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Wednesday, December 13, 2017

MASSACHUSETTS TO RECEIVE $2.4 MILLION FROM MEDICAL DEVICE COMPANY OVER UNLAWFUL MARKETING

MASSACHUSETTS TO RECEIVE $2.4 MILLION FROM MEDICAL DEVICE COMPANY OVER UNLAWFUL MARKETING 
Payment Part of $12 Million Settlement Resolving Multistate Investigation
BOSTON – Massachusetts will receive $2.4 million from a medical device company in a multistate settlement resolving allegations that it unlawfully promoted a device used in certain surgical procedures, Attorney General Maura Healey announced today.
In a consent judgment entered today in Suffolk Superior Court, Medtronic Sofamor Danek, Inc. and Medtronic Sofamor Danek USA, Inc. (Medtronic) have agreed to resolve claims they engaged in a deceptive marketing strategy regarding its Infuse® Bone Graft device that is used to stimulate bone growth.

“Companies cannot use deceptive practices to increase their profits, while compromising the safety and well-being of patients,” said AG Healey. “With this settlement, we are bringing more than $2 million back to Massachusetts after uncovering this unlawful conduct.”

The payment is part of a $12 million multistate settlement that concludes an investigation conducted by AG Healey and state attorneys general in Oregon, California, Illinois and Washington.

Infuse is a medical device used in certain spinal fusion procedures as an alternative to more traditional bone grafting. The AG’s complaint, filed along with the consent judgment today, alleges that Medtronic used deceptive company-sponsored scientific literature to convey false and misleading claims about Infuse’s safety, comparative efficacy, and superiority in order to expand the market for Infuse. 

Specifically, the complaint alleges that in order to promote Infuse, Medtronic collaborated with physician-authors – many of whom were paid millions in consulting fees by the company – to publish studies in peer-reviewed journals that unfairly and deceptively omitted discussion of adverse results, downplayed side-effects, overstated the comparative efficacy of Infuse, and failed to disclose consultant ties to Medtronic. The complaint alleges Medtronic knowingly disseminated these deceptive articles and benefited financially from them.  
In addition to the monetary payment, 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.

Medtronic is also required to make clinical trial data relating to Infuse publicly available through the government-run website ClinicalTrials.gov, and comply with other injunctive terms relating to its marketing and promotional practices for Infuse.

This matter was handled by Assistant Attorney General Lisa Gaulin of the AG’s Health Care Division, with assistance from Eric Gold, Chief of the Health Care Division, and Assistant Attorneys General Courtney Aladro and Emily Gabrault through the Health Care Division.

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