Policy & Compliance

  • March 13, 2025

    NY AG James Pitches Bill To Expand Consumer Protection Law

    New York Attorney General Letitia James on Thursday announced legislation that would expand the state's ban on deceptive business practices to also protect against unfair and abusive practices, an idea backed by Biden-era Federal Trade Commission and Consumer Financial Protection Bureau heads.

  • March 13, 2025

    Calif. AG Appealing State Limits On Pay-For-Delay Ban

    California enforcers are appealing to the Ninth Circuit after a lower court found that a new state law restricting "reverse payment" settlements between brand-name and generic-drug makers cannot be used to regulate deals that were struck outside the state.

  • March 13, 2025

    PBMs Tell FTC 5-Month Delay Too Long For In-House Insulin Trial

    The nation's "Big Three" pharmacy benefit managers say they want to get to trial in the Federal Trade Commission's administrative suit against them sooner rather than later, arguing that the agency's request for a five-month delay would be too long, but they're open to a three-week postponement.

  • March 13, 2025

    HHS Calls Back Terminated Attys Clearing Medicare Appeals

    The U.S. Department of Health and Human Services on Thursday moved to reinstate about 15 attorneys who were cut loose in recent weeks, restoring staff many in the agency saw as critical to clearing a backlog of Medicare appeals.

  • March 13, 2025

    9th Circ. Ends Idaho Abortion Law Row After Mutual Dismissal

    A Ninth Circuit panel has dropped an appeal from Idaho claiming the state's strict abortion ban doesn't conflict with a federal law protecting emergency abortions, after the Trump administration announced its decision to drop the Biden-era legal challenge. 

  • March 13, 2025

    Days Into New Role, FDA's Top Lawyer Is Out

    The top lawyer of the U.S. Food and Drug Administration resigned just two days after she was selected for the role, according to a Thursday announcement by the agency on social media site X.

  • March 13, 2025

    Lacking Votes, White House Pulls Weldon Nomination At CDC

    The White House pulled Dr. Dave Weldon's nomination to lead the Centers for Disease Control and Prevention on Thursday after support among GOP lawmakers wavered, and it became clear he didn't have the votes to clear a Senate committee.

  • March 12, 2025

    GOP Senators Take Aim At CFPB Medical Debt Rule

    Republican senators have introduced a measure to overturn the Consumer Financial Protection Bureau's recent rule banning medical debt from credit reports, one of the latest Biden-era regulations to be targeted for legislative repeal.

  • March 12, 2025

    Cancer Cause Or Red Herring? Jury Weighs Plant Bellwether

    A medical sterilization company told a Colorado jury Wednesday that four women can't get millions in damages based on the "possibility" that emissions from a sterilization plant caused their cancer, at the close of a six-week trial in which the plaintiffs argued the company should be punished for its negligence.

  • March 12, 2025

    Law360 Cheat Sheet: Novartis' Fight Over Generic Entresto

    Novartis has led a wide-ranging litigation campaign to block generic versions of its bestselling cardiovascular drug Entresto that has involved multidistrict litigation, trips to several circuit courts and cases against the federal government. Here, Law360 breaks down how the various cases intersect and what's still playing out.

  • March 12, 2025

    Women Attys, AGs Urge Justices To Protect Provider Choice

    Women attorney groups and a group of state attorneys general urged the U.S. Supreme Court to reject South Carolina's attempt to stop Medicaid patients from seeing Planned Parenthood healthcare providers, saying in an amicus brief Wednesday that patients have a right to choose their healthcare providers and have a private right of action to enforce that right.

  • March 12, 2025

    SEC Says Ex-Allarity Execs Concealed Doomed FDA Approval

    The U.S. Securities and Exchange Commission sued three former executives of clinical-stage pharmaceutical company Allarity Therapeutics Inc. in Massachusetts federal court, alleging Wednesday that they schemed to conceal from the public that the company's new drug application for its flagship drug had no chance of gaining regulatory approval.

  • March 12, 2025

    Trump Admin Seeks To End ACA Access For 'Dreamers'

    The U.S. Department of Health and Human Services on Wednesday proposed a regulation that would do away with the Biden administration's rule allowing recipients of Deferred Action for Childhood Arrivals to qualify for Affordable Care Act coverage.

  • March 12, 2025

    Judge Says Hospital Orgs.' Input Not Needed In Multiplan MDL

    The Illinois federal judge handling multidistrict litigation targeting Multiplan's out-of-network reimbursement rates has rejected two hospital organizations' bid to weigh in as he considers whether he should dismiss the case.  

  • March 12, 2025

    NC Organ Procurer Sues CMS Over Hospital Waiver

    A North Carolina-based organ procurement organization told a federal court Wednesday that the Centers for Medicare & Medicaid Services has violated federal law by giving a waiver to a hospital to work with another organ procurement service from a different region. 

  • March 12, 2025

    HHS To Eliminate 6 Regional Offices For Legal Staff

    The U.S. Department of Health and Human Services said Tuesday it will close six out of 10 regional offices where attorneys for the agency work.

  • March 12, 2025

    Harvard Docs Say Gov't Censored Articles With Gender Terms

    A pair of Harvard Medical School researchers sued the Trump administration in Massachusetts federal court on Wednesday, claiming their work was erased from a government-run patient safety website because their articles contained terms like "LGBTQ" and "transgender."

  • March 11, 2025

    FTC Merger Suit, Hospital DEI Probe And Qui Tam At 11th Circ.

    The Federal Trade Commission initiated its first merger challenge since the start of President Donald Trump's current term, arguing that a private equity firm's plans to buy a medical device company would lead to an unlawful level of market concentration.

  • March 11, 2025

    'Paucity' Of Proof Thwarts NC State Law Claims In Gardasil MDL

    A North Carolina federal judge has found that Merck did not violate state law by not including warnings about its Human Papillomavirus vaccine Gardasil, saying there was a "paucity" of evidence that the vaccines cause certain injuries to recipients.

  • March 11, 2025

    Conversion Therapy Ban At High Court: 5 Cases To Know

    The U.S. Supreme Court is set to hear a First Amendment challenge to a Colorado ban on mental health professionals using "conversion" therapy intended to help change minors' gender identity or sexual orientation.

  • March 11, 2025

    Zydus Cuts Deal With States, Tribes In Opioid Nuisance Suit

    Zydus Pharmaceuticals Inc. has reached a deal in principle with states and Native American tribes that should quash claims related to the company's alleged role in exasperating the opioid crisis.

  • March 11, 2025

    Hospital Orgs. Say MultiPlan Must Not Duck Price-Fix Claims

    Hundreds of American hospitals are "on the brink of collapse" and letting MultiPlan and a host of insurers who have been accused of conspiring to underpay out-of-network providers off the hook will not improve matters, two groups that represent thousands of hospitals have told the court.

  • March 11, 2025

    Alaska's RICO Claims Advance Against PBM In Opioid Suit

    An Alaska federal judge has allowed most of the state's Racketeer Influenced and Corrupt Organization Act claims to move forward against pharmacy benefits manager Express Scripts for its alleged role in the opioid epidemic.

  • March 11, 2025

    Feds Turn To FCA As Enforcement Weapon In Opioid Crisis

    Federal prosecutors are expanding their use of the False Claims Act to target pharmacies accused of contributing to the opioid crisis, a legal strategy that exposes the defendants to hefty penalties.

  • March 11, 2025

    Trump Admin Drops Suit Over COVID Nasal Spray Ads Claims

    The U.S. Department of Justice quietly moved Monday to drop a Utah federal court lawsuit filed on behalf of the Federal Trade Commission accusing a sinus nasal spray company of falsely claiming its products could help prevent and treat COVID-19.

Expert Analysis

  • 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.

  • 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.