News & Analysis as of

Medical Devices Class Action Food and Drug Administration (FDA)

Knobbe Martens

"Improper” Listing of Patents in the FDA’s Orange Book

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As we previously discussed, on November 7, 2023, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listings of device patents in the Food and Drug...more

Searcy Denney Scarola Barnhart & Shipley

The Role of the FDA in the Exactech Recall: A Critical Analysis

Exactech has issued multiple recalls for its implantable joint replacement devices over the past few years. While Exactech has largely issued these recalls voluntarily, it has done so at the request—and with the oversight—of...more

Searcy Denney Scarola Barnhart & Shipley

Lessons Learned from the Exactech Recall: How We Can Improve Medical Device Safety in the Future

In response to scrutiny from the U.S. Food and Drug Administration (FDA), Exactech has recalled hundreds of thousands of defective medical implant devices sold between 2004 and 2021. Despite these recalls—which began in...more

Searcy Denney Scarola Barnhart & Shipley

Alternatives to the Exactech: Exploring Other Surgical Tools and Techniques

Over the past couple of decades, hundreds of thousands of patients in the United States have received defective medical implants manufactured by Exactech. While the U.S. Food and Drug Administration (FDA) has identified...more

Gardner Law

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

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Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

Harris Beach PLLC

New York Medical and Life Sciences: Year in Review 2023

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From pharmaceuticals to cosmetics, preemption to expert preclusion, New York state and federal courts issued decisions in 2023, which further shaped the landscape in the medical and life sciences legal world. To prepare the...more

Faegre Drinker Biddle & Reath LLP

5 Major Drug and Medical Device Developments in 2023

A popular New Year’s trend is to say “goodbye” to all the things that didn’t serve you in 2023, as you usher in new intentions and habits for 2024. Although there were many great trial outcomes and continuing scientific wins...more

American Conference Institute (ACI)

[Event] Drug & Medical Device Litigation - December 5th - 6th, New York, NY

Hosted by American Conference Institute, the 28th Annual Conference on Drug & Medical Device Litigation returns for another exciting year with curated programming and networking opportunities with 400+ industry...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

Ogletree, Deakins, Nash, Smoak & Stewart,...

Illinois Federal Judge Finds Another Eyewear Virtual Try-on Class Action Is Exempt Under BIPA’s Healthcare Exemption

A federal judge in Illinois recently ruled that online shoppers cannot sustain claims that a virtual try-on (VTO) tool that allegedly scans facial geometry to preview the look of sunglasses on their face violates the...more

Foley Hoag LLP

Product Liability Update - January 2023

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MASSACHUSETTS - Massachusetts Federal Court Holds State Law Claims Alleging Misleading “Rapid Release” Labeling Of OTC Acetaminophen Tablets Preempted By Federal Food, Drug, And Cosmetic Act, As Tablets’ Dissolution Rate...more

Harris Beach PLLC

Medical and Life Sciences: Year in Review 2022

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From pharmaceuticals to toothpaste, preemption to public health, New York state and federal courts issued decisions in 2022 that further shaped the landscape in the medical and life sciences legal world. To prepare the best...more

Faegre Drinker Biddle & Reath LLP

5 Major Drug and Device Developments of 2022

As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702...more

Harris Beach PLLC

New York Medical and Life Sciences: Year in Review 2021

Harris Beach PLLC on

From pharmaceuticals to dietary supplements, preemption to public health, New York state and federal courts issued decisions in 2021, which further shaped the landscape in the medical and life sciences legal world. To prepare...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - August 2019

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

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