Legal: Page 2

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.
West Virginia AG sues J&J, Ethicon over mesh marketing

Washington state reached a $9.9 million settlement for a similar case in April, and a trial between California and Johnson & Johnson over alleged deceptive marketing of pelvic mesh began in July.
By Maria Rachal • Sept. 19, 2019
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
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
DOJ alleges spine maker paid $7M to surgeons in kickbacks

According to the lawsuit, privately held Life Spine failed to report some of the $7 million it paid to surgeons from 2012 to 2018.
By Nick Paul Taylor • July 25, 2019
Opinion
Medical device corrections, removals and recalls: Where are we now?

Companies must balance maintaining a credible relationship with FDA while resisting actions that may not ultimately be in the best interests of patient safety, write Hogan Lovells' Jodi Scott and Wil Henderson.
By Jodi Scott and Wil Henderson • July 19, 2019
Sterigenics strikes deal to reopen Willowbrook sterilization plant

The closure of the Illinois facility caused millions of dollars of losses for major medical device firms like Medtronic, Boston Scientific and Smiths Medical.
By David Lim • UPDATED: Sept. 9, 2019 at 10:41 a.m.
CMS outlines home infusion therapy benefit in proposed rule

Home infusion therapy allows for the delivery of certain drugs, such as anti-infectives, chemotherapy or treatment for immune deficiencies, with the use of a durable medical equipment pump at a patient's home.
By David Lim • July 12, 2019