Medtronic to Settle Infuse Claims, Expected to Set Aside Funds for Future Lawsuits
According to the Wall Street Journal, Medtronic said that it would pay $22 million to settle current claims over its controversial spine surgery product Infuse, and is setting aside $140 million for other expected lawsuits.
The Journal reported that the Infuse device includes the biologic drug BMP-2, which serves as an “alternative to conventional spinal fusion, which normally would require harvesting a small amount of bone from the patient’s hip.”
The product was very successful following its 2002 U.S. Food and Drug Administration (FDA) approval, with annual sales of about $800 million. The news outlet also reported that it has been implanted in more than 1 million people.
After its release, researchers began to link the product to complications. Eventually, the research was published in the Milwaukee Journal Sentinel, which led to a review by the U.S. Senate Committee on Finance over Medtronic’s marketing.
This led to allegations that Medtronic employees were “involved in drafting and editing favorable articles about Infuse while the company paid millions to the surgeons whose names lent weight to the studies.”
Most of the lawsuits state that Medtronic, through payments to the spine surgeons, illegally promoted Infuse for uses that were not approved by the FDA, in addition to the injury claims.
Medtronic said it would pay out $22 million to resolve the claims of about 950 injured people. Additionally, the company said that it would set aside additional funds for about 750 cases filed by other injured patients, as well as any future litigation.
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ZKB’s ‘Did You Know’? Medtronic said that the number of Infuse lawsuits could reach 2,600 cases going forward.