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Health
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August 14, 2024
Grassley Asks HHS For Clarity On Cannabis Position
Sen. Chuck Grassley has asked federal health officials to clarify their position on marijuana, arguing that a recent U.S. Department of Health and Human Services report is at odds with its recommendation to loosen restrictions on the drug.
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August 14, 2024
Florida AG Can't Nix Hospitals', School Boards' Opioid Claims
A Florida state appeals court on Wednesday reversed a trial court's order allowing the state's attorney general to wipe out a group of suits by hospitals and school boards in opioid litigation, holding that she doesn't have the authority to release their claims without their consent.
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August 14, 2024
Novartis' $45B Biz Can Survive If Generic Debuts, Judge Says
A D.C. federal judge told Novartis to stop acting like it would be destroyed financially by having a generic version of its best-selling drug Entresto enter the market, saying the drugmaker will be fine if it loses $3 billion in U.S. sales out of its $45 billion global revenue.
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August 14, 2024
6th Circ. Backs Ohio Dept. In Ex-Auditor's Disability Bias Suit
The Sixth Circuit upheld an Ohio state health department's win over a former auditor's lawsuit alleging she was fired for requesting a schedule adjustment because of her depression and anxiety, saying Wednesday that the worker refused to engage in conversations that could've identified a suitable accommodation.
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August 14, 2024
Hospital Groups Tell High Court HHS 'Stingy' In SSI Pay Row
Six of the nation's leading hospital associations told the Supreme Court on Wednesday that the U.S. Department of Health and Human Services is being "stingy" when miscalculating a formula that could cost hospitals treating low-income patients more than a billion dollars in special payments each year.
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August 14, 2024
Texas Sues HHS Over 'Arbitrary' Nursing Home Staffing Rule
The state of Texas on Wednesday challenged a new federal rule that sets minimum staffing standards at nursing homes, contending the Biden administration overstepped its statutory authority and crafted a rule almost impossible to meet because of nursing shortages.
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August 14, 2024
HHS Calls For More Research, Planning To Combat Heat Risks
Citing a sharp increase in deaths from extreme heat, the Biden administration unveiled a national strategy Wednesday that calls for better communicating the health risks of hot weather to the public and taking other steps to protect people from life-threatening heat waves.
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August 14, 2024
Nursing Co. Exec Can't Split Up Fraud, Wage-Fixing Charges
A Nevada federal magistrate judge has struck two blows against a home healthcare staffing executive facing criminal charges of fixing nurses' wages and hiding that probe when selling the business for $12.5 million, as the judge refused to break up the allegations and recommended against dismissing the fraud counts.
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August 14, 2024
Samsung Biotech Unit Hit With Patent Suit Over Bone Drugs
The pharmaceutical giant Amgen Inc. is fighting a bid by a South Korean rival to sell biosimilar versions of its highly popular bone drugs Prolia and Xgeva, telling a New Jersey federal court that the proposed medications will infringe 34 patents.
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August 14, 2024
1st Circ. Revives Vax Refusal Suit Against Beth Israel
The First Circuit on Tuesday revived a suit against health facility system Beth Israel Lahey Health Inc. from an office manager who was fired over her refusal to be vaccinated against COVID-19, disagreeing with a lower court that said she hadn't shown a genuine religious belief meriting a vaccine exemption.
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August 14, 2024
Surgeon Keeps Win In 'Hyperkinetic' Gallbladder Surgery Suit
A Virginia appeals panel won't revive a man's medical malpractice claims against his surgeon over complications from surgery to remove his "hyperkinetic" gallbladder, rejecting his argument that the surgeon was wrongly allowed to present evidence about the condition.
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August 14, 2024
K&L Gates Hires 340B Health Counsel In DC
K&L Gates LLP's newest healthcare counsel, Amanda Smith, has never worked at a private practice law firm until now.
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August 13, 2024
Anesthesia Co. Says FTC Lacks Authority To Bring 'Rollup' Suit
U.S. Anesthesia Partners has told the Fifth Circuit the Federal Trade Commission lacks authority to bring its case directly in federal court without also filing an administrative case accusing the group of monopolizing the Texas anesthesiology market.
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August 13, 2024
Judge Urged To Toss Novel Insider Trading Conviction
Former Ontrak CEO Terren Peizer has moved to rid himself of a first-of-its-kind insider trading conviction, arguing that the government's case "watered down" the standard it had to prove by failing to demonstrate that he believed Ontrak was about to lose its biggest customer at the time he shed $20 million in stock.
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August 13, 2024
Entresto Release Delayed As Novartis Goes To Fed. Circ.
A Delaware federal judge said Monday that Novartis is unlikely to prove that it's entitled to an injunction that would block MSN Pharmaceuticals from launching a generic version of its top-selling drug Entresto, but stayed the generic release briefly so Novartis could appeal to the Federal Circuit.
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August 13, 2024
9th Circ. Reverses Order Sending Insulin Suit To State Court
The Ninth Circuit on Tuesday sided with CVS Caremark and Express Scripts, ruling that a lower court erred in 2023 when it agreed to send California's allegations of inflated insulin prices back to state court.
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August 13, 2024
Ga. Court Ropes Hospital Back Into Patient Death Suit
A Georgia appeals court reinstated Tuesday a suit accusing a hospital of failing to properly treat an unstable patient and instead taking her home to be left alone, which allegedly caused her death, saying an allegation of failure to screen a patient didn't require a medical expert's report.
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August 13, 2024
Former In-House Atty Says Healthcare Co. Can't Duck Suit
A onetime assistant general counsel for Panoramic Health told a Colorado federal judge on Tuesday that her former employer could not escape the wrongful-termination suit she filed in May, arguing that a bid to dismiss the case must fail because she had plausibly alleged that her firing was a result of having reported compliance issues.
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August 13, 2024
Gene Tech Co. Execs Pilfered Biz Amid Collapse, Suit Says
The senior lender to Sequencing Health Inc. has sued former officers and directors of the now-defunct genomic science company, alleging they squandered the company's assets, awarded themselves big bonuses and shut down the business, costing Oxford tens of millions of dollars in losses.
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August 13, 2024
Wash. Social Media Ban Violates Workers' Free Speech
The Washington State Court of Appeals has said a state law barring injured workers from posting videos of their state workers' compensation medical exams on social media is an unconstitutional violation of free speech rights.
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August 13, 2024
Mother Can't Revive Suit Against GE For Child's Brain Damage
A Pennsylvania appeals panel won't reinstate a mother's suit against General Electric Co. and subsidiary Datex-Ohmeda Inc. alleging that a faulty anesthesia machine caused her child permanent brain damage, finding the trial court rightly found that the state doesn't have jurisdiction over the claims.
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August 13, 2024
Spinal Implant Patents Verdict Must Stand, Pa. Judge Says
A Pennsylvania federal judge declined to order a new trial Tuesday in a patent infringement suit brought against medical device maker Globus Medical Inc., ruling that the jury verdict in the company's favor had sufficient evidentiary support and that the jurors did not seem confused by the law at issue.
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August 13, 2024
NC Lawmakers Ask 4th Circ. To Restore Abortion Drug Limits
North Carolina Republican lawmakers want the Fourth Circuit to reinstate restrictions on the abortion drug mifepristone, telling the court the new rules concerning the medication are not preempted by U.S. Food and Drug Administration regulations.
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August 13, 2024
NY, NJ And Conn. Score $4.5M Penalty Over Enzo Data Breach
Molecular diagnostics company Enzo Biochem Inc. has agreed to pay a $4.5 million penalty after an investigation found that the company failed to implement recommended security protocols ahead of a data breach that affected millions of patients, New York's attorney general announced Tuesday.
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August 13, 2024
Ga. Justices To Weigh Arbitrator's Closed-Door Discussions
The Georgia Supreme Court on Tuesday agreed to weigh if an arbitrator's ex parte communications with BioTek Services LLC in an allergy testing payment dispute warranted vacating BioTek's $1.7 million arbitration award over compensation for its testing of patients from Docs of CT LLC.
Expert Analysis
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Opinion
States Should Loosen Law Firm Ownership Restrictions
Despite growing buzz, normalized nonlawyer ownership of law firms is a distant prospect, so the legal community should focus first on liberalizing state restrictions on attorney and firm purchases of practices, which would bolster succession planning and improve access to justice, says Michael Di Gennaro at The Law Practice Exchange.
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Navigating FDA Supply Rule Leeway For Small Dispensers
As the November compliance deadline for the U.S. Food and Drug Administration's new pharmaceutical distribution supply chain rules draws closer, small dispensers should understand the narrow flexibilities that are available, and the questions to consider before taking advantage of them, say attorneys at Faegre Drinker.
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Series
Solving Puzzles Makes Me A Better Lawyer
Tackling daily puzzles — like Wordle, KenKen and Connections — has bolstered my intellectual property litigation practice by helping me to exercise different mental skills, acknowledge minor but important details, and build and reinforce good habits, says Roy Wepner at Kaplan Breyer.
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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.