Legal: Page 2
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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 -
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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 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 -
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 -
AdvaMed
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 -
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 Nick Paul Taylor • 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 -
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 -
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 -
Fotolia
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 Susan Kelly • Aug. 20, 2019 -
Stanford University
Senators push HHS for details of response to DNA test scam
Lawmakers propose pre-claim review of genetic test orders to root out fraud.
By Nick Paul Taylor • Aug. 15, 2019 -
Ambu to pay $3.3M to settle False Claims Act allegations
The Danish medical device maker is accused of manufacturing products in China and Malaysia and knowingly selling them to U.S. government agencies in violation of the 1979 Trade Agreements Act.
By Susan Kelly • Aug. 12, 2019 -
Brian Tucker Industry Dive Image | courtesy of California Office of Attorney General
Q&ACalifornia's AG on suing J&J for deceptive mesh marketing, defending ACA
Xavier Becerra also spoke to MedTech Dive about medical product safety.
By Dana Elfin • Aug. 08, 2019 -
Fotolia
Zimmer hit with $7.7M in damages in hip implant case
The company has now paid more than $400 million in metal-on-metal hip implant cases but still expects to pay out around $130 million more in relation to lawsuits involving Durom Cup and similar devices sold by its Biomet unit.
By Nick Paul Taylor • Aug. 06, 2019 -
Appeals court kicks ACLA lawsuit back to lower court
The ruling is a blow to the government, which argued collection of market data was inextricably intertwined with the establishment of payment rates and therefore wasn't reviewable by the courts.
By David Lim • July 31, 2019 -
Humana accuses Abbott of duping it to pay to remove dodgy heart devices
The suit alleges St. Jude, now a part of Abbott, knew about a battery depletion defect in its heart rhythm devices for four years before notifying FDA, and then schemed to have the insurer pay for surgeries to remove patients' implants.
By Susan Kelly • July 30, 2019
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