9th Circuit: Failure-To-Warn Claim For Nonprescription Drugs Is Not Preempted

9th Circuit: Failure-To-Warn Claim For Nonprescription Drugs Is Not Preempted

SAN FRANCISCO -- A mother's failure-to-warn claim against a manufacturer of generic ibuprofen is not preempted under the U.S. Supreme Court's prescription drug preemption ruling in Wyeth v. Diana Levine, a panel of the Ninth Circuit U.S. Court of Appeals ruled Jan. 24 (Margarita Gaeta, et al. v. Perrigo Pharmaceuticals Company, et al., No. 09-15001, 9th Cir.; 2011 U.S. App. LEXIS 1382).

Augustine Gaeta received Halothane, an anesthetic known to be toxic to the liver, and took 400 milligrams of ibuprofen afterward for pain and later for a fever.  Within 10 days, he developed liver failure and subsequently underwent a liver transplant, losing his toes and fingers due to complications.

Perrigo Pharmaceuticals made some of the generic ibuprofen Augustine took, and his mother, Margarita Gaeta, sued the company.  The U.S. District Court for the Northern District of California granted Perrigo summary judgment on the basis of federal preemption.

After the intervening Levine (No. 06-1249, U.S. Sup.; 2009 U.S. LEXIS 1774) ruling, the District Court was asked to reconsider, but it found that Levine did not apply to nonprescription drugs.  The plaintiff appealed.

"The state law duty to warn by an appropriate label on the generic ibuprofen drug was not preempted by federal law," the Ninth Circuit panel said.  "Compliance with both state and federal law was not 'impossible.'  Additional warnings would not stand as an obstacle to the accomplishment of purposes and objective of Congress."

"Perrigo failed to present clear evidence that the [Food and Drug Administration] would have rejected the specific hepatotoxicity warnings proposed by the Gaetas," the panel said.

The panel reversed summary judgment and remanded the case.

The ruling makes the Ninth Circuit the third federal appeals court to find that failure-to-warn claims involving generic drugs are not preempted.  The U.S. Supreme Court will hear arguments in a case involving generic metoclopramide on March 30.

[Editor's Note:  Full coverage will be in the Feb. 3 issue of Mealey's Emerging Drugs & Devices.  In the meantime, the opinion is available at www.mealeysonline.com or by calling the Customer Support Department at 1-800-833-9844.  Document #28-110203-005Z.  For all of your legal news needs, please visit www.lexisnexis.com/mealeys.]

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