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Warning Labels Manufacturers Medical Devices

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

Butler Snow LLP

Trust the reProcess? A Practical and Legal Overview of Reprocessing Single-Use Medical Devices in the United States

Butler Snow LLP on

Allow me to set the stage. Our plaintiff claims he felt a nagging pain in his shoulder for months and finally went to see the local orthopedic surgeon. The surgeon apparently informed him that the tissue and cartilage in his...more

Harris Beach PLLC

FDA Proposes Strengthening Warning Labels on Breast Implants

Harris Beach PLLC on

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

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

Knobbe Martens

FDA Issues Final Rule on Use of Symbols in Labeling

Knobbe Martens on

The Food and Drug Administration published a Final Rule in the Federal Register revising labeling regulations for medical devices and certain biological products to allow for the use of symbols without adjacent explanatory...more

Stoel Rives LLP

Prop 65 Law Alert: California Proposes Significant Changes to Proposition 65 Warning Requirements

Stoel Rives LLP on

On March 7, 2014, the Office of Environmental Health Hazard Assessment (“OEHHA”), the agency responsible for implementing California’s Proposition 65 (“Prop 65”), issued proposed changes to existing regulations that would...more

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