The Massachusetts state attorney general’s office has settled with Stryker Biotech LLC over allegations the company improperly marketed orthopedic products for indications that were not approved by the U.S. Food and Drug Administration. While drugs and medical devices are often prescribed “off-label”, at doctors’ discretion, it is illegal for pharmaceutical and medical device companies to market the products for those “off-label” purposes.
The Hopkinton-based medical device company, a unit of Stryker Corp. (NYSE: SYK), will pay $1.35 million to the state, following a multi-year investigation, the attorney general’s office said.
The investigation alleged that Stryker Biotech violated the state’s Consumer Protection Act by engaging in unfair and deceptive trade practices that boosted sales of products used promote bone growth. Under the terms of a settlement filed yesterday in Suffolk Superior Court, 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,” Attorney General Martha Coakley said in a statement. “Our office will vigorously pursue any allegations that health care companies are compromising patient safety in pursuit of profits.”
Among the most serious allegations is that Stryker falsified documents from Massachusetts hospitals’ Institutional Review Boards in order to obtain permission for the use of the bone growth products, which was required by Stryker’s FDA approval for the devices. The complaint, filed in Suffolk Superior Court Wednesday, also alleges that the company promoted the use of two of its products together, a treatment that had not been studied or approved by the FDA. The company did not stop marketing the product combination even after reports of adverse events in patients, according to the complaint.
The settlement prohibits Stryker from engaging in unfair and deceptive trade practices, including marketing Stryker products for “off-label” uses and misleading health care providers about the appropriate uses of Stryker products.