Medtronic ($MDT) has reached a $22 million settlement with 950 claimants over liability claims related to Infuse Bone Graft. The company denied any wrongdoing and said it will continue to "vigorously defend" the product in remaining cases.
About 750 filed cases are pending. They were brought forth by about 1,200 individual plaintiffs, and the majority of them are in the early stages, Medtronic said in a statement. Law firms representing an additional 2,600 claimants may file similar claims in the future, according to the statement.
Medtronic said it will take a charge of between $120 million and $140 million in its recently completed fiscal fourth quarter. The charge represents the latest settlement, estimated settlement costs of the additional 3,800 filed and unfiled claims and costs associated with the settlements themselves.
The Infuse Bone Graft can be used in the treatment of degenerative disc disease in the spine, tibia fractures and dental procedures, according to Medtronic. The statement says it has been used by more than one million patients since winning FDA approval in 2002.
Infuse has long been a source of controversy. In 2012 Medtronic agreed to pay $85 million to settle a shareholder class action lawsuit brought forth by the Minneapolis Firefighters' Relief Association alleging that the company failed to reveal that a large proportion of the bone graft's sales came from off-label uses. In June 2013, another shareholder lawsuit about Infuse was filed, according to Law360. FierceMedicalDevices was unable to determine the status of the lawsuit by presstime.
The Senate Finance Committee also got involved. It issued an October 2012 report which found that "without public disclosure of their roles, Medtronic employees collaborated with physician authors to edit--and in some cases, write--segments of published studies on its bone-growth product Infuse."
To counter safety concerns, Medtronic agreed to submit Infuse data to the Yale University Open Data Access project, which examined the results of 17 trials on more than 2,000 patients in two separate reviews. But the company didn't get the results it wanted. The reviews found that the spinal implant performs no better than traditional bone grafts and carries an increased risk of cancer, sterility and other side effects.
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