Synthes subsidiary Norian Corp. faces 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.”
Synthes faces 44 misdemeanor counts related to the shipments. Former executives at the Swiss device maker’s North American division, Michael Huggins, Thomas Higgins, Richard Bohner and John Walsh, each face a single misdemeanor charge.
The indictment alleges that Norian conducted unauthorized clinical trials in vertebral compression fracture surgeries. The bone cement was not approved for the procedures, allegedly due to evidence that it might cause pulmonary embolism — potentially fatal blood clots in the lungs — that the company and the executives are accused of concealing.
Although three patients died during the procedures, according to the indictment, it’s never been established that Norian XR, a calcium phosphate-based bone void filler the FDA cleared in 2002 to treat fractures, caused the deaths.
But the company and the accused executives were allegedly aware of the risks and knew that at least two patients had died, the indictment alleges:
“Notwithstanding this knowledge, the company allegedly proceeded to market the product for [vertebral compression fractures] without putting it through FDA-required testing. The company, it is alleged, did not stop marketing the product until after a third patient had died on the operating table. The indictment further alleges that 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 coverup in which they lied to the FDA during an official inspection in May and June 2004.”
Synthes, which acquired Norian in 1999, stopped selling the product in 2004. The company said it “believes that its marketing practices … were proper” and that it “intends to vigorously defend itself against the charges.”
If convicted, Norian faces $26.5 million in fines and five years’ probation . Synthes could face nearly $9.3 million in fines and five year’s probation and full restitution.
Huggins, 51, Higgins, 52, Bohner, 55, and Walsh, 46, each face a maximum of one year in prison, a $100,000 and one year of supervised release.