Lawyers seek leniency for ex-Synthes executives

Attorneys for four local executives guilty in a case involving an illegal clinical trial of a bone cement in the spines of elderly patients - three of whom died - argued for leniency in federal court in Philadelphia on Monday.

The former executives of the medical-device maker Synthes Inc. in West Chester pleaded guilty in 2009 but say they were not intimately involved in testing the bone cement, according to their lawyers.

"The evidence of intent is insufficient," said Adam S. Hoffinger, lead attorney for Thomas B. Higgins, one of the four former executives.

The executives face up to a year in prison. In hearings this week, U.S. District Judge Legrome D. Davis is being asked to set sentencing guidelines.

Hoffinger and most of the eight defense attorneys at the front tables in Davis' courtroom Monday were from law firms in Washington. At one point, one of the D.C. lawyers tried to submit evidence and begin discussing it.

Davis gently scolded the lawyer and asked, "Are you all from Washington?" Catherine M. Recker, a member of the legal team for defendant Michael D. Huggins and the lone local lawyer among the eight, stood briefly, if only to signal that the local legal establishment was represented.

Davis will eventually sentence Huggins, of West Chester; Higgins, of Berwyn; Richard E. Bohner, of Malvern; and John J. Walsh, of Coatesville. In court the four sat quietly, and whispered occasionally with their lawyers.

Synthes and Norian Inc., a wholly owned subsidiary, pleaded guilty to charges related to introducing adulterated and misbranded bone cements into interstate commerce and paid fines totaling $23.6 million. Synthes sold Norian to comply with the plea, selling the assets May 24 to Kensey Nash Inc., of Exton, for $22 million. Earlier, in late April, Johnson & Johnson agreed to buy Synthes for $21.3 billion.

The four former executives pleaded guilty in 2009 to one misdemeanor count each for their parts in the scheme to market Norian for off-label use on spines in their roles as corporate officers with the responsibility to prevent such violations. Three patients died over 13 months in 2003 and 2004.

Pharmaceutical executives rarely get prison time for corporate crimes. The responsible-corporate-officer doctrine was born of two Supreme Court cases that said an executive could be found guilty if illegal activity happened on his or her watch and he or she should have known about it, or failed to stop the activity once becoming aware of it.

In this case, defense attorneys prefer a strict definition - and, in their view, application - of the law. They don't dispute that their clients worked at Synthes during the time in question. But they are disputing what their clients did or how it should be viewed and, finally, if prosecutors' assertions about their conduct are deemed true, whether Davis should consider that in his sentences. The four have agreed to pay $100,000 each in fines, but they would prefer no prison time and as little probation as possible.

Assistant U.S. Attorney Mary E. Crawley did not say it in court Monday, but the prosecutor's court filings during the two years since the guilty pleas indicate she hopes for the maximum of a year in prison.

"The thing that distinguishes a legitimate clinical trial from human experimentation is adherence to FDA rules," Crawley said in court Monday. "These defendants knew what the FDA requirements were. They were aware of significant patient safety issues. Without regard to patient safety issues and without regard to the law, they went ahead."

Davis is letting attorneys for all four defendants and the prosecution argue about each side's presentencing memos to the judge. He said he was trying to avoid giving appeals courts any reason to send the case back to him. But, as for those sentencing guidelines?

"I will make my own decision," Davis said.