Legal: Page 2

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

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

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

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

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

Q&A

California'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

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