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Senators introduce anti-preemption bill

Device Regulation Alert: Safety, Compliance and Reimbursement News, August 18, 2008

Senators Edward Kennedy (D-MA) and Patrick Leahy (D-VT) introduced a bill designed to overturn the Supreme Court’s decision in Riegel v. Medtronic by explicitly allowing consumers to sue medical device makers under state law, according to a Leahy press release.

In February, the Supreme Court ruled 8-1 that the Federal Food, Drug, and Cosmetic Act preempts state product liability lawsuits seeking damages for injuries caused by FDA-approved devices. In June, Representatives Frank Pallone (D-NJ) and Henry Waxman (D-CA) introduced the Medical Device Safety Act of 2008 (H.R. 6381). Kennedy and Leahy introduced a companion bill (S. 3398) in July.

In a statement, Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association, said the bill would not improve patient safety, but would result in delayed patient access to medical devices, more lawsuits, and state court review and regulation of medical devices. Ubl said the Supreme Court decision reaffirmed that the FDA, not the courts, should regulate medical devices.

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