Posted byOrthoEx Posted in, ,
Posted on Jul 21, 2017

Walter Eisner • Thu, July 20th, 2017

Medtronic plc says it has reached an agreement with “substantially all” remaining claimants involving the Infuse bone graft product.

In a June 27, 2017 10K filing with the SEC, the company announced the agreements with approximately 6,000 claimants. The company also said it has set aside $300 million for “certain litigation charges” in the filing.

The company had previously disclosed reaching settlements in more than 4,000 Infuse patient lawsuits. In December 2016, a judge in St. Louis cleared the way for the first jury trial involving personal injuries allegedly caused by Infuse. That trial could have opened sealed internal documents that could have been used in other trials.

According to the Minneapolis Star Tribune, the company paid at least $85 million in a settlement to shareholders in 2012 to resolve allegations that it failed to reveal that most sales of Infuse were for off-label surgeries. In 2014, Medtronic said it paid $22 million to 950 injured Infuse patients. The company denied wrongdoing in each settlement.

Remaining Investigations

While the announcement settles private claims, the company is still under investigation by various state attorneys general who have issued subpoenas or document requests in Massachusetts, California, Oregon, Illinois, and Washington seeking more information regarding the Infuse device.