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Effort Underway to Overturn Medical Device Lawsuit Ban

Feb 20, 2009 | Parker Waichman LLP Two lawmakers are working to overturn a year-old Supreme Court decision that took away the rights of consumer to sue when they are injured by defective medical devices.  According to The New York Times, Rep. Henry Waxman (D-Calif) and Rep. Frank Pallone (D-New Jersey) plan to soon reintroduce a bill to restore consumers' rights, and similar action is expected in the Senate.

Last February, the Supreme Court ruled in a case called Riegel vs. Medtronic  that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require Food & Drug Administration (FDA) approval of medical devices preempt product liability lawsuits in state courts. That law clearly says that states can’t maintain requirements that are different from federal standards. But Congress didn’t specify if those federal standards preempted state common law claims.

Medtronic and the Bush Administration asserted that allowing state personal injury lawsuits against the makers of defective medical devices amounts to a state “requirement” different from FDA requirements because such complaints are based on state laws.  Eight members of the high court agreed with Medtronic.  The Court recently heard another case, Wyeth vs. Levine, that could extend a similar lawsuit shield to drug makers.

The real-world impact if the Supreme Court's ruling was felt just last month when a federal judge in Minneapolis dismissed hundreds of lawsuits filed by people injured by the defective Medtronic Sprint Fidelis defibrillator lead.  In his decision,  the judge wrote that “the court recognizes that at least some plaintiffs have suffered injuries from using Sprint Fidelis leads, and the court is not unsympathetic to their plight. But plaintiffs assert claims for which the court simply cannot provide a remedy.”  The judge also wrote that it was up to Congress to change the law that bars such lawsuits.

But while the Medtronic dismissal is one of the largest of its kind, The New York Times said that many other people injured by defective devices have found they have no legal recourse.  They include a  woman burned internally by a device meant to reduce menstrual bleeding; a man who sustained internal injuries from a prostrate treatment device; and numerous patients who say they were injured by faulty joints or heart implants.

According to The New York Times, both Waxman and Pallone have criticized the Riegel decision.  For his part, Pallone said he expects the House Energy and Commerce Committee to hold hearings this session to question whether the FDA. process for approving devices is adequate.

Many consumer advocates also decry the ruling because of the FDA's poor track record of policing medical device, something that has been well-documented in recent months.  In fact, last month the Government Accountability Office issued a report that criticized the agency for failing to conduct appropriate medical device reviews. Around the same time of FDA scientists wrote then President-elect Obama imploring him to reform the agency, which they characterized as corrupt.  The letter explained that  that FDA’s regulation of  medical devices was “corrupted and distorted by current FDA managers, thereby placing the American people at risk.”  The letter also provided specifics about how scientists who differed in opinion from FDA management were threatened with disciplinary action.

"Consumers face the worse of all possible worlds,”  David C. Vladeck, a professor at Georgetown University Law Center and a medical industry watchdog, told the Times. “The FDA has shown itself incapable of keeping dangerous products off the market, and now the Supreme Court has said patients can’t sue companies for redress.”


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