Legal: Page 2
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Boston Heart to pay $26.7M to settle alleged doctor kickback scheme
Allegations against the clinical diagnostics company included that it made payments to doctors disguised as investment returns in exchange for referrals.
By Susan Kelly • Nov. 27, 2019 -
Roche facing $137M in damages over diagnostic patent dispute after jury verdict
The ruling relates to technology used in Roche's cobas line of immunoassay analyzers.
By Nick Paul Taylor • Nov. 27, 2019 -
Hospitals — and now insurers — to reveal secret rates under latest Trump admin pitch
Industry lobbies are sure to fight back against what would be a landmark shift in healthcare.
By Samantha Liss • Nov. 15, 2019 -
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 Nick Paul Taylor • 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 Nick Paul Taylor • Oct. 15, 2019 -
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 -
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 Nick Paul Taylor • Oct. 10, 2019 -
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 -
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 -
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 Nick Paul Taylor • Sept. 19, 2019 -
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 Nick Paul Taylor • Sept. 17, 2019 -
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 -
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