Thursday, January 12, 2012

Report: Stryker Biotech charged with misbranding

By Lori Valigra

Stryker Biotech, a unit of medical device company Stryker Corp. based in Hopkinton, and three former sales managers were accused by a prosecutor of putting patients at risk by marketing an unapproved mixture of products to strengthen the growth of human bone, according to a Bloomberg story.

The prosecutor made the statement at the start of a federal criminal trial in Boston.

The United States has charged Stryker Biotech with misbranding and its sales force with conspiring to defraud surgeons into combining the company’s OP-1 and OP-1 Putty with the bone filler Calstrux, the story said. Some patients suffered bad side effects and needed additional surgery, the U.S. said.

“That mixture was never studied clinically,” Assistant U.S. Attorney Susan Winkler told the jury in her opening statement today, as quoted by Bloomberg. “They did not know if it worked. They did not know if it was safe, and they marketed it to doctors anyway.”

The U.S. Food and Drug Administration allowed the company to supply its products under a narrow, provisional humanitarian exemption, although the company had no FDA approval for adding Calstrux, which was later pulled from the market. A lawyer for Stryker Biotech told jurors the product worked.

In August 2010, the Massachusetts state attorney general’s office settled with Stryker Biotech for $1.35 million over allegations the company improperly marketed orthopedic products for indications that were not approved by the U.S. Food and Drug Administration. While drugs and medical devices are often prescribed “off-label,” at doctors’ discretion, it is illegal for pharmaceutical and medical device companies to market the products for those off-label purposes.

Also, a Massachusetts federal judge granted former Stryker Biotech executive Mark Philip a motion to sever charges against him, according to MassDevice.com. The ongoing government case alleges that the company and former executives committed conspiracy to defraud the FDA, conspiracy to commit wire fraud, and wire fraud.