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May 20, 2009

Regulating the Safety of Pharmaceuticals: The FDA, Preemption, and the Public's Health

Author Affiliations

Author Affiliations: O’Neill Institute for National and Global Health Law, Georgetown University, Washington, DC.

JAMA. 2009;301(19):2036-2037. doi:10.1001/jama.2009.680

In 2008, the US Supreme Court held that the Medical Device Amendments (MDA) bar common law claims challenging the safety or effectiveness of a medical device approved by the US Food and Drug Administration (FDA).1Riegel v Medtronic Inc2 had broad implications for patient safety because it removed all means of judicial recourse for most consumers injured by defective medical devices. At that time, the Supreme Court agreed to hear Wyeth v Levine,3 which consumer safety advocates feared would similarly preempt pharmaceutical lawsuits with far-reaching effects. There are 11 000 FDA-regulated drugs, with nearly 100 more approved each year,4 and patients would have no safety net in the event the FDA fails to detect and correct safety hazards. In a recent 6-3 decision, the Supreme Court ruled that the FDA's approval of a drug label does not preempt a state law product liability claim charging the drug maker with failing to warn adequately about the risks.3 The Court, therefore, rejected a major push by the pharmaceutical industry to invoke compliance with federal safety standards as a complete defense to tort liability.