Legal: Page 2

Delaware court deals blow to Boston Scientific in Channel Medsystems lawsuit

Boston Scientific's attempt to terminate its $275 million acquisition of cryoablation device maker Channel Medsystems was ruled inappropriate by the Delaware Court of Chancery Wednesday. 

By David Lim • Dec. 19, 2019

EU Parliament finalizes 4-year MDR delay for some Class I devices

The delay will help slightly reduce the crush of products needing notified body review by May 26, 2020.  

By David Lim • UPDATED: Dec. 17, 2019 at 12:38 p.m.

Feds charge lab owner in latest genetic testing kickback scheme

The charges come just two months after the Department of Justice shone the light on an alleged scam involving 35 people and multiple genetic testing and telemedicine companies costing Medicare $2.1 billion.

By Susan Kelly • Dec. 02, 2019

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