8 avril, 2005 20:40
6th Circuit Rejects Fraud Case Against Pacemaker Company
John Noland
The Associated Press
04-08-2005
A federal appeals court on Wednesday 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.
The 6th U.S. Circuit Court of Appeals reversed a lower court decision in June 2003 to allow the case to proceed.
Appeals Judge R. Guy Cole Jr., writing for a unanimous three-judge panel, ruled that because the claims against Medtronic Inc. 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.
Louis Gilligan, one of the Cincinnati lawyers who filed the lawsuit, said he and partner Gregory Utter will consider whether to appeal. Gilligan noted that the appeals court did not rule on whether the case had merit.
Gilligan and Utter filed the case under the False Claims Act, which allows private citizens to sue on behalf of the government if they believe it has been defrauded. Under the law, if such a claim succeeds, the private citizens may be eligible to recover part of any money recovered.
The government has the right under the law to take over prosecution of the claim. Gilligan said the Justice Department declined to take it over when he met with its representatives last year.
Medtronic, based in Minneapolis, said it is pleased with the decision. The products have not been sold for at least 12 years, and the company has talked to doctors and the Food and Drug Administration about the issues with the wires, spokeswoman Valerie Lind said Wednesday.
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. Gilligan and Utter claimed that Medtronic should have informed the FDA of the new thickness of the wires' coating.
Gilligan and Utter previously had represented patients who lost their case for money damages from Medtronic. The patients contended that they had to endure additional surgeries and risk to replace the defective wires made by the medical technology company. Medtronic denied wrongdoing.
The wires, or leads, connected the pacemaker with the heart.
Gilligan said he estimated that Medicare spent more than $100 million in the 1980s and '90s for surgeries to replace the defective wires in about 30,000 cases.
A telephone message seeking a response was left Wednesday with Charles Miller, a Justice Department spokesman in Washington.
