Policy & Compliance

  • June 01, 2024

    Blockbuster Summer: 10 Big Issues Justices Still Must Decide

    As the calendar flips over to June, the U.S. Supreme Court still has heaps of cases to decide on issues ranging from trademark registration rules to judicial deference and presidential immunity. Here, Law360 looks at 10 of the most important topics the court has yet to decide.

  • May 31, 2024

    Final Defendant Gets 2 Years In Prison For DC Clinic Blockade

    An anti-abortion activist was sentenced to two years incarceration in D.C. federal court Friday, the final defendant to be sentenced among nine others charged in a 2020 blockade at a reproductive health clinic.

  • May 31, 2024

    Judge Doubts Okla. Can Stop Title X Cut Over Abortion Stance

    A Tenth Circuit judge appeared skeptical Friday that Oklahoma could prevent federal officials from stripping $4.5 million in funding over the state's refusal to provide abortion referrals, suggesting the state's claim of anti-abortion discrimination is better suited to an attack on Title X writ large.

  • May 31, 2024

    Judge Wonders If Wash. Social Media Ban Blocks Free Speech

    A Washington appellate judge on Friday questioned the constitutionality of a state law barring injured workers from posting video of their state workers' compensation medical exams on social media, saying it could be cutting off someone's only way of communicating with the outside world.

  • May 31, 2024

    15 States Sue To Block Biden's ACA Trans Discrimination Rule

    The Biden administration was hit with a lawsuit on Friday over its rule clarifying the application of the Affordable Care Act's nondiscrimination protections to gender identity, with a group of 15 states claiming the guidance is an effort "to enshrine sweeping gender-identity mandates without congressional consent."

  • May 31, 2024

    Texas Supreme Court Rejects Challenge To Abortion Ban

    The Texas Supreme Court unanimously rejected a petition Friday that challenged the state's near-total ban on abortion, ruling the law's narrow exceptions for pregnant women in life-threatening emergencies are broad enough to withstand a constitutional challenge.

  • May 30, 2024

    Physician, Health Cos. Spar Over Docs In Fla. Qui Tam Suit

    A doctor and several healthcare businesses accused each other of withholding evidence in a Florida federal False Claims Act lawsuit, with the doctor saying several key Zoom meeting records were destroyed, although the businesses have alleged the doctor refused to provide a financial agreement she made with a cohort.

  • May 30, 2024

    Ozempic Maker Says Texas Pharmacy Selling Knockoff Drug

    The manufacturer behind the Ozempic weight loss drug has asked a federal court to prohibit a Houston-area pharmacy from selling compounded, non-FDA-approved medications that claim to contain the drug's key ingredient.

  • May 30, 2024

    Sen. Warren Pushes CMS On 'Medical Loss Ratio' Data

    Sen. Elizabeth Warren, D-Mass., is urging the Centers for Medicare & Medicaid Services to collect more data to determine whether private healthcare insurers in Medicare Advantage that employ vertical integration are evading a statutory requirement that they spend the bulk of their earnings on medical claims.

  • May 30, 2024

    Dental Co., Ex-Worker Agree To Arbitrate OT Spat

    A New York federal judge granted a former dental assistant's request to arbitrate her claims accusing a dental company of failing to pay hourly workers all their overtime wages owed or on a weekly basis as state law mandates for manual laborers.

  • May 29, 2024

    FDA Sued Over Controversial Lab Test Rule

    A clinical lab trade group that has been highly critical of the U.S. Food and Drug Administration's new final rule on laboratory-developed tests filed a lawsuit late Wednesday, saying the agency doesn't have the authority to regulate the tests as medical devices.

  • May 29, 2024

    Acting Boston US Atty Says Fraud Cases Still High Priority

    Prosecuting a range of fraud cases despite finite resources will remain a priority for Massachusetts acting U.S. Attorney Joshua Levy as he enters his second year in the job, he told reporters on Wednesday in a question and answer session at his office.

  • May 29, 2024

    Whistleblower Counsel Can't Get 'Exorbitant' $11.5M Fee

    A Boston federal judge slashed an "exorbitant" $11.5 million fee request made by counsel for a False Claims Act whistleblower in a case involving lab testing company Fresenius Medical Care, hammering the attorneys for inflated hourly rates, inflated time entries and a host of questionable billing practices.

  • May 28, 2024

    Staffing Rule Suit, Mayo COVID Claims And An Oathless Expert

    Nursing home trade groups sue over "nightmare" staffing rule, former Mayo Clinic workers get another shot at claims they were illegally fired over COVID-19 policy breaches, and an unsworn expert letter tanks a medical malpractice suit in Iowa. Law360 Healthcare Authority looks at those and other notable developments in healthcare litigation over the past week.

  • May 28, 2024

    Alaska Opioid Suit Moves Forward In Early Loss For PBMs

    An Alaska federal judge is allowing public nuisance claims to move forward against Express Scripts as pharmacy benefit managers are increasingly targeted in opioid litigation.

  • May 28, 2024

    More States Look To Rx Boards To Tackle Drug Prices

    State efforts to tackle high drug prices are gaining momentum through the creation of special boards that can evaluate — and sometimes cap — spending on the costliest prescription drugs, a trend likely to generate legal challenges from Big Pharma.

  • May 28, 2024

    5th Circ. Flips Cancer-Drug Maker's Defeat In Hair Loss MDL

    The Fifth Circuit has vacated a summary judgment ruling in favor of four women who say two drugmakers failed to warn consumers that their chemotherapy drug could cause hair loss, saying it was impossible for the companies to simultaneously comply with federal and state failure-to-warn laws.

  • May 28, 2024

    Healthcare Tech Co. To Pay $1.5M To End Class Wage Claims

    A healthcare software consulting company agreed to a $1.5 million deal resolving claims it violated Washington state wage law by requiring its software training staff to work up to 80 hours and seven days a week, according to a motion to approve the deal filed in federal court.

  • May 28, 2024

    The Most Likely Healthcare Targets In A Post-Chevron World

    Attorneys in the healthcare arena have a keen interest in a U.S. Supreme Court challenge to the Chevron deference doctrine, particularly in light of the sheer volume of guidance issued by the U.S. Department of Health and Human Services and its subsidiary agencies. With the high court now poised to decide Chevron’s fate, Law360 looks at health law that could be targeted in a post-Chevron world.

  • May 28, 2024

    Nursing Co. Strikes Deal To End EEOC Misgendering Probe

    A Washington nursing facility has reached a deal with the U.S. Equal Employment Opportunity Commission to settle a charge from a worker who said the business sat idle while co-workers repeatedly and intentionally referred to them by the wrong pronouns.

  • May 28, 2024

    Edwards Urges Full Fed. Circ. To Limit FDA Safe Harbor

    Edwards Lifesciences has petitioned the full Federal Circuit to narrow its interpretation of a U.S. Food and Drug Administration safe harbor that essentially allows patent infringement during drug development, arguing that if Congress wanted the statute to be interpreted broadly, "it would have said exactly that."

  • May 28, 2024

    Anesthesia 'Rollup' Decision May Hurry PE Regulator Suits

    A recent Texas court ruling in a Federal Trade Commission case focused on an anesthesiology practice's alleged "rollup" strategy could spur regulators to move faster against private equity owners of healthcare businesses.

  • May 28, 2024

    'Creative' Suits Aim To End Secret Arbitration At Ariz. Facilities

    Arizona's top law enforcement official is pursuing an unusual series of legal challenges that aim to strike down confidential arbitration agreements at long-term care facilities and shine a light on allegations of elder abuse or neglect.

  • May 23, 2024

    RFK Jr.'s Anti-Vax Suit Against Wash. AG Tossed

    A Washington federal judge has dismissed a lawsuit brought by Robert F. Kennedy Jr. on behalf of NBA legend John Stockton trying to shield doctors who make anti-vaccine statements, ruling claims that a medical board probe has chilled speech are speculative.

  • May 23, 2024

    NJ Justices Toss Direct Appeals Over Hospital Contract Bid

    The New Jersey Supreme Court ruled Thursday that an independent state-owned teaching hospital's conduct cannot be challenged directly in the state's intermediate appellate court because it isn't considered an administrative agency, affirming the dismissal of two protests over the hospital's selection of a pharmacy vendor.

Expert Analysis

  • FDA's Recent Litigation Records Are Strong, But Imperfect

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    The U.S. Food and Drug Administration has notched its share of litigation wins in recent years thanks to a number of key advantages, but the FDA has been less successful in certain highly visible arenas, Jonathan Berman and Colleen Heisey at Jones Day.

  • 5 Steps For Healthcare Companies After Biden's AI Order

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    Rather than simply monitoring for the issuance of agency guidelines on artificial intelligence in the wake of President Joe Biden's October executive order, health and life sciences companies should take action now and begin building internal operational and technical infrastructures designed to govern the use of AI, says Joy Sharp at Faegre Drinker.

  • Giving The Gov't Drug Patent March-In Authority Is Bad Policy

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    The Biden administration's recent proposal to allow government seizure of certain taxpayer-funded drug patents is a terrible idea that would negate the benefits of government-funded research, to the detriment of patients and the wider economy, says Wayne Winegarden at Pacific Research Institute.

  • How Clients May Use AI To Monitor Attorneys

    Excerpt from Practical Guidance
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    Artificial intelligence tools will increasingly enable clients to monitor and evaluate their counsel’s activities, so attorneys must clearly define the terms of engagement and likewise take advantage of the efficiencies offered by AI, says Ronald Levine at Herrick Feinstein.

  • When Patients Have Standing For Hospital Antitrust Suits

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    Brown v. Hartford Healthcare Corp., recently decided by a Connecticut state court, provides a useful examination of how antitrust standing issues may be analyzed when patients directly sue a healthcare system for anti-competitive conduct, says Charles Honart at Stevens & Lee.

  • ESG Around The World: Singapore

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    Singapore is keen to establish itself as a leading international financial center and a key player in the sustainable finance ecosystem, and key initiatives led by its government and other regulatory bodies have helped the Asian nation progress from its initially guarded attitude toward ESG investment and reporting, say attorneys at Morgan Lewis.

  • The Pop Culture Docket: Judge D'Emic On Moby Grape

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    The 1968 Moby Grape song "Murder in My Heart for the Judge" tells the tale of a fictional defendant treated with scorn by the judge, illustrating how much the legal system has evolved in the past 50 years, largely due to problem-solving courts and the principles of procedural justice, says Kings County Supreme Court Administrative Judge Matthew D'Emic.

  • Performing Music Makes Me A Better Lawyer

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    The discipline of performing live music has directly and positively influenced my effectiveness as a litigator — serving as a reminder that practice, intuition and team building are all important elements of a successful law practice, says Jeff Wakolbinger at Bryan Cave.

  • 'Patient' Definition Ruling Raises Discount Drug Questions

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    A South Carolina federal court's recent decision in Genesis Health Care v. Becerra supports a broader definition of a "patient" eligible to receive discounted drugs under the Section 340B program, but raises a host of novel questions regarding how the decision will affect covered entities and enforcement actions, say attorneys at McDermott.

  • Breaking Down High Court's New Code Of Conduct

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    The U.S. Supreme Court recently adopted its first-ever code of conduct, and counsel will need to work closely with clients in navigating its provisions, from gift-giving to recusal bids, say Phillip Gordon and Mateo Forero at Holtzman Vogel.

  • Legal Profession Gender Parity Requires Equal Parental Leave

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    To truly foster equity in the legal profession and to promote attorney retention, workplaces need to better support all parents, regardless of gender — starting by offering equal and robust parental leave to both birthing and non-birthing parents, says Ali Spindler at Irwin Fritchie.

  • Activist Short-Sellers Are The Dark Knights Of Wall Street

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    While so-called activist short-sellers have been subject to increased scrutiny in recent years, these investors work in the shadows like Batman to expose fraud on Wall Street, often generating leads that may move regulators to take action, say attorneys at Labaton Sucharow.

  • Steps Toward A Unified Health Financing System For Calif.

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    A new law authorizes the secretary of the California Health and Human Services Agency to move forward with designing a unified healthcare financing system, though the notable absence of healthcare payers in the law's list of specified stakeholders raises questions about the state's position regarding private payer options, says Ima Nsien at Squire Patton.