News & Analysis as of

Liability Medical Devices

Searcy Denney Scarola Barnhart & Shipley

Defective Medical Devices and Their Impact on Patient Safety

Defective medical devices present serious risks for patients. Just how big—and how severe—is the problem? Consider this from the U.S. Food and Drug Administration (FDA): “Each year, the FDA receives over two million medical...more

White & Case LLP

New EU Responsibility and Liability Landscape for Smart Medical Devices in a Global Context

White & Case LLP on

Artificial intelligence (AI) is already indispensable in the healthcare and life sciences sector. Intelligent medical devices promise nothing less than a revolution in the art of healing. With its legislative projects on AI...more

Searcy Denney Scarola Barnhart & Shipley

The Dangers of Defective Medical Devices: How to Protect Yourself

Defective medical devices can present serious—and even life-threatening—risks for patients. Yet, sadly, many patients don’t realize that their medical devices are defective until it is too late. Sometimes, manufacturers and...more

Searcy Denney Scarola Barnhart & Shipley

FDA Recalls: How to Stay Informed About Unsafe Products

Unsafe product recalls are alarmingly common. While all companies have a legal obligation to ensure that their products are safe for use or consumption, companies fail to meet this obligation far too often. In many cases,...more

Harris Beach Murtha PLLC

New York Clarifies Limits on Medical Device Manufacturer’s Duty to Warn

A manufacturer produces a medical device for physicians to use to administer a particular type of treatment to their patients. When does that manufacturer have a duty under New York state law to warn a physician of risks...more

Gardner Law

Product Liability Prevention: A Proactive Approach for FDA-Regulated Industries

Gardner Law on

Medical device, drug, food, cosmetic, and other FDA-regulated product manufacturers face the constant threat of product liability lawsuits. Claims of injuries from allegedly defective products can lead to significant...more

Foley & Lardner LLP

Distributor’s Claims Against Manufacturer Under Puerto Rican Law Are Denied

Foley & Lardner LLP on

Lyvette Mercado Velez, a dietitian, entered into a distribution agreement with Insulet Corporation, a leading medical device manufacturer, to promote and sell diabetes treatment products and services in Puerto Rico. Shortly...more

Harris Beach Murtha PLLC

New York Medical and Life Sciences: Year in Review 2023

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

Butler Snow LLP

20 Questions to Ask When Defending a Medical Device Case

Butler Snow LLP on

In the game of “20 Questions,” one player secretly chooses an object and the other players are allowed 20 questions to identify it. In that spirit, answering the following 20 questions may identify a defense strategy that...more

Butler Snow LLP

The Learned Intermediary Doctrine: Debunking Myths

Butler Snow LLP on

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

Butler Snow LLP

Looking Beyond the Pandemic – AI and Digital Health Kick into Warp Speed

Butler Snow LLP on

What This Means for the FDA and the Industry - The COVID-19 pandemic has spurred the development of digital health products utilizing artificial intelligence (AI) and machine learning (ML). When the pandemic passes, there...more

Nelson Mullins Riley & Scarborough LLP

Artificial Intelligence and Product Liability Law: Predicting Liability Risks Based on the Existing Regulatory and Legal Framework

U.S. Food and Drug Administration-approved artificial intelligence-based algorithms are rapidly growing in number. These algorithms are, for the most part, designed to help healthcare providers implement existing workflows...more

Blake, Cassels & Graydon LLP

Blakes Continuity Podcast: Life Sciences: Liability and Immunity During COVID-19

Businesses in the life sciences industry are rightfully concerned about potential negligence claims during COVID-19. Will courts provide immunity or forgiveness? To learn more about how businesses can mitigate the risks,...more

Patterson Belknap Webb & Tyler LLP

HHS Issues Advisory Opinion Further Clarifying Scope of PREP Act Immunity

Since invoking its powers under the PREP Act last month to shield certain actors aiding in the fight against COVID-19 from tort liability for their efforts, the Department of Health and Human Services (“HHS”) has been...more

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