Synthes Inc Executives plead guilty and face up to 1 year prison time

Although this topic is outside the field of vascular medical devices it does set a precedent for medical devices in general. The general background is that Synthes Inc is a maker of orthopedic related medical devices. The company is accused of facilitating the use of their product, Norian XR in an off label, non FDA approved, use which resulted in the death of three patients.

“Today’s resolution is grounded in the principle that Mike Huggins was a responsible corporate officer at Synthes,” Mr. Huggins’s lawyers, Gregory Poe and Catherine Recker, said in an e-mailed statement.

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The executives, Michael D. Huggins, 51, of West Chester, Pa., and John J. Walsh, 46, of Coatesville, Pa., pleaded guilty on Monday in federal court in Philadelphia to one misdemeanor count of shipping misbranded Norian XR across state lines.

The NY Times first reported this story June 16, 2009

In the indictment, prosecutors charged that Synthes officials considered seeking permission in 2001 from the F.D.A. to run a trial of the bone filler in back operations but rejected the idea. Instead, company officials approached selected doctors to do operations with the understanding that the company “would help them publish the clinical results,” the indictment charges.

The filler was approved in 2002 by the F.D.A. for use in general bone repair, but regulators insisted that Synthes not promote its use for spinal procedures.

By 2002, Synthes had received information from a researcher at the University of Washingtonwho reported lab and animal tests showing that Norian bone filler could generate large blood clots if it escaped from bone, the indictment states.

Shortly afterward, executives considered alerting the sales force not to promote the bone filler for unapproved uses, but they decided not to do so, prosecutors charged. Instead, the device maker began to hold sessions for doctors on how to use the bone filler and was about to promote it more aggressively when the company received a report in 2004 about the death of a third patient, court papers state.

The company, which never reported the patient deaths to the F.D.A., also misled an agency inspector, prosecutors charged.

Norian faces possible fines of $28 million, while Synthes, its parent, faces fines of $8 million.

The individuals charged are Michael B. Huggins, the president of the Synthes spinal division; Thomas E. Higgins, the company’s senior vice president for global strategy; Richard E. Bohner, a vice president for operations; and John J. Walsh, a regulatory affairs executive.

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