House Democrats Hammer On Arguments Against FDA Pre-Emption
This article was originally published in The Gray Sheet
Executive Summary
A Supreme Court ruling favoring federal pre-emption for PMA-approved devices will shift the financial burden of faulty devices from manufacturers to U.S. consumers and taxpayers, Congressional Democrats argue
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Anti-pre-emption bill
Reps. Frank Pallone, Jr., D-N.J., Chairman of the House Energy and Commerce Subcommittee on Health, and Henry Waxman, D-Calif., Chairman of the House Oversight and Government Reform Committee, on June 26 introduce legislation that would reverse the U.S. Supreme Court's February decision in Riegel v. Medtronic. Chairman of the Senate Health, Education, Labor and Pensions Committee Ted Kennedy D-Mass., and Chairman of the Senate Judiciary Committee Patrick Leahy, D-VT, will soon introduce a companion bill in the Senate to overturn the court's decision, which in many cases immunizes medical device companies from state law suits brought by patients who are injured by a PMA-approved device. "This decision ignores both congressional intent and 30 years of experience in which FDA regulation and tort liability played complementary roles in protecting consumers from device risks," Kennedy said (1"The Gray Sheet" May 19, 2008, p. 5.