Policy & Compliance

  • May 06, 2025

    Trump Orders FDA To Speed Up Drug Plant Approvals

    President Donald Trump directed the U.S. Food and Drug Administration to cut the approval timelines for new manufacturing facilities by domestic drugmakers and also to pressure foreign drugmakers to comply with quality control inspections, according to a recent executive order.

  • May 06, 2025

    Ind. Hospital Merger Hits 'Public Advantage' Law Roadblock

    Opposition from Indiana's top law enforcement official to the combination of Terre Haute's only two hospitals could spell the end to the hotly contested deal.

  • May 06, 2025

    New AG, Same DOJ Stance On Whistleblower Law

    The Trump administration's forceful defense of the qui tam provisions of the False Claims Act is significant but not surprising, given the government's increasing reliance on whistleblowers to thwart fraud and abuse.

  • May 05, 2025

    Columbia Inks $750M Settlement Over OB-GYN Sex Abuse

    A New York state court on Monday signed off on a $750 million settlement secured by hundreds of patients who say they were sexually abused by a former Columbia University obstetrician-gynecologist, according to an announcement by the patients' attorneys.

  • May 05, 2025

    DC Circ. Has Doubts About Narcolepsy Drug Appeal

    The D.C. Circuit is now set to decide whether the U.S. Food and Drug Administration was wrong to declare a rival narcolepsy treatment not the "same drug" as another produced by Jazz Pharmaceuticals Inc., after appearing highly skeptical of the drug company's arguments that it was.

  • May 05, 2025

    High Court Urged To Back HHS Authority On Preventive Care

    The federal government urged the U.S. Supreme Court on Monday to overturn a Fifth Circuit ruling that found the U.S. Department of Health and Human Services' secretary lacked authority over a preventive healthcare services task force, arguing the HHS secretary's oversight stemmed from multiple laws and precedent.

  • May 05, 2025

    UnitedHealth Tells Court Not To Review Special Master Report

    A special master rightly determined that no reasonable jury could render a verdict for the U.S. Department of Justice in a massive False Claims Act case targeting Medicare Advantage plans operated by UnitedHealth, the health insurance company told a D.C. federal judge.

  • May 05, 2025

    Trump Admin Urges Dismissal Of States' Abortion Pill Suit

    The Trump administration on Monday asked a Texas federal judge to dismiss a lawsuit seeking to roll back access to the abortion medication mifepristone, contending the three states pursuing the case waited too long to file and are suing in the wrong jurisdiction.

  • May 05, 2025

    Wash. Panel Quizzes State In Biologist's Vax Mandate Case

    Washington appellate judges hinted on Monday they might revive an ex-state biologist's suit claiming she was wrongfully denied a religious accommodation to keep her position without getting the COVID-19 vaccination, citing factual questions as to whether her job duties were essential and whether she was technically fired.  

  • May 05, 2025

    Fla. Judge Wants Briefs In ACA Trans Health Fight

    A Florida federal judge Monday requested briefing from the U.S. Department of Health and Human Services and the state of Florida on how to handle a suit challenging the Biden administration's regulations clarifying gender identity-based discrimination under the Affordable Care Act.

  • May 05, 2025

    20 AGs Sue To Stop 'Illegal Dismantling' Of HHS

    Twenty attorneys general sued the Trump administration Monday in Rhode Island federal court alleging that massive cuts to the U.S. Department of Health and Human Services violate the Constitution and usurp congressional authority.

  • May 05, 2025

    Fed. Circ. Affirms Coverage Denial Over Pre-Service Surgery

    A lower court did not err when it upheld the denial of a Navy veteran's shoulder disability claim based on a surgery that he had before entering the service, a Federal Circuit panel ruled.

  • May 05, 2025

    Kaiser Permanente Escapes 401(k) Forfeiture Suit, For Now

    A California federal judge tossed a proposed class action alleging Kaiser Permanente misspent forfeitures from an employee 401(k) plan, concluding the allegations failed to state a claim for a violation of federal benefits law.

  • May 05, 2025

    Novartis, Incyte Settle Drug Royalty Fight On Eve Of Trial

    A Manhattan federal judge put off trial on Monday in a five-year quest by Novartis to recover what it says are $500 million in missing royalties from its agreement to commercialize an Incyte compound used to treat blood cancers, with the sides announcing they reached a settlement.

  • May 02, 2025

    Fla. Lawmakers Vote To Repeal Law That Limits Death Suits

    Florida lawmakers have voted to do away with a statute that plaintiffs attorneys say unfairly and arbitrarily limits pain-and-suffering damages in fatal medical malpractice cases, but an attorney representing healthcare providers says that repealing the law will cause a flood of new lawsuits.

  • May 02, 2025

    Ill. Judge Questions Legal Theory In Multiplan Pricing MDL

    An Illinois federal judge handling multidistrict litigation accusing Multiplan of conspiring with insurers to fix out-of-network reimbursement rates seemed unsure Friday that a viable antitrust theory is at play, saying the plaintiffs' alleged market dynamic seems similar to various individuals independently deciding to hire the same "really good painter."  

  • May 02, 2025

    Boston Scientific, FDA Sued Over 'Unsafe' Spinal Implant

    Boston Scientific evaded safety regulations to market a defective spinal cord stimulator and the U.S. Food and Drug Administration rubber-stamped those alterations in an instance of "agency capture," according to a California federal lawsuit filed by a patient suffering from ongoing pain after the device was implanted.

  • May 01, 2025

    Planned Parenthood Slams HHS 'Attacks' On Teen Program

    Planned Parenthood on Thursday pressed a D.C. federal court to block the U.S. Department of Health and Human Services' "attacks" on a long-running, successful public health initiative aimed at preventing teen pregnancy, claiming that HHS has implemented new, "deeply inconsistent" requirements threatening the program's funding.

  • May 01, 2025

    Aetna And Humana Accused Of Medicare Kickbacks And Bias

    The federal government brought a bombshell False Claims Act suit Thursday against Aetna, Elevance and Humana, claiming the insurers paid hundreds of millions of dollars in illegal kickbacks to brokers in exchange for enrollments into their Medicare Advantage plans, with Humana and Aetna also accused of discriminating against disabled beneficiaries.

  • May 01, 2025

    HHS Report Finds 'Serious Concerns' On Trans Care For Youth

    The U.S. Department of Health and Human Services on Thursday released a report it says raises "serious concerns" about medical interventions used to aid young people in gender transition.

  • May 01, 2025

    Couple's J&J Pelvic Mesh Claims Too Late, 11th Circ. Affirms

    The Eleventh Circuit held Thursday that a couple's lawsuit against Johnson & Johnson over injuries allegedly caused by a pelvic mesh device made by the company's med-tech unit was filed too late despite evidence that the woman's doctors had expressed uncertainty for years about whether the mesh was causing her pain.

  • May 01, 2025

    Publix Can't Slip 'Zero-Market Share' Opioid Claims

    Publix Super Markets Inc. can't slip opioid-related claims from nine municipalities in which the supermarket chain alleges it has no pharmacies, an Ohio federal judge overseeing sprawling national opioid litigation ruled.

  • May 01, 2025

    CFPB, Lenders Float Deal To Vacate Medical Debt Rule

    The Consumer Financial Protection Bureau has agreed to a proposed consent judgment that would vacate a Biden-era rule banning an estimated $49 billion in medical debt from credit reports, striking a deal with lender trade groups that sued in Texas federal court to block the rule.

  • May 01, 2025

    PBMs Tell 6th Circ. Ohio's Pricing Case Belongs In Fed Court

    Express Scripts and Prime Therapeutics urged the Sixth Circuit to undo a district court order returning a lawsuit from Ohio's attorney general alleging they drove up prescription drug prices to state court, arguing Wednesday an after-the-fact disclaimer of federal program-based claims isn't enough to sever a federal law connection.

  • May 01, 2025

    J&J Talc Unit Says New Doc 'Key' To Talc Study Libel Suit

    A Johnson & Johnson talc unit has asked a New Jersey federal court to reinstate its libel suit over a scientific article linking talcum powder to mesothelioma, arguing that newly discovered evidence shows statements in the article are false.

Expert Analysis

  • 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.

  • Preserving The FCA Is Crucial In Trump's 2nd Term

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    While the Trump administration may pursue weaker False Claims Act enforcement, it remains an essential tool in safeguarding public funds and maintaining corporate accountability, so now is not the time to undermine ethical behavior, or reduce protections and incentives for whistleblowers, says Adam Pollock at Pollock Cohen.

  • PREVAIL Bill Is Another Misguided Attempt To Restrict PTAB

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    The decade-long campaign against the U.S. Patent and Trademark Office's Patent Trial and Appeal Board — currently focused on the PREVAIL Act that's slated for markup in the Senate — is not really about procedural issues, and it is not aimed at securing more accurate patentability decisions, says Clear IP's Joseph Matal, former acting director at the USPTO.

  • Justices Face Tough Question On HHS Hospital Pay Formula

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    In Advocate Christ Medical Center v. Becerra, the U.S. Supreme Court will determine whether the U.S. Department of Health and Human Services properly applied certain Medicare reimbursement adjustments to hospitals — a decision that could significantly affect hospitals' ability to seek higher Medicare reimbursement for low-income patients, say attorneys at Sheppard Mullin.