Health insurer Humana levels a Racketeer Influenced & Corrupt Organizations lawsuit against Medtronic over its Infuse bone graft product.
UPDATED June 2, 2014, with comment from Medtronic.
Health insurer Humana (NYSE:HUM) leveled a racketeering lawsuit against Medtronic (NYSE:MDT) last week, accusing the medical device company of rigging the presentation of data on its controversial Infuse bone graft product and of pushing its use in off-label procedures.
The lawsuit, citing the Racketeer Influenced & Corrupt Organizations statute known as RICO, alleges that Medtronic ran a deliberate campaign to fudge the data on Infuse to conceal adverse events and induce insurers such as Humana to cover Infuse procedures.
"Defendants paid for and sponsored publication of academic and peer-reviewed literature that falsely represented Infuse and [recombinant bone morphogenetic protein-2] as safe and effective for uses not approved by the Food & Drug Administration. Defendants knew or should have known that Humana would rely on the fraudulent literature to pay for Infuse and/or BMP," according to the lawsuit. "Defendants also aided and facilitated hospitals and physicians in obtaining payments from Humana through false statements and fraudulent omissions and concealment to obtain insurance payouts where Infuse and/or BMP was used. Humana would not have paid for such claims had it known the true facts regarding the uses of Infuse and/or BMP or the risks and efficacy of such uses."
In a statement emailed to MassDevice.com today, a Medtronic spokeswoman said the company "vigorously disagrees" with the accusations that it sought to influence the publication of data on Infuse and called the lawsuit's claims "baseless."
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