The Fridley, Minn.-based company said that it is approaching agreements to settle approximately 6,000 cases against it which asserted personal injury claims due to the bone graft product in an SEC filing.
“As of June 1, 2017, the company has reached agreements to settle substantially all of these claims, resolving this litigation,” Medtronic wrote in an SEC filing.
While Medtronic did not release exact financial details of the settlements, it did report that it has set aside $300 million for “certain litigation charges” in the filing.
The company also said that it had received subpoenas or document requests from Attorney Generals in Massachusetts, California, Oregon, Illinois and Washington seeking more information regarding the Infuse device and that it had “accrued expenses in connection with these matters,” according to the filing.
“We continue to cooperate in the State AG inquiries and are hopeful an acceptable resolution can be reached,” Medtronic spokesperson Eric Epperson told the Star Tribune via email last week.
Approved in 2002 for use in spinal fusion surgery, Infuse at 1 point had annual sales of nearly $1 billion. The bone-grafting product has since been linked to abnormal bone growth, certain cancers and male reproductive problems. Medtronic has been accused of not only downplaying the product’s risks but also promoting it for off-label use.