Policy & Compliance
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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.
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November 10, 2025
Mich. Justices To Hear If Signed Form Shields Hospital
The Michigan Supreme Court has agreed to hear arguments on whether a patient's signed consent form alone is enough to defeat a medical malpractice suit claiming a Michigan hospital was responsible for an independent contractor physician's alleged negligence.
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November 07, 2025
Mich. County Not Liable For Officers' Age Bias, Judge Says
A Michigan federal judge has tossed a registered nurse's suit alleging Berrien County discriminated against her because of her age, finding that although the nurse showed she was harassed by jail officers because of her age, she didn't demonstrate that the county was responsible for it.
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November 07, 2025
8th Circ. Upholds EpiPen Co. Worker's Reinstatement
The Eighth Circuit affirmed an arbitration award ordering EpiPen maker Meridian Medical to reinstate an employee accused of falsifying job training records, ruling Friday the decision doesn't violate public policy since there are no federal regulations governing auto-injector training that forbids reinstatement for a procedural training violation.
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November 07, 2025
Couple Says Pilot's Reckless Flying Caused Helicopter Crash
An operator of air ambulance helicopters allowed one of its pilots to make "dangerous, careless, and reckless" flight decisions that resulted in a 2023 crash in the mountains of North Carolina during a patient transport, a couple has alleged in a new lawsuit.
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November 07, 2025
ERISA Recap: 6 Things Attys May Have Missed In Oct.
Two appeals court judges used a decision in an employee stock ownership plan case to urge the full Eleventh Circuit to rethink its requirements for filing federal benefits suits, a marketing company shut down a 401(k) forfeiture case, and CVS and Duke University were hit with new suits. Here, Law360 looks back at six noteworthy ERISA developments from last month.
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November 06, 2025
Conduent Pummeled With Suits Over Monthslong Data Breach
Conduent Business Services LLC has been hit with a barrage of class action lawsuits in New Jersey federal court alleging it failed to adequately protect sensitive personal and health information of more than 10.5 million individuals that were compromised in a major data breach.
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November 06, 2025
Med Groups Call To Break Up 'Politicized' CDC Vax Committee
A Massachusetts doctor and a group of public health trade associations want the federal government to break up a key vaccine committee tasked with nationwide vaccine policy, arguing in an amended lawsuit Thursday that the panel has been tainted with anti-vaccine sentiment.
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November 05, 2025
1st Circ. Questions Trump Admin On NIH Indirect Cost Cuts
A First Circuit panel seemed poised on Wednesday to uphold a district court decision finding that the Trump administration lacks the authority to cap indirect costs for research grants at the National Institutes of Health.
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November 05, 2025
Pharmacy Groups Urge 8th Circ. To Back Ark. PBM Limits
A pair of pharmacy trade groups is urging the Eighth Circuit to allow Arkansas to enforce a law barring pharmacy benefit managers from owning pharmacies, arguing the law is a rational response to "abusive" PBM practices.
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November 05, 2025
Judge Demands Facts In Pa. Medicaid-Paid Abortion Ban Case
A Pennsylvania Commonwealth Court judge on Wednesday repeatedly asked healthcare providers at oral arguments to show her facts on why a statewide ban on Medicaid-funded abortions was unconstitutional, often remarking that the case was short on evidence to support making changes to the coverage exclusion.
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November 05, 2025
Worker Can Keep OT Claim Against Health Care Co.
A worker's overtime claim can proceed against a healthcare company that provides services through the U.S. Department of Labor to individuals who have suffered injuries while working at nuclear facilities, a South Carolina federal judge ruled Wednesday, while tossing other wage- and benefits-related claims.
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November 05, 2025
Mich. AG Urges State High Court To OK Insulin Price Probe
The Michigan Supreme Court weighed overturning two of its prior rulings on consumer protection law Wednesday as the state's attorney general sought the court's blessing for an insulin price-gouging investigation.
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November 04, 2025
5th Circ. Judge Says FCA Illegally Steps On Executive Power
Fifth Circuit Judge James C. Ho says his court should reconsider what he called "serious constitutional problems with the qui tam provisions of the False Claims Act," arguing that whistleblowers who sue under the law "are neither appointed by, nor accountable to, the president," and that conflicts with presidential authority.
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November 04, 2025
Judges Wade Into Abortion Pill Access And Rx Pricing Fights
In a flurry of recent legal activity, courts across the country have been drawn into the nation's most contentious healthcare debates over access to medication abortions and efforts to cap the cost of prescription medications.
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November 04, 2025
Meet The Attys Behind Drugmakers' Conn. Price Cap Suit
Attorneys from Goodwin Procter LLP and Wiggin and Dana LLP are teaming up to represent the Association for Accessible Medicines in its challenge to a Connecticut drug price cap set to take effect at the start of 2026.
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November 04, 2025
NY Court Splits On Emotional Damage From Fatal Birth Injury
New York’s highest court handed a loss to legal advocates who had hoped a mother’s suit over the ramifications of the death of her newborn baby would help overturn a 20-year-old precedent on prenatal torts. A dissenting judge called a legal barrier to emotional damage recovery “contrary to common sense.”
Expert Analysis
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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.
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Cos. Should Inventory Issues To Prep For New Congress
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.
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Incoming Admin May Shake Up Life Sciences Regulation
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.