X

Thank you for sharing!

Your article was successfully shared with the contacts you provided.
Civil Litigation Click here for the full text of this decision The appellees’ claims, as certified by the trial court, conflict with the FDA’s specific requirements for active ingredients and labeling of pediculicide drug products. FACTS:A trial court in Orange County certified a class of plaintiffs to pursue product liability claims against Warner-Lambert Co. and other makers of over-the-counter head lice repellants. The trial court found that issues, including whether the defendants misrepresented their products through advertising and marketing and whether the products were fit for their intended use, were common to all plaintiffs. The trial court characterized the claims as ones primarily concerned with marketing and promotion. The plaintiffs breach of warranty claims were proper for class-action disposal, the trial court ruled, because all plaintiffs would be challenging whether the products were chemically and scientifically ineffective, regardless of individual results. The defendants contend that class action in state court is improper because the plaintiffs claims are pre-empted by the federal Food, Drug, and Cosmetic Act, 21 U.S.C. �301-397, which regulates over-the-counter drugs. HOLDING:Vacated and remanded. The plaintiffs claims are pre-empted. As the trial court’s own certification order discussed, the plaintiffs’ claims rest on whether the anti-lice products were formulated, not whether there is a defect or a digression from FDA-approved formulation guidelines or whether the defendants’ advertising confirmed to those guidelines. This litigation would impose a state requirement that is “different from or in addition to, or that is otherwise not identical with,” a requirement under the Act, the court determines. “We conclude appellees’ claims, as certified by the trial court, conflict with the FDA’s specific requirements for active ingredients and labeling of pediculicide drug products.” OPINION:Gualtney, J.; McKeithen, C.J., Burgess and Gualtney, JJ. DISSENT:Burgess, J. The dissent would hold that the claims are not preempted by FDA regulations and would rule on the merits of the appeal.

Want to continue reading?
Become a Free ALM Digital Reader.

Benefits of a Digital Membership:

  • Free access to 3 articles* every 30 days
  • Access to the entire ALM network of websites
  • Unlimited access to the ALM suite of newsletters
  • Build custom alerts on any search topic of your choosing
  • Search by a wide range of topics

*May exclude premium content
Already have an account?

 
 

ALM Legal Publication Newsletters

Sign Up Today and Never Miss Another Story.

As part of your digital membership, you can sign up for an unlimited number of a wide range of complimentary newsletters. Visit your My Account page to make your selections. Get the timely legal news and critical analysis you cannot afford to miss. Tailored just for you. In your inbox. Every day.

Copyright © 2020 ALM Media Properties, LLC. All Rights Reserved.