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November 9, 2009

Hopkinton Biotech Faces Legal Trouble

A former CEO and current sales managers with Hopkinton-based Stryker Biotech were charged in federal court with participating in an alleged fraudulent marketing scheme of medical devices.

Charges were filed against former CEO Mark Philip of Lexington and current sales managers William Heppner of Illinois, David Art of California and Jeff Whitaker or North Carolina.

The company and Philip were also charged with making false statements to the U.S. Food and Drug Administration.

The indictment alleges that all the defendants participated in a scheme to promote medical devices used during invasive surgeries. The devices in question were approved by the FDA to treat a rare condition that affects fewer than 4,000 patients in the United States. But, according to the U.S. Attorney’s office, Stryker promoted the devices for much broader medical applications that had never been studied in clinical trials.

The federal charges against Stryker, Philip, Heppner, Ard and Whitaker include five counts of wire fraud and one count of conspiracy. The company, Ard and Whitaker were also charged with misbranding.

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