Product News and Recalls

Medical Device Safety Act of 2008

June 29, 2008 – U.S. Representatives Frank Pallone, Jr. (D-NJ) and Henry A. Waxman (D-CA) have introduced legislation named the Medical Device Safety Act of 2008, a direct response to a recent decision by the United States Supreme Court that would provide immunity for manufacturers of defective medical devices.

In February of 2008, the Supreme Court issued an opinion entitled Riegel v. Medtronic, Inc., in which the Court held that the Medical Device Amendments of 1976 preempt state lawsuits brought by patients who are injured by defective medical devices as long as the devices were approved by the FDA. According to the presenters of the Medical Device Safety Act of 2008, the Court’s “flawed” 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.”

The complete Congressional press release can be found here.

Similar legislation will be introduced in the Senate by Senator Edward Kennedy (D-MA), Chairman of the Senate Health, Education, Labor, and Pensions Committee, and Senator Patrick Leahy (D-VT), Chairman of the Senate Judiciary Committee.

Representative Pallone is Chairman of the House Energy and Commerce Subcommittee on Health. Representative Waxman is Chairman of the House Oversight and Government Reform Committee.