Policy & Compliance

  • 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.

  • May 21, 2024

    FTC Noncompete Ban Raises Stakes For Nonprofit Hospitals

    The Federal Trade Commission seems eager to apply its employee noncompete ban to healthcare, with a key target in mind: nonprofit healthcare providers that, in the agency's view, act more like for-profit businesses.

  • May 21, 2024

    Judge Shopping Row, Henrietta Lacks And SC Abortion Clock

    BigLaw lawyers get deeper into sanction spat, a case over profits from harvested cancer cells, and a Texas Supreme Court decision in a Fen-Phen malpractice suit. Law360 Healthcare Authority looks at those and other developments from the week in healthcare litigation.

  • May 21, 2024

    DC Circ. Says Drugmakers Can Limit Pharmacy Discounts

    The D.C. Circuit held Tuesday that a federal drug discount program does not bar manufacturers from restricting deliveries of discounted drugs to contract pharmacies, rejecting the U.S. Department of Health and Human Services' expansive interpretation of the 340B drug pricing program.

  • May 21, 2024

    Mich. Judge Doubts Abortion Laws Pass Constitutional Muster

    A Michigan state judge on Tuesday was skeptical state regulators could impose a waiting period and other requirements on people seeking abortions without violating a state constitutional amendment enshrining the right to abortion.

  • May 21, 2024

    NY High Court Upholds State Abortion Coverage Mandate

    New York's highest court on Tuesday upheld a state law requiring employee health plans to cover medically necessary abortions, finding a 2021 U.S. Supreme Court decision didn't change the state court's determination that an exemption process in the law was constitutional.

  • May 21, 2024

    Counties Not 'Persons' In Texas Opioid MDL Appeal

    A Texas appeals panel found Tuesday that counties are not considered "persons" under the state's common law and therefore are not subject to the Texas Medical Liability Act's requirement that they serve expert reports to pharmacy defendants in the state's opioid multidistrict litigation.

  • May 21, 2024

    Custom Drug Makers Stay On DOJ Radar In Fla. Fraud Case

    Federal law enforcement's stake in a recent whistleblower lawsuit focused on expensive skin creams shows the agency's focus on pharmacies providing custom medications — long recognized as a lucrative avenue for Medicare fraudsters — hasn't waned.

  • May 21, 2024

    Experts Skeptical Of Federal Plan To Address Drug Shortages

    A recent federal proposal meant to ease drug shortages by giving hospitals a incentive to stockpile medications may do more harm than good in the effort to ensure drugs are consistently available.

  • May 21, 2024

    Ga. Says Feds Shouldn't Prevail In Medicaid Expansion Suit

    Georgia urged a federal judge on Monday not to rule in favor of the Biden administration in its suit attempting to keep its Medicaid program for low-income residents running until 2028, arguing the government has "no authority" to make it apply for a program extension when "illegal acts" delayed the program's launch.

  • May 21, 2024

    Baker Donelson Lands Health Law Pair From Nelson Mullins

    Baker Donelson Bearman Caldwell & Berkowitz PC has added to its health law group and data protection, privacy and cybersecurity team two attorneys who previously worked at Nelson Mullins Riley & Scarborough LLP.

  • May 21, 2024

    Strategic Hiring Was The New Normal For BigLaw In 2023

    The 400 largest law firms by headcount in the U.S. grew more slowly in 2023 than in the previous two years, while Kirkland & Ellis LLP surpassed the 3,000-attorney threshold, according to the latest Law360 ranking.

  • May 21, 2024

    The Law360 400: Tracking The Largest US Law Firms

    The legal market expanded more tentatively in 2023 than in previous years amid a slowdown in demand for legal services, especially in transactions, an area that has been sluggish but is expected to quicken in the near future.

  • May 21, 2024

    Paul Hastings' FDA Chair Departs For Arnold & Porter

    The chair of the U.S. Food and Drug Administration practice at Paul Hastings LLP has left for Arnold & Porter Kaye Scholer LLP just a few months after joining Paul Hastings, the firm said Tuesday.

  • May 20, 2024

    Texas Atty Chided For 'Crappy Strategy' Of Ducking Subpoena

    A transplant surgeon at Memorial Hermann Texas Medical Center accused of tampering with patients' donor acceptance criteria failed to show up to a Houston court hearing — partly thanks to his attorney — in three families' wrongful death case after being subpoenaed, in what a Harris County judge told his attorney was "a crappy strategy."

Expert Analysis

  • How To Navigate The FTC's New Private Equity Frontier

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    The Federal Trade Commission's recent district court complaint against an anesthesia firm and its private equity partner tests key bounds of the agency's stand-alone authority, and defense strategies can include challenges to both the geographic and the service market fronts, say attorneys at Baker McKenzie.

  • Newman Suspension Shows Need For Judicial Reform

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    The recent suspension of U.S. Circuit Judge Pauline Newman following her alleged refusal to participate in a disability inquiry reveals the need for judicial misconduct reforms to ensure that judges step down when they can no longer serve effectively, says Aliza Shatzman at The Legal Accountability Project.

  • An Overview Of Congress' Proposed Drug Shortage Solutions

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    Recently, Congress has seen a number of bipartisan bills that seek to prevent and respond to national drug shortages, though disagreements over the right vehicle and timeline have slowed progress, says Miranda Franco at Holland & Knight.

  • SEC's Life Sciences Actions Utilize Novel Tools And Theories

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    Recent enforcement actions show that the U.S. Securities and Exchange Commission is employing new forms of data analytics and noteworthy applications of insider trading laws in its scrutiny of fraud within the life sciences and health industries, say Edward Imperatore and Jina Choi at MoFo.

  • ESG Around The World: Japan

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    Japan is witnessing rapid developments in environmental, social and corporate governance policies by making efforts to adopt a soft law approach, which has been effective in encouraging companies to embrace ESG practices and address the diversity of boards of directors, say Akira Karasawa and Landry Guesdon at Iwata Godo.

  • How And Why Your Firm Should Implement Fixed-Fee Billing

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    Amid rising burnout in the legal industry and client efforts to curtail spending, pivoting to a fixed-fee billing model may improve client-attorney relationships and offer lawyers financial, logistical and stress relief — while still maintaining profit margins, say Kevin Henderson and Eric Pacifici at SMB Law Group.

  • Potential Broader Effects Of FDA's Lab-Developed Test Rule

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    Though it's unclear whether the U.S. Food and Drug Administration's proposed rule for regulating lab-developed tests will ever go into effect, it nonetheless functions as a threatened hammer that may make legislative efforts to regulate such tests more palatable, say attorneys at King & Spalding.

  • Judicial Independence Needs Defense Amid Political Threats

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    Amid recent and historic challenges to the judiciary from political forces, safeguarding judicial independence and maintaining the integrity of the legal system is increasingly urgent, says Robert Peck at the Center for Constitutional Litigation.

  • 2 New Ways FDA Is Changing Lab-Developed Test Regulation

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    The U.S. Food and Drug Administration's recently announced rulemaking and voluntary pilot program signal the agency's dedication to ramping up oversight of lab-developed tests, which have been largely unregulated by the FDA until now, say attorneys at Sidley.

  • How Law Firms Can Use Account-Based Marketing Strategies

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    Amid several evolving legal industry trends, account-based marketing can help law firms uncover additional revenue-generating opportunities with existing clients, with key considerations ranging from data analytics to relationship building, say Jennifer Ramsey at stage LLC and consultant Gina Sponzilli.

  • AGs' Distaste For Food Bill May Signal Other State Issues

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    States' recent opposition to a proposed federal law that would block them from regulating out-of-state agricultural production could affect issues beyond this narrow debate, such as the balance of state and federal regulatory power, reproductive rights post-Dobbs, and energy production and water use, say Christopher Allen and Stephen Cobb at Cozen O'Connor.

  • Strategic Succession Planning At Law Firms Is Crucial

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    Senior partners' reluctance to retire, the rise of the nonequity partner tier and generational differences in expectations are all contributing to an increasing number of departures from BigLaw, making it imperative for firms to encourage retirement among senior ranks and provide clearer leadership pathways to junior attorneys, says Laura Leopard at Leopard Solutions.

  • What An NCAA Drug Test Change Could Mean For Cannabis

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    If the NCAA follows through with its decision to remove cannabis from its banned list of substances, it will affect college athletes, athletic directors, public relations employees, and marketing departments at universities and colleges, and it will have a significant economic effect on the cannabis industry, say Stanley Jutkowitz and Sydney Jenkins at Seyfarth.