Want to know what's happening next in healthcare?

MedCityNews is the leading online news source for the business of innovation in healthcare.


“I read MedCity because it captures the pulse of what's going on in healthcare innovation, a go to source. I also like how MedCity supports women in digital health.”

Dr. Charlene Ngamwajasat, @doctorcharlene, Physician and techie


Sign up for our daily newsletter


Medtronic to pay $85M to settle Infuse-related class action lawsuit

6:22 pm by | 4 Comments

Medtronic (NYSE:MDT)  announced Friday that it will pay $85 million to settle a class action securities fraud lawsuit related to its controversial bone growth product Infuse, but denied any wrongdoing.

The Minneapolis Firefighters’ Relief Association brought the lawsuit against the device maker and alleged that the company and some of its current and former officers misrepresented how it markets Infuse that led the company’s stock to be inflated between Nov. 20, 2006 and Nov. 17, 2008.  Here is a portion of the complaint, according to the law firm Bernstein Litowitz Berger and Grossman LLP, which represented the plaintiff.

Specifically, the Defendants misled shareholders regarding a near decade-long campaign to illegally promote INFUSE for uses not approved by the Food and Drug Administration, or so-called “off-label uses,” and concealed from shareholders the fact that the reported sales and future growth of this business line and its associated revenues was driven by misconduct that invited, and ultimately brought about, the scrutiny of federal regulators and an abrupt decline in sales.

Advertisement

For those who don’t know, Infuse is part of Medtronic’s spinal division that has been hurt by falling sales amid charges that the product is unsafe. Critics also allege that researchers who studied Infuse and were compensated by Medtronic overstated its benefits and downplayed potential risks.

To quell the uproar, Medtronic CEO Omar Ishrak took the unprecedented step of making a $2.5 million grant to independent Yale researchers who are reviewing Infuse data. He hopes the review will vindicate Infuse.

Given the negative connotation that surrounds the product, perhaps it comes as no surprise that the one word conspicuous by its absence from Medtronic’s  lawsuit settlement announcement was Infuse.

Copyright 2014 MedCity News. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Arundhati Parmar

By Arundhati Parmar

Arundhati Parmar is the Medical Devices Reporter at MedCity News. She has covered medical technology since 2008 and specialized in business journalism since 2001. Parmar has three degrees from three continents - a Bachelor of Arts in English from Jadavpur University, Kolkata, India; a Masters in English Literature from the University of Sydney, Australia and a Masters in Journalism from Northwestern University in Chicago. She has sworn never to enter a classroom again.
More posts by Author

4 comments
don j c
don j c

this infuse has damned near ended my life first two days excellant results with my inner - outer L3--L5   S 1  fusion w laminectomy w compression with the 10 titanium bone baskets ,rods and pedicle screws ,after walking fairly well on day 3 .by 5 pm that night I had 105  f  fever, then by 10pm I was tied to bed delirium -halucenations , kidney -liver failure ,heart failure,toxic encephalopathy of the brain ,bowel-gut illeous  ,

total incontenents ,bowel-bladder lasted for more than a year and a 1/2  .I lost more than 10 years of my memory ,I awoke ,I didn't even know my wife of 28 yrs ,I didn't like her ,I didn't know or like the child I adopted ,

I had permanent partial paralysis of small intestine -stomach leading to 11 total surgeries 5 in last 3 years I have no taste ,I can only eat 2 oz of food and live on greek yogurt ,and 2 oz pieces of meat .no fruits or vegs ,breads or grains ,I had a massive 17.2 cm by 19 . cm bezore from the combo of those three items two surgeries .chet tubes ,feeding tubes .

any on eels get such good care from the infusion or the bone baskets get ahold of me

518-681-7806

stuckwithestem
stuckwithestem

I have an estem by medtronics and want to know if I can be compensated for the pain and suffering I deal with because it has never worked and my insurance company will not pay for me to have it taken out

don j c
don j c

yes I know I cannot have mine out ,the stuff in the infuse unit made so much excess bone its like 5 inches thigk and I would never  walk ever again if they could get it out .

don j c
don j c

yes join the class action lawsuits