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Medical Device Safety Act of 2009
May 12, 2009: Subcommittee Hearings Held.
Health Leaders Introduce Legislation Reversing Supreme Court's Medical Device Decision
Washington, Mar 5 -
U.S. Reps. Frank Pallone, Jr. (D-NJ), Chairman of the Energy and Commerce Subcommittee on Health, and Henry A. Waxman (D-CA), Chairman of the Energy and Commerce Committee, today introduced legislation in the House that will reverse a U.S. Supreme Court decision that denies injured patients the ability to seek compensation for their injuries and gives medical device makers blanket immunity.
In February 2008, the U.S. Supreme Court, for the first time, immunized medical device companies from lawsuits brought by patients who are injured by certain medical devices. In Riegel v. Medtronic, Inc., the Court found that those claims are barred by a preemption clause included in the Medical Device Amendments of 1976 (MDA). This decision ignores both congressional intent and 30 years of experience in which federal regulation, through the U.S. Food and Drug Administration (FDA), and tort liability played complementary roles in protecting consumers from device risks.
The Court's decision has left consumers 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 removed 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 2009 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.
"Yesterday the Supreme Court rightfully upheld a patient's right to legal recourse after sustaining an injury from a pharmaceutical product," Pallone said. "Today, we introduce legislation that gives patients that same right when injured by a medical device. This legislation puts safety first and eliminates the blanket immunity that medical device companies currently enjoy thanks to an unfortunate Supreme Court decision last year. We introduce this legislation today with strong bipartisan support, and I look forward to moving it through my subcommittee quickly."
"As the Supreme Court affirmed in its Wyeth decision yesterday, lawsuits by injured consumers play a critical role in helping to ensure safety," said Chairman Waxman. "The Court noted that these lawsuits 'uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly.' The same is true for medical devices. We must act quickly to enact this important legislation that will restore the ability of patients injured by defective medical devices to seek compensation, and realign the incentives for manufacturers to ensure the ongoing safety of their products."
The Court premised its decision on the theory that approval by the FDA adequately protects patients from unsafe medical devices, but the two lawmakers said that theory has proven false time and again. They point to numerous recent stories of patients who have suffered serious injuries from defective FDA-approved devices or devices without adequate safety warnings, like implantable cardiac defibrillators and pacemakers.
The Medical Device Safety Act of 2009 is endorsed by the National Conference of State Legislatures, the New England Journal of Medicine, the American Bar Association, AARP, the Center for Justice & Democracy, Consumer Federation of America, Consumers Union, Homeowners Against Deficient Dwellings, National Association of Consumer Advocates, National Consumers League. OWL - The Voice of Midlife and Older Women, Progressive States Network, Public Citizen, and the National Research Center for Women & Families
A companion bill has been introduced in the U.S. Senate by Sens. Edward Kennedy (D-MA), Chairman of the Senate Health, Education, Labor & Pensions Committee, and Patrick Leahy, Chairman of the Senate Judiciary Committee.