Health

  • August 15, 2024

    Full 11th Circ. To Weigh Georgia Deputy's Trans Health Win

    The Eleventh Circuit agreed Thursday to a full-court rehearing of an appeal from Georgia county officials looking to overturn a deputy's win in her suit alleging a health plan coverage exclusion for gender-affirming surgery violated federal anti-discrimination law.

  • August 15, 2024

    Fake Prescription Caper Yields $10.2M Fine For Bankrupt Co.

    A Manhattan federal judge hit a defunct unit of bankrupt biotechnology concern DMK Pharmaceuticals Corp. with a $10.2 million fine Thursday, after the subsidiary admitted to criminally faking horse-drug prescriptions in a scheme that generated $4.2 million.

  • August 15, 2024

    NC Small Biz Challenges VA Bid Process For Prostate Drug

    A service-disabled veteran-owned small business in North Carolina is challenging the U.S. Department of Veterans Affairs' bid process for prostate medication, saying the terms unfairly favor foreign manufacturers despite purporting to prioritize American-made products.

  • August 15, 2024

    Okla. Says 10th Circ. PBM Ruling Defies High Court Precedent

    Oklahoma urged the U.S. Supreme Court to review a Tenth Circuit decision nullifying certain parts of a state law regulating pharmacy benefit managers, arguing the appeals court's ruling openly conflicts with sister circuits and previous high court rulings while pushing federal benefits law beyond its limits.

  • August 14, 2024

    ICE Faces Trimmed Suit Over Detainee's COVID-19 Death

    A California federal court on Tuesday again allowed U.S. Immigration and Customs Enforcement to trim a lawsuit alleging it failed to protect a man who died in detention but kept claims alleging ICE failed to oversee its facilities or protect the man from COVID-19.

  • August 14, 2024

    Doctor Loses Challenge To Nursing Home's Vax Policy

    A New Jersey federal judge on Wednesday tossed a CareOne doctor's challenge to the nursing home operator's COVID-19 vaccine mandate, saying she did not pass the Third Circuit's test for an exemption for failing to exhaust her administrative remedies.

  • August 14, 2024

    J&J Vision Unit Sues Ex-Marketing Exec Over Move To Rival

    Johnson & Johnson's vision unit sued a former marketing director on Tuesday, saying her move to a direct competitor is an "imminent threat of immediate, irreparable harm" and asking a New Jersey federal court to enforce her noncompete agreement and other post-employment obligations.

  • August 14, 2024

    HHS Eyes 2025 For New Medicare Appeal Rule

    In response to a Connecticut federal judge's stern demand for quicker progress, the U.S. Department of Health and Human Services has said in a court filing that it should be able to implement a new rule creating an avenue for Medicare beneficiaries to appeal their hospitalization status by Jan. 1.

  • August 14, 2024

    GSA Hit With Protest Over $985M Migrant Kid Transport Deal

    Trailboss Enterprises Inc. is protesting the General Services Administration's decision to award a $985.4 million transportation and logistics contract for unaccompanied children in federal custody to a competitor, saying it lost the contract because of a flawed selection process.

  • August 14, 2024

    NC Judge OKs $15.2M Deal For Medical Device Investors

    A North Carolina federal judge has given the first green light to a $15.25 million settlement that will resolve a securities class action claiming that Bioventus Inc. misled investors about its internal controls and financial health and its readiness to implement new Medicare regulations, leading to inflated stock prices.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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. 

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Expert Analysis

  • New OSHA Memo Helps Clarify Recordkeeping Compliance

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    Based on recent Occupational Safety and Health Administration guidance on whether musculoskeletal disorders are recordable injuries under the agency's recordkeeping regulation, it appears that OSHA may target active release techniques and stretching programs during its inspections, say attorneys at Morgan Lewis.

  • 2 Regulatory Approaches To Psychedelic Clinical Trials

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    Comparing the U.S. and Canada's regulatory frameworks for clinical trials of psychedelic drugs can be useful for designing trial protocols that meet both countries' requirements, which can in turn help diversify patient populations, bolster data robustness and expedite market access, say Kimberly Chew at Husch Blackwell and Sabrina Ramkellawan at AxialBridge.

  • Series

    Fishing Makes Me A Better Lawyer

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    Atop the list of ways fishing makes me a better lawyer is the relief it offers from the chronic stress of a demanding caseload, but it has also improved my listening skills and patience, and has served as an exceptional setting for building earnest relationships, says Steven DeGeorge​​​​​​​ at Robinson Bradshaw.

  • A Healthier Legal Industry Starts With Emotional Intelligence

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    The legal profession has long been plagued by high rates of mental health issues, in part due to attorneys’ early training and broader societal stereotypes — but developing one’s emotional intelligence is one way to foster positive change, collectively and individually, says attorney Esperanza Franco.

  • To Make Your Legal Writing Clear, Emulate A Master Chef

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    To deliver clear and effective written advocacy, lawyers should follow the model of a fine dining chef — seasoning a foundation of pure facts with punchy descriptors, spicing it up with analogies, refining the recipe and trimming the fat — thus catering to a sophisticated audience of decision-makers, says Reuben Guttman at Guttman Buschner.

  • Circuit Judge Writes An Opinion, AI Helps: What Now?

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    Last week's Eleventh Circuit opinion in Snell v. United Specialty Insurance, notable for a concurrence outlining the use of artificial intelligence to evaluate a term's common meaning, is hopefully the first step toward developing a coherent basis for the judiciary's generative AI use, says David Zaslowsky at Baker McKenzie.

  • 'Food As Health' Serves Up Fresh Legal Considerations

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    The growth of food as medicine presents a significant opportunity for healthcare organizations and nontraditional healthcare players to improve patient outcomes and reduce costs, though these innovative programs also bring compliance considerations that must be carefully navigated, say attorneys at McDermott.

  • DC Circ. Ruling Heightens HHS Contract Pharmacy Challenges

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    The D.C. Circuit's recent ruling that the Section 340B program does not bar manufacturers from restricting deliveries of discounted drugs to contract pharmacies represents a second strike against the U.S. Department of Health and Human Services' current contract pharmacy policy and raises the stakes surrounding an upcoming Seventh Circuit ruling on the same issue, say attorneys at Foley Hoag.

  • FTC Theories Of Harm After Anesthesia Co. Ruling

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    As Federal Trade Commission litigation against U.S. Anesthesia Partners proceeds following a Texas federal court's recent decision to dismiss a private equity sponsor from the suit, the case attempts to incorporate and advance some of the commission's theories of competitive harm from the final 2023 Merger Guidelines, say attorneys at Mintz.

  • 9th Circ. COVID 'Cure' Case Shows Perks Of Puffery Defense

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    The Ninth Circuit's March decision in a case surrounding a company's statements about a potential COVID-19 cure may encourage defendants to assert puffery defenses in securities fraud cases, particularly in those involving optimistic statements about breakthrough drugs that are still untested, say attorneys at Cahill Gordon.

  • FTC Focus: Exploring The Meaning Of Orange Book Letters

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    The Federal Trade Commission recently announced an expansion of its campaign to promote competition by targeting pharmaceutical manufacturers' improper Orange Book patent listings, but there is a question of whether and how this helps generic entrants, say Colin Kass and David Munkittrick at Proskauer.

  • Investors Can Aid In The Acceptance Of Psychedelic Medicine

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    Psychedelic medicine is ready to have its breakthrough moment, and although it still faces political, legal and communications challenges, private equity investors can play a significant role in changing the public perception on psychedelics from taboo to acceptance, say Kimberly Chew at Husch Blackwell, Charlie Panfil at the Daschle Group and Ethan Lutz at FTI Consulting.

  • Class Actions At The Circuit Courts: May Lessons

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    In this month's review of class action appeals, Mitchell Engel at Shook Hardy discusses four notable circuit court decisions on topics from automobile insurance to securities — and provides key takeaways for counsel on issues including circuit-specific ascertainability requirements and how to conduct a Daubert analysis prior to class certification.

  • Perspectives

    Trauma-Informed Legal Approaches For Pro Bono Attorneys

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    As National Trauma Awareness Month ends, pro bono attorneys should nevertheless continue to acknowledge the mental and physical effects of trauma, allowing them to better represent clients, and protect themselves from compassion fatigue and burnout, say Katherine Cronin at Stinson and Katharine Manning at Blackbird.

  • Series

    Playing Music Makes Me A Better Lawyer

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    My deep and passionate involvement in playing, writing and producing music equipped me with skills — like creativity, improvisation and problem-solving — that contribute to the success of my legal career, says attorney Kenneth Greene.

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