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Failure To Warn Prescription Drugs

Morrison & Foerster LLP

Himes v. Somatics – California’s New Causation Standard for the Learned Intermediary Doctrine

In Himes v. Somatics, LLC, No. S273887, 2024 WL 3059637 (Cal. June 20, 2024), the Supreme Court of California delivered a win to the defense, upholding the learned intermediary doctrine in cases involving prescription drugs...more

Console and Associates, P.C.

Suboxone Shown to Cause Tooth Decay in Patients

Suboxone is a medication used to treat opioid addiction, containing buprenorphine and naloxone. While Suboxone is highly effective in helping individuals overcome opioid dependence, there have been concerns about its...more

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

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

Faegre Drinker Biddle & Reath LLP

Lack of “Newly Acquired Information” Defeats Plaintiffs’ Claims in Zofran MDL

Zofran (ondansetron) has often been used to combat nausea during pregnancy. It has never been approved by the FDA for that indication, but clinical experience has not supported an association with pregnancy-related risks –...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

Faegre Drinker Biddle & Reath LLP

Ninth Circuit Asks California Supreme Court to Clarify the Causation Standard Applicable When the Learned Intermediary Doctrine...

How demanding is the causation standard in a California failure to warn claim when a learned intermediary testifies that he would have read and incorporated more stringent warnings if they had been available? Is the plaintiff...more

Faegre Drinker Biddle & Reath LLP

Ninth Circuit Affirms Exclusion of Expert and Resulting Summary Judgment in In re: Incretin-Based Therapies MDL

Early last year, the In re: Incretin-Based Therapies MDL court held that the plaintiffs’ warnings claims were preempted, excluded plaintiffs’ general causation experts, and granted summary judgment to all defendants on dual...more

Faegre Drinker Biddle & Reath LLP

Another Brick in the Wall: The District Court Finds Preemption in Fosamax Case After Remand From the Supreme Court

We have written before about the Supreme Court’s impossibility preemption decision, Merck Sharpe & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019) (Albrecht) (here, here, here, and here), highlighting some open questions and...more

Bradley Arant Boult Cummings LLP

30(b)(6) vs. 702 – Is Your Witness a Party or an Expert?

Earnest v. Sanofi U.S. Services et al, U.S. Circuit Court of Appeals for the Fifth Circuit, No. 20-30184 (Feb. 10, 2022) - The plaintiff sued Sanofi U.S. Services, Inc. and Sanofi-Aventis U.S., LLC in the Eastern District...more

Nutter McClennen & Fish LLP

Product Liability 2021 Year in Review

Massachusetts federal and state courts issued several important product liability decisions in 2021. Nutter’s Product Liability practice group reviewed these cases and report on their significant holdings as follows...more

Butler Snow LLP

The Learned Intermediary Doctrine: Debunking Myths

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The learned intermediary doctrine is not sexy. Its application doesn’t require depositions or a jury trial. Look no further than its name:  it’s a legal doctrine. Nevertheless, drug and device manufacturers still face a...more

Faegre Drinker Biddle & Reath LLP

Going Paperless: What Manufacturers Need to Know Before Digitizing Warnings

By the time the COVID-19 pandemic began, society was well into the so-called “Digital Age,” relying heavily on electronic communications, apps, websites, and the like to go about daily activities. Everything from ordering...more

Faegre Drinker Biddle & Reath LLP

Southern District of Texas Holds Learned Intermediary Doctrine Applies to Clinical Trials

Does the learned intermediary doctrine apply in the context of a clinical trial? According to the Southern District of Texas, it does. The case in question is Butler et al. v. Juno Therapeutics, Inc., a tragic case...more

Faegre Drinker Biddle & Reath LLP

Double Whammy: Fifth Circuit Affirms Dismissal of Suit Against Generic and Brand-Name Drug Manufacturers

Some product liability suits are dead on arrival. At least, that is the position the Fifth Circuit took late last week in affirming the dismissal of a pro se plaintiff’s suit against a collection of generic and brand-name...more

Faegre Drinker Biddle & Reath LLP

Preemption Torpedoes State Law Claims against Generics Makers in Zantac MDL

A judge in the United States District Court for the Southern District of Florida presiding over the In Re: Zantac (Ranitidine) Products Liability Litigation multidistrict litigation, MDL No. 2924, has held that state labeling...more

Conn Kavanaugh

Defining the Boundaries for Pre-emption of Drug Labeling Claims

Conn Kavanaugh on

Drug warning labels must comply with federal regulations and receive approval from the Food and Drug Administration (“FDA”) before going to market. Therefore, manufacturers may argue that state law actions related to the...more

Searcy Denney Scarola Barnhart & Shipley

Injured Patients Want Consolidation of Zantac Lawsuits

Litigation Update - On January 30, 2020, class action, consumer protection and pharmaceutical lawyers from around the country will be in federal court in Tampa, Florida to argue before a panel of federal judges whether...more

Faegre Drinker Biddle & Reath LLP

Third Circuit Clarifies Next Steps in Fosamax Decision

On remand from the U.S. Supreme Court, the U.S. Court of Appeals for the Third Circuit has in turn remanded the case to the district court to determine whether state law claims are preempted by federal law in the 500+...more

Mayer Brown

If This Isn’t A Product Of Passion Or Prejudice, What Is?

Mayer Brown on

By now, you’ve probably read reports of the $8 billion punitive verdict against Johnson & Johnson in an individual case alleging failure to warn that young men using its antipsychotic drug Risperdal could develop breasts. ...more

Spilman Thomas & Battle, PLLC

Product Lines - Toxic Torts and Products Liability Insights: Issue 3, 2019

Welcome to the third 2019 issue of Product Lines – our quarterly e-newsletter that focuses on toxic torts and products liability issues.... In This Edition: - Vitamin E Found in Cannabis-Containing Vape Products Linked...more

Faegre Drinker Biddle & Reath LLP

Does Pennsylvania Recognize Strict Liability Claims Against Medical Device Manufacturers? A Pennsylvania federal court calls the...

For at least two decades, Pennsylvania law has recognized an exemption from strict liability for prescription drug manufacturers based on the state Supreme Court’s interpretation of the Restatement (Second) of Torts Sec. 402A...more

Faegre Drinker Biddle & Reath LLP

Worth the Wait? Some Semi-Mature Thoughts on Albrecht

For some long-awaited events, a little time and distance can add a measure of clarity. Not always – many still are processing the Game of Thrones finale, with no end in sight. But over the past few weeks pharmaceutical...more

Faegre Drinker Biddle & Reath LLP

District of Delaware Grants Motions for Summary Judgment in Three Risperdal Gynecomastia Cases

In a trio of recent decisions arising out of cases alleging that an antipsychotic medication, Risperdal, and its generic, risperidone, had caused gynecomastia (breast tissue growth) in men, the United States District Court...more

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