Synthes Inc. and its Norian Corp. subsidiary have agreed to plead guilty to charges that it illegally tested a <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">bone cement product. As part of the agreement with the US Attorney’s Office and the Department of Health and Human Services, Synthes has agreed to sell Norian and enter a corporate integrity agreement. Synthes and Norian will also pay fines of $23.2 million.
The product in question, Norian XR Bone Cement, was approved by the Food & Drug Administration (FDA) in 2002 for use in the arm, but not the spine. As we reported earlier, the FDA-cleared label for Norian XR warned against such use. Studies have shown that the use of Norian XR in the spine can cause blood clots that could become lodged in the lungs, leading to death. Synthes received a warning letter from the FDA in November 2004 regarding improper marketing of the product for vertebral compression fractures. Norian XR was finally pulled from the market after the warning letter.
Last year, Synthes Inc. and its Norian subsidiary were indicted on charges of illegally testing Norian XR bone cement on humans. Federal prosecutors alleged that Synthes conducted clinical trials in which Norian XR was injected during spinal surgery on about 200 patients. The surgeries took place between 2002 and 2004, and many involved elderly people with compression fractures. The illegal trials ended after the third patient death, prosecutors said.
Synthes was charged with a misdemeanor count of shipping an adulterated and misbranded version of Norian XR, while its Norian unit was charged with a felony count of conspiracy to impede the FDA and 110 counts of shipping the adulterated and misbranded product. Under the agreement announced yesterday, Norian will pay about $23 million and Synthes will pay almost $700,000 in fines and forfeitures, the Justice Department said.
If Synthes fails to sell off all of its Norian assets by May 2011, the unit’s products would be excluded from reimbursements under US health care programs like Medicare and Medicaid. The assets of Norian would not be allowed to be transferred to another part of the Synthes “corporate family” as part of the divestiture.
“Device manufacturers have a legal obligation not to test their devices on humans without FDA oversight,” Zane David Memeger, U.S. Attorney for the Eastern District of Pennsylvania, said in a statement. “This case is especially troubling because in search of greater profits Norian bypassed this process.”
Last year, four Synthes executives were charged with a single count each of shipping misbranded Norian XR in interstate commerce in relation to the same case. Those executives later entered guilty pleas and are awaiting sentencing.