Former Synthes executives sentenced to prison for unauthorized bone cement trials

Three former executives from Synthes Inc., a parent company of the West Chester, Penn. Norian Corporation, have been sentenced to prison on charges of conducting illegal clinical trials without the approval of the FDA.

Former Synthes president Michael Huggins, former Synthes spine division president Thomas Higgins and former Synthes regulatory affairs official John Walsh were convicted of conspiring along with Norian to conduct trials for two bone cements — Norian XR and Norian SRS — between May 2002 and the fall of 2004, according to a U.S. Department of Justice press release. The cements, which were used to treat vertebral compression fractures, were used in the trials despite an FDA label warning against using Norian XR for spine surgery.

Higgins and Huggins were sentenced to 9 months in prison; Walsh was sentenced to 5 months. In addition to the time served, the defendants were ordered to pay a fine of $100,000 each. Norian is to pay $22.5 million in penalties; its parent company, Synthes, is paying $669,800 in fines and forfeitures, according to an earlier U.S. Department of Justice press release. Synthes has agreed to sell all Norian assets within a limited period of time as part of a conviction agreement.

Former Synthes vice president Richard Boehner is awaiting sentencing at a later date.

The release noted that previous research showed the cements caused blood clotting and, in one animal test, the clots became lodged in the animal’s lungs. However, the company marketed the bone cement for vertebral compression fractures without necessary FDA testing.

According to the release, the company did not stop marketing the cement until three patients had died on the operating table. “After the death of the third patient in January 2004, Norian and Synthes did not recall Norian XR from the market – which would have required them to disclose details of the three deaths to the FDA – but, instead, compounded their crimes by carrying out a cover-up in which they made false statements to the FDA during an official inspection in May and June 2004,” the release noted.

“When corporate executives authorize clinical trials of a medical device without the FDA’s permission and without regard for known safety risks, including death, those executives must be held accountable,” David Memeger, U.S. Attorney stated in a press release. “In this case, the defendants conducted illegal human experiments beyond the scrutiny of the FDA. Today’s sentences should clearly put health care industry executives on notice that when they violate the law and harm individuals for the sake of corporate profits, they will go to prison.”

A media contact for Synthes declined requests by Orthopedics Today for comment.