Kroger settles with biotechnology firm

Bryan Cohen May 11, 2011, 2:14am


SALEM, Ore. (Legal Newsline) - Oregon Attorney General John Kroger announces on Wednesday that his office has reached a $167,000 settlement with a biotechnology firm over allegedly unlawful marketing practices.

The Massachusetts-based Stryker Biotech LLC was indicted federally in 2009 over an alleged marketing scheme to promote the firm's Stryker's OP-1 and Calstrux bone products. The Oregon Department of Justice alleged that Stryker promoted Calstrux as a carrier for OP-1 Putty and OP-1 Implant, a use not approved by the U.S. Food and Drug Administration.

"We will not tolerate dishonesty by medical device and drug manufacturers," Kroger said.

OP-1 and OP-1 Putty are morphogenic agents that can be used to promote bone growth in limited circumstance when bones are unable to mend. Calstrux is a bone void filler that is used to fill up the unfilled space in a bone during multiple orthopedic procedures. When some surgeons found Stryker's OP-1 and OP-1 putty hard to work with, the company introduced Calstrux as a vehicle to allegedly hold the OP-1. The FDA never determined that this was a safe and effective purpose.

Stryker allegedly did not disclose the products' known safety risks or that the products were never studied or approved for use together, which led to Calstrux being pulled from the market. Nine units of Calstrux had allegedly been sold in Oregon.

The company agreed to pay $167,000 to resolve claims related to the off-label marketing and to pay for attorney and investigative costs.

The settlement also prohibits the company from making any claim regarding the effectiveness or safety of a product for uses that are unapproved by the FDA or deceiving or misleading healthcare professionals about the appropriate use of Stryker products.

The Oregon Department of Justice's Medicaid and Financial Fraud units have recovered $33.5 million for Oregon in the last year from companies like GlaxoSmithKline, AstraZeneca and Omnicare for allegedly defrauding Oregon consumers and the state Medicaid program.

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