July 21st, 2009

The Philadelphia Inquirer reports:

Two senior executives of a West Chester-based manufacturer of medical devices pleaded guilty yesterday in connection with illegal clinical trials of a bone cement on about 200 patients, three of whom died.

The company, Synthes USA Inc., did not tell the patients that they were participating in what amounted to human experimentation, according to a 97-count indictment filed June 16 by the U.S. Attorney’s Office in Philadelphia.

Michael D. Huggins, 51, of West Chester, was president and chief operating officer of Synthes’ spine division from late 1994 to January 2008.

John J. Walsh, 46, of Coatesville, has served as director of regulatory and clinical affairs in the same division since August 2003.

Before U.S. District Judge Laurence F. Stengel, each pleaded guilty to a single misdemeanor count of introducing adulterated medical devices into interstate commerce. They face $100,000 fines and a year in prison when they are sentenced Oct. 22.

Two more Synthes executives, Thomas B. Higgins and Richard A. Bohner, are expected to plead guilty to the same charge in coming weeks, according to Huggins’ plea memorandum.