Creek Ltd. (2008 WL 5006537)  reversing a trial court’s grant of judgment notwithstanding the verdict  (JNOV) in a food-borne illness case involving campylobacter. Sarti is alarming. The California court substantially lightened the plaintiff’s burden of proof by requiring her to come forth with only enough evidence to “infer” a causational nexus between her illness and the defendant’s food. Close examination of the facts in Sarti reveals that the plaintiff in that case may not have proven anything to establish a causational nexus.


Sarti involves a woman who allegedly became ill with campylobacter the morning after she consumed a raw ahi tuna appetizer at the defendant’s restaurant. According to the Cleveland Clinic, campylobacter has a two- to five-day incubation period. The court does not explain in its decision what, if any, expert testimony was introduced to explain how the incubation period was compatible with the plaintiff’s allegations. Without expert testimony explaining away the apparent insurmountable problem of the incubation period, plaintiff's case should fail as a matter of law. In other words, the plaintiff’s case should never have survived summary judgment.


Not only does the incubation period make the plaintiff’s claim problematic, but other sources of contamination were identified. For example, the court explained that “Sarti herself worked as a supermarket checker the day she became ill, and could, at least in theory, have picked up campylobacter from a leaking bag of raw chicken she might have scanned.”

The plaintiff’s expert offered some theories about how the tuna dish could have become cross-contaminated. According to the health department, “Wipe down rags were not being sanitized between in wiping down surfaces. There was also an insufficient amount of sanitizer in the dishwasher. Chicken tongs were sometimes uses for other food. Raw vegetables were stored under ‘raw meat.’”

The Sarti decision does not indicate whether the plaintiff’s expert could identify any of these theories as more or less likely than sources having nothing to do with the defendant’s restaurant (and, in fact, given the incompatibility of the incubation period, one would think that the defendant’s restaurant should be discounted as the cause). The court does not explain how a reasonable jury could conclude that the plaintiff’s cross-contamination theories were any more likely than the alternative theories for the plaintiff’s illness.

Instead of citing evidence or expert testimony, the Sarti court relies upon a series of food-borne illness cases in California going back nearly a century that address issues of causation. All of the cases relied upon predate DNA serotyping of bacteria, pulsed-field gel electrophoresis, modern techniques of epidemiology, microbiology and medicine. Sarti is seemingly a reversion to the dark ages of food science when it was reasonable to believe that the last thing a person ate is what made the person sick. The Sarti court ignores the science and believes that a jury should be able to do the same.

The Billable Hour - Reflections on the CLE

I had the privilege of participating as a speaker at the Billable Hour CLE held recently at Seattle University School of Law. As an “outside” counsel, here were some of the most significant things I learned:


1. Clients may find the billable-hour system “frustrating.” Though for complex matters, lawyers and clients have to discover the perfect alternative.


2. For business clients, tension exists between alternative fee arrangements, such as fixed fee or contingent fee, and value received. Clients worry about whether alternative fee arrangements will yield lower-quality services and attorney windfalls.


3. For complex litigation (what I do), budgeting early and often is key. Some businesses require monthly budget updates. Designing realistic budgets and tracking those budgets as close to real-time as possible may be key.


4. In-house counsel have clients who are often more demanding than may be apparent to outside counsel. Outside counsel should recognize that their value is measured in large part by the degree to which they help in-house counsel make their own clients happy.


5. Business clients are very concerned about lawyer-firm staffing inefficiencies. Clients do not want to subsidize excessive salaries for new attorneys (often more than salaries for experienced in-house lawyers). Clients are also concerned that senior lawyers may be billing for tasks more appropriately accomplished by less-senior lawyers.


6. “Experts” in the legal profession expect the harsh economics of 2009 to be the best bet in decades for seeing significant change in the industry and the billable-hour paradigm.


 

Registration Still Open For The ACI Food-Borne Illness Litigation Conference in Scottsdale

December 4-5 is the American Conference Institute’s 2nd National Forum on Food-Borne Illness Litigation. The first forum turned out to be a very engaging and diverse forum (e.g. plaintiffs lawyers, industry lawyers, top state and federal officials) on emerging issues in food-borne illness. I will be one of the many speakers. Ralph Weber, an accomplished trial lawyer from Wisconsin, and I will be offering "practical advice for litigating the case, retaining experts, assessing damages and planning a trial strategy." The focus of my presentation will be a discussion of how to develop trial strategy and themes at the earliest possible point, selection of experts and assessment of damages.

I’d urge anybody involved in dealing with risks from food-borne illness think about attending. If you register, mention the promotion code 724L09.S and you’ll get $200 off the conference price. Hope to see you there.

Nitty-Gritty on Menu Labeling Regulations and What Can Be Done to Stem Consumer Litigation

As restaurant chains operating in King County, Washington are readying to comply with the new menu labeling law, serious questions arise. Does each menu item have to be sent to an expensive lab for testing? How accurate does the nutritional information need to be? How does a restaurant account for the inevitable variables of made-to-order meal preparation (an extra tablespoon of cooking oil can add 120 calories to a dish)?  Does a restaurant that complies with the King County law open itself to consumer labeling claims because its nutritional information cannot be 100 percent accurate?

According to the Seattle Post Intelligencer (“PI”), the question concerning the tools that can be used by a restuarant  chain to determine nutritional information may have been resolved in King County. The article reports that restaurant chains in King County have been given authority to “use nutritional software to calculate what was in each menu item rather than the pricey proposition of sending every dish off to a laboratory.”

What is not clear are what protections against consumer protection/tort liability a restaurant may have for “the natural variations that come with cooking restaurant food” or the variability between laboratory analysis and nutritional software. As one restaurateur said, “If you’re working by hand and making pasta, putting in cream and tossing in things as you go, it’s probably fairly close, but there are going to be variances because it’s not prepackaged . . . . Even if you’re cutting a meatloaf, if the specifications [sic] on the meatloaf is 12 ounces and (instead) cuts 13 ounces, it’s going to be off by 6 to 8 percent.”

Legal liability from variables in restaurant cooking is “not a theoretical fear.” As pointed out by the PI, “Applebee’s is facing a $5 million lawsuit over just that issue, after an independent lab found more calories and fat in a menu item than the chain’s nutritional information claimed.” One of the complaints filed against Applebee’s was by a person from the Seattle area.

Serious hurdles exist for any plaintiff’s attorney to prove liability and damages or certify as a class a nutritional labeling case against a restaurant:

1.  Menu labeling suits are based on the theory that the nutritional information disclosed was 80, 90 or even 95 percent accurate and not 100 percent accurate. Does a reasonable consumer really believe that nutritional labeling of restaurant menu items has no room for error? Given the inherent and obvious variabilities involved, isn’t 80, 90 or 95 percent accuracy for nutritional information reasonable?

 2. Even more significant, how does a plaintiff prove causation? Obesity, heart disease and other medical problems are complex medical problems. Even the medical community does not agree on causes of obesity. Surely, obesity , diabetes, and heart problems can't stem from a single meal or even a series of meals from just one restaurant that was 5 percent off in its estimate of nutritional information.

3. Even if liability can be established, class certification seems dubious. How can issues of liability or damages, which by definition vary with each person, ever be considered “common” or “typical” among a vast group of customers sufficient to justify class certification?

As we have seen over and over again in recent legal history, none of these barriers will deter every lawyer. The potential recovery and the targets (i.e. large restaurant chains) are too big not to try. Already, multiple putative class actions have been filed against Applebee’s.

Practically, several things should happen to protect restaurants doing their best to disclose nutritional information to their customers. First, restaurants should be advised to make sure their customers appreciate the variabilities and room for error in their nutritional information. The better a restaurant can prove that a plaintiff was not reasonable in reliance on 100 percent accuracy, the better its chance of having the plaintiff’s claims dismissed.

Second, there should be a legislative solution. The state legislature should exempt from the state consumer protection statute claims for nutritional labeling that meet an accepted standard. Why should restaurants that make their best efforts to disclose nutritional information to their customers be penalized? Without legislation, tort law and consumer protection statutes have the perverse effect of discouraging restaurants from providing disclosures to their customers.

Court to Rule on Consumers' Expectations For Organic Cosmetics

Dr. Bronner’s Magic Soaps (“Dr. Bronner’s”) received a favorable ruling recently in its suit against competitors that it believes are misleading consumers by labeling cosmetic products as “Organic”. Part of Dr. Bronner’s claim appears to be that “Organic” standards established by the U.S. Department of Agriculture (“USDA”) set the bar for consumer expectations of "Organic" cosmetic products. The USDA’s National Organic Program (“NOP”) standards, according to the USDA, do not apply to “cosmetics, body care, or personal care products”.  Dr. Bronner’s argues in its complaint that “[p]ersonal care products labeled as in compliance with ‘Organic’ or ‘Made with Organic [up to three specified ingredients]’ under the NOP criteria reflect basic organic consumer expectations . . . .” (Brackets in original.)

Last week, a California Superior Court in San Francisco overruled the demurrer of Ecocert France (SAS) and Ecocert, Inc. A demurrer is essentially a request made to a court, asking it to dismiss a lawsuit on the grounds that no legal claim is asserted.

According to Dr. Bronner’s, the “Court turned aside the defendants’ arguments that Dr. Bronner’s, in its complaint filed with the Court, had not sufficiently spelled out how actual consumers, the company and competition in the organic personal care industry have been hurt by the defendants’ deceptive practices.” The court’s ruling does not necessarily mean that Dr. Bronner’s is likely to succeed, only that it has articulated colorable claims. The court did not rule on the merits of these claims.

This case should be watched closely by those in cosmetics and food industries. Dr. Bronner’s claims turn, at least in part, on its view of “consumer expectations.” Do consumers have expectations as to what “Organic” means? Does it mean something different for cosmetic products? These are just a few of the significant questions that may be addressed in the litigation.

Salmon Labeling Probably Headed to Supreme Court

The U.S. Supreme Court  signaled last week that it may review a California Supreme Court decision finding that federal law does not preempt claims for violations of state consumer protection laws concerning “selling artificially colored farmed salmon without disclosing to . . . customers the use of color additive.” Following a petition for certiorari filed in April, the Supreme Court issued an order last week inviting the Solicitor General “to file a brief in this case expressing the views of the United States.”

The Bush administration generally favors federal preemption of state consumer protection laws. Most Supreme Court watchers believe that the Court will grant certiorari if the Solicitor General advocates doing so.  This case, if considered by the Supremes, is sure be significant with wide ranging implications for consumer protection claims concerning food product labeling.
 

The Billable Hour

A little off topic - I've been asked to speak at an upcoming CLE program at Seattle University Law School entitled "The Billable Hour: An Examination of Compensation."  For those responsible for legal budgets (whether an in-house lawyer managing a budget or an outside lawyer like myself who is working within a budget), this promises to be a provocative conversation. According to the  SU Law School online flyer: 

"there has been a growing concern that the demands of increased billable hours [are] having unintended consequences and compromising the health and well-being of lawyers and the communities they service. At the same time, time-based billing practices can raise ethical questions and create perverse disincentives."

My own take, and I'm looking forward to what others think, is that lawyers and clients should regularly assess how they measure the value of their relationship. The billable hour is one of many available "tools" and continues to be among the most viable and ethical.  Problems arise when lawyers and clients rely on the hourly billing format in a vacuum.

For example, an hourly billing arrangment without an agreed budget frequently leads to disintegration of client-lawyer relationships.  Similarly, an hourly billing arrangment without agreement by the lawyer and the client about WHO is doing the billing leads to problems.

Outside lawyers and firms also shouldn't treat the hourly billing arrangement as a religon. For some clients and projects, straight hourly billing may not make sense. Other arrangments such as flat-fee billing, incentive billing, blended rates, etc. may make more sense for both the client and law firm.


 

 

California Menu Labeling Laws--Restaurants Beware of Asking What Your Customer Wants!

Yesterday, California became the first state in the Union to write into law menu labeling requirements. Like municipal ordinances recently enacted in New York City and Seattle, the California law requires certain “chain” restaurants to disclose nutritional information and calorie content information for certain items.

The law, to be phased in between 2009 and 2011, applies to restaurant chains with at least 20 locations that “offer for sale substantially the same menu items, or operates as a franchised outlet of a parent company . . . with the same name in the state that offer for sale substantially the same menu items.”

The new California law reads like a lawyer’s dream. Numerous exemptions are granted for certain grocery stores, “certified farmer’s markets” and others. Exemptions are also created to the exemptions. For example, “separately owned food facilities to which this section otherwise applies that are located in the grocery store” are not included in the “grocery store” exemption. To further add to the confusion, “grocery store” is defined to include convenience stores, though the law fails explain what that means. Does this mean that the law applies to a hamburger chain restaurant but not to the neighboring chain “convenience store” that sells the same hamburger but also a quart of milk? Does this make any sense? Won’t this statutue almost certainly generate significant litigation?

The labeling requirements apply to “standard menu items,” which are defined as “a food or beverage item offered for sale by a food facility through a menu, menu board, or display tag at least 180 days per calendar year . . . .” Yet a “standard menu item” does not include “a food item that is customized on a case-by-case basis in response to an unsolicited customer request.” What does "unsolicited customer request" mean? What about a sandwich shop that offers nearly infinite combinations of products? According to SUBWAY, “there are more than two million different sandwich combinations available" its menu.

Aside from being riddled with ambiguities, inconsistencies and impossible-to-interpret language, this blog has previously made the case that menu regulation should be the domain of uniform federal law and not inconsistent, piecemeal local ordinances. The California law is yet another argument in favor of federal preemption.

Section one of the California law cites national obesity statistics from the Centers for Disease Control and the federal Nutritional Labeling and Education Act of 1990. Nothing about this bill is specific to California. Because the law only applies to large restaurant chains, its impact is mostly on large national or regional companies. Ironically, the California legislature understood the problem of inconsistent regulation and chose to preempt all local and municipal regulation of restaurant menus. If menu regulation is an issue that needs regulation (and there are many good arguments why it does not), it should be taken up by Congress, the FDA and the USDA, not  states or local municipalities.
 

Anatomy of a Food-Borne Illness Claim - Part I

Recently, I’ve received several requests for resources explaining the anatomy of a food-borne illness claim. In other words, what events can be expected, and when? What can or should a company (in particular the legal department) do in response to a claim?

Part I – Notice of an Outbreak (and Possible Claims)

 

First off, don’t panic. Your company’s crisis management team (which has been well-rehearsed for this scenario) should convene action upon the first notice of a possible outbreak—even before verification and before claims are apparent. Food safety experts should contact the health departments that may have identified the outbreak. Together with the legal, sales and quality assurance departments, your food safety experts should be involved in a full investigation of the possible outbreak. The earlier the intervention, the greater the possibility of collecting key information that may be useful in determining whether your company is linked to the outbreak and pinpointing other possible sources of the outbreak. Public relations experts should also be consulted at the first possible moment.

 

Checklist for the legal department:

 

  • Log events, actions and communications. This is critical for responding to government agencies and to claims.
  • Record all reported injuries. Collecting information about potential claims early is a key to mitigating those claims and future legal costs.
  • Notify insurers. Insurance companies require prompt notice; insurers may also have assets available for crisis response.
  • Document the investigation. Litigation may be protracted, and a well-documented investigation may be key to the company’s defense.
  • Institute a litigation “hold” on the destruction of any company documents or emails. Don’t turn a bad situation into a nightmare; spoliation claims can take on a life of their own.
  • Retain product samples for future testing. This may be critical to support experts’ opinions at trial and to preserve claims against suppliers.
  • Review and retain vendor/supplier documents. Recovery against suppliers could be as important as or more important than insurance recovery.
  • Assess the merits of a consumer hotline. It could be helpful in disseminating accurate information to consumers (inaccurate or conflicting information can lead to litigation) and in collecting information about the pool of potential plaintiffs.
  • Assess the merits of a consumer/vendor reimbursement program. Like having a consumer hotline, providing immediate reimbursement could help dampen the volume of future plaintiffs.

Stay tuned for Part II – Receipt of the Demand Letter.

Tuna's Not Just for Breakfast Anymore - Third Circuit Refuses FDA's Pleas for Federal Preemption

By Guest Blogger Amena Jefferson (Stoel Rives Summer Associate and UW law student)

Federal preemption is on the table once again. The U.S. Court of Appeals for the Third Circuit recently decided Fellner v. Tri-Union Seafoods, No. 07-1238, 2008 WL 3842925 (3d Cir. Aug. 19, 2008). In this case, the plaintiff allegedly fell ill from mercury poisoning after consuming canned tuna “almost exclusively” for five years (1999-2004). The plaintiff sought recovery under the New Jersey Product Liability Act for Tri-Union’s failure to warn of the risks posed by methylmercury in its canned tuna.

The FDA previously issued a consumer advisory and a backgrounder about the risk of mercury in tuna. In 2004, while a similar lawsuit was pending in California (People v. Tri-Union Seafoods), the FDA sent a letter to the attorney general of California noting that state warning claims are preempted because the “existence of the lawsuit would ‘frustrate the FDA’s carefully considered federal approach’” to methylmercury content in tuna. A California court determined, based on the FDA’s action, that claims under California Proposition 65 were preempted by federal law.

The Third Circuit disagreed. It reversed the district court’s ruling that the state claims are preempted, and instead concluded that no preemption exists because FDA advisories on tuna and methylmercury are not “law.” The appellate court concluded that the FDA letter merits “a particularly low level of deference” because it is not “the product of an agency proceeding.” Yet, the the Third Circuit never indicated how a warning could have been issued without running afoul of the FDA and federal law, other than to say that a warning “could have specified that the risks become material only with frequent tuna consumption, and that moderate fish consumption offers positive health benefits.”

So how does this make sense? On the one hand, the FDA specifically said it intended to preempt state law; on the other, the court said it didn’t. The decision opens the door for even more confusing and conflicting local and state labeling requirements. Can this kind of confusion and conflict promote customer safety? Why is the Third Circuit going out of its way to disagree with the FDA and side with a person choosing a canned-tuna-only diet? Are state tort laws really meant to protect someone who makes this kind of extreme dietary choice?
 

Developing A Strategy For Crisis Management

An upcoming panel discussion at the Nutritional Law Symposium in Utah and a call from a reporter about the Maple Leaf Foods issue in Canada have me thinking a lot about crisis management. How a business responds at the outset of an alleged food-borne outbreak determines its fate in many ways.
 

Implementing a strategy from the start is a must to minimize the impact of a crisis. Yet the million- or billion-dollar question is, how do you develop the right save-the-business strategy when events are overwhelming and occurring at light speed? You need to bring together quality assurance, legal and food safety personnel (epidemiologists, microbiologists and other food safety experts) who can respond immediately to find the source of the outbreak and work with public health officials. A business must ascertain at the earliest possible moment the source and scope of the crisis. Once a business understands whether an outbreak is limited to a particular outlet or product line, and how many people might be affected, it can formulate a public relations, recall and legal strategy to limit exposure.

The key is execution. Everyone on the crisis management team must work in sync and understand their roles. And the secret to execution is preparation. Long before a crisis, a team (usually a combination of personnel from outside and inside the business) should be in place, rehearsed and ready. History is full of lessons: Some businesses executed crisis management well and emerged from dire crises stronger than before; others were unprepared, and their brands have long been forgotten.

Continue Reading...

"Canada is Next"

Anyone interested in trends in cross-border mass-torts litigation and the nightmare this is becoming should read a recent article in Bloomberg Law Reports entitled "Brave New World: The Dawn of Hyper-Complex Litigation"

In the article, appears the following:

"The Canadian Double-Down"

"At a January 2008 products liability symposium, a well-regarded New York City plaintiffs’ attorney stood before a room of lawyers and in-house counsel. The topic of his presentation was, in part, to forecast the next direction of mass tort litigation. His message to those listening was clear. 'Canada is next.' "

The article goes on to explain that the threshold for mass tort class actions in Canada may now be lower than in the U.S.:  "in certifying the class, the [Canadian] court was not troubled by the fact that class members could not prove a present physical injury or a 'foreseeable and recognizable psychiatric illness' as a result of the alleged product defect."

The bottom line advice in the Bloomberg article, as it has been in this blog, is that businesses (especially those in the food industry) need to continue to re-double efforts at risk avoidance and crisis management. As courts outside the U.S. become more open to mass tort claims, exposure for businesses selling products internationally only amplifies.

King County Menu Labeling Goes into Effect August 1, 2008--Yet Another Call for Preemption?

Effective August 1, King County, Washington, will impose the strictest menu labeling law in the nation. King County’s law imposes menu labeling requirements, on restaurant chains that have the following characteristics:

1. The same name.
2. Operating permits from Public Health—Seattle and King County.
3. Fifteen or more locations in King County or nationwide—this legislation does not affect food establishments with 14 or fewer locations.
4. Gross annual revenues of $1 million or more.
5. Standardized menu items that use standard recipes.

The county won’t start imposing fines until January 2009. Yet for small restaurants that just meet the 15-restaurant and $1 million thresholds, or for franchise owners, these requirements can be onerous, especially if the restaurant maintains a large menu or large variety of seasonal foods. Costs for nutritional testing on a variety of products can be prohibitively expensive. Will this law have the perverse effect of limiting consumer choice and use of seasonal, local products on menus?

Even for larger restaurant chains that already provide nutritional information, King County’s law will impose requirements that may increase costs because King County’s rules may be inconsistent with nationwide distribution and marketing.

Restaurants in both New York City and San Francisco faced with similar (though arguably less onerous) local regulations are challenging the laws in those cities. Among other things, there are serious First Amendment issues (though lawyers in New York City are apparently relying on the King County law to show how it could be made to comply with First Amendment speech protections).

Menu laws are also being challenged on grounds of federal preemption (even though the FDA has apparently taken the position that its laws do not preempt local menu regulations). I have written several times on this blog about the need for federal preemption. No area demands federal preemption more than regulation of chain restaurant menus.

For evidence why the federal and not local governments should be regulating nutrition, look at King County’s self-stated reasons for passing its law: “rising health care costs, our growing number of obese, diabetic and chronically ill residents, and a lack of information to inform choices that improve our health.” Are any of these reasons unique to King County? The studies relied on by King County are national and not unique to King County. The restaurants targeted are national and are generally not King County-based restaurant chains.

Only the national government has the resources to investigate the obesity epidemic—something that has baffled scientists and for which there is no proven cause or cure. Before our restaurant industry is impacted and consumer choice is further limited, shouldn’t we devote the full resources of the federal government to the problem? Do we expect the obesity epidemic be solved by an inconsistent patchwork of local county laws?

Good Time To Review Crisis Management Plans

Incredibly, the Salmonella Saintpaul outbreak remains unsolved. First reported onset of illness date was April 10, yet the traceback is still not complete.

Personal injury and economic damage claims await for the FDA and CDC to determine causation. Produce industry, particularly in Mexico, stands to suffer long lasting injury. 

Whether or not your business stands to be impacted (or has been impacted) by the current outbreak, now is a great time to review and rehearse your crisis management plan. I recommend that your team include the following (whether in-house personnel or outside consultants):

  • Scientific - Epidemiology, Microbiology, Infectious Disease - Quantifies risks, assists public health officials and supports litigation;
  • Accounting - Estimates costs of response options and manages system for customer reimbursement;
  • Public Relations - Coordinates all internal and external communications and develops a plan to limit impact to the brand;
  • Quality Assurance - Assists in conducting traceback;
  • Sales and Marketing - Notifies suppliers and buyers, monitors recall effectiveness and coordinates product returns;
  • Legal - Assists with fact investigations, assists coordination with regulatory officials, addresses liability issues, deals with issues of insurance coverage and prepares for litigation;
  • COORDINATOR/TEAM LEADER - selecting a member of the team that can bridge a diversity of disciplines and demonstrate leadership is critical.
Again, most crisis management experts recommend frequent dress rehearsal. Simulating a crisis is the best way to train your team and the only way to determine its strengths and weaknesses. Effective crisis management can mean the difference of millions of dollars (lost sales, destroyed product and personal injuries) and consumer confidence (i.e. the future of your company).

More on The Raw Milk Debate - Consumer Choice vs. Consumer Protection

Recently discussed on this site was how the raw milk debate is in many ways ground zero for the debate between consumer protection and consumer choice. The Seattle Post Intelligencer ran an interesting piece today focusing on just that debate.

I found comments attributed in the article to Kansas State professor Doug Powell most salient:
Doug Powell says he's not surprised that government health officials denounce the dangers of raw milk then turn around and license the sale of the same milk.
"In part, it's because of the almost evangelical way people talk about raw milk and that America is founded on consumer choice," said the associate professor of food safety at Kansas State University.
"The numbers of illnesses from outbreaks caused by unpasteurized milk are not that high. You could very easily make the cases that 'Wow, maybe tomatoes should be regulated a whole lot more than we do now because the numbers of cases of salmonella saintpaul are up to 550 now,' " said Powell, who is also scientific director for the International Food Safety Network.
While I'm not sure I agree that "America is founded on consumer choice," professor Powell is surely right that the conflict between consumer choice and consumer protection is bringing raw milk to boil. Professor Powell is also correct that from a public health standpoint, fresh produce presents a greater and more certain danger.

Implicit in the Post-Intelligencer article is that the debate suffers from a lack of consumer information. For example, do we really understand the alleged benefits of raw milk? There is some information on the web but is this peer-reviewed information that consumers can trust? On the flip side, consumers should be given better information than the kind of "scared straight" quality of information currently available. Both those who advocate against raw milk and those who support it can surely agree that both would be served by better research and consumer information.


A Cry for Federal Preemption?

In Arkansas, a putative class action has been filed by consumers who allege violations of consumer protection laws of four states because they purchased Tyson chicken products with packaging labeled, “Raised Without Antibiotics.” The plaintiffs claim that the packaging was “deceptive,” and they were “de-frauded” because the feed consumed by the chickens contained Ionophores, which is classified by the FDA as an antibiotic.

The putative class action follows a Lanham act case filed by Tyson’s competitors in the U. S. District Court, District of Maryland. The product labeling was approved by the USDA under its authority from the Poultry Products Inspection Act (“PPIA”), 21 U.S.C. § 451. Despite approval from the USDA, the court ruled that the competitor’s claims could proceed and enjoined Tyson from future use of such labeling. The court reasoned that the USDA regulates labeling, not advertising. Deciding that the labeling was also advertising, the court held the labeling was fair game for a Lanham act suit.

Effectively, the court opened the floodgates for class action litigation for labeling approved by the USDA. The decision is significant. It promises to energize the growing movement of consumer labeling class action work. The decision may also have a destabilizing effect on producers that rely on FDA and USDA rulings and regulations. Already, producers of organic milk face challenges under state consumer protection acts for alleged product mislabeling of milk as organic, despite organic certification approved by the USDA.

One of two things will happen: (1) full-time product-labeling litigation work for lawyers or (2) legislation by the U.S. Congress enabling federal preemption. The latter is obviously the more sane course. Nothing is more inefficient than regulation of product labeling through state consumer class action claims. Expert regulatory agencies such as the FDA and the USDA, not judges and juries, should decide what constitutes appropriate labeling and advertising of food products.

"Shotgun Questionnaire"--An Important Tool in Food Liability Defense

Food-borne illness cases generally involve strict liability. If a plaintiff can show illness and a causational link between the illness and adulterated food produced by the defendant, the defendant generally will be liable for damages proven by the plaintiff. In defense of first-party injured-plaintiff claims, negligence and the standard of care employed by the defendant is frequently irrelevant to issues of liability.

Because the defendant food seller’s actions may not be relevant, litigated issues frequently center on “causation” (i.e. was the plaintiff’s alleged illness caused by the defendant’s product). From the defense perspective, the plaintiff’s deposition and discovery of plaintiff’s food history and other possible sources of exposure are often key to assessing causation. Oregon’s “shotgun questionnaire” used by its public health investigators provides a great outline.

Importance of Experts At Outset of Outbreak

A few weeks ago, I gave a presentation at a CLE seminar about how to use and challenge expert witnesses in a food case. One of the interesting discussions that occurred during my talk was about the importance of retention of experts at an early stage, even before health department officials finalize their findings.

Given the limited resources of most state and local health departments, I have always believed there is little to lose by offering the assistance of credible and known epidemiologists, microbiologists, etc. Additional resources in an outbreak investigation (and, therefore, additional investigation) can mean the difference between the health department pointing at your client and the health department pointing at another source. Several other defense lawyers, and, surprisingly, state health department officials, agreed. Examples of successful early intervention were elicited.

FSIS to Start Posting Plant Testing Data

I wrote earlier about Dr. David Goldman's talk at the ACI Food-Borne Illness Litigation conference and his comments regarding supermarkets. Another significant issue concerns posting by FSIS of microbiological testing results from meat and poultry plants on its Web site. Continue Reading...

Mitigating Supermarket Liability

Last week I had the privilege of attending and speaking at the American Conference Institute’s foodborne illness conference in Scottsdale, Arizona. One of the other speakers was David Goldman, M.D., Ph.D., Assistant Administrator of the Office of Public Health Science, Food Safety and Inspection Service (“FSIS”), United States Department of Agriculture (“USDA”). Dr. Goldman provided some interesting information about foodborne contamination from supermarkets. Continue Reading...

California Farm-Raised Salmon Cases - Preemption

The California Supreme Court last week issued an opinion that federal law does not preempt complaints brought under state deceptive-marketing laws against grocery stores for allegedly selling artificially colored salmon. 

The trial court found that claims were preempted by section 337(a) of title 21 of the U.S. Code, a provision of the Federal Food, Drug, and Cosmetic Act (“FDCA”) (21 U.S.C.
§ 301, et seq.).The Court of Appeal affirmed the resulting judgment of dismissal. The California Supreme Court concluded “that section 337(a) does not preempt the action as plaintiffs do not seek to ‘enforce[], or to restrain violations’ of, the FDCA.  (§ 337(a).) Rather, plaintiffs’ claims for deceptive marketing of food products are predicated on state laws establishing independent state disclosure requirements 'identical to'  the disclosure requirements imposed by the FDCA, something Congress explicitly approved in section 343-1.  (§ 343-1(a)(3).)”

Preemption of Organic Foods Claims

We recently published a client alert about the claims being asserted against retailers for selling as “organic” milk that some believe may not be organic, as defined under the Organic Foods Production Act of 1990 A prime issue in this litigation is preemption. Claims are asserted not under federal law, but under state consumer protection statutes.