Med-tech giant Medtronic has agreed to pay $22 million to settle a lawsuit related to a controversial bone-growth product. The product, INFUSE, has been the target of of legal action but despite looming lawsuits and the recent settlement, Minneapolis-based Medtronic says it still stands behind the bone graft product.
According to the Wall Street Journal, some law firms have advised Medtronic that they may bring a large number of similar claims against the company in the future. The company estimates those law firms represent approximately 2,600 additional unfiled claimants. The majority of these cases are still in the early procedural stages and none have resulted in a finding of liability against Medtronic.
On May 6, the company announced the settlement resolves the claims of about 950 patients. Earlier, just a day ahead the trial and following several days of pretrial motions, a California trial judge entered summary judgment in favor of Medtronic in the first INFUSE bone graft case scheduled to go to trial.
The company is not admitting any liability in the case, and according to a Medtronic statement, the company “continues to stand behind INFUSE Bone Graft.” The product was developed and sold by Medtronic’s Memphis-based spinal division.
According to Twin Cities Business magazine, Medtronic’s INFUSE is a genetically modified version of a naturally occurring protein that encourages the fast growth of bone. Back in 2002, the Food and Drug Administration approved the drug for specific uses including a certain type of back surgery, and it was lauded as a “game changer.”
However, it seemed to have adverse effects, and unwanted bone growth caused pain and complications in some of the users. In 2011, medical publication The Spine Journal reported that the issues had not been reported in clinical research. Bizjournals.com reports that in 2013, Medtronic released the results of a third-party independent review of INFUSE that was performed by Yale University researchers. The two-year study included data from spinal clinical trials involving more 2,000 patients. Just a small number of patients developed cancer but neither the company nor the study found any definitive links to the drug.
Meanwhile, Medtronic anticipates it will take a special charge in the range of $120 - $140 million in its recently completed fourth quarter under the guidelines of SEC. This charge accounts for the $22 million settlement announced on Tuesday, and certain costs associated with these settlements.