Policy & Compliance

  • May 07, 2024

    20 Years Ago, One Case Opened Up Billions In FCA Liability

    On the 20-year anniversary of a landmark whistleblower case, attorneys look back on how Franklin v. Parke-Davis shaped the healthcare landscape, put Boston on the map as a hotbed of False Claims Act litigation and changed the drug industry's off-label marketing practices.

  • May 07, 2024

    DOJ Inks FCA, Opioid-Branding Enforcement Settlements

    The U.S. Department of Justice has been busy over the past week settling a variety of False Claims Act claims as well as a case against a pharmaceutical company for allegedly violating the Food, Drug and Cosmetic Act with deceptive opioid marketing.

  • May 07, 2024

    9th Circ. Asks Idaho To Define 'Recruit' In Abortion Travel Ban

    A Ninth Circuit panel grappled Tuesday with an Idaho law that makes it a criminal offense to help minors travel out of state to receive abortions without parental permission, with one judge struggling to understand what it means to "recruit" a pregnant teen to get an abortion under the law.

  • May 07, 2024

    Gov't Seeks Early Win In Ga. Medicaid Expansion Suit

    The Biden administration is urging a federal judge to take its side in a lawsuit in which Georgia is attempting to keep its Medicaid program for low-income residents running until 2028, arguing that the state never properly asked for a program extension and that the court lacks jurisdiction to extend its end date.

  • May 06, 2024

    Judge Trims ESOP Valuation Suit Against Healthcare Co.

    A California federal judge has trimmed a lawsuit against KPC Healthcare Inc., its employee stock ownership plan committee and its investment manager Alerus Financial alleging that a sale of company stock was mismanaged.

  • May 06, 2024

    UChicago Can't Ditch Data Sharing Privacy Claim

    A University of Chicago Medical Center patient accusing the hospital of illegally sharing her and other patients' identifying information with Meta can pursue her claims that the info sharing constitutes a federal wiretap violation, an Illinois federal judge said.

  • May 06, 2024

    Hooper Lundy Adds Government Relations Director

    An attorney who worked in-house for healthcare industry trade and advocacy associations has joined healthcare boutique Hooper Lundy & Bookman PC as director of government relations and public policy.

  • May 03, 2024

    Ala. High Court Won't Rethink Decision On Frozen Embryos

    The Alabama Supreme Court on Friday refused to revisit its February decision finding that frozen embryos count as children, a first-of-its-kind decision that has been received as potentially ruinous for in vitro fertilization services in the Yellowhammer State.

  • May 03, 2024

    Aetna To Pay $2M To End LGBTQ Fertility Coverage Suit

    A group of Aetna policyholders said Friday that the insurance giant has agreed to pay $2 million and revise certain health insurance guidelines to settle a proposed class action alleging its definition of infertility made it difficult and expensive for LGBTQ couples to obtain coverage for fertility treatments.

  • May 03, 2024

    Ohio Statehouse Catch-Up: Trans, Abortion Laws Face Battles

    Ohio lawmakers have shepherded controversial bills impacting healthcare, social media and other matters into law in recent months, prompting lawsuits and even a veto from Gov. Mike DeWine.

  • May 03, 2024

    6 States Strike $270M Opioid Deal With Amneal

    The New York state attorney general on Friday said that a $270 million multistate deal had been reached with opioid manufacturer Amneal Pharmaceuticals for its role in the addiction epidemic over allegations that the company failed to report suspicious orders of the narcotics.

  • May 02, 2024

    7th Circ. Mostly Backs Ill. Home Health Kickbacks Judgment

    The Seventh Circuit on Thursday largely left intact an Illinois federal judge's $6 million ruling that a home health care company broke federal kickback laws, refusing to reverse the lower court's liability finding but directing it to ensure its damages award was calculated correctly.

  • May 02, 2024

    Endo Judge Hopes Criminal Sentence Warns Opioid Makers

    A Michigan federal judge said Thursday she hoped Endo's criminal sentence for falsely advertising a pain medication as "abuse deterrent" would itself be a deterrent for other opioid makers, as she accepted the company's recent $200 million settlement deal with federal prosecutors. 

  • May 02, 2024

    Feds Call Out Gilead's Efforts To Revise HIV Drug IP Judgment

    The U.S. Department of Justice has asked a Delaware federal judge to reject Gilead Sciences' motion to modify a judgment finding that two medications in its HIV prevention regimen directly infringe voided patents owned by the government, arguing that the pharmaceutical company's attempt to rewrite the judgment is "unnecessary as well as improper."

  • May 02, 2024

    Lawmaker Wants Antitrust Probe Of Health Insurance Data Co.

    Sen. Amy Klobuchar, D-Minn., is calling for antitrust enforcers to investigate concerns that MultiPlan and other healthcare data companies are hurting competition by helping health insurers effectively collude when making pricing decisions.

  • May 02, 2024

    Biden Announces $3B To Fund Lead Pipe Replacement

    The Biden administration is distributing $3 billion to states so they can replace lead water pipes that pose a health risk to those who rely on them for drinking water, as part of the larger goal to remove all lead service lines nationwide.

  • May 02, 2024

    State Legislators Urge Feds To Change Cannabis' Status

    A coalition of state lawmakers on Thursday urged the heads of the U.S. Department of Justice and its drug enforcement agency to prioritize changing cannabis' status as a highly restricted drug.

  • May 01, 2024

    Sens. Slam UnitedHealth's Security Lapses, Breach Response

    UnitedHealth's top executive faced heavy criticism during his first appearance before a U.S. Senate committee since a cyberattack rocked its Change Healthcare subsidiary, with lawmakers blasting the company for lacking basic security measures and for still not being able to confirm the scale and scope of the incident.

  • May 01, 2024

    Ariz. AG Warns Repeal Of 1864 Abortion Ban May Be Too Late

    Legislation narrowly adopted Wednesday to repeal Arizona's 1864 abortion law won't be enough on its own to keep the near-total ban from taking effect this summer, the state attorney general warned, because the bill lacks an emergency clause.

  • May 01, 2024

    J&J Unit Cuts Deal To End Cancer Drug Trade Secret Fight

    A New Jersey federal judge has signed off on a consent judgment that permanently bars Chinese drugmaker Jiangsu Hengrui Pharmaceuticals Co. from misappropriating Johnson and Johnson's pharmaceutical subsidiary Janssen's trade secrets for its popular chemotherapy drug Yondelis.

  • May 01, 2024

    5th Circ. Judge Skeptical Of Medicare Drug 'Price-Setting'

    A Fifth Circuit judge on Wednesday sharply criticized the Biden administration's Medicare drug pricing program, characterizing it as government "price-setting" and questioning "what possible procompetitive justification" there can be for penalizing companies that don't participate.

  • April 30, 2024

    Ex-Olympus Exec Says He Was Fired For Flagging FDA Issue

    The former global head of product development at medical manufacturer Olympus Corp. said he was fired earlier this year after he reported multiple compliance concerns regarding the company's practices and related to nearly 100 products, according to a suit filed Monday in Pennsylvania federal court.

  • April 30, 2024

    Judge Strikes Parts Of NC Law Restricting Abortion Drug

    A North Carolina federal judge struck down parts of a state law Tuesday that restricts access to the abortion medication mifepristone, finding some provisions violate the U.S. Constitution's supremacy clause by enacting safety regulations already considered by the U.S. Food and Drug Administration, such as requiring in-person prescribing, dispensing and scheduling around the drug.

  • April 30, 2024

    BCBS Says Federal Drug Law Preempts NM Medical Weed Row

    A group of insurers, including Blue Cross and Blue Shield of New Mexico, urged a New Mexico federal judge to reject a proposed class action seeking to compel them to cover their policyholders' medical marijuana costs, arguing that state law doesn't require it and federal law forbids it.

  • April 30, 2024

    Aetna Resists State Court Remand In Provider Payment Suit

    A lawsuit alleging Aetna units have underpaid emergency healthcare workers' benefit claims should be heard in an Ohio federal court, the insurer said in opposing a remand to the state level, based in part on the argument that two of the corporate defendants don't belong in the case.

Expert Analysis

  • Digging Into The Debate On FDA's Proposed Lab Test Rule

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    A proposed 10-word amendment from the U.S. Food and Drug Administration represents a sea change in device regulation as it would summarily end decades of FDA enforcement discretion for laboratory developed tests, and the public comments offer some insight into the future of this long-running saga, say attorneys at Mintz.

  • Law Firm Strategies For Successfully Navigating 2024 Trends

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    Though law firms face the dual challenge of external and internal pressures as they enter 2024, firms willing to pivot will be able to stand out by adapting to stakeholder needs and reimagining their infrastructure, says Shireen Hilal at Maior Consultants.

  • AI In Health Law: The Top Guest Articles Of 2023

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    As the use of artificial intelligence accelerated this year, Expert Analysis writers examined AI's significant impact on the healthcare sector, ranging from key compliance considerations for companies utilizing AI tools to regulators' efforts to keep up with rapidly evolving technologies.

  • The Most-Read Legal Industry Law360 Guest Articles Of 2023

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    A range of legal industry topics drew readers' attention in Law360's Expert Analysis section this year, from associate retention strategies to ethical billing practices.

  • Inside Higher Education's New FCA Liability Challenges

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    As the educational sector expands its use of government funding, schools are at increased risk under the False Claims Act, but recent settlements offer valuable lessons about new theories of liability they may face and specific procedures to reduce their exposure, say James Zelenay and Jeremy Ochsenbein at Gibson Dunn.

  • AI Executive Order's Life Science, Healthcare Industry Effects

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    The recent White House executive order to manage risks associated with artificial intelligence includes provisions specific to healthcare and life sciences that merit special attention, including transparency, human oversight of AI output, and real world performance monitoring, say attorneys at Ropes & Gray.

  • HHS Advisory Highlights Free Product Inducement Risks

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    A recent U.S. Department of Health and Human Services advisory opinion highlights concerns that valuable free products and other inducements may influence patients and providers to choose one manufacturer’s product over another, notwithstanding that such free healthcare products may be a benefit, say attorneys at Morgan Lewis.

  • Attorneys' Busiest Times Can Be Business Opportunities

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    Attorneys who resolve to grow their revenue and client base in 2024 should be careful not to abandon their goals when they get too busy with client work, because these periods of zero bandwidth can actually be a catalyst for future growth, says Amy Drysdale at Alchemy Consulting.

  • In The World Of Legal Ethics, 10 Trends To Note From 2023

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    Lucian Pera at Adams and Reese and Trisha Rich at Holland & Knight identify the top legal ethics trends from 2023 — including issues related to hot documents, artificial intelligence and cybersecurity — that lawyers should be aware of to put their best foot forward.

  • How Attorneys Can Be More Efficient This Holiday Season

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    Attorneys should consider a few key tips to speed up their work during the holidays so they can join the festivities — from streamlining the document review process to creating similar folder structures, says Bennett Rawicki at Hilgers Graben.

  • Top 10 Whistleblowing And Retaliation Events Of 2023

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    The U.S. Securities and Exchange Commission and federal and state courts made 2023 another groundbreaking year for whistleblower litigation and retaliation developments, including the SEC’s massive whistleblower awards, which are likely to continue into 2024 and further incentivize individuals to submit tips, say attorneys at Proskauer.

  • Children's Book Writing Makes Me A Better Lawyer

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    Becoming a children's book author has opened doors to incredible new experiences of which I barely dared to dream, but the process has also changed my life by serving as a reminder that strong writing, networking and public speaking skills are hugely beneficial to a legal career, says Shaunna Bailey at Sheppard Mullin.

  • The State Of CFPB Focus On Credit Reporting Of Medical Debt

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    An increase in credit reporting complaints and the Consumer Financial Protection Bureau's recent annual report on the Fair Debt Collection Practices Act — which focuses on medical debt in credit reporting — are both evidence of the fact that the bureau will continue to prioritize oversight of credit reporting of medical debt, says Kristen Watson at Burr & Forman.