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Manufacturers › Failure to Report

Foster Garvey PC

Non-Compliance with Oregon’s Extended Producer Responsibility Law May Result in Penalties of $25,000 per Day

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Under Oregon’s Extended Producer Responsibility (EPR) law, the deadline for producers of consumer packaging, paper and food serviceware to register and report their production of such materials to the Circular Action Alliance...more

Foley Hoag LLP

Product Liability Update - January 2023

Foley Hoag LLP on

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

Goodwin

Novel DOJ Settlement For Sunshine Act Violations

Goodwin on

On October 29, 2020, the U.S. Department of Justice (“DOJ”) announced a unique False Claims Act (“FCA”) settlement with medical device manufacturer Medtronic USA Inc. (“Medtronic”) for $9.2 million to resolve allegations...more

Hogan Lovells

MDR single report exemption and ASRs: Coming to an end for most reporters

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The Medical Device Reporting (MDR) regulation provides a mechanism for the U.S. Food and Drug Administration (FDA or the Agency), as well as medical device manufacturers, to identify and monitor adverse events (deaths,...more

Kelley Drye & Warren LLP

[Webinar] Keeping Up with the Consumer Product Safety Commission: Update on Recent CPSC Developments - March 29th, 12:00pm EST

Kelley Drye & Warren LLP on

With the complexity of today’s product safety regulatory environment and the civil penalty amounts for failure to report safety hazards, it is more important than ever for manufacturers and retailers to identify and resolve...more

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