Policy & Compliance

  • May 14, 2024

    Mich. AG Says Eli Lilly 'Cherry-Picking' Enforcement Data

    Michigan's attorney general has hit back against Eli Lilly's arguments that recent consumer protection law recoveries show her office is not being hampered in its investigations, as she seeks subpoenas in a probe of the pharmaceutical giant's pricing for an insulin drug.

  • May 14, 2024

    Holland & Knight Atty On 'Historic' Women's Health Moment

    Julia Hesse, a veteran healthcare attorney who recently joined Holland & Knight LLP, talks about her multifaceted practice, pressing public policy issues, and why menopause care can be the next big thing in women's healthcare.

  • May 14, 2024

    Huge Payouts Pressure Hospitals To Address Doc Sex Abuse

    A string of high-profile settlements and the conviction of a prominent urologist in New York are motivating more victims of sexual abuse to come forward and intensifying the legal scrutiny facing hospitals as they navigate a culture that grants doctors substantial authority.

  • May 14, 2024

    Convicted Fraudster Says Exchanges With Atty Are Privileged

    A convicted fraudster who had his sentence commuted by then-President Donald Trump — now charged with launching another scam shortly after leaving prison — is embroiled in a fight with New Jersey federal prosecutors over his attempt to assert attorney-client privilege for communications with an Israeli attorney who allegedly participated in the scheme.

  • May 14, 2024

    BigLaw Attys Fight Sanctions Over Alleged Judge Shopping

    Attorneys from Shook Hardy & Bacon LLP, Cooley LLP, Lightfoot Franklin & White LLC and prominent LGBTQ rights organizations did not engage in judge shopping when walking away from cases challenging an Alabama law banning certain medical procedures for transgender youth, the lawyers have told an Alabama federal court.

  • May 14, 2024

    Medicaid Work Mandates Resurface In Legal, Political Fights

    Work requirements can help solve the tricky politics of expanding Medicaid in some states. But the job mandates can also trigger regulatory and legal challenges that make them tough to carry out.

  • May 14, 2024

    Chinese Drug Co. Sanctioned After 'Tortuous' 3-Year Info Fight

    Chinese drug firm Zhejiang Huahai Pharmaceutical Co. Ltd. has been hit with sanctions after its chief executive officer failed to sit for a court-ordered deposition in sprawling multidistrict litigation taking place in New Jersey over generic drugs that U.S. authorities say were contaminated with carcinogens.

  • May 13, 2024

    USPTO Eyes Change To Patent Applicants' Disclaimer Practice

    The U.S. Patent and Trademark Office is looking to add a requirement for patent applicants filing so-called terminal disclaimers in order to overcome rejections by patent examiners over obviousness-type double patenting, a move that lawyers and a former USPTO official say could change the agency's approach considerably, especially for patents covering brand-name drugs.

  • May 13, 2024

    'Grinch' Is Not A Protected Class, HHS Tells 4th Circ.

    The U.S. Department of Health and Human Services has urged the Fourth Circuit to reject a chemist's discrimination, hostile work environment and retaliation claims, arguing that "Grinch" is not a protected class and federal law doesn't protect an individual "from not being well-liked in the workplace."

  • May 13, 2024

    Biogen Investors Seek Class Cert. In Alzheimer's Drug Suit

    A proposed class of Biogen shareholders urged a Massachusetts federal court to certify their now-revived class action alleging the drugmaker made misleading statements about a deficient Alzheimer's drug, arguing it can sufficiently lead the suit with Block & Leviton LLP as class counsel.

  • May 13, 2024

    11th Circ. Says Ga. County's Trans Health Ban Violates Title VII

    A split Eleventh Circuit panel upheld a win Monday for a transgender sheriff's deputy who challenged a Georgia county health plan's refusal to pay for gender-affirmation surgery, ruling the coverage exclusion violated federal anti-discrimination law.

  • May 13, 2024

    Nursing Home Says Buyer's Lease Silence Endangers Future

    An Ohio-based nursing home operator claimed Monday that its Pickaway County nursing home is in "imminent danger" because the company's owners are threatening the licensing and management of the nursing home by refusing to acknowledge terminated leases and not making the transition to a new lessee and operator.

  • May 13, 2024

    'Prolific' Asbestos Injury Firm Accused Of Fraud, Racketeering

    A "prolific" Illinois-based asbestos litigation law firm allegedly engaged in a yearslong scheme involving perjured testimony, suppressed evidence and baseless claims to extract as much money from as many companies as possible, according to one of the companies repeatedly targeted by the firm.

  • May 13, 2024

    Oil Co. Ends EEOC Disability Bias Suit Over Opioid Meds

    An oilfield equipment supplier will pay $35,000 to end a suit in Texas federal court by the U.S. Equal Employment Opportunity Commission accusing it of yanking a job offer from a welder because of his opioid use disorder medication, the EEOC said.

  • May 10, 2024

    Wash. Judge Doubles Hospital System's Penalty In Wage Case

    A Washington state judge has ordered a healthcare system to pay nearly $230 million to 33,000 workers, doubling the damages a jury awarded to the employees in April based on the company's "willful" violations of wage law.  

  • May 10, 2024

    Pharma Cos., FDA Debate 'Same Drug' In Orphan Drug Case

    Two pharmaceutical companies and the U.S. Food and Drug Administration faced off in D.C. federal court Friday over allegations that the federal agency wrongly approved a treatment that rivals Jazz Pharma's narcolepsy drug despite Jazz's exclusivity rights under the Orphan Drug Act.

  • May 10, 2024

    Okla. Tells Justices 10th Circ. Wrong On PBM Law

    Oklahoma's insurance department Friday asked the U.S. Supreme Court to take up its petition seeking review of a Tenth Circuit decision overturning portions of a state law regulating pharmacy benefit managers, arguing that high court intervention is needed to resolve disagreement among the circuits on federal preemption.

  • May 10, 2024

    UPMC Inks $38M Deal To End Neurosurgery FCA Suit

    The University of Pittsburgh Medical Center has agreed to pay $38 million to put an end to a False Claims Act suit brought by three medical workers from its neurological surgery department who said the medical center fraudulently billed federal healthcare programs.

  • May 10, 2024

    Texas Justices Limit Damages In Unwanted Pregnancy Case

    The Texas Supreme Court said Friday that a woman who sued her doctor for failing to perform a sterilization procedure can't collect damages for emotional and physical pain in connection with her wrongful pregnancy claim, holding that the birth of a healthy child isn't a compensable injury but "a life with inherent dignity and profound, immeasurable value."

  • May 10, 2024

    What To Know About Biden's ACA Nondiscrimination Rule

    Recently finalized regulations tackling what constitutes discrimination under the Affordable Care Act could have significant impacts on health plans that include greater liability for third-party plan administrators, attorneys say. Here are three things employers should know now that the final rule is on the books.

  • May 09, 2024

    Judge Clarifies Gilead Didn't Directly Infringe HIV Drug IP

    A Delaware federal judge on Thursday rejected Gilead Sciences' request to amend her judgment finding that two medications in its HIV prevention regimen, Truvada and Descovy, directly infringed the government's invalidated patents, but clarified her judgment to say that non-party patients or physicians committed the infringement.

  • May 09, 2024

    Doc Can't Escape Second Prednisone Overprescribing Suit

    A Pennsylvania federal judge won't strike claims for punitive damages and references to "outrageous" conduct from a complaint alleging that a doctor wrongly overprescribed medications including prednisone, saying the complaint plausibly alleged that he knowingly had a patient on a medication plan that harmed her.

  • May 09, 2024

    9th Circ. Says Judge Defied Order To Revive Opioid Case

    The Ninth Circuit on Thursday again revived a nearly 7-year-old case against a California doctor for allegedly selling opioid prescriptions and ordered that the case be reassigned, saying the presiding judge had defied the plain language of a previous order to reinstate the indictment.

  • May 09, 2024

    DOJ Task Force To Target Healthcare Monopoly, Collusion

    The U.S. Department of Justice's Antitrust Division sharpened its focus Thursday on healthcare platforms that combine doctors with insurers, data and more in what the administration's top competition official called the "alarming" accumulation of assets.

  • May 09, 2024

    La. Lawmakers OK Local Tax Break For Certain Eye Meds

    Louisiana would expand a local sales tax exemption to include prescriptions used to treat eye-related conditions under a bill that was unanimously passed by the state Senate and next goes to the governor.

Expert Analysis

  • Issues Ahead As Psychedelic Medicine Faces Pivotal Moment

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    Recent regulatory changes and decriminalization efforts have opened doors for research and development in psychedelic medicine, but challenges like stigma, access and funding persist, meaning companies will need to address these issues to support the industry’s credibility, say consultants at FTI Consulting.

  • An Overview Of 6 PBM Bills Moving Through Congress

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    As legislators turn to pharmacy benefit manager reform as a potential next step in addressing the cost of prescription drugs, six congressional committees have recently advanced PBM-related legislation with generally high bipartisan support, suggesting that a final package is likely to advance through Congress, say Rachel Stauffer and Katie Waldo at McDermott+Consulting.

  • 10th Circ. ERISA Ruling Is Promising For Self-Funded Plans

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    Though some recent appellate decisions have seemingly narrowed application of Employee Retirement Income Security Act preemption, which generally helps protect self-funded health plans from state regulation, the Tenth Circuit's decision in PCMA v. Mulready takes a big step toward reaffirming preemption, say attorneys at Bass Berry.

  • What Large Language Models Mean For Document Review

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    Courts often subject parties using technology assisted review to greater scrutiny than parties conducting linear, manual document review, so parties using large language models for document review should expect even more attention, along with a corresponding need for quality control and validation, say attorneys at Sidley.

  • Checking In On How SuperValu Has Altered FCA Litigation

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    Four months after the U.S. Supreme Court's ruling in U.S. ex rel. Chutte v. SuperValu, the decision's reach may be more limited than initially anticipated, with the expansion of the scienter standard counterbalanced by some potential defense tools for defendants, say Elena Quattrone and Olivia Plinio at Epstein Becker.

  • Participating In Living History Makes Me A Better Lawyer

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    My role as a baron in a living history group, and my work as volunteer corporate counsel for a book series fan association, has provided me several opportunities to practice in unexpected areas of law — opening doors to experiences that have nurtured invaluable personal and professional skills, says Matthew Parker at the Nebraska Department of Health and Human Services.

  • Private Equity Owners Can Remedy Law Firms' Agency Issues

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    Nonlawyer, private-equity ownership of law firms can benefit shareholders and others vulnerable to governance issues such as disparate interests, and can in turn help resolve agency problems, says Michael Di Gennaro at The Law Practice Exchange.

  • Cos. Must Overhaul Data Privacy Approach To Avoid Lawsuits

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    With the proliferation of third-party trackers and the increasing complexity of privacy laws, companies need to significantly change their approach to online privacy to avoid litigation by focusing on responsible data collection practices and ongoing monitoring of ad tech tools, says Ian Cohen at LOKKER.

  • Biden Admin's Mental Health Proposal May Not Be Enough

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    The Biden administration's recent proposed updates to federal mental health care rules acknowledge the difficulty that Americans face in finding and affording care, but may have limited impact due to enforcement challenges, a lack of providers and other issues, say Khaled Klele and Jessica Osterlof at Riker Danzig.

  • How To Protect Atty-Client Privilege While Using Generative AI

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    When using generative artificial intelligence tools, attorneys should consider several safeguards to avoid breaches or complications in attorney-client privilege, say Antonious Sadek and Christopher Campbell at DLA Piper.

  • How New Lawyers Can Leverage Feedback For Growth

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    Embracing constructive criticism as a tool for success can help new lawyers accelerate their professional growth and law firms build a culture of continuous improvement, says Katie Aldrich at Fringe Professional Development.

  • ESG Around The World: Australia

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    Clive Cachia and Cathy Ma at K&L Gates detail ESG-reporting policies in Australia and explain how the country is starting to introduce mandatory requirements as ESG performance is increasingly seen as a key investment and corporate differentiator in the fight for global capital.

  • Info Exchanges Must Stay Inside Now-Invisible Antitrust Lines

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    While the antitrust agencies recently withdrew long-standing enforcement policy statements for being "overly permissive" on information exchanges, we should not assume that all information exchanges are inherently suspect — they are still permissible if carefully constructed and vigorously managed, say attorneys at Nelson Mullins.