Medical devices investigation. Medical device maker Synthes Inc. and its Norian subsidiary have been indicted on charges of illegally testing Norian XR bone cement on humans. According to Bloomberg.com, those trials – some of which were conducted at VA hospitals – allegedly resulted in the deaths of three patients from severe low blood pressure following surgery with Norian XR.
According to The Wall Street Journal, the U.S. Justice Department has been investigating Synthes and Norian for illegal off-label promotion of the XR product since 2006. That year, the company was served with a grand-jury subpoena.
Norian XR bone cement was approved by the Food & Drug Administration (FDA) in 2002 for use in the arm, but not the spine. In fact, according to Bloomberg.com, 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.
Federal prosecutors allege that Synthes conducted clinical trials
In spite of this danger, federal prosecutors allege that Synthes conducted clinical trials in which Norian XR was injected during spinal surgery on about 200 patients, the Associated Press said.
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 claim.
According to the Associated Press, the indictment against Synthes charges that it trained 52 physicians to conduct the illegal trials. Prosecutors also claim that Synthes’ Norian division conducted “Test Market Kick-Off” surgeon meetings and one surgeon forum from August 2003 through mid-January 2004 to train spine surgeons for the trials, Bloomberg.com said.
Following the patient deaths, Synthes rejected the idea of recalling Norian XR or removing it from the market. According to Bloomberg.com, prosecutors also charge that the West Chester, PA based company lied to FDA investigators during an inspection at the Norian plant in around April 2004.
This is not the first time Synthes’ marketing of Norian XR
According to The Wall Street Journal, this is not the first time Synthes’ marketing of Norian XR has been called into question. The company 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, the Journal said.
The indictment charges Norian with a total of 52 felony counts, including conspiracy to impede the functions of the FDA, making false statements in connection with an FDA inspection, and shipping adulterated and misbranded Norian XR bone cement in interstate commerce, the Journal said.
Synthes faces 44 misdemeanor counts of shipping adulterated and misbranded Norian XR in interstate commerce between 2002 and 2004. Four Synthes executives are charged with a single count each of shipping Norian XR in interstate commerce, the Associated Press Reported.