Statute
FDCA
242 published works
InsureReinsure
UPDATE: Recusal Issue Arises in U.S. Supreme Court’s Consideration of Wyeth v. Levine Drug Labeling Preemption Case
As previously reported here, the U.S. Supreme Court heard oral arguments in Wyeth v. Levine on November 3, 2008. The case involves the question of whether the Food and Drug…
Drug & Device Law
Defeating FDCA-Based Negligence Per Se On State-Law Grounds
By Bexis
We’ve been keeping an eye on some interesting litigation in the District of Columbia, Iacangelo v. Georgetown University, C.A. No. 05-2086 (PLF). It’s not even a drug or device case,…
InsureReinsure
California Federal Court: Off-Label Promotion: State Law Consumer Fraud Claims and Federal RICO Claims Are Not Necessarily Preempted by Food, Drug and Cosmetics Act
The United States District Court for the Central District of California recently held that state law consumer fraud claims and federal fraud claims pursuant to the Racketeer Influenced and Corrupt…
Food Safety Counsel
Chapter 4: Responding To The Complaint – Procedural Considerations
Return to Defending Claims. Once a claim is filed in state court, the first decision should always be whether to remove the lawsuit to federal court. Often times, because food-borne…
TortsProf Blog
Lilly Does Indeed Settle Off-Label Marketing Cases; Includes Misdemeanor Plea
One story is here. Lilly pleaded guilty to a misdemeanor violation of the FDCA and is paying a $515 million fine, described as the largest fine in history. The balance…
Drug & Device Law
Guest Post – In Defense Of Preemption & FDA Regulatory Authority
By Bexis
This is the first of what we hope will be many guest posts by Bert Rein, a founding partner of Wiley Rein, LLP. Among many other accomplishments, Bert represents Wyeth…
Drug & Device Law
Off-Label Promotion MDL Dismissed under FDCA
By Bexis
As far back as the Bone Screw litigation, we've argued that many attempts to gin up litigation about alleged off-label promotion are really prohibited back-door attempts at private enforcement of…
Drug & Device Law
Sleeper Case, Sleeper Issue
By Bexis
It got hardly any attention in the blawgosphere at the time – aside from us, 360, and the hardcore Supreme Court junkies over at SCOTUSBlog (and even they buried it…
Drug & Device Law
Chicken of the Sea is Sunk
By Bexis
Yesterday, the Third Circuit decided Fellner v. Tri-Union Seafoods LLC, No. 07-1238, slip op. (3d Cir. Aug. 19, 2008) (link here). The case involves our favorite subject: tuna fish. Aaah,…
Drug & Device Law
Preemption Affirmed in Colacicco
By Bexis
The Third Circuit has affirmed the finding of extensive preemption in the Colacicco/McNellis suicidality litigation. Here's a copy of the opinion. Judge Sloviter wrote the opinion. There is a dissent,…