Tuesday, November 07, 2006

FDA Pharma Preemption: Recent Court Opinions

The news comes from both sides of the USA when it comes to the FDA Preamble as to preemption and its applicability in drug litigation. One supporter of the FDA's position says, "The FDA's bottom-line concern is that 'state-law attempts to impose additional warnings can lead to labeling that does not accurately portray a product's risks, thereby potentially discouraging safe and effective use of approved drugs." Source here.

First, the cases rejecting preemption - McNellis v. Pfizer Inc., 2006 WL 2819041 (D.N.J. Sept. 29, 2006), and others:

In McNellis the Court did not allow the preemption defense. The Court held that the regulations do not conflict with New Jersey's failure-to-warn laws. Recognizing the preamble as "an official agency statement" that favors pre-emption of conflicting state law claims, the court gave no deference to the FDA's interpretation because the agency's position has not been consistent over time, the regulations allow increased warnings when new risks emerge, and the relevant Act does not contain an express preemption clause.

You can find McNellis here: here (PDF Alert). You can find the Perry brief that was submitted on behalf of the Plaintiff by going here. (PDF)

After McNellis, Perry v. Novartis Pharma. Corp., No. 05-5350 (E.D. Pa. Oct. 16, 2006) was rendered and it also rejected the FDA's argument. The Perry Court found that a state law requirement to provide an additional warning would not create a conflict or make it impossible to comply with state and federal law.

A 2nd Circuit case, Desiano v. Warner-Lambert (2d Cir. Oct. 5, 2006) also did not agree with the FDA's position.

Court Opinion siding with the FDA Preemption argument:

In re Bextra and Celebrex Marketing Sales Practices and Product Liability Litigation, 2006 WL 2374742 (N.D. Cal. Aug. 16, 2006),

In Bextra and Celebrex, the U.S. District Court for the Northern District of California dismissed state law failure-to-warn claims involving a prescription drug because they conflict with the FDA's determination of the proper warning and pose an obstacle to the full accomplishment of the objectives of the Food, Drug and Cosmetic Act. The original label for the drug was approved in 1998, was revised in 1999 to add cardiovascular risks, and was later revised in 2005.

In dismissing claims that cardiovascular warnings were not adequate, the Court gave deference to the FDA's interpretation of the reach of the agency's labeling regulations. Note that the Court rules that consumer fraud claims were not deemd preempted.

The Court relied on the Geier decision.