Stryker Corp. Says it Faces Federal Probe Over OP-1 and Calstrux ProductsMar 11, 2009 | Parker Waichman LLP
Stryker Corp. is facing a federal probe over some of its bone growth products. The news comes just a few weeks after a Stryker sales rep agreed to plead guilty to promoting the off-label use of the products, despite knowing that such use could lead to dangerous complications.
A second sales rep had also entered a guilty plea to a similar charge last November. As we previously reported, both employees had agreed to cooperate with the Justice Department's investigation as part of their plea deals.
According to Reuters, the Justice Department investigation focuses on Stryker's OP-1 and Calstrux products. The New York Times reported in February that the Food & Drug Administration (FDA) has only allowed limited use of the OP-1 products in patients whose broken shin or thigh bones had failed to heal properly.
These limited approvals are known as “humanitarian device exemptions.” 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.
According to Reuters, federal prosecutors are looking into accusations that Stryker sold misbranded medical devices and submitted false reports to the FDA regarding the number of patients treated with the products under the humanitarian device exemptions.
As we reported last month, the plea agreements with the Stryker sales reps stated that they 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." Prosecutors also said other Stryker employees distributed brochures giving instructions for mixing bone products in ways not approved by the FDA.
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.
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.