Regulatory Focus™ > News Articles > Medtronic Settles Deceptive Advertising Lawsuit for $12M

Medtronic Settles Deceptive Advertising Lawsuit for $12M

Posted 13 December 2017 | By Zachary Brennan 

Medtronic Settles Deceptive Advertising Lawsuit for $12M

State attorneys general in Massachusetts, Oregon, California, Illinois and Washington on Wednesday announced a $12 million multi-state settlement with Medtronic to resolve claims the company deceptively marketed one of its devices known as Infuse.

The complaint alleged that Medtronic used deceptive company-sponsored scientific literature to convey false and misleading claims about the device’s safety, comparative efficacy and superiority to expand its market.

Specifically, the complaint alleged that to promote the device, used in spinal fusion procedures, Medtronic paid millions in consulting fees to physician-authors who published studies in peer-reviewed journals that deceptively omitted adverse events, downplayed side-effects, overstated the device’s comparative efficacy and failed to disclose consultant ties to Medtronic.

In addition to the $12 million, $2.4 million of which will go to Massachusetts, the settlement adds new requirements to Medtronic's promotional use of clinical trial information and its dissemination of published journal articles on Infuse trials.

Medtronic is also required to make trial data relating to Infuse available through ClinicalTrials.gov and to comply with other injunctive terms relating to its marketing and promotional practices for Infuse.

Medtronic said in a statement that the state inquiries "had been previously disclosed, and this agreement brings closure to this matter. As part of the agreement, Medtronic has agreed to pay a total of $12M to be divided among the five states. 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." 

In addition to this settlement, in 2014, Medtronic agreed to pay $22 million to end product liability lawsuits involving nearly 1,000 people who used Infuse.


Categories: Regulatory News

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