Supreme Court Divided In Decision In Product Liability Case Related To Prescription Drugs

Main Category: Litigation / Medical Malpractice
Also Included In: Pharma Industry / Biotech Industry;  Regulatory Affairs / Drug Approvals
Article Date: 05 Mar 2008 - 12:00 PDT

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The Supreme Court on Monday voted 4-4 in a case related to whether FDA approval of medications protects manufacturers from product liability lawsuits filed in state courts, the New York Times reports. The tie vote will allow a product liability lawsuit against Warner-Lambert, which Pfizer acquired in 2000, to proceed (Greenhouse, New York Times, 3/4). Chief Justice John Roberts did not participate in the vote, "presumably because he owns Pfizer stock," the Wall Street Journal reports (Anderson, Wall Street Journal, 3/4).

The case focuses on a 1996 Michigan law that limits product liability lawsuits related to medications approved by FDA. Under the law, such lawsuits can proceed in the state only when plaintiffs can prove pharmaceutical companies withheld or misrepresented information to FDA that would have prompted the agency to withdraw the medications from the market or reject their approval. Michigan is the only state to have such a law. In 2005, a federal district court dismissed a lawsuit filed by Michigan patients against Warner-Lambert over health problems linked with the diabetes medication Rezulin based on the law. However, the 2nd U.S. Circuit Court of Appeals later reinstated the lawsuit (Kaiser Daily Health Policy Report, 2/26).

The tie vote by the Supreme Court affirms the appeals court decision but does not set a precedent for future cases. According to the Times, the case "presented a narrow slice of the broad pre-emption issue that the court will take up in its next term" (New York Times, 3/4).

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