Qui Tam

Biotech Company and Its Top Management Indicted for Illegal Promotion, Making False Statements to the FDA

By Nolan and Auerbach

The Federal Bureau of Investigation (FBI) Boston announced October 28, 2009, that Stryker Biotech and its top management had been indicted for illegal promotion of medical devices used in surgery. The Hopkinton, Mass.-based biotech and some of its employees were charged in federal court with participating in a fraudulent marketing scheme of medical devices used during invasive spinal and long bone surgeries, as well as with making false statements to the United States Food and Drug Administration (FDA).

According to the FBI’s press release, the allegations are that all the defendants participated in an illegal, off-label marketing scheme to promote medical devices used during invasive surgeries. In particular, the defendants are alleged to have promoted devices used to stimulate bone growth in long bones and the spine, which have highly restrictive FDA approval, for off-label, more widespread uses.

For the full press release, go to: http://boston.fbi.gov/dojpressrel/pressrel09/bs102809.htm.

For more information about qui tam law and health care fraud, contact Nolan and Auerbach, PA.

Full post as published by Pharma 101 - Pharmaceutical Fraud on October 30, 2009 (boomark / email).