Another Medtronic Lawsuit Accuses The Infuse Bone Graft System For Use In Non-FDA -Approved Surgical Procedures, Coaching Doctors and Misrepresentation.
The attorneys at Wright & Schulte reports that Humana has filed a lawsuit against Medtronic, Inc., for the alleged fraudulent misrepresentation of its Infuse Bone Graft and deceiving the insurance company into paying claims related to the medical device. The Medtronic lawsuit also contends that the medical device manufacturer sponsored academic publications that misrepresented Infuse and paid doctors to promote the Medtronic bone graft product as safe to use in different spinal surgeries despite the fact that the U.S. Food & Drug Administration (FDA) approved the product in 2002 only for lower-back procedures. The lawsuit was filed in the U.S. District Court, Western District of Tennessee. (Humana Inc. v. Medtronic Sofamor Danek USA Inc.,14-cv-02405)
Infuse Bone Graft is a synthetic liquid form of protein, called recombinant human bone morphogenetic proteins (rhBMP-2). The bone graft system was used for spinal surgeries even though In 2008, the FDA warned of “life-threatening complications” associated with rhBMP-2 in cervical spine fusion. The FDA’s safety alert further stated that these products had not been approved for use in cervical spine surgeries and warned surgeons against using them.
[fda.gov/medicaldevices/safety/alertsandnotices/publichealthnotifications/ucm062000.htm, July 1, 2008]
According to Bloomberg, Medtronic lawsuit claims the manufacturer made about $900 million in Infuse sales in 2011 and the “vast majority” of sales were for off-label uses. Bloomberg also stated a Medtronic’s earning report showed Infuse accounted for $471 million in sales for the company in fiscal year 2014. Humana’s lawsuit also contends that Medtronic paid doctors for using and endorsing the product and sponsored “fraudulent studies and peer-reviewed publications” to misrepresent the safety of Infuse. A Medtronic spokesman called Humana’s claims “baseless,” because the company has listed health risks associated with the product since 2002 and Medtronic did not compensate doctors to promote Infuse,
according to the Bloomberg report. However, a U.S. Senate investigative committee found in 2012 that Medtronic paid doctors who promoted Infuse to other doctors more than $200 million in consulting fees and royalties, the Bloomberg news article said.
[bloomberg.com/news/2014-06-02/medtronic-sued-by-humana-over-bone-graft-product-correct-.html, June 2, 2014]
In May, Medtronic agreed to pay $22 million to settle 950 Medtronic lawsuits that were filed across the country regarding the Infuse Bone Graft Device. The company also agreed to pay the U.S. Department of Justice $9.9 million to settle a Medtronic lawsuit that accused the company of paying kickbacks to doctors if they implanted Medtronic’s defibrillators and pacemakers and other heart-rhythm devices, according to Bloomberg.
Wright & Schulte LLC offers free lawsuit evaluations to victims of alleged Medtronic Infuse injuries. Please visit our website at www.yourlegalhelp.com or call 1-800-399-0795 to learn more about your options for legal recourse.
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