Policy & Compliance

  • December 02, 2025

    States Hit Abbott With FCA Suit Over Infant Formula Recall

    Seven states, including California, Michigan and New York, on Monday intervened in a False Claims Act suit brought by the federal government against Abbott Laboratories over the 2022 infant formula crisis seeking to recoup funds spent on the tainted baby food.

  • December 02, 2025

    CR Bard's Faulty Blood Filter Killed Wash. Woman, Suit Says

    The family of a woman allegedly killed by a faulty blood filter implant accused device maker C.R. Bard Inc. in Washington federal court Monday of taking dangerous shortcuts as it rushed its line of products to market.

  • December 02, 2025

    Judge Blocks Planned Parenthood Funding Cut In 22 States

    A Massachusetts federal judge Tuesday stopped the Trump administration from halting Medicaid reimbursements to Planned Parenthood clinics in 22 states, ruling the funding cutoff likely violated requirements to warn the states ahead of time about the change.

  • December 02, 2025

    6th Circ. Affirms UnitedHealth's Escape From Preempted Suit

    The Sixth Circuit on Tuesday backed a decision to toss a worker's lawsuit accusing his employer and UnitedHealth and its subsidiaries of defrauding him into reimbursing his health insurance company for $25,000, agreeing with a lower court that federal benefits law completely preempted his state law claims.

  • December 02, 2025

    U Of Colo. To Pay $10M In Religious Bias Suit Over Vax Policy

    The University of Colorado's medical school will pay $10.3 million to a group of employees and students who claimed in federal court that their religious exemption requests to the university's COVID-19 vaccine mandate were unlawfully denied, according to the group's attorneys.

  • December 02, 2025

    Lawyers Adapt To Crop Of New FDA Pilots

    A slew of new FDA pilot programs is forcing life science attorneys to adjust to a new reality of programs that shed bureaucratic processes and eschew some of the typical push-and-pull with industry players.

  • December 02, 2025

    Health Hires: Goodwin Partner Joins Incyte, Gilead GC Exits

    Law360 Healthcare Authority looks at the week's most notable personnel changes in the healthcare and life sciences industries.

  • December 02, 2025

    Post-Gazette Publisher Tries Again To Pause Benefits Order

    If the Pittsburgh Post-Gazette must restore its union-represented editorial staff's pre-2020 healthcare benefits, it will shut down, the newspaper's publisher claimed in a brief filed with the Third Circuit, requesting another shot at pausing an injunction that compelled the paper to restore the benefits.

  • December 02, 2025

    Defamation Litigation Roundup: FDA, Lively, Alexander Bros.

    In this month's review of defamation fights, Law360 highlights a pharmaceutical company's suit against a former U.S. Food and Drug Administration official, as well as the latest decision siding against President Donald Trump in his fights with media companies.

  • December 02, 2025

    5th Circ. Wary Of FDA Process Behind Rule For New Vapes

    A Fifth Circuit panel appeared skeptical Tuesday that the U.S. Food and Drug Administration properly accounted for how a new rule for premarket authorization of new tobacco products would affect small businesses in the industry.

  • December 02, 2025

    Breast Pump Co. To Pay $1M For Alleged Tricare Overbilling

    The U.S. Attorney's Office for the Eastern District of Pennsylvania reached a $1 million settlement with a breast pump company and its owner, resolving allegations that they submitted false claims for reimbursement for service members and their families.

  • December 02, 2025

    Plan Members Assert Standing In Cigna Data Breach Fight

    A group of Cigna health plan participants who claimed that the company failed to protect their data when it tracked their website activities asked a Pennsylvania federal judge not to throw out the suit, arguing that the proposed class had standing to sue over the alleged violations of state and federal privacy laws.

  • December 02, 2025

    Under New Chair, Fed. Vax Panel To Redo Hep B Vote

    The new chair of an influential federal vaccine advisory panel is set to lead a vote this week on whether to roll back federal recommendations that newborns get vaccinated against hepatitis B.

  • December 02, 2025

    Justices Skeptical Of NJ Subpoena For Anti-Abortion Donors

    Several U.S. Supreme Court justices appeared sympathetic Tuesday to an anti-abortion pregnancy-center network's bid to challenge a subpoena from the New Jersey attorney general, pressing the state on whether its demand for donor identities and internal documents risked unconstitutionally chilling First Amendment associational rights.

  • December 02, 2025

    Safe-Injection Site Ignites New Religious Liberty Debate

    Law360 Healthcare Authority talks to Benjamin A. Barsky of the University of California College of the Law, San Francisco about safe injection sites, religious liberty arguments in healthcare, and a Third Circuit ruling with possible ramifications for both.

  • December 02, 2025

    Conflict Looms Over State Medical Debt Credit-Report Bans

    An about-face by the Consumer Financial Protection Bureau on medical debt and credit reports is animating a legal debate over preemption and state-level prohibitions meant to protect consumers.

  • December 02, 2025

    Hospital Says EEOC Neglected Presuit Conciliation Obligation

    The U.S. Equal Employment Opportunity Commission failed to satisfy its conciliation obligations before filing an age discrimination lawsuit against a Colorado hospital, the facility told a federal court, arguing that the case should be paused for the parties to try to work out a deal.

  • December 02, 2025

    $4.6M Garnet Health Deal Over Retirement Plan Gets Initial OK

    A New York federal judge granted initial approval Tuesday to a $4.6 million class action settlement between Garnet Health Medical Center and workers who challenged their employee retirement plan's fees and investments, which comes after parties reported a deal to end the case in September.

  • December 01, 2025

    Hospitals Slam HHS' Move From Drug Discounts To Rebates

    The American Hospital Association is leading litigation challenging the Trump administration's abrupt changes to a decades-old program governing the distribution of discounted prescriptions to low-income patients, telling a Maine federal court Monday that the government is unlawfully ignoring the costly impacts a rebate system will have on hospitals.

  • December 01, 2025

    1st Circ. Tosses Omni's Medicare Fraud Suit Over UTI Tests

    A First Circuit panel declined to revive Omni Healthcare's False Claims Act suit accusing MD Labs of billing Medicare for unnecessary urinary tract infection tests, explaining in a published opinion Monday that Omni Healthcare's own staff ordered each test — sometimes even replacing doctors' orders for cheaper tests with the pricier ones.

  • December 01, 2025

    2nd Circ. Backs Anti-Abortion Groups' Free Speech Rights

    New York Attorney General Letitia James can't sue faith-based groups promoting a so-called treatment to reverse medication-induced abortions, finding the groups are likely to succeed on the merits of their First Amendment challenge, the Second Circuit said Monday.

  • December 01, 2025

    J&J Narrows Ex-Employees' Prescription Benefits Suit

    Johnson & Johnson narrowed a proposed class action claiming it unlawfully overcharged employees through a prescription drug benefits program, with a New Jersey federal judge ruling workers leading the suit failed to show how allegedly excessive fees the company paid to a benefits manager caused participants' costs to rise.

  • December 01, 2025

    Judge Upholds Mich. MedMal Cap, Cuts $8.5M Verdict

    A Michigan federal judge has slashed the $8.5 million a jury awarded to the estate of a cancer patient suing over his doctor's treatment decisions to about $615,000, ruling that a state law limiting noneconomic damages in medical malpractice cases is constitutional. 

  • November 26, 2025

    Up Next At High Court: ISP Liability & State Subpoena Suits

    The U.S. Supreme Court will return Monday for the first week of its December oral argument session, during which the justices will consider whether internet service providers can be held liable for contributing to their customers' infringing activity online and whether the subjects of state subpoenas are required to first challenge them in state court. 

  • November 26, 2025

    Nurse For App-Based Health Co. Can't Revive Retaliation Suit

    A Washington appeals court refused to revive a nurse's suit claiming she was fired from an app-based medical provider for complaining that it underpaid and overworked independent contractors, ruling she failed to show her termination was because of her concerns rather than reports that she was unprofessional.

Expert Analysis

  • 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.

  • Navigating DOJ's Patchwork Whistleblower Regime

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    In the past few months, the U.S. Department of Justice and several individual U.S. attorney’s offices have issued different pilot programs aimed at incentivizing individuals to blow the whistle on misconduct, but this piecemeal approach may create confusion and suboptimal outcomes, say attorneys at BakerHostetler.

  • What To Expect Next From Federal Health Tech Regulation

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    Healthcare organizations should pay close attention to federal health information technology regulators' recent guidance concerning barriers to accessing electronic health information, which signals that more enforcement in this area is likely forthcoming, say attorneys at Ropes & Gray.

  • 5 Areas Congress May Investigate After GOP Election Wins

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    With Republicans poised to take control of Congress in addition to the executive branch next year, private companies can expect an unprecedented uptick in congressional investigations focused on five key areas, including cryptocurrency and healthcare, say attorneys at Cahill Gordon.

  • Takeaways From State Votes On Abortion In The 2024 Election

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    Attorneys at Epstein Becker discuss how 10 states voted on ballot initiatives to either protect or restrict access to abortion in the 2024 general election, and analyze overarching trends.

  • Loper Bright Offers New Materiality Defense To FCA Liability

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    The U.S. Supreme Court's decision in Loper Bight Enterprises v. Raimondo, ending Chevron deference, may have created a new defense to False Claims Act liability by providing the opportunity to argue that a given regulation is not material to the government's payment decision, says Tanner Cook at Husch Blackwell.

  • How Expanded Birth Control Coverage May Affect Employers

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    Employers should consider the potential impact of recently proposed regulations that would expand group health plans' required coverage of preventive services and contraceptives, including questions about how the agencies would implement their plans to eliminate the prescription requirement and alter the exceptions process, says Jennifer Rigterink at Proskauer.

  • Legislation Most Likely To Pass In Lame Duck Session

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    As Congress begins its five-week post-election lame duck session, attorneys at Greenberg Traurig break down the legislative priorities and which proposals can be expected to pass.