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FDCA
242 published works
Drug & Device Law
Failure-to-Warn Claim Targeting Branded Drug Held Preempted: Litigation-Driven Expert Analysis Is Not “Newly Acquired Information” for Purposes of the “Changes Being Effected” Regulation
Under Wyeth v. Levine, 555 U.S. 555 (2009), and PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), failure-to-warn claims targeting a pharmaceutical are preempted unless the manufacturer could have provisionally…
Drug & Device Law
On Pleading Negligence Per Se
By Bexis
Bexis has just submitted revisions and updates to Chapter 4 of his treatise, Drug and Medical Device Product Liability Deskbook. Chapter 4 is “The Federal Framework,” and one of the…
Drug & Device Law
Federal Court Confirms that Anti-Vaxxers Do Not Have a Constitutional or Statutory Right to Endanger Everyone Else.
Last year we recounted a decision that denied a preliminary injunction to selfish New Mexicans who think that they have a right to endanger others by refusing to be vaccinated…
Drug & Device Law
For Preemption, “Newly Acquired” Does Not Mean “By Plaintiff”
They say the smartest people are the ones who are always learning something new. Those who are open to new ideas and concepts. People who are eager to acquire new…
Food Safety News
A discussion of tara and GRAS status
Recent foodborne illnesses have raised questions about the legal status of tara (Caesalpinia spinosa) under United States food law. There are three legal pathways for ingredients to be used in…
Inside Class Actions
A Closer Look: Express Federal Preemption for OTC Medications Subject to Monographs
Manufacturers of over-the-counter (OTC) medications often move to dismiss consumer class actions based on federal preemption. The Federal Food, Drug, and Cosmetic Act (FDCA) contains an express preemption clause that…
Drug & Device Law
Federal Preemption of State Attempts To Ban FDA-Approved Abortion Drugs After Dobbs
By Bexis
Given what we saw in states such as Mississippi, Oklahoma, and Idaho even before the Supreme Court’s in Dobbs v. Jackson Women’s Health Org., ___ S. Ct. ___, 2022 WL…
Canna Law Blog
Six Requirements for CBD Product Labels
Because the Food and Drug Administration (FDA) says that CBD-infused foods and dietary supplements cannot be lawfully sold or marketed in the United States, we’re left with a patchwork of…
Drug & Device Law
The Intersection Between the Lanham Act and the FDCA
FDA’s exclusive enforcement powers prohibit plaintiffs from bringing what amount to private FDCA violation claims in the guise of private civil litigation. 21 U.S.C. §337(a). That is the foundation on…
Food Safety News
Federal court orders company to stop distribution of pet food contaminated with Salmonella
By News Desk
A federal court Monday ordered a Carneys Point, NJ, company to stop distributing adulterated pet food that is in violation of the Federal Food, Drug and Cosmetic Act (FDCA). Pet…