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 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."

"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

  • Cyberdyne CEO has severed spines on his agenda
    Editor’s Note: This article is from Bloomberg.com‘s Natasha Khan. Cyberdyne Inc.’s CEO, Yoshiyuki Sankai, is researching ways to repair damaged body tissue. The 57-year-old scientist’s vision: to treat patients with spinal injuries by using stem-cell related technology to repair nerve connections and robotic suits that aid movement. Sankai’s company is setting its sights on better […]
  • Teknor Apex to showcase wide range of PVC compounds for medical devices at Medtec China
    Building on its international leadership role as a supplier of medical-grade PVC compounds, Teknor Apex Company has developed flexible and rigid formulations that address the special needs of device manufacturers. The company will highlight these capabilities at Medtec China 2015. “Teknor Apex produces or markets medical-grade PVC compounds in China, Singapore, Europe, and the United […]
  • The Raspberry Pi eco-system goes interstellar with the new Raspberry Pi Sense HAT
    Newark element14 has globally launched the latest addition to the expanding ecosystem of Raspberry Pi accessories, the Raspberry Pi Sense HAT, as featured in the ‘Astro Pi’ space mission. The Sense HAT will enable enthusiasts to control the same hardware used in space. The Sense HAT attaches to the Raspberry Pi board, and can be […]
  • CommScope completes acquisition of TE Connectivity’s Telecom
    CommScope Holding Company, has completed its previously announced acquisition of TE Connectivity’s Telecom, Enterprise and Wireless businesses, a leader in fiber optic connectivity for wireline and wireless networks. The all-cash transaction, valued at approximately $3 billion, strengthens CommScope’s position as a leading communications infrastructure provider with deeper resources to meet the world’s growing demand for network […]
  • SPI awards IKO Prosthetic Creative System the Student Design International Design Excellence Award
    SPI: The Plastics Industry Trade Association congratulated IKO Prosthetic Creative System for winning the SPI Student Design Award, part of the Industrial Designers Society of America’s (IDSA’s) International Design Excellence Awards (IDEA) program. The award was presented to IKO, an innovative, youth-focused prosthetic design company led by Chicago-based designer Carlos Torres, by SPI’s Senior Director of […]
  • New assay could revolutionize diagnosis and treatment of life-threatening disease
    Invasive Fungal Disease (IFD) is an emerging global health problem associated with high mortality rates in severely immunocompromised patients, such as those undergoing intensive chemotherapy or stem cell transplantation, and in patients suffering immune compromising conditions such as AIDS. The most common causative agents of this disease have been identified as Candida and Aspergillus species, […]
  • Molex delivers ISO 13485-compliant, medical-grade surgical cables from its class 100,000 clean room facility
    Molex, LLC operates a fully ISO 146441-1:1999 Class 8-certified clean room, satisfying strict particulate contamination levels specified by ISO-compliant requirements. Located in Thailand, the facility has less than 100,000 particulates (≥0.5µm) per cubic foot of air and manufactures a variety of ISO 13485-compliant medical cables and surgical cables used in operating theatres, hospitals, laboratories and […]
  • Swept-Source OCT: Patent license agreement between Massachusetts General Hospital and Heidelberg Engineering
    Heidelberg Engineering has entered into a patent license agreement with Massachusetts General Hospital (MGH) in Boston. The agreement grants global and exclusive rights to 77 basic patents and patent applications which relate to swept-source OCT technology and its application in ophthalmology. Spectral domain OCT has become indispensable to eye care professionals worldwide to diagnose and […]
  • MIT’s MultiFab presents a stark challenge to incumbent 3D Printer manufacturers’ hardware, software, and business Models
    MIT’s Computational Fabrication Group recently announced the MultiFab, a low-cost 3D printer that can combine up to 10 different resins in one part and also includes a 3D scanning system to identify and fix errors during production. According to Lux Research, these capabilities are rare in commercial 3D printers today due to the manufacturers’ need […]
  • AVX releases Accu-P MP medical grade film chip capacitors for medical devices
    AVX Corporation, a leading manufacturer of passive components and interconnect solutions, has released a new series of thin film chip capacitors specifically designed to meet the demanding performance specifications for implantable medical devices. Delivering extremely tight capacitive tolerances, exceptionally repeatable performance, and remarkably low ESR and high Q at high frequencies—including VHF, UHF, and RF […]
  • RIVANNA commences manufacturing of its Accuro device
    Rivanna Medical announced that it has begun manufacturing its FDA-cleared Accuro device, a handheld and untethered smart-phone-sized device that is designed to guide spinal anesthesia with automated 3D navigation technology in addition to ultrasound imaging of abdominal, musculoskeletal, cardiac and peripheral vascular anatomies. The product will be launched at the ASA annual meeting in San […]

Leave a Reply