News & Analysis as of

Medical Devices Liability

Foley & Lardner LLP

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

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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 PLLC

New York Medical and Life Sciences: Year in Review 2023

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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

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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

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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

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

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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