Supreme Court Hears Arguments In Case Related To Product Liability For Medications Approved By FDA

Main Category: Litigation / Medical Malpractice
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 27 Feb 2008 - 10:00 PST

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The Supreme Court on Monday heard arguments in the first of two cases that could determine whether FDA approval of medications protects manufacturers from product liability lawsuits filed in state courts, the New York Times reports (Harris, New York Times, 2/26).

The first 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, which Pfizer acquired in 2000, 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 (Kivlan, CongressDaily, 2/25).

Comments From Justices
Justice Stephen Breyer said, "Who would you rather have make the decision as to whether this drug is, on balance, going to save people or, on balance, going to hurt people? An expert agency ... or 12 people pulled randomly from a jury pool who see before them only the people whom the drug hurt and don't see those who need the drug to cure them?" (Bravin, Wall Street Journal, 2/26). He added, "What worries me is, what happens when the jury is wrong?" Justice Samuel Alito said that product liability lawsuits filed in state courts "very seriously interfere with what the FDA is doing" (New York Times, 2/26).

However, Justice Ruth Bader Ginsburg said, "At least since the 1930s, state tort litigation of the very kind that Justice Breyer has described has gone on," adding, "Even though the FDA has approved a drug, an injured party can say this was a defective drug" (Wall Street Journal, 2/26).

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