Recently, there has been a proliferation of putative class actions targeting allegedly misleading statements (or omissions) on the FDA-approved labels for over-the-counter (“OTC”) drugs.  Last year, we explained how these types of claims are vulnerable to a strong federal preemption defense.  In short, because the Federal Food, Drug, and Cosmetic Act (“FDCA”) explicitly forbids states from imposing OTC labeling requirements that are “different from,” “in addition to,” or “otherwise not identical” with those provided under federal law, 21 U.S.C. § 379r(a), state-law claims that directly challenge or conflict with the FDA’s decision-making for OTC drug labels are expressly preempted.

In Patora v. Vi-Jon, LLC, 2023 WL 5610300 (S.D.N.Y. Aug. 30, 2023), the Southern District of New York rejected the latest in a long line of attempts to evade this clear principle.  In Patora, plaintiffs alleged that some of defendant’s laxative products—which were recalled after testing positive for bacterial contamination—were falsely labeled because they did not list bacteria as an ingredient or warn of potential bacterial contamination.  As has become typical in these types of OTC labeling cases, the Patora plaintiffs alleged that they would not have purchased the products if they were “properly” labeled as containing bacteria and sought purely economic damages.

Defendant moved to dismiss on federal preemption grounds, arguing that the FDA-approved monograph for its laxative products only required listing of active and inactive ingredients, both of which are defined in the FDCA as including components “intended” to be in the drug.  Because there was no intent to include bacteria in the product, the FDCA did not require it to be listed on the label.  And because the monograph did not require a bacteria warning, the plaintiffs could not, either.  The Court agreed, dismissing plaintiffs’ claims in full.

Defendants facing OTC labeling claims should continue to raise federal preemption defenses where plaintiffs’ allegations conflict with an FDA-approved monograph.  Although plaintiffs will undoubtedly continue to look for holes and carve-outs, the purpose of Section 379r is to prevent a “patchwork of inconsistent packaging regulations” that would inevitably result if states were permitted to enforce their own unique requirements.  See Goldstein v. Walmart, Inc., 637 F. Supp. 3d 95, 113 (S.D.N.Y. 2022).  As evidenced by Patora and other recent decisions, federal preemption continues to be a strong defense in these putative false labeling class actions.

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Photo of Steve Petkis Steve Petkis

Steve Petkis is a litigation associate in the firm’s Washington, DC office. He has experience defending a variety of clients in their most sensitive and complex litigation matters in both state and federal court.

Steve is skilled in all phases of litigation, including…

Steve Petkis is a litigation associate in the firm’s Washington, DC office. He has experience defending a variety of clients in their most sensitive and complex litigation matters in both state and federal court.

Steve is skilled in all phases of litigation, including discovery, trial, and appeal. In particular, he has played a lead role in crafting and executing dispositive, expert, and evidentiary briefing strategies, resulting in key victories at all stages. As a member of multiple trial teams, Steve also has stand-up court experience and has been responsible for taking and defending fact and expert depositions, drafting key witness examinations, and developing post-trial findings of fact and conclusions of law.

Steve previously served as a law clerk to Judge Katherine B. Forrest on the United States District Court for the Southern District of New York. He maintains an active pro bono practice focused on civil rights and criminal justice issues.

Photo of Andrew Soukup Andrew Soukup

Andrew Soukup has a wide-ranging complex litigation practice representing highly regulated businesses in class actions and other high-stakes disputes. He has built a successful record of defending clients from consumer protection claims asserted in class-action lawsuits and other multistate proceedings, many of which…

Andrew Soukup has a wide-ranging complex litigation practice representing highly regulated businesses in class actions and other high-stakes disputes. He has built a successful record of defending clients from consumer protection claims asserted in class-action lawsuits and other multistate proceedings, many of which were defeated through dispositive pre-trial motions.
Andrew is co-chair of the firm’s Class Action Litigation practice group.

Andrew has helped his clients achieve successful outcomes at all stages of litigation, including through trial and appeal. He has helped his clients prevail in litigation against putative class representatives, government agencies, and commercial entities. Representative victories include:

  • Delivered wins in multiple nationwide class actions on behalf of large financial companies related to fees, disclosures, and other banking practices, including the successful defense of numerous lenders accused of violating the Paycheck Protection Program’s implementing laws, which contributed to Covington’s recent recognition as a “Class Action Group Of The Year.”
  • Successfully defending several of the nation’s leading financial institutions in a wide variety of litigation and arbitration proceedings involving alleged violations of RICO, FCRA, TILA, TCPA, FCBA, ECOA, EFTA, FACTA, and state consumer protection and unfair and deceptive acts or practices statutes, as well as claims involving breach of contract, fraud, unjust enrichment, and other torts.
  • Successfully defended several of the nation’s leading companies and brands from claims that they deceptively marketed their products, including claims brought under state consumer protection and unfair deceptive acts or practices statutes.
  • Obtained favorable outcomes for numerous clients in commercial disputes raising contract, fraud, and other business tort claims.

Because many of Andrew’s clients are subject to extensive federal regulation and oversight, Andrew has significant experience successfully invoking federal preemption to defeat litigation.

Andrew also advises clients on their arbitration agreements. He has successfully helped numerous clients avoid multi-district class-action litigation by successfully enforcing the institutions’ arbitration agreements.

Clients praise Andrew for his personal attention to their matters, his responsiveness, and his creative strategies. Based on his “big wins in his class action practice,” Law360 named Mr. Soukup a “Class Action Rising Star.

Prior to practicing law, Andrew worked as a journalist.

Photo of Emily Ullman Emily Ullman

Emily Ullman has a complex civil litigation practice focusing on products liability and mass torts work, primarily representing members of the life sciences industry and consumer goods manufacturers and suppliers across federal and state courts. In addition, she counsels companies facing transactions, regulatory…

Emily Ullman has a complex civil litigation practice focusing on products liability and mass torts work, primarily representing members of the life sciences industry and consumer goods manufacturers and suppliers across federal and state courts. In addition, she counsels companies facing transactions, regulatory interactions, or strategic decisions that expose them to tort risk.