Medtronic’s litigation seems to be moving forward, as the pharmaceutical giant agrees to settle a class action lawsuit involving the marketing of Infuse Bone Graft for $85 million. The company has been involved in the suit since 2008, when it was filed by the Minneapolis Firefighters Relief Association. Now, the lawsuit also includes groups such as the Oklahoma Teachers' Retirement System, the Oklahoma Firefighters Pension Fund and the Westmoreland County Employee Retirement System. Essentially, the plaintiffs accuse Medtronic of artificially inflating its stock by misleading shareholders, omitting the fact that Infuse’s success is largely attributed to off-label use.
Infuse, which facilitates bone growth through rhBMP-2, is approved for use in the lower spine and two types of dental surgery. However, 85 percent of the time the device is not used for these purposes, according to ABC News. Instead, Infuse was being used in procedures involving the cervical spine. According to a U.S. Food and Drug Administration (FDA) public health notification issued in 2008, this can lead to “life-threatening complications”. Allegedly, Medtronic had been marketing Infuse for this type of off-label use; doctors are allowed to use medical devices off-label, but it is illegal for companies to advertise towards it.
The company did not admit any fault when it agreed to settle the case, denying “that it made any misrepresentations or omissions or that it otherwise engaged in any wrongdoing.” cites Star Tribune. Medtronic made a similar move last December, when it settled a suit with the U.S. Department of Justice for $23.5 million without claiming fault.
• Medtronic is settling a class action lawsuit for the amount of $85 million without admitting fault
• The suit alleged that Medtronic artificially inflated its stock by misleading investors about the off-label use of Infuse
• Infuse caused problems when it was used in the cervical spine, a procedure not approved by the FDA