Litigation: Labeling lawsuit defenses

Defense strategies for makers of food, beverages, cosmetics, tobacco, medicines and more

This year has seen a continuation of the product liability trends of 2012: namely, plaintiffs attorneys including manufacturers of food, beverages, tobacco, medicines and medical devices as their primary targets. These lawsuits have focused on labeling of these products like never before. 

In response, defense attorneys have successfully used new regulatory and First Amendment defenses to thwart these lawsuits. These defenses have been invoked in a number of circuits, but many circuits have not yet decided on the applicability of these regulatory and First Amendment defenses to labeling actions, so defense lawyers and in-house counsel across the country need to be aware of these trends.

In the food, beverage and cosmetic industries, manufacturers have faced increasing challenges to labeling that otherwise complies with Food and Drug Administration (FDA) regulations, but includes a questionable claim about health or other benefits. These manufacturers can use the FDA’s action or conscious choice not to act as a defense against other federal causes of action, such as the Lanham Act. In Pom Wonderful LLC v. Coca-Cola Co., the 9th Circuit affirmed dismissal of the Lanham Act claim because the defendant complied with the Food, Drug, and Cosmetic Act, which does not provide a method or cause of action for private enforcement. 

Food, beverage and cosmetic defendants can also argue that if the FDA is considering a similar claim but has not yet reached a decision, a plaintiff’s claims should be dismissed under the primary jurisdiction doctrine. That doctrine gives courts the discretion to allow the FDA to decide the issue in the first instance so as to avoid later conflicts with the FDA’s decision. In Astiana v. The Hain Celestial Group, Inc., a Northern District of California judge dismissed without prejudice the plaintiff’s state law fraud and consumer protection claims based on the need for the FDA to be the first to decide what “natural” means in order to avoid later conflicts.

In the drug and medical device contexts, manufacturers have been sued for allowing their representatives to promote their products for uses that the FDA hasn’t approved. However, it is completely legal for a doctor to prescribe a medicine for an off-label use. In some specialties, such as pediatrics, off-label use of medicines is often the accepted standard of care. The 2nd Circuit in U.S. v. Caronia recently held that truthful off-label marketing is protected under the First Amendment and cannot be prosecuted under the misbranding provisions of the Food, Drug, and Cosmetic Act. No case has held that misleading or false off-label marketing is protected; this decision merely extends to truthful promotions.

Tobacco companies have also recently been successful in challenging the FDA requirement that would have required cigarette packages to display grotesque images of diseased lungs and the like. The D.C. Circuit held in R.J. Reynolds Tobacco Co. v. Food & Drug Administration that such a requirement was effectively government-mandated speech and violated the First Amendment. 

In sum, in-house counsel need to be aware of numerous emerging defenses from around the country when dealing with labeling lawsuits in a variety of contexts so that they can ensure their outside counsel are also aware of these developments in the law. 

Contributing Author

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Sara Turner

Sara M. Turner is a shareholder at Baker, Donelson, Bearman, Caldwell & Berkowitz, PC (Birmingham). Her practice focuses on litigation of product liability, commercial, long...

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Contributing Author

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Kris Anderson

Kris Anderson is an associate at Baker, Donelson, Bearman, Caldwell & Berkowitz, PC (Birmingham). He concentrates his practice in litigation, including commercial disputes, business torts,...

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