A Call for Continued State Law Tort Reform

The recent federal trial court decision in Dusek v. Pfizer Inc., Civil Action No. H-02-3559 (S.D. Tex. 2/20/04) dismissing plaintiffs' products liability claims against Pfizer in connection with the prescription drug Zoloft' on the ground of conflict preemption has given the pharmaceutical industry some hope that compliance with Food and Drug Administration (FDA) regulations will afford protection from common law failure-to-warn claims. The court granted summary judgment on the ground that a cause of action based on the plaintiff's proposed additional warning to the product label that Zoloft can cause suicidal ideation would conflict with the FDA's decision not to add such a warning because no causal link had in fact been established and it would in effect be false and misleading in violation of federal law. This should not deter continued efforts to obtain tort reform at the state level, however, where the continued influx of pharmaceutical product liability claims continues to burden courts and the pharmaceutical industry. With the exception of Michigan, no other jurisdiction has codified compliance with FDA regulations as a bar to common law failure-to-warn claims. Instead, a handful of states have adopted modified versions of the defense, which, for example, bar punitive damages for drugs approved by the FDA (or for other products that otherwise meet government standards) or create a rebuttable presumption of non-liability in light of FDA approval. Although these statutes are helpful, they lack the force that a true “FDA compliance” defense offers and have failed to stem the tide of state court product liability filings against the pharmaceutical industry.