According to the indictment, the company conducted two XR "Test Market Kick-Off" surgeon meetings, and one surgeon forum, from August of 2003 through mid-January 2004, training approximately 52 spine surgeons how to use Norian XR to treat VCFs. It is charged that, after the third person died on the operating table during a surgery in which a Norian cement was used to treat VCFs, the company cancelled the future surgeon forums. The indictment alleges that the company considered, but rejected, the idea of recalling or removing XR from the market, either of which actions would have required them to notify the FDA.

Three months later, according to the indictment , when the FDA conducted an unannounced inspection at the Norian plant in West Chester, focused on whether or not Norian and Synthes had conducted an unauthorized clinical trial of XR, a number of Synthes employees, including individual defendants Huggins, Bohner and Walsh, made materially false and misleading statements to the FDA investigator.


"The Department of Defense is outraged by a company that potentially puts our military personnel, their family members, and veterans at undue risk for serious medical complications or even death, just to increase their corporate bottom line," said DCIS Assistant Special Agent in Charge Kenneth Maupin. "Criminal matters that affect the welfare, morale and readiness of our men and women in the military are of the highest priority to the Defense Criminal Investigative Service. Our military put their lives on the line every day for the American people. They deserve to feel safe that they and their families are not put at undue risk when having a medical procedure."

"Corporate profits and individual greed, which caused senior managers of Synthes to skirt the rules and compromise patient safety, were at the core of this investigation," said VA Inspector General George Opfer. "This team of investigators worked tirelessly to move this case forward and our citizens were well served by their efforts."

If convicted defendant Norian Corporation faces a maximum possible sentence of a fine of $26,000,000, five years probation, full restitution, forfeiture of $469,800 and special assessments of $20,800. Defendant Synthes faces a maximum possible sentence of a fine of $8,800,000, five years probation, full restitution, forfeiture of $469,800 and a special assessment of $5,500. Each of the individual defendants faces a maximum sentence of one year in prison, a fine of $100,000, full restitution and one year of supervised release.

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