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We’re big fans of the preemption defense in prescription drug cases.

It’s the FDA’s job to assess the safety and efficacy of new drugs. The FDA can surely do that job more dispassionately than jurors, who are not scientific experts and who are, by definition, judging the safety of a product, after the fact, in the context of an injured plaintiff seeking damages. Moreover, the FDA has now said repeatedly, in both amicus curiae briefs and the preamble to a new regulation, that the agency imposes the optimal warnings needed on drugs and juries should not second-guess those expert decisions.

What’s the right approach, however, for counsel defending a case in which preemption does not apply (or does apply, but the trial court has not seen the light)? A recent California case provides some guidance.

O’Neill v. Novartis Consumer Health, __ Cal. Rptr. 3d __, 2007 WL 586606 (Cal. App. 2d Dist. Feb. 27, 2007), involved the consolidated trial of two plaintiffs who claimed to have been injured by ingesting over-the-counter cold and cough remedies containing phenylpropanolamine (or “PPA”). Since these were over-the-counter products, the preemption analysis is different than it is for prescription drugs, and the appellate decision doesn’t say whether Novartis raised preemption as a defense.

Both sides introduced a ton of evidence at trial about the FDA’s regulation of PPA. For our purposes, the interesting issue is the jury instructions on that issue. Plaintiffs asked that the jury be instructed:

“FDA standards and regulations are only minimal in nature and do not establish the standard of care for a reasonable manufacturing company under the circumstances of this case. It is not a defense to a claim that a product is defective that the manufacturer built the product in accordance with government standards or specifications.”

Id. at *2. Plaintiffs also sought this instruction:

“Even if a manufacturer of over the counter products literally complies with FDA regulations, it is not immune from liability under the laws of the State of California for injuries caused by its products.”


The trial court refused to give those instructions. On the design defect claim, it instead instructed:

“FDA action or inaction, though not dispositive, may be considered to show whether a product is safe or not safe.”

Id. On the failure to warn claim, the court instructed:

“FDA action or inaction, though not dispositive, may be considered to show whether a risk was known or scientifically knowable. [And going on to say that warnings on over-the-counter drugs may be only minimal in nature.]”

The California appellate court affirmed the trial court’s decisions.

The court reasoned that, even when FDA decisions are not binding (as they would be in the case of preemption), the FDA’s conclusions deserve serious consideration. And the court distinguished cases that reject a “government contractor” defense on the ground that a government entity that is buying a product is acting as the product’s owner, not as a regulatory body charged with ensuring that a product is safe. Id. at *4. In the court’s words:

“While the FDA’s standards and decisions do not immunize a drug manufacturer from liability, they are nevertheless entitled to ‘serious consideration’ on the issue of the safety of PPA at the time of appellant’s injuries.”


This recent decision (and older ones like it) show the way for defending cases in which preemption has not eliminated claims before trial. If claims are preempted, they will not be submitted to the jury. If claims are not preempted, the defendant should present evidence that the FDA carefully regulated the product and the FDA and industry both acted reasonably given the information that was known or reasonably scientifically knowable about the product’s risks and benefits. The defendant should ask the court to instruct the jury that this evidence, even if not binding, deserves serious consideration when deciding whether or not the product is safe.

Winning as a matter of law is better than winning at trial. It’s quicker, cheaper, and poses less risk. But if preemption has not carried the day, defendants should still ask a factfinder to consider the FDA’s role and to credit the manufacturer for complying with the applicable regulatory framework.