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States, NEJM editors against preemption

Device Regulation Alert: Safety, Compliance and Reimbursement News, August 25, 2008

More people are taking sides on the issue of preemption—whether pharmaceutical and medical device manufacturers can be sued for personal injuries if their products receive FDA approval.

The medical device industry won a preemption battle in February when the Supreme Court ruled manufacturers could not be sued for personal injuries if their devices passed the FDA’s most stringent pre-marketing review. The ruling didn’t sit well with lawmakers, who have introduced anti-preemption bills in both the House of Representatives and the Senate.

The pharmaceutical industry will get its chance to argue for preemption when the Supreme Court hears Wyeth v. Levine November 3. Although the outcome doesn’t directly affect medical device manufacturers, a ruling against preemption could undermine the earlier ruling.

Attorneys General for 47 states signed a brief arguing people injured by drugs should have a right to sue pharmaceutical companies.

The editors of the New England Journal of Medicine (NEJM) alsofiled 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.

Not everyone is lining up against preemption, 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.

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