Medtronic agreed to a $2.4 million settlement in a case at Massachusetts’ Suffolk Superior Court as part of a $12 million settlement of a multistate investigation into unlawful marketing claims for its Infuse bone graft device.
The settlement concludes an investigation conducted by Massachusetts Attorney General Maura Healey and state attorneys general in Oregon, California, Illinois and Washington. The AG’s complaint alleged the company used deceptive company-sponsored scientific literature to convey false and misleading claims about Infuse’s safety, comparative efficacy, and superiority.
The settlement imposes requirements on Medtronic’s promotional use of clinical trial information and its dissemination of published medical journal articles relating to clinical trials of Infuse. Under the settlement, the company is required to make clinical trial data relating to Infuse publicly available through the government-run website ClinicalTrials.gov.