June 11, 2012 Articles

Preemption Cases: 2011's El Nino Flood

By Jim O'Reilly

If the Supreme Court's flow of decisions were measured like weather, 2011 was the El Nino flood of preemption case law affecting products liability. As a three-decade observer of federal preemption case law, I was amazed that the justices devoted so much effort to preempting state tort liability, to a degree unheard of in past decades.

The very pro-preemption decision in Bruesewitz v. Wyeth, 131 S. Ct. 1068 (2011), wears the Scalia style of statutory text assessment and gives vaccines some new immunity from contagions such as civil damage awards. A vaccine will not be vulnerable to design challenges once it has passed the review of the small group of regulators at the Food and Drug Administration (FDA) who evaluate vaccines. This ruling may not bar the cases alleging manufacturing defects (as many ingredients now come from third-world suppliers) or weak warnings or clinical malpractice, but it slams the door on virtually all routine tort suits involving vaccines. The statutory term "unavoidable" was the turning point of the justices' competing opinions. Sadly, funding shortfalls that plague FDA vaccine review are overlooked by the advocates of preemption; the Potemkin Village of regulatory certainty within the small vaccine branch at the FDA can mislead the uninitiated into expecting that the FDA would have perfectly screened each vaccine for defects.

A generic drug maker defeated the drug consumer's claim of label-warnings inadequacy in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011). The plaintiff's bar was disappointed; they had celebrated the landmark decision in Wyeth v. Levine, 555 U.S. 555, 129 S. Ct. 1187 (2009), denying a preemption shield to the more research-intensive drug makers who could add new cautions to drug labels using a special FDA exception. This principle, rolled out in drug-warning cases in lower courts since 2009, gave hope that injured consumers could prevail. But again, the Court majority banned product-defect claims for plaintiffs, here the increasing volume of patients using generic drugs. These copies of the same drugs so recently reviewed in Levine have means of adding warnings, but the Court drew a differentiation favoring the generic makers. Soon after the decision, Public Citizen petitioned the FDA to allow the extra warnings that the defense bar had claimed to be forbidden under current FDA norms.

Preemption of auto safety took a back seat to torts, and the defenders of rear seat belts suffered a near miss in Williamson v. Mazda Motor of America, Inc., 131 S. Ct. 1131 (2011). The Court held that no preemption applied; while a state tort suit "may restrict the manufacturer's choice," that restriction did not rise to the level of a preemptive "obstacle to the accomplishment of the full purposes and objectives" of the statute. That's because National Highway Traffic Safety Administration rulemaking for rear seat belts did not consider the lap/shoulder belt choice to be significant and left it to the carmaker. The Mazda holding, contrasted with the Court's earlier precedent in Geier v. American Honda Motor Co., 529 U.S. 861 (2000), on front-seat air bags, restrains carmakers from a joyful embrace of preemptive design rules in all cases.

Three non-product preemption cases accompanied this trio of liability cases, and aspects of these cases will have some relevance in future consumer tort claims.

Manufacturers who use arbitration clauses to block litigation won big in AT&T Mobility LLC v. Concepcion, 131 S. Ct. 1740 (2011). California's consumer-protective statute constraining a seller's mandatory arbitration demand was preempted, so that a cell phone seller's allegedly "unconscionable" sales methods could not be the subject of class lawsuits.

Arizona state legislative efforts to penalize the hiring of undocumented immigrants were upheld and implied-preemption arguments failed in Chamber of Commerce v. Whiting, 131 S. Ct. 1968 (2011). This will surely be cited in each significant dispute over implied-preemption intent claims. And the force of a comprehensive statute may override common-law tort claims such as nuisance. Analogous statutes displacing the older tort concepts may open some creative arguments, citing to American Electric Power Co., Inc. v. Connecticut, 131 S. Ct. 2527 (2011). The death of this concept of nuisance affects numerous other tort contexts as well.

What's to be done? Plaintiffs' lawyers are vigorously protesting Big Pharma's effort to kill the 2009 Levine no-preemption finding in pending legislation on drug user fees. And overall, analysts for the defense are heartened by the wave of preemption cases that favor business interests, hoping for a 2012 election to augment the five pro-defendant justices on these issues.

Keywords: preemption, Supreme Court, 2011

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