In Defective Drug Design Lawsuit, Justice Scalia Defies The Tort Reformers

Big news in yesterday’s Bruesewitz v. Wyeth Supreme Court decision. In short, the Court was asked:

Whether Section 22(b)(1) of the National Childhood Vaccine Injury Act of 1986 ["NCVIA"]— which expressly preempts certain design defect claims against vaccine manufacturers “if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warning” — preempts all vaccine design defect claims, regardless whether the vaccine’s side effects were unavoidable.

The Court answered yes, after reviewing this language of the NCVIA:

No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.

Briefly summarized, the Act precludes all lawsuits for vaccine-related injuries except for those claiming the vaccine was not “properly prepared and was accompanied by proper directions and warnings.” The Act appears to presume that all vaccines are appropriately designed, and so concerns itself only with improper preparation or warnings.

I’ll leave the deeper commentary to others; the case is largely self-explanatory. More interesting to me is a particular section of the opinion. Justice Scalia, who authored the opinion, is generally not considered to be the friend of injured patients, but here he is, writing on behalf of six Justices, about pharmaceutical design defects:

Drug manufacturers often could trade a little less efficacy for a little more safety, but the safest design is not always the best one. Striking the right balance between safety and efficacy is especially difficult with respect to  vaccines, which affect public as well as individual health. Yet the Act, which in every other respect micromanages manufacturers, is silent on how to evaluate competing designs. Are manufacturers liable only for failing to employ an alternative design that the FDA has approved for distribution (an approval it takes years to obtain)? Or does it suffice that a vaccine design has been approved in other countries? Or could there be liability for failure to use a design that exists only in a lab? Neither the Act nor the FDA regulations provide an answer, leaving the universe of alternative designs to be limited only by an expert’s imagination.

Jurors, of course, often decide similar questions with little guidance, and we do not suggest that the absence of guidance alone suggests preemption. But the lack of guidance for design defects combined with the extensive guidance for the two grounds of liability specifically mentioned in the Act strongly suggests that design defects  were not mentioned because they are not a basis for  liability.

The mandates contained in the Act lead to the same conclusion. Design-defect torts, broadly speaking, have two beneficial effects: (1) prompting the development of improved designs, and (2) providing compensation for inflicted injuries. 

Hallelujah! Trial lawyers like me, and particularly the subset of trial lawyers who specialize in defectively designed drug cases, have been arguing for years that these sorts of mass tort cases are good for society because they ensure adequate compensation for people injured through no fault of their own and because these mass torts cases create legal, economic, and moral incentives for companies to improve the design of their products, including pharmaceutical products, to ensure they are as safe as possible.

But, despite all of the social good we do (as Justice Scalia confirmed), we’re continually under attack. Two examples from this week.

Via Russell Jackson, Lester Brickman has a new book out arguing that only the wealthy should be allowed access to civil justice. He doesn’t phrase it that way, of course, but instead argues that the contingency fee – the only way that the vast majority of Americans, particularly those who are disabled by their injuries and so cannot work – should be eliminated and replaced by, well, nothing. If you’re injured, but not rich enough to pay six figures or more in attorneys’ fees and case expenses, then too bad for you. Great idea, professor.

Via The Volokh Conspiracy, Todd Zywicki and Jeremy Kidd have a new book out (summarized in this draft article) arguing that the very sort of product liability that Justice Scalia appraised should be completely eliminated because, well, I don’t know: I can’t make heads or tails of their argument. They simply presume every case is frivolous, as if big corporations like drug companies never actually did things like secretly experimenting on children. It took two professors to come up with that one.

At least Brickman, Zywicki and Kidd are confined to the walls of academia, while injured patients gain new allies in the least expected areas. 

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