In a Pharmaceutical Products Liability Case, Why Would a Failure to Warn Case Be Preempted by Federal Law?

In Watson v. Mylan Pharmaceuticals, Inc., No. 16-3349, (D. Kan. 2017), the United States Court of Appeals for the Tenth District sorted out the requirements of state versus federal law in a products liability case.

Carmen Watson (“Watson”) was allegedly injured by Mylan Pharmaceutical’s (“Mylan”) anti-acne drug, Amnesteem, an FDA-approved generic version of Accutane. In her complaint, she sought $110,000,000 in damages, claiming she was not warned of Amnesteem’s dangerous side-effects, in violation of the Kansas Product Liability Act, the Kansas Consumer Protection Act, and Kansas common law.
Mylan moved to dismiss, arguing Watson’s claims were preempted by federal law where state tort law requires generic drug manufacturers to provide adequate warning labels but federal law required those manufacturers to use the same safety and efficacy labels as their brand-name counterparts. In response, Watson argued Mylan should have warned of Amnesteem’s dangers by providing “extra precaution inserts.

The district court granted Mylan’s motion to dismiss, concluding Watson’s claims were preempted by federal law because it is impossible for generic drug manufacturers to comply both with state laws that would require alterations to a drug or its labeling to make the drug safer and with federal law that prohibits changes to approved drugs.

In the appeal, this court looks at whether Watson has pled sufficient factual allegations to state a claim to relief. Watson claims she was not given the opportunity to present evidence before the district court dismissed her complaint. Watson also argues her claims were not preempted on the ground that the warnings on the Amnesteem box were outdated. Watson did not include failure-to-update allegations in her complaint. And she opposed dismissal of her complaint not on the basis of Mylan’s failure to update Amnesteem’s warning to correspond to Accutane’s warning, but on the basis that Mylan had failed to provide “extra precaution inserts”.

A failure-to-update theory requires more than merely the fact of the failure to update. It requires that the failure to include the updated language proximately caused[the plaintiff’s injuries. In her appellate brief, Watson states only that Amnesteem’s warning was “outdated.” Thus, even if this Court accepted the view that a failure-to-update theory is not preempted by federal law, Watson has failed to even describe such a claim, let alone plead one.

Therefore, the lower court’s decisions are affirmed.

The Metier Law Firm is committed to assisting people with personal injury claims throughout Colorado, Wyoming and Nebraska, and we frequently serve as co-counsel to law firms nationwide. Tom Metier recently secured the largest personal injury verdict in Colorado

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