Summary
Stryker Corporation (SYK) disclosed in an 8-K filing on March 10, 2009, that its subsidiary, Stryker Biotech, is currently a target of a federal grand jury investigation. The investigation, led by the U.S. Attorney's Office for the District of Massachusetts, centers on allegations of illegal promotion of OP-1 products and Calstrux, the sale of misbranded medical devices, and the submission of false reports to the FDA concerning patient numbers treated with OP-1 under a Humanitarian Device Exemption. This development expands upon previous reports of subpoenas received by the company and certain employees regarding false Institutional Review Board approvals and the aforementioned issues. Notably, the company acknowledges that some former Stryker Biotech employees have already pleaded guilty to charges related to this ongoing investigation. Stryker is actively engaged in responding to the U.S. Attorney's Office concerning these serious allegations.
Key Highlights
- 1Stryker's subsidiary, Stryker Biotech, is a target of a federal grand jury investigation.
- 2The investigation pertains to the illegal promotion of OP-1 products and Calstrux.
- 3Allegations also include the sale of misbranded medical devices.
- 4False reports to the FDA regarding patient numbers for OP-1 under a Humanitarian Device Exemption are under scrutiny.
- 5The investigation is being conducted by the U.S. Attorney's Office for the District of Massachusetts.
- 6Certain former Stryker Biotech employees have pled guilty to charges related to the investigation.
- 7Stryker is cooperating and responding to the U.S. Attorney's Office.