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.

Marketing Missive: FDA Issues Warning Letter to Procter and Gamble for Unlawfully Marketing Cold and Flu Medications Containing Vitamin C

By Guest Blogger Tyler Anderson

On October 29, 2009, the FDA issued a warning letter to Procter and Gamble notifying the company that its “Vicks DayQuil Plus Vitamin C” and “Vicks NyQuil Plus Vitamin C” are illegally marketed combinations of drug ingredients and a dietary ingredient. Both of the over-the-counter (OTC) medicines, which contain Vitamin C in addition to several drug ingredients, are marketed as treatments for cold and flu symptoms. The FDA issued the warning letter (1) to clarify that these single dosage form combinations of drug ingredients and dietary ingredients cannot legally be marketed because they have not been proven safe and effective, and (2) because the agency has previously determined that there is not sufficient data to show that Vitamin C is safe and effective in preventing or treating the common cold.

Under its OTC monograph system, the FDA allows some OTC drugs to be marketed without agency approval. The FDA found the two Vicks products did not comply with the applicable FDA monograph, and therefore the products must first be evaluated and approved under the agency’s new drug approval process before they can be legally marketed.