Clinical Trial: When Research Goes Wrong

Three patients died in an unapproved medical trial conducted between 2003 and 2004. Now, the executives of Snythes Inc., a medical-device company, are awaiting sentencing this week after pleading guilty to a misdemeanor as “responsible corporate officers,” according to Business Week.

The Synthes officials allegedly bypassed FDA protocol to have surgeons test 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 patients who died suffered a severe drop in blood pressure following the injections. The surgeons involved could not rule out the bone cement as a factor in the deaths, but it also wasn’t definitively responsible.

Synthes pleaded guilty to corporate health care fraud charges and agreed to pay $23 million in fines.

Prosecutors in the case want one-year prison terms for”human experimentation.” According to prosecutors, the executives not only tested the bone cement […]