Document Type
Comment
Abstract
Plaintiff, Karen Bartlett, suffered serious injuries after ingesting a generic form of Clinoril®, sulindac, manufactured by Defendant, Mutual Pharmaceutical. Plaintiff filed suit against Defendant in New Hampshire state court to recover damages for Plaintiff’s injuries. Plaintiff filed a design defect claim and a failure to warn claim alleging that the generic drug’s label inadequately warned of the risk of developing certain severe skin reactions. Defendant removed the suit to federal court. The District Court dismissed the failure to warn claim.
A jury awarded Plaintiff twenty-one million dollars based on Plaintiff’s design defect claim. The First Circuit affirmed, holding that neither the Food, Drug, and Cosmetic Act (FDCA) nor the Food and Drug Administration’s (FDA) regulations pre-empted Plaintiff’s design defect claim as Defendant could comply with federal and state law by simply choosing not to make the drug. The U.S. Supreme Court granted certiorari, reversed, and HELD, that design defect claims that turn on the adequacy of a generic drug’s warnings are pre-empted by federal law, which expressly prohibits manufacturers of generic drugs from making any unilateral changes to the drug’s label.
Recommended Citation
Deryk Loiacono,
The Lack of Pre-Emption for Prescription Drugs: How Juries Have Replaced the FDA as Medical Experts,
19 J. Tech. L. & Pol'y
(2014).
Available at: https://scholarship.law.ufl.edu/jtlp/vol19/iss2/4