Torts - Cases, Principles, and Institutions Fifth Edition, 2016a

Witt & Tani, TCPI 9. Liability without Fault?
new medical [products]” if juries in all 50 States were free to contradict the FDA’s expert
determinations. And the FDA conveys its warnings with one voice, rather than whipsawing the
medical community with 50 (or more) potentially conflicting ones. After today’s ruling, however,
parochialism may prevail.
The problem is well illustrated by the labels borne by “vesicant” drugs, many of which are
used for chemotherapy. As a class, vesicants are much more dangerous than drugs like
Phenergan, but the vast majority of vesicant labels—like Phenergan’s—either allow or do not
disallow IV push. Because vesicant extravasation can have devastating consequences, and
because the potentially lifesaving benefits of these drugs offer hollow solace to the victim of such
a tragedy, a jury’s cost-benefit analysis in a particular case may well differ from the FDA’s. . . .
To be sure, state tort suits can peacefully coexist with the FDA’s labeling regime, and they
have done so for decades. But this case is far from peaceful coexistence. The FDA told Wyeth
that Phenergan’s label renders its use “safe.” But the State of Vermont, through its tort law, said:
“Not so.”
The state-law rule at issue here is squarely pre-empted. Therefore, I would reverse the
judgment of the Supreme Court of Vermont.
Notes
1. Preemption by agencies. In both Geier and Wyeth v. Levine, the view of the agency
charged with implementing the federal statute was the subject of significant focus for the Court—
even if the agency did not ultimately prevail in Wyeth. What should be the significance of such
agency views? One author argues that “the ever-growing role of agencies gives scholars the
coherent analytical framework for the Court’s preemption jurisprudence . . . that they have long
sought.” Catherine M. Sharkey, Inside Agency Preemption, 110 MICH. L. REV. 521 (2012).
Professor Sharkey points to a comment Justice Breyer made from the bench in a preemption case
dealing with an administrative automobile safety regulation:
Justice Stephen Breyer . . . tipped his hand during oral argument [in Williamson v.
Mazda Motor of America, 562 U.S. __, 131 S. Ct. 1131 (2011)], asking rhetorically:
“Who is most likely to know what 40,000 pages of agency record actually mean and
say? People in the agency. And the second most likely is the [Solicitor General’s]
office, because they will have to go tell them. . . . So if the government continuously
says, this is what the agency means and the agency is telling them, yes, this is what
it means, the chances are they will come to a better, correct conclusion than I will
with my law clerks. . . .”
Id. As Professor Sharkey notes, the Court in Levine “looked with particular disdain” on the
agency preemption provision in Levine—far more disdain than Breyer suggested here in his
comments from the bench two years later. Why? Because of, as Professor Sharkey puts it, “the
procedural irregularities that accompanied FDA’s inclusion of its preemptive intent statement in
the preamble to the drug labeling rule.”
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