May 6, 2014 — Medtronic Inc. announced today that they will settle about 950 Infuse bone graft lawsuits for $22 million, and an additional $120-140 million will be set aside to resolve over 3,000 additional claims.
Medtronic says the settlement is not an admission of wrongdoing or liability. The company “continues to stand behind Infuse Bone Graft…and will vigorously defend the product and company actions in the remaining cases.”
Another 750 lawsuits involving 1,200 plaintiffs are still pending in courts around the United States. Law firms expect that another 2,600 claims will be filed.
In 2012, Medtronic paid $85 million to settle a shareholder lawsuit alleging that the company failed to disclose that over 85% of Infuse sales were for “off-label” surgeries that were not approved by the FDA. In some cases, the surgeries were performed by doctors who were paid by Medtronic.
Problems with Infuse emerged in 2008, when the FDA issued a Public Health Notification to warn against using Infuse “off-label” in the neck. Within four years, the FDA received 38 reports of severe swelling in the neck and throat.
In 2011, The Spine Journal and investigative journalists with MedPage Today and The Milwaukee Sentinel uncovered evidence that Medtronic paid a small group of influential spine surgeons $210 million over the course of 15 years. Some of these doctors published articles that promoted Infuse but failed to disclose risk information. After the U.S. Senate Finance Committee investigated, they discovered that Medtronic secretly ghostwrote and edited parts of the papers.