Food-Drug Cases in Court

Article excerpt

PHILADELPHIA, Pennsylvania, United States (AP) - By 2003, surgeons trained by a Pennsylvania medical-device company had seen serious complications from an unauthorized test of a bone-cement product.

The cement had been approved to treat broken bones, but not weight-bearing hips and spines. Yet Synthes Inc. officials forged ahead with their own tests, teaching doctors how to use it for fractures in places not approved by federal regulators.

Then, a patient died in the operating room in Plano, Texas. Within months, two more died in surgery in northern California. Even then, no one called the FDA.

In a rare move, US prosecutors are seeking prison time for four top Synthes executives who pleaded guilty last year to misdemeanors as "responsible corporate officers." The closely watched criminal case is playing out this week in Philadelphia, where attorneys for the government and the executives are making their cases before US District Judge Legrome D. Davis. The judge has not yet scheduled individual sentencing dates.

Prosecutors call their crimes intentional and say a Synthes consultant warned early on that the tests amounted to "human experimentation."

The defendants deny any intent to violate US Food and Drug Administration protocols.

A lawyer for former Synthes Vice President Richard Bohner argued Tuesday that his client "made repeated good-faith efforts to prevent off-label promotion."

Davis agreed, to a point. But he asked why Bohner didn't do more.

"I think that's a question that he asks himself every day, why he didn't go farther. And that's why he's here," lawyer Brent J. Gurney said. …