Ninth Circuit, joining other courts, finds that state law failure-to-warn claims are not preempted by FDA regulations

By Shemia Fagan
January 27, 2011

In Gaeta v. Perrigo Pharmaceuticals Co.,the Ninth Circuit this week joined its sister circuits in holding that the Supreme Court case Wyeth v. Levine, 129 S. Ct. 1187 (2009), which established that failure-to-warn cases against brand name drug manufacturers are not preempted by federal law, also established no preemption of such claims against generic drug manufactures.

In Gaeta, a minor child had been treated with a "hepatotoxic" drug -- one know to cause liver failure -- after having two benign moles removed.  He was prescribed ibuprofen for pain but his parents purchased Perrigo's generic over-the-counter ibuprofen.  The child developed a fever and was eventually referred to the emergency room with a diagnosis of liver failure.  He received a liver transplant. 

The child's parents filed suit against Perrigo alleging, among other things, that Perrigo failed to warn prescribing physicians and consumers of the increased risk of acute liver injury and renal failure when ibuprofen is taken concurrently with other hepatotoxic drugs.

Perrigo opposed the claim on two preemption grounds:  First, that it is impossible for Perrigo to comply with both state law duties to warn and the FDA regulations governing generic drugs; and, alternatively, that plaintiffs' state law claim obstructs the full accomplishment of the purposes and objectives of Congress in enacting the approval process for manufacturers of generic drugs. 

The Ninth Circuit rejected both arguments, finding that California's state law duty to warn -- by placing an appropriate label on generic ibuprofen -- would neither be impossible to comply with nor obstruct the objectives of Congress.  The Court further held that, absent evidence that the FDA would have rejected the specific hepatotoxicity warnings proposed by plaintiffs, their state law failure-to-warn claim was not preempted by FDA regulations.


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