Medtronic Forks Over $12 Million in Deceptive Marketing Settlement

Medtronic has agreed to pay a total of $12 million in a five-state settlement of litigation over its controversial Infuse bone graft device. Oregon Attorney General Ellen Rosenblum announced the settlement with Medtronic Sofamor Danek Inc. and Medtronic Sofamor Danek USA Inc. to resolve allegations that the company unlawfully promoted Infuse, used in spinal fusion procedures, to doctors. Other states participating in the settlement are California, Illinois, Massachusetts, and Washington. Oregon alleged that Medtronic made deceptive claims about Infuse by using trusted scientific publications to report that Infuse was superior to other therapies and that patients who used Infuse experienced fewer side effects than what research actually showed. “It is unacceptable for a company to use company-sponsored literature with misleading data to try to show that its product is more effective than other therapies,” Rosenblum said in the statement. “By using these misleading claims, the company created a higher demand for Infuse in a range of surgeries—which led to greater and undeserved profits for the company.” Medtronic admitted to no wrongdoing in the settlement. “Medtronic entered into this agreement solely for the purpose of settlement, and nothing related to it can be taken as an admission or concession of any violation of law, rule, regulation or of any liability or wrongdoing,” a company spokesman said in an email to MD+DI. Infuse is Medtronic's trade name f...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Medical Device Business Source Type: news