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.
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.
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
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.
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."
failed to present clear evidence that the [Food and Drug Administration] would
have rejected the specific hepatotoxicity warnings proposed by the Gaetas," the
panel reversed summary judgment and remanded the case.
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.]
- Document #28-110203-005Z
For more information, call
editor Tom Moylan at 215-988-7739, or e-mail him at firstname.lastname@example.org.