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Health
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May 09, 2024
Judge Clarifies Gilead Didn't Directly Infringe HIV Drug IP
A Delaware federal judge on Thursday rejected Gilead Sciences' request to amend her judgment finding that two medications in its HIV prevention regimen, Truvada and Descovy, directly infringed the government's invalidated patents, but clarified her judgment to say that non-party patients or physicians committed the infringement.
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May 09, 2024
Doc Can't Escape Second Prednisone Overprescribing Suit
A Pennsylvania federal judge won't strike claims for punitive damages and references to "outrageous" conduct from a complaint alleging that a doctor wrongly overprescribed medications including prednisone, saying the complaint plausibly alleged that he knowingly had a patient on a medication plan that harmed her.
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May 09, 2024
Rail Co. Accused Of Retaliation Over FMLA Use
CSX Transportation Inc. has been hit with a Florida federal lawsuit brought by its workers, who allege in their proposed class action that the rail company discouraged them from lawfully using the Family and Medical Leave Act, including by punishing them for taking advantage of the law.
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May 09, 2024
First Zantac Trial Plaintiff Says She Can't Live Normal Life
An Illinois woman suing the former manufacturers of Zantac heartburn medication and claiming her long-term use of the drug caused her colon cancer testified Thursday that she has struggled to control her bowels since her 2015 diagnosis and has experienced multiple accidents in public places that left her humiliated and fearful to leave her home.
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May 09, 2024
Judge Halts DEA's Hearing On Proposed Psychedelics Ban
An administrative law judge with the U.S. Drug Enforcement Administration has ordered the agency to cancel a June 10 hearing on its proposal to ban two psychedelic substances while a researcher's federal lawsuit challenging the agency's actions plays out in court, according to an order made public Thursday.
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May 09, 2024
Ex-Dental Device CEO Cops To $10.7M Investor Fraud
The former CEO of a dental device company pled guilty Thursday to defrauding investors out of $10.7 million with false claims that his company received the U.S. Food and Drug Administration's approval for a device he promised would take the place of X-rays.
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May 09, 2024
9th Circ. Says Judge Defied Order To Revive Opioid Case
The Ninth Circuit on Thursday again revived a nearly 7-year-old case against a California doctor for allegedly selling opioid prescriptions and ordered that the case be reassigned, saying the presiding judge had defied the plain language of a previous order to reinstate the indictment.
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May 09, 2024
Ex-Official Says NJ, Ethics Board Are 'Stonewalling' Discovery
A former New Jersey health official has asked a state judge to order the state and its ethics commission to provide full discovery around his claims that he was fired in 2020 for raising concerns about the governor's chief of staff earmarking COVID-19 tests for relatives, accusing the Garden State of "stonewalling" his requests for documents and communications.
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May 09, 2024
Caremark Can Seek Arb. In Oklahoma Tribe's Prescription Suit
An Oklahoma federal court judge has paused a dispute between the Muscogee (Creek) Nation and Caremark LLC until the pharmaceutical company can resolve a bid to compel the tribe into arbitration in an Arizona court over unpaid reimbursement claims.
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May 09, 2024
DOJ Task Force To Target Healthcare Monopoly, Collusion
The U.S. Department of Justice's Antitrust Division sharpened its focus Thursday on healthcare platforms that combine doctors with insurers, data and more in what the administration's top competition official called the "alarming" accumulation of assets.
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May 09, 2024
6th Circ. Panel Skeptical Of NLRB Hazard Pay Ruling
A Sixth Circuit panel questioned on Thursday a National Labor Relations Board decision finding a Michigan nursing home violated federal labor law with its handling of temporary hazard pay and staffing during the COVID-19 pandemic, with judges appearing skeptical the company had to bargain over the changes.
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May 09, 2024
Philly Doctor Loses Bid To Restore $15M Bias Award
A Philadelphia federal judge on Thursday denied a former Thomas Jefferson University Hospital surgeon's request to reinstate a $15 million jury verdict against his onetime employer, reasoning that the judge would have reached the same conclusion as a previous judge who vacated the award before recusing himself from a new trial.
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May 09, 2024
Ex-Celtic 'Big Baby' Gets 40 Mos. In Health Fraud Case
Former Boston Celtics forward Glen "Big Baby" Davis was sentenced to 40 months in prison Thursday after being convicted for his role in a scheme to submit fraudulent invoices to an NBA healthcare plan.
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May 09, 2024
IRS Publishes Inflation-Adjusted HSA Amounts
The Internal Revenue Service issued the inflation-adjusted amounts Thursday for health savings accounts for 2025 as well as the maximum amount that may be made available for excepted benefit health reimbursement arrangements.
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May 09, 2024
NYC Denies IVF Coverage To Gay Male Workers, Court Told
New York City unlawfully discriminates against gay male employees by refusing to cover in vitro fertilization under its healthcare plan while providing heterosexual and lesbian workers with those benefits, according to a proposed class action filed Thursday in federal court.
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May 08, 2024
Quinn Emanuel Atty Says Asset Freeze Hurt Outcome Defense
The U.S. government's overreach in restraining millions more than it could reasonably trace back to a $1 billion fraud by Outcome Health prevented the company's former CEO from hiring Quinn Emanuel Urquhart & Sullivan LLP attorneys to defend the charges like he originally wanted, an Illinois federal judge heard Wednesday.
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May 08, 2024
Alaska Comm. To Pay $5.3M To Settle Bidding Violation Claims
Alaska Communications Systems Holding Inc. on Wednesday agreed to pay nearly $5.3 million and implement compliance measures to resolve a Federal Communications Commission investigation into the telecommunications provider's bidding and rate setting processes for rural medical patients.
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May 08, 2024
Conn. Healthcare Facility Owes $13.4M For Patient's Death
A state trial court judge on Wednesday refused a Connecticut healthcare facility's requests to scuttle a $10 million jury verdict over a patient's death, agreeing to ratchet an estate's victory up to nearly $13.4 million because of interest dating back more than four years.
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May 08, 2024
GW Hospital Bargained In Bad Faith, NLRB Dems Say In Redo
A split National Labor Relations Board panel said Wednesday that George Washington University Hospital sabotaged union negotiations with unworkable proposals, reasserting precedent that employers bargain in bad faith by insisting on contract provisions that effectively nullify unions.
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May 08, 2024
Duke Doctor Partially Resuscitates NC Firing Suit
The North Carolina state appeals court has partially revived a fired Duke University hospital resident's lawsuit alleging that health care system officials terminated him because of his depression after an inadequate firing-review process that violated an employment contract.
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May 08, 2024
In Final Memo, Blumenauer Eyes Path Forward For Cannabis
Rep. Earl Blumenauer, D-Ore., a longtime champion of cannabis reform in Congress who plans to retire this year, is calling marijuana reform a "winning issue" for policymakers and outlined numerous actions both legislators and federal agencies can take to move the issue forward.
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May 08, 2024
Ga. Doctor, Urology Clinic Want New Trial In $15M Death Case
Attorneys for a Georgia doctor and urology clinic urged the Georgia Court of Appeals on Wednesday to set aside a $15 million jury verdict and order a new trial in a wrongful death case filed by the wife of an 80-year-old man who died following a November 2016 prostate surgery.
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May 08, 2024
Fla. Lab Owner Gets 10 Years For Unneeded Medical Tests
A Florida medical lab owner has been sentenced to 10 years in prison after pleading guilty to charges related to accusations that he billed Medicare for $53 million in unnecessary genetic cancer screening tests.
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May 08, 2024
Sleep Apnea Co. Hits Ch. 11 Over $41.5M In Debt, Cash Woes
California-based ProSomnus, which produces devices to prevent sleep apnea, said a balance sheet heavy with more than $41.5 million in debt and difficulty in funding its continued operations forced it to file for Chapter 11 protections in Delaware.
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May 08, 2024
Simpson Thacher-Led Silver Lake Lands $20.5B For 7th Fund
Technology-focused private equity shop Silver Lake, advised by Simpson Thacher & Bartlett LLP, announced Wednesday the closing of its seventh flagship fund after securing $20.5 billion from investors, beating out the amount raised in its predecessor fund by about half a billion dollars.
Expert Analysis
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4 Legal Ethics Considerations For The New Year
As attorneys and clients reset for a new year, now is a good time to take a step back and review some core ethical issues that attorneys should keep front of mind in 2024, including approaching generative artificial intelligence with caution and care, and avoiding pitfalls in outside counsel guidelines, say attorneys at HWG.
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Bribery Settlement Gives Insight On DOJ Policies
Chemical company Albemarle’s recent $218 million settlement with the government to resolve foreign bribery claims provides valuable data points for companies on the U.S. Department of Justice’s voluntary self-disclosure policy and its clawback pilot program, say Michael DeBernardis and Tiauna Mathieu at Hughes Hubbard.
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A Primer On New Calif. Health Transaction Reporting Rules
New California regulations regarding the reporting of certain transactions involving healthcare entities, which took effect on Jan. 1, address some industry feedback about overly broad requirements but still leave several areas of concern, says Andrew Demetriou at Husch Blackwell.
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Opinion
Waiving COVID-19 IP Protections Would Harm US Industry
President Joe Biden should turn down a World Trade Organization proposal to waive crucial intellectual property protections behind COVID-19 tests and diagnostics — protections that allow U.S. companies to sustain millions of jobs and develop life-saving treatments that benefit patients in every country, says former U.S. Circuit Judge Paul Michel, now at the Council for Innovation Promotion.
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Series
In The CFPB Playbook: Rulemaking Rush Before Election Year
In this quarterly Consumer Financial Protection Bureau activity recap by former bureau personnel, attorneys at McGuireWoods explain the regulator's recent push to finalize new rules about data aggregators, digital payment apps and more before the election-year Congressional Review Act window opens.
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What The Law Firm Of The Future Will Look Like
As the legal landscape shifts, it’s become increasingly clear that the BigLaw business model must adapt in four key ways to remain viable, from fostering workplace flexibility to embracing technology, say Kevin Henderson and Eric Pacifici at SMB Law Group.
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4 PR Pointers When Your Case Is In The News
Media coverage of new lawsuits exploded last year, demonstrating why defense attorneys should devise a public relations plan that complements their legal strategy, incorporating several objectives to balance ethical obligations and advocacy, say Nathan Burchfiel at Pinkston and Ryan June at Castañeda + Heidelman.
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Digging Into The Debate On FDA's Proposed Lab Test Rule
A proposed 10-word amendment from the U.S. Food and Drug Administration represents a sea change in device regulation as it would summarily end decades of FDA enforcement discretion for laboratory developed tests, and the public comments offer some insight into the future of this long-running saga, say attorneys at Mintz.
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Opinion
What Insurers Gain When Litigating Coverage Denials
Lately, insurance companies have denied coverage for lawsuits alleging liability relating to the ordinary operations of highly regulated businesses, such as those in the pharmaceutical and energy sectors — demonstrating time and again how litigation can be a vehicle for carriers to mitigate their own costs, say attorneys at Reed Smith.
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Law Firm Strategies For Successfully Navigating 2024 Trends
Though law firms face the dual challenge of external and internal pressures as they enter 2024, firms willing to pivot will be able to stand out by adapting to stakeholder needs and reimagining their infrastructure, says Shireen Hilal at Maior Consultants.
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10 Privacy Compliance Areas To Focus On In 2024
The fast pace of change in the cybersecurity realm means reactive approaches to new laws, regulations and enforcement actions are not effective ways to build or scale privacy programs, so companies should plan strategically and prepare for a few emerging risks and requirements in the first half of this year, says Sam Castic at Hintze Law.
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AI In Health Law: The Top Guest Articles Of 2023
As the use of artificial intelligence accelerated this year, Expert Analysis writers examined AI's significant impact on the healthcare sector, ranging from key compliance considerations for companies utilizing AI tools to regulators' efforts to keep up with rapidly evolving technologies.
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The Most-Read Legal Industry Law360 Guest Articles Of 2023
A range of legal industry topics drew readers' attention in Law360's Expert Analysis section this year, from associate retention strategies to ethical billing practices.
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Inside Higher Education's New FCA Liability Challenges
As the educational sector expands its use of government funding, schools are at increased risk under the False Claims Act, but recent settlements offer valuable lessons about new theories of liability they may face and specific procedures to reduce their exposure, say James Zelenay and Jeremy Ochsenbein at Gibson Dunn.
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AI Executive Order's Life Science, Healthcare Industry Effects
The recent White House executive order to manage risks associated with artificial intelligence includes provisions specific to healthcare and life sciences that merit special attention, including transparency, human oversight of AI output, and real world performance monitoring, say attorneys at Ropes & Gray.