A division of Synthes Inc., the world's largest maker of bone-related medical devices, has agreed to plead guilty to trying to circumvent the FDA and agreed to pay the maximum $22.5 million fine, the U.S. Attorney's Office in Philadelphia has announced.
Norian Corp., a division of West Chester-based Synthes Inc., will plead to one felony count of conspiracy to impair and impede the lawful functions of the FDA, and 110 misdemeanor counts of shipping adulterated and misbranded Norian XR across state lines.
Synthes agreed to a fine of $669,800 when it pleads guilty to one misdemeanor count of shipping the product. The agreement also calls for Synthes to sell Norian.
The government said that from May 2002 until the fall of 2004, Norian promoted the use of products in clinical trials of surgery to treat vertebral compression fractures, a painful ailment commonly found in the elderly.
The product had been approved for other surgical uses, but not in the spine, where research showed that it could react with blood and form clots. Three patients died.
"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 this afternoon in a statement.