Legal: Page 2

BD to pay $60M to settle Bard pelvic mesh deceptive marketing claims

The payout is a fraction of the at least $475 million Johnson & Johnson has been ordered to pay states over the past year and a half for similar product liability cases.

By Maria Rachal • Sept. 25, 2020

Medtronic-Axonics sacral neuromod patent battle heats up

The Patent Trial and Appeal Board is moving forward on reviews requested by the bladder and bowel dysfunction-focused device maker taking on the medtech giant.

By Maria Rachal • UPDATED: Sept. 24, 2020 at 1:22 p.m.

FDA posts Essure adverse events pulled from social media

The spreadsheet includes details of 53 deaths and 1,376 reports of serious injuries related to the controversial birth control implant but the agency is unsure if it contains duplicate reports. 

By Nick Paul Taylor • UPDATED: Aug. 14, 2020 at 5:32 p.m.

Edwards to pay Abbott $468M to settle mitral, tricuspid repair device patent disputes

Jefferies analysts called the settlement "a very good deal" for Edwards as it opens up a market opportunity that may be worth $3 billion come 2024.

By Nick Paul Taylor • July 14, 2020

DOJ charges medtech exec with $69M in COVID-19 test fraud, notes Theranos parallel

The Department of Justice said the case against an Arrayit Corporation exec is the first criminal securities fraud prosecution in relation to the pandemic.

By Nick Paul Taylor • June 10, 2020

Court sides with Nevro over Boston Scientific in pain device patent dispute

A judge in the U.S. Court of Appeals for the Federal Circuit found a lower court erred in invalidating four Nevro patents covering high-frequency spinal cord stimulation.

By Nick Paul Taylor • April 10, 2020

Natera breaks ties with Qiagen on NGS testing, citing Illumina deal

The companies teamed up two years ago to develop cell-free DNA assays for a Qiagen reader system, but Thermo Fisher-bound Qiagen later shifted course, which Natera said was a "material breach of the agreement."

By Nick Paul Taylor • March 13, 2020

California's new cybersecurity law sidesteps most medical devices, lawyers say

How the state enforces its "internet of things" or connected devices law "may end up becoming a source of persuasive authority for the FDA in its decision making" on cybersecurity guidance, said White and Williams' Joshua Mooney.

By Fred Donovan • Feb. 28, 2020

Baxter overstated income by $278M, internal probe finds

The fallout may drag on from Baxter's use of a flawed method to calculate exchange rates over several years. The medtech continues to work with the SEC and potential investor class action lawsuits could follow.

By Nick Paul Taylor • Feb. 14, 2020

Tenet to pay $1.4M to settle claims it unnecessarily implanted cardiac monitors

The unneeded procedures subjected patients to "needless peril, and taxpayers end up with the bill," said an HHS Office of Inspector General special agent.

By Samantha Liss • Feb. 12, 2020

Brexit happened. EU MDR looms. 3 key questions on medtech's future in Europe

The U.K. can skip the new in vitro diagnostic rules entirely, and in theory, could unilaterally stop applying MDR after the transition period ends. Both scenarios seem unlikely.

By Nick Paul Taylor • Feb. 04, 2020

Medtech in limbo as Brexit arrives

Although the industry has lobbied for the departing member state to implement the Medical Device Regulation and stick closely to EU rules, a minister in the U.K. government said legislative alignment “just ain't happening.”

By Nick Paul Taylor • Feb. 03, 2020

J&J hit with $344M verdict in California pelvic mesh trial

The false and deceptive marketing decision dwarfs the $117 million settlement a coalition of more than 40 states reached in October.

By Maria Rachal • Jan. 31, 2020

Natera takes ArcherDX to court over cancer testing patent

Genetic testing company Natera claims it has exclusive rights to use multiplex PCR in certain cancer settings.

By Nick Paul Taylor • Jan. 28, 2020

Supreme Court declines to quickly hear ACA case

It's unlikely the case will be decided before the election, which will thrust the debate over the fate of the landmark law into the spotlight during another presidential campaign.

By Samantha Liss • Jan. 21, 2020

Edwards' US patent challenge to Abbott MitraClip IP denied

In a decision Thursday, the Patent Trial and Appeal Board thwarted Edwards Lifesciences' petition arguing certain Abbott mitral valve repair claims are unpatentable, the latest in a transatlantic battle between the companies.

By Nick Paul Taylor • Jan. 17, 2020

ResMed pays more than $37.5M to settle false claims allegations

The settlement covers accusations that the sleep apnea and respiratory conditions medical equipment maker provided free and below-cost products and services to spur patient referrals.

By Nick Paul Taylor • UPDATED: Jan. 20, 2020 at 10:23 a.m.

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