Medical device company Medtronic plc has agreed to pay institutional investors $43 million in a proposed class-action settlement of a lawsuit related to its bone-growth product, Infuse.
Infuse contains a synthesized human hormone that causes bone to grow. It is used as an alternative bone graft fill to iliac crest bone harvesting. Over the years, the range of reported complications have included infection, male sterility, bone and nerve injury, urinary problems, severe pain, and difficulty breathing. Since 2008, Medtronic has been sued by more than 10,000 people who claim to have experienced serious complications because of having received an Infuse bone graft.
Five years ago, Medtronic was sued by institutional investors who claimed that the company paid surgeons to conceal the adverse side effects of Infuse. The investors also allege that the company overstated the disadvantages of alternative treatments.
The proposed settlement comes seven months after U.S. District Court Judge John Tunheim agreed to certify the case as a class-action lawsuit and three months after the judge rejected a motion to dismiss charges against Medtronic’s former CEO, CFO, public coordinator, and senior clinical and regulatory affairs director.
In the proposed settlement agreement, Medtronic has denied all allegations of liability and wrongdoing related to the case. If the agreement is approved, Medtronic will pay $43 million, which includes attorneys fees to shareholders who acquired Medtronic shares between September 8, 2010 and June 28, 2011.
OTW spoke with Eric Epperson, a spokesperson for Medtronic. Epperson commented, “Medtronic reached an agreement in principle to settle a previously-disclosed federal securities class action, resolving and bringing to close virtually all outstanding INFUSE Bone Graft litigation cases. This announced agreement is merely a compromise of vigorously disputed claims that avoids the costs and disruptions of continued litigation. It is in no way an admission of liability or wrongdoing by Medtronic. Resolving this litigation will allow the company to continue to dedicate funding for productive activities on advancing therapies and patient care.”
