Humana levels racketeering lawsuit against Medtronic over Infuse bone graft

Humana levels racketeering lawsuit against Medtronic over Infuse bone graft

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 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."

"Medtronic strongly believes that the safety profile reported to the FDA and detailed in product labeling support the continued safe use of Infuse bone graft for approved indications. The company has reported potential adverse events to the FDA, and those risks have been reflected on the product’s label from the time of the FDA’s approval," the spokeswoman wrote. "Medtronic vigorously disagrees with any suggestion that the company improperly influenced peer-reviewed published manuscripts. Medtronic does not compensate physicians for the use or endorsement of our products, and disagrees with any suggestion to the contrary. Physicians are compensated for their intellectual property rights and contributions through royalty payments, and for legitimate and documented consulting services provided to the company. Royalty and consulting agreements help medical device companies develop life-saving technologies and are a commonplace and appropriate practice in the medical device industry.

"The claims in this case are baseless. The potential risks and benefits of Infuse bone graft have been described in the product labeling since 2002, and all payers had access to that information. Medtronic stands behind Infuse bone graft and will continue to vigorously defend the product and our actions in court," she wrote.

The controversy over the Infuse product, a bone morphogenetic protein that stimulates bone growth, erupted during the summer of 2011 when the Spine Journal dedicated its entire June issue (PDF) to problems with the product.

shareholder lawsuit accused Medtronic and its leadership of misleading investors about its prospects for Infuse, and the ensuing clamor spurred federal investigations into allegations that Medtronic’s paid consultants may have concealed Infuse’s risks. In the fall of 2012 a U.S. Senate report blasted Medtronic over its handling of the Infuse product, saying the company deliberately obscured evidence of adverse events and promoted off-label use of the product and paid out millions to the doctors who co-wrote positive studies, charges that the company "vigorously" denied.

And last year, a Medtronic-funded Yale University project examining patient-level data on Infuse found that, although Infuse is equivalent iliac crest bone grafts, company-sponsored studies under-reported adverse events associated with Infuse.

Last month Medtronic agreed to pay $22 million to settle an estimated 950 lawsuits filed over Infuse, admitting to no wrongdoing in what it termed a "compromise" of disputed claims.

RSS From Medical Design & Outsourcing

  • Athermal laser machining cuts bioabsorbable polymers and more
    A the recent MD&M East trade show in New York, Norman Noble, discussed the capability of athermal laser manufacturer. The company has developed the Noble S.T.E.A.L.T.H. (System To Enable Ablation Laser Technology Haz-free). The athermal laser machining process was developed to create precise features in any material, including bioabsorbable polymers, shape memory metals and other […]
  • Exciting possibilities for metallic glass in the medical device world
    Researchers are exploring the potential of metallic glass as a versatile, pliable material that is stronger than steel, with a bevy of possible medical device applications. Yale University engineers have discovered a unique method for designing metallic glass nanostructures across a wide range of chemicals, a technique that could have applications for everything from watch […]
  • Strong Precision Technologies’ medical divisions to unify under MedTorque brand
    Strong Precision Technologies announced on July 2, 2015, that its two medical divisions will now go to market under a single brand, MedTorque. The move reflects the increasing integration of the division formerly known as Inland Midwest with MedTorque, its sister division in Kenosha, WI. “We will continue providing our customers with the personalized level of service […]
  • Olympus offers next-day product replacement guarantee for medical devices
    Olympus, a medical and surgical procedures solutions company, announced that it is guaranteeing next-day replacements for surgical equipment at no additional charge. Olympus is the first surgical product manufacturer to offer this type of guarantee. The service became available to customers with an Olympus Full Service Agreement earlier this year. “Canceled procedures can be costly for healthcare facilities […]
  • More accurate prediction on prognosis in multiple myeloma from SkylineDx
    SkylineDx, a biotechnology company specializing in the development and commercialization of genetic tests, is launching its MMprofiler assay. This test enables clinicians to more accurately predict the prognosis of patients with multiple myeloma (bone marrow cancer) than traditional methods. The MMprofiler measures the activity of 92 genes which are directly or indirectly related to the […]
  • Flint Mobile swaps card reader for camera, accept mobile payments anywhere
    Flint Mobile, the swipe-free mobile payments app, has significantly expanded its payment management and loyalty capabilities for small, service-centric businesses, like the ones run by on-the-go medical equipment professionals. The toggle-free mobile technology makes the process quite simple for both parties, as all transactions are conducted through the mobile device’s camera without the need of any external […]
  • Should scientists be allowed to genetically alter human embryos?
    Scientists have at their disposal, a way to explore the possible prevention of genetic diseases before birth. But should they? Currently, the most promising path forward involves editing the genes of human embryos, a procedure threaded with controversy. An article in “Chemical & Engineering News” (C&EN), the weekly newsmagazine of the American Chemical Society (ACS), parses […]
  • Tackling chronic sinusitis by addressing underlying factors
    The stuffy noses and sinus pressure of head colds are uncomfortable, but for most people, they go away within days. For those with chronic sinusitis, however, those symptoms and others drag on for weeks. Now scientists are onto a potential new therapy that could address one of the underlying factors associated with the condition. They […]
  • Implantable “artificial pancreas” could help diabetes patients control their blood sugar
    Living with Type 1 diabetes requires constant monitoring of blood sugar levels and injecting insulin daily. Now scientists are reporting in the American Chemical Society (ACS) journal, “Industrial & Engineering Chemistry Research,” the development of an implantable “artificial pancreas” that continuously measures a person’s blood sugar or glucose level and can automatically release insulin as […]
  • Drug Deactivation program roll out to all facilities for safe disposal of unused prescription medications
    Verde Technologies announced that New Brighton-based Meridian Behavioral Health, the largest for-profit substance abuse and addiction treatment group in Minnesota, has become its most recent partner in the deactivation and safe disposal of prescription medications including methadone. Meridian is the first behavioral health group to roll out the Deterra Drug Deactivation System to all 17 […]
  • Lophius Biosciences introduces T-activated ImmunoScan Cocktail
    Lophius Biosciences announced the commercial launch of T-Track ImmunoScan and T-activated ImmunoScan Cocktail. Based on a proprietary and very specific cocktail of stimulants in combination with the Company’s T-activation technology, T-Track ImmunoScan and T-activated ImmunoScan Cocktail specifically target different cell types involved in both the adaptive and innate immune system. T-Track ImmunoScan and the T-activated […]


Leave a Reply