Legal News

Test First, Market Later: Bone-Cement Execs Plead Guilty

By Ashby Jones

Well, the one and only bone cement prosecution the Law Blog’s ever covered has all but wrapped up. Two executives of Synthes pleaded guilty for their role in the company's illegal trials of bone-mending cement that led to the deaths of three patients. Click here for the Bloomberg story; here for previous LB coverage.

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. They each face as long as one year in prison and a $100,000 fine, a United States attorney, Michael Levy, said in a statement.

The FDA approved Synthes' Norian XR bone cement in 2002 for use in certain defects but not for use in surgeries to treat vertebral compression fractures of the spine, a painful condition commonly suffered by older people.

According to the indictment, the West Chester-based company allegedly marketed its bone cement for spinal surgery without putting it through FDA-required testing. Further, the indictment claimed the company didn't stop the marketing until after a third patient had died on the operating table and failed to order a recall because it "would have required them to disclose details of the three deaths to the FDA." Three patients died from a rapid drop in blood pressure during operations, prosecutors said.

"Today's resolution is grounded in the principle that Mike Huggins was a responsible corporate officer at Synthes," Huggins's lawyers, Gregory Poe and Catherine Recker, said in an e-mailed statement to Bloomberg. Walsh’s lawyer was not reached for comment.

Full post as published by Law Blog - WSJ.com on July 21, 2009 (boomark / email).