Policy & Compliance

  • 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. 

  • April 10, 2024

    4th Circ. Sides With CMS' Definition Of 'Line-Extension Drug'

    The Fourth Circuit on Wednesday affirmed a summary judgment ruling in favor of the Centers for Medicare & Medicaid Services in a rule challenge by Vanda Pharmaceuticals, which took issue with the agency's criteria for what constitutes a line-extension drug.

  • April 10, 2024

    Pharmacy Gets Eli Lilly's Mounjaro Suit Tossed

    A Florida federal judge has thrown out Eli Lilly & Co.'s suit accusing an online pharmacy of wrongly selling a compounded version of its drug Mounjaro, saying Eli Lilly was "using state law to enforce the terms of" federal law.

  • April 10, 2024

    Justices Asked To Ban FCA Suits Relying On Patent Reviews

    Valeant Pharmaceuticals is going to the U.S. Supreme Court to argue that information cited in Patent Trial and Appeal Board reviews cannot later be used by whistleblowers in False Claims Act lawsuits.

Expert Analysis

  • How Mental Health Ruling Paves Road For Equal Coverage

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    The Tenth Circuit’s recent ruling in E.W. v. Health Net, which clarified the pleading requirements necessary to establish a Mental Health Parity and Addiction Equity Act violation, is a win for plaintiffs as it opens the door to those who have been denied coverage for behavioral health treatment to prove a mental health parity violation, says Mark DeBofsky at DeBofsky Law.

  • ESG Around The World: Mexico

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    ESG has yet to become part of the DNA of the Mexican business model, but huge strides are being made in that direction, as more stakeholders demand that companies adopt, at the least, a modicum of sustainability commitments and demonstrate how they will meet them, says Carlos Escoto at Galicia Abogados.

  • The Case For Post-Bar Clerk Training Programs At Law Firms

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    In today's competitive legal hiring market, an intentionally designed training program for law school graduates awaiting bar admission can be an effective way of creating a pipeline of qualified candidates, says Brent Daub at Gilson Daub.

  • 10 Takeaways From New HHS Federal Compliance Guidelines

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    The U.S. Department of Health and Human Services' recently issued general compliance program guidance is the first of its kind that would apply across all health care stakeholders, and signals the agency’s first step to improve and update existing compliance guidance, says Melissa Wong at Holland & Knight.

  • 2 HHS Warnings Highlight Anti-Kickback Risks For Physicians

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    Two recent advisory opinions issued by the U.S. Department of Health and Human Services' Office of Inspector General involve different scenarios and rationales, but together they illustrate the OIG's focus on and disapproval of contractual joint ventures and other revenue-maximizing physician arrangements, say Robert Threlkeld and Elliott Coward at Morris Manning.

  • Attorneys Have An Ethical Duty To Protect The Judiciary

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    The tenor of public disagreement and debate has become increasingly hostile against judges, and though the legislative branch is trying to ameliorate this safety gap, lawyers have a moral imperative and professional requirement to stand with judges in defusing attacks against them and their rulings, says Deborah Winokur at Cozen O'Connor.

  • Cross-Market Implications In FTC's Anesthesia Complaint

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    The Federal Trade Commission's recent complaint against a private equity firm's acquisition of anesthesiology practices highlights the controversial issue of cross-market harm in health care provider mergers, and could provide important insights into how a court may view such theories of harm, say Christopher Lau and Dina Older Aguilar at Cornerstone Research.

  • AI Can Help Lawyers Overcome The Programming Barrier

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    Legal professionals without programming expertise can use generative artificial intelligence to harness the power of automation and other technology solutions to streamline their work, without the steep learning curve traditionally associated with coding, says George Zalepa at Greenberg Traurig.

  • 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.