In a closely watched matter culminating years of litigation, Medtronic on December 12, 2017, entered into a $12 Million multi-state settlement resolving allegations that the medical device company had misled consumers about the safety, efficacy, and effectiveness of its Infuse® Bone Graft Device (“Infuse”). The settlement represents continued coordination among States to prosecute marketing fraud and false advertising within the medical device industry.
Within both the U.S. medical device manufacturing arena as well as the life science compliance communities, few companies stand out like Medtronic Sofamor Danek, U.S.A, Inc. (“Medtronic”). Medtronic has long been considered a leader in ethics and compliance for medical devices. In fact, in 2017, AdvaMed awarded its coveted MedTech Ethical Leadership Award, which is sponsored by PwC, to Thomas Schumacher, Medtronic’s Chief Compliance Officer, for demonstrating “outstanding leadership in the advancement of ethics and ethical behavior in the medical device and diagnostics industry.”
However, Medtronic, a leading manufacturer of devices for use in spinal surgery, also has had its share of missteps with government authorities. In December 2017, Medtronic settled its most recent issue with multiple state attorneys general. This case is notable not for the size of the settlement ($12 million), but rather for the remedial actions Medtronic agreed to, as well as the proposition that even good companies, with robust compliance programs, can still have problems.