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Policy & Compliance

  • May 12, 2025

    Fla. Pharmacy Beats Novo Nordisk Suit Over Ozempic 'Copies'

    A Florida federal judge on Monday granted a compounding pharmacy a win in Novo Nordisk Inc.'s suit claiming it violated a state statute by selling "essentially copies" of Novo Nordisk's blockbuster Ozempic and Wegovy weight loss drugs, ruling that the claims are moot, preempted and nonviable.

  • May 12, 2025

    20 AGs Suing HHS Move to Halt Cuts At 4 Affected Agencies

    States challenging the Trump administration's plans for massive cuts to the U.S. Department of Health and Human Services are asking a Rhode Island federal court to block any planned terminations at four of the department's agencies and programs.

  • May 12, 2025

    Will Justices Finally Rein In Universal Injunctions?

    The U.S. Supreme Court is expected to address for the first time Thursday the propriety of universal injunctions, a tool federal judges have increasingly used to broadly halt presidential orders and policy initiatives, and whose validity has haunted the high court's merits and emergency dockets for more than a decade.

  • May 12, 2025

    Agencies Win Stay Of Mental Health Parity Rule Suit

    A D.C. federal court on Monday agreed to stay a suit from a benefits-focused employer trade group seeking to block a recently finalized mental health parity rule, after the DOL and other federal agencies told the court they plan to rescind or modify the rule.

  • May 12, 2025

    King & Spalding Taps Fresenius Medical Care Leader In DC

    King & Spalding LLP has rehired Patrick Murphy, a life sciences and healthcare regulatory compliance attorney, who told ¼«ËÙÈü³µ Pulse in an interview on Monday that he never lost contact with his former colleagues even after spending a quarter-century working as an in-house attorney.

  • May 09, 2025

    CFPB's Vought Set To Ditch Dozens Of Guidance Docs

    The Consumer Financial Protection Bureau's acting Director Russell Vought is withdrawing dozens of the agency's interpretive rules, policy statements and other guidance documents dating back to 2011, according to a Federal Register draft notice filed Friday.

  • May 08, 2025

    Panel Says Colo. Hospitals Need Notice Of Retaliation Claims

    A Colorado appeals court on Thursday sided with a Denver health system in a precedential ruling, finding healthcare workers who sue public hospitals under a state anti-retaliation statute must warn hospitals about their claims.

  • May 08, 2025

    Albertsons Says Counties Have 'Paradoxical Status' In MDL

    A group of pharmacies led by Albertsons Cos. Inc. have told the Texas Supreme Court that two counties can't assert claims against them in the state's opioid multidistrict litigation while simultaneously denying they qualify as claimants.

  • May 08, 2025

    3rd Circ. Rejects Challenge To Medicare Drug Price Program

    The Third Circuit on Thursday rejected AstraZeneca's challenge to the Medicare drug price negotiation program, ruling that the pharmaceutical giant was unable to show how it is injured by the program's guidance or how it violates its due process rights.

  • May 08, 2025

    Judge Asks DOJ To Define DEI In Health Grant Case

    A Massachusetts federal judge on Thursday ordered U.S. Department of Justice lawyers to provide the Trump administration's definitions of diversity, equity and inclusion, saying he needs to know so he can consider whether that is a valid basis for pausing federal health research grants.

  • May 08, 2025

    Conn. High Court Snapshot: Rehab Permit And Towing Tiff

    The Connecticut Supreme Court, in its upcoming term, will consider whether an existing substance abuse treatment center has the right to challenge the opening of a competitor nearby, and determine if a murder suspect is owed a new trial over an allegedly botched jury poll.

  • May 08, 2025

    5th Circ. Says Late Filing Dooms Fired Worker's Vax Bias Suit

    The Fifth Circuit declined to revive an ex-Texas Children's Hospital worker's bias suit claiming she was fired for seeking a religious exemption to its COVID-19 vaccination requirement, rejecting her argument that a lost password excused missing a deadline to file the case.

  • May 07, 2025

    Ga. Panel Weighs New Trial In EMT Negligence Suit

    The Georgia Court of Appeals on Wednesday considered whether to order a new trial in a man's lawsuit alleging an EMT negligently administered fentanyl to his mother after she fell out of a window, causing her heart to stop.

  • May 06, 2025

    New Suits Target HHS Cuts, PBM Rates And Med. Device Regs

    The Trump administration is facing a wave of new allegations over its restructuring of the Department of Health and Human Services, with state attorneys general, local governments, labor groups and nonprofits alleging in recent days that the cuts exceed executive authority.

  • May 06, 2025

    Fed Lawmakers Demand Halt On Cuts Affecting Tribal Health

    A bipartisan group of U.S. senators is urging U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. to halt any further actions that would affect tribal healthcare and to ensure necessary resources and staffing to fully deliver services for American Indians and Alaska Natives.

  • May 06, 2025

    What's Ahead For FDA Enforcement: 3 Things To Watch

    Companies regulated by the FDA should remain vigilant and expect scrutiny under the new Trump administration, not just from the agency itself but also from DOJ officials, the plaintiffs bar and others, attorneys at a boutique firm say.

  • May 06, 2025

    Battle Brewing In Michigan Over Nurse Practice Expansion Bill

    Facing a doctor shortage, Michigan lawmakers are considering a bill that would allow nurse practitioners to treat patients without oversight from a licensed doctor. The effort is already receiving pushback from the state's medical board.

  • May 06, 2025

    UBH Can't Escape Residential Treatment Coverage Suit

    United Behavioral Health can't dodge a proposed class action claiming it used restrictive guidelines and bundled reimbursement requests to deny claims for residential mental health treatment, with a California federal judge saying plan participants' allegations were detailed enough to stay in court.

  • May 06, 2025

    How A Small Pa. Firm Defended A Huge Fraud Case

    When attorneys at Grail Law took on representation of one of three defendants facing trial for their purported roles in a $22 million healthcare fraud, the team knew it was up against the federal government's robust resources, and in a case that had already netted a string of guilty pleas.

  • May 06, 2025

    Buchanan Adds Senate Health Policy Vet To Gov't Practice

    Buchanan Ingersoll & Rooney PC has hired the majority staff director of the U.S. Senate's Health, Education, Labor and Pensions Committee who aided Republican lawmakers, including its chair, Sen. Bill Cassidy, in advancing health policy legislation.

  • May 06, 2025

    Trump Orders FDA To Speed Up Drug Plant Approvals

    President Donald Trump directed the U.S. Food and Drug Administration to cut the approval timelines for new manufacturing facilities by domestic drugmakers and also to pressure foreign drugmakers to comply with quality control inspections, according to a recent executive order.

  • May 06, 2025

    Ind. Hospital Merger Hits 'Public Advantage' Law Roadblock

    Opposition from Indiana's top law enforcement official to the combination of Terre Haute's only two hospitals could spell the end to the hotly contested deal.

  • May 06, 2025

    New AG, Same DOJ Stance On Whistleblower Law

    The Trump administration's forceful defense of the qui tam provisions of the False Claims Act is significant but not surprising, given the government's increasing reliance on whistleblowers to thwart fraud and abuse.

  • May 05, 2025

    Columbia Inks $750M Settlement Over OB-GYN Sex Abuse

    A New York state court on Monday signed off on a $750 million settlement secured by hundreds of patients who say they were sexually abused by a former Columbia University obstetrician-gynecologist, according to an announcement by the patients' attorneys.

  • May 05, 2025

    DC Circ. Has Doubts About Narcolepsy Drug Appeal

    The D.C. Circuit is now set to decide whether the U.S. Food and Drug Administration was wrong to declare a rival narcolepsy treatment not the "same drug" as another produced by Jazz Pharmaceuticals Inc., after appearing highly skeptical of the drug company's arguments that it was.

Expert Analysis

  • Top 10 Whistleblowing And Retaliation Events Of 2024

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    From a Florida federal court’s ruling that the False Claims Act’s qui tam provision is unconstitutional to a record-breaking number of whistleblower tips filed with the U.S. Commodity Futures Trading Commission, employers saw significant developments in the federal and state whistleblower landscapes this year, say attorneys at Proskauer.

  • How White Collar Defense Attys Can Use Summary Witnesses

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    Few criminal defense attorneys have successfully utilized summary witnesses in the past, but several recent success stories show that it can be a worthwhile trial tactic to help juries understand the complex decision-making at issue, says Jonathan Porter at Husch Blackwell.

  • Nutraceutical Patent Insights As Market Heats Up

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    Companies entering the expanding nutraceutical market and seeking patents to protect their innovations should evaluate successful nutraceutical claim language and common patent challenges in this field, say attorneys at Sterne Kessler.

  • 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.