Product Defects, Manufacturing Defects, Food and Drug Administration (FDA)

Defective Medical Devices and Their Impact on Patient Safety

Searcy Denney Scarola Barnhart & Shipley on 8/8/2025

Defective medical devices present serious risks for patients. Just how big—and how severe—is the problem? Consider this from the U.S. Food and Drug Administration (FDA): “Each year, the FDA receives over two million medical...more

Product Liability 2022 Year in Review

Nutter McClennen & Fish LLP on 1/24/2023

Massachusetts federal and state courts issued several important product liability decisions in 2022. Nutter’s Product Liability practice group reviewed these cases and report on their significant holdings as follows ...more

Indiana State and Federal Courts Rule That Manufacturing Defect Claims May Survive Preemption in PMA Context

Faegre Drinker Biddle & Reath LLP on 8/31/2020

Indiana courts have recently addressed preemption issues in matters involving devices approved by the Food and Drug Administration (FDA) through the premarket approval (PMA) process. First, the Indiana Court of Appeals...more

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

Cozen O'Connor on 6/3/2016

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

Product Liability Update - July 2015

Foley Hoag LLP on 7/30/2015

Massachusetts Supreme Judicial Court Holds Failure-to-Warn Claim Against Drug Manufacturer Not Preempted Because There Was No “Clear Evidence” FDA Would Not Have Approved Plaintiffs’ Suggested Warning; Also Holds...more

Product Defects › Manufacturing Defects › Food and Drug Administration (FDA)

Defective Medical Devices and Their Impact on Patient Safety

Product Liability 2022 Year in Review

Indiana State and Federal Courts Rule That Manufacturing Defect Claims May Survive Preemption in PMA Context

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

Product Liability Update - July 2015

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