Medical device maker Medtronic Inc. announced on Tuesday that it would include in its fourth-quarter results a charge between $120 and $140 million to settle hundreds of lawsuits over its InFuse bone-growth product.
The charge will account for 1,200 claims already filed and 2,600 claims Medtronic estimates will be filed. The Fridley, Minnesota, medical device maker had previously agreed to pay $22 million to settle 950 InFuse suits, according to the Minneapolis/St. Paul Business Journal.
The U.S. Food and Drug Administration (FDA) granted approval in 2002 for use of InFuse in spinal fusion, a surgical procedure used to reduce back pain. The first reports in medical journals claimed superior results for InFuse surgery, with low risks, but in 2008, the FDA said it had received reports of life-threatening complications in off-label uses of InFuse, such as fusions in the upper spine. In 2011 The Spine Journal devoted an entire issue to critiques of InFuse research by surgeons who had been paid by Medtronic. Spine said the research overstated InFuse’s benefits and failed to report serious complications including male sterility, infections, increased cancer risk, bone dissolution, and even worsened back and leg pain, according to Reuters. Responding to the critique, Medtronic agreed to release its clinical data for two independent reviews overseen by Dr. Harlan Krumholz of Yale University. Medtronic funded the reviews. Krumholz said that over all Medtronic “failed to find a big benefit,” for InFuse over a traditional bone graft using bone from the patient’s own body. He told Bloomberg News that he remained concerned that products like InFuse reach the market with too little study – before or afterward.