Policy & Compliance

  • 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.

  • April 09, 2024

    Sanofi Sees End To 4,000 Suits Over Zantac

    The consequences of the demise of Roe rippled through state courts, big employers say they didn't get the generic-drug bargain they signed up for, and pharmaceutical giant Sanofi moved closer to resolving thousands of claims centering on the heartburn drug Zantac. Here, Law360 looks at the major healthcare litigation from the past week.

  • April 09, 2024

    Philips, Feds Enter Consent Decree Over Sleep Apnea Devices

    Philips Respironics can't make sleep apnea breathing machines until it hires an independent monitor, undergoes inspections and meets its obligations under a plan to remediate patients affected by a 2021 recall of such devices, the U.S. Department of Justice and U.S. Food and Drug Administration announced Tuesday.

  • April 09, 2024

    3 Years In, 'No Surprises' Gets Mixed Reviews From Providers

    It's been more than three years since President Joe Biden signed federal "surprise" medical billing legislation. But after a rocky roll-out and several successful legal challenges, some are giving the No Surprises Act mixed reviews, including its particularly contentious independent dispute resolution process.

  • April 09, 2024

    Calif. Healthcare Attys Working Late Thanks To New Regs

    Attorneys working on healthcare deals in California are logging longer hours and getting less sleep as they grapple with new regulations that came into effect this month.

  • April 09, 2024

    Court Axes Subpoena Of Ex-Wife In 1st Abortion Death Suit

    The woman at the center of the nation's first abortion wrongful death suit since the landmark Dobbs decision need not produce info about how she allegedly obtained abortion-inducing drugs from two women, a Texas appeals court ruled Tuesday, saying doing so would violate the woman's Fifth Amendment right against self-incrimination.

  • April 09, 2024

    6th Circ. Ruling May Alter State Certificate Of Need Laws

    A Sixth Circuit finding that part of Kentucky's certificate of need law is unconstitutional shows that circuit courts are still figuring out how medical spending control statutes fit with modern U.S. Supreme Court case law.

  • April 09, 2024

    Idaho Abortion Ban Tees Up Battle On 'Trafficking' Restrictions

    As Idaho officials prepare to defend a near-total abortion ban at the U.S. Supreme Court this month, a state abortion "trafficking" statute is also heading for a federal court challenge that forecasts future constitutional battles over attempts to criminalize out-of-state travel.

  • April 09, 2024

    Tighter Limits On 'Junk' Insurance May Spur New Legal Fights

    The Biden administration's new rule limiting short-term insurance plans isn't likely to end debates over how strictly to regulate health coverage that falls outside Affordable Care Act protections.

  • April 09, 2024

    White House, Senate Dems Want $1.3B To Fight COVID Fraud

    The White House has been working with Senate Democrats on a $1.3 billion plan to expand the federal government's toolkit for going after pandemic fraudsters who took advantage of the influx of aid made available to different facets of the public during the COVID-19 pandemic.

  • April 09, 2024

    Life Sciences GCs On Tighter Regs, Outside Counsel Advice

    General counsel at life sciences venture capital firms are navigating increased regulation in healthcare and looking to outside counsel to act as true advisers and problem-solvers as the healthcare industry becomes more complex.

  • April 09, 2024

    Health Equity Advocates Notch Win with Dental Coverage Rule

    A new rule from the Department of Health and Human Services aimed at getting more adult dental care covered as an "essential" Affordable Care Act benefit promises to help close a critical healthcare equity gap.

  • April 09, 2024

    Ariz. High Court Restores Civil War-Era Abortion Ban

    The Arizona Supreme Court on Tuesday revived the state's nearly 160-year-old abortion ban, concluding that a far more recent law that had allowed abortion through 15 weeks of pregnancy did not replace the older prohibition.

  • April 09, 2024

    Crowell & Moring Hires Senior Health Atty From Capitol Hill

    Crowell & Moring LLP has hired a health care attorney from the U.S. House of Representatives who most recently served as a senior counsel in that body's Committee on Energy & Commerce, the firm announced Tuesday.

  • April 08, 2024

    Walmart Beats Investor Suit Over Opioid Probe Disclosures

    Walmart beat back an investor class action on Monday alleging it failed to properly disclose that it was the subject of parallel criminal and civil investigations over its opioid sales, with a Delaware federal judge ruling that the suit's challenged statements were not false or misleading.

Expert Analysis

  • 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.

  • 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.