Tag Archives: preemption

U.S. v. California: The District Court’s Preliminary Injunction Ruling

by Bernard Bell — Friday, July 27, 2018

On March 6, 2018, the Justice Department sued California over its “sanctuary” laws.  U.S. v. California, Dkt No. 18-264, Complaint (E.D. Cal.); Thomas Fuller & Vivien Yee, Jeff Sessions Scolds California in Immigration Speech: “We Have a Problem,” N.Y. Times A22 (March 7, 2018).  The District Court has now ruled on the federal government’s preliminary […]

Hatch-Waxman and Defective Generic Drug Labels: The Disjunction Between Federal Drug Safety Law and State Warning Defect Law (Part II)

by Bernard Bell — Monday, June 4, 2018

In an earlier post I outlined a regulatory anomaly regarding liability for defective drug labels.  Hatch-Waxman expedited entry of generics medications into the market, by relieving generic-brand manufacturers of the need to conduct further testing.  Concomitantly, the statute placed control of the contents of the drug label in the hands of the original recipient of […]

Hatch-Waxman and Defective Generic Drug Labels: The Disjunction Between Federal Drug Safety Law and State Warning Defect Law (Part I)

by Bernard Bell — Tuesday, May 29, 2018

Consider the following hypothetical.  A drug company develops and patents a pharmaceutical to sell under brand-name.  It secures FDA approval and enjoys its patent monopoly for many years.  But after that patent monopoly expires, generic brand-makers flood into the market and undercut the brand-name’s price.  Pharmacists substitute the generic for the brand name.  The label […]

State Preemption: Arizona vs. Local Control

by Micah Berman — Monday, Sept. 5, 2016

This blog tends to focus on federal regulation or state regulation, but local regulation is also particularly important in some areas of law – particularly public health law, my area of focus. Recently, there have been coordinated efforts to limit local regulation through the use of state-level preemption.  Recent examples from my home state of […]