Policy & Compliance
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January 15, 2025
Gilead, Feds Resolve HIV Drug Patent Dispute Amid Appeal
Gilead Sciences and the federal government have agreed to dismiss all claims and counterclaims in a yearslong intellectual property and contract battle over HIV prevention drugs Truvada and Descovy, according to stipulations of voluntary dismissal filed Wednesday in both the Federal Circuit and Delaware federal court.
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January 15, 2025
FTC Won't Disqualify Commissioners From PBM Insulin Case
The Federal Trade Commission denied bids from Caremark Rx, Express Scripts and OptumRx that sought to bar the commission's Democratic members from participating in a case accusing the pharmacy benefit managers of inflating insulin prices.
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January 15, 2025
Ruling On Fla. Gender Law Animus Is Flawed, 11th Circ. Told
Florida urged an Eleventh Circuit panel on Wednesday to overturn an order declaring the state's ban on certain types of medical treatment for gender dysphoria unconstitutional, arguing the lower court wrongly used the condition as a proxy for transgender individuals in ruling that the prohibition was proof of discriminatory animus.
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January 15, 2025
9th Circ. Eyes Undoing Trans Patients' Win In ACA Bias Suit
The Ninth Circuit seemed inclined Wednesday to strike down a trial court win for patients who challenged Blue Cross Blue Shield of Illinois' administration of their employer-provided health plans containing gender-affirming care exclusions, with two judges questioning why those employers weren't part of the case.
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January 15, 2025
DOJ Reports $2.9B Haul Under FCA, Largest In 3 Years
Litigation under the False Claims Act generated a little over $2.9 billion in settlements and judgments in the most recent fiscal year, a 5% bump over 2023's total and the most in three years, according to data released Wednesday by the U.S. Department of Justice.
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January 15, 2025
Former FDA Official Joins King & Spalding Life Sciences Team
King & Spalding on Wednesday announced that a former U.S. Food and Drug Administration official has joined the firm's government matters and regulation practice group after an eight-year stint at the agency.
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January 15, 2025
Holland & Knight Adds Ex-GOP Rep. To Policy Advisory Team
Holland & Knight LLP has hired seven-term Indiana Republican Congressman Larry Bucshon as a senior policy adviser.
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January 14, 2025
New EMTALA Suit in Idaho Seeks To Keep Injunction
An Idaho health system filed a lawsuit Tuesday alleging that Idaho's strict abortion ban conflicts with an emergency stabilization law and is seeking to keep the ban blocked while it prepares to take up the legal battle once fought by the Biden administration.
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January 14, 2025
Dispute Over Eli Lilly Weight Loss Drug Reignited
Compounding pharmacies have reignited a suit against the U.S. Food and Drug Administration over the removal of a lucrative weight loss drug from the shortage list, with a Texas federal judge ordering both sides to turn in briefing on injunctive relief during a Tuesday hearing.
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January 14, 2025
FTC Issues Second Report On PBMs, Expanding Study Scope
The Federal Trade Commission released a second "interim" report on pharmacy benefit managers and their effects on specialty drug prices Tuesday, claiming that the companies have driven up prices well over acquisition costs and continue to squeeze independent pharmacies out of the market through low reimbursement rates.
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January 14, 2025
Both Michigan US Attys Resign Ahead Of Inauguration
Michigan's U.S. attorneys, Dawn Ison in the Eastern District and Mark Totten in the Western District, announced their departures this week ahead of President-elect Donald Trump's inauguration.
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January 14, 2025
Healthcare Laws Taking Effect In 2025
This year, the healthcare industry will see a host of new laws touching on everything from private equity transactions and oversight to drug price caps and medical leave policies.
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January 14, 2025
Whistleblowing Compliance Pro Secures 4th FCA Settlement
A repeat whistleblower has cost hospitals more than $43 million in federal settlements over the last 18 years, illustrating the increased use of data analysis and other trends in False Claims Act litigation.
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January 14, 2025
2nd Circ. Rules Prison Docs Can't Escape Indifference Claims
A Second Circuit panel on Monday ruled two New York prison doctors must face a former inmate's deliberate indifference claims for allegedly overlooking his cancer symptoms despite medical exam results, while also finding the inmate's claims were not time-barred, though the court said the state and facility are protected by sovereign immunity.
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January 14, 2025
Mass. AG Says Insulin Makers, Middlemen Colluded On Costs
Insulin makers Eli Lilly, Sanofi and Novo Nordisk conspired with pharmacy benefit managers OptumRX, Express Scripts and CVS Caremark to jack up prices by as much as 1,000%, the Massachusetts attorney general alleged in a suit.
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January 14, 2025
Assisted Living Co., Ex-Worker End Race-Based Pay Bias Suit
An assisted living facility and a former employee have agreed to close her suit claiming she was paid less than colleagues and belittled by her supervisor because she is Indian American, according to a New York federal court filing.
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January 13, 2025
Lincare Pays $1.15M To End Wash. Medicaid Fraud Probe
Lincare Inc. agreed to pay $1.15 million to resolve a Washington probe into allegations the medical equipment supplier overbilled Medicaid for rental payments for patients' oxygen equipment over a six-year period, the Washington State Office of the Attorney General announced Monday.
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January 13, 2025
Blue Cross Can't Skirt NC Hospital's Defamation Claims
A local hospital can pursue some of its defamation claims against Blue Cross and Blue Shield of North Carolina in a suit alleging the health insurer wrongly denied millions of dollars in reimbursements and falsely accused the facility of fraud, a federal judge ruled Monday.
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January 13, 2025
Duke Health Worker Agrees To Arbitrate Bias Suit, For Now
A former Duke University Health System Inc. radiology technologist who accused the healthcare network of firing her for being pregnant with her second child told a North Carolina federal judge Monday she is all right with her former employer's request to take the matter to arbitration.
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January 13, 2025
RFK Jr.'s Wash. Anti-Vax Suit Can't Get High Court Save
The U.S. Supreme Court on Monday rejected Robert F. Kennedy Jr.'s bid for an emergency order to temporarily block a state of Washington medical board investigation into alleged anti-vaccine statements made by retired doctors.
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January 13, 2025
Feds Say NC Medical Biz Owner Overbilled For Nutrient Drinks
A North Carolina businessman who ran a durable medical equipment business under multiple names overbilled the state's Medicaid program $1.85 million for special enteral nutritional formulas used to treat inherited metabolic disorders when he was actually just providing people common nutritional shakes like Ensure, the federal government said.
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January 13, 2025
Supreme Court Turns Away IP Safe Harbor Dispute
The U.S. Supreme Court on Monday said it won't consider whether the Federal Circuit has overexpanded a safe harbor for drug development, in litigation where Meril Life Sciences escaped allegations that it infringed Edwards Lifesciences' heart valve patents.
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January 10, 2025
Home Care Co. Must Pay $15M In DOL OT Suit
An Ohio federal judge granted the U.S. Department of Labor a win in its lawsuit accusing a third-party home care agency of failing to pay employees overtime and ordered the company to pay $15 million in unpaid wages and damages.
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January 10, 2025
Justices To Review ACA Preventive Care Fight
The U.S. Supreme Court agreed Friday to review a Fifth Circuit decision finding a task force setting coverage requirements on preventive care was unconstitutional, setting up a high-stakes battle over the Affordable Care Act that could affect individuals' insurance coverage for things like colon and breast cancer screenings.
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January 09, 2025
CFPB Hit With 2nd Suit Over Medical Debt Reporting Rule
The Consumer Financial Protection Bureau has been hit with a second lawsuit challenging its new rule that would wipe billions of dollars in medical debt off consumer credit reports, with ACA International filing a complaint in Texas federal court arguing healthcare markets are outside the agency's regulatory authority.
Expert Analysis
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Giving The Gov't Drug Patent March-In Authority Is Bad Policy
The Biden administration's recent proposal to allow government seizure of certain taxpayer-funded drug patents is a terrible idea that would negate the benefits of government-funded research, to the detriment of patients and the wider economy, says Wayne Winegarden at Pacific Research Institute.
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How Clients May Use AI To Monitor Attorneys
Excerpt from Practical Guidance
Artificial intelligence tools will increasingly enable clients to monitor and evaluate their counsel’s activities, so attorneys must clearly define the terms of engagement and likewise take advantage of the efficiencies offered by AI, says Ronald Levine at Herrick Feinstein.
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When Patients Have Standing For Hospital Antitrust Suits
Brown v. Hartford Healthcare Corp., recently decided by a Connecticut state court, provides a useful examination of how antitrust standing issues may be analyzed when patients directly sue a healthcare system for anti-competitive conduct, says Charles Honart at Stevens & Lee.
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ESG Around The World: Singapore
Singapore is keen to establish itself as a leading international financial center and a key player in the sustainable finance ecosystem, and key initiatives led by its government and other regulatory bodies have helped the Asian nation progress from its initially guarded attitude toward ESG investment and reporting, say attorneys at Morgan Lewis.
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The Pop Culture Docket: Judge D'Emic On Moby Grape
The 1968 Moby Grape song "Murder in My Heart for the Judge" tells the tale of a fictional defendant treated with scorn by the judge, illustrating how much the legal system has evolved in the past 50 years, largely due to problem-solving courts and the principles of procedural justice, says Kings County Supreme Court Administrative Judge Matthew D'Emic.
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Performing Music Makes Me A Better Lawyer
The discipline of performing live music has directly and positively influenced my effectiveness as a litigator — serving as a reminder that practice, intuition and team building are all important elements of a successful law practice, says Jeff Wakolbinger at Bryan Cave.
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'Patient' Definition Ruling Raises Discount Drug Questions
A South Carolina federal court's recent decision in Genesis Health Care v. Becerra supports a broader definition of a "patient" eligible to receive discounted drugs under the Section 340B program, but raises a host of novel questions regarding how the decision will affect covered entities and enforcement actions, say attorneys at McDermott.
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Breaking Down High Court's New Code Of Conduct
The U.S. Supreme Court recently adopted its first-ever code of conduct, and counsel will need to work closely with clients in navigating its provisions, from gift-giving to recusal bids, say Phillip Gordon and Mateo Forero at Holtzman Vogel.
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Legal Profession Gender Parity Requires Equal Parental Leave
To truly foster equity in the legal profession and to promote attorney retention, workplaces need to better support all parents, regardless of gender — starting by offering equal and robust parental leave to both birthing and non-birthing parents, says Ali Spindler at Irwin Fritchie.
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Activist Short-Sellers Are The Dark Knights Of Wall Street
While so-called activist short-sellers have been subject to increased scrutiny in recent years, these investors work in the shadows like Batman to expose fraud on Wall Street, often generating leads that may move regulators to take action, say attorneys at Labaton Sucharow.
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Steps Toward A Unified Health Financing System For Calif.
A new law authorizes the secretary of the California Health and Human Services Agency to move forward with designing a unified healthcare financing system, though the notable absence of healthcare payers in the law's list of specified stakeholders raises questions about the state's position regarding private payer options, says Ima Nsien at Squire Patton.
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Writing Thriller Novels Makes Me A Better Lawyer
Authoring several thriller novels has enriched my work by providing a fresh perspective on my privacy practice, expanding my knowledge, and keeping me alert to the next wave of issues in an increasingly complex space — a reminder to all lawyers that extracurricular activities can help sharpen professional instincts, says Reece Hirsch at Morgan Lewis.
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What Lawyers Must Know About Calif. State Bar's AI Guidance
Initial recommendations from the State Bar of California regarding use of generative artificial intelligence by lawyers have the potential to become a useful set of guidelines in the industry, covering confidentiality, supervision and training, communications, discrimination and more, say attorneys at Debevoise.