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Manufacturers Failure To Warn Prescription Drugs

Morris James LLP

Recent Developments in Depo-Provera Litigation: Formation and Progress of Multidistrict Litigation (MDL)

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The legal landscape surrounding Depo-Provera, a long-acting injectable birth control, has entered a pivotal phase. With the growing number of lawsuits alleging that the drug caused serious brain tumors known as meningiomas,...more

Foley Hoag LLP

Product Liability Update - April 2025

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Foley Hoag LLP publishes this quarterly Update primarily concerning developments in product liability and related law from federal and state courts applicable to Massachusetts, but also featuring selected developments for New...more

Hissey, Mulderig & Friend, PLLC

Ozempic, Other Diabetes-Weight Loss Drugs Linked to 162 Deaths, According to FDA Data

Ozempic and other diabetes-weight loss drugs have been linked to at least 162 deaths and 10,000 cases involving “serious” injuries since 2018, according to data from the U.S. Food and Drug Administration (FDA)....more

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

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

Goodell, DeVries, Leech & Dann, LLP

Federal Court Dismisses All Generic Ranitidine Claims in Zantac Multidistrict Litigation—with Prejudice

A federal court in Florida has dismissed all claims—without leave to amend—against all generic ranitidine and store-brand manufacturers in the multidistrict litigation over the heartburn medication Zantac and its generic...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

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

Quinn Emanuel

August 2019: Product Liability Litigation Update

Quinn Emanuel on

Merck v. Albrecht:  Impossibility Preemption Defense as a Question of Law and Guidance on the “Clear Evidence” Standard. A decade ago in Wyeth v. Levine, the Supreme Court held that drug manufacturers, when faced with...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

Morrison & Foerster LLP - Class Dismissed

Supreme Court Decides Prescription Drug Preemption Case in Favor of Drug Manufacturer

The United States Supreme Court finally clarified its 11-year-old “clear evidence” standard for pharmaceutical preemption.  In its much-anticipated opinion delivered by Justice Breyer, the Court unanimously reversed the Third...more

Morgan Lewis

Supreme Court Clarifies Judges Must Decide Impossibility Pre-Emption

Morgan Lewis on

The US Supreme Court held on May 20 that a judge, not a jury, must decide the question of whether federal law prohibited drug manufacturers from adding warnings to the drug label that would satisfy state law. To succeed on a...more

Hogan Lovells

U.S. Supreme Court rules judges must decide whether preemption applies, and clarifies when it does

Hogan Lovells on

Opinion highlights importance of a "clear" record at FDA - On 20 May the U.S. Supreme Court unanimously ruled that federal preemption questions arising under the Federal Food, Drug, and Cosmetic Act (FD&C Act) are for a...more

McDermott Will & Schulte

US Supreme Court Refines Impossibility Preemption Doctrine, Changes Litigation Dynamics

Following confusion from a 2009 decision, the US Supreme Court on May 20, 2019, decided a significant impossibility preemption case. This new decision will change the dynamics of litigation involving the impossibility...more

Jones Day

Supreme Court Sides with Merck in Unanimous Fosamax® Product-Liability Decision

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The Situation: Name-brand pharmaceutical manufacturers are often sued with claims that they should have strengthened the warnings on their labels, even where (as here) the Food and Drug Administration ("FDA") would not allow...more

McDonnell Boehnen Hulbert & Berghoff LLP

Merck Sharp & Dohme Corp. v. Albrecht (2019)

Last week, in Merck Sharp & Dohme Corp. v. Albrecht, the Supreme Court continued its explication of the balance between state law tort liability that can be imposed on drug makers and the extent to which this liability can be...more

Husch Blackwell LLP

Supreme Court Reiterates That Federal Law Preemption For Product Warnings Is A Matter For Judge, Not Jury

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On Monday, the United States Supreme Court found that a judge is better suited than a jury to decide if consumers’ tort claims are preempted by federal regulations. In the case, Merck Sharp & Dome, Corp. v. Albreecht, the...more

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