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Medical Devices › Inadequate Warning

Console and Associates, P.C.

Philips CPAP Recall Update: Shocking Revelation From FDA Investigations and More

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What is the latest with the CPAP lawsuits? As 2022 begins, the thoughts of sleep apnea patients and their families are, naturally, returning to the Philips CPAP machine recall 2021....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

Akin Gump Strauss Hauer & Feld LLP

A Client's Guide to FDA Recalls

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Product recalls are critical events for firms that produce food and medical products. The lives and health of patients and consumers can be at stake. Companies risk enforcement action by the Food and Drug Administration...more

Hogan Lovells

FDA Issues Draft Guidance on Requirements for Public Warnings for Recalled Products

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FDA recently released a draft guidance clarifying the regulatory requirements for public warnings in the event of a recall under the agency’s recall guideline at 21 CFR Part 7. ...more

Foley Hoag LLP

Product Liability Update - January 2014

Foley Hoag LLP on

In this Issue: ..Massachusetts Federal Court Rejects Exception to “Learned Intermediary” Rule for Prescription Drug Advertised Directly to Consumers, and Excludes Expert Opinion of Inadequate Warnings as Unqualified...more

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