State Tort Claims Not Preempted for Failure to Warn Regarding Generic Drug

Torts—Federal Preemption Not Applicable to Failure to Warn Generic Drugs

Kellogg v. Wyeth, __ F. Supp. 2d __, 2008 WL 5272715 (D. Vt., December 17, 2008)

FEDERAL LAW DOES NOT PREEMPT STATE LAW FAILURE TO WARN CLAIMS AGAINST GENERIC DRUG MANUFACTURER

A precursor to the United States Supreme Court's landmark denial of preemption in Wyeth v. Levine, 555 U.S.__(March 4, 2009), the Vermont District Court found no federal preemption to state tort claims that the manufacturer of metoclopramide (generic equivalent of gastric reflux drug Reglan) failed to properly warn consumers of the drug's potential side effects. In so ruling the court was prescience of the Supreme Court's ruling and properly rejected the reasoning of the Kentucky District Court who on essentially the same facts and arguments found the state tort claims to be preempted. Morris v. Wyeth, __F. Supp. 2d__, 2008 WL 4696924 (W.D. Ky., October 24, 2008).

The defense arguments in all three cases were the same. The defense claimed it was impossible to comply with the federal requirements and then the individual, jury-made, case by case requirements in 50 different states at the same time. The defense claimed the agency had expressed an intent to preempt in its preamble and that this was an area where the FDA was better suited to regulate at a predictable and practical national level the industry and consumer safety. In fact, the defense argued, without preemption a manufacturer could be forced to “misbrand” its drug in order to comply with state law where a particular state might require a warning in conflict, perhaps even disapproved by the FDA.

The Vermont District court first reaffirmed that there is a strong presumption against preemption especially in areas such as health and safety and welfare which are so typically the purview of the states. There must be a clear congressional intent to create preemption.

The court rejected the “misbranding” argument stating a tort judgment does not compel a manufacturer to do anything with its label and there is no evidence the agency has ever pursued a “misbranding” claim against a manufacturer who improved its warning in response to a state tort law suit.

The court observed that the FDA labeling regulations are minimal standards and complimentary not exclusive to state tort law claims. Finally, there was no evidence that this case would have required the manufacturer to publish a warning that had in fact already been scrutinized and rejected by the FDA which was the limited circumstance addressed in the FDA's statement in the preamble of the act on the subject of preemption.