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Appeals Court Rejects Pacemaker Fraud Case

April 8, 2005

A federal appeals court rejected a claim by two lawyers who argued that the federal Medicare program was defrauded by a company that made defective wires for heart pacemakers.

Appeals Judge R. Guy Cole Jr., writing for a unanimous three-judge panel, ruled that because the claims against Medtronic had been previously disclosed publicly, the federal court lacked jurisdiction to hear the claim and must dismiss it. Previous lawsuits over the adequacy of the wires would have brought the issue to the government's attention, making it unnecessary for citizens to sue on its behalf, Cole wrote.

In 1989, Medtronic changed the coating used on two versions of the wires. The company obtained the FDA's approval, but then altered the specifications to change the thickness of the coating, the appeals court noted in its ruling. After the change in the specifications, many wires malfunctioned and had to be replaced, the court noted. The lawyers, Louis Gilligan and partner Gregory Utter, claimed that Medtronic should have informed the FDA of the new thickness of the wires' coating.