Policy & Compliance

  • April 24, 2024

    Motley Rice, Morgan & Morgan Among Ozempic MDL Leaders

    The Pennsylvania federal judge overseeing multidistrict litigation over alleged risks associated with Ozempic and similar drugs has appointed lawyers from Motley Rice LLC, Morgan & Morgan PA and six other firms to leadership roles, according to an order issued Tuesday.

  • April 24, 2024

    Bill To Repeal 'Zombie' 1864 Abortion Ban Clears Ariz. House

    Legislation that would repeal an 1864 law banning almost all abortions in Arizona narrowly cleared the state House on Wednesday after a handful of Republican lawmakers crossed party lines to help Democrats muscle the measure through following a bruising debate.

  • April 24, 2024

    Justices Spar On Interplay Of EMTALA, Idaho Abortion Ban

    The U.S. Supreme Court held a feisty debate Wednesday over whether an Idaho abortion ban is superseded by a federal law requiring doctors at Medicare-funded hospitals to give emergency care, including abortions, to women suffering a medical crisis.

  • April 23, 2024

    Misplaced Fears Leave Pregnant Subjects Out Of Drug Trials

    With federal drug regulators set to release new guidance meant to diversify clinical trial populations, new research largely undermines one key rationale for omitting pregnant and lactating people from drug and device development: the fear of legal liability.

  • April 23, 2024

    Retiring Health Exec Talks Past, Future Of Accountable Care

    The National Association of Accountable Care Organizations will see Chief Executive Officer Clif Gaus retire this fall, bringing an end to his nearly 12-year tenure at the organization. The group, which Gaus helped found, advocates for a care delivery model wherein providers share responsibility for both the quality and cost of care.

  • April 23, 2024

    Doctor Renews $20M Claim His Hospital Made Up 25 Murders

    An Ohio physician accused of 25 counts of murder and found guilty of none just renewed his $20 million malicious-prosecution suit against Trinity Health Corp., the parent company of his former employer, claiming that the company misled prosecutors to get him indicted as a distraction from the internal issues of the hospital where he worked.

  • April 23, 2024

    Divisive Cost Cap Deadline Looms For Calif. Healthcare Cos.

    California healthcare attorneys are preparing for the state's first cap on healthcare spending proposed by a new state office tasked with making care affordable. Industry leaders are sharply split on the viability of a proposed 3% target, which some say may ultimately do more harm than good for a state suffering from skyrocketing healthcare costs.

  • April 23, 2024

    Dating Apps Tell Court Idaho Abortion Ban's Bad For Business

    The online dating industry is weighing in on the latest abortion case to reach the U.S. Supreme Court, joining other groups making a business-first argument against an evolving patchwork of state abortion laws.

  • April 23, 2024

    Appellate Courts Confront Legal Fights On Transgender Care

    The national debate over transgender rights reached the U.S. Supreme Court and surfaced in three circuit courts over the last week as judges take up fiercely litigated questions on gender-affirming care and participation in sports.

  • April 23, 2024

    Ex-Faegre Atty, 33, Makes High Court Debut In Abortion Case

    Fifteen months ago, Josh Turner was a BigLaw litigation associate in Minneapolis preparing to make the jump to public service. On Wednesday, the 33-year-old, now heading constitutional litigation for the Idaho attorney general, will make his first appearance at the U.S. Supreme Court in a closely watched emergency abortion case.

  • April 23, 2024

    DOJ Unveils $139M Deal For Larry Nassar Victims

    The U.S. Department of Justice will pay $138.7 million to settle 139 tort claims accusing the Federal Bureau of Investigation of not doing enough to stop the sprawling, decades-long sexual abuse of hundreds of victims at the hands of USA Gymnastics physician Larry Nassar, according to a Tuesday announcement.

  • April 22, 2024

    Ohio AG Slams Halt Of Transgender Care, Youth Sports Limits

    Ohio Attorney General Dave Yost argued Monday in an emergency motion with the Ohio Supreme Court that the lower-court judge overstepped his authority when halting a bill, in its entirety, that would limit transgender care and participation in youth sports in the state.

  • April 22, 2024

    J&J Says Worker's Drug Costs Suit Misses Big Picture

    Johnson & Johnson asked a New Jersey federal judge to toss a worker's suit claiming employees were overcharged for their prescriptions under a drug benefit program because of a contract with a pharmacy benefits manager, saying employees didn't show they could've gotten a better deal elsewhere.

  • April 22, 2024

    5 New State Employment Laws Passed This Year So Far

    State legislatures around the country are winding down legislative sessions that began in January, bringing newly enacted employment laws into effect in the coming months. From child labor to pay inequality to mandatory overtime, Law360 looks at five state laws that employers will have to comply with.

  • April 19, 2024

    Allergan To Face Kickback Claim In Suit Over Child Botox Use

    A Texas federal judge has axed allegations that pharmaceutical company Allergan Inc. defrauded the U.S. government when it promoted the unapproved use of Botox to treat migraines in children but will allow claims that the company bribed doctors to conduct the procedure to move forward.

  • April 19, 2024

    Up Next At High Court: Abortions & Presidential Immunity

    The U.S. Supreme Court will return Monday for the term's final week of oral arguments, during which it will consider several high-stakes disputes, including whether a federal healthcare law can preempt state abortion bans and whether former President Donald Trump is entitled to immunity from criminal charges related to official acts.

  • April 19, 2024

    'Anti-Vax Momma' Admits To Selling Fake Immunization Creds

    A woman who went by the Instagram handle @AntiVaxMomma pled guilty on Friday to selling fake U.S. Centers for Disease Control and Prevention vaccination cards and falsely registering buyers in New York state's immunization database.

  • April 19, 2024

    Feds Want Prison For Ga. Chiropractor In NBA Health Fraud

    Federal prosecutors have asked a New York federal judge to impose a 10- to 16-month prison sentence for a chiropractor who admitted to conspiring with former Celtics forward Glen "Big Baby" Davis to commit healthcare and wire fraud by submitting fake invoices to the NBA health plan.

  • April 18, 2024

    Jury Awards $98M To Wash. Healthcare Workers In Wage Suit

    A Seattle jury said Thursday a Washington-based healthcare system should pay thousands of its employees almost $100 million for its illegal timeclock rounding and meal break practices, an award that's expected to be doubled because a judge has already determined that the company's violations were willful.

  • April 18, 2024

    Clinic Head Gets 9 Years For Medicare Kickback, Tax Scheme

    A health clinic manager was sentenced to nine years in prison and ordered to pay $40 million in restitution to the government for participating in a multimillion-dollar healthcare kickback scheme that involved tax fraud, according to documents in a New York federal court.

  • April 18, 2024

    Endo Pleads Guilty To Marketing Opioids As 'Crush Proof'

    Endo Health Solutions Inc. pled guilty Thursday in Michigan federal court to putting out a drug it falsely advertised as being "crush proof" and "abuse deterrent," part of its larger agreement with the government to resolve nearly $2 billion in civil and criminal claims against the company.

  • April 18, 2024

    Would-Be Whistleblowers Drop ER Service Overbilling Claims

    A North Carolina federal judge has granted two whistleblowers' request to drop their suit accusing a pair of healthcare companies and their affiliates of overcharging both state and federal Medicare and Medicaid programs for emergency services provided at multiple regional hospitals, dismissing the case without prejudice.

  • April 18, 2024

    FDA Head Gets GOP Rep.'s Rebuke Over Pot Rescheduling

    The Republican chair of a U.S. House of Representatives Appropriations subcommittee on Thursday chided the commissioner of the U.S. Food and Drug Administration for the agency's recommendation last year to loosen restrictions on marijuana.

  • April 17, 2024

    Lab Whistleblower Drops COVID Test Suit After Feds Pass

    An ex-lab director has dropped his False Claims Act lawsuit alleging he was ousted from a diagnostic testing firm for raising concerns about regulatory violations and improper billing of federal health care programs, closing his Washington federal court case just days after the government declined to intervene.

  • 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.

Expert Analysis

  • 9th Circ. Ruling Puts Teeth Into Mental Health Parity Claims

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    In its recent finding that UnitedHealth applied an excessively strict review process for substance use disorder treatment claims, the Ninth Circuit provided guidance on how to plead a Mental Health Parity and Addiction Equity Act violation and took a step toward achieving mental health parity in healthcare, says Mark DeBofsky at DeBofsky Law.

  • Breaking Down DOJ's Individual Self-Disclosure Pilot Program

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    The U.S. Department of Justice’s recently announced pilot program aims to incentivize individuals to voluntarily self-disclose corporate misconduct they were personally involved in, complementing a new whistleblower pilot program for individuals not involved in misconduct as well as the government's broader corporate enforcement approach, say attorneys at Paul Weiss.

  • FDA Warning Letter Tightens Reins On 'Research Only' Labels

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    A recent warning letter from the U.S. Food and Drug Administration to Agena Bioscience alleged the company’s diagnostic devices were labeled for research use only, but improperly promoted for human clinical purposes, signifying a reinforcement — and a potential narrowing — of the agency's policy on products labeled “research only,” say attorneys at Sheppard Mullin.

  • First 10b5-1 Insider Trading Case Raises Compliance Issues

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    The ongoing case against former Ontrak CEO Terren Peizer is the U.S. Department of Justice's first insider trading prosecution based primarily on the filing of 10b5-1 plans, and has important takeaways for attorneys reviewing corporate policies on the possession of material nonpublic information, say attorneys at Cadwalader.

  • Policy Misrepresentations Carry Insurance Rescission Risks

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    The Second Circuit's recent decision in Medical Mutual v. Gnik, finding that material misrepresentation in a clinic's insurance applications warranted policy rescission, is a clear example of the far-reaching effects that misrepresentations can have and provides a reminder that policyholders should employ relatively straightforward steps to decrease risks, say attorneys at Hunton.

  • The Pros And Cons Of NIST's Proposed March-In Framework

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    Recent comments for and against the National Institute of Standards and Technology’s proposed guidance on march-in rights — which permit the government to seize federally funded patents — highlight how the framework may promote competition, but could also pose a risk to contractors and universities, say Nick Lee and Paul Ragusa at Baker Botts.

  • 2 Recent Suits Show Resiliency Of Medicare Drug Price Law

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    Though pharmaceutical companies continue to file lawsuits challenging the Inflation Reduction Act, which enables the federal government to negotiate for lower prescription drug prices, recent decisions suggest that the reduced drug prices are likely here to stay, says Jose Vela Jr. at Clark Hill.

  • Defense Attys Must Prep For Imminent AI Crime Enforcement

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    Given recent statements by U.S. Department of Justice officials, white collar practitioners should expect to encounter artificial intelligence in federal criminal enforcement in the near term, even in pending cases, say Jarrod Schaeffer and Scott Glicksman at Abell Eskew.

  • Lessons For Nursing Facilities From DOJ Fraud Settlement

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    The U.S. Department of Justice's recent settlement with the owner of skilled nursing and assisted living facilities in Florida provides a cautionary tale of potential fraud risks, and lessons on how facilities can mitigate government enforcement actions, say Callan Stein and Rebecca Younker at Troutman Pepper.

  • HHS' Updated Tracking Tech Guidance Offers Little Clarity

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    The U.S. Department of Health and Human Services' Office for Civil Rights' updated guidance on the use of online tracking technologies appears more focused on legal issues raised in ongoing litigation with the American Hospital Association and less on practical guidance for covered entities, say attorneys at Sheppard Mullin.

  • Takeaways From The 2023 DOJ Fraud Section Report

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    Attorneys at Wiley discuss notable trends from the U.S. Department of Justice's recently reported Fraud Section activity last year and highlight areas of enforcement to watch for in the future, including healthcare fraud and Foreign Corrupt Practices Act violations.

  • NIST March-In Framework Is As Problematic As 2021 Proposal

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    While the National Institute of Standards and Technology's proposed march-in framework on when the government can seize patents has been regarded as a radical departure that will support lowering prescription drug costs, the language at the heart of it is identical to a failed 2021 notice of proposed rulemaking, says attorney Kelly Morron.

  • Spartan Arbitration Tactics Against Well-Funded Opponents

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    Like the ancient Spartans who held off a numerically superior Persian army at the Battle of Thermopylae, trial attorneys and clients faced with arbitration against an opponent with a bigger war chest can take a strategic approach to create a pass to victory, say Kostas Katsiris and Benjamin Argyle at Venable.