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Focus on facts to defeat preemption: while preemption is primarily a question of law, factual evidence about a federal agency's action or inaction can help plaintiffs defeat a motion to dismiss.

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Until recently, a motion to dismiss on federal preemption grounds was rare. But efforts by the Bush administration to push preemption as a way of accomplishing its stated goal of tort "reform" have changed the legal landscape. (1) Increasingly, plaintiff lawyers are finding they must master arguments against preemption to prevail in their clients' cases.

In one of the administration's bolder moves, the FDA last year inserted language in the preamble of a new prescription drug labeling rule saying that any state tort law concerning prescription drug labeling was preempted by the rule. (2) Most recently, however, in a letter brief to a Pennsylvania district court that was hearing a challenge to the preemption claim, the FDA conceded that not all failure-to-warn cases are preempted. It argued instead that "a court must ask whether the warning sought by the plaintiff would have rendered the drug misbranded in the agency's judgment at the relevant time, or if any newwarnings proposed to be added to the warning label would have been rejected by the agency as unsubstantiated." (3)

The administration is targeting more than one area of state tort law. It is using regulatory agencies to establish the federal preemption defense across the board. For example,

Over the past few years, the Office of the Comptroller of the Currency has issued a variety of rules that purport to preempt state consumer protection laws with respect to banking. Over the past several months, the National Highway Traffic Safety Administration [NHTSA], in conjunction with two notices concerning proposed safety standards for cars, has stated that the new standards would preempt state product liability law. And in February [2006], the Consumer Product Safety Commission [CPSC] issued a mattress flammability standard that purports to preempt state tort law. (4)

The preemption attack typically comes in the form of a motion to dismiss or for summary judgment. It is a win-win proposition for the defendant. If the attack fails, the defendant has lost nothing--it is simply in the same position it was before filing the motion. And if the attack succeeds, the defendant avoids having to submit to potentially damaging discovery or, more significant, any rulings on the merits of the plaintiff's claims.

This defense tactic has the added benefit of possibly obtaining a ruling in which the court transfers responsibility to adjudicate state law claims to the federal agency. For example, recently Judge Charles Breyer of the Northern District of California, accepting the FDA's statement that its approval of prescription drug labels preempts state failure-to-warn claims, stated: "The FDA is in a better position than the court to determine whether state laws that encourage manufacturers to propose defensive labels upset the FDA's careful balance of statutory objectives." (5)

Plaintiffs should still argue that federal law does not preempt their state law claims as a matter of law, but now the argument may need to be strengthened by factual evidence--of what a federal agency did or failed to do--gleaned through discovery to help plaintiffs defeat preemption claims. For example, it is appropriate to argue that a preemption motion raises factual questions on which discovery is necessary when a defendant is seeking dismissal based on "conflict preemption"--that a federal agency has allegedly considered and rejected the specific claim the plaintiff is making.

The U.S. Supreme Court, in rejecting a conflict preemption defense, held that a federal agency's consideration and rejection of a safety standard is not the same as the agency mandating a specific safety standard. (6) Accordingly, through discovery, you can obtain the evidence necessary to establish that the federal agency did not mandate a specific safety standard, and thus conflict preemption does not apply.

Defendant manufacturers usually recite factual information to convince the court that a federal agency has already fully considered the plaintiff's alleged safety risk (and not required a stronger warning or a product recall) or the plaintiff's claim of false or...

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