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States, NEJM editors against preemption

Pharma Compliance Alert, August 20, 2008

Forty-seven states and the editors of the New England Journal of Medicine (NEJM) don’t want the Supreme Court to rule in favor of preemption when it hears Wyeth v. Levine this fall.

The case centers on whether FDA approval is enough to shield companies from product liability lawsuits at the state level. A Vermont jury awarded Diana Levine $6.7 million after she sued Wyeth for negligence and failure-to-warn product liability. Wyeth appealed to the Vermont Supreme Court, which upheld the verdict. Wyeth then appealed to the U.S. Supreme Court, which is scheduled to hear the case November 3.

In a release, Vermont Attorney General William Sorrell said people injured by drugs should have a right to sue pharmaceutical companies. “The attempt by the drug industry and the current administration to knock out these types of lawsuits is shameful,” Sorrell added. Attorneys General for 46 other states signed Sorrell’s brief.

The editors of the NEJM also filed a brief against preemption, calling the issue one of immense importance. The editors said the FDA “is in no position to ensure the safety of prescription drugs.” The agency is not able to determine all risks of drugs before it approves drugs for sale and it cannot address hazards that become apparent after approval.

The NEJM editors blamed part of the problem on the FDA’s dependence on pharmaceutical companies to supply information. They also criticized pharmaceutical companies for withholding key information from the FDA.

Not everyone is lining up against the industry, however. In June, the Department of Justice (DOJ) filed a brief supporting Wyeth. The DOJ argued the FDA weighs the risks and benefits of a drug and considers the overall health consequences of including particular instructions or warnings in a drug’s labeling.

“Because FDA’s approval strikes a balance between competing considerations, state laws that strike a different balance conflict with FDA’s determination and are impliedly preempted,” the DOJ said in the brief.

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