Policy & Compliance

  • December 20, 2024

    Sens. Aim To Protect Generics With Skinny Labels In New Bill

    A bipartisan group of senators from Colorado, Arkansas, Vermont and Maine have introduced a bill that would shield generic-drug and biosimilar manufacturers from infringement liability when using approved "skinny labels."

  • December 20, 2024

    3rd Circ. Denies Challenge To Pa. Autism Settlement

    A Third Circuit panel on Friday rejected claims a settlement requiring around-the-clock care for a woman with autism is too impractical to be enforced, reversing a lower-court decision and handing a victory to the Pennsylvania woman's family.

  • December 20, 2024

    Psychedelics Law Reformers Hit Multiple Setbacks In 2024

    In 2024, advocates, physicians and researchers attempted to broaden lawful access to federally illegal psychedelic drugs through a variety of avenues — the new drug approval process, litigation and a ballot initiative — with the upshot that the law remains largely unchanged and, for the most part, still restricts legal use and possession of these substances.

  • December 20, 2024

    Lambda Legal Adds Attorney In NY Focused On Trans Rights

    LGBTQ+ advocacy group Lambda Legal has hired a new senior attorney focused on the organization's work defending the transgender community.

  • December 20, 2024

    Top NJ Cases Of 2024: COVID Test Kits And Political Favors

    After failed attempts in previous years, 2024 was the year prosecutors secured convictions in separate cases against a longtime New Jersey senator and a healthcare software executive. In another closely watched white collar matter, a Garden State law firm executive met his fate for stealing from his employer. 

  • December 19, 2024

    PhRMA Wins Bid To Halt W.Va. Drug Discount Expansion Law

    The country's biggest pharmaceutical lobbying group has won preliminary injunctions against a West Virginia law that the Pharmaceutical Research and Manufacturers of America claims unconstitutionally expands a federal drug discount program, with a federal judge finding that the law threatens to create a situation where "the fox guards the henhouse."

  • December 19, 2024

    FTC Says PBMs Can't Get Preliminary Block In Insulin Case

    The Federal Trade Commission urged a Missouri federal judge Thursday not to temporarily block its in-house case accusing pharmacy benefits managers of artificially inflating insulin prices through unfair rebate schemes, arguing Congress clearly empowered such in-house adjudications and the officials who handle them.

  • December 19, 2024

    9 Charged In $20M Medicaid Fraud Linked To Philly Pharmacy

    Nine people associated with a South Philadelphia pharmacy have been charged with an alleged five-year scheme to defraud Medicare and Medicaid out of $20 million by submitting false claims for prescription reimbursement of expensive medications like HIV drugs, the Pennsylvania Attorney General's Office said Thursday.

  • December 19, 2024

    Generic-Drug Cos. Get State AGs' Trial Order Flipped

    A Connecticut federal court has sided with the generic-drug makers accused of price-fixing by state-level enforcers and will allow a narrower case involving 15 drugs to move ahead prior to a much broader case involving more than 100 medications.

  • December 19, 2024

    FDA Declaration May Restart Compounders' Shortage Suit

    Federal regulators pulled Eli Lilly's lucrative weight-loss and diabetes drug off the national shortage list Thursday and gave compounding pharmacists two months to stop making copycat versions of the injectable medication, a move with the potential to reignite a Texas legal clash.

  • December 19, 2024

    Addiction Group Pays $2M In Mass. AG False Billing Probe

    An addiction treatment physician group with offices across western Massachusetts will pay $2 million to settle allegations that it overcharged for visits and billed for tests that were not medically necessary, the state's attorney general said Thursday.

  • December 19, 2024

    NYU Langone Wrongly Exempts IT Workers From OT, Suit Says

    New York University's academic medical center improperly classifies information technology workers as overtime-exempt despite their duties not falling under an exemption, causing them to lose out on extra wages, a proposed class and collective action filed in New York federal court said.

  • December 18, 2024

    Patent Limits For Biosimilar Litigation Lands In Spending Bill

    Congress' spending package to keep the government open through March would also limit how many patents a biologics maker can assert when trying to prevent a competitor from getting on the market.

  • December 18, 2024

    FDA's Gastro Drug Fast-Track Denial Survives DC Circ.

    A D.C. Circuit panel upheld federal regulators' refusal to streamline approval of a drug to treat nausea in patients with a chronic gastric condition, ruling that the U.S. Food and Drug Administration was right to consider the drug's development plan when deciding whether it qualified for fast tracking.

  • December 18, 2024

    Destroyed Docs Merit Harsher Sanctions, Mich. Panel Says

    A Michigan appellate panel on Tuesday said fees awarded to the estate of a man who died after choking in an adult foster care facility were likely too low, finding a lower court erred by limiting the scope of available sanctions over the destruction of "copious amounts" of digital evidence.

  • December 18, 2024

    Philip Morris Sues FDA Over New Cigarette Warning Labels

    Tobacco giant Philip Morris and a group of Georgia convenience store interests have sued the U.S. Food and Drug Administration over a rule that would add graphic warnings to cigarette labels, alleging the agency is exceeding its statutory authority in a move that would mark a "sea change" for the industry.

  • December 18, 2024

    CVS Fueled Opioid Epidemic In Rush For Profits, Feds Say

    The U.S. Department of Justice unveiled a suit Wednesday accusing CVS, the nation's largest pharmacy chain, of knowingly filling invalid prescriptions for powerful opioids and ignoring internal pleas from its pharmacists as it allegedly put profits over safety. 

  • December 18, 2024

    FTC Wants Express Scripts' Defamation Suit Tossed

    The Federal Trade Commission told a Missouri federal court that Express Scripts Inc. has no basis to challenge an interim agency report that only offered "qualified conclusions" from an ongoing study about how pharmacy benefit managers affect prescription drug prices.

  • December 18, 2024

    Senate Sends $895B Defense Bill To Biden's Desk

    The U.S. Senate on Wednesday easily passed an $895.2 billion defense policy and budget bill for 2025, despite criticism over a contentious clause effectively barring gender-affirming healthcare coverage for service members' transgender children.

  • December 18, 2024

    Top Conn. Cases Of 2024: Kickbacks, Paybacks And Bribes

    Judges and juries in Connecticut awarded several multimillion-dollar verdicts against companies big and small in 2024, socking Johnson & Johnson in a talc case in which the already substantial damages could multiply and ordering a pharmacy that paid kickbacks to cough up nearly four times the money it cost the state.

  • December 18, 2024

    Justices Will Decide If Medicaid Recipients Can Pick Providers

    The U.S. Supreme Court on Wednesday partially granted the state of South Carolina's petition to review a Fourth Circuit decision blocking its Medicaid program from ending its provider agreement with Planned Parenthood, agreeing to determine if the Medicaid Act allows a beneficiary to choose a specific provider. 

  • December 17, 2024

    NC Panel Revives Negligence Suit Against State Health Dept.

    An adult care center's constitutional claims accusing the North Carolina Department of Health and Human Services of negligently asserting bogus penalties and unfairly suspending admissions at the facility are timely, a North Carolina state appellate panel ruled Tuesday, reviving a case that previously landed before the North Carolina Supreme Court.

  • December 17, 2024

    3 Healthcare Decisions This Week You Don't Want To Miss

    The Third Circuit issued a precedential ruling allowing Pennsylvania to dip into the $300 million budget surplus of an insurance fund for doctors facing medical malpractice claims. Meanwhile in Texas, a split appellate panel found that a member of a national hospital chain can enforce an arbitration agreement with an employee. 

  • December 17, 2024

    Express Scripts, OptumRx Can't Ditch LA County Opioid Suit

    A California judge ruled Tuesday that Los Angeles County can keep pursuing a lawsuit claiming pharmacy benefit managers Express Scripts and OptumRx colluded with drugmakers to fuel the opioid epidemic, though the county must rework its complaint to specify how regulators were allegedly deceived.

  • December 17, 2024

    House GOP Asks CVS How Its PBM Treats Smaller Pharmacies

    Lawmakers on Capitol Hill are demanding documents from CVS on its pharmacy benefit manager's treatment of independent pharmacies, continuing to press the healthcare giant over potentially anticompetitive conduct.

Expert Analysis

  • 10 Noteworthy CFPB Developments From 2024

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    In a banner year for consumer finance regulation, the Consumer Financial Protection Bureau made significant strides in its efforts to rein in Big Tech and nonbank financial firms, including via rules regarding open banking, credit card late fees, and buy now, pay later products, say attorneys at Wiley.

  • The Future Of GLP-1 Policy After Drug Shortage Ends

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    If and when the U.S. Food and Drug Administration determines that GLP-1 RA drugs are no longer in short supply, regulators will face questions of how to balance access to GLP-1 RAs with statutory and policy considerations applicable to compounded drugs, say attorneys at Skadden.

  • Top 10 Whistleblowing And Retaliation Events Of 2024

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    From a Florida federal court’s ruling that the False Claims Act’s qui tam provision is unconstitutional to a record-breaking number of whistleblower tips filed with the U.S. Commodity Futures Trading Commission, employers saw significant developments in the federal and state whistleblower landscapes this year, say attorneys at Proskauer.

  • How White Collar Defense Attys Can Use Summary Witnesses

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    Few criminal defense attorneys have successfully utilized summary witnesses in the past, but several recent success stories show that it can be a worthwhile trial tactic to help juries understand the complex decision-making at issue, says Jonathan Porter at Husch Blackwell.

  • Nutraceutical Patent Insights As Market Heats Up

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    Companies entering the expanding nutraceutical market and seeking patents to protect their innovations should evaluate successful nutraceutical claim language and common patent challenges in this field, say attorneys at Sterne Kessler.

  • How White Collar Attys Can Use Mythic Archetypes At Trial

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    A careful reading of a classic screenwriting guide shows that fairy tales and white collar trials actually have a lot in common, and defense attorneys would do well to tell a hero’s journey at trial, relying on universal character archetypes to connect with the jury, says Jack Sharman at Lightfoot Franklin.

  • What 2024 Election Means For Drugs, Medicare And Medicaid

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    With Republicans running the White House, U.S. House of Representatives and U.S. Senate, the incoming administration is likely to provide pathways — through new initiatives and others returning from Trump's previous presidency — for a range of potential changes to drug pricing, Medicare and Medicaid, say attorneys at Morgan Lewis.

  • Justices Mull Sex-Based Classification In Trans Law Case

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    After the U.S. Supreme Court heard oral argument in U.S. v. Skrmetti this week, it appears that the fate of the Tennessee law at the center of the case — a law banning gender-affirming healthcare for transgender adolescents — will hinge on whether the majority read the statute as imposing a sex-based classification, says Alexandra Crandall at Dickinson Wright.

  • Key Takeaways From FDA's Latest Social Media Warnings

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    The U.S. Food and Drug Administration's latest untitled letter concerning a drug company's social media promotion provides lessons for how companies should navigate risk presentation, FDA labeling requirements and superiority claims, say attorneys at Sheppard Mullin.

  • Rank-And-File DOJ Attorneys Will Keep Calm And Carry On

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    Career prosecutors at the U.S. Department of Justice often pride themselves on their ability to remain apolitical in order to ensure consistency and keep the department’s mission afloat, and the incoming Trump administration is unlikely to upend this tradition, says Michael Landman at Bird Marella.

  • Unpacking Arguments From High Court's Rural Hospital Case

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    During oral arguments in Advocate v. Becerra, the U.S. Supreme Court justices focused questions on the meaning of being "entitled to" supplementary security income assistance, and there's reason for optimism that the likely split decision will break in favor of hospitals, say attorneys at King & Spalding.

  • Health Policy Predictions For Trump's Second Administration

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    As President-elect Donald Trump's nominations for health policy and enforcement heads work their way through the confirmation process, healthcare organizations can look at nominee backgrounds, campaign statements and actions from Trump's previous presidency to predict incoming priorities, say attorneys at McDermott.

  • What Trump's Next Term May Mean For Biz Immigration

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    Leonard D'Arrigo at Harris Beach discusses the employment-based immigration policies businesses can potentially expect during President-elect Donald Trump’s second term, based on policies enacted during his first administration, statements made during his campaign and proposals in Project 2025.