Orthopedic executives enter guilty pleas in relation to unauthorized clinical trials

On Monday, two top Synthes executives pleaded guilty for their roles in unauthorized clinical trials using bone cement products for the treatment of vertebral compression fractures in which three patients died during surgery.

In the United States District Court for the Eastern District of Pennsylvania, Michael D. Huggins, 51, of West Chester, Pa., and John J. Walsh, 46, of Coatesville, Pa., pleaded guilty to one count of introducing adulterated and misbranded Norian XR and Norian SRS into interstate commerce. The bone cement products are manufactured by the Norian Corp., a subdivision of Synthes.

Huggins, the former president of Synthes North America and former president of the company’s spine division, and Walsh, the director of regulatory and clinical affairs in the company’s spine division, could each face up to a year in prison, a potential fine of up to $100,000 and a year of supervised release. They will each pay a $100,000 fine as part of their plea agreement.

Huggins and Walsh were released on a $100,000 unsecured bond and told to relinquish their passports. However, they can retrieve their passports for overseas travel if they receive prior approval from pre-trial services.

“Mr. Huggins was accused of a single strict liability misdemeanor under what is known as the ‘responsible corporate officer’ doctrine,” Gregory L. Poe and Catherine M. Recker, attorneys for Huggins, said in a statement released to Orthopedics Today. “Strict liability means that no showing of knowing or intentional misconduct is required. In resolving this case, Mr. Huggins accepts responsibility for what occurred on his watch as a corporate officer at Synthes. Mr. Huggins has earned an impeccable reputation in the medical device industry and in his community. He has always made clear that he did not do anything knowingly or intentionally wrong.”

As reported on the ORTHOSuperSite, Synthes, Norian, Huggins, Walsh and two other individual defendants were indicted in June on charges of allegedly conducting unauthorized clinical testing of Norian-brand cements for the treatment of vertebral compression fractures from May 2002 to fall 2004.

Norian Corp. faces 52 federal felony counts ranging from conspiracy to impair and impede the lawful functions of the FDA to making false statements to an FDA investigator during an official inspection.

Both products were approved by the FDA as bone void fillers to be used in areas other than the extremities, spine and pelvis. Labeling for Norian SRS stated that it was not to be mixed with other substances, and labeling for Norian XR warned against using the product for vertebral compression fractures.

The federal government claimed that the companies allegedly trained surgeons to mix Norian SRS with barium sulfate to treat vertebral compression fractures. In addition, the government charged that the companies trained surgeons to use Norian XR for these fractures as part of their “test-market” for the product.

Editor’s note: Messages to Walsh’s attorney, Craig G. Margolis, were not returned by press time.

Reference:
United States v. Norian Corporation, et al, Criminal No. 09-403 (E.D. Pa.)