Can patients sue drug manufacturers for violating state law despite FDA approval?

As reported by Adam Liptak in the New York Times, the first case to be heard by the U.S. Supreme Court in its October 2008 term (October 6, 2008) addresses the legal effect of Food and Drug Administration (FDA) approval of drug labeling. Wyeth v. Levine involves a physician assistant (P.A.) error in 2000. Diana Levine, a professional musician, sought treatment for severe migraines. When the P.A. administered the treatment Levine had received in the past – Demerol for pain and Phenergan for nausea – the P.A. injected the Phenergan via “IV push,” thinking she was injecting into a vein, but missing and injecting intra-arterially. Although Phenergan is typically safe if administered intramuscular or through intravenous drip, it causes “swift and irreversible” gangrene when “exposed to arterial blood.” Ms. Levine lost her right hand and arm below the elbow to gangrene.

She sued both the clinic and Phenergan’s manufacturer, Wyeth on the basis that its label, approved by the FDA, did not disclose the risk of danger of administration by IV push. The label did warn that “inadvertent intra-arterial injection” could cause “gangrene requiring amputation,” but made no mention of IV push. Wyeth contended that the FDA rejected a proposed change, but Levine argued that Wyeth could still have supplemented the labelling. Although the clinic settled, Wyeth declined to do so, arguing that it claims of deficient drug labeling were preempted by FDA approval. The difference is that FDA regulations require only minimum safety standards, in contrast to state law, which imposed stricter warning requirements. A jury found in favor of Ms. Levine, and the Vermont Supreme Court upheld the decision , finding that FDA minimum safety labeling requirements “provide[d] a floor, not a ceiling, for state regulation.”

Recommended Action: Plaintiffs’ lawyers are concerned that pharmaceuticals may be insulated from inadequate drug labelling if the U.S. Supreme Court agrees with Wyeth and the FDA’s position that states are preempted from imposing additional safety requirements on medications. As reflected by the fact that the clinic settles with Ms. Levine even as the drug maker fights on, healthcare providers don’t have the same luxury as manufacturer of reliance on FDA labelling. A growing trend and “best practice” among physicians is the use of informed consents to advise patients fully of all risks associated with particular medications. We recommend that providers review the medications used in their practice and consider implementation of informed consents to avoid claims of inadequate disclosure of risks.

Harry Nelson is a partner in Fenton & Nelson, LLP, a law firm that counsels healthcare providers on FDA-related and other compliance issues. For additional information, please contact Fenton & Nelson at harry@fentonnelson.com

©Harry Nelson 2008