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DLA Piper

Certain DSCSA Deadline Extensions Set to Eclipse in 2025

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The Drug Supply Chain Security Act (DSCSA) (section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 USC §360eee – 1) was introduced in response to several drug contamination, counterfeiting, and diversion...more

Alston & Bird

FDA Publishes Guidance on Medical Device Shortages During Public Health Emergencies

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Our FDA/Food, Drug & Device and Health Care teams discuss new guidance from the Food and Drug Administration (FDA) on federal notification requirements for medical device manufacturing shortages during public health...more

Goldberg Segalla

Pittsburgh Jury’s Attempt to Award $22 Million in Johnson & Johnson Talc Case Highlights Trial Complexities

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On Jan. 6, a Pittsburgh jury concluded a month-and-a-half long trial involving a suit asserting that decedent Michaeleen Lee developed mesothelioma from exposure to asbestos-containing talcum powder products made by Johnson &...more

Morrison & Foerster LLP

FDA Issues Action Levels for Lead in Baby Food

On January 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final guidance establishing action levels for lead in processed food intended for babies and young children. This is the first FDA guidance directly...more

Alston & Bird

Manufacturers Take Note: FDA Clarifies In-Process Sampling Under Section 211.110

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Our FDA/Food, Drug & Device Team reviews how new draft guidance from the Food and Drug Administration (FDA) can help manufacturers better understand requirements for drug product manufacturing....more

Cozen O'Connor

Maryland’s Lawsuit Adds to Growing Wave of PFAS Litigation

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Maryland AG Anthony Brown has filed a lawsuit against W.L. Gore & Associates, Inc. (Gore) alleging violations of state and federal consumer and environmental protection laws stemming from contamination caused by per- and...more

DLA Piper

Life Sciences Year in Review and What's Ahead

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2024 was eventful in the life sciences space – and key trends are expected to continue in the new year. ...more

Robins Kaplan LLP

The Robins Kaplan Justice Report - January 2025

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For decades, Depo-Provera has been presented as a game-changing contraceptive—a quick injection every three months that promised simplicity and effectiveness. For millions of women worldwide, it seemed like the perfect...more

Husch Blackwell LLP

Connecticut Court Awards Punitive Damages in Recent Asbestos Trial

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The Estate of Nicholas Barone trial in Bridgeport Superior Court in Connecticut before Judge William Clark concluded with a $15 million plaintiff’s verdict on 5/16/2024. The jury also awarded punitive damages, the exact...more

Alston & Bird

Class Action & MDL Roundup 2024 Q3 – Our Market Research is Sustainable

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Welcome to the Class Action & MDL Roundup, our quarterly review of decisions and settlements in the class action arena. In this edition, it’s not a breach if it isn’t stolen, a greenwashing claim is washed away, and a...more

Robins Kaplan LLP

Stripping Away Individual Rights Through Corporate Immunity

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A new trend is emerging among corporations to seek immunity from prosecution and prevent consumers from suing after the corporation’s product injures a consumer. As an example, Bayer/Monsanto1 is currently seeking legislative...more

Searcy Denney Scarola Barnhart & Shipley

The Link Between Certain Medications and Cancer Risk

When you take a medication your doctor prescribes, the last thing you expect is for it to do more harm than good. But, unfortunately, medications are not always as safe as they should be. In fact, some medications have been...more

Dechert LLP

Dechert Re:Torts - January 2025

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PFAS in the Spotlight: EPA and FDA Zero in on Seafood and Water The 2024 PFAS Strategic Roadmap highlights EPA’s desire to implement further regulation and oversight to study and reduce exposure to PFAS. Seafood and...more

ArentFox Schiff

New Lawsuits Targeting Personalized AI Chatbots Highlight Need for AI Quality Assurance and Safety Standards

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The parents of two Texas children recently brought a lawsuit against Character Technologies, Inc., alleging that its chatbot, Character.AI, encouraged self-harm, violence, and provided sexual content to their children. They...more

King & Spalding

FDA Issues Draft Guidance on Accelerated Approval Focused on How the Agency Will Implement New Authorities

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On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics (Draft Accelerated Approval...more

Hissey, Mulderig & Friend, PLLC

Roundup Users With Lymphoma May Qualify to File a Lawsuit

Exposure to the weedkiller Roundup (glyphosate) has been linked to an increased risk of non-Hodgkin's lymphoma....more

Baker Donelson

Changes to California Proposition 65 "Safe Harbor" Warnings to Impact Manufacturers and Internet Retailers

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California's Proposition 65 regulations are changing January 1, 2025. Proposition 65, enacted in November 1986, requires companies to provide clear and reasonable warnings to California consumers regarding exposures to...more

Bennett Jones LLP

Ontario Court of Appeal Changes the Test Under Rule 24.01—The Passage of Time is Prejudicial

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In Barbiero v Pollack, 2024 ONCA 904 (Barbiero) the Court of Appeal for Ontario upheld the motion judge’s dismissal of a class proceeding for delay under Rule 24.01 of the Rules of Civil Procedure. The plaintiff had not set...more

Robins Kaplan LLP

Silent Dangers: The Link Between Depo-Provera, Brain Tumors, and Health Inequities

Robins Kaplan LLP on

For decades, Depo-Provera has been presented as a game-changing contraceptive—a quick injection every three months that promised simplicity and effectiveness. For millions of women worldwide, it seemed like the perfect...more

Morrison & Foerster LLP

Administrative Judge Sides with Leachco in Action Against CPSC

Leachco, a small family-owned business in Oklahoma that manufactures and sells infant lounging products, recently won a rarely litigated issue against CPSC. In July 2024, an administrative law judge (ALJ) denied relief sought...more

IMS Legal Strategies

The Water’s Fine? Navigating Water Contamination Litigation

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Perhaps one of the most quintessential concerns for corporate defendants in the last decade is that of nuclear verdicts. In just a decade, from 2013 to 2022, there were 115 verdicts of $100 million or more. The Institute for...more

Fishman Haygood LLP

U.S. Third Circuit Rejects Claims of Preemption and Allows Fosamax Cases to Proceed

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In 2022, over 500 plaintiffs filed a case alleging that Merck Sharp & Dohme Corp., a drug manufacturing company, failed to provide adequate warnings that one of their drugs increased the risk of atypical femoral fractures....more

Goldberg Segalla

Court Reverses Denial of J&J’s Motion for Summary Judgment on Causation Grounds

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Court: Supreme Court of New York, Appellate Division, First Department - The Supreme Court of New York, Appellate Division, First Department earlier this week unanimously granted defendants Johnson & Johnson and LTL...more

Akin Gump Strauss Hauer & Feld LLP

PFAS Litigation: New Claims against Upstream Manufacturers

While the results of consumer products litigation surrounding PFAS have been uneven (see prior blog posts), a new type of claimant may be emerging based on a recent claim filed by a Georgia-based carpet manufacturer against...more

Searcy Denney Scarola Barnhart & Shipley

Protecting Yourself from Dangerous Products: Tips for Consumers

Dangerous products are far more common than they should be. Despite manufacturers’ and retailers’ obligations to avoid putting dangerous products on the market, numerous people suffer serious and fatal injuries caused by...more

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