The U.S. Justice Department has joined a whistleblower fraud lawsuit against 750-bed Duke University Medical Center in Durham, N.C., the department announced last week.
Duke becomes the 15th hospital identified in the civil False Claims Act suit, which was filed in 1994 in federal court in Seattle by former medical device salesman Kevin Cosens. Fourteen other hospitals have paid more than $29 million to settle allegations that from 1987 to 1994 they billed Medicare for procedures using experimental cardiac devices not approved by the Food and Drug Administration. At least another 85 hospitals have been named but not yet identified in the still-sealed lawsuit.
Cosens, formerly employed by several medical device manufacturers, could not be reached for comment. But his San Diego attorney, Don Warren, said the amount of alleged wrongful billing by Duke exceeded $6 million and total estimated damages from all hospitals surpass $200 million.
"In some instances the devices were harmful and did not make it through the Food and Drug Administration review process," Warren said.
A Justice Department spokesman declined to comment further on the suit.
"We have been aware of this matter since responding to a subpoena from the government in 1994," said Gary Stiles, M.D., chief medical officer of the Duke University Health System. "We believe that the lawsuit involving dozens of the nation's most prominent hospitals is based on an unlawfully adopted government policy, which the government subsequently abandoned in 1995 through specific regulatory action that now permits Medicare beneficiaries to receive the very same high-quality medical care that the government is calling improper in this lawsuit."