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Ad Law Access
FDA & FTC Issue Joint Warning Letters to Companies Marketing Products to Overcome Opioid Addiction and Withdrawal
The FDA & FTC today posted warning letters to 11 marketers and distributors of opioid cessation products, alleging that such products were unapproved new drugs that violated the Federal Food,…
Drug & Device Law
No Old Kentucky Home for Parallel FDCA-Based Tort Claims
By Bexis
Several years ago, in a post entitled “Negligence Per Se Trivia,” we included the following: In Kentucky, negligence per se has been codified, and claims based on federal (but not…
All About Advertising Law
The Tide Is Slowly Turning Against Food Labeling False Advertising Claims That Do Not Involve Affirmative Misrepresentations
Joining a growing trend in federal court jurisprudence, the U.S. District Court for the Central District of California dismissed a class action complaint because it found that the Mott’s fruit…
Drug & Device Law
Federal Right To Try Legislation – Is It Any Better?
By Bexis
We’ve generally been skeptical of state “Right To Try” statutes, for several reasons. First, to the extent that they try to circumvent the FDCA, they’re likely to be preempted. Second,…
The Energy Law Blog
U.S. Supreme Court’s Decision Not to Take Certiorari in United States v. DeCoster is a Reminder to the Food and Drug Industries to be Mindful of the Park Doctrine
By Sean Toomey
Earlier this year there was hope in the food and drug industries that the Supreme Court would revisit and possibly revise the Responsible Corporate Officer Doctrine, also known as the Park Doctrine,…
Drug & Device Law
Boxed Warnings and Adequacy as a Matter of Law
By Bexis
One of the (many) things that made last year’s decision in Barron v. Abbott Laboratories, Inc., ___ S.W.3d ___, 2016 WL 6596091 (Mo. App. Nov. 8, 2016), so hideous that…
Drug & Device Law
Non-Existent Duty to Warn of Mensing Not Enough to Get Around Mensing Preemption
Earlier this week, we discussed how the presentation of the federal question of express preemption from the face of a complaint can lead to removal. Part of why the defendant drug…
The Daily Intake
FDA Targets Tobacco Products Claims
Pursuant to Section 201(rr) of the Food, Drug and Cosmetic Act, as amended by the Tobacco Control Act, a “tobacco product” is any product made or derived from tobacco intended…
SDNY Blog
Judge Seibel Dismisses Class Action Alleging Too Much Empty Space in Muscle Milk Containers
This week, Judge Seibel dismissed a putative class action against the makers of Muscle Milk and other protein powder products. The plaintiff alleged that the products were mislabeled under the Food, Drug, and…
TortsProf Blog
FL: R.J. Reynolds Argues Engle is Preempted, Violates Due Process
R. J. Reynolds is arguing to the Florida Supreme Court that Engle is preempted by FDA v. Brown & Williamson Tobacco Corp. to the extent that Florida state tort law…