Policy & Compliance

  • November 03, 2025

    Colorado Judge Denies AbbVie's Bid To Block State Drug Law

    A Colorado federal judge denied AbbVie Inc.'s bid for a preliminary injunction, which would have barred the state from enforcing its laws and penalties surrounding federal 340B drug pricing.

  • October 31, 2025

    Drugmakers Can't End States' Dermatology Price-Fixing Suits

    A Connecticut federal judge on Friday refused to throw out the vast majority of claims in a nationwide antitrust enforcement action accusing a long list of pharmaceutical companies of fixing the prices of generic dermatology drugs, rejecting the companies' argument that the claims were filed too late.

  • October 31, 2025

    Amgen Again Challenges Colo. Price Cap For Arthritis Drug

    Amgen has once again sued Colorado over its price cap for the arthritis drug Enbrel, claiming that the Centennial State's drug price-control statute violates the U.S. Constitution, conflicts with federal patent law and threatens patients' access to lifesaving medications.

  • October 31, 2025

    Hawaii Judge Declares FDA's Mifepristone Regs Unlawful

    The U.S. Food and Drug Administration failed to sufficiently justify restrictions on the abortion drug mifepristone, a Hawaii federal judge ruled in an order declaring the restrictions unlawful under the Administrative Procedure Act.

  • October 31, 2025

    Aetna Strikes $650K Deal In Lipedema Patients' Coverage Suit

    Aetna has agreed to pay up to $650,000 to resolve a class action claiming it unlawfully refused to cover liposuction for over two dozen patients with a rare condition called lipedema, according to a filing in California federal court.

  • October 31, 2025

    Garnet Health Inks $4.6M Deal In Retirement Fee, Fund Suit

    Garnet Health Medical Center has agreed to fork over $4.6 million to end a proposed class action alleging the New York healthcare network mismanaged employee retirement plan fees and investments, according to settlement documents filed by workers Friday in New York federal court.

  • October 31, 2025

    3 Argument Sessions Benefits Attys Should Watch In Nov.

    The Third Circuit will hear a union's appeal in a withdrawal liability battle, a union health plan defends its partial win in a coverage fight at the Ninth Circuit, and pharmacy benefit managers will take a challenge to the Federal Trade Commission's authority to the full Eighth Circuit. Here are three arguments to keep an eye on in November.

  • October 31, 2025

    NC Attorney General, HCA Duel Over Merger Commitments

    The North Carolina Attorney General's Office and HCA Healthcare have offered competing interpretations of a 2019 merger agreement in their efforts to secure a pretrial win in the state's compliance case involving the purchase of an Asheville hospital system.

  • October 30, 2025

    J&J's Janssen Says 3rd Circ. Should Reverse $1.6B FCA Win

    Johnson & Johnson's Janssen Products LP urged the Third Circuit to overturn a $1.6 billion False Claims Act judgment over two of its HIV drugs, arguing the district court allowed whistleblowers to prove fraud based solely on "off-label" marketing rather than any false claim actually submitted to the government.

  • October 30, 2025

    Generic-Drug Firms Want To Fast-Track Conn. Price Cap Fight

    An industry group for generic and biosimilar pharmaceutical companies has asked a Connecticut federal judge to fast-track its lawsuit seeking to block the state's new drug price cap, claiming it will suffer "imminent harm" if the case is delayed.

  • October 30, 2025

    Judge Unpauses 'Important' Suit Over Vax Guidelines

    A Massachusetts federal judge agreed Thursday to lift a government shutdown-related stay of litigation challenging new COVID-19 vaccine recommendations for children and pregnant women, calling the case a "matter of national importance" that warrants keeping the case moving over the U.S. Department of Justice's objection.

  • October 30, 2025

    Health Group Urges 1st Circ. To Deny FCA Suit Fee Challenge

    A Massachusetts health network has asked the First Circuit to deny a whistleblower's attempt to secure more attorney fees for a False Claims Act suit, arguing that a federal judge properly denied numerous claims for fees after a $2.5 million settlement.

  • October 30, 2025

    Surgical Co. Gets Tobacco Fee ERISA Suit Kicked To Texas

    A proposed class action alleging that a surgical center operator discriminated against workers who use tobacco by making them pay more for health coverage belongs in Texas, a Kentucky federal judge said, ruling that the business doesn't have enough connection to Kentucky.

  • October 29, 2025

    DOJ Subpoena Called 'Pressure' To Ax Gender-Affirming Care

    The U.S. Department of Justice issued a subpoena to intimidate a telehealth organization into ending gender-affirming medical care, a Seattle federal judge said in a ruling that found the agency is using the guise of an investigation to further the Trump administration's stated goal of eliminating transgender and gender-diverse patients' access to healthcare.

  • October 29, 2025

    Healthcare Workers Trade HCA For Subsidiaries In Wage Deal

    A respiratory therapist has reached a tentative deal in a proposed collective action against a healthcare facility operator accused of manipulating workers' time sheets to pay them less overtime wages, North Carolina federal court records show.

  • October 29, 2025

    FDA Unveils Plan To Speed Biosimilar Drugs To Market

    The Trump administration on Wednesday said it plans to slash the cost of biologics by shortening the time required to bring a biosimilar drug to market and making it easier for patients to switch to the cheaper products.

  • October 29, 2025

    3 Pharmaceutical Firms Will Pay $4M To Tribes In Opioid MDL

    Indivior, Sun Pharmaceuticals and Zydus Pharmaceuticals have inked deals to compensate tribes for their role in the opioid crisis, according to stipulated dismissals entered on Wednesday in Ohio federal court.

  • October 28, 2025

    Off-Label Prescribing Was Common, Novo Nordisk Tells Jury

    A whistleblower suing drugmaker Novo Nordisk for allegedly defrauding Washington state's Medicaid system acknowledged from the witness stand Tuesday that she previously prescribed hemophilia drugs for off-label use in her own practice — despite concerns she raised in her lawsuit about other doctors' off-label prescription of Novo Nordisk's drug NovoSeven.

  • October 28, 2025

    4 Emergency Medical Care Rulings You Don't Want To Miss

    Following a Michigan appellate court's recent finding that evidence brought in a wrongful death suit against paramedics was enough to get around immunity protections, Law360 Healthcare Authority looks at significant rulings affecting emergency medical care in 2025.

  • October 28, 2025

    Home Health Aide Says Cos. Shaved Time Off Pay

    Home health care companies failed to pay aides for the hours they worked by failing to properly calculate their overtime, while also having a "problematic clocking system" that led to time-shaving issues, a suit filed in New York federal court on Tuesday claims.

  • October 28, 2025

    High Court Medicaid Ruling Adds To Safety-Net Hospital Pain

    Earlier this year, U.S. Supreme Court Justice Ketanji Brown Jackson raised a warning about the future of the nation's safety-net hospitals in a case focused on "disproportionate share" Medicaid payments. Funding cuts at issue in the case are now hitting hospitals.

  • October 28, 2025

    Akin Beats Malpractice Claim Over Alleged IP Theft Plot

    A Third Circuit panel on Tuesday refused to revive a malpractice claim against Akin Gump Strauss Hauer & Feld LLP lodged in a lawsuit that accused attorneys of manipulating patent litigation to steal a former Cornell University graduate student's DNA sequencing intellectual property.

  • October 28, 2025

    HHS Can't Yet Yank Sex Ed Grants Over 'Gender Ideology' Info

    An Oregon federal judge has halted the U.S. Department of Health and Human Services' plans to revoke federal funding for teen sexual health education programs that included "gender ideology," agreeing with states that this is likely a case of executive overreach.

  • October 28, 2025

    4th Circ. Overturns Landmark W.Va. Opioid Verdict

    The Fourth Circuit on Tuesday overturned a key ruling by a West Virginia judge in the first federal bellwether in multidistrict opioid litigation that went in favor of the country's three biggest drug distributors, finding that the oversupply of opioids can create a public nuisance.

  • October 28, 2025

    Wash. Hospital System Can't Undo $230M Wage Suit Loss

    A hospital system can't undo a $230 million judgment against it because it didn't sufficiently counter evidence that its default rounding system was unlawful and assumed caregivers wouldn't take a second meal break, a Washington state appeals panel ruled.

Expert Analysis

  • How White Collar Attys Can Use Mythic Archetypes At Trial

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    A careful reading of a classic screenwriting guide shows that fairy tales and white collar trials actually have a lot in common, and defense attorneys would do well to tell a hero’s journey at trial, relying on universal character archetypes to connect with the jury, says Jack Sharman at Lightfoot Franklin.

  • What 2024 Election Means For Drugs, Medicare And Medicaid

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    With Republicans running the White House, U.S. House of Representatives and U.S. Senate, the incoming administration is likely to provide pathways — through new initiatives and others returning from Trump's previous presidency — for a range of potential changes to drug pricing, Medicare and Medicaid, say attorneys at Morgan Lewis.

  • Justices Mull Sex-Based Classification In Trans Law Case

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    After the U.S. Supreme Court heard oral argument in U.S. v. Skrmetti this week, it appears that the fate of the Tennessee law at the center of the case — a law banning gender-affirming healthcare for transgender adolescents — will hinge on whether the majority read the statute as imposing a sex-based classification, says Alexandra Crandall at Dickinson Wright.

  • Key Takeaways From FDA's Latest Social Media Warnings

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    The U.S. Food and Drug Administration's latest untitled letter concerning a drug company's social media promotion provides lessons for how companies should navigate risk presentation, FDA labeling requirements and superiority claims, say attorneys at Sheppard Mullin.

  • Rank-And-File DOJ Attorneys Will Keep Calm And Carry On

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    Career prosecutors at the U.S. Department of Justice often pride themselves on their ability to remain apolitical in order to ensure consistency and keep the department’s mission afloat, and the incoming Trump administration is unlikely to upend this tradition, says Michael Landman at Bird Marella.

  • Unpacking Arguments From High Court's Rural Hospital Case

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    During oral arguments in Advocate v. Becerra, the U.S. Supreme Court justices focused questions on the meaning of being "entitled to" supplementary security income assistance, and there's reason for optimism that the likely split decision will break in favor of hospitals, say attorneys at King & Spalding.

  • Health Policy Predictions For Trump's Second Administration

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    As President-elect Donald Trump's nominations for health policy and enforcement heads work their way through the confirmation process, healthcare organizations can look at nominee backgrounds, campaign statements and actions from Trump's previous presidency to predict incoming priorities, say attorneys at McDermott.

  • What Trump's Next Term May Mean For Biz Immigration

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    Leonard D'Arrigo at Harris Beach discusses the employment-based immigration policies businesses can potentially expect during President-elect Donald Trump’s second term, based on policies enacted during his first administration, statements made during his campaign and proposals in Project 2025.

  • Weak Reasoning Underlies Fla. Judge's Bold Qui Tam Ruling

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    U.S. District Judge Kathryn Mizelle's groundbreaking decision in U.S. ex rel. Zafirov v. Florida Medical Associates LLC, holding that qui tam provisions of the False Claims Act are unconstitutional, relies on weak logic to reach a conclusion that differs from every other court that has ruled on the issue, says Ethan Greenberg at Anderson Kill.

  • Medicare Overpayment Rules Are A Mixed Bag For Providers

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    The Centers for Medicare & Medicaid Services' updated rules for handling agency overpayments adopt a more reasonable definition of what it means to have "identified" an overpayment, which is a win for providers, but their new time frame for investigating related overpayments is unrealistic, says Susan Banks at Holland & Knight.

  • Expect More State-Level Scrutiny Of Noncompetes Ahead

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    Despite the nationwide injunction against the Federal Trade Commission’s noncompete ban, and the incoming Republican administration, employers should anticipate that state legislatures will continue to focus on laws that limit or ban noncompetes, including those that target certain salary thresholds or industries, says Benjamin Fryer at FordHarrison.

  • Cos. Should Inventory Issues To Prep For New Congress

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    As the legislative and oversight agendas of the 119th Congress come into sharper focus, corporate counsel should assess and plan for areas of potential oversight risk — from tax policy changes to supply chain integrity — even as much uncertainty remains, say attorneys at WilmerHale.

  • Incoming Admin May Shake Up Life Sciences Regulation

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    Though President-elect Donald Trump has not yet articulated policy priorities regarding the life sciences industry, the sector is positioned to see significant changes that could affect everything from drug exclusivity and generic drug approvals, to the availability of over-the-counter drugs, to laboratory-developed tests and digital health, say attorneys at Morgan Lewis.