Policy & Compliance

  • 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. 

  • 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.

Expert Analysis

  • SEC's Life Sciences Actions Utilize Novel Tools And Theories

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    Recent enforcement actions show that the U.S. Securities and Exchange Commission is employing new forms of data analytics and noteworthy applications of insider trading laws in its scrutiny of fraud within the life sciences and health industries, say Edward Imperatore and Jina Choi at MoFo.

  • ESG Around The World: Japan

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    Japan is witnessing rapid developments in environmental, social and corporate governance policies by making efforts to adopt a soft law approach, which has been effective in encouraging companies to embrace ESG practices and address the diversity of boards of directors, say Akira Karasawa and Landry Guesdon at Iwata Godo.

  • How And Why Your Firm Should Implement Fixed-Fee Billing

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    Amid rising burnout in the legal industry and client efforts to curtail spending, pivoting to a fixed-fee billing model may improve client-attorney relationships and offer lawyers financial, logistical and stress relief — while still maintaining profit margins, say Kevin Henderson and Eric Pacifici at SMB Law Group.

  • Potential Broader Effects Of FDA's Lab-Developed Test Rule

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    Though it's unclear whether the U.S. Food and Drug Administration's proposed rule for regulating lab-developed tests will ever go into effect, it nonetheless functions as a threatened hammer that may make legislative efforts to regulate such tests more palatable, say attorneys at King & Spalding.

  • Judicial Independence Needs Defense Amid Political Threats

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    Amid recent and historic challenges to the judiciary from political forces, safeguarding judicial independence and maintaining the integrity of the legal system is increasingly urgent, says Robert Peck at the Center for Constitutional Litigation.

  • 2 New Ways FDA Is Changing Lab-Developed Test Regulation

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    The U.S. Food and Drug Administration's recently announced rulemaking and voluntary pilot program signal the agency's dedication to ramping up oversight of lab-developed tests, which have been largely unregulated by the FDA until now, say attorneys at Sidley.

  • How Law Firms Can Use Account-Based Marketing Strategies

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    Amid several evolving legal industry trends, account-based marketing can help law firms uncover additional revenue-generating opportunities with existing clients, with key considerations ranging from data analytics to relationship building, say Jennifer Ramsey at stage LLC and consultant Gina Sponzilli.

  • AGs' Distaste For Food Bill May Signal Other State Issues

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    States' recent opposition to a proposed federal law that would block them from regulating out-of-state agricultural production could affect issues beyond this narrow debate, such as the balance of state and federal regulatory power, reproductive rights post-Dobbs, and energy production and water use, say Christopher Allen and Stephen Cobb at Cozen O'Connor.

  • Strategic Succession Planning At Law Firms Is Crucial

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    Senior partners' reluctance to retire, the rise of the nonequity partner tier and generational differences in expectations are all contributing to an increasing number of departures from BigLaw, making it imperative for firms to encourage retirement among senior ranks and provide clearer leadership pathways to junior attorneys, says Laura Leopard at Leopard Solutions.

  • What An NCAA Drug Test Change Could Mean For Cannabis

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    If the NCAA follows through with its decision to remove cannabis from its banned list of substances, it will affect college athletes, athletic directors, public relations employees, and marketing departments at universities and colleges, and it will have a significant economic effect on the cannabis industry, say Stanley Jutkowitz and Sydney Jenkins at Seyfarth.

  • When Calif. Health Shield Law Reaches Beyond State Borders

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    In light of California's newly signed shield law to increase protections for reproductive health and gender-affirming care, it's important to understand how the law's covered services and key legal protections could affect patients and providers nationwide, says Natalie Birnbaum at Nelson Hardiman.

  • FDA's Lab-Developed Test Rule Faces High Hurdles

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    The U.S. Food and Drug Administration's recently announced plans to explicitly regulate lab-developed tests will likely face resistance from industry stakeholders and congressional actions, and lead to significant litigation, say attorneys at Hogan Lovells.

  • FTC's Health Co. Suit Indicates Agency's Private Equity Focus

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    The Federal Trade Commission's latest lawsuit against an anesthesia company and its private equity investor highlights the agency's willingness to regulate the health care industry even when relevant acquisitions are relatively dated or when the controlling entity's economic interest is under 50%, say attorneys at Simpson Thacher.