Recent Nuclear Verdicts Highlight Danger of Punitive Damages -
In October and November 2023, four separate products liability trials ended with large plaintiff verdicts. Three of these verdicts were against Monsanto in...more
12/4/2023
/ Chemicals ,
Class Action ,
Dismissals ,
Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Inspections ,
Mass Tort Litigation ,
Monsanto ,
Negligence ,
PFAS ,
Popular ,
Punitive Damages ,
SCOTUS ,
Strict Product Liability
The FDA issued Revised Draft Guidance addressing communications by drug and device manufacturers about “off-label” uses of approved products.
The Revised Draft Guidance supersedes FDA’s 2014 Draft Guidance on...more
11/3/2023
/ Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Manufacturers ,
Medical Devices ,
Off-Label Promotion ,
Off-Label Use ,
Online Platforms ,
Pharmaceutical Industry ,
Real World Evidence
Senators Focus Attention on Litigation Funding’s Opacity -
Building on the momentum we previously noted related to litigation funding, on September 14, Senator John Kennedy introduced the Protecting Our Courts from Foreign...more
10/31/2023
/ CERCLA ,
Compliance ,
Consolidated Appropriations Act (CAA) ,
Cybersecurity ,
Environmental Protection Agency (EPA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Final Rules ,
First Amendment ,
Food and Drug Administration (FDA) ,
Foreign Investment ,
Litigation Funding ,
Medical Devices ,
PFAS ,
Political Campaigns ,
Proposed Legislation ,
Regulatory Oversight ,
SCOTUS ,
Social Media ,
Third Party Funding ,
Toxic Substances Control Act (TSCA) ,
Transparency ,
Vulnerability Assessments ,
Wireless Technology
Delaware Supreme Court Rejects No-Injury Medical Monitoring Claims -
As part of our ongoing coverage of issues in Medical Monitoring, we noted that the Delaware Supreme Court received a certified question from the U.S....more
10/2/2023
/ Air Pollution ,
Appeals ,
DE Supreme Court ,
Draft Guidance ,
Environmental Protection Agency (EPA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Rules of Civil Procedure ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Medical Monitoring ,
Motion to Exclude ,
OECA ,
PFAS ,
Software
Introducing Dechert Re:Torts, a monthly publication that offers a summary of significant cases, rules and pertinent issues, brought to you by Dechert’s Product Liability and Mass Torts Group. Our snapshots help you stay...more
2/1/2023
/ Asbestos ,
Environmental Protection Agency (EPA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Mass Tort Litigation ,
Modernization of Cosmetics Regulation Act of 2022 (MoCRA) ,
Multidistrict Litigation ,
Patent Infringement ,
PFAS ,
Popular ,
Product Recalls ,
Proposed Amendments ,
Proposed Rules ,
Registration Requirement ,
Reporting Requirements ,
Risk Management ,
Strict Product Liability ,
Toxic Substances Control Act (TSCA)
In June of this year, FDA announced a proposed rule that would permit approval for nonprescription drug products with an Additional Condition for Nonprescription Use—a category of nonprescription drugs where FDA determines...more
10/19/2022
/ Abbreviated New Drug Application (ANDA) ,
Adverse Events ,
Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Healthcare Workers ,
Labeling ,
Manufacturers ,
Over The Counter Drugs (OTC) ,
Prescription Drugs ,
Proposed Rules ,
Reporting Requirements ,
Retailers ,
Strict Product Liability