9th Circuit: FDA Regulations Do Not Pre-empt State Failure to Warn Claims

By Adrianne E. Walvoord
Special to the Legal

The 9th U.S. Circuit Court of Appeals issued an opinion yesterday in Gaeta v. Perrigo Pharmaceuticals Company finding that a generic drug manufacturer’s duty to warn under state law was not pre-empted by federal law.

The Gaetas filed suit against Perrigo and several other manufacturers of generic ibuprofen after their son developed liver failure and other serious complications resulting in a liver transplant and extremity amputations, after taking generic ibuprofen for 10 days following a surgical procedure to remove benign moles.  During the procedure, the plaintiffs’ son received an anesthetic known to be hepatotoxic or harmful to the liver.

The plaintiffs alleged defective design, defective marketing, breach of express and implied warranty, negligence and gross negligence, and deceit by concealment. They consistently argued that the manufacturers failed to warn prescribing physicians and consumers of the increased risk of acute liver injury failure when ibuprofen is taken concurrently with other drugs known to be hepatotoxic.

Perrigo moved for summary judgment on pre-emption grounds, arguing that the Gaetas’ state law failure-to-warn claims conflicted with FDA regulations relating to the labeling and marketing of generic drugs.

The district court granted summary judgment, holding that the plaintiffs’ claims were pre-empted because a generic manufacturer could not comply with the heightened state law warning requirements without running afoul of the FDA regulations requiring generic drug labels to conform to the approved labeling for brand name drugs.

After the district court’s decisions in Gaeta, the Supreme Court in Wyeth v. Levine determined that federal regulations did not pre-empt state law claims in name-brand drug cases. The district court denied reconsideration of the Gaetas’ claim despite Levine, and the 9th Circuit accepted the appeal, which was an issue of first impression, to determine “what effect, if any, the Supreme Court’s decision in Levine has on the question whether applicable FDA regulations pre-empt state tort law claims for inadequate labeling against generic -- as opposed to brand name-- manufacturers.”

In reaffirming Levine, the Gaeta court did not give generic drug manufacturers a reprieve from their duty and stated that “drug manufacturers bear primary responsibility for maintaining their labels consistent with safe and effective use of their products.”

There are currently two cases in the Supreme Court involving the question whether federal regulations pre-empt state law failure to warn claims against generic manufacturers.

The 9th Circuit’s sound reasoning in Gaeta provides a good litmus test on a generic manufacturer’s ability and duty to provide warning for its drugs. I believe the Supreme Court will be hard-pressed to find against its decision in Levine; for it to hold otherwise would mean that consumers injured by generic drugs would be left without a remedy while a remedy remained available to those harmed by name-brand drugs. Because estimates show as many as 70 percent of prescriptions are filled with generic drugs, the stakes are high.

Adrianne E. Walvoord is an associate at Anapol Schwartz Weiss Cohan Feldman & Smalley handling pharmaceutical and medical device litigation involving complex medical, scientific, and legal issues.  She practices in federal court, as well Pennsylvania and New Jersey state courts. She also currently represents juveniles affected by the Luzerne County Juvenile Detention Center scandal. Contact her at awalvoord@anapolschwartz.com.

Comments

[clinical negligence claims]

I find your post very interesting. You have depicted very good facts that is very useful. Thanks for sharing.

[My lawyer]

Wow - the law here in England & Wales is complicated but you guys also have the added state level law then the national level. How does anyone ever know where they stand unless a Supreme Court ruling is made ?