Policy & Compliance

  • 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.

  • May 23, 2024

    UBH Urges 9th Circ. To Take Up Petition In Health Claim Fight

    United Behavioral Health implored the Ninth Circuit to grant the insurance company's petition for appellate court intervention in a consolidated action alleging mismanagement of mental health and substance use disorder treatment claims, arguing a California federal court clearly erred by allowing further pleadings on a denial of benefits claim.

  • May 23, 2024

    Ambulance Co. Owner Accused Of $1M Pandemic Loan Fraud

    The owner of a California ambulance company who was charged last year with tax evasion and filing false returns has been further accused of fraudulently securing $1 million from federal pandemic relief loan programs, according to the U.S. Department of Justice.

  • May 23, 2024

    Cancer Society Strategist Starts 'New Adventure' With Venable

    Venable LLP has hired the former strategic director for the American Cancer Society's Cancer Action Network as a senior policy adviser for its legislative and government affairs practice group and its health policy team.

  • May 22, 2024

    Wash. Health System Wants $230M Worker Class Win Axed

    A Washington hospital system is seeking to derail a nearly $230 million judgement in favor of workers in a class wage case, contending the plaintiffs' key expert who testified at a state court trial recommended that jurors calculate damages based on a flawed equation that didn't account for differences in pay classifications.

  • May 22, 2024

    NC Panel Revives Retention Claim In Faulty Back Surgery Suit

    A North Carolina appeals court has revived a family's negligent retention claim against a clinic over a doctor who was ousted from the profession for unnecessary and faulty surgeries, finding the claim does not fall under the state's four-year statute of repose for medical malpractice claims.

  • May 22, 2024

    Anti-Abortion Activist Gets Two Years For DC Clinic Blockade

    An anti-abortion activist convicted of invading and blockading a Washington, D.C., reproductive health clinic was sentenced to two years of incarceration Wednesday, becoming the ninth defendant to get prison time in the D.C. federal court case.

Expert Analysis

  • Cross-Market Implications In FTC's Anesthesia Complaint

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    The Federal Trade Commission's recent complaint against a private equity firm's acquisition of anesthesiology practices highlights the controversial issue of cross-market harm in health care provider mergers, and could provide important insights into how a court may view such theories of harm, say Christopher Lau and Dina Older Aguilar at Cornerstone Research.

  • AI Can Help Lawyers Overcome The Programming Barrier

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    Legal professionals without programming expertise can use generative artificial intelligence to harness the power of automation and other technology solutions to streamline their work, without the steep learning curve traditionally associated with coding, says George Zalepa at Greenberg Traurig.

  • Preparing Law Students For A New, AI-Assisted Legal World

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    As artificial intelligence rapidly transforms the legal landscape, law schools must integrate technology and curricula that address AI’s innate challenges — from ethics to data security — to help students stay ahead of the curve, say Daniel Garrie at Law & Forensics, Ryan Abbott at JAMS and Karen Silverman at Cantellus Group.

  • ESG Around The World: South Korea

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    Numerous ESG trends have materialized in South Korea in the past three years, with impacts ranging from greenwashing prevention and carbon neutrality measures to workplace harassment and board diversity initiatives, say Chang Wook Min and Hyun Chan Jung at Jipyong.

  • General Counsel Need Data Literacy To Keep Up With AI

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    With the rise of accessible and powerful generative artificial intelligence solutions, it is imperative for general counsel to understand the use and application of data for myriad important activities, from evaluating the e-discovery process to monitoring compliance analytics and more, says Colin Levy at Malbek.

  • A Look At Healthcare Timelines Set By Biden's AI Order

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    President Joe Biden's artificial intelligence executive order establishes standards for using AI in the healthcare industry, including a number of staggered deadlines that should help coordinate a more unified federal approach to AI governance, say attorneys at Holland & Knight.

  • A Look At Successful Bid Protests In FY 2023

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    Attorneys at Sheppard Mullin look beyond the statistics in the U.S. Government Accountability Office’s recent annual report on bid protests, sharing their insights about nine categories of sustained protests, gained from reading every fiscal year 2023 decision in which the protester had a positive result.

  • Navigating Discovery Of Generative AI Information

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    As generative artificial intelligence tools become increasingly ubiquitous, companies must make sure to preserve generative AI data when there is reasonable expectation of litigation, and to include transcripts in litigation hold notices, as they may be relevant to discovery requests, say Nick Peterson and Corey Hauser at Wiley.

  • FDA's Lab-Developed Test Rule May Bring Historic Challenges

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    If finalized, the U.S. Food and Drug Administration's proposed rule for regulating laboratory-developed tests will provoke some of the most interesting legal challenges that the agency has faced in decades, with outcomes that will likely reverberate across the agency's product centers, says Stacy Amin at MoFo.

  • Finding Focus: Strategies For Attorneys With ADHD

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    Given the prevalence of ADHD among attorneys, it is imperative that the legal community gain a better understanding of how ADHD affects well-being, and that resources and strategies exist for attorneys with this disability to manage their symptoms and achieve success, say Casey Dixon at Dixon Life Coaching and Krista Larson at Stinson.

  • AI Use May Trigger False Claims Act's Public Disclosure Bar

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    The likely use of publicly available artificial intelligence tools to detect government fraud by combing through large data sets will raise complex questions about a False Claims Act provision that prohibits the filing of claims based on previously disclosed information, say Nick Peterson and Spencer Brooks at Wiley Rein.

  • Beware Privacy Risks In Training AI Models With Health Data

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    Because data used to train artificial intelligence models may be protected by the Health Insurance Portability and Accountability Act or other regulations, users of these models should conduct proper diligence to avoid costly compliance failures, say Neha Matta and Barbara Bennett at Frost Brown.

  • Unpacking GAO's FY 2023 Bid Protest Report

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    The U.S. Government Accountability Office's recent bid protest report reflects an increase in sustained protests, illustrating that disappointed offerors may see little reason to refrain from seeking corrective action — but there is more to the story, say Aron Beezley and Patrick Quigley at Bradley Arant.