Tuesday, June 3, 2014

The Medtronic scandal that refuses to disappear

Remember Infuse. the Medtronic bone graft product? Remember the US Senate investigation of the University of Minnesota? And the special issue of The Spine Journal about Medtronic's biased, misleading research on Infuse? “It harms patients to have biased and corrupted research published,” five doctors wrote in a joint editorial that accompanied the reports, according to the New York Times.  “It harms patients to have unaccountable special interests permeate medical research.”

Well, it's back.  According to the Pioneer Press: 

"Health insurance company Humana Inc. has sued Fridley-based Medtronic, saying the medical device manufacturer fraudulently misrepresented a spine surgery product called Infuse, causing Humana to pay for 'ineffective and unsafe use' of the product."

}Humana claims Medtronic and its Memphis, Tenn.-based spine division paid for and sponsored publication of academic literature that falsely represented Infuse as safe and effective for uses not approved by the Food and Drug Administration (FDA)."

"Humana alleges Medtronic coached hospitals and physicians on how to obtain payments from Humana when using Infuse in spine procedures."

"The insurance company seeks compensatory and punitive damages, accusing Medtronic of intentional and/or negligent misrepresentations; fraudulent concealment and omissions; violations of the Racketeer Influenced and Corrupt Organizations Act ("RICO"); and violations of the consumer protection statutes in all 50 states. The insurer also alleges breach of express and implied warranties as well as unjust enrichment."

Read about it here.

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