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Federal law does not preempt a state law negligent failure to warn claim based upon a drug manufacture’s failure to advise of specific birth defects.

July 19, 2016
Anderson v. Janssen Pharms., Inc., 2016 Pa. Super. Unpub. LEXIS 1641 (Pa. Super. Ct. 2016)

The plaintiffs recovered a jury verdict based upon the defendant drug manufacturer’s failure to warn health care providers of the risks of specific birth defects associated with the use of Topamax during pregnancy. The defendant argued, in part, that the plaintiffs’ claims were preempted by federal law because it was precluded from changing the warning classification of the drug without prior FDA approval. Rejecting this argument, the Pennsylvania Superior Court noted that the issue was not whether the defendant could unilaterally change the drug’s classification but, rather, what other steps the defendant could have taken to make doctors aware of the known risks. Relying on its decision in Czimmer v. Janssen Pharms., Inc., and distinguishing the Supreme Court’s holding in PILVA, Inc. v. Mensing, the Superior Court noted that the different legal standards applied to generic and brand-name drug manufacturers and may lead to different preemption results.

Case Law Alerts, 3rd Quarter, July 2016

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