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Manufacturers Failure To Warn Medical Devices

Faegre Drinker Biddle & Reath LLP

Yes, Michigan Applies the Learned Intermediary Doctrine

For decades, both state and federal courts in Michigan have routinely applied the learned intermediary doctrine in products liability cases involving prescription medical products. Under the doctrine, a manufacturer’s duty to...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

Napoli Shkolnik

Product Liability: How it Works For and Against Victims of Defective Medical Devices

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Crafting the perfect medical device is never an exact science—but a patient should never suffer because of defects in a product that was intended to improve their quality of life. Determining whether a device manufacturer or...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

“Alternative Avenues” Argument in Failure-to-Warn Cases Adding an Additional Wrinkle to Medical Device Litigation

A developing line of cases across the nation may have large implications for medical device manufacturers defending against failure-to-warn claims. While a treating physician’s failure to read or rely on the manufacturer’s...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

Treating Physician’s Informed Consent Process and Decision-Making in Device Selection Lead to Partial Summary Judgment for Device...

A series of recent rulings out of the Southern District of Texas in an inferior vena cava (IVC) filter case reflect how well-planned discovery can lead to a successful multipronged summary judgment motion and can effectively...more

Foley Hoag LLP

Product Liability Update - April 2021

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UNITED STATES SUPREME COURT - • United States Supreme Court Holds Due Process Permits Exercise Of Specific Personal Jurisdiction Over Out-Of-State Vehicle Manufacturer For Product Liability Claims For Harm To Forum...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

Butler Snow LLP

Pro Te: Solutio – Vol. 12, No. 1

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Welcome to 2019! We hope that your New Year’s resolutions included time to sit down and enjoy our latest edition of Pro Te: Solutio. We have three intriguing articles in this edition, which are sure to provide useful...more

Snell & Wilmer

Arizona Limits Failure to Warn Claims Against Medical Device Manufacturers

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On December 18, 2018, the Arizona Supreme Court issued an opinion clarifying manufacturers’ duty to warn consumers under Arizona common law. The Court held that the federal Medical Device Amendments (“MDA”) impliedly...more

Searcy Denney Scarola Barnhart & Shipley

Firefighter Awarded $1.2 Million Due to IVC Filter Injuries

Due to a failure to warn doctors and patients of the complications of IVC filter usage, Houston firefighter Jeffrey Pavlock was awarded $1.2 million in a jury verdict against Cook Medical after experiencing blood vessel and...more

Morrison & Foerster LLP

Will High Court Provide Clarity On 'Clear Evidence'?

The U.S. Supreme Court may soon revisit one of its seminal decisions defining products liability law for pharmaceutical manufacturers. That decision — Wyeth v. Levine — addressed whether a branded manufacturer could be held...more

Foley Hoag LLP

Product Liability Update: October 2017

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Massachusetts Federal Court In Multi-District Litigation Holds Under Six States’ Laws That Manufacturer Of Brand-Name Pharmaceutical Is Not Liable For Injuries Caused By Generic Equivalents Whose Manufacturers Were Required...more

Sands Anderson PC

Fourth Circuit Excludes FDA Evidence in Transvaginal Mesh Products Liability Case

Sands Anderson PC on

In the Southern District of West Virginia, Johnson & Johnson and its subsidiary, Ethicon, Inc., were sued for defective design and failure to warn for their transvaginal mesh TVT-O, in addition to a loss of consortium claim....more

Knobbe Martens

Medical Device Manufacturers’ Duty to Warn Expands

Knobbe Martens on

The Washington State Supreme Court recently released its decision in Taylor v. Intuitive Surgical, Inc. where it held that Washington law requires medical device manufacturers to warn hospitals that purchase their products of...more

Cozen O'Connor

Washington: Product Manufacturers Must Warn Hospitals; May Be Strictly Liable for Failure to Warn

Cozen O'Connor on

In Washington, manufacturers of medical devices now have a duty to warn hospitals that purchase their devices. Additionally, product manufacturers of “unavoidably unsafe products” face strict liability for failure to warn...more

Morrison & Foerster LLP

What The Intuitive Ruling Means For Medical Device Makers

Last month, in Taylor v. Intuitive Surgical Inc., the Washington Supreme Court saddled medical device manufacturers with a new duty to warn under Washington law — the duty to warn hospitals about potential risks their...more

Cozen O'Connor

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

Cozen O'Connor on

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

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