News & Analysis as of

Appeals Supreme Court of the United States Food and Drug Administration (FDA)

Greenbaum, Rowe, Smith & Davis LLP

First Circuit Decision Regarding Anti-Kickback Statute Standard Widens Circuit Split and Creates Potential for Supreme Court...

The U.S. Court of Appeals for the First Circuit, in United States v. Regeneron, has joined the Sixth and Eighth Circuits in adopting the “but-for” standard to find that a violation of the Anti-Kickback Statute (AKS) triggers...more

Troutman Pepper Locke

Supreme Court Says Affected Retailers May Challenge ENDS Manufacturer’s Marketing Denial Orders

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On June 20, the Supreme Court concluded that marketing denial orders (MDOs) issued by the Food and Drug Administration (FDA) can be challenged not only by the applicants (typically, the manufacturer or importer of the...more

Jones Day

U.S. Supreme Court Invites Solicitor General to Submit Briefing on "Skinny Labels"

Jones Day on

On June 23, 2025, the Supreme Court invited the Solicitor General to submit a brief expressing the views of the United States—dramatically increasing the likelihood that the Court will eventually grant review—in Hikma...more

Epstein Becker & Green

Federal Jurisdiction and Review Standards at Issue in Cases Ranging from Terrorism to Tobacco - SCOTUS Today

Epstein Becker & Green on

With six more decisions, the U.S. Supreme Court decided no fewer than 11 cases in two business days last week, following 12 others over the previous two weeks. In other words, summer vacation is upon us, as the Court’s...more

Carlton Fields

FDA v. Wages and White Lion Investments: A Reminder of the Deference to Agency Determinations Post-Loper Bright

Carlton Fields on

In FDA v. Wages and White Lion Investments LLC, the U.S. Supreme Court’s unanimous decision in favor of the Food and Drug Administration serves as a reminder of the deference still accorded to regulatory agencies post-Loper...more

Knobbe Martens

U.S. Supreme Court Defers to Agency Decision-Making in FDA’s Denial of Premarket Approval of Flavored E-Cigarette Products

Knobbe Martens on

We previously reported a decision by the U.S. Food and Drug Administration (FDA), denying the premarketing authorization of several flavored e-cigarette product. On April 2, 2025, the Supreme Court of the United States...more

Latham & Watkins LLP

Supreme Court Upholds FDA’s Denial of Marketing Authorization for Flavored Tobacco Products

Latham & Watkins LLP on

On April 2, 2025, the Supreme Court unanimously held that the US Food and Drug Administration (FDA) lawfully denied marketing authorization for certain flavored e-liquids used in electronic nicotine delivery systems (ENDS),...more

Faegre Drinker Biddle & Reath LLP

Supreme Court Decides Food and Drug Administration v. Wages and White Lion Investments, LLC

On April 2, 2025, the U.S. Supreme Court decided Food and Drug Administration v. Wages and White Lion Investments, LLC, No. 23-1038, holding that FDA’s denial of the respondents’ application to market certain flavored...more

Dorsey & Whitney LLP

The Supreme Court Update - April 2, 2025

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The Supreme Court of the United States issued two decisions today: FDA v. Wages and White Lion Investments, L.L.C., No. 23-1038: This case concerns the validity of the FDA’s denial of electronic cigarette manufacturers’...more

Troutman Pepper Locke

Supreme Court Weighs Vape Venue Dispute

Troutman Pepper Locke on

On January 21, the Supreme Court heard arguments in a case addressing who may challenge Food and Drug Administration (FDA) marketing denial orders for new tobacco products....more

McDonnell Boehnen Hulbert & Berghoff LLP

In re Cellect in View of Supreme Court's "Long Conference"

In view of the Supreme Court's "long conference" on September 30th, it seems timely to review the arguments, pro, con, and amicus briefs submitted to the Court asking for certiorari over the Federal Circuit's In re...more

Haug Partners LLP

D.C. Circuit Dismisses FTC Antitrust Suit: Exclusive Pharma Patent Licenses Remain Permissible Under The Patent Act

Haug Partners LLP on

On Friday, August 25, 2023, the U.S. Court of Appeals For The District Of Columbia Circuit affirmed dismissal of an antitrust action brought by the Federal Trade Commission regarding Endo Pharmaceuticals’s grant of an...more

A&O Shearman

SCOTUS denies cert in skinny label appeal from the Federal Circuit

A&O Shearman on

On May 15, 2023, the Supreme Court of the United States denied Teva Pharmaceuticals USA, Inc.’s (“Teva”) petition for certiorari in Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline, LLC, ending a nearly nine-year court...more

(ACOEL) | American College of Environmental...

Bounty Laws and Citizen Suits

In a jurisprudential pile-up, the Fifth Circuit has become the arena for two simultaneous legal battles that may shape the law of standing and realign federal environmental law. While all eyes are on the U.S. Supreme Court...more

Epstein Becker & Green

Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care

On April 21, 2023, the U.S. Supreme Court ruled to preserve access to the prescription abortion drug mifepristone. However, while the case continues in the U.S. Court of Appeals for the Fifth Circuit, the future of...more

Proskauer - Employee Benefits & Executive...

Understanding Recent Litigation on Medication Abortion: A Guide for Health Plan Sponsors

Last Friday, the United States Supreme Court stayed a federal district court order that suspended the U.S. Food and Drug Administration’s approval of the drug mifepristone, which is used as part of a two-drug regimen to...more

ArentFox Schiff

Investigations Newsletters: US Supreme Court Requests Solicitor General's Views in FCA Rule 9(b) Context

ArentFox Schiff on

US Supreme Court Requests Solicitor General’s Views in FCA Rule 9(b) Context - On May 16, 2022, the US Supreme Court requested a brief from the US Solicitor General on the level particularly required by Federal Rule of...more

Harris Beach Murtha PLLC

Important 2020 Patent Law Decisions from the Court of Appeals for the Federal Circuit

Whether you are pursuing patents on your new technology, thinking about bringing patent infringement litigation or defending patent infringement claims in court, knowing the important developments in patent law will help you...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - November 2020 #2

Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., Appeal No. 2019-2402 (Fed. Cir. Nov. 5, 2020) - In our Case of the Week, the Federal Circuit addressed a lingering question about venue following the...more

Cozen O'Connor

ALERT: U.S. Supreme Court Grants Certiori to Decide Whether FDA Excluded Warnings Pre-Empt State Law Claims

Cozen O'Connor on

The U.S. Supreme Court today agreed to consider a Third Circuit ruling that revived litigation over Merck’s alleged failure to warn about a risk of femoral fractures from its osteoporosis drug Fosamax. The precise question...more

Jones Day

Supreme Court Hears Oral Arguments in Sandoz Inc. v. Amgen

Jones Day on

On April 26, 2017, the U.S. Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. (Nos. 15-1039, 15-1195), on appeal from the Federal Circuit's July 21, 2015, opinion interpreting various provisions of the Biologics...more

Knobbe Martens

Supreme Court Grants Certiorari in Amgen v. Sandoz

Knobbe Martens on

On January 13, 2017, the Supreme Court granted certiorari in Amgen v. Sandoz, 794. F.3d 1347 (Fed. Cir. 2015) and Sandoz v. Amgen, 773 F.3d 1274 (Fed. Cir. 2014), appealed from the Federal Circuit. The petitions involve the...more

Knobbe Martens

The Supreme Court’s Decisions Not to Hear Patent Cases Leaves Federal Circuit Decisions on Key Questions Intact

Knobbe Martens on

The Supreme Court recently declined to hear several patent cases, thus leaving the decisions by the Federal Circuit intact. Issues that were not taken up by the Supreme Court include (1) whether performing patented methods...more

Haight Brown & Bonesteel LLP

Product Liability Alert: Failure-To-Warn Suit Against Generic Drug Maker Proceeds Despite Argument of Federal Preemption

On January 20, 2015, the U.S Supreme Court denied cert in Teva v. Superior Court of California, Orange County, refusing to review a California state court ruling allowing patients to proceed with claims that Teva...more

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