Medtronic has agreed to pay a total of $12 million in a five-state settlement of litigation over its controversial Infuse bone graft device.
Oregon Attorney General Ellen Rosenblum announced the settlement with Medtronic Sofamor Danek Inc. and Medtronic Sofamor Danek USA Inc. to resolve allegations that the company unlawfully promoted Infuse, used in spinal fusion procedures, to doctors. Other states participating in the settlement are California, Illinois, Massachusetts, and Washington.
Oregon alleged that Medtronic made deceptive claims about Infuse by using trusted scientific publications to report that Infuse was superior to other therapies and that patients who used Infuse experienced fewer side effects than what research actually showed.
“It is unacceptable for a company to use company-sponsored literature with misleading data to try to show that its product is more effective than other therapies,” Rosenblum said in the statement. “By using these misleading claims, the company created a higher demand for Infuse in a range of surgeries—which led to greater and undeserved profits for the company.”
Medtronic admitted to no wrongdoing in the settlement.
“Medtronic entered into this agreement solely for the purpose of settlement, and nothing related to it can be taken as an admission or concession of any violation of law, rule, regulation or of any liability or wrongdoing,” a company spokesman said in an email to MD+DI.
Infuse is Medtronic's trade name for its recombinant bone morphogenic protein-2 (rhBMP-2) product, a genetically engineered version of a naturally occurring protein that stimulates bone growth and gives surgeons some control over where that growth occurs.
FDA gave limited approval for its use in 2002 as an alternative to conventional spinal fusion to treat degenerative disc disease and open fractures on the tibia, and for some oral and dental procedures, but off-label use of the device became commonplace.
In 2011, Spine Journal published a feature stating that a critical review of the product found that "the actual risk of adverse events was 10 to 50 times the estimates originally reported."
The journal reached the conclusion that the original industry-sponsored studies related to Infuse had problems with conflicts of interest, biased study designs, invalid claims about the risks and complications of using patients' own bone to assist fusion.
Common and serious potential adverse events linked to the products were not reported in the studies.The alleged misconduct was also the subject of a 16-month investigation by the U.S. Senate Finance Committee.
Medtronic has faced thousands of consumer lawsuits over Infuse. The company spokesman said Medtronic has resolved “substantially all” of the remaining consumer product liability claims regarding Infuse. Those settlements were confidential, he said.
The five-state settlement also requires Medtronic to ensure its marketing and promotional practices do not unlawfully promote Infuse. In particular, Medtronic is expected to make clinical trial data relating to Infuse publically available through the government-run website ClinicalTrials.gov; refrain from making false, misleading, or deceptive claims regarding Infuse; use information about clinical trials relating to Infuse for promotional purposes in a manner that is truthful, non-misleading, accurate, fairly balanced, consistent with approved labeling, appropriately substantiated by objective evidence, and compliant with FDA regulations; disseminate published medical journal articles reporting on clinical trials relating to Infuse only if they are truthful, scientifically and medically valid, and disclose any Medtronic sponsorship of the trials if applicable; contractually require medical journal article authors to comply with authorship standards, acknowledge Medtronic sponsorship, and comply with conflict of interest disclosure standards in articles about company-sponsored trials of Infuse where Medtronic approved the release of data; and comply with applicable federal regulations relating to the disclosure to FDA of information regarding Medtronic’s financial relationships with investigators for Medtronic-sponsored clinical trials of Infuse.