Pre-empting lawsuits threatens drug safety
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Pre-empting lawsuits threatens drug safety "Preemption of common law tort actions is not only unjust but will also result in the reduced safety of drugs", according to Drs Curfman, Morrissey and Drazen from the NEJM. Pre-emption is based on the supremacy clause in the US constitution that states that federal law takes precedence when federal and state laws are at odds. Their comments were prompted by a US Supreme Court ruling in April this year that a state-level product liability lawsuit against Medtronic was pre-empted as the device had received US FDA approval. The 1976 law granting authority to the FDA to regulate medical devices contains a pre-emption clause. There is no such clause in the Food, Drug and Cosmetics Act, which grants authority to the FDA to regulate drugs. However, in a case soon to argued before the US Supreme Court (Wyeth vs Levine), the court’s judges will determine whether pre-emption of state tort litigation, although not explicitly stated, is implied by the law.
Shifting views The FDA and previous governments have viewed tort litigation as a key component of the regulatory framework concerning drugs and medical devices. Lawsuits by consumers were seen as complementing the agency’s regulatory actions and helping to enhance patient safety. This view has shifted somewhat in recent times, with the FDA reversing its position and claiming that pre-emption applies to common law tort actions. The agency believes tort liability stifles product innovation and can delay the product approval process. There is also concern regarding the ability of lay juries to make determinations about product safety.
Court versus Congress In the wake of the Medtronic device case, Congressmen Henry Waxman and Frank Pallone Jr are trying to introduce legislation designed to "unambiguously eliminate" pre-emption of common law tort actions for medical devices. Depending on how the Supreme Court rules in Wyeth vs Levine, Congress may need to consider drafting similar legislation for drugs. Curfman GD, et al. Why doctors should worry about preemption. New England 801052646 Journal of Medicine 359: 1-3, No. 1, 3 Jul 2008
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Reactions 12 Jul 2008 No. 1210
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