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Stryker Unit Charged With Fraud, Misbranding For Illegal Marketing Scheme

This article was originally published in The Gray Sheet

Executive Summary

Stryker's biotech division and four former and current executives face charges of wire fraud, conspiracy, device misbranding and false statements related to the marketing of its OP-1 orthopedic bone growth biologic/device combination products

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Stryker settlement

Stryker Biotech will pay $1.35 million to settle claims that the firm illegally marketed its OP-1 orthopedic bone growth biologic/device products for unapproved uses, falsified documents and misled health care providers about the approved uses of the products, Massachusetts Attorney General Martha Coakley announced Aug. 26. According to the state's 1complaint, Stryker marketed its OP-1 Implant and OP-1 Putty products, designed to treat weakened or deteriorated bones, outside of their "very limited" humanitarian device approvals, and falsified Institutional Review Board documentation at several hospitals, allowing the devices to be used without required IRB review. The complaint also cites the company for unlawfully promoting use of the OP-1 products with its Calstrux bone void filler. The Aug. 25 settlement includes $325,000 in civil penalties and $875,000 to fund efforts to combat unlawful marketing and support other consumer programs. A federal grand jury indicted Stryker Biotech and several executives in October 2009 (2"The Gray Sheet" Nov. 2, 2009)

Stryker settlement

Stryker Biotech will pay $1.35 million to settle claims that the firm illegally marketed its OP-1 orthopedic bone growth biologic/device products for unapproved uses, falsified documents and misled health care providers about the approved uses of the products, Massachusetts Attorney General Martha Coakley announced Aug. 26. According to the state's 1complaint, Stryker marketed its OP-1 Implant and OP-1 Putty products, designed to treat weakened or deteriorated bones, outside of their "very limited" humanitarian device approvals, and falsified Institutional Review Board documentation at several hospitals, allowing the devices to be used without required IRB review. The complaint also cites the company for unlawfully promoting use of the OP-1 products with its Calstrux bone void filler. The Aug. 25 settlement includes $325,000 in civil penalties and $875,000 to fund efforts to combat unlawful marketing and support other consumer programs. A federal grand jury indicted Stryker Biotech and several executives in October 2009 (2"The Gray Sheet" Nov. 2, 2009)

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