Stryker Facing Federal Grand Jury Investigation Over the Marketing of OP-1
BY LAUREN UZDIENSKI, MARCH 12, 2009
As Stryker's long-awaited FDA panel session for OP-1 approaches, the company announced that it's facing a federal grand jury investigation into marketing practices surrounding the device. Specifically, allegations include the illegal promotion of OP-1 products and Calstrux, misbranding of devices and submission of false reports to the FDA regarding the number of patients treated with OP-1 under the company's Humanitarian Device Exemption (HDE), according to an 8-K filed this week.
OP-1 is currently FDA-approved by HDE only for use in cases involving either a revision posterolateral spinal fusion in patients who have already had a failed posterolateral spinal fusion or as an alternative to autograft in recalcitrant long bone nonunions where use of autograft is unfeasible and alternative treatments have failed. HDE devices are used to treat conditions that occur in less than 4,000 patients per year.
Two former Stryker sales reps pleaded guilty in November 2008 and February 2009, respectively, to promoting OP-1 for indications other than those approved by the FDA. These latest revelations could jeopardize the OP-1 panel outcome later this month and further strain Stryker's relationship with the FDA and the federal officials who have been investigating the company for the past several years.
