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Policy & Compliance

  • April 23, 2025

    Eli Lilly Sues 4 Telehealth Cos. For Weight Loss Drug Copies

    Eli Lilly filed a new round of lawsuits Wednesday over the compounding of its popular weight loss drugs Mounjaro and Zepbound, accusing four telehealth companies of making copies of the medications while alleging that two companies violated laws requiring doctors to make medical decisions, not corporations. 

  • April 22, 2025

    Free Speech Experts Question DOJ Letter To Medical Journal

    A federal prosecutor's letter to a medical journal skeptically asking about its commitment to nonpartisan debate is an unusual intrusion into editorial decision-making and may interfere with the publication's First Amendment rights, free speech experts say.

  • April 22, 2025

    'Fetal Personhood' Animates Neb. Aborted-Remains Debate

    Nebraska lawmakers are sparring over a bill that would require healthcare facilities to bury or cremate fetal remains following an elective abortion. Supporters envision a "dignified" disposition. Opponents decry a requirement targeting providers while advancing the “fetal personhood” doctrine.

  • April 22, 2025

    Hogan Lovells Adds Ex-HHS Atty To Health Practice

    Hogan Lovells on Tuesday announced the arrival of a former U.S. Department of Health and Human Services attorney to the firm's global regulatory and intellectual property practice group.

  • April 22, 2025

    Trump's Healthcare Order A Mixed Bag For Big Pharma

    While Trump's executive order last week is more of a general road map than a clear plan for cutting prices, experts say it signals key policy priorities for the administration — including on a point of serious contention between drug companies and federal regulators.

  • April 22, 2025

    Pharma Co. Owner Cops To Selling $60M Of Sham HIV Drugs

    An owner of a pharmaceutical company has pled guilty in Florida to participating in a $60 million nationwide scheme to illegally distribute misbranded and adulterated HIV drugs to patients.

  • April 22, 2025

    MoFo Adds Perkins Coie FDA Regulatory Leader In DC

    Morrison Foerster LLP has hired a former Perkins Coie LLP leader who focuses his practice on a range of regulatory matters involving the U.S. Food and Drug Administration as its new head of food and regulatory, the firm announced Tuesday.

  • April 22, 2025

    Trump Deregulation Order Puts Target On Nurse Survey Rule

    The Trump administration's push for mass deregulation is raising the hopes of nursing facilities that have spent years pushing back on a controversial rule limiting when a registered nurse must be present during facility safety inspections.

  • April 22, 2025

    State Legislatures Pull Back On Certificate-Of-Need Laws

    Lawmakers in a handful of states are considering a fresh round of repeals and rollbacks to certificate-of-need laws, an often divisive tool designed to control healthcare costs by limiting duplication of services. That means more changes to a legal landscape that has evolved significantly since the advent of the statutes in the 1970s.

  • April 22, 2025

    Save Mart Reaches $20.5M Deal On Nonunion Retiree Benefits

    California-based Save Mart Supermarkets will pay about $20.5 million to escape a suit from workers who alleged the company unlawfully revoked a monthly health reimbursement that it promised to nonunion retirees and their spouses for life, according to a proposed deal filed in federal court.

  • April 22, 2025

    Nossaman Health Atty Talks Staffing, Evolving Calif. Law

    A former Procopio Health attorney has made the jump to Nossaman LLP at a time when California law around peer and judicial review processes for medical staff is evolving.

  • April 21, 2025

    Premera's Teen Trans Policy 'Textbook' Sex Bias, Judge Says

    Premera Blue Cross discriminated based on sex against transgender teens at the center of a lawsuit alleging the insurer and health plan administrator illegally denied coverage for gender-affirming chest surgery, according to a Washington federal judge who also denied class certification because the teens' claims are not typical of class members.

  • April 21, 2025

    Harvard Sues Trump Admin Over $2B Funding Freeze

    Harvard University on Monday hit the Trump administration with a suit in Massachusetts federal court, escalating a high-profile battle after the government slashed more than $2 billion in funding amid allegations the elite school has failed to properly address antisemitism on its campus.

  • April 21, 2025

    NJ Panel Revives Ex-Group Home Worker's Whistleblower Suit

    A New Jersey appeals court reinstated a group home worker's lawsuit alleging she was fired for raising concerns about staffing levels and training, reasoning Monday that she met the pleading standards for the state's whistleblower law.

  • April 21, 2025

    Unions Demand Halt To DOGE's Info Access At DOL, HHS

    A D.C. federal judge must block Elon Musk's Department of Government Efficiency from accessing sensitive systems in the U.S. Department of Labor and Department of Health and Human Services, unions argued in a preliminary injunction bid, saying the government's search for "waste, fraud and abuse" doesn't warrant access.

  • April 21, 2025

    HCA, Workers Eye Mediation in Wage Suit

    HCA Healthcare Inc. asked a North Carolina federal court to press pause on a respiratory therapist's class and collective action accusing the company of manipulating workers' time sheets to pay them less overtime wages, saying the parties are planning to attend mediation in July.

  • April 21, 2025

    Justices Mull 5th Circ. Redo In ACA Preventive Care Fight

    The U.S. Supreme Court on Monday appeared skeptical of a Fifth Circuit ruling that found members of a task force setting preventive services coverage requirements under the Affordable Care Act were unconstitutionally appointed, with multiple justices suggesting kicking the case back down to the circuit court for additional arguments.

  • April 21, 2025

    Justices Kick Flavored-Vape Dispute Back To 5th Circ.

    After the U.S. Supreme Court affirmed the U.S. Food and Drug Administration's authority to reject an e-cigarette company's application to market flavored vapes, the high court on Monday granted summary disposition on one other pending case on the same subject, while denying certiorari to three others.

  • April 19, 2025

    Up Next At High Court: Preventive Healthcare, LGBTQ Books

    The U.S. Supreme Court will hear arguments in five cases this week, including disputes over the constitutionality of a task force that sets preventive healthcare coverage requirements, a school district's introduction of LGBTQ-themed storybooks and whether parties can establish standing based on harms affecting third parties. 

  • April 18, 2025

    Walgreens To Pay DOJ $300M Over Invalid Prescriptions

    Walgreens revealed in a U.S. Securities and Exchange Commission filing Friday that it will pay upward of $300 million to resolve U.S. Department of Justice allegations that it knowingly filed millions of prescriptions for opioids and other drugs that didn't have a legitimate medical purpose or weren't valid.

  • April 18, 2025

    Lilly Blasts Compounders' 'Scattershot' Bid To Reverse FDA

    Eli Lilly urged a Texas federal judge to deny a request from pharmacies that produce copycat doses of its popular weight loss drug to have the court reverse an FDA decision taking the drug off a national shortage list, saying the bid was filled with unreliable "scattershot" arguments.

  • April 18, 2025

    Mass General Inks $8.25M Deal To End Retirement Fee Suit

    Boston-based healthcare system Mass General Brigham Inc. agreed to pay $8.25 million to settle a proposed class action alleging it unlawfully allowed its employee retirement plan to pay excessive administrative fees, according to a filing in Massachusetts federal court.

  • April 17, 2025

    Incyte Can Get Novartis' Privileged Info On Drug Royalty Deal

    Novartis must produce certain privileged documents to Incyte concerning its understanding of their contract for royalty payments from sales of Incyte's blood cancer drug, unless Novartis agrees its former outside counsel, who negotiated the terms, won't testify about that topic at the upcoming contract breach trial, a New York federal judge said Thursday.

  • April 17, 2025

    RI Judge Wants To Know Who's Behind $11B Health Grant Cuts

    A Rhode Island federal judge on Thursday pressed the Trump administration for details about the decision-makers behind the cancellation of billions in grants supporting state public health programs.

  • April 17, 2025

    Arkansas Bans PBMs From Owning Pharmacies

    Pharmacy benefit managers operating in Arkansas will soon be prohibited from owning pharmacies in the state after Gov. Sarah Huckabee Sanders signed a bill that lawmakers say is meant to minimize conflicts of interest and safeguard patients.

Expert Analysis

  • The Future Of GLP-1 Policy After Drug Shortage Ends

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    If and when the U.S. Food and Drug Administration determines that GLP-1 RA drugs are no longer in short supply, regulators will face questions of how to balance access to GLP-1 RAs with statutory and policy considerations applicable to compounded drugs, say attorneys at Skadden.

  • 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.