U.S. Reps. Frank Pallone, Jr. (D-NJ), Chairman of the House Energy and Commerce Subcommittee on Health, and Henry A. Waxman (D-CA), Chairman of the House Oversight and Government Reform Committee, recently introduced legislation in the House that will reverse a U.S. Supreme Court decision earlier this year involving medical devices. A companion bill will soon be introduced in the Senate by U.S. Sens. Edward Kennedy (D-MA), Chairman of the Senate Health, Education, Labor, and Pensions Committee, and Patrick Leahy (D-VT), Chairman of the Senate Judiciary Committee.
In February, the U.S. Supreme Court immunized medical device companies from state lawsuits brought by patients who are injured by certain medical devices. In Riegel v. Medtronic, Inc. the Court found that the product liability claims are barred by a preemption clause included in the Medical Device Amendments of 1976 (MDA). This decision was wrong. It ignored both congressional intent and 30 years of experience in which FDA regulation and tort liability played complementary roles in protecting consumers from device risks.
Because of the Court’s decision, seriously injured people are without any ability to seek compensation for their injuries, medical expenses and lost wages resulting from injuries caused by defective premarket approval (PMA) devices or inadequate safety warnings. It also removes one of the industry’s most important incentives to maintain product safety after approval and disclose newly-discovered risks to patients and physicians.
The Medical Device Safety Act of 2008 protects patients from dangerous and defective devices by correcting the Court’s flawed interpretation of the MDA. The legislation explicitly clarifies that state product liability lawsuits are preserved. People should contact thier elected Congressmen and Senator to voice support of this legislation to ensure that injured people have a right to compensation for injuries caused by dangerous and defective medical devices.