Wyeth, balancing and the common law

Federal preemption in the product liability field is a very hot issue in the law today.  The principles being reviewed by the courts in this area would cross over to eliminate other common law claims like nuisance.  But more broadly, the reasoning applied in these preemption cases also provides insights useful for state courts in determining whether to expand their common law when their legislatures have spoken in that subject area. 

Last term, the U.S. Supreme Court found federal preemption in the medical device field in Riegel v. Medtronics, Inc., 128 S.Ct. 999 (2008).  This term, the Court granted certiorari in drug labeling case making a similar preemption argument.  Wyeth v. Levine, Docket No. 06-1249.  The New York Times had an article on the upcoming Wyeth case yesterday, citing a professor for the proposition that federal preemption is the fiercest battle in the product liability field today, and The Wall Street Journal calls the case the "Mother of all preemption cases." 

Wyeth involves a Vermont failure-to-warn claim (with a $7.4 million jury verdict).  While the defendant used the FDA-approved language, the jury found the defendant should have said something more.  One point the petitioner's brief on merits (Seth Waxman, counsel of record) notes is the different perspective of an individual jury and an entity that must balance competing interests:  to allow an individual jury to override the FDA's language would "substitute the ex post judgment of lay jurors whose members consider injury through the lens of a single patient's injury, rather from the perspective of overall public health, with the countervailing benefits of the drug to the entire potential patient population in mind."  (p. 4)

A similar point was made by the Court in Reigel, when it noted that a "jury sees only the cost of a more dangerous design, and is in not concerned with its benefits..."  128 S.Ct. at 1008.   The Chief Justice in Vermont, dissenting from the decision upholding the verdict similarly noted that a jury's consideration of drug safety "through the lens of a single patient who has already been catastrophically injured" "is virtually guaranteed to provide different conclusions in different courts about what is ‘reasonably safe' than the balancing approach" taken by the FDA.

As the petitioner in Wyeth elaborates upon in its brief, a jury-by-jury approach inherently produces risk-adverse determinations.  (p. 28.)  The Wyeth brief goes on to note that agency balancing among competing objectives (p. 47) causes the clash between the case-by-case risk adverse, individual jury approach. 

Reigel and Wyeth discuss these principles in the context of comparing a federal statutory and regulatory framework against individual common law claims.  The same reasoning, however, seems applicable when a state supreme court is deciding whether to expand the common law, if the state legislature has addressed the topic in a way that involved balancing of competing interests.

When a legislature articulates the scope of a duty, it is implicitly, and sometimes very explicitly (in findings of fact, preambles and the like), setting a balance between competing interests, examined from a general public interest perspective.  While setting a duty at X point might reduce injuries for example, competing cost interests, with concomitant impacts on the economy, come into play.  When a legislature has engaged in balancing from the broader perspective of the public's general interest and embodied that balance in a statutory or regulatory framework, then an expansion of the common law could upset that balance, just as much as an individual jury verdict can clash with a regulatory labeling approval.  A clash with an individual jury verdict can arise when either a legislature or the delegated executive branch has spoken in a way reflecting a balancing of public policy considerations.  Consideration whether the common law should allow an individual jury decision to upset a general legislative balance involves the same type of analysis as these direct preemption cases.