The trial begins today on a federal criminal charge against a unit of Stryker Corp. (NYSE: SYK), a $20-billion medical device maker. The company is charged with marketing an unapproved mixture of materials to strengthen human bones.
Three members of Stryker’s sales force are also charged with wire fraud and conspiracy and each faces a sentence of up to 20 years in federal prison if convicted.
Stryker says that adverse events from the use of the material, called Calstrux, totaled less than 1% over more than 10,000 surgeries. Prosecutors say the company did not have approval to use Calstrux in the mixture:
That mixture was never studied clinically,” Assistant U.S. Attorney Susan Winkler told the jury in her opening statement today. “They did not know if it worked. They did not know if it was safe, and they marketed it to doctors anyway.
Calstrux was eventually pulled from the market. The trial is expected to last 8 weeks.
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