Topic
Adverse Event Reporting
32 published works
Retail & Consumer Products Law Observer
FDA Provides Updated Instructions for Reporting Serious Adverse Events under MoCRA
On December 14, 2023, the FDA issued an update with further instructions on serious adverse event reporting under the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”), which is enforceable…
Food Poison Journal
Over two weeks ago I asked: Hey, FDA and CFIA, why no recall of Revive Pineapple & Mango Smoothies – there are dozens ill? Daily Harvest French Lentil + Leek Crumbles now at 329 “adverse illness events” with 113 hospitalized
By Bill Marler
Still no Revive Pineapple & Mango Smoothie recall, although The FDA appears to be investigating Revive. Also, there has been no update from either Daily Harvest nor The FDA as…
Drug & Device Law
E.D. Virginia Loosens the Reins in Horse Prescription Drug Case
This is a follow-up post on the case of Knapp v. Zoetis, Inc. – an animal drug case. While not our typically fare, it is still a prescription drug case…
Food Safety News
FDA checking on ‘adverse events’ while other outbreak investigations continue
By News Desk
The FDA is investigating “adverse event reports” involving at least 31 people, according to an announcement from the agency. Little information is available on the situation, with the Food and…
Drug & Device Law
First Circuit Asks Whether Massachusetts Recognizes a Duty to Report Adverse Events to the FDA
Last year we reported on Plourde v. Sorin Group USA, Inc., 2021 WL 736153 (D. Mass. 2021), which held that the plaintiff’s failure-to-warn claims were expressly preempted by 21 U.S.C.…
Drug & Device Law
More Updates
By Bexis
This post is to update our readers about subsequent developments in matters covered in some of our prior blogposts. First, slightly over a year ago we praised Gayle v. Pfizer,…
Drug & Device Law
Quasi-Guest Post – Plaintiffs’ Beast of Burden: Adverse Event Reports Precede Causation
By Bexis
We're calling this a "quasi" guest post because the author, Reed Smith's Dean Balaes, is actually trying out to join our blogging team. This is his inaugural post, of what…
Health Law Rx
You Can’t Always Get What You Want
The Florida Fifth District Court of Appeal harmonized the interpretation of state statutory and constitutional language in the first post Amendment 7 case dealing with access to adverse medical incident…
Pannone Corporate News and Opinion
The Duty of Candour: a level playing field?
When Andy Burnham, then MP for Leigh, proposed a statutory duty of candour back in 2017, he no doubt hoped progress might now have been made. His draft Bill, prompted…
DC Medical Malpractice & Patient Safety Blog
Bureaucrats let medical device makers hide 1 million reports of patient harms
If a surgical staple gun malfunctioned so seriously that it generated not a few dozen formal complaints but more than 10,000 reported incidents, shouldn’t patients, doctors, and hospitals have the…