Four pharmaceutical executives could learn Tuesday if they'll go to prison for their role in an unauthorized medical-product trial in which three patients died on the operating table during spine surgery.
The former Synthes Inc. officials have pleaded guilty to a misdemeanor involving the off-label use of a bone-cement product. They would be the first executives sent to prison under the 1975 Park Doctrine, which holds them accountable as "responsible corporate officers," whether they intended to break the law or not.
The government accused the former officials of human experimentation, while the defendants denied any intent to violate U.S. Food and Drug Administration protocols.
The company's own expert warned that the off-label use by company-trained surgeons was not only illegal, but immoral, Assistant U.S. Attorney Mary E. Crawley argued Monday.
"Without regard to patient safety, and without regard to the law, they went ahead anyway ... because there was a lot of money to be made," Crawley said.
Synthes' pilot studies showed the bone cement could cause blood clots in humans, while pig research suggested such clots could move to the lungs, the June 2009 indictment charged. The cement had been approved for surgical use in other body parts, but not the weight-bearing spine.
The defendants are: former Synthes North America President Michael D. Huggins, 53, of West Chester; former senior vice president Thomas B. Higgins, 54, of Berwyn; vice president Richard E. Bohner, 57, of Malvern; and director of regulatory and clinical affairs John J. Walsh, 48, of Coatesville.
Huggins' lawyer said his client did not know many of the particulars of what occurred, even if, with his plea, he has agreed to shoulder some responsibility.
"The question is, what did Mr. Huggins know and when did he know it?" lawyer Gregory Poe said.
He will presumably try to answer that Tuesday when the sentencing hearing resumes in Philadelphia before U.S. District Judge Legrome Davis. Each defense lawyer is expected to argue his client's case before prosecutors take the floor to press for prison time.
Defense lawyers spent Monday raising objections to government pre-sentencing reports on their clients.
The judge suggested the case hinges on whether "the company's culture, the behavior, exceeded the boundaries of what the FDA would allow."
West Chester-based Synthes and a subsidiary, Norian Corp., separately pleaded guilty in November to a felony and 110 misdemeanors, and agreed to pay $23 million in fines.
The patients who died suffered severe hypotension, or low blood pressure, following injections of Norian bone cement, authorities said. None of the surgeons could rule out the product as a factor in the deaths, an FDA investigator has said.
However, nor was it ever ruled the cause of death.