Two former Stryker sales reps will cooperate with a federal probe. Two former Stryker sales reps will cooperate with a federal probe into the company’s marketing of bone growth products after reaching plea agreements with U.S. prosecutors. According to The New York Times, the sales reps pled guilty to promoting the off-label use of the bone growth products even though they knew that such use could cause serious side effects in patients.
Three of the Stryker bone growth products under investigation are the OP-Implant, OP-1 Putty and Calstrux. The Justice Department has been trying to determine if Stryker abused humanitarian allowances for the OP-1 products. Its investigation is also focused on allegations that Stryker promoted off-label use of Calstrux and other bone growth products.
Limited approvals are known as “humanitarian device exemptions”
Neither the OP-1 Putty or the OP-1 Implant have been approved for widespread use. According to The New York Times, the Food & Drug Administration (FDA) has only allowed limited use of the OP-1 Implant for in patients whose broken shin or thigh bones had failed to heal properly.
It has allowed a similar use of OP-1 Putty for patients who had failed spinal fusion procedures.
These limited approvals are known as “humanitarian device exemptions”, the Times said. Under such approvals, a device may only be used in up to 4,000 patients a year.
The FDA grants such allowances when it believes a small group of patients may be helped by a device whose effectiveness has not been fully proven.
Last July, the FDA warned that Stryker Corp.’s OP-1 Implant and OP-1 Putty had been linked to potentially fatal complications when used in off-label procedures involving the cervical spine.
According to the FDA warning, the complications involved swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports describe difficulty swallowing, breathing or speaking. In many cases, the complications were life threatening and required further surgery.
Bone-void filler called Calstrux
According to the Boston Business Journal, another bone product involved in the probe is a bone-void filler called Calstrux. Calstrux was recalled in 2006 because of a “lack of labeling precautions.”
At the time, the FDA warned that adverse reactions had been reported when Calstrux and other bone growth products had been mixed.
According to the Boston Business Journal, U.S. Attorney Michael Sullivan’s office reached plea agreements with the two Stryker sales reps in November 2008 and February 2009.
The agreements said the sales reps had encouraged medical professionals to combine Stryker’s bone products, even though they knew doing so was not approved by the FDA and had produced “adverse events in some patient,” the Business Journal said.
Prosecutors also said other Stryker employees distributed brochures giving instructions for mixing bone products in ways not approved by the FDA.
Justice Department seeks to determine whether Stryker knew the products
According to The New York Times, the Justice Department may be seeking to determine whether Stryker knew the products were being promoted for unauthorized use. Under the plea agreements, the sales reps will cooperate with the Justice Department’s investigation. Each agreed to “testify truthfully and completely before any grand jury, and at any hearing or trial”, the Boston Business Journal said.