Stryker Biotech and 4 former and current executives charged with the illegal marketing and sale of bone-healing devices for purposes not approved by the FDA have been denied a request for more information on the federal government's case against them.

In its October 2009 indictment, a federal grand jury in the District of Massachusetts alleged that, from February 2006 to February 2008, Stryker Biotech, former company president Mark Philip and sales managers William Heppner, David Ard and Jeffrey Whitaker had marketed Calstrux, a bone void filler, as a product to be mixed with OP-1, a protein that aids bone growth, even though the FDA had not approved the mixture.

Following an FDA investigation into the company's alleged fraudulent marketing scheme, the Justice Department charged the company and the 4 individuals with 16 counts of wire fraud, conspiracy to defraud the United States and to distribute a misbranded medical device, and false statements made to the FDA.

Claiming that they needed more information to better prepare their defense, the defendants filed a joint motion for a bill of particulars explaining which paragraphs in the indictment referred to which individuals and more specifics about the allegations, such as precisely when and where the alleged fraudulent actions occurred. The U.S. attorneys agreed to clarify which paragraphs in the indictment that refer only to "Stryker Biotech" also relate to the conduct of individual defendants.

Following this agreement, a U.S. magistrate judge last week denied the defendants' motion for a bill of particulars, finding that "the indictment and subsequent discovery provided by the government adequately inform the defendants of the charges brought against them and provide sufficient information to allow the defendants to prepare an adequate defense."

At the time of the indictment, Stryker Corp. released a statement saying it was "disappointed with this action and still hopes to be able to reach a fair and just resolution of this matter." The company says it has no further comment on the allegations brought against its Biotech division.

The wire fraud charges alone carry penalties of up to 20 years of imprisonment and fines of at least $250,000 each for the 4 individuals named in the indictment, plus fines of at least $500,000 for Stryker Biotech.

Irene Tsikitas

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