A trial date has been set for March 2012 in the case involving medical device maker Orthofix Inc. In September the Judge William Young in Boston’s Federal Court rejected a plea arrangement in which the company agreed to pay $42 million in criminal and civil penalties arising from its off-label promotion of bone growth stimulators. Judge Young had earlier told the company lawyers and prosecutors that the company’s conduct may have been egregious enough to warrant a sentence that deprived the company of its patents for products involved. The whistleblower case was originally brought by Jeffrey Bierman, a Missouris businessman and owner of a company that provided billing services to doctors and hospital. He sued under the federal False Claims Act which allows whistleblowers to file cases on behalf of the government and to share in recoveries. The issues related to the company bone growth stimulators in which the company claimed that patients needed to purchase these devices instead of renting them. They cost around $5,000 but are needed by recovering surgical patients for no longer than six months. The government eventually joined in the case. Five Orthofix employees have pleaded guilty in connection with the probe. If the company patents involved are taken, it would be the first time that such a penalty would have been imposed on a medical device manufacturer. The trial is expected to last several weeks.
Jeffrey Newman represents whistleblowers. firstname.lastname@example.org