Coakley settles with medical device company

By Keith Loria | Aug 26, 2010


BOSTON (Legal Newsline) - Massachusetts Attorney General Martha Coakley announced on Thursday that she has reached a $1.35 million settlement with a medical device company that allegedly violated the state's Consumer Protection Act.

Stryker Biotech LLC, a Hopkinton, Mass.-based medical device company, allegedly marketed certain orthopedic products that were never reviewed or approved by the U.S. Food and Drug Administration.

In a lawsuit against the company, Coakley alleged that Stryker misled health care providers about the correct uses of OP-1 Implant and OP-1 Putty and engaged in unfair and deceptive trade practices that boosted sales of these products, which are used in orthopedic procedures that promote bone growth.

"Stryker Biotech subverted review procedures designed to safeguard patients and promoted uses of its products that were not shown to be safe or effective," Coakley said.

"Our office will vigorously pursue any allegations that health care companies are compromising patient safety in pursuit of profits."

Under terms of the settlement, Stryker will pay $875,000 to fund efforts to combat unlawful marketing and other programs to benefit health care consumers, another $325,000 in civil penalties and $150,000 for costs associated with the litigation.

The settlement also bars the company and related Stryker entities, including Stryker Corporation, Stryker Sales Corporation and Howmedica Osteonics, from further engaging in unfair and deceptive trade practices.

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