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Akron Univ. School of Law

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Thursday, September 27, 2007

Pharmaceutical Regulation Pre-emption of State Law

Law.com has a brief overview of the Warner-Lambert v. Kent, 06-1498 case recently granted cert. by the United States Supreme Court.  It states,

The Supreme Court said Tuesday it will decide a case that centers on whether federal regulation of pharmaceuticals pre-empts 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 appeals courts are one criterion the justices consider when deciding to take a case.

The Supreme Court's interest in weighing in on the federal pre-emption of state laws is rooted in a surge of product liability lawsuits in state courts, "particularly in the area of drugs and medical devices," said Paul Smith, an attorney at Jenner & Block.

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