Stryker Biotech, LLC, (Stryker) of Hopkinton, MA, the company's former president Mark Philip, and current sales managers William Heppner, David Ard, and Jeff Whitaker have been charged in federal court with five counts of wire fraud and one count of conspiracy for participation in a fraudulent marketing scheme of medical devices used during invasive spinal and long bone surgeries. Stryker, Ard and Whitaker were also charged with misbranding. In addition, Stryker and Philip were charged with making false statements to the U.S. Food and Drug Administration.

According to the Grand Jury indictment, Stryker was given FDA approval of a Humanitarian Device Exemption (HDE) for its OP-1 Implant and OP-1 Putty to be used as alternatives to autografts in certain patients to stimulate bone growth in long bones and the spine. HDEs are for devices intended to treat conditions affecting fewer than 4,000 patients in the U.S. and not sold for profit. The indictment says Stryker received feedback saying the OP-1 product handled poorly - like wet sand and did not have enough product volume. Stryker then developed Calstrux, a malleable putty-like substance that Stryker intended to be mixed with the OP products to increase the volume and handling qualities.

However, according to the indictment, Stryker's Section 510(k) premarket notification to the FDA statd that Calstrux was intended to be, and in 2004 was FDA-approved to be, a bone void filler product. Stryker did not apply for approval of a mixture of OP-1 with Calstrux and the FDA did not approve of the use. Stryker allegedly did not perform any clinical trials to determine safety or efficacy of the combination of products.

Stryker then allegedly presented Calstrux to its sales force as a carrier/extender for OP-1 products and suggested that Calstrux should accelerate sales of OP-1. Calstrux was then promoted to surgeons and surgical staff as a product to be used with OP-1 as a carrier or extender. The defendants are alleged to have advised surgeons on recipes for preparing mixtures of Calstrux and OP-1, suggesting formulating the combination into logs, bricks, "tootsie rolls," or cigars. The recipes varied as to liquid content and ratio of Calstrux to OP-1.

In mid-2005, Stryker began to receive reports about adverse events stemming from the combination of materials. These adverse events included inflammation, drainage, and impaired wound healing. Some patients needed further operations. During those operations, some surgeons noted the OP-1/Calstrux mixture had migrated from the surgical site. Some patients suffered unwanted bone growth in the areas where the mixture had migrated, which occasionally had to be removed surgically.

The company faces fines of more than $500,000. The defendants face fines and possible prison time if convicted.

The details in the indictment are allegations; the defendants are presumed to be innocent unless and until proven guilty beyond a reasonable doubt in a court of law.

Based on information provided by the Grand Jury Indictment.

The Department of Justice press release on the case can be accessed at:
http://www.fda.gov/downloads/NewsEvents/Newsroom/PressAnnouncements/UCM188306.pdf

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