Synthes’ executives were indicted in June and were accused of testing Norian XR for the treatment of fractures in the vertebrae on 200 patients without their consent from Dec. 2001-late 2004. According to the report, three patients died. Norian XR is not approved by the U.S. Food & Drug Administration for the treatment of spinal fractures.
Michael D. Huggins, former president and COO of Synthes, and John J. Walsh, director of regulatory and clinical affairs of Synthes, could be fined up to $100,000 and face up to one year in prison when sentenced on Oct. 22. In the plea bargain, Mr. Huggins states he was aware of and involved in the testing process, and Mr. Walsh states that he continued to promote the use of Norian XR for spinal surgery even after the patients died.
Two other Synthes executives are expected to enter guilty pleas in the coming weeks connected to the Norian tests.
Read the Inquirer’s report about the Synthes executives’ guilty pleas for illegal clinical trials.
