Policy & Compliance

  • July 08, 2024

    DC Circ. Supports NLRB Order Against Puerto Rico Hospital

    The National Labor Relations Board rightly found that a hospital in Puerto Rico violated federal labor law by unilaterally slashing workers' hours, the D.C. Circuit ruled, saying the hospital can't excuse its actions with claims about financial effects from the pandemic.

  • July 08, 2024

    Hospital Must Face Ex-Worker's Religious Bias Suit

    An Oregon federal judge refused to release a hospital from a former employee's suit claiming she was fired because she objected to receiving a COVID-19 vaccine in light of her Christian beliefs, saying a jury is best suited to decide if there was bias when the company refused to accommodate her.

  • July 05, 2024

    9th Circ. Backs Remand Of Cedars-Sinai Patient Data Suits

    The Ninth Circuit held Friday that a trio of proposed class actions accusing Cedars-Sinai of improperly sharing patients' personal information with tech companies indeed belong in California state court, agreeing with a lower court that the health provider wasn't acting at the direction of the federal government.

  • July 05, 2024

    How Reshaped Circuit Courts Are Faring At The High Court

    Seminal rulings from the U.S. Supreme Court's latest term will reshape many facets of American society in the coming years. Already, however, the rulings offer glimpses of how the justices view specific circuit courts, which have themselves been reshaped by an abundance of new judges.

  • July 05, 2024

    Breaking Down The Vote: The High Court Term In Review

    The U.S. Supreme Court's lethargic pace of decision-making this term left the justices to issue a slew of highly anticipated and controversial rulings during the term's final week — rulings that put the court's ideological divisions on vivid display. Here, Law360 takes a data dive into the numbers behind this court term.

  • July 05, 2024

    High Court Flexes Muscle To Limit Administrative State

    The U.S. Supreme Court's dismantling of a 40-year-old judicial deference doctrine, coupled with rulings stripping federal agencies of certain enforcement powers and exposing them to additional litigation, has established the October 2023 term as likely the most consequential in administrative law history.

  • July 05, 2024

    The Sharpest Dissents From The Supreme Court Term

    The U.S. Supreme Court's session ended with a series of blockbuster cases that granted the president broad immunity, changed federal gun policy and kneecapped administrative agencies. And many of the biggest decisions fell along partisan lines.

  • July 05, 2024

    5 Moments That Shaped The Supreme Court's Jan. 6 Decision

    When the high court limited the scope of a federal obstruction statute used to charge hundreds of rioters who stormed the Capitol, the justices did not vote along ideological lines. In a year marked by 6-3 splits, what accounts for the departure? Here are some moments from oral arguments that may have swayed the justices.

  • July 05, 2024

    The Funniest Moments Of The Supreme Court's Term

    In a U.S. Supreme Court term teeming with serious showdowns, the august air at oral arguments filled with laughter after an attorney mentioned her plastic surgeon and a justice seemed to diss his colleagues, to cite just two of the term's mirthful moments. Here, we look at the funniest moments of the term.

  • July 05, 2024

    Hackensack Meridian Sues Feds, Citing Chevron Ruling

    After the U.S. Supreme Court overturned the Chevron deference last month, making it easier to challenge federal regulators in court, New Jersey's largest healthcare network became one of the first to seek remedies citing the ruling.

  • July 05, 2024

    The Firms That Won Big At The Supreme Court

    This U.S. Supreme Court term featured high-stakes oral arguments on issues including gerrymandering, abortion and federal agency authority, and a hot bench ever more willing to engage in a lengthy back-and-forth with advocates. Here's a look at the law firms that argued the most cases and how they fared.

  • July 03, 2024

    HHS Scores Early Win In Boehringer's Medicare Pricing Suit

    A Connecticut federal judge on Wednesday sided with the U.S. Department of Health and Human Services in Boehringer Ingelheim's challenge to a new Medicare drug price negotiation program, rejecting the pharmaceutical company's claim that the program is unconstitutional.

  • July 03, 2024

    Red States Get ACA Trans Discrimination Rule Blocked

    Federal judges in Mississippi and Texas granted conservatives states' requests Wednesday to freeze a new rule protecting access to healthcare for the LGBTQ+ community, with both judges ruling that states are likely to succeed in showing that the U.S. Department of Health and Human Services overstepped when it created the regulations.

  • July 03, 2024

    Contentious Ala. Gender Care Case Partly Paused

    Favoring "judicial efficiency," an Alabama federal court has partially granted the Biden administration's opposed motion to stay a case challenging the state's ban on gender-affirming healthcare for transgender youth while the U.S. Supreme Court reviews a similar Tennessee ban, though some briefing, including for summary judgment, was permitted to proceed.

  • July 03, 2024

    4 Mass. Rulings You Might Have Missed In June

    Massachusetts state courts last month dealt with thorny contract disputes, mistakenly disclosed emails between a defendant and an attorney, and a company's overtime policy change that may not have been spelled out to workers.

  • July 03, 2024

    Gov't Says Justices' Decision Doesn't Fully Solve OT Suit

    The recent U.S. Supreme Court decision pushing deadlines to challenge federal regulations doesn't entirely solve an overtime dispute between three home care companies and the U.S. Department of Labor, the government told the Third Circuit.

  • July 03, 2024

    NC Appeals Court OKs Hospital's 'Facility Fees' For ER Patient

    The North Carolina Court of Appeals has found that Novant Health was allowed to charge an emergency room patient "facility fees" because a contract she signed for healthcare included language requiring payment for anything not covered by insurance.

  • July 03, 2024

    Steward Health Downfall Prompts Calls For Tighter Regs

    The magnitude of the financial troubles plaguing bankrupt hospital operator Steward Health Care has turned the Chapter 11 case into a flash point that should prompt a regulatory overhaul, according to a new report released by advocacy group Private Equity Stakeholder Project.

  • July 02, 2024

    Chamber, Pharma Slam Colorado Drug Price Controls

    The U.S. Chamber of Commerce and a prominent pharmaceutical industry group have urged a Colorado federal court to bar a state review board from setting price controls on prescription drugs, arguing that the practice is "irreconcilable" with federal patent law.

  • July 02, 2024

    Ga. Justices Say COVID Order Tolls Med Mal Repose Statute

    The Georgia Supreme Court on Tuesday said that a judicial emergency order handed down during the COVID-19 pandemic can be used to toll the state's five-year medical malpractice statute of repose.

  • July 02, 2024

    Abortion, Trans Healthcare Top Lower Court Litigation

    Major healthcare decisions at the U.S. Supreme Court dominated the headlines in recent weeks. But there has also been significant movement in state and other appellate courts on the Affordable Care Act, Medicaid coverage, and transgender care, and among other weighty matters. Law360 Healthcare Authority looks at the significant disputes and decisions that shaped the industry over the last week.

  • July 02, 2024

    4 Takeaways From FDA's Clinical Trial Diversity Guidance

    Long-awaited U.S. Food and Drug Administration guidance sheds new light on clinical trial action plans meant to improve health outcomes for more populations. Here are four takeaways from the FDA's latest clinical trial diversity guidelines.

  • July 02, 2024

    Arizona AG Abortion Opinion May Influence Courts, Doctors

    A new advisory opinion reassuring Arizona doctors they can use their good-faith judgment to provide an emergency abortion, despite a 15-week state ban, isn’t binding on the courts. But it may still exert influence on judges and prosecutors in a state with a fast-changing abortion landscape.

  • July 02, 2024

    Veteran Medicare Advocate Judy Stein Welcomes 'New Cadre'

    In 1986, Connecticut attorney Judy Stein took out a loan to launch the Center for Medicare Advocacy in a one-room office above a bakery. Today, she's reflecting on a career fighting for people in need of healthcare support, including the landmark Jimmo settlement, as she welcomes new leadership to the group.

  • July 02, 2024

    3rd Circ. Asked To Remand OT Suit After Justices' Ruling

    Three home care companies in overtime disputes with the U.S. Department of Labor urged the Third Circuit to reverse and remand a ruling that they waited too long to challenge a 2013 ruling on in-home caregivers' ability to earn minimum wage under a new U.S. Supreme Court precedent.

Expert Analysis

  • Class Actions At The Circuit Courts: June Lessons

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    In this month's review of class action appeals, Mitchell Engel at Shook Hardy considers two recent decisions from the Third and Tenth Circuits, and identifies practice tips around class action settlements and standing in securities litigation.

  • How Congress Is Tackling The US Healthcare Shortage

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    With healthcare shortages continuing across the U.S. despite industry efforts to improve patient access to care, increased Medicare support for graduate medical education could be a crucial component of the solution, say Sarah Crossan and Miranda Franco at Holland & Knight.

  • The Current State Of Healthcare Transaction Reviews In Calif.

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    As of April, certain healthcare transactions in California have been subject to additional notification compliance requirements, and complying with these new rules could significantly delay and discourage some deals, says Andrew Demetriou at Husch Blackwell.

  • High Court's Abortion Pill Ruling Shuts Out Future Challenges

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    The U.S. Supreme Court's unanimous ruling in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine maintains the status quo for mifepristone access and rejects the plaintiffs' standing theories so thoroughly that future challenges from states or other plaintiffs are unlikely to be viable, say Jaime Santos and Annaka Nava at Goodwin.

  • Orange Book Warnings Highlight FTC's Drug Price Focus

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    In light of heightened regulatory scrutiny surrounding drug pricing and the Federal Trade Commission's activity in the recent Teva v. Amneal case, branded drug manufacturers should expect the FTC's campaign against allegedly improper Orange Book listings to continue, say attorneys at Ropes & Gray.

  • A Plaintiffs-Side Approach To Cochlear Implant Cases

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    As the number of cochlear implants in the U.S. continues to grow, some will inevitably fail — especially considering that many recalled implants remain in use — plaintiffs attorneys should proactively prepare for litigation over defective implants, says David Shoop at Shoop.

  • Inside Antitrust Agencies' Rollup And Serial Acquisition Moves

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    The recent request for public comments on serial acquisitions and rollup strategies from the Federal Trade Commission and U.S. Justice Department mark the antitrust agencies' continued focus on actions that fall below premerger reporting thresholds, say attorneys at Paul Weiss.

  • Short-Term Takeaways From CMS' New Long-Term Care Rules

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    The Centers for Medicare & Medicaid Services' new final rule on nursing home staffing minimums imposes controversial regulatory challenges that will likely face significant litigation, but for now, stakeholders will need to prepare for increased staffing expectations and more specialized facility assessments without meaningful funding, say attorneys at Morgan Lewis.

  • FDA's Data Monitoring Guidance Reveals Future Expectations

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    As the world of clinical research grows increasingly complex, the U.S. Food and Drug Administration's recent draft guidance on the use of data monitoring committees in clinical trials reveals how the agency expects such committees to develop, say Melissa Markey and Carolina Wirth at Hall Render.

  • FDA Warning Indicates Scrutiny Of Regenerative Health Cos.

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    The U.S. Food and Drug Administration's recent warning letter to Akan Biosciences is a quintessential example of the agency's enforcement priorities for certain products involving human cells and tissues, and highlights ongoing scrutiny placed on manufacturers, say Dominick DiSabatino and Cortney Inman at Sheppard Mullin.

  • 2 Regulatory Approaches To Psychedelic Clinical Trials

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    Comparing the U.S. and Canada's regulatory frameworks for clinical trials of psychedelic drugs can be useful for designing trial protocols that meet both countries' requirements, which can in turn help diversify patient populations, bolster data robustness and expedite market access, say Kimberly Chew at Husch Blackwell and Sabrina Ramkellawan at AxialBridge.

  • 'Food As Health' Serves Up Fresh Legal Considerations

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    The growth of food as medicine presents a significant opportunity for healthcare organizations and nontraditional healthcare players to improve patient outcomes and reduce costs, though these innovative programs also bring compliance considerations that must be carefully navigated, say attorneys at McDermott.

  • DC Circ. Ruling Heightens HHS Contract Pharmacy Challenges

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    The D.C. Circuit's recent ruling that the Section 340B program does not bar manufacturers from restricting deliveries of discounted drugs to contract pharmacies represents a second strike against the U.S. Department of Health and Human Services' current contract pharmacy policy and raises the stakes surrounding an upcoming Seventh Circuit ruling on the same issue, say attorneys at Foley Hoag.