Stryker has agreed to pay the state of Massachusetts $1.35 million to resolve allegations that the company marketed OP-1 without regulatory approval and withheld patient safety information from health care providers to boost sales.

Massachusetts’ Democratic Attorney General Martha Coakley, who lost last year’s U.S. Senate race to Republican Scott Brown, issued a statement saying that Stryker Biotech had compromised patient safety in pursuit of profits.

Stryker said the settlement was not an admission of liability.

The settlement came after Coakley filed a complaint last month accusing Stryker of falsifying hospital Institutional Review Board documents, subverting clinical review procedure, promoting an unapproved device and misleading physicians. Coakley first notified Stryker in March of 2009 that the company was under state investigation.

Under the terms of the agreement, Stryker will pay $325,000 in civil penalties, $875,000 to fund efforts to combat unlawful marketing and other programs, and $150,000 to cover costs of the three-year investigation.

In October 2009, three sales managers and former Stryker executive Mark Philip were indicted by a federal grand jury for misleading the FDA about the use of OP-1. The three sales managers pled guilty while Philip pled not guilty.

While this settles Stryker’s case with the State of Massachusetts, the federal issues are not concluded.

http://ryortho.com/fda.php?news=706_Stryker-Settles-State-OP1-Complaint

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