Civil Liability, Food and Drug Administration (FDA)

First Circuit Decision Regarding Anti-Kickback Statute Standard Widens Circuit Split and Creates Potential for Supreme Court...

Greenbaum, Rowe, Smith & Davis LLP on 7/29/2025

The U.S. Court of Appeals for the First Circuit, in United States v. Regeneron, has joined the Sixth and Eighth Circuits in adopting the “but-for” standard to find that a violation of the Anti-Kickback Statute (AKS) triggers...more

6 Frequently Asked Questions with Lab Defense Attorney Nick Oberheiden

Oberheiden P.C. on 4/5/2022

Clinical laboratories have come under increased scrutiny in the past few years, especially those that deal with COVID-19 testing or drug testing. These federal investigations can be surprising and confusing for lab...more

The FASTER Act: What Companies Need to Know about the New Food Allergy Law

Farella Braun + Martel LLP on 7/1/2021

While the Food Allergy Safety, Treatment, Education, and Research Act (FASTER Act) only makes a minor change to add sesame as a major food allergen, it signals the government’s intent to closely examine food allergen...more

U.S. will ban targeted health menace of menthol cigarettes and flavored cigars

Patrick Malone & Associates P.C. | DC Injury... on 5/6/2021

The Biden Administration will ban menthol cigarettes and flavored cigars with new regulations to be issued within the next year - actions that Big Tobacco is expected to battle but which proponents say could have big health...more

Revisiting “Is ‘The Government Said I Could’ A Civil Liability Defense?” During COVID-19

Butler Snow LLP on 6/2/2020

Late last year we covered a decision finding a mine operator could not be held liable for unpermitted discharges under the Clean Water Act because it had properly disclosed them to the state permitting authority, which “chose...more

National Restaurant Assoc. Guidelines For Re-Opening

Downs Rachlin Martin PLLC on 5/8/2020

Restaurant and hospitality businesses prepare to reopen: guidelines. As various states begin to ease stay-at-home restrictions and restaurants and hospitality business prepare to re-open, the National Restaurant...more

Will Congress vaporize proposals to curb tobacco use, protect kids’ health?

Patrick Malone & Associates P.C. | DC Injury... on 4/26/2016

Just days after federal health officials warned about teen-agers’ increasing use of e-cigarettes (vaping) and hookahs, members of a House committee have approved a legislative move that shields vaping manufacturers from...more

Civil Liability › Food and Drug Administration (FDA)