Policy & Compliance

  • April 17, 2024

    FDA's Foot-Dragging On Menthol Ban Sparks Frustration

    The U.S. Food and Drug Administration's yearslong delay to ban menthol has left public health groups frustrated over why the agency has failed to act on what the groups see as an obvious way to improve public health and prevent needless deaths, prompting a second lawsuit over taking menthol off store shelves.

  • April 17, 2024

    'Ringleader' Of Black Market HIV Drug Scam Gets 9 Years

    A New York federal judge on Wednesday sentenced a pharmacy operator to nine years in prison for spearheading a $13 million scheme to sell black market HIV medication and collect fraudulent reimbursements from Medicaid and Medicare.

  • April 16, 2024

    Eli Lilly's Insulin Price Cap Deal Collapses After Cert. Denial

    Eli Lilly & Co. and insulin buyers have called off a proposed nationwide settlement that would've capped insulin prices and been worth up to $500 million over several years, a decision that was made after the buyers lost a class certification bid early this year, according to the buyers' counsel.

  • April 16, 2024

    Healthcare Industry Sees Spate Of New Data Sharing Suits

    A $7 million-plus settlement between a federal regulator and a mental healthcare provider accused of improperly sharing patient data highlights the ubiquitous ties between health systems and tech giants like Facebook — and the growing legal and regulatory scrutiny over those relationships.

  • April 16, 2024

    Ohio Bans On Transgender Care, Youth Sports Halted By Judge

    An Ohio state court on Tuesday blocked a law that bans gender-affirming healthcare for children and prohibits transgender girls from competing in girls' school sports, issuing a temporary restraining order more than a week before the statute was to go into effect.

  • April 16, 2024

    NY High Court Zeroes In On Abortion Coverage Exemptions

    New York's highest court grappled Tuesday with whether a state regulation's exemption process shielding religious groups from a requirement that employee health plans cover abortions conflicted with a 2021 U.S. Supreme Court decision, with multiple judges questioning the constitutionality of the carveout procedure.

  • April 16, 2024

    Ex-NBA Guard Gets 18 Months In Healthcare Scheme

    A former Detroit Pistons point guard was sentenced to 18 months in prison Tuesday after being convicted of one of two counts over an alleged scheme to defraud the NBA's healthcare plan, with a Manhattan federal judge saying his proceeds were "not chump change" and faulting his behavior on pretrial release.

  • April 16, 2024

    As Hospitals Hire Outside Help, Who's Liable If Patients Sue?

    A medical malpractice case that’s triggered repeated disagreement in Michigan courts underscores the complexity of hospital "agent" liability amid increasing healthcare industry reliance on contractor nurses and doctors.

  • April 16, 2024

    Knotty Preemption Inquiry Awaits High Court In Abortion Case

    The U.S. Supreme Court next week will hear a dispute over an Idaho abortion ban and a federal emergency care law. The case promises to challenge the court to decide whether the two vastly different statutes actually conflict.

  • April 16, 2024

    Va. Hospital System Beats COVID Vaccine Bias Suit

    A Virginia healthcare system defeated a suit claiming it unlawfully refused to excuse two Christian employees from its COVID-19 vaccination requirement, with a federal judge finding they could have taken a version of the vaccine that didn't conflict with their religious beliefs.

  • April 16, 2024

    Ex-FDA Chief On Election Year Healthcare Policy

    Former FDA chief counsel Stacy Cline Amin of Morrison Foerster LLP talks to Law360 about march-in rights, the Inflation Reduction Act and healthcare policy issues in a presidential election year.

  • April 15, 2024

    Justices Face Off Over Shadow Docket Procedures

    The U.S. Supreme Court's internal disagreements over how to manage its emergency docket were on full display Monday in its decision allowing Idaho to enforce a ban on gender-affirming care for minors — a case the court's liberals said wasn't worthy of their intervention, but its conservatives touted as a win in the fight against universal injunctions.

  • April 15, 2024

    Mental Health Co. Cerebral To Pay $7M Over Data Failures

    Mental health service provider Cerebral Inc. will pay more than $7 million to settle claims from the Federal Trade Commission, saying it failed to protect users' sensitive health data and made it difficult for patients to cancel services and stop recurring charges, according to a Monday court filing.

  • April 15, 2024

    Justices Allow Idaho To Enforce Gender Care Ban, Sans Plaintiffs

    The U.S. Supreme Court allowed the state of Idaho on Monday to begin enforcing its ban on gender-affirming care for minors, reshaping a preliminary injunction the majority said was far too broad to keep in place as the litigation plays out, perhaps for years.

  • April 15, 2024

    Feds Seek Prison For Group That Invaded Abortion Clinic

    Prosecutors are seeking prison sentences for six anti-abortion activists convicted of storming a Washington, D.C., abortion clinic, including a six-year term for the alleged "criminal mastermind" behind this and other blockades.

  • April 12, 2024

    Ex-Biotech CEO Gets 7 Years In Fake COVID Test Case

    A former biotech CEO accused of defrauding investors by touting a phony rapid finger-prick COVID test was sentenced to seven years in prison in D.C. federal court Friday.

  • April 12, 2024

    NY Health Network To Pay $1M For Deceptive COVID Test Bills

    Long Island, New York-based hospital network Northwell Health will pay $1 million over allegations that it fraudulently billed patients for a hospital visit after they came for what they thought was a free COVID-19 test, the state's attorney general said Friday.

  • April 12, 2024

    Trade Groups Urge Senators To Advance Patent Reform Bills

    Groups representing inventors, startups and medical technology companies are putting pressure on U.S. senators to pass bills that would prospectively limit the ability of courts to throw out patent lawsuits, a month after tech industry groups argued the legislation would trigger an onslaught of patent litigation.

  • April 11, 2024

    Sandoz Says Feds Misclassified Generics As 'Innovator Drugs'

    Pharmaceutical company Sandoz Inc. sued the Centers for Medicare & Medicaid Services in Washington, D.C., federal court on Wednesday, alleging the agency ignored the company's objection to classifying two of its generics as "innovator drugs," which could impact Sandoz's rebate obligations under Medicaid.

  • April 11, 2024

    UnitedHealth Patients' Addiction Coverage Suit Revived, Again

    The Ninth Circuit on Thursday revived for the second time a proposed class action accusing UnitedHealth of wrongly rejecting coverage for outpatient substance use disorder treatments in violation of federal benefits law, finding the plaintiff plausibly alleged the insurer employed an excessively strict review process for those claims.

  • April 11, 2024

    Full 8th Circ. Hears Ark. Bid To Revive Youth Trans Care Ban

    An en banc panel of the Eighth Circuit weighing whether to revive an Arkansas state law that banned gender-affirming care for children and teens heard oral arguments Thursday, as Arkansas officials sought to demonstrate that the law does not unconstitutionally discriminate based on sex.

  • April 11, 2024

    Medtronic Can't Ditch Ex-Sales Rep's Retaliation Claim

    Medical device maker Medtronic can't avoid a whistleblower retaliation claim by a former sales rep who says he was pushed out after reporting what he suspected to be a kickback scheme to the U.S. Food and Drug Administration, a federal judge said Wednesday.

  • April 10, 2024

    Pfizer Unit Cuts $39M Deal Ending Effexor Antitrust Claims

    A proposed class of direct buyers asked a New Jersey federal judge on Tuesday to approve a $39 million settlement to end allegations that Pfizer Inc. unit Wyeth engaged in a scheme with Teva Pharmaceuticals to delay generic competition for the antidepressant drug Effexor XR.

  • April 10, 2024

    Wash. Healthcare Workers Owed $100M In Wages, Jury Told

    Counsel for two classes encompassing more than 30,000 current and former healthcare workers told a Washington state jury on Wednesday that Providence Health & Services should pay nearly $100 million in damages for using an illegal time clock rounding method that shortchanged employees and failing to provide required meal breaks.

  • April 10, 2024

    DOJ Hits Regeneron With False Claims Act Suit Over Eylea

    The federal government has brought a False Claims Act intervenor complaint in Massachusetts against Regeneron, alleging the pharmaceutical giant fraudulently withheld information from its Medicare reports seeking reimbursement for its drug Eylea, the U.S. Department of Justice announced Wednesday. 

Expert Analysis

  • Preparing Law Students For A New, AI-Assisted Legal World

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    As artificial intelligence rapidly transforms the legal landscape, law schools must integrate technology and curricula that address AI’s innate challenges — from ethics to data security — to help students stay ahead of the curve, say Daniel Garrie at Law & Forensics, Ryan Abbott at JAMS and Karen Silverman at Cantellus Group.

  • ESG Around The World: South Korea

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    Numerous ESG trends have materialized in South Korea in the past three years, with impacts ranging from greenwashing prevention and carbon neutrality measures to workplace harassment and board diversity initiatives, say Chang Wook Min and Hyun Chan Jung at Jipyong.

  • 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.