Stryker Under Investigaton by Feds

Medical device maker Stryker Corp. continues to stir in hot water over allegations involving the promotion of off-label use of human growth products OP-1 and Calstrux.

The Kalamazoo, Mich.-based company disclosed in a filing with the U.S. Securities and Exchange Commission that its BioTech division, which is headquartered in Hopkinton, Mass., received a letter last week from the U.S. attorney’s office in Massachusetts saying that it is the target of a federal investigation for allegedly illegally promoting two human growth products, misbranding medical devices and reporting false information to the FDA.

This revelation comes only months after two former Stryker sales representatives pleaded guilty to charges that they promoted off-label use of products, even though they knew they earlier caused problems with patients. Justin Demmig faces up to three years in prison and a $250,000 fine at his June 3 sentencing, Darnell Martin admitted to similar activity and is scheduled for a May 13 sentencing.

The U.S. attorney is also looking into whether Stryker abused a federal exemption that allowed it to sell only limited quantities of bone growth products for “humanitarian” reasons, according to the New York Times. Stryker officials said the company is in the process of responding to the U.S. attorney.