Synthes, Four Execs Indicted

Synthes Inc., based in West Chester, Pa., and four of its executives have been indicted on federal charges of promoting off-label use of a bone filler not approved by the U.S. Food and Drug Administration.

The orthopedic device maker, which is the American subsidiary of a multinational company of the same name in Solothurn, Switzerland, is defending its record, saying that it hasn’t taken any illegal actions with regards to Norian XR, a fast-setting, injectable, cement material used as a bone void filler in surgery to repair certain fractures.

“As a global leader in the medical device industry, Synthes has a long reputation for setting the highest legal and ethical standards in the development and commercialization of medical products,” a statement by the company says.

The indictment charges that from May 2002 until fall 2004 Norian conspired with others, including Synthes, its parent company, to conduct unauthorized clinical trials of two versions of Norian in surgeries to treat vertebral compression fractures of the spine. These surgeries were allegedly performed “despite a warning on the FDA-cleared label for Norian XR against this use, and in the face of serious medical concerns about the safety of the devices when used in the spine,” the indictment said.

The four executives, Michael B. Huggins, 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, were charged with criminal misdemeanors involving the shipment of unapproved medical devices. Those charges carry a possible prison sentence of one year.

Norian, based in Cupertino, Calif., faces possible fines of $28 million, while Synthes, its parent company, faces fines of $8 million.