Protecting Consumers When Drug Manufacturers Fail To Warn Patients About Known Health Risks

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Litigation / Medical Malpractice
Article Date: 20 Aug 2008 - 3:00 PDT

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Attorney General Martha Coakley's Office joined Vermont and 45 other states in filing an amicus curiae brief with the U.S. Supreme Court arguing that states should have the power to protect consumers when drug manufacturers fail to warn patients about known health risks. The brief, filed last week, argues that Congress did not intend to supersede longstanding state laws that protect consumers and require adequate labeling of risks associated with pharmaceuticals.

"State laws serve the valuable purpose of exposing dangers about drugs and alerting manufacturers and regulators about issues and potential risks associated with pharmaceuticals," said Attorney General Coakley. "The outcome of this case will affect the fate of hundreds of state tort suits, consumer protection actions of state attorneys general, and the role of the states in our federal government."

The amicus brief, filed last Thursday by Vermont Attorney General William H. Sorrell, Attorney General Coakley, and 45 other state attorneys general, involves the case of Diane Levine, a professional musician who was given Wyeth's anti-nausea drug, Phenergan. In April 2000, Levine received Phenergan through the "IV Push" method, and the drug was mistakenly injected into an artery, causing injuries that led to the amputation of her right arm below the elbow. Levine sued Wyeth and argued that Wyeth violated state law by failing to provide adequate warnings about the IV Push method of administering Phenergan. A jury awarded Levine $6.8 million. Wyeth appealed the lower court's decision to the Vermont Supreme Court, arguing that Phenergan complied with all federal labeling requirements and challenging Vermont's power to impose additional requirements. Vermont's Supreme Court affirmed that decision in 2006.

The "friend of the court" brief urges the Court to uphold the jury verdict against drug manufacturer Wyeth. The brief also calls on the Court to reject Wyeth's argument that a drug manufacturer should be immune from lawsuits as along as the federal Food and Drug Administration (FDA) approved the labeling when the drug was introduced on the market.

The case will be argued before the U.S Supreme Court on Nov. 3, 2008.

Office of Attorney General Martha Coakley