Attorney General Ellen Rosenblum today announced a five-state $12 million settlement with Medtronic Sofamor Danek, Inc. and Medtronic Sofamor Danek USA, Inc.(“Medtronic”) to resolve allegations that the company unlawfully promoted their Infuse® Bone Graft Device used in spinal fusion procedures to doctors. Oregon will receive $2.4 million of the settlement.
The settlement resolves the five states’ allegations against Medtronic for violating Oregon’s unfair trade practices laws. 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,” said Attorney General Rosenblum. “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.”
The alleged misconduct was the subject of the June 2011 issue of The Spine Journal, which challenged the Medtronic-sponsored medical literature and studies. It was also the subject of a 16-month investigation by the Senate Finance Committee. In addition, Oregon Health Science University (OHSU) published an analysis by their evidence based medicine group, which found a higher rate of adverse events and lower effectiveness than reported in Medtronic’s company-sponsored studies. The research from OHSU was instrumental in Oregon’s case.
The Complaint and Stipulated Judgment were submitted to Multnomah Circuit Court, and are pending court review. As part of the settlement, Medtronic will be required to ensure its marketing and promotional practices do not unlawfully promote Infuse. In particular, Medtronic shall:
- 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, does not contain overreaching messaging, 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 clinical 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 medical journal articles reporting on Medtronic-sponsored trials of Infuse where Medtronic approved the release of clinical trial data;
- 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.
The states participating in the settlement are Oregon, California, Illinois, Massachusetts and Washington.
Rosenblum commended the work of Assistant Attorney General David Hart and his investigative team at the Civil Enforcement Division of the Oregon Department of Justice.
Kristina Edmunson, Department of Justice, Kristina.Edmunson@doj.state.or.us, 503-378-6002