One doctor employed by the medical device manufacturer Synthes, Inc., called it “human experimentation.” That doctor was fired.
Four of the company executives who stuck around for the illegal testing of the company’s bone cement on patients during back surgeries from 2002 to 2004 will be sentenced Monday in federal district court in Philadelphia.
Medical device and pharmaceutical company executives rarely go to prison when their companies break the law, but this could be different.
Three patients died on the operating table shortly after surgeons injected bone cements SRS, with barium sulfate, or XR into their vertebrae. The bone cements were produced by Norian, a wholly-owned subsidiary of Synthes. Synthes hoped the bone cements would fill gaps in the vertebrae of millions of older people and fill the company coffers.
The problem was that Synthes did not have approval from the U.S. Food and Drug Administration to use the cement for the specific back procedure (vertebral compression fractures) and never bothered to seek approval for a human trial, in which patients get to choose whether to participate, among other criteria. The company ignored those problems. Employees supplied the bone cement to surgeons, trained them in its use, and often helped in the operating room.
Judge Lagrome D. Davis is scheduled to sentence Michael D. Huggins, Thomas B. Higgins, Richard E. Bohner and John J. Walsh in four separate hearings, starting at 8 a.m.
Synthes, is a Swiss-based company, but has facilities and U.S. headquarters in West Chester and the four men live nearby.
- Huggins, 53, of West Chester, was the Synthes North America President for most of the relevant period.
- Higgins, 54, of Berwyn, was president of Synthes Spine Division for most of the relevant period.
- Bohner, 57, of Malvern, was senior vice president of operations.
- Walsh, 48, of Coatesville, director of regulatory and clinical affairs, though he joined Synthes full-time in 2003.
All four pleaded guilty to a single misdemeanor count under the responsible corporate officer doctrine.
That doctrine holds executives responsible if illegal activity happened on their watch or if they did nothing to stop the activity upon learning of it. But prosecutors argued the four went beyond just being on the payroll and were actively involved in the illegal promotion and trial. Davis seems to have agreed, based on his answers to defense objections in a pre-sentencing filing last week.
“Based on the record evidence of relevant conduct, the court finds that the patients were directly and proximately harmed by the conduct of defendants and others at Synthes,” Davis wrote last week, without revealing his decisions on sentences. “Defendants subjected the patients to the risks of SRS and XR without the patients’ full informed consent and without the FDA’s authorization.
“Some of those patients were injured and some died. By conducting unauthorized clinical trials of SRS mixed with barium sulphate and XR on human beings, defendants disregarded the safety of all members of society.”
In court filings, attorneys for all four defendants argued for probation and a $100,000 fine.
Prosecutors from the U.S. Attorney’s Office in Philadelphia argued in filings for the maximum of one year in prison and the $100,000 fine for Huggins, Higgins and Bohner. Only because Walsh was employed by Synthes for a shorter amount of time than the others, prosecutors said, nine months and a $100,000 fine was appropriate.
Sunday’s Inquirer story is here. Philly.com has a pharma-device page with links to other material on this case.
Synthes is being bought by Johnson & Johnson for $21.3 billion.
Chairman of the board and former CEO Hansjorg Wyss was not charged. Prosecutors declined to say why.
In a proxy statement filed by J&J in October, the Synthes’ contribution included only a couple paragraphs on the bone cement case. Referring to the $24.3 million to settle the criminal charges, the company said in the filing, “The payments did not have a material effect on the financial performance or financial position of the group.”
The indictments of the company and individuals were announced June 16, 2009. That press release is here.
The Superseding Information is here.
The Settlement Agreement is here.