US-based Medtronic has agreed to pay approximately $22m to end product liability lawsuits involving 950 claimants who used its controversial Infuse bone graft product, subject to certain conditions.
Medtronic said this agreement is a compromise of disputed claims and is not in any way an admission of liability or validity of any defence in the litigation by the company.
According to Medtronic, the Infuse bone graft is designed to be used in the treatment of degenerative disc disease in the spine, tibia fractures and dental procedures.
Medtronic said that it continues to stand behind Infuse bone graft, which has been used in more than one million patients since it was approved more than ten years ago.
The company said that a California judge ruled in favour of Medtronic in the first Infuse bone graft case scheduled to go to trial and it will continue to vigorously defend the product and company actions in the remaining cases.
The company also noted that around 750 filed cases brought by approximately 1,200 individual plaintiffs remain pending in various US courts, and the majority of them are still in the early procedural stages.
As previously disclosed in Medtronic's SEC filings, certain law firms representing an additional 2,600 claimants may file similar claims in the future.
Medtronic anticipates it will take a special charge of between $120m to $140m in its recently completed fourth quarter under the guidelines of FAS 5.
This charge represents the latest settlement, estimated settlement of the approximately 3,800 (1,200 filed; 2,600 unfiled) additional claims, and certain costs associated with these settlements.
Image: Medtronic world headquarters, Minneapolis, US. Photo: courtesy of Medtronic.