Policy & Compliance
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August 01, 2024
Novo Nordisk Loses Challenge To Medicare Drug Price Talks
Another challenge to a Medicare drug price negotiation program has failed after a New Jersey federal judge ruled once again that the program is voluntary and rejected claims that it violates the constitutional rights of pharmaceutical giant Novo Nordisk.
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August 01, 2024
DLA Piper Hires Longtime Williams & Jensen Partner In DC
DLA Piper has hired a former Williams & Jensen PLLC attorney who spent 24 years there working on healthcare public policy issues and representing biopharmaceutical companies and various insurance providers, the firm has announced.
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August 01, 2024
Hogan Lovells Recruits Two From Foley Hoag To Health Team
Hogan Lovells said Thursday it has hired two Foley Hoag partners experienced in complex regulatory, legislative and legal policy affecting medical technology and biopharmaceutical companies to join the firm's health practice.
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July 31, 2024
Wells Fargo Let Workers' Prescription Costs Soar, Suit Says
A group of former Wells Fargo employees have accused the banking giant of mismanaging its prescription drug benefits program, costing its Employee Retirement Income Security Act plan and employees millions of dollars in premiums and medication costs, according to a proposed class action in Minnesota federal court.
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July 31, 2024
Wash. Hospital Workers Keep $230M Wage Win, Attys Get 30%
A Washington state court rejected a hospital system's attempt to undo its nearly $230 million loss in a class wage and hour case, ruling Wednesday that jurors reasonably relied on expert damages calculations, while also signing off on a roughly $70 million attorney fee award for class counsel.
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July 31, 2024
Inhaler Patents 'Must Be' In Orange Book, Teva Tells Fed. Circ.
Teva Pharmaceuticals USA Inc. urged the Federal Circuit to upend a lower court decision ejecting inhaler device patents from an important government database, arguing that the delisting, won by Amneal Pharmaceuticals Inc. in an infringement lawsuit, ignores broad protection envisioned under intellectual property law.
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July 31, 2024
10th Circ. Finds Plenty To Prove Colo. Doctor's COVID Fraud
A Tenth Circuit panel has affirmed fraud convictions for a former Colorado physician, concluding that there was a wealth of evidence to find him guilty of swindling government COVID-19 aid programs and spending the money on himself.
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July 31, 2024
CVS Appeal Blocked In Whistleblower Suit Over Drug Prices
A Pennsylvania federal judge has barred CVS Health Co. from making an interlocutory appeal over his interpretation of regulations in a whistleblower's lawsuit claiming the company's prescription entities falsely reported drug prices to the government. The judge recommended that a trial date be set in the decade-long litigation instead.
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July 31, 2024
1st Circ. Mostly Backs $5M Award In Biotech Recruiting Spat
The First Circuit left intact the vast majority of a $5 million post-trial award against a life sciences recruiting firm found to have misappropriated trade secrets from a rival involving placements at Takeda and Vedanta Biosciences.
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July 30, 2024
Life Sciences Cases To Watch 2024: A Midyear Report
From the U.S. Supreme Court down to the federal district courts, judges and lawmakers are grappling with questions crucial to the life sciences industry. Here are some of the biggest life sciences cases to watch in the second half of 2024.
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July 30, 2024
Immunity Bars Most Vaccine Challenges, Conn. Justices Rule
The Connecticut Supreme Court on Tuesday narrowed a challenge to a law that eliminated religious exemptions to the state's school vaccination mandates, ordering a trial judge to dismiss two parents' constitutional claims while leaving open for future proceedings a free exercise claim filed under a state statute.
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July 30, 2024
AIDS Org Sues Express Scripts For PBM Monopoly
The world's largest HIV/AIDS healthcare organization is joining the slew of litigants suing pharmacy benefit manager Express Scripts, claiming in a new complaint that the pharmacy giant has leveraged monopoly power in Louisiana to suppress competition among independent specialty pharmacies that focus on rare and complex medical conditions.
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July 30, 2024
Judge Wants Device Warning Answers From Mich. Justices
A Michigan federal judge ruled Tuesday that medical device manufacturer NuVasive Inc. must face a patient suit alleging its limb-lengthening device caused metal poisoning, while also asking the Michigan Supreme Court to break its silence on medical manufacturers' duty to warn patients directly.
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July 30, 2024
Florida Residents Urge 11th Circ. Keep Block On Gender Law
Transgender adults and children in Florida on Monday urged the Eleventh Circuit to reject the state's attempt to enforce a law restricting gender-affirming treatment for transgender minors and adults while the case is on appeal.
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July 30, 2024
Mixed Ruling in NC Knocks Down Rare Abortion Restriction
An unusual provision in North Carolina's anti-abortion law — it would require doctors to document that a fertilized egg was implanted in the uterus before prescribing abortion medications — failed its biggest legal test to date this week.
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July 30, 2024
Medicare Rules Face Double Punch From High Court Cases
A pair of administrative law decisions from the U.S. Supreme Court this past term will equip ambitious plaintiffs with more ammo to challenge regulations implementing federal healthcare programs.
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July 30, 2024
PBMs Urge Justices To Reject Review Of Okla. Law Dispute
An industry trade group representing pharmacy benefits managers urged the U.S. Supreme Court not to disturb its Tenth Circuit victory, which held that an Oklahoma statute regulating PBMs ran afoul of preemption provisions in both the Employee Retirement Income Security Act and Medicare Part D.
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July 30, 2024
HHS' New AI Leader Talks Next Chapter For Health IT
More than two decades ago, the federal government created an office to support healthcare's shift from analog to digital recordkeeping. Today, that office and its leader, Micky Tripathi, are tasked with steering the industry as it faces a new digital turning point: artificial intelligence.
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July 30, 2024
5 Podcasts For Health, Life Sciences Lawyers
For healthcare and life sciences attorneys who have been in the throes of their work this summer, have no fear: There is still time for leisure. And what better way to relax or stay informed than listening to a podcast while exercising, lounging by the pool or decompressing between meetings?
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July 30, 2024
Psychedelics And The Law: A Midyear Review
A groundbreaking effort to secure federal approval for a psychedelic medication hit an unexpected snag. Religious groups asserting the right to access controlled substances had mixed success in federal court. Physicians seeking to administer psilocybin to terminally ill patients will finally have their day in court. Here are the major developments in psychedelics law from the first half of 2024.
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July 30, 2024
Former Prosecutor 'Coming Back Home' To NJ Boutique
After prosecuting federal healthcare crimes in New Jersey, a former assistant U.S. attorney has returned to boutique firm Calcagni & Kanefsky LLP to guide clients as part of the firm's white collar criminal and regulatory defense and investigations practice with a focus on healthcare litigation and licensing, the firm announced Tuesday.
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July 30, 2024
Mich. COVID-19 Liability Law Shields Regular Healthcare Too
A 2020 law protecting healthcare providers and facilities from liability for their response to the early COVID-19 pandemic also applies to regular care provided during that time, a Michigan appellate panel said, finding that resources diverted because of the state's response affected other areas of care.
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July 29, 2024
Feds Say Tenn., NC Hospitals Overpaid Doctors For Referrals
A Tennessee-based hospital system violated the False Claims Act by taking $27.8 million in public healthcare allotments while overpaying doctors, sometimes by three times the average physician's pay, to make internal referrals, according to a lawsuit the U.S. Department of Justice has joined.
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July 29, 2024
Wash. Says At-Home Rape Kit Law Targets Harm, Not Speech
Washington pushed back against a company's bid to pause enforcement of a ban on the sale of "DIY" DNA collection kits to sexual assault survivors, saying the prohibition is meant to prevent victims from being tricked into thinking the kit results will stand up in court.
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July 29, 2024
Boehringer Appeals HHS Win In Medicare Drug Price Suit
Boehringer Ingelheim Pharmaceuticals Inc. notified a Connecticut federal court Friday that it will appeal its loss in a lawsuit challenging a new Medicare drug price negotiation program on the grounds that it unlawfully compels the pharmaceutical giant to declare prices "fair," takes its property and imposes an excessive fine.
Expert Analysis
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What Large Language Models Mean For Document Review
Courts often subject parties using technology assisted review to greater scrutiny than parties conducting linear, manual document review, so parties using large language models for document review should expect even more attention, along with a corresponding need for quality control and validation, say attorneys at Sidley.
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Checking In On How SuperValu Has Altered FCA Litigation
Four months after the U.S. Supreme Court's ruling in U.S. ex rel. Chutte v. SuperValu, the decision's reach may be more limited than initially anticipated, with the expansion of the scienter standard counterbalanced by some potential defense tools for defendants, say Elena Quattrone and Olivia Plinio at Epstein Becker.
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Participating In Living History Makes Me A Better Lawyer
My role as a baron in a living history group, and my work as volunteer corporate counsel for a book series fan association, has provided me several opportunities to practice in unexpected areas of law — opening doors to experiences that have nurtured invaluable personal and professional skills, says Matthew Parker at the Nebraska Department of Health and Human Services.
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Private Equity Owners Can Remedy Law Firms' Agency Issues
Nonlawyer, private-equity ownership of law firms can benefit shareholders and others vulnerable to governance issues such as disparate interests, and can in turn help resolve agency problems, says Michael Di Gennaro at The Law Practice Exchange.
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Cos. Must Overhaul Data Privacy Approach To Avoid Lawsuits
With the proliferation of third-party trackers and the increasing complexity of privacy laws, companies need to significantly change their approach to online privacy to avoid litigation by focusing on responsible data collection practices and ongoing monitoring of ad tech tools, says Ian Cohen at LOKKER.
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Biden Admin's Mental Health Proposal May Not Be Enough
The Biden administration's recent proposed updates to federal mental health care rules acknowledge the difficulty that Americans face in finding and affording care, but may have limited impact due to enforcement challenges, a lack of providers and other issues, say Khaled Klele and Jessica Osterlof at Riker Danzig.
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How To Protect Atty-Client Privilege While Using Generative AI
When using generative artificial intelligence tools, attorneys should consider several safeguards to avoid breaches or complications in attorney-client privilege, say Antonious Sadek and Christopher Campbell at DLA Piper.
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How New Lawyers Can Leverage Feedback For Growth
Embracing constructive criticism as a tool for success can help new lawyers accelerate their professional growth and law firms build a culture of continuous improvement, says Katie Aldrich at Fringe Professional Development.
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ESG Around The World: Australia
Clive Cachia and Cathy Ma at K&L Gates detail ESG-reporting policies in Australia and explain how the country is starting to introduce mandatory requirements as ESG performance is increasingly seen as a key investment and corporate differentiator in the fight for global capital.
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Info Exchanges Must Stay Inside Now-Invisible Antitrust Lines
While the antitrust agencies recently withdrew long-standing enforcement policy statements for being "overly permissive" on information exchanges, we should not assume that all information exchanges are inherently suspect — they are still permissible if carefully constructed and vigorously managed, say attorneys at Nelson Mullins.
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Twitter Legal Fees Suit Offers Crash Course In Billing Ethics
X Corp.'s suit alleging that Wachtell grossly inflated its fees in the final days of Elon Musk’s Twitter acquisition provides a case study in how firms should protect their reputations by hewing to ethical billing practices and the high standards for professional conduct that govern attorney-client relationships, says Lourdes Fuentes at Karta Legal.
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Avoid Telehealth Pitfalls In A Post-Pandemic Environment
As federal and state governments roll out various changes to regulation of telehealth services, health practitioners should remain vigilant and ensure that necessary professional standards — such as proper note-taking and documentation — are not neglected in a remote environment, say attorneys at Kaufman Borgeest.
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ABA's Money-Laundering Resolution Is A Balancing Act
While the American Bar Association’s recently passed resolution recognizes a lawyer's duty to discontinue representation that could facilitate money laundering and other fraudulent activity, it preserves, at least for now, the delicate balance of judicial, state-based regulation of the legal profession and the sanctity of the attorney-client relationship, say attorneys at Ballard Spahr.