Policy & Compliance
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November 17, 2025
Mass. Justices Say Panel Overstepped In Sepsis Death Suit
Massachusetts' highest court on Monday reinstated medical malpractice claims against a nurse practitioner over a patient's sepsis death, saying a tribunal had stepped beyond its role in vetting an offer of proof by the man's widow.
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November 17, 2025
9th Circ. Strikes Down Trans Patients' Win In ACA Bias Case
The Ninth Circuit upended a win Monday for patients who challenged Blue Cross Blue Shield of Illinois' administration of their employer-provided health plans containing gender-affirming care exclusions, ordering a lower court to reexamine the case in light of intervening authority from the U.S. Supreme Court.
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November 17, 2025
Corporate Pilot Fired For Flagging Safety Concerns, Suit Says
The former head of aviation for an oral surgery management services company in North Carolina says he was canned because of his age and hearing disability and for allegedly reporting flight scheduling practices that he said flouted federal safety laws.
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November 17, 2025
No High Court Review For FDA Fast-Track Denial
The U.S. Supreme Court on Monday said it would not consider whether federal drug regulators went astray in denying fast-track review for a digestive disorder medication being developed by Vanda Pharmaceuticals.
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November 14, 2025
Texas Judge Rejects Bid To Block Kenvue's $398M Dividend
Texas can't stop the makers of Tylenol from marketing the drug as safe for children and pregnant women or halt a nearly $400 million payment to shareholders, a state court ruled on Friday, rejecting arguments by Attorney General Ken Paxton's motion.
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November 14, 2025
Fla. Pharmacy To Pay $17M To Settle COVID False Claims Case
A Tampa, Florida, pharmacy has agreed to pay over $17 million to settle allegations that it knowingly filed false Medicare claims for over-the-counter COVID-19 tests that hadn't gone out to recipients.
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November 14, 2025
Drug Buyers Defend Class Cert. In 3rd Circ. Generics Case
Direct purchasers and end-payers in the sprawling multidistrict litigation over alleged price-fixing of generic drugs are fighting requests from Actavis and Mylan to undo class certification in the cases, arguing to the Third Circuit that the litigation is a classic example of a class action matter.
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November 14, 2025
10th Circ. Sides With Rehab Facility In Bias, Retaliation Suit
The Tenth Circuit refused Friday to reopen an occupational therapist's lawsuit claiming she was unceremoniously let go by a Kansas rehabilitation clinic for reporting a colleague's inappropriate behavior toward women, saying she couldn't revive her suit using arguments the trial court never considered.
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November 14, 2025
Horizon BCBS To Pay $100M To End NJ AG's Overcharge Suit
Horizon Blue Cross Blue Shield of New Jersey has agreed to pay the state $100 million to resolve allegations that it fraudulently secured a multibillion-dollar contract to administer public employee health plans and then systematically overcharged taxpayers for years, Attorney General Matthew J. Platkin announced Friday.
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November 13, 2025
NC Biz Court Bulletin: Rulings Spotlight Coverage Clashes
The North Carolina Business Court plowed into the fourth quarter with two big decisions in insurance disputes that involved $50 million in COVID-19-related losses at a chain of outlet malls, and an industrial accident at a Nucor Corp. iron plant in Louisiana.
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November 13, 2025
Donor Info Subpoena Chills Speech, Anti-Abortion Org Says
An organization that operates anti-abortion pregnancy centers told the U.S. Supreme Court on Thursday that New Jersey is undermining its own subpoena power in a bid to avoid constitutional review of its request for information about the group's donors.
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November 13, 2025
Weight-Loss Drug MDL In Pa. Grows With 3 New Jersey Cases
Three New Jersey cases were grouped into multidistrict litigation accusing Eli Lilly & Co. and Novo Nordisk of downplaying alleged side effects of weight loss drugs like Ozempic and Trulicity, according to a transfer order filed in Pennsylvania federal court.
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November 13, 2025
Claims Firms Accused Of Misleading Plaintiffs In Pharma MDL
A Pennsylvania federal judge has been asked to slow down aggressive marketing campaigns from claims recovery firms that are accused of using false and misleading advertising to attract plaintiffs in a multidistrict litigation action against pharmaceutical companies.
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November 12, 2025
Valsartan Cancer Expert Blocked, Ending First Injury Trial
What was set to be the first bellwether case in the sprawling multidistrict litigation over contaminated blood pressure medication Valsartan was decided Monday when a New Jersey federal judge excluded as "pure speculation" the plaintiff's medical expert who testified that the drug caused a patient's liver cancer.
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November 12, 2025
Judge Questions Cigna Site Users' Standing In Data Suit
A Pennsylvania federal judge suggested Wednesday that she may toss a proposed class action alleging Cigna failed to safeguard private health data by tracking plan members' website usage in violation of state wiretapping and federal privacy laws, ordering the plaintiffs to demonstrate that they have standing to sue.
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November 12, 2025
Judge Won't Halt Injunction Blocking Trump's Trans Care Ban
A Washington federal judge rejected the Trump administration's bid to halt a temporary injunction, saying the president took too long to request a pause in the order, which blocks federal officials from withholding federal healthcare funds to hospitals in four states that provide gender-affirming care.
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November 10, 2025
Law360 MVP Awards Go To Top Attorneys From 76 Firms
The attorneys chosen as Law360's 2025 MVPs have distinguished themselves from their peers by securing significant achievements in high-stakes litigation, complex global matters and record-breaking deals.
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November 11, 2025
A New Mental Health Rx? FDA Braces For AI Chatbots
Patients suffering from depression may someday soon get an unusual kind of prescription that doesn’t involve a pill or an injection: Download a chatbot. Law360 Healthcare Authority has the key takeaways from an FDA meeting focused on regulating AI-powered mental health chatbots.
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November 11, 2025
'Exceptionalism,' Preemption And A Test For FDA Authority
University of Pittsburgh law professor Greer Donley talks to Law360 Healthcare Authority about preemption challenges and mifepristone regulation following the GenBioPro decision at the Fourth Circuit.
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November 11, 2025
Calif. Justices Uphold Misgendering Law for Care Facilities
The California Supreme Court has revived a state law requiring long-term care facilities to use residents' preferred names and pronouns, holding that the statute regulates discriminatory conduct, not speech.
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November 11, 2025
A Novo Trial Win, AI Suicide Suits, and Humana v. ChenMed
Law360 Healthcare Authority looks Novo Nordisk's jury trial win on claims it defrauded Washington's Medicaid and Medicare systems, new suits alleging OpenAI disregarded safety risks leading up to the release of a version of ChatGPT last year and other litigation developments shaping the shaping the healthcare industry this week.
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November 10, 2025
IRhythm Denied Early Win On Investor Scienter & Loss Claims
Heart monitor maker iRhythm Technologies cannot get an early win in a proposed investor class action alleging it made misleading disclosures about one of its devices, a San Francisco federal judge has determined.
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November 10, 2025
Pfizer Again Asks Judge To Toss States' Price-Fixing Case
Pfizer has again asked a Connecticut federal judge to throw out claims it faces in a sprawling dermatology drug price-fixing lawsuit filed by multiple states against several pharmaceutical companies, arguing allegations against it were "scant and cursory."
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November 10, 2025
FDA Lifts Hormone Replacement 'Black Box' Warnings
The U.S. Food and Drug Administration on Monday said it was removing the "black box" warnings from hormone replacement therapy treatments for menopause for the risks of cardiovascular disease, breast cancer and probable dementia.
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November 10, 2025
Gov't Can Support Anti-Abortion Group In NJ Subpoena Fight
The U.S. Supreme Court on Monday granted Solicitor General D. John Sauer's request to file an amicus brief and participate in oral argument in an anti-abortion pregnancy center's bid to revive its challenge to a subpoena from the New Jersey attorney general demanding information about its donors.
Expert Analysis
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How White Collar Defense Attys Can Use Summary Witnesses
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.
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Nutraceutical Patent Insights As Market Heats Up
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.
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How White Collar Attys Can Use Mythic Archetypes At Trial
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.
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What 2024 Election Means For Drugs, Medicare And Medicaid
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.
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Justices Mull Sex-Based Classification In Trans Law Case
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.
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Key Takeaways From FDA's Latest Social Media Warnings
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.
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Rank-And-File DOJ Attorneys Will Keep Calm And Carry On
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.
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Unpacking Arguments From High Court's Rural Hospital Case
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.
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Health Policy Predictions For Trump's Second Administration
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.
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What Trump's Next Term May Mean For Biz Immigration
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.
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Weak Reasoning Underlies Fla. Judge's Bold Qui Tam Ruling
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.
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Medicare Overpayment Rules Are A Mixed Bag For Providers
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.
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Expect More State-Level Scrutiny Of Noncompetes Ahead
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.