News & Analysis as of

Manufacturer Liability Health Care Providers

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

Knobbe Martens

Major Med Device Product Developer GE HealthCare Collaborating with Healthcare Providers

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For good reasons, including product safety, quality assurance, development of delivery procedures and instructions, it has been a common practice for medical device companies and innovators to consult with physicians during...more

Hogan Lovells

The next era of digital therapeutics

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Products incorporating artificial intelligence/machine learning (AI/ML) algorithms have enormous potential for health care. The power of AI can enhance the capabilities of software that has the potential to benefit more...more

American Conference Institute (ACI)

[Event] Drug & Medical Device Litigation - December 7th - 8th, New York, NY

The premier event for drug and medical device product liability lawyers to gain essential winning litigation strategies. ACI’s 26th Annual Flagship Conference on Drug and Medical Device Litigation is returning to New York...more

McGuireWoods LLP

Healthcare Headlines: Episode 7 — Evolving Landscape of Healthcare Provider & Medical Product Liability

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Hosted by McGuireWoods partner Amber McGraw Walsh, former chair of the firm’s nationally recognized Healthcare Department, episode 7 of the Healthcare Headlines video series welcomes Sam Tarry, partner and former chair of the...more

Jackson Walker

Texas House Passes Pandemic Liability Protection Act

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Texas businesses watched the 2021 Texas legislative session closely for the potential pandemic liability relief provided in Senate Bill 6 (SB 6), or the Pandemic Liability Protection Act. With the passage of SB 6, Jackson...more

Epstein Becker & Green

Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast

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This Diagnosing Health Care episode looks at the adjustments to business operations and compliance programs that pharmaceutical and medical device companies need to consider as they launch new products during the ongoing...more

K&L Gates LLP

K&L Gates Triage: The Opioid Epidemic & the Confidentiality of Substance Use Disorder Records: an Update on 42 CFR Part 2 - Part 1...

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This episode is the first in a series focusing on recent efforts by the Substance Abuse and Mental Health Services Administration (SAMHSA) to update 42 C.F.R. Part 2 (Part 2) regulations related to the confidentiality of...more

American Conference Institute (ACI)

[Event] Drug and Medical Device Litigation – the Must-Attend Event for the Life Sciences Products Liability Community - December...

Actionable Strategies for Drug and Medical Device Products Liability Litigators and In-house Counsel - ACI’s Drug and Medical Device Litigation conference is the only event which brings together an exceptional in-house...more

Patrick Malone & Associates P.C. | DC Injury...

After thousands of lawsuits, FDA bans mesh used in pelvic prolapse procedures

After years of patient complaints about injuries and tens of thousands of lawsuits, the federal Food and Drug Administration yanked from the market a surgical mesh widely used to repair pelvic conditions in women....more

King & Spalding

FDA’s Focus on Devices Impacting Women’s Health is Fully Underway: Breast Implant Advisory Set for March 25-26

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Late last year, the Food and Drug Administration’s (FDA’s) Device Center announced a new objective when it comes to devices – “ensuring that the FDA is consistently first among the world’s regulatory agencies to identify and...more

Baker Donelson

HRSA to Enforce 340B Program Oversight of Drug Manufacturers Next Year and Share 340B Ceiling Prices with Covered Entities

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Two recent announcements by the Health Resources and Services Administration (HRSA) highlight the agency's plans for increased oversight in the next year of drug manufacturers under the 340B drug pricing program and...more

Robinson+Cole Health Law Diagnosis

HHS Delays 340B Program Final Rule on Drug Ceiling Price and Manufacturer Civil Monetary Penalties (Again)

On June 1, 2018, the Health Resources and Services Administration (HRSA) announced it was once again delaying the final rule that had set forth the calculation for the 340B Program ceiling price and drug manufacturer civil...more

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