Philly.com, a Philadelphia news sheet has reported on the case of two former Synthes executives who have been jailed for their roles in the medical device company’s illegal promotion and clinical test of bone cements used by doctors in back surgeries, three of which ended with patients dying on the operating table. Former Synthes executives Michael Huggins and Thomas Higgins were sentenced Monday to nine months in prison with three months probation and a $100,000 fine.
Huggins, Higgins, Former VP Richard Bohner and director of regulatory and clinical affairs John Walsh all admitted to misdemeanor counts connected with the off-label use of the bone cement in vertebral compression fracture surgeries.
“This is a case where the regulations in place to perform clinical trials and protect human subjects were not just ignored, they were flouted”In addition to the personal charges, Norian Corp. faced a total of 52 felony counts, including conspiracy to obstruct the Food & Drug Administration and “to commit crimes against the United States,” according to a Justice Dept. release. The company was also slapped with seven counts of making false statements in an FDA investigation and 44 counts of releasing “adulterated and misbranded” shipments of its Norian XR cement “with intent to defraud.”
Last year, Synthes pleaded guilty to the charges and agreed to pay fines totaling $23.2 million. The deal also called for Synthes to dispose of Norian, which as reported yesterday resulted in the company being sold to Kensey Nash. Under the terms of the sale Kensey Nash will manufacture the Norian products, and Synthes will exclusively distribute the products worldwide.
Read the full Philly.com article here.
Source: Philly.com, massdevice, medlatest staff