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Pharmaceutical Industry › Preemption › Warning Labels

Nutter McClennen & Fish LLP

Product Liability 2023 Year in Review

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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

Conn Kavanaugh

Defining the Boundaries for Pre-emption of Drug Labeling Claims

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Drug warning labels must comply with federal regulations and receive approval from the Food and Drug Administration (“FDA”) before going to market. Therefore, manufacturers may argue that state law actions related to the...more

Nutter McClennen & Fish LLP

Product Liability 2019 Year in Review

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Massachusetts state and federal courts issued a number of important product liability decisions in 2019. The Product Liability practice group at Nutter recently reviewed these cases. Highlighted below are some of the key...more

Nutter McClennen & Fish LLP

Product Liability 2018 Year in Review

Nutter McClennen & Fish LLP on

Massachusetts state and federal courts issued a number of important product liability decisions in 2018. The Product Liability practice group at Nutter recently reviewed these cases. Highlighted below are some of the key...more

Skadden, Arps, Slate, Meagher & Flom LLP

Skadden's 2019 Insights: Significant Rulings Expected for Ongoing Mass Tort, Consumer Class Action Issues

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In 2019, significant developments are expected on issues that have been percolating in the mass tort and class action litigation arena for several years. The U.S. Supreme Court is expected to rule on cases relating to...more

Foley Hoag LLP

Product Liability Update: October 2017

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Massachusetts Federal Court In Multi-District Litigation Holds Under Six States’ Laws That Manufacturer Of Brand-Name Pharmaceutical Is Not Liable For Injuries Caused By Generic Equivalents Whose Manufacturers Were Required...more

Shook, Hardy & Bacon L.L.P.

Tenth Circuit Finds Citizen Petition Denial to be "Clear Evidence" of Conflict Preemption

Shook, Hardy & Bacon L.L.P. on

A U.S. Court of Appeals has held that a Food and Drug Administration (FDA) denial of a citizen petition can be “clear evidence” of conflict preemption under the test set forth by the Supreme Court in Wyeth v. Levine, 555 U.S....more

Holland & Knight LLP

Healthcare Law Update: June 2017

Holland & Knight LLP on

Medicaid - Florida's Medicaid Third-Party Liability Act Pre-empted by Federal Law - By Eddie Williams - In Gallardo v. Dudek, Sec. of Florida Agency for Health Care Administration, No. 4:16cv116-MW/CAS, 2017 WL...more

Sheppard Mullin Richter & Hampton LLP

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

Sheppard Mullin Richter & Hampton LLP on

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

Latham & Watkins LLP

Generic vs. Branded Liability: Mensing Holds Sway Until FDA Completes Rulemaking

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FDA’s delay on the final version of generic labelling rules until April 2017 means both branded and generic drug manufacturers face continued uncertainty. The U.S. Food and Drug Administration (FDA) recently announced it...more

Nutter McClennen & Fish LLP

Product Liability: 2015 Year in Review

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Massachusetts state and federal courts issued a number of important product liability decisions in 2015. The Product Liability and Toxic Tort Litigation Group at Nutter recently reviewed these cases. Highlighted below are...more

Morrison & Foerster LLP

Liability for Brand Drug Manufacturers All But Clear

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Earlier this month, a federal district court in Illinois denied GlaxoSmithKline’s (GSK) renewed summary judgment motion based on federal preemption of failure-to-warn claims in an opinion setting tough standards for brand...more

Farella Braun + Martel LLP

Preemption Defense: Is Inaction by the FDA Enough?

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A seeming contradiction between two recent federal district court rulings on preemption and the U.S. Food and Drug Administration’s oversight of pharmaceuticals creates some uncertainty about whether evidence submitted by the...more

Haight Brown & Bonesteel LLP

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

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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

Searcy Denney Scarola Barnhart & Shipley

Ongoing Reglan Litigation — New Appellate Ruling

Searcy Denney Scarola Barnhart & Shipley on

Earlier this week, a Missouri appeals court issued an opinion that will hopefully have a significant impact on ongoing litigation against the manufacturers of metoclopramide, the generic version of Reglan. In this latest...more

Baker Donelson

U.S. Supreme Court Bartlett Decision in Favor of Generic Drug Manufacturers

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In a 5-4 decision, the United States Supreme Court held that state law design defect claims against manufacturers of generic pharmaceuticals are preempted by federal law when the claim hinges on the adequacy of the drug's...more

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