Policy & Compliance

  • May 15, 2024

    Anti-Trans Groups Fail To Block Wash. Youth Shelter Law

    A federal judge on Wednesday threw out a lawsuit filed by two anti-transgender groups challenging a Washington state law intended to ensure shelter for teens seeking gender-affirming care or reproductive health services, ruling that speculating on possible injury was not enough to clear a standing hurdle.

  • 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.

Expert Analysis

  • The Road Ahead For Florida's Drug Importation Program

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    Though the U.S. Food and Drug Administration approved Florida's drug importation program in January, a series of hurdles — including requisite buy-in from Canada — and potential legal challenges must be addressed before importation can begin, say attorneys at Ropes & Gray.

  • Assessing CDC's Revised Guideline On Opioid Prescriptions

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    Kenneth Weinstein, Nicholas Van Niel and Kate Uthe at Analysis Group look at newly available data to evaluate the impact that the Centers for Disease Control and Prevention's revised opioid monitoring guideline have had on prescription trends in recent years, highlighting both specific and overall decreases.

  • Valeant Ruling May Pave Way For Patent-Based FCA Suits

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    The Ninth Circuit’s recent ruling in Silbersher v. Valeant marks a significant development in False Claims Act jurisprudence, opens new avenues for litigation and potentially raises the stakes for patent applicants who intend to do business with the government, say Joshua Robbins and Rick Taché at Buchalter.

  • Suits Against Insulin Pricing Are Driven By Rebate Addiction

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    A growing wave of lawsuits filed by states, cities and counties against insulin manufacturers and pharmacy benefit managers improperly allocate the blame for rising insulin costs, when in actuality the plaintiffs are partially responsible, says Dan Leonard at Granite Capitol Consulting.

  • When Physician Retirement Arrangements May Be Legal

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    A recent advisory opinion from the Office of Inspector General regarding physician retirement arrangements sheds light on key considerations and mitigating factors that may be useful when attempting to balance healthcare operational needs with statutory conformity, says Magda Rodriguez at Day Pitney.

  • ESG Around The World: Gulf Cooperation Council

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    The Gulf Cooperation Council is in the early stages of ESG policy implementation, but recent commitments by both states and corporations — including increases in sustainable finance transactions, environmental commitments, female representation on boards and human rights enforcement — show continuing progress toward broader ESG goals, say attorneys at Cleary.

  • Navigating ACA Reporting Nuances As Deadlines Loom

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    Stephanie Lowe at Liebert Cassidy walks employers through need-to-know elements of Affordable Care Act reporting, including two quickly approaching deadlines, the updated affordability threshold, strategies for choosing an affordability safe harbor, and common coding pitfalls.

  • Lessons From Rare Post-Verdict Healthcare Fraud Acquittal

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    A Maryland federal court recently overturned a jury verdict that found a doctor guilty of healthcare fraud related to billing levels for COVID-19 tests, providing defense attorneys with potential strategies for obtaining acquittals in similar prosecutions, says attorney Andrew Feldman.

  • ChristianaCare Settlement Reveals FCA Pitfalls For Hospitals

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    ChristianaCare's False Claims Act settlement in December is the first one based on a hospital allegedly providing private physicians with free services in the form of hospital-employed clinicians and provides important compliance lessons as the government ramps up scrutiny of compensation arrangements, say attorneys at Sheppard Mullin.

  • Patent Waiver For COVID Meds Would Harm US Biopharma

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    If the Biden administration backs the World Trade Organization in waiving patent rights on COVID-19 treatments, it would negatively affect the U.S. biopharmaceutical industry and help foreign competitors, without necessarily expanding global access to COVID-19 care, says clinical pathologist Wolfgang Klietmann.

  • New CMS Rule Will Change Nursing Facility Disclosures

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    A new rule from the Centers for Medicare & Medicaid Services significantly expands disclosure requirements for nursing facilities backed by private equity companies or real estate investment trusts, likely foreshadowing increased oversight that could include more targeted audits, say Janice Davis and Christopher Ronne at Morgan Lewis.

  • Skirting Anti-Kickback Causation Standard Amid Circuit Split

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    Amid the federal circuit court split over the causation standard applicable to False Claims Act cases involving Anti-Kickback Statute violations, which the First Circuit will soon consider in U.S. v. Regeneron, litigators aiming to circumvent the heightened standard should contemplate certain strategies, say Matthew Modafferi and Terence Park at Frier Levitt.

  • Gilead Ruling Signals That Innovating Can Lead To Liability

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    A California appeals court's ruling last month in Gilead Life Sciences v. Superior Court of San Francisco that a drug manufacturer can be held liable for delaying the introduction of an improved version of its medication raises concerns about the chilling effects that expansive product liability claims may have on innovation, says Gary Myers at the University of Missouri School of Law.