Synthes Execs Plead Guilty in Norian XR Illegal Testing CaseJul 21, 2009 | Parker Waichman LLP Two Synthes Inc. executives have pleaded guilty to participating in illegal clinical trials of the company's Norian XR bone cement, according to a New York Times report.
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 month, Synthes Inc. and its Norian subsidiary were indicted on charges of illegally testing Norian XR bone cement on humans. 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.
The indictment charged 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. Synthes faced 44 misdemeanor counts of shipping adulterated and misbranded Norian XR in interstate commerce between 2002 and 2004.
In addition, four Synthes executives were charged with a single count each of shipping misbranded Norian XR in interstate commerce. According to The New York Times, two of those executives - Michael D. Huggins, 51, of West Chester, Pa., and John J. Walsh, 46, of Coatesville, Pa. - have entered guilty pleas to those charges. They face up to a year in prison and a $100,000 fine, the Times said.
According to the Philadelphia Business Journal, Huggins served as president and COO of Synthes’ spine division from 1994 to January 2008; Walsh is director of regulatory and clinical affairs for the spine division, a post he has held since 2003.