Policy & Compliance

  • May 15, 2024

    AstraZeneca Sales Reps Win Early Cert. In Gender Bias Suit

    An Illinois federal judge on Tuesday granted a bid by workers to conditionally certify a collective in a lawsuit alleging AstraZeneca paid women less than men, giving the green light for notices to be sent out to female sales representatives who have worked at the pharmaceutical giant since late 2018.

  • May 14, 2024

    Hospitals Liable For Failing To Admit Killer, Pa. Justices Told

    The Pennsylvania Supreme Court was reminded Tuesday, during oral arguments over whether someone can be officially treated at a hospital without filling out an application, that the case before them concerned a man who killed his girlfriend after he was turned away despite claiming homicidal and suicidal impulses.

  • May 14, 2024

    Vein Tech Maker Faces Investor Suit Over DOJ Kickback Probe

    Vein disease device maker Inari Medical Inc. and three of its current and former executives face a proposed investor class action over claims that the company's share price fell after it disclosed an investigation into its compliance with federal anti-kickback laws.

  • May 14, 2024

    States Accuse EEOC Of 'Smuggling' Abortion Into PWFA Rule

    Louisiana and Mississippi have sued the U.S. Equal Employment Opportunity Commission seeking to invalidate regulations implementing the Pregnant Workers Fairness Act, claiming the agency's stance that employers must provide workers accommodations if they get an abortion flouts U.S. Supreme Court precedent and the PWFA itself.

  • May 14, 2024

    White House Targets Kidney Transplant Bias Amid Lawsuits

    A White House effort to reduce bias in the organ transplant system comes as some Black litigants are pressing legal claims against a national transplant network they say used a flawed, racially biased calculation to delay kidney transplants.

  • May 14, 2024

    Ariz. Justices Stay 1864 Abortion Ban To Allow For Appeal

    Enforcement of Arizona's 1864 anti-abortion law will remain on hold for at least 90 days as state Attorney General Kris Mayes evaluates whether to ask the U.S. Supreme Court to take up the case.

  • 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."

Expert Analysis

  • 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.

  • White House AI Order Balances Innovation And Regulation

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    President Joe Biden’s recently issued executive order on artificial intelligence lays out a sprawling list of directives aimed at establishing standards for safety, security and privacy protection, and may help strike the balance between the freedom to innovate and the need to impose regulation in this rapidly evolving space, say Kristen Logan and Martin Zoltick at Rothwell Figg.

  • Reading Between The Lines Of HHS' National Lab Opinion

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    The U.S. Department of Health and Human Services' Office of Inspector General recently rejected a national laboratory's request to pay a referring lab to process specimens, but the request might have been an attempt to exploit the OIG's advisory opinion process for a competitive advantage, says Mary Kohler at Kohler Health Law.

  • A Closer Look At Proposed HHS Research Misconduct Rule

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    The U.S. Department of Health and Human Services' proposed updates to its policies on research misconduct codify many well-known best practices, but also contain some potential surprises for the research community and counsel, say attorneys at Hogan Lovells.

  • Handling Religious Objections To Abortion-Related Job Duties

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    While health care and pharmacy employee religious exemption requests concerning abortion-related procedures or drugs are not new, recent cases demonstrate why employer accommodation considerations should factor in the Title VII standard set forth by the U.S. Supreme Court’s 2023 Groff v. DeJoy ruling, as well as applicable federal, state and local laws, say attorneys at Epstein Becker.