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 Monday.
The former executives of 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 Synthes executives.
The executives face up to a year in prison. In hearings this week, federal 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, D.C. At one point, one of the D.C. crew tried to submit evidence and begin discussing it.
Judge Davis gently scolded the attorney and asked somewhat rhetorically, "Are you all from Washington?" as if to say we don't operate that way in Philly. Catherine M. Recker, a member of the legal team for defendant Michael D. Huggins and the lone local attorney among the eight, stood up 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 its wholly-owned subsidiary Norian pleaded guilty to charges related to introducing adulterated and misbranded bone cements into interstate commerce, and paid fines totaling $23.6 million. Synthes divested 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 during a 13-month span in 2003-04.
Pharmaceutical executives rarely get jail 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 already 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 didn't 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 [Food and Drug Administration] 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 is 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.