Legal: Page 3

  • Feds sue South Dakota surgeon, distributorships over alleged spinal implant kickbacks

    The suit comes amid a backdrop of growing fraud concerns related to physician-owned entities providing medical products to doctors. 

    By Dana Elfin • Nov. 14, 2019
  • Life Spine, execs settle implants kickback case for nearly $6M

    The medtech said it had made significant progress strengthening its compliance program even before it began negotiations with the government.

    By Dana Elfin • Nov. 11, 2019
  • Medtronic sues Axonics in patent battle for sacral neuromodulation market

    Axonics' new system to treat fecal incontinence, which began a commercial launch this quarter, is challenging Medtronic's dominant InterStim product line.

    By Dana Elfin • Nov. 06, 2019
  • Warren, Murray, Smith redouble scrutiny of FDA over Pre-Cert safety, authority

    FDA maintains it has the statutory authority to conduct the software Pre-Cert pilot, but acknowledged it will need help from Congress to update what it calls a 40-year-old regulatory paradigm for 21st century technologies.

    By David Lim • Oct. 31, 2019
  • Sanford agrees to $20M settlement to resolve kickback allegations

    The case centered on implants sold by a physician-owned distributorship and allegations a Sanford Health neurosurgeon used those devices to perform medically unnecessary procedures.

    By Oct. 29, 2019
  • Cardinal Health, other distributors settle for $215M in Ohio opioid case

    The deal announced Monday with Cardinal, McKesson and AmerisourceBergen sidesteps what would have been the first federal trial related to charges they encouraged overprescribing the painkillers.

    By Jonathan Gardner • Oct. 21, 2019
  • Doctor hit with guilty verdict for reusing contaminated catheters, defrauding Medicare

    A California physician submitted approximately $12 million worth of claims to Medicare for the medically unnecessary procedures, pocketing $4.5 million.

    By Dana Elfin • Oct. 18, 2019
  • Two weeks from Brexit deadline, UK floats device contingency

    A no-deal Brexit would not meet any of MedTech Europe's four priorities. 

    By Oct. 15, 2019
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    Hospitals, manufacturers could donate cybersecurity software under proposed regs

    With the cost of protecting systems from malicious hackers increasing, the idea to tweak the anti-kickback laws recognizes some physician practices don't have the resources or expertise to keep pace, one lawyer told MedTech Dive.

    By David Lim • Oct. 14, 2019
  • CDS software, labels for staplers and breast implants among FDA 2020 guidance priorities

    The annual publication comes days after the White House issued an executive order aimed at limiting agency use of the documents.

    By David Lim • Oct. 11, 2019
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    HHS hesitant to include implantable medical devices in Anti-Kickback safe harbor

    The government appears to be considering various methods to exclude device manufacturers from its care coordination safe harbor while allowing digital health technologies used to remotely monitor patients to take advantage of it.

    By David Lim • Oct. 10, 2019
  • Fresenius to pay $5.2M to settle Medicare overbilling allegations

    DOJ alleged the company overbilled Medicare for more than seven years by ordering hepatitis B tests for patients it knew to be immune to the virus.

    By Oct. 10, 2019
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    Alex Wong via Getty Images

    HHS pitches sweeping revamp of Anti-Kickback Statute, Stark Law

    Several new safe harbors are proposed to encourage value-based care, allow patient engagement through furnishing of tools and supports, and permit certain remuneration in some CMS-sponsored models.

    By David Lim • Oct. 09, 2019
  • Supreme Court slaps down Zimmer's request for review of $248M damages award in Stryker patent case

    Zimmer Biomet exhausted its last possibility for review in the nearly nine-year-old infringement case involving a Stryker device patent, which awarded one of the highest ever amounts of enhanced damages in a patent infringement case.

    By Dana Elfin • Oct. 07, 2019
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    Getty Images

    AI clinical support opens physicians to potential liabilities: JAMA

    Legal considerations for doctors using clinical decision support software come amid challenges for regulators attempting to define a framework to oversee the emerging technologies.

    By David Lim • Oct. 07, 2019
  • DOJ charges 35 people in $2.1B Medicare genetic testing fraud scheme

    CMS also announced it took adverse administrative action against CGx testing companies and providers who filed more than $1.7 billion in claims to Medicare.

    By David Lim • Sept. 30, 2019
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    Public health alert or legal advertising? It can be hard to tell.

    AdvaMed applauded the FTC's move to send letters warning lawyers and lead generating firms over potentially unfair and deceptive ads seeking clients for personal injury suits. 

    By Dana Elfin • UPDATED: Sept. 26, 2019 at 11:01 a.m.
  • J&J settles with West Virginia over allegations on mesh, hips

    The $3.9 million settlement resolves the state attorney general's claims that Ethicon and DePuy unlawfully marketed the much-litigated surgical mesh and hip replacement devices.

    By Maria Rachal • UPDATED: May 5, 2020 at 9:40 a.m.
  • UK shares 'responsible person' advice as no-deal Brexit looms

    The update comes against a backdrop of rising concerns that Britain will leave the European Union without a deal.

    By Sept. 19, 2019
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    Wikipedia user Coolcaesar / edited by Industry Dive

    Establishment Labs gets IP boost ahead of pitch for breast implant market

    The patent news is a positive for efforts to claim a slice of the volatile breast implant market, analysts at Cowen said. 

    By Sept. 17, 2019
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    Quest didn't steal Cedars-Sinai blood test in trade secrets row, jury says

    Hospitals are increasingly using intellectual property to spur transition of early-stage discoveries into products that can be commercialized through licensing agreements.

    By Dana Elfin • Sept. 16, 2019
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    Alpha Stock

    Boston Scientific says Biocardia doesn't own women's health patents, denies stealing trade secrets

    Boston Scientific is asking a court to determine it didn't steal BioCardia's trade secrets and to clear up patent ownership of an early-detection diagnostic tool for ovarian cancer it acquired when it purchased nVision.

    By Dana Elfin • Sept. 09, 2019
  • Telemedicine CEO pleads guilty in $424M Medicare kickback scheme

    The executive admitted to seeking and getting bribes from patient recruiters, pharmacies and brace suppliers in return for arranging for doctors to order medically unnecessary orthotic braces.

    By Dana Elfin • Sept. 09, 2019
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    Wikipedia user Coolcaesar / edited by Industry Dive

    Dexcom beats WaveForm's patent suit over CGM sensors

    A U.S. District Court judge's decision ends the ongoing dispute between San Diego-based continuous glucose monitor maker Dexcom and WaveForm Technologies, a subsidiary of blood glucose meter manufacturer AgaMatrix.

    By Dana Elfin • Aug. 26, 2019
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    Conformis sues Zimmer Biomet over patent infringement

    Knee implant maker Conformis is seeking triple damages amid its claim that Zimmer Biomet infringed multiple of its patents for patient-specific instrument systems and techniques for joint replacement surgery.

    By Aug. 20, 2019