Stryker Biotech, a maker of artificial joints and other medical devices, will pay $1.35 million to the Commonwealth of Massachusetts.
The payment will resolve allegations that it marketed certain orthopedic products for uses that had not been reviewed and approved by the U.S. Food and Drug Administration (FDA) and misled health care providers about the appropriate uses of its products.
As a result of a multi-year investigation, Massachusetts Attorney General Martha Coakley alleged that Stryker violated the state's Consumer Protection Act by engaging in unfair and deceptive trade practices that boosted sales of certain products used in orthopedic procedures to strengthen and promote growth of bones.
Under the terms of the settlement, Stryker will pay $325,000 in civil penalties, $875,000 to fund efforts to combat unlawful marketing and other programs to benefit health care consumers, and $150,000 to cover attorneys' fees and investigative costs.
"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."
Unauthorized uses
The attorney general's investigation focused on the company's marketing of OP-1 Implant and OP-1 Putty, which are bone morphogenetic protein products designed to promote bone growth and are used to treat orthopedic conditions involving weakened or deteriorated bones. The OP-1 products were granted a limited approval by the FDA that restricted the use of the products. With this limited form of approval, the OP-1 products could be used in patients only after a hospital's Institutional Review Board reviewed and approved their use.
In a complaint filed in Suffolk Superior Court, the attorney general's office alleged that Stryker promoted OP-1 products for conditions that fell outside their very narrow FDA-approved uses and withheld information from health care professionals about the restrictions imposed on the use of the OP-1 products. The complaint also claimed that a Stryker sales representative falsified Institutional Review Board documentation for several Massachusetts hospitals, resulting in the use of OP-1 products in patients without adequate and required review.
In addition, the AG's complaint alleged that Stryker promoted the use of its OP-1 products in combination with Calstrux, a bone void filler made by Stryker, even though the mixture of the two products had not been studied and had not been approved by the FDA. Stryker continued to promote the unproven and unstudied OP-1/Calstrux mixture even after company officials became aware of reports that the mixture had caused adverse effects in patients, including poor wound healing and inflammation, according to the complaint.
The settlement bars Stryker and related Stryker entities including Stryker Corporation, Stryker Sales Corporation and Howmedica Osteonics, from engaging in unfair and deceptive trade practices, including marketing Stryker products for uses that have not been reviewed and approved by the FDA and misleading health care providers about the appropriate uses of Stryker products.
