Maryclaire Dale, AP
Four white-collar defendants hope to avoid prison when they are sentenced for conducting unapproved medical trials that left three patients dead. The former executives of Snythes Inc., a medical-device company with U.S. headquarters in suburban Philadelphia, pleaded guilty to a misdemeanor as "responsible corporate officers." In a rare move under that statute, U.S. prosecutors are seeking one-year prison terms for what they call "human experimentation."
They say the Synthes officials bypassed Food and Drug Administration rules as they hurried to have surgeons test the bone cement in people with spine fractures. The product was not approved for that use, and three people died in the operating room in 2003 and 2004. The defendants are former Synthes North America President Michael D. Huggins; former senior vice president Thomas B. Higgins; ex-director of regulatory and clinical affairs John J. Walsh; and former Synthes Vice President Richard Bohner.
Both Synthes, with a U.S. headquarters in West Chester, and its subsidiary Norian Corp., pleaded guilty to corporate healthcare fraud charges and agreed to pay $23 million in fines. The defendants deny any intent to violate FDA protocols, and at least one argued that he made repeated, good-faith efforts to prevent off-label use. However, in a key pre-trial ruling issued last week, U.S. District Judge Legrome D. Davis rejected many of the arguments raised by the defense since the 2009 guilty pleas.
"The patients were directly and proximately harmed by the conduct of defendants and others at Synthes," Davis wrote. "Defendants subjected the patients to the risks of SRS and XR (bone cement) without the patients' full informed consent and without the FDA's authorization. Some of those patients were injured and some died." One defense lawyer has pointed out the disconnect between the fact that doctors can use products "off-label," but companies cannot promote them for those alternative uses. The bone cement was used in about 200 spine patients.
Earlier pilot studies had shown the cement could cause blood clots in humans, while pig research suggested such clots could move to the lungs, according to the June 2009 indictment. However, with competitors ahead in the race to market, Synthes was eager to move forward, authorities charged. The patients who died suffered a severe drop in blood pressure following the injections. None of the surgeons could rule out the bone cement as a factor in the deaths, but it also wasn't definitively blamed for them.
One patient died in Plano, Texas, and two others in northern California. Each was frail, with multiple health problems, Davis said. According to prosecutors, the defendants not only tested the bone cement on humans, but failed to report the deaths and lied to FDA investigators. Each defendant has lost his job and been fined $100,000.