News & Analysis as of

Labeling Food and Drug Administration (FDA) Preemption

Holland & Knight LLP

Ninth Circuit Holds That California Food-Labeling Law Is Not Preempted by Federal Law

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In 1990, Congress enacted the Nutrition Labeling and Education Act (NELA) as an amendment to the Food, Drug and Cosmetic Act (FDCA). Among other things, NELA 1) provided for modernization and standardization of the familiar...more

Sheppard Mullin Richter & Hampton LLP

FDCA Preemption: A Powerful Tool for Defending Class Actions

Several recent cases arising under the federal Food, Drug, and Cosmetic Act (“FDCA” or the “Act”), 21 U.S.C. § 301 et seq., highlight the usefulness of preemption as a defense against putative class actions concerning drugs,...more

Nutter McClennen & Fish LLP

Product Liability 2023 Year in Review

Massachusetts federal and state courts issued several important product liability decisions in 2023. Nutter’s Product Liability practice group reviewed these cases and report on their significant holdings as follows ...more

Nelson Mullins Riley & Scarborough LLP

First Substantial Reform of Cosmetics Law Since FDR Administration

President Biden signed into law the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”), as part of the Consolidated Appropriations Act, 2023. This is the first major reform of cosmetics regulation since the Federal...more

Hogan Lovells

Modernization of U.S. cosmetics regulation will be phased in over time - A detailed overview and preliminary analysis of the new...

Hogan Lovells on

On December 29, 2022, U.S. President Biden signed into law the "Consolidated Appropriations Act, 2023," which includes the Modernization of Cosmetics Regulation Act of 2022 (MOCRA). MOCRA reflects the most significant...more

Faegre Drinker Biddle & Reath LLP

Circuit Does Not Quite Clarify the Supreme Court’s Not-Quite-Clarification of “Clear Evidence” in Albrecht

The U.S. Supreme Court’s 2019 decision in Merck Sharp & Dohme, Inc. v. Albrecht, 139 S.Ct. 1668 (2019), discussed... addressed impossibility preemption in label change lawsuits. In Albrecht, the Supreme Court purported to...more

Butler Snow LLP

No Way Around It: The Need for Federal "Permission and Assistance" Can Preempt a State Tort Duty

Butler Snow LLP on

In the simplest case for federal preemption, federal law prohibits conduct that a state tort duty would require, such as a change in the design of an approved medical device to cure an alleged defect. Because federal law is...more

Butler Snow LLP

Pro Te: Solutio – Vol. 12, No. 2

Butler Snow LLP on

Pro Te: Solutio returns for its second edition of 2019. As the year grinds on, our attorneys at Butler Snow are taking proactive and creative steps to confront and solve the issues that affect our areas of practice. The...more

Patterson Belknap Webb & Tyler LLP

How Much Is Too Much Deference to FDA Warning Letters in Consumer Class Actions?

Consumer class actions involving goods regulated by the Food and Drug Administration (“FDA”) coexist in parallel with FDA enforcement efforts.  Consumers have no private right of action to enforce the Food, Drug, and...more

Bilzin Sumberg

Mislabeling Claims Against Poland Spring Water Survive Dismissal

Bilzin Sumberg on

Water: two parts hydrogen, one part oxygen. It seems simple enough, but for companies selling bottled water, liability lurks below the surface. According to a recent lawsuit, consumers care not only about what is in their...more

Patterson Belknap Webb & Tyler LLP

FDA Withdraws Proposed Rule Abolishing Generic Preemption; Recognizes “Downsides” Of Expanded Tort Liability

On December 13, 2018, the FDA withdrew a proposed rule that would have authorized manufacturers of generic drugs to use the Changes Being Effected (CBE) procedure to add new safety information to their labeling—something that...more

Sheppard Mullin Richter & Hampton LLP

Proposed New FDA Labeling Rules Would Result in Increased Generic Drug Product Liability Claims

After several years of delay, FDA announced this summer that it expects to publish new rules in April 2017 that will permit generic drug companies to make unilateral changes to their warning labels, even if the brand does...more

Morrison & Foerster LLP - Class Dismissed

Federal Preemption Claims: Clear Evidence and an Unclear Standard

Last week, a federal court in Utah granted Aventis Inc.’s motion for summary judgment based on federal preemption of failure-to-warn claims. Cerveny v. Aventis, Inc., 2016 U.S. Dist. LEXIS 34182 (D. Utah Mar. 16, 2016). The...more

McDermott Will & Emery

ANDA Update - October 2015

McDermott Will & Emery on

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

Proskauer - Advertising Law

Sun-Blocked: California Court Dismisses Sunscreen Labeling Case

It’s summertime, and for many of us that means buying and applying sunscreen. Lots of it. Indeed, when selecting sunscreen rated at, say, SPF 30, we rely on national standards promulgated by the FDA. It thus comes as no...more

Faegre Drinker Biddle & Reath LLP

House Passes Voluntary GMO Labeling Bill

The U.S. is a step closer to enacting a consistent, national approach to certifying and labeling genetically modified (GMO) foods. On July 23, 2015, the U.S. House of Representatives passed H.R. 1599, the Safe and Accurate...more

Carlton Fields

Food for Thought: Ninth Circuit Holds Cosmetic Labeling Claims Not Preempted by FDCA, Primary Jurisdiction Appropriately Invoked

Carlton Fields on

In April 2015, the Ninth Circuit held in a cosmetic labeling class action that the Food, Drug, and Cosmetic Act (FDCA) did not expressly preempt state causes of action predicated on federal cosmetics labeling laws and that...more

Haight Brown & Bonesteel LLP

Feel The Burn: Court of Appeal Strikes Down State Law Claims Regarding Mislabeled Sunscreen Products Under Finding of Federal...

In Eckler v. Neutrogena (certified for publication 7/1/15, Case No. B2536910), the California Court of Appeal, Second Appellate District, upheld the trial court’s determination that plaintiffs’ claims of mislabeling sunscreen...more

King & Spalding

First Circuit Finds Federal Preemption of State Tort Claims That Conflict With A Medication’s FDA-Approved Labeling & Warnings

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An opinion issued by the U.S. Court of Appeals for the First Circuit on February 20, 2015 held that the Federal Food, Drug, and Cosmetic Act (“FDCA”) preempted claims that Lexapro’s U.S. Food and Drug Administration (FDA)...more

Morrison & Foerster LLP

FDA Proposed Rule in Flux?

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more

K&L Gates LLP

Supreme Court Takes a Pass on Generic Drug Labeling Appeal

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In the watershed case of PLIVA, Inc. v. Mensing, the United States Supreme Court determined that federal law preempts state law failure-to-warn claims against generic pharmaceutical manufacturers. More specifically, Mensing...more

Sheppard Mullin Richter & Hampton LLP

A Short-Lived Victory for Generic Drug Manufacturers?

On June 24, 2012, the U.S. Supreme Court handed down its decision in Mutual Pharmaceutical Co. Inc. v. Bartlett, 570 U.S. ____ (2013), finding that design-defect claims against generic drug companies are pre-empted where...more

Morrison & Foerster LLP

A Narrow Exception To The Mensing Preemption Defense

The Sixth Circuit recently held that a failure-to-warn claim could proceed against a generic manufacturer that had failed to timely follow the brand-name label. Fulgenzi v. Pliva Inc., Case No. 12-3504 (6th Cir. March 13,...more

Skadden, Arps, Slate, Meagher & Flom LLP

"Complex Mass Tort Product Liability Alert: Supreme Court Hears Oral Argument Regarding Scope of Generic Drug Preemption"

Today, the Supreme Court of the United States held oral argument in Mutual Pharmaceutical Co. v. Bartlett, a follow-up to its landmark ruling in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), which addressed federal...more

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