Policy & Compliance

  • August 14, 2024

    Texas Sues HHS Over 'Arbitrary' Nursing Home Staffing Rule

    The state of Texas on Wednesday challenged a new federal rule that sets minimum staffing standards at nursing homes, contending the Biden administration overstepped its statutory authority and crafted a rule almost impossible to meet because of nursing shortages.

  • August 14, 2024

    HHS Calls For More Research, Planning To Combat Heat Risks

    Citing a sharp increase in deaths from extreme heat, the Biden administration unveiled a national strategy Wednesday that calls for better communicating the health risks of hot weather to the public and taking other steps to protect people from life-threatening heat waves.

  • August 14, 2024

    1st Circ. Revives Vax Refusal Suit Against Beth Israel

    The First Circuit on Tuesday revived a suit against health facility system Beth Israel Lahey Health Inc. from an office manager who was fired over her refusal to be vaccinated against COVID-19, disagreeing with a lower court that said she hadn't shown a genuine religious belief meriting a vaccine exemption.

  • August 14, 2024

    Medical Device Maker Pleads Guilty To $2.4M Tax Evasion

    A man who made millions of dollars on medical devices and sold one purporting to eradicate viruses by using sound waves pled guilty to evading $2.4 million in taxes in a trust scheme involving his girlfriend, according to Florida federal court documents.

  • August 13, 2024

    CMS Takes Baby Steps In New 'Breakthrough' Device Policy

    The Centers for Medicare and Medicaid Services recently finalized highly anticipated guidance providing a new pathway for Medicare coverage of breakthrough medical devices, but attorneys worry the agency's plans to accept just five products each year will blunt the program's impact.

  • August 13, 2024

    Test-Makers See Way Out Of FDA Rule With Chevron Reversal

    This spring, despite widespread industry opposition, the U.S. Food and Drug Administration granted itself oversight of laboratory-developed diagnostic tests. Now, industry groups say they're facing a costly and convoluted agency approval process — one they hope they can dismantle based on the Supreme Court's recent decision to overturn Chevron deference.

  • August 13, 2024

    Wash. Social Media Ban Violates Workers' Free Speech

    The Washington State Court of Appeals has said a state law barring injured workers from posting videos of their state workers' compensation medical exams on social media is an unconstitutional violation of free speech rights.

  • August 13, 2024

    Biotechs Walk Tightrope On Drug Price Negotiation Messaging

    Biotech companies whose products have been affected by Medicare price negotiations under the Inflation Reduction Act largely reassured investors on recent earnings calls of their success, even as they argue in court that the program could upend their businesses and the larger industry.

  • August 13, 2024

    NC Lawmakers Ask 4th Circ. To Restore Abortion Drug Limits

    North Carolina Republican lawmakers want the Fourth Circuit to reinstate restrictions on the abortion drug mifepristone, telling the court the new rules concerning the medication are not preempted by U.S. Food and Drug Administration regulations.

  • August 13, 2024

    NY, NJ And Conn. Score $4.5M Penalty Over Enzo Data Breach

    Molecular diagnostics company Enzo Biochem Inc. has agreed to pay a $4.5 million penalty after an investigation found that the company failed to implement recommended security protocols ahead of a data breach that affected millions of patients, New York's attorney general announced Tuesday.

  • August 13, 2024

    Janssen Wants New FCA Trial As Relators Seek $1.85B Win

    Janssen has urged a New Jersey federal judge to toss a jury's $150 million False Claims Act verdict that found the pharmaceutical company illegally profited from the off-label marketing of popular HIV medications, while whistleblowers have asked the court for a whopping $1.85 billion judgment consisting of trebled damages and statutory penalties.

  • August 13, 2024

    FTC Makes 2nd Request In Review Of Medical Device Co. Deal

    Medical device company Surmodics Inc. disclosed Monday that federal regulators are taking a closer look at its agreement to be acquired by private equity giant GTCR in a $627 million deal.

  • August 13, 2024

    As Attacks Rise, OSHA Lags On Health Workplace Protections

    State and federal lawmakers are considering legislation to combat the growing issue of healthcare workplace violence, but legal experts say the Occupational Safety and Health Administration still lacks specific rules for healthcare workplaces even as it brings claims against them for failing to protect workers.

  • August 12, 2024

    9th Circ. Won't Rethink Upending Sutter Health Antitrust Win

    The Ninth Circuit refused Monday to reconsider a panel's split decision overturning Sutter Health's defeat of insurance plan purchasers' $400 million antitrust suit, summarily rejecting hospital system arguments that the court wrongly put in play corporate "purpose" and decades-old communications.

  • August 12, 2024

    Paragard IUD Makers Gearing Up For Defect Dismissal Bid

    Teva Pharmaceuticals and The Cooper Cos. have five days to reach out to plaintiffs who may be included in a motion to dismiss the sprawling litigation over alleged defects in the Paragard IUD, a Georgia federal judge said Monday.

  • August 12, 2024

    NJ Hospital Ex-Worker's Tactics Doom Class Cert., Court Told

    A former employee of a New Jersey healthcare network who seeks to certify a class of employees alleging they were denied proper overtime didn't comply with deposition requests, the company told a federal court, arguing that the certification request should be denied.

  • August 12, 2024

    Big Tobacco To Pay $600M In 'Historic' Mass. Deal

    Philip Morris Inc. and RJ Reynolds Tobacco Co. will pay nine-figure sums as part of a $600 million settlement between Massachusetts and major tobacco companies that resolves yearslong disputes about how much the cigarette makers owe, the state attorney general announced Monday.

  • August 09, 2024

    Takeda Should Face Certified Antitrust Classes, Judge Says

    A New York federal judge on Friday recommended certifying two classes of direct purchasers and end payors in consolidated antitrust actions accusing Takeda Pharmaceuticals Co. of unlawfully inflating the price of its diabetes treatment Actos by delaying entry of generic alternatives.

  • August 09, 2024

    Valeant's Legal Gripe A Total 'Nothingburger,' Justices Told

    A lawyer who assembled a whistleblower lawsuit against a major pharmaceutical company using publicly available patent board filings says the larger legal question of whether he can do that is way too niche for the U.S. Supreme Court to bother thinking about.

  • August 09, 2024

    Medicare Drug Price Suit Nixed Over 'Forum Shopping' In Ohio

    The Department of Health and Human Services has notched yet another win in litigation challenging the constitutionality of the Medicare drug price negotiation program, securing the dismissal of a suit brought by several chambers of commerce.

  • August 09, 2024

    DC Circ. Pans Suit Claiming HHS Caused Health Aid Shortage

    The D.C. Circuit said Friday that a judge properly dismissed a proposed class action blaming the U.S. Department of Health and Human Services for a lack of home health aides willing to assist Medicare beneficiaries with chronic illnesses, saying the private providers aren't required to accept those patients.

  • August 09, 2024

    FDA Rejects Latest Effort To Treat PTSD With MDMA

    The U.S. Food and Drug Administration has rejected a new drug application to treat post-traumatic stress disorder with the psychedelic drug MDMA, an entactogen also known as ecstasy or molly, the company that backed the effort announced Friday.

  • August 09, 2024

    Aetna Illegally Axed Exec's Disability Benefits, Judge Says

    A California federal judge said Aetna was wrong to end an executive's disability benefits after it found he suffered from a mental illness instead of a physical disability, stating the insurer used flawed doctor opinions and may have been motivated by cutting costs.

  • August 07, 2024

    Feds Let The Wrong Family Bury Hopi Artist's Body, Kids Say

    The children of a renowned Hopi artist have sued the United States in Arizona federal court on claims that an Indian Health Service facility gave their deceased mother's body to the wrong family, saying they couldn't give her a proper burial due to the government's negligence.

  • August 07, 2024

    NC Hospital Can't Avoid Doc's False Report Claims

    A North Carolina federal court should only throw out part of a doctor's lawsuit alleging his former employer made a false report to a federal oversight board about an internal investigation, a magistrate judge has recommended, reasoning that the physician plausibly claimed his reputation and business prospects were harmed.

Expert Analysis

  • 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.

  • Writing Thriller Novels Makes Me A Better Lawyer

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    Authoring several thriller novels has enriched my work by providing a fresh perspective on my privacy practice, expanding my knowledge, and keeping me alert to the next wave of issues in an increasingly complex space — a reminder to all lawyers that extracurricular activities can help sharpen professional instincts, says Reece Hirsch at Morgan Lewis.

  • What Lawyers Must Know About Calif. State Bar's AI Guidance

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    Initial recommendations from the State Bar of California regarding use of generative artificial intelligence by lawyers have the potential to become a useful set of guidelines in the industry, covering confidentiality, supervision and training, communications, discrimination and more, say attorneys at Debevoise.

  • Industry Must Elevate Native American Women Attys' Stories

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    The American Bar Association's recent research study into Native American women attorneys' experiences in the legal industry reveals the glacial pace of progress, and should inform efforts to amplify Native voices in the field, says Mary Smith, president of the ABA.