Stryker Biotech Indicted for Illegal Promotion of Medical Devices

Stryker Biotech LLC, a leading manufacturer of medical devices used in surgeries, its former company president and other executives have been indicted on federal charges of illegally promoting products used in spinal operations.

The Massachusetts-based company and some high-ranking past and present employees allegedly engaged in fraudulent marketing schemes and made false statements to the Food and Drug Administration involving promotion of two products, known as OP-1 Implant and OP-1 Putty.

Company Presidents, Others Named in Indictment

Stryker Biotech’s former president, Mark Philip, and current sales managers William Heppner, David Ard, and Jeff Whitaker face charges of wire fraud, misbranding, making false statements, and conspiracy, according to a Department of Justice press release.

Stryker and its employees are accused of promoting the surgical products for uses that were not FDA approved. The devices are used to stimulate bone growth in long bones and the spine, but were only provisionally approved on an emergency basis for use in up to 4,000 patients in the United States and not for sale for profit.

However, the company promoted use of the products beyond those limitations and encouraged doctors to use them in combination with another bone filling product, called Calstrux, federal prosecutors allege.

The federal indictment also charges that some of the defendants later lied to the FDA about how many patients had been treated with OP-1 Putty.

Sales Associates Plead Guilty to Scheme

Earlier this year, two former Stryker sales associates pleaded guilty to charges they falsified company documents and promoted unapproved, off-label uses of the same bone growth products.

One of the employees admitted paperwork saying clinical trials of the devices had been completed were falsified. The other worker admitted promoting unapproved uses of the company’s bone-growth products.

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