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.

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