Hundreds of lawsuits over its InFuse bone-growth product. Medtronic Inc. will record a charge between $120 million and $140 million in its fourth quarter results for hundreds of lawsuits over its InFuse bone-growth product, the company said on Tuesday.
The medical device maker, based in Fridley, Minnesota, has already agreed to pay $22 million to settle 950 InFuse suits, according to the Minneapolis/St. Paul Business Journal. The charge announced yesterday will account for 1,200 claims already filed and 2,600 claims Medtronic estimates will be filed.
InFuse receives approval from the U.S. Food and Drug Administration (FDA) in 2002
InFuse received approval from the U.S. Food and Drug Administration (FDA) in 2002 for use in spinal fusion, a surgical procedure commonly used to reduce back pain. Early reports in medical journals claimed superior results for InFuse surgery, with little risk, but in 2008, the FDA warned of reports of life-threatening complications in off-label uses, such as fusions in the upper (cervical) spine.
The controversy culminated in a 2011 special issue of The Spine Journal; the issue was devoted entirely to critiques of InFuse research by surgeons paid by Medtronic. Spine said the research did not report serious complications including infections, increased cancer risk, male sterility, bone dissolution, and worsened back and leg pain, according to Reuters.
Medtronic then agreed to release its clinical data for independent reviews overseen by Dr. Harlan Krumholz of Yale University and Medtronic provided $2.5 million to fund the reviews. “The general, overall picture is that they failed to find a big benefit,” for InFuse over a bone graft using bone from the patient’s own body, Krumholz concluded. He told Bloomberg News that he remained concerned that such products reach the market with too little study either before or afterward.