News & Analysis as of

Injunctive Relief Food and Drug Administration (FDA)

McDermott Will & Emery

Hatch-Waxman or Not, Clinical Trials Aren’t Subject to Injunction

McDermott Will & Emery on

Analyzing the permissible scope of an injunction under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit reversed the district court’s prohibitions on an open-label extension (OLE) of a then-running...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Pharmaceutical Patent Protections

This week, we take a closer look at two precedential cases concerning pharmaceutical patent protections as applied to drugs in development. In Incyte Corp. v. Sun Pharm., Judge Hughes entered a dissent pushing back on the...more

Harris Beach Murtha PLLC

Medical and Life Sciences: New York 2024 Year in Review

From medical devices to OTC drugs, preemption to expert preclusion, New York state and federal courts issued decisions in 2024 which further shaped the landscape in the medical and life sciences legal world. To prepare the...more

MoFo Life Sciences

Patent Vs. Trade Secret Considerations For Cell And Gene Therapies

MoFo Life Sciences on

Understanding what to patent versus what to keep as a trade secret is an increasingly important and challenging decision facing companies developing biologics products, such as cell and gene therapies, where technologies are...more

BakerHostetler

Challenge to the FDA's Approval of Abortion Medication

BakerHostetler on

On Friday, April 7, both the Northern District of Texas and the Eastern District of Washington issued decisions impacting the Food and Drug Administration’s (FDA) approval of the abortion drug mifepristone. The Texas decision...more

Goodwin

A Tale of Two Lawsuits: Federal Court in Texas Suspends FDA Approval of Medication Abortion Drug Mifepristone Nationwide, While...

Goodwin on

The US Supreme Court’s June 2022 decision in Dobbs v. Jackson Women’s Health Organization — which overturned Roe v. Wade and nearly 50 years of a federal constitutional right to abortion — has had a tectonic impact. Less than...more

Holland & Knight LLP

Food and Beverage Labeling Defense Strategies

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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

Husch Blackwell LLP

50 State Update On Pending Legislation Pertaining To Employer-Mandated Vaccinations

Husch Blackwell LLP on

Per recent federal employment law guidance, private employers can generally require employees to get vaccinated for COVID-19 as long as they comply with federal employment laws that prohibit discrimination on the basis of...more

Cozen O'Connor

1st Amendment Win For Credit Card Surcharges| Texas Sues Over Electricity Bills | Dodgy COVID Fees

Cozen O'Connor on

2022 AG Elections- Former South Dakota Attorney General Steps Back into Contention for AG’s Office- •Marty Jackley, who formerly served as U.S. Attorney for South Dakota, South Dakota AG, and President of the National...more

Harris Beach Murtha PLLC

FDA and FTC Take Action Regarding Pandemic-Related Products

Harris Beach Murtha PLLC on

In response to the COVID-19 pandemic, numerous manufacturers and distributors of products ranging from CBD, to herbal products and supplements, to ingestible silver, began to market their products as those that could...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

Faegre Drinker Biddle & Reath LLP

The FDA Is in the Doghouse

An unusual pet food case filed this summer in the District Court of Colorado has a pet food manufacturer as the plaintiff rather than a defendant. Lystn, LLC v. FDA, No. 1:19CV01943 (D. Colo. July 5, 2019)....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

Harris Beach Murtha PLLC

Doe v. Merck: Vaccine Autism Lawsuit Dismissed as Baseless

The claim that the MMR vaccine caused autism was meritless on its face, held the U.S.D.C., Eastern District of New York (Doe v. Merck & Co, Inc.). The action filed on behalf of “Baby Doe” stemmed from Merck-manufactured...more

Holland & Knight LLP

Food and Beverage Law Update: September 2018

Holland & Knight LLP on

Labor and Employment - Jimmy John's Avoids Joint-Employer Finding in Worker Overtime Litigation - In In re: Jimmy John's Overtime Litigation, 2018 WL 3231273 (N.D. Ill. June 14, 2018), a federal district court ruled that...more

Sheppard Mullin Richter & Hampton LLP

Ninth Circuit Confirms that Class Action Plaintiffs Must Plausibly Establish Future Intent To Re-Purchase To Maintain Claims for...

The ruling in Lanovaz v. Twinings N. Am., Inc., 2018 U.S. App. LEXIS 15248 (9th Cir. June 6, 2018), settles what was arguably an open issue among district courts within the Ninth Circuit. A plaintiff must have an intent to...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update | November 2017

NOSB Votes to Continue Allowing Hydroponics - The National Organic Standards Board (NOSB) has reportedly voted to continue allowing food grown in water-based nutrient solutions to be labeled “organic,” rejecting a...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | May 2017

Senators Call For Removal of Dioxane from Cosmetic Products - U.S. Sens. Chuck Schumer (DN. Y.) and Kirsten Gillibrand (DN. Y.) have petitioned the Food and Drug Administration to prohibit detectable levels of 1,4dioxane...more

Foley & Lardner LLP

Will You, Won't You Join The Biosimilar Patent Dance?

Foley & Lardner LLP on

In the latest dispute surrounding the “patent dance” provisions of the Biologics Price Competition and Innovation Act (BPCIA), Genentech, Inc. has filed a complaint against Amgen, Inc., alleging that after opting into the...more

Carlton Fields

Food for Thought: A Review of 2016 Litigation

Carlton Fields on

Food for Thought is a review of significant court decisions affecting the food, beverage, dietary supplements and personal care products industry. Although many cases in this edition focus on class certification, others...more

Proskauer - Advertising Law

Update on Second Circuit Ruling in Church & Dwight v. SPD Swiss Precision Diagnostics “Weeks Estimator” Home Pregnancy Test...

Last month we summarized the Second Circuit’s important decision in a dispute between plaintiff-appellee Church & Dwight and its principal competitor, defendant-appellant SPD Swiss Precision Diagnostics, concerning SPD’s...more

Proskauer - Advertising Law

Second Circuit Affirms Ruling that SPD Swiss Precision Diagnostics Falsely Advertised Clearblue Weeks Estimator Home Pregnancy...

In an important recent false advertising decision in a suit brought by home pregnancy test manufacturer Church & Dwight against its principal competitor SPD Swiss Precision Diagnostics, a Second Circuit panel unanimously...more

Foley & Lardner LLP

Senate Judiciary Introduces CREATES Act To Expedite Access To Affordable Drugs

Foley & Lardner LLP on

Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of...more

Cozen O'Connor

Olympus Duodenoscope Recall: Lessons Learned on How to Manage a Class II Device Failure

Cozen O'Connor on

Earlier this year Olympus Corp. (“Olympus”) announced that it would recall and redesign its TJF-Q180V duodenoscope following its link to deadly patient infections in the United States and abroad. This situation presents an...more

Foley & Lardner LLP

Amgen Hedges Its Bets With Cross-Petition For Certiorari Of Biosimilar Decision

Foley & Lardner LLP on

Although Amgen originally did not petition the Supreme Court for certiorari to review the first Federal Circuit decision interpreting the BPCIA framework for resolving biosimilar patent disputes, Amgen now has filed a...more

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