Four former Synthes executives excluded from federal health-care programs

Four former executives of medical device manufacturer Synthes, Inc., who went to federal prison for their role in an illegal clinical trial of bone cement, are out of prison now but probably won't be working in health care anytime soon.

Michael Huggins, Thomas Higgins, Richard Bohner and John Walsh were officially excluded from federal health-care programs on Tuesday, meaning no company employing them will be eligible to receive reimbursement for services or drugs through programs such as Medicare and Medicaid. Given the private sector's dependence on government money, companies rarely hire people on the excluded list.

The Office of Inspector General of the Department of Health & Human Services has been implementing exclusions since about 1981. HHS began imposing the penalties in 1977. A link to the OIG site is here.

Many exclusions last for five years. After the exclusion period, reinstatement is not automatic and must be applied for.

The prison sentences set new marks for health-care fraud cases prosecuted under the responsible corporate officer doctrine.

All four men lived in suburban Philadelphia while working for Synthes, which was based in Switzerland and had its U.S. headquarters in West Chester. The company was among the industry leaders in making rods and plates, screws and nails to fix broken bones.

In the early 2000s, while trying to tap into the lucrative market for a particular type of spinal surgery, Synthes taught surgeons how to use its Norian bone cement without FDA approval for that procedure and conducted unauthorized trials on humans. Three patients died on the operating table in 2003-04.

Synthes and its subsidiary, Norian, pleaded guilty to federal charges and paid fines of $23 million.

Hansjorg Wyss, the former chief executive officer, chairman of the board and largest shareholder, was not charged in the case. Huggins reported to Wyss.

The four executives pleaded guilty to one misdemeanor count. By law, Judge Legrome D. Davis could not sentence the men to more than one year. Huggins went to prison for nine months, as did Higgins. Bohner received an eight month sentence and Walsh got five months.

Families of the three patients who died are suing the company and/or individuals involved.

On June 14, health-care giant Johnson & Johnson completed its $19.3 billion acquisition of Synthes.

A link to previous Inquirer stories on the Synthes bone cement case is here.