Two Synthes Execs Plead Guilty To Off-Label Bone-Mending Cement Trials

A pair of Synthes Inc. executives have pleaded guilty for their roles in the company¹s illegal trials of bone-mending cement that led to the deaths of three patients.

The executives, Michael D. Huggins, 51, of West Chester, Pa., and John J. Walsh, 46, of Coatesville, Pa., pleaded guilty recently in federal court in Philadelphia, Pa., to one misdemeanor count of shipping misbranded Norian XR across state lines. They each face up to one year in prison and a $100,000 fine, United States attorney Michael Levy said in a statement.

Synthes, a manufacturer of bone-related medical devices based in Switzberland, its Norian Corporation unit and four executives were indicted last month over claims they had conspired to hold unauthorized clinical trials of Norian-brand cements from May 2002 to late 2004. Three patients died from a rapid drop in blood pressure during operations, prosecutors said.

The 52-count indictment accuses executives at the company, which is based in West Chester, Pa., of bypassing U.S. Food and Drug Administration approval of the trials while knowing that the Norian XR and Norian SRS cement products posed significant risks.