The defendants won – the Court found the claims preempted – by 6-3, so that’s good. But the result was in large part driven by the plaintiffs’ tactical choice (in retrospect unfortunate for them, although maybe the issue was waived below) not to challenge the validity of Napier v. Atlantic Coast Line Railroad Co., 272 U.S. 605 (1926) . Napier had held that the Locomotive Inspection Act (the relevant statute) imposed field preemption, wiping out all state authority, including tort claims, over, among other things, locomotive parts. That’s because Congress provided that the statute applied to “the entire locomotive and tender and all parts and appurtenances thereof.” Kurns, 2012 WL 631857, at *4.
T’ain’t no field preemption in prescription medical product liability litigation. That more than anything else is why we didn’t blog about Kurns before now. So is there anything there we can use?
First, even though the supposed presumption against preemption first got its start in field preemption cases (see our post here, citing Rice v. Santa Fe Elevator Corp., 331 U.S. 230 (1947), Jones v. Rath Packing Co., 430 U.S. 519, 525 (1977), and Hillsborough County v. Automated Medical Laboratories, Inc., 471 U.S. 707, 715-18 (1985)), there’s not a peep about the elusive presumption in Kurns. That’s not really surprising, since Justice Thomas, who eviscerated the presumption against preemption in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), is also the author of Kurns. So we can say, “one more nail in the coffin….”
Another thing we like about Kurns is that it describes preemption in the absence of a statutory preemption clause as “occur[ing] through the direct operation of the Supremacy Clause.” Id. at *4 (citation and quotation marks omitted). That’s another beef we have with the presumption against preemption – there’s no principled basis for interpreting the constitution itself as narrowly as flaky decisions like Wyeth v. Levine, 555 U.S. 555 (2009), have done. Can you imagine a similar presumption against application of the Due Process clause? The Equal Protection clause? The First Amendment? We can’t either.
We also enjoyed the Court’s rare venture into substantive tort law. Kurns arose in Pennsylvania. 2012 WL 631857, at *3. That the Court chose (2012 WL 631857, at *7) to discuss Pennsylvania tort principles in terms of the Restatement (Third) of Torts Products Liability §2 (1997) resonates with us because whether Pennsylvania law follows the Second (§402A) or Third Restatement in product liability actions is a matter of considerable dispute – as we discussed in our post, here. Like the Third Circuit before it, the United States Supreme Court has come down on the side of the newer (and in most, but not all, situations better for defendants) Third Restatement.
The Court’s actual discussion of product liability law was rather arcane – are “warning defects” fundamentally different than “design defects”? Since a “warning” claim necessarily warns about risks arising from a product’s design, the Court held that the “gravamen” of the warning claim was the design of a locomotive part, which fit within Napier field preemption:
A failure-to-warn claim alleges that the product itself is unlawfully dangerous unless accompanied by sufficient warnings or instructions. Thus, the “gravamen” of petitioners’ failure-to-warn claims is still that [plaintiff] suffered harmful consequences as a result of his exposure to asbestos contained in locomotive parts and appurtenances. Because [plaintiffs’] failure-to-warn claims are therefore directed at the equipment of locomotives, they fall within the pre-empted field defined by Napier.
Kurns, 2012 WL 631857, at *7 (various quotations, including to the Third Restatement, omitted). Although the Court doesn’t phrase it as such, this is a reiteration of the fundamental principle underlying Restatement §402A, comment k – where a product has inherent risks (as do both asbestos and prescription medical products) warnings are necessary to make an unavoidably unsafe design “reasonable.”
Kurns also included a warning-specific variant of the propositions that tort claims regulate conduct and are therefore properly subject to preemption as state-law “requirements.” The Court stated:
This duty to warn and the accompanying threat of liability will inevitably influence a manufacturer’s choice whether to use that particular design. By influencing design decisions in that manner, failure-to-warn liability has a direct and substantial effect on the physical elements of a [product].
2012 WL 631857, at *7 n.4 (citation and quotation marks omitted). This proposition isn’t in serious dispute anymore, see id. at *8 (rejecting for the umpteenth time an argument that the common law is diffferent) – unlike when we were starting out – but it’s nevertheless useful to have another Supreme Court case to cite, if needed.
Finally, the discussion, id. at *8, of a railroad’s right to buy (under Napier) federally compliant products being “meaningless” if the state could prevent defendants from selling them also tends to refute plaintiffs’ assertions of liability for “wrongfully marketing” FDA-approved drugs and devices. Take the Court’s statement in Kurns, “a railroad’s ability to equip its fleet of locomotives in compliance with federal standards is meaningless if manufacturers are not allowed to produce locomotives and locomotive parts that meet those standards,” and substitute drug/device facts. Then, one has:
[A] [hospital’s] ability to equip its[self with prescription medical products] in compliance with [FDA] standards is meaningless if manufacturers are not allowed to produce [drugs and medical devices] that meet those standards.
Id. at *8. So Kurns is another arrow in our quiver, there, as well.
Not terribly great, but definitely better than nothing.