Policy & Compliance

  • January 13, 2026

    Gov't Didn't Allege Formula Was Contaminated, Abbott Says

    Abbott Laboratories has urged a Michigan federal judge to throw out a suit brought by the federal government over the 2022 infant formula shortage, saying the government is trying to recoup a "belated windfall" and no tainted formula left its plant's doors.

  • January 13, 2026

    Federal Drug Pricing Policies Irk Biotech Insiders

    As the federal government targets drug and other healthcare costs, biotech insiders say they're getting exasperated.

  • January 13, 2026

    Justices Seem Poised To Greenlight Transgender Athlete Bans

    The conservative wing of the U.S. Supreme Court voiced skepticism of allowing transgender athletes to compete in women's and girls' sports Tuesday, while also signaling a willingness to keep its ruling narrowly tailored.

  • January 13, 2026

    Blip Or Trend? FDA Guidance Fell Off Steeply In 2025

    The U.S. Food and Drug Administration issued far less industry guidance last year after President Donald Trump returned to office. The change has pharmaceutical attorneys bracing for more unpredictability.

  • January 12, 2026

    The Curious, Very Long Delay In A Pioneering Drug Prices Suit

    When Merck & Co. launched a fiery challenge to Medicare's landmark drug price negotiations, it blazed a trail for many similar suits. But 31 months later, the challenge is stalled where it started as Merck begs for a ruling, other suits speed along the path it created and huge costs now seem unavoidable.

  • January 12, 2026

    Feds To Drop Appeal In 340B Rebate Pilot Challenge

    The U.S. Department of Health and Human Services on Monday suggested it will end its appeal of a First Circuit order temporarily blocking it from instituting a rebate program that would change how the agency distributes payments in the federal 340B drug discount program that provides medications at reduced costs to low-income Americans. 

  • January 12, 2026

    ERISA Recovery Suit Against UnitedHealth Proceeds With Trims

    A UnitedHealth plan participant who was injured in a car crash may pursue claims under the Employee Retirement Income Security Act's civil enforcement provision, an Ohio federal court ruled Friday, while also allowing his wife, who was involved in a separate accident, to proceed with certain state-law claims.

  • January 12, 2026

    Yale Asks Judge To Rethink $32M Baby Formula Death Verdict

    Yale University and the affiliated Yale New Haven Hospital have asked a Connecticut state court judge to reconsider a verdict of nearly $32 million over the death of a premature baby, contending that she failed to grasp battery and informed consent law when issuing her decision after a bench trial.

  • January 12, 2026

    DC Circ. Told $100K H-1B Fee Threatens Congress' Tax Power

    The U.S. Chamber of Commerce urged the D.C. Circuit to bar the Trump administration from charging employers its new $100,000 H-1B visa fee, arguing it presents a "grave threat" to Congress' exclusive power to levy taxes.

  • January 12, 2026

    HHS' Pediatric Health Cuts Blocked As Likely 'Retaliatory'

    A D.C. federal judge has temporarily blocked the U.S. Department of Health and Human Services from cutting nearly $12 million in pediatric health funding to the American Academy of Pediatrics, finding HHS could be retaliating for a lawsuit challenging the agency's changes to members on a federal vaccine committee. 

  • January 12, 2026

    Justices Want SG Input On Arthritis Drug Competition Fight

    The U.S. Supreme Court on Monday asked the Trump administration to weigh in on whether state unfair competition claims should be used to block a competitor from selling compounded versions of drugs in certain states.

  • January 12, 2026

    No High Court Review For California Opioid 'Nuisance' Suit

    The U.S. Supreme Court on Monday said it would not weigh in on a circuit court decision that a California public nuisance lawsuit against pharmacy benefit managers over their opioid-dispensing practices belongs in state court.

  • January 12, 2026

    Justices Pass On Houston Hospital Workers' COVID Vax Fight

    The U.S. Supreme Court declined Monday to hear a challenge to a Houston hospital's win in a lawsuit brought by a group of employees who said they were unlawfully terminated after refusing the COVID-19 vaccine.

  • January 09, 2026

    Mylan, Aurobindo Must Face Generic Drug Price-Fixing Claims

    A Connecticut federal judge on Friday refused to hand a quick win to Mylan Pharmaceuticals and Aurobindo Pharma USA in sprawling antitrust litigation against 26 total pharmaceutical companies, ruling that a coalition of states has enough evidence to raise a genuine dispute about whether the companies conspired to fix drug prices.

  • January 09, 2026

    Up Next At High Court: Pollution Lawsuits & Trans Athletes

    The U.S. Supreme Court will kick off the new year by hearing disputes over the constitutionality of state laws banning transgender female athletes from female-only sports and whether state or federal courts are the proper forum for lawsuits seeking to hold major oil companies accountable for harm caused by their oil production activities along Louisiana's coast. 

  • January 09, 2026

    Mich. Bid For Behavioral Managed Care Contracts Can't Stand

    A Michigan Court of Claims judge ruled the state health department's bid for Medicaid managed care contract proposals would unlawfully interfere with the duties of local governmental bodies that provide and coordinate behavioral health care.

  • January 09, 2026

    Veterinary Group Says DOJ Accreditation Points Irrelevant

    The American Veterinary Medical Association has told a Tennessee federal court that the government's concerns about professional groups are irrelevant to a veterinary school's antitrust case challenging the association's accreditation requirements.

  • January 09, 2026

    Ex-Prosecutor OK For Drug Pricing MDL, Special Master Says

    Former Connecticut Assistant Attorney General Joseph Nielsen and his law firm, Lowey Dannenberg PC, should not be disqualified from representing insurers in multidistrict litigation over generic drug price-fixing because he did not have any special knowledge that the states suing drugmakers hadn't already shared with the private plaintiffs, according to a special master's report and recommendation.

  • January 08, 2026

    Walgreens Gets $392K Sanction Against Blue Cross Insurers

    A Chicago federal judge on Thursday ordered a host of Blue Cross Blue Shield insurers to pay Walgreens more than $392,000 in attorney fees and expenses for discovery misconduct in their suit that accuses the drugstore company of fraudulently overcharging for prescription drugs.

  • January 08, 2026

    9th Circ. Redo Raises New Issues On Abortion Coverage Law

    A Ninth Circuit panel that previously sided with Washington in a church's challenge to a state law mandating employer health coverage of abortion services voiced fresh concerns about both sides' positions when revisiting the case Thursday, roughly six months after rescinding the initial opinion without explanation.

  • January 08, 2026

    Ex-UnitedHealth GC Joins WilmerHale As Partner In London

    After more than 25 years as a general counsel handling some of the direst corporate crises imaginable, former UnitedHealth Group general counsel Rupert Bondy is returning to London to co-lead WilmerHale's crisis management and strategic response group.

  • January 07, 2026

    Potomac Law Adds Former DOJ, HHS Civil Rights Atty

    Potomac Law Group has hired a healthcare attorney with over 15 years working on LGBTQ+ protections and other civil rights issues at the Justice Department and the Department of Health and Human Services.

  • January 07, 2026

    Covenant Health Sued Over Patient Data Security Breach

    Nonprofit healthcare system Covenant Health Inc. has been hit with a proposed class action over a data breach that reportedly compromised the information of nearly half a million people.

  • January 06, 2026

    8th Circ. Revives Jail Suicide Suit Against Mental Health Org.

    An Eighth Circuit panel unanimously revived a lawsuit Tuesday by the family of an Iowa jail inmate who died by suicide, holding that a jury could find that a mental health provider's alleged incomplete report to jail staff put the inmate at greater risk.  

  • January 06, 2026

    Judge Hints Conn. Dentist's Press Release Claims Lack Teeth

    A Connecticut appellate judge seemed to doubt Tuesday that a dentist had asserted clear constitutional claims against state officials who issued a press release about his $300,000 False Claims Act settlement, suggesting the case might actually sound in defamation.

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.