A medical device firm and its parent company have agreed to plead guilty and pay about $24 million for illegally testing bone cement on about 200 spinal patients, three of whom died in surgery, the Associated Press reports.
The medical device company, Norian Corp., a subsidiary of Synthes Inc., will be sold to an outside buyer as part of the settlement. According to Bloomberg, it marks the first divestiture of a medical device maker ever ordered by the U.S. in a health-fraud case. Synthes, the parent company, is headquartered in Switzerland but bases its U.S. operations in Pennsylvania.
Federal authorities said Norian trained surgeons to test the bone-mending cement on the spinal surgery patients even though that use of the product was not approved by the Food and Drug Administration. The New York Times reports Norian’s products, which were approved to patch the skull and a part of the arm, are believed by the authorities to cause potentially fatal blood clots.
The trials, which began in 2002, were stopped only after the third death in January 2004, according to the U.S. Attorney’s Office in Philadelphia. All of the patients died from a rapid drop in blood pressure during surgery.
According to AP, federal officials say the company failed to report the deaths to the FDA and lied to the agency investigators.
U.S. Attorney Zane David Memeger said medical device manufacturers “have a legal obligation not to test their devices on humans without FDA oversight” and called the case “especially troubling” because Norian bypassed FDA approval “in search of greater profits.”
Norian will plead guilty to conspiracy to impede FDA functions, a felony charge. Both Norian and Synthes will plead guilty to misdemeanor counts of interstate shipping of adulterated and misbranded Norian XR. Four Synthes executives also pleaded guilty to the misdemeanor shipping charge and await sentencing.
“Synthes remains committed to operating in accordance with the highest legal and ethical standards, and bringing closure to this matter will permit the company to focus on its mission to improve patient care,” the company said in a statement.