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Warning Labels Manufacturers Pharmaceutical Industry

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

Foley Hoag LLP

Product Liability Update - April 2023

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MASSACHUSETTS - First Circuit Holds Failure-To-Warn Claims Against Drug Manufacturer Preempted By Federal Food, Drug, And Cosmetic Act Because Animal Studies Cited By Plaintiffs Did Not Demonstrate Risks Beyond Those In...more

Nutter McClennen & Fish LLP

Product Liability 2019 Year in Review

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

Harris Beach PLLC

FDA Proposes Strengthening Warning Labels on Breast Implants

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The Food and Drug Administration has issued a new draft breast implant guidance recommending that manufacturers strengthen labeling about the potential complications and risks of the medical devices, particularly by adding...more

Holland & Knight LLP

FDA Releases New Enforcement Policy for OTC Sunscreen Drug Products Marketed Without an Approved Application

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In May 2018, the Food & Drug Administration (FDA) released a new enforcement policy for over-the-counter (OTC) sunscreen drug products marketed without an approved application. While sunscreens have been commercially...more

Mintz

Massachusetts Supreme Judicial Court Allows Innovator Liability Claims to Proceed Under A Recklessness Standard

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Today, the Massachusetts Supreme Judicial Court made an important ruling concerning innovator liability with respect to pharmaceuticals. Though precluding negligence and traditional product liability claims against brand-name...more

Steptoe & Johnson PLLC

WV Supreme Court Kicks Failure to Warn Case Under Michigan Law

The West Virginia Supreme Court of Appeals recently upheld the Mass Litigation Panel’s grant of summary judgment against a class of Plaintiffs alleging birth defects resulting from the use of prescription medicine in...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

Haight Brown & Bonesteel LLP

Reversal of $48 Million Product Liability Verdict Required Due to Inconsistent Jury Findings on Failure to Warn Claims and...

In Trejo v. Johnson & Johnson, et al. (No. B238339, filed 6/30/2017), the California Second Appellate District held, among other things, that the jury’s finding that defendant was liable for negligent failure to warn was...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

Searcy Denney Scarola Barnhart & Shipley

Big Pharma Should Take Reporting Adverse Events to FDA More Seriously

The U.S. Food and Drug Administration’s requirement that pharmaceutical companies report dangerous side effects cause by medicines they manufacture is being flouted by a few bad actors. Such violations of the federal law are...more

Butler Snow LLP

Alabama No Longer An Outlier State: Legislature Says “No” To Innovator Liability

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I. Introduction - Since the United States Supreme Court’s decision in Pliva, Inc. v. Mensing, the plaintiffs’ bar has been feverishly searching for an alternate theory of recovery when the claimant took a generic...more

McGuireWoods LLP

European Commission Seeking Comments On Draft Text Laying Out The Safety Features To Appear On Pharmaceutical Packaging

McGuireWoods LLP on

On 12 August 2015, the European Commission published its long awaited discussion draft of the European Union Delegated Act (EUDA) addressing safety features to appear on the outer packaging of medicinal products for human...more

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