Former Synthes leader jailed for unethical implant trials

 Michael Huggins, former North America President of bone implant specialist Synthes, has received a nine-month sentence for his role in an unauthorised clinical trial of bone cement that caused three human deaths.

Three other former Synthes executives, convicted of involvement in the same criminal activity, are awaiting sentence.

The US Justice Department had prosecuted the four executives in a drive to hold individuals to account for corporate crimes.

The executives had senior roles in Synthes’ Norian unit, which manufactured osteobiological implants. Norian was purchased by US company Kensey Nash earlier this year for $22 million.

Between 2002 and 2004, the Justice Department said, Norian carried out unauthorised clinical trials of Synthes’ Norian XR bone cement in surgeries to treat vertebral compression fractures (VCF), despite a warning against such use on the product label.

Initial studies had shown that the bone cement reacted chemically with human blood in vitro, producing clots – and that when used in a pig, the cement caused blood clots in the lungs.

Synthes continued to test the product on humans until it had caused three deaths, and even then the company misled the FDA, the Justice Department said.

In April 2011, Johnson & Johnson purchased Synthes for approximately $21.3 billion to merge it with its own troubled DePuy orthopaedic device business.