News & Analysis as of

Liability Food and Drug Administration (FDA)

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

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

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

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

Foley & Lardner LLP

Yes, You Can Patent Food Products!

Foley & Lardner LLP on

Companies in the food and beverage industry might overlook significant advantages by not patenting their innovations. While there’s a common belief that “recipes” cannot be patented, unique formulations and other aspects of...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

Hinch Newman LLP

Advertising Law Alert: FTC Announces New Health Products Compliance Guidance

Hinch Newman LLP on

In December 2022, the the Federal Trade Commission published new guidance regarding representations about the benefits and safety of health-related products: Health Products Compliance Guidance. Federal Trade Commission...more

Foley & Lardner LLP

Top Legal Issues Facing the Manufacturing Sector in 2022

Foley & Lardner LLP on

As the global economy faces the third year of the pandemic, manufacturers are no longer focused on figuring out when things will return to “normal.” Instead, they are applying lessons learned from the past few years to become...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

Schwabe, Williamson & Wyatt PC

‎Latest Federal Court Cases - August 2021 #2

Our Case of the Week this week is a re-write of our Case of the Week on October 5, 2020. The case involves a drug that could be used for multiple therapeutic purposes. A patent covered use of the product for a specific...more

Butler Snow LLP

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

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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

Vicente LLP

Protecting Your CBD Business From Product Liability Lawsuits

Vicente LLP on

With any new consumer product craze, lawsuits will inevitably follow. The hemp-CBD industry is no exception. The current wave of CBD-related lawsuits has primarily been product liability claims. As no company wants to...more

Jackson Lewis P.C.

COVID-19 Vaccination: Setting Up On-Site Programs

Jackson Lewis P.C. on

The Biden administration has called for all people at least 18 to be eligible for the COVID-19 vaccine by April 19, 2021. Most states have already done so. A BenefitsPro article cites a 2017 survey from the Society for...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, December 2020 # 6

Hogan Lovells on

In Washington: POLITICO reporter Burgess Everett tweeted that Senate Majority Leader Mitch McConnell (R-KY) says “negotiators should drop both state and local aid and liability shield provisions in order to reach consensus...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

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – July 2020 #17

Hogan Lovells on

In Washington - Senate Republicans delayed the release of their trillion dollar coronavirus relief package Thursday as they grapple with smoothing out policy disputes. ...more

Holland & Knight LLP

PREP Act: Liability Protection Is Available During COVID-19 Pandemic

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Issues relating to liability for pharmaceutical, personal protective equipment (PPE) and diagnostic test businesses as well as for physicians and healthcare personnel in the coronavirus (COVID-19) context remains a salient...more

King & Spalding

Tort Immunity under PREP Act and COVID-19 Response Declaration

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Pursuant to the Public Readiness and Emergency Preparedness Act (“PREP Act”), on March 17, 2020, the Secretary of Health and Human Services (“HHS”) published the Declaration Under the Public Readiness and Emergency...more

(ACOEL) | American College of Environmental...

Vaped and Confused

E-cigarettes have vaulted to the front pages lately, and for tragic reasons.  To date, at least six users have died from severe lung disease tied to vaping, and nearly 400 others have reported serious medical symptoms in 36...more

Troutman Pepper Locke

Delaware Supreme Court Issues Guidance On Board Oversight Responsibilities

Troutman Pepper Locke on

A director’s duty to make a good faith effort to oversee the operations and management of a Delaware company is well-established. In a recent case, Marchand v. Barnhill, the Delaware Supreme Court provided guidance to boards...more

Polsinelli

To BE or not to BE a GMO (UPDATED)

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On June 11, 2019, President Trump signed an executive order directing the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and United States Department of Agriculture (USDA) to ease rules for...more

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