News & Analysis as of

Article III Food and Drug Administration (FDA)

Jackson Lewis P.C.

What U.S. Supreme Court Decision on Standing Tells Us About Challenges to Corporate DEI Initiatives

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The U.S. Supreme Court held that a group of doctors, nurses, and medical associations did not have the right under the U.S. Constitution, a doctrine known as “standing,” to challenge Food and Drug Administration (FDA)...more

Mintz - Securities Litigation Viewpoints

Supreme Court in Jarkesy Limits the SEC’s Powers to Use In-House Administrative Courts

On June 27, the Supreme Court issued its decision in the closely-watched SEC v. Jarkesy, holding that the SEC could no longer seek civil monetary penalties for fraud in its in-house courts consistent with the Seventh...more

ArentFox Schiff

SCOTUS Update: Supreme Court Clarifies Organizational Standing in FDA-Related Ruling

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A recent US Supreme Court decision, which grabbed headlines because it involved an abortion-related drug, with potential repercussions in litigation far-removed from health care due to the decision hinging on “standing,”...more

Akerman LLP - Health Law Rx

What’s it to You? Justice Scalia’s 41-Year-Old Gatekeeping Question on “Standing” Influences Court to Uphold FDA’s Regulation of...

Mifepristone is safe for now. On June 13, 2024, the Supreme Court unanimously held that the plaintiffs — doctors and medical associations alike — lacked standing to challenge 2000 and 2019 FDA approvals of mifepristone (brand...more

Holland & Knight LLP

Supreme Court Abortion Pill Ruling Doesn't Challenge FDA's Authority

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The U.S. Supreme Court on June 13, 2024, unanimously ruled that plaintiffs did not have legal standing to challenge the U.S. Food and Drug Administration's (FDA) actions to establish dosing and availability requirements for...more

Sheppard Mullin Richter & Hampton LLP

Supreme Court Unanimously Preserves Access to Mifepristone

In a decision joined by all nine justices, the Supreme Court preserved the Food and Drug Administration’s (“FDA’s”) regulatory approval of mifepristone, ensuring continued access to the widely-used abortion medication across...more

Dorsey & Whitney LLP

The Supreme Court Update - June 14, 2024

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On Thursday, June 13, the Supreme Court of the United States issued three decisions: FDA v. Alliance for Hippocratic Medicine, No. 23-235: This case involves an attempt to rescind the Food and Drug Administration’s...more

Fenwick & West LLP

SCOTUS Unanimously Preserves Access to Abortion Pill

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On Thursday, June 13, the Supreme Court maintained access to the abortion pill, mifepristone. This medication, in conjunction with misoprostol, was used in nearly two-thirds of all U.S. abortion and miscarriage treatments...more

Jenner & Block

Client Alert: Access to Mifepristone Still Standing for Now, but Questions Remain

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On Thursday morning, the Supreme Court issued its decision in FDA v. Alliance for Hippocratic Medicine. Justice Kavanaugh wrote for a unanimous Court dismissing the Alliance for Hippocratic Medicine from the case for lack of...more

Faegre Drinker Biddle & Reath LLP

Supreme Court Decides Food and Drug Administration v. Alliance for Hippocratic Medicine

On June 13, 2024, the U.S. Supreme Court decided Food and Drug Administration v. Alliance for Hippocratic Medicine, No. 23-235, together with Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine, No. 23-236,...more

Foley Hoag LLP

Oral Arguments in FDA v. Alliance for Hippocratic Medicine: Mifepristone Case Likely to Turn on Article III Standing Requirements

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Nearly two years after the Court overturned Roe v. Wade in June 2022, additional challenges are being brought that may limit access to abortion in the U.S. Mifepristone was originally approved in 2000 by the U.S. Food and...more

Jenner & Block

Client Alert: The Supreme Court Signals That Access to Mifepristone Will Likely Remain Safe for Now

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On March 26, 2024, the Supreme Court heard arguments in the two consolidated cases concerning access to mifepristone pending before the Court, FDA v. Alliance for Hippocratic Medicine, Case No. 23-235 and Danco Laboratories,...more

Manatt, Phelps & Phillips, LLP

Supreme Court Will Hear Medication Abortion Case; Three States Ask to Intervene in District Court

The Big Picture - On December 13, 2023, the Supreme Court announced its intention to review the August 16 ruling by the Fifth Circuit in Alliance for Hippocratic Medicine (AHM) v. U.S. Food and Drug Administration, et al....more

McDermott Will & Emery

See Here: No Standing Based on Vague Future Plans or Adverse Priority Findings

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit dismissed an appeal from a final written decision in an inter partes review (IPR) proceeding, finding that the petitioner lacked standing because it suffered no injury in fact....more

Holland & Knight LLP

Food and Beverage Labeling Defense Strategies

Holland & Knight LLP on

A trio of recent cases challenging disparate food and beverage labels offers a few common substantive and procedural lessons for companies. First, the back panels – when considered in light of U.S. Food and Drug...more

Nutter McClennen & Fish LLP

Product Liability 2022 Year in Review

Massachusetts federal and state courts issued several important product liability decisions in 2022. Nutter’s Product Liability practice group reviewed these cases and report on their significant holdings as follows ...more

Quarles & Brady LLP

Federal Court Deals Blow to FDA’s Compounding MOU

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On September 21, 2021, D.C. District Court Judge Christopher Cooper gave an initial victory to the seven compounding pharmacies (“the pharmacies”) challenging Food and Drug Administration’s (“FDA”) final standard Memorandum...more

Holland & Knight LLP

Food and Beverage Law Update: March 2021

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Insurers have prevailed in several lawsuits filed by restaurants in connection with losses related to COVID-19. For example, in Emerald Coast Restaurants, Inc. v. Aspen Specialty Ins. Co., No. 3:20cv5898-TKW-HTC, 2020 WL...more

Carlton Fields

Conflict Within the Southern District of Florida: Should the Primary Jurisdiction Doctrine Be Applied to Stay Class Actions...

Carlton Fields on

Judge Robert Scola refused to apply the primary jurisdiction doctrine to stay a class action based on the alleged misrepresentation of the amount of CBD in products sold by Diamond CBD, diverging from Judge Ursula Ungaro’s...more

King & Spalding

U.S. District Court Overturns HHS Interpretation of Final Rule that Permitted Sponsors of Certain Drug and Device Trials to Avoid...

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If Sustained, Court Decision Will Require Disclosure of Results for a Decade of Certain Clinical Trials - Section 801 of the Food and Drug Administration Amendments Act of 2007 (“Section 801”), which is codified at 42...more

Carlton Fields

Court Stays CBD Class Action Until FDA Rolls Out Regulation

Carlton Fields on

A class action lawsuit alleging that Green Roads of Florida LLC misrepresented the amount of CBD contained in various products has been stayed pursuant to the primary jurisdiction doctrine because the plaintiffs’ claims...more

King & Spalding

Eleventh Circuit Rules That the Mere Purchase of Dietary Supplements Allegedly Sold in Violation of the FDCA Is Sufficient, by...

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A recent Eleventh Circuit decision took a broad view of what type of economic injury is sufficient to confer Article III standing, concluding that two dietary supplement companies’ alleged violations of a federal statute...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l December 2019 #2

LEGISLATION, REGULATIONS & STANDARDS - Senate Confirms FDA Commissioner - The U.S. Senate has voted to confirm Stephen Hahn as the commissioner of the U.S. Food and Drug Administration (FDA). Hahn, an expert in...more

Holland & Knight LLP

Healthcare Law Update: October 2019

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In recent years, the healthcare industry has been turning greater attention to the need to engage or involve patients in developing new technologies and systems to improve healthcare delivery. These patient engagement...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l August 2019 #4

LEGISLATION, REGULATIONS & STANDARDS - DOJ Announces Guilty Plea in E. Coli Prosecution - The U.S. Department of Justice (DOJ) has announced that Memet Beqiri had pleaded guilty to “a charge related to his meat...more

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