Saturday, January 8, 2011

Vaccines and Drugs: A Brave New Tort World

Torts & Compensation Section Chair Cathy Sharkey (NYU) introduced the panel by noting its diversity.  In addition to academics, the panel included a policy expert and a practicing lawyer.  The papers from the panel will be published in an upcoming volume of the Indiana Health Law Review

Robert Rabin (Stanford) began the presentations by providing an outline of the vaccine no-fault program at issue in the upcoming Bruesewitz case.  The program was enacted in 1986 and became effective in 1988 at the behest of manufacturers concerned with high damages awards.  The goal was to ensure the continued availability of vaccinations while providing compensation for those adversely affected.  The program is an adversarial process that does not eliminate recourse to the tort system.  Pursuant to the program, those who believe they have been injured by a vaccination need not establish fault, only causation.  A vaccine court was established to resolve causation issues by specialists with knowledge of vaccines.  Damages are capped, and punies are not available.  The claimant has the option to accept the award or reject it and sue in tort.

James Copland (Manhattan Institute/Point of Law) began by noting the issue in Bruesewitz was whether design defects in vaccines are preempted.  Copland stated he would focus on policy arguments and not address statutory construction.  Copland listed several goals of the tort system as deterrence, compensation, and equity (he exemplified this as redistribution, not necessarily an individual justice perspective).  On the deterrence issue, the question is whether the FDA sufficiently deters or whether the tort system should provide additional deterrence.  Copland distinguished type 1 errors (a vaccine or drug being released and causing unknown side effects and injuring someone) and type 2 errors (being overly conservative and not releasing a drug on time, depriving someone of the beneficial effects).  He opined that type 2 errors are more common than type 1 errors, citing an empirical study he co-authored on the issue.  Copland argues the FDA probably overdeters rather than underdeters, and he supports a compensation scheme to handle the compensatory aspects of vaccine injuries. 

Mary Davis (Kentucky), who described herself as the "lone tort wolf" on the panel, began by outlining the doctrine of preemption.  She described the series of preemption cases since 1992 as the courts seeking clarity.  Based on the Supremacy Clause, the touchstone of preemption is Congressional intent to override state tort claims.  Preemption has both an express and an implied version.  Davis noted the Court has tried to avoid nuances in its rulings, and there is a presumption against preemption.  She read language from a recent preemption opinion to the effect that the text of the preemption clause, if susceptible of more than one meaning, will be construed narrowly.  She then turned to Bruesewitz itself, stating the clause to be interpreted was unusual.  She argued that the injury was not "unavoidable," because the manufacturer exercised discretion in creating the vaccine at issue.  She concluded by stating of the FDA process that science aims at certainty, but it is difficult if not impossible to attain.  Tort can function as a safety valve in those instances science fails.

Mal Wheeler (Wheeler Trigg O'Donnell), who has argued many significant preemption cases, sought to bring a "real world" perspective to the panel.  In describing the progress of several of his major cases, he emphasized the role of fortuity in the unfolding of litigation, arguing that the certainty of preemption was preferable.  He also challenged the notion that Wyeth altered the law of preemption, stating the case used language that had been used before. 

In closing comments, Rabin stated that he did not believe tort suits would undermine the no-fault vaccination scheme, noting the difference between causation and design defect issues.  Copland predicted "an enormous uptick" of plaintiff activity if vaccination design defect suits are not preempted.  Davis lauded the vaccine program as a good example of interplay between administrative and tort approaches to injury; she emphasized the information-forcing role of discovery in tort.  Wheeler concluded by noting that there was no empirical evidence that a U.S.-style tort system was necessary.  He argued that the FDA needs more resources.

At the end of the panel's comments, Sharkey presented the Prosser Award to Judge Guido Calabresi, who was unable to attend due to a family wedding in Italy.  Sharkey read a letter from Judge Calabresi, in which he expressed his delight at being honored.  Mike Rustad rotated into the position of Chair of the Section.

--CJR

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