08.01.08

Kennedy, Leahy Introduce Bill To Reverse Supreme Court Medical Device Decision

The chairmen of two Senate panels Thursday night introduced legislation to reverse a U.S. Supreme Court decision handed down earlier this year which immunized medical device companies from state lawsuits brought by patients who are injured by faulty devices.  Senator Edward Kennedy (D-Mass.), who chairs the Senate Health, Education, Labor and Pensions Committee, and Senator Patrick Leahy (D-Vt.), who chairs the Senate Judiciary Committee, introduced the legislation Thursday.

In February, the U.S. Supreme Court, for the first time, ruled that medical device companies could not be sued by patients who are injured by certain medical devices in state courts.  The Court’s decision, based on a flawed interpretation of a clause included in the Medical Device Amendments of 1976 (MDA), closed the courtroom doors on thousands of Americans suffering from faulty medical devices.  In June, the Judiciary Committee held a hearing to examine decisions by the Supreme Court have led to federal preemption of many state laws established to protect Americans, including laws to shield Americans from dangerous products, medical liability, and predatory lending practices.  Two witnesses, Bridget Robb and Maureen Kurtek, testified about how recent rulings by the Supreme Court have limited the rights of consumers to seek recovery for harmful practices by medical device companies and HMOs. 

The Kennedy-Leahy legislation, the Medical Device Safety Act, would provide protections for patients from dangerous and defective medical devices.  The bill clarifies that state product liability lawsuits are preserved.  The legislation is also retroactive to the date of enactment of the MDA.

“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 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 Judiciary Committee has held two hearings this year to examine the impact of Supreme Court decisions on Americans’ daily lives.  In addition to the June 11 hearing examining faulty medical devices, Leahy chaired a hearing on July 20 exploring the shield recent Supreme Court decisions have provided for corporate misconduct, favoring big business over consumers.

Companion legislation was introduced last month in the House of Representatives by 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.

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