Supreme Court to Hear Case Pitting Federal v. State Product Liability Law

September 27, 2007

The Supreme Court said this week that it will decide a case that centers on whether federal regulation of pharmaceuticals preempts state law.

The case involves a product liability lawsuit against Pfizer’s Warner-Lambert unit.

A group of Michigan plaintiffs led by Kimberly Kent in April 2000 sued Warner-Lambert Co. over alleged injuries caused by its Rezulin diabetes drug. Rezulin was ordered off the market in March 2000 by the Food and Drug Administration after it was linked to nearly 400 deaths and hundreds of cases of liver failure.

A federal district court dismissed the suit in 2005, citing a Michigan law that shields FDA-approved pharmaceuticals from liability lawsuits. The case was brought under Michigan law but was moved to federal court because other states were also involved.

An exception in Michigan’s law that allowed the suits to proceed if a pharmaceutical company misrepresents information presented to the FDA was pre-empted by federal laws governing the regulation of pharmaceuticals, the district court said.

The 2nd U.S. Circuit Court of Appeals, based in New York, reinstated the suit. The appeals court disagreed that the exception in Michigan’s law for cases involving fraud against the FDA was pre-empted by federal law.

That decision conflicted with other appeals court rulings in previous cases. Such conflicts in the federal apepals courts are one criteria the justices consider when deciding to take a case.

The case is Warner-Lambert v. Kent, 06-1498. Oral arguments haven’t yet been scheduled. The case will likely be decided before the court’s term ends in June.

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