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Kennedy, Colleagues Introduce Bill To Reverse Supreme Court Decision, Protect Consumers From Dangerous Medical Devices

Press Release

Location: Washington, DC


Senator Edward M. Kennedy, Chairman of the Senate Health, Education, Labor and Pensions Committee, and Senator Patrick J. Leahy, today proposed legislation to enable injured patients to sue manufacturers of faulty medical devices. Senator Leahy introduced the bill, the Medical Device Safety Act of 2008, in the Senate today on behalf of Senator Kennedy and himself.

The legislation will reverse a Supreme Court decision last February, Riegel v. Medtronic Inc., that shields medical device companies from lawsuits brought by patients who are injured by certain medical devices. The Court ruled that such claims are barred by a preemption clause in the Medical Device Amendments of 1976 (MDA).

Anthony Coley, a spokesman for Senator Kennedy said, "Senator Kennedy believes the Court's decision ignores both Congressional intent and 30 years of experience in which FDA regulation and tort liability have had complementary roles in protecting consumers from faulty medical devices. The Senator feels the issue is a matter of basic fairness. Medical device companies should responsibly design and manufacture safe products and they should be held accountable when these products injure consumers. Congress never intended in the 1976 Act to protect manufacturers from liability for injuries caused by flawed devices. This bill rightly protects consumers and makes Congressional intent crystal clear."

"I am pleased to join with Senator Kennedy to introduce this legislation to make explicit that the preemption clause in the Medical Device Amendments that the Supreme Court relied upon is not, and never was, intended to preempt all common law claims of consumers injured by a federally approved medical device," said Senator Leahy. "I hope this legislation is passed quickly to send the strong signal that the Senate intends to hold the Court accountable to the American people who are being shut out of courtrooms across the country."

"The Supreme Court decision was a victory for big business over consumers, the law and common sense; and it must be reversed," said Senator Harkin. "Those who are injured by a faulty medical device deserve to have their day in court. An injured consumer is entitled to compensation and to have their medical expenses and lost wages paid for, regardless of whether the FDA approved a device or not."

"The FDA used to be the gold standard, but the agency has come under scrutiny recently. If manufacturers are putting faulty devices on the market, they must be held accountable to the patients who use them, the way Congress always intended," said Senator Mikulski. "I will continue to fight for legislation like this that puts the health and safety of Americans ahead of manufacturers' interests."

"This legislation will ensure that federal law is interpreted by courts correctly. It will protect patients' rights and ensure that device manufacturers are held responsible for their mistakes," Senator Bingaman said.

"Instead of defending the rights of patients injured by medical devices, the Supreme Court sided with manufacturers and shielded them from responsibility when their products hurt people. We are standing up for those who deserve justice and making sure manufacturers of defective devices are held accountable," said Senator Clinton.

"The device industry wants legal protections that no other manufacturer enjoys," said Senator Brown. "FDA approval isn't a safety blanket for industry. When a faulty product slips through the approval process, consumers shouldn't pay the price."

The Senate bill is also co- sponsored by Senators Dodd, Harkin, Mikulski, Bingaman, Murray, Reed, Clinton, Obama, Sanders, Brown, and Whitehouse. Companion legislation, HR 6381, has been introduced in the House of Representatives by Rep. Frank Pallone, Jr.


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