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Health
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August 20, 2024
Fed Circ. Finds No Fault In Denial Of Flu Vaccine Claim
The Federal Circuit on Tuesday affirmed the denial of a family's petition for compensation alleging their child developed narcolepsy as a result of the FluMist vaccine, saying the special master's determination that the family hasn't properly established the link was not arbitrary.
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August 20, 2024
Colorado County Says Aetna Owes $1.1M In Rebates
Aetna Life Insurance Co. is withholding more than $1 million in pharmacy rebates from a Colorado county under an inapplicable early termination clause after local leaders switched to United Healthcare for health insurance services in 2023, according to a federal lawsuit.
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August 20, 2024
Vax Patent Battles Heat Up As Attention On Pandemic Wanes
It's been over four years since clinical trials began for COVID-19 vaccines, and while the shots have helped the pandemic recede, the lucrative technology has spurred numerous patent suits, many of which are still in the early stages. Here's a look at some of the key cases in the U.S.
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August 20, 2024
FTC Endorses Push For Broader Access To Biosimilar Drugs
The Federal Trade Commission is backing a proposal that would make it easier for drugmakers to show biosimilar medicines are safe substitutes for their more expensive counterparts, a move the agency says would boost competition and reduce confusion.
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August 20, 2024
Pathology Trade Group 2nd To Sue FDA Over Lab-Test Rule
A molecular pathology trade group has filed a lawsuit against the U.S. Food and Drug Administration, challenging a recent final rule to regulate laboratory-developed tests as medical devices and arguing the agency has abused its power — the second such case filed in recent months.
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August 20, 2024
'Full Steam Ahead' For Pandemic IG Despite Sunset Fear
A pandemic watchdog office is poised to shutter in seven months — its pleas for an extension have gone unheeded. But in the meantime, its remaining employees, some working away in their nondescript Alexandria, Virginia, office, others from their homes, are hustling to recover millions of dollars from COVID-19 fraudsters.
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August 20, 2024
A Deep Dive Into Law360 Pulse's 2024 Women In Law Report
The legal industry continues to see incremental gains for female lawyers in private practice in the U.S., according to a Law360 Pulse analysis, with women now representing 40.6% of all attorneys and 51% of all associates.
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August 20, 2024
These Firms Have The Most Women In Equity Partnerships
The legal industry still has a long way to go before it can achieve gender parity at its upper levels. But these law firms are performing better than others in breaking the proverbial glass ceiling that prevents women from attaining leadership roles.
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August 20, 2024
Catching Up With Delaware's Chancery Court
A nearly record-breaking attorney fee got the nod in Delaware last week, along with Chancery Court settlements involving an international private jet service and a chain of trampoline parks. New disputes involved a famous burger restaurant chain, a computer-chip maker, a now-defunct genomic science company, and a historic manor house in west London.
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August 20, 2024
Philadelphia, Insurer Settle Trans Firefighter's Surgery Suit
The city of Philadelphia, Independence Blue Cross and a firefighters union agreed to settle a transgender firefighter's suit claiming she was unlawfully denied coverage for facial feminization surgery, just weeks after a Pennsylvania federal judge refused to let the insurer out of the case.
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August 20, 2024
J&J Boosting Cardio Portfolio With Up To $1.7B V-Wave Buy
Johnson & Johnson said Tuesday it has agreed to acquire V-Wave Ltd., the maker of an implant device that aims to treat heart failure, for up to $1.7 billion as it looks to bolster its cardiovascular disease portfolio.
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August 19, 2024
TPG Dumped Opioid Co. On 'Unsuspecting' Endo, Suit Says
After pushing Par Pharmaceutical to grow its market share in generic opioids and disregard federal requirements to report suspicious orders, TPG Capital saw other opioid manufacturers being inundated with litigation and sold Par to "an unsuspecting" Endo International PLC, according to a lawsuit filed in New York bankruptcy court.
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August 19, 2024
Biogen Paid To Help Curb Generic Tecfidera Sales, Says Suit
Biogen illegally impaired competition for its multiple sclerosis drug Tecfidera by paying major pharmacy benefit managers to prioritize the brand over generics while it worked to shift the market to a different version of the medication, a multi-employer welfare plan alleged Friday.
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August 19, 2024
Hospital Says NLRB Injunction Bid Relies On Disputed Facts
A National Labor Relations Board official's request for an injunction compelling a Michigan hospital to resume recognizing a Service Employees International Union affiliate is short on uncontested facts and heavy on pressure to adopt the official's findings, the hospital argued Monday, urging a federal judge to deny the request.
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August 19, 2024
Ore. Jury Awards $25M For Surgery Death, Clears Gastro Doc
A state court jury in Portland, Oregon, has awarded more than $24.6 million to the family of a colonoscopy patient who died, holding a healthcare provider group 40% responsible and an anesthesiologist 60% responsible, while saying the gastroenterologist who performed the procedure bore no fault.
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August 19, 2024
9th Circ. Told Psilocybin Petition Is Backed By Precedent
A Ninth Circuit panel on Monday dissected opposing arguments from the U.S. Drug Enforcement Administration and a Seattle doctor over whether there is precedent to allow the dispensing of psilocybin — a psychedelic compound — to treat terminally ill patients.
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August 19, 2024
9th Circ. Agrees Nursing Home Must Pay Fees In COVID Case
The Ninth Circuit has ruled that a nursing home must pay plaintiffs' legal fees in an appeal over the remand of a suit accusing it of causing two dozen patients' COVID-19 deaths, saying the home knew the court had already issued a precedential ruling on the issue.
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August 19, 2024
MOVEit MDL Judge's Call For Order Met With Atty Squabbles
A federal judge's effort to streamline multidistrict litigation over a 2023 data breach involving Progress Software's MOVEit file transfer tool instead led to a lengthy and contentious joint filing in which the parties accused one another of gamesmanship.
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August 19, 2024
Chancery Resets Del. Hearing In Masimo-Politan Proxy Battle
Pointing to "very significant stockholder franchise issues at play" and a dwindling Masimo Corp. stockholder vote countdown, a Delaware vice chancellor on Monday scheduled a Sept. 13 hearing on Politan Capital Management LP challenges to Masimo's actions in the run-up to the contested Sept. 19 vote.
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August 19, 2024
Canadian Court Won't Yet Enforce $140M Hospital Award
Webuild SpA has told a Delaware federal court of a Canadian court's decision to wait on enforcing a $140 million arbitral award related to a Chilean hospital project, saying it is relevant to Webuild's bid in Delaware to dismiss a petition seeking to confirm the same award.
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August 19, 2024
4th Circ. Cuts Liberty Loose In Medicare Reimbursement Row
A North Carolina widow can't revive a proposed class action accusing Liberty Mutual of failing to reimburse Medicare for her deceased husband's medical costs, the Fourth Circuit said Monday, finding she wasn't injured and therefore lacked standing to sue.
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August 19, 2024
UnitedHealthcare Says Humana Can't Access Its Records
UnitedHealthcare has asked the Texas high court to review a decision requiring it to turn over Medicare plan documents for the state's teachers to a competing insurer, arguing that recent updates to the Public Information Act were too broadly interpreted by a lower appellate court.
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August 19, 2024
Philly To Pay $25M For Breaking Prison Conditions Settlement
A federal judge has ordered Philadelphia to set aside $25 million to ramp up recruitment and retention efforts for the city's Department of Prisons, just over a month after the court found the city in contempt of a settlement in a lawsuit over prison conditions.
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August 19, 2024
Second Pharmacist To Avoid Meningitis Murder Trial
A pharmacist charged with murder in a deadly fungal meningitis outbreak that killed dozens of people is expected to plead no contest to involuntary manslaughter charges this week, averting a Michigan trial that had been set for November.
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August 19, 2024
NIH Program To Use Tribal Research To Combat Opioid Crisis
The National Institutes of Health is investing $268 million over the next seven years in a program that will employ Indigenous research methods to help combat opioid use and the overdose crisis plaguing Indian Country with an additional focus on pain management and mental health and wellness.
Expert Analysis
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1st Gender Care Ban Provides Context For High Court Case
The history of Arkansas' ban on gender-affirming medical care — the first such legislation in the U.S. — provides important insight into the far-reaching ramifications that the U.S. Supreme Court's decision in U.S. v. Skrmetti next term will have on transgender healthcare, says Tyler Saenz at Baker Donelson.
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Texas Ethics Opinion Flags Hazards Of Unauthorized Practice
The Texas Professional Ethics Committee's recently issued proposed opinion finding that in-house counsel providing legal services to the company's clients constitutes the unauthorized practice of law is a valuable clarification given that a UPL violation — a misdemeanor in most states — carries high stakes, say Hilary Gerzhoy and Julienne Pasichow at HWG.
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6 Lessons From DOJ's 1st Controlled Drug Case In Telehealth
Following the U.S. Department of Justice’s first-ever criminal prosecution over telehealth-prescribed controlled substances in U.S. v. Ruthia He, healthcare providers should be mindful of the risks associated with restricting the physician-patient relationship when crafting new business models, says Jonathan Porter at Husch Blackwell.
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Series
After Chevron: Scale Tips Favor Away From HHS Agencies
The loss of Chevron deference may indirectly aid parties in challenging the U.S. Department of Health and Human Services' interpretations of regulations and could immediately influence several pending cases challenging HHS on technical questions and agency authority, say attorneys at Ropes & Gray.
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Series
After Chevron: FDA Regulations In The Crosshairs
The U.S. Supreme Court's overturning of the Chevron doctrine is likely to unleash an array of challenges against the U.S. Food and Drug Administration, focusing on areas of potential overreach such as the FDA's authority under the Federal Food, Drug and Cosmetic Act, say attorneys at Debevoise.
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In Memoriam: The Modern Administrative State
On June 28, the modern administrative state, where courts deferred to agency interpretations of ambiguous statutes, died when the U.S. Supreme Court overruled its previous decision in Chevron v. Natural Resources Defense Council — but it is survived by many cases decided under the Chevron framework, say Joseph Schaeffer and Jessica Deyoe at Babst Calland.
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Series
After Chevron: Expect Limited Changes In USPTO Rulemaking
The U.S. Supreme Court’s recent ruling overturning Chevron deference will have limited consequences for the U.S. Patent and Trademark Office given the USPTO's unique statutory features, but it is still an important decision for matters of statutory interpretation, especially those involving provisions of the America Invents Act, say Andrei Iancu and Cooper Godfrey at Sullivan & Cromwell.
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How High Court Approached Time Limit On Reg Challenges
The U.S. Supreme Court's decision in Corner Post v. Federal Reserve Board effectively gives new entities their own personal statute of limitations to challenge rules and regulations, and Justice Brett Kavanaugh's concurrence may portend the court's view that those entities do not need to be directly regulated, say attorneys at Snell & Wilmer.
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How To Clean Up Your Generative AI-Produced Legal Drafts
As law firms increasingly rely on generative artificial intelligence tools to produce legal text, attorneys should be on guard for the overuse of cohesive devices in initial drafts, and consider a few editing pointers to clean up AI’s repetitive and choppy outputs, says Ivy Grey at WordRake.
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Calif. Ruling Heightens Medical Product Maker Liability
The California Supreme Court's decision in Himes v. Somatics last month articulates a new causation standard for medical product manufacturer liability that may lead to stronger product disclosures nationwide and greater friction between manufacturers and physicians, say attorneys at Cooley.
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Constitutional Protections For Cannabis Companies Are Hazy
Cannabis businesses are subject to federal enforcement and tax, but often without the benefit of constitutional protections — and the entanglement of state and federal law and conflicting judicial opinions are creating confusion in the space, says Amber Lengacher at Purple Circle.
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Series
Boxing Makes Me A Better Lawyer
Boxing has influenced my legal work by enabling me to confidently hone the skills I've learned from the sport, like the ability to remain calm under pressure, evaluate an opponent's weaknesses and recognize when to seize an important opportunity, says Kirsten Soto at Clyde & Co.
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Opinion
Industry Self-Regulation Will Shine Post-Chevron
The U.S. Supreme Court's Loper decision will shape the contours of industry self-regulation in the years to come, providing opportunities for this often-misunderstood practice, says Eric Reicin at BBB National Programs.
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3 Ways Agencies Will Keep Making Law After Chevron
The U.S. Supreme Court clearly thinks it has done something big in overturning the Chevron precedent that had given deference to agencies' statutory interpretations, but regulated parties have to consider how agencies retain significant power to shape the law and its meaning, say attorneys at K&L Gates.
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Roundup
After Chevron
In the month since the U.S. Supreme Court overturned the Chevron deference standard, this Expert Analysis series has featured attorneys discussing the potential impact across 26 different rulemaking and litigation areas.