U.S. Supreme Court rejects implied immunity for drug companies
In a pleasant surprise for consumers, the Supreme Court rejected, on a 6-3 vote, the attempt by drug companies to achieve product liability immunity for all drugs approved for sale by the FDA. On March 5, the majority of Justices upheld a jury verdict in favor of a professional musician who lost an arm as a result of defective warning labels on an antinausea drug. This case was a deviation from recent decisions where the Supreme Court had appeared to signal a willingness to pre-empt state law injury cases where federal law implied an intention to "cover the field".
The decision in Levine v. Wyeth ended speculation that the Court would grant manufacturers the same preemptive immunity that they gave medical device manufacturers in a decision issued last year. Drug company stocks closed on an upward trend after the decision, suggesting that knowledgeable investing professionals did not consider the matter a significant blow to the viability of drug company profits.
In the majority opinion, written by Justice Stevens, the Court concluded that Congress had considered state personal injury actions to be an important adjunct to the Food and Drug Administration in protecting consumers from defective medications or labeling. Stevens went on to note, with the majority's approval, that the FDA had "limited resources to monitor the 11,000 drugs on the market" and its dramatic change in position under the Bush administration was "entitled to no weight". The Court concluded that the Bush Justice Department brief filed on behalf of the Defendant Wyeth and arguing for preemption was "undeserving of deference", and instead referred back to the FDA's longer-term policy of "welcoming" state personal injury suits that provided added protection to consumers.
Justice Thomas concurred with the majority decision, simply confirming that to imply preemption under these circumstances was an unduly aggressive interpretation of the law. Justices Roberts, Alito and Scalia dissented, arguing for an activist "implied preemption" that contradicted their normal claim to be strict constructionists. As they have demonstrated previously, these dissenters are willing to be "activists" when protection of business interests, as opposed to civil or consumer interests, is under consideration.
The case will have little or no impact in Michigan, where Legislators expressly exempted FDA-approved drugs from the operation of product liability laws during a spasm of "tort reform" during the Engler administration.