Medical Device Maker Under Investigation

Stryker, a leading maker of medical devices is reportedly the subject of a Justice Department investigation into Stryker’s marketing of human bone growth products. The investigation has already resulted in guilty pleas by former company sales representatives. Two former sales representatives pleaded guilty to charges that they had promoted off-label use of the products even though they knew that such use had earlier caused problems in some patients.
The investigation is reported to involve several issues. These include whether Stryker abused a federal exemption that authorized it to sell only limited quantities of its bone growth products for “humanitarian” reasons. The products are used by surgeons to aid the growth of bones that fail to heal properly.
One Stryker product, called OP-1, is a protein that promotes bone growth. The other product called OP-1 putty, is a moldable compound that includes the protein. Neither has been formally approved by the Food and Drug Administration for widespread medical use. In 2001, the F.D.A. approved limited use of OP-1 in patients whose broken shin or thigh bones had failed to heal properly. In 2004, the F.D.A. allowed limited use of OP-1 putty in patients who had failed spinal fusion procedures.
The F.D.A. has the power to grant a “humanitarian” exemption” when it believes that a small group of patient may benefit from a treatment, even though the effectiveness has not been fully proved. Under this exemption, a device can be used in up to 4,000 patients a year.
The Justice Department investigation is reported to be seeking to determine whether Stryker knew the products were being promoted for unauthorized, or off-label, use.
Stryker is already operating under federal oversight as a result of an earlier Justice Department investigation of kickbacks paid by makers of artificial hips and knees to doctors.