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We might not have even read the Supreme Court’s recent – and long and convoluted − agency deference decision, Kisor v. Wilkie, ___ S. Ct. ___, 2019 WL 2605554 (U.S. June 26, 2019), except that it tripped several of our automatic searches by citing both Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), and PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011).  See Kisor, 2019 WL 2605554, at *5 n.2.  Kisor, after all, has nothing to do with prescription medical product liability litigation, it being an appeal from a denial of government benefits.

But Kisor cited Riegel and Mensing as part of a string citation for the proposition, “we have referred to that doctrine as Auer deference, and applied it often.”  Id.  Seeing the Court’s mention of two of our favorite preemption cases as examples of the application of agency deference also brought to mind the fact that the worst decision since the DDL Blog has been in existence − Wyeth v. Levine, 555 U.S. 555 (2009) – was also a prime example of the Court refusing to defer to the FDA’s position.

Because, in these three instances, preemption and agency deference had risen or fallen together, we decided to fight our way through Kisor, all 45 Westlaw headnotes and two concurring opinions of it.

The first thing that’s apparent to even a preemption neophyte is that this phenomenon of preemption and agency deference rising or falling together is not the view of the Court.  Several of the justices who are the most reliable supporters of tort preemption (Alito, Gorsuch, and Kavanaugh) are agency deference skeptics, while all of the justices who usually oppose tort preemption (Ginsburg, Breyer, Kagan, and Sotomayor) are proponents of agency deference.  Chief Justice Roberts likes both agency deference (in this context, anyway) and preemption, whereas Justice Thomas hates the former and is idiosyncratic on the latter.  So we have the liberal-conservative Supreme Court split working at cross purposes.

Indeed, it turns out that the Riegel and Mensing citations were not even in a part of the Kisor opinion that commanded a majority of the Court.  Part II-A did not have the Chief’s joinder.  It’s another example, like the recent Albrecht decision, of the anti-preemption side of the Court discussing preemption.  This section also uses an example of judicial deference to the FDA, but not (as might be expected) in a preemption context:

An FDA regulation gives pharmaceutical companies exclusive rights to drug products if they contain “no active moiety that has been approved by FDA in any other” new drug application.  Has a company created a new “active moiety” by joining a previously approved moiety to lysine through a non-ester covalent bond?

Kisor, 2019 WL 2605554, at *5 (citations omitted).  Primarily, this example is used (and cited elsewhere in the opinion) of an paradigm of the often recondite nature of agency regulation, which is advanced as a basis for having agency deference.  “If you are a judge, you probably have no idea of what the FDA’s rule means, or whether its policy is implicated when a previously approved moiety is connected to lysine through a non-ester covalent bond.”  Id. at *6.

Probably the core of Kisor – and a part that is a majority opinion − is its discussion of the hoops that courts must jump through before they can defer to an agency’s interpretation.  To the extent that preemption turns on agency deference, that’s a significant issue:

  • “[A] court should not afford Auer deference unless the regulation is genuinely ambiguous.”
  • “[B]efore concluding that a rule is genuinely ambiguous, a court must exhaust all the ‘traditional tools’ of construction.”
  • “[T]he agency’s reading must . . . be ‘reasonable.’”
  • “[A] court must make an independent inquiry into whether the character and context of the agency interpretation entitles it to controlling weight.”

Kisor, 2019 WL 2605554, at *8-9 (citations omitted).

One of the “important markers” for when agency deference is appropriate is something we have seen recently in the preemption context:

[T]he regulatory interpretation must be one actually made by the agency.  In other words, it must be the agency’s “authoritative” or “official position,” rather than any more ad hoc statement not reflecting the agency’s views. . . .  [T]he requirement of “authoritative” action must recognize a reality of bureaucratic life:  Not everything the agency does comes from, or is even in the name of, the Secretary. . . .  But there are limits.  The interpretation must at the least emanate from those actors, using those vehicles, understood to make authoritative policy in the relevant context.

Kisor, 2019 WL 2605554, at *9 (citations omitted).

Recall the “force of law” discussion in Albrecht only a couple months ago:

[T]he only agency actions that can determine the answer to the pre-emption question, of course, are agency actions taken pursuant to the FDA’s congressionally delegated authority. . . .  Federal law permits the FDA to communicate its disapproval of a warning by means of notice-and-comment rulemaking setting forth labeling standards, by formally rejecting a warning label that would have been adequate under state law, or with other agency action carrying the force of law.  The question of disapproval “method” is not now before us . . . [but] whatever the means the FDA uses to exercise its authority, those means must lie within the scope of the authority Congress has lawfully delegated.

Albrecht, 139 S. Ct. at 1679 (citations omitted).

Reading these two analyses together, it seems like a variety of lesser FDA actions are now of questionable relevance.  Various FDA enforcement letters and all forms 483 are simply the view of one FDA official, and as we’ve pointed out, need not even be reviewed by an FDA legal officer before being issued.  They are owed no judicial deference, and thus have no basis being used in any preemption discussion – particularly as a basis for purported “parallel claims.”  The same would seem to be true of FDA guidance and “draft” guidance documents – unless an authoritative FDA decision with force of law happens to incorporate one.  That sometimes happens with final approval letters.

On the other hand, Citizen’s Petitions are a different animal.  Pursuant to 21 C.F.R. §10.30(e), such petitions must be decided by the “Commissioner.”  Actions on such petitions are considered “agency action” and published in the Federal Register.  Id. §§10.30(e)(2)(i), (e)(4).  They produce a formal “record.”  Id. § 10.30(i).  To the extent that both preemption and judicial deference depend on something being “authoritative” “official,” or “carrying force of law,” FDA responses to Citizen’s Petitions would seem to qualify.

Another interesting discussion is found in footnote 6 (also part of the Kisor majority opinion), concerning agency briefs.  The “general rule . . . is not to give deference to agency interpretations advanced for the first time in legal briefs.”  Kisor, 2019 WL 2605554, at *10 n.6.  But amicus curiae briefs are different.  Since an agency appearing as amicus is “not a party to the litigation . . . there [is] simply no reason to suspect that the interpretation [does] not reflect the agency’s fair and considered judgment.”  Id. (citations and quotation marks omitted).  This aspect of Kisor is significant because the FDA is often asked to provide views on preemption as an amicus.

Given the focus in Albrecht on “force of law” as a prerequisite to preemption, the discussion in Kisor (this part not an opinion of the Court) on “interpretive” agency rules is significant:

[T]he section allows agencies to issue “interpret[ive]” rules without notice and comment.  A key feature of those rules is that (unlike legislative rules) they are not supposed to have the force and effect of law. . . .  Instead, interpretive rules are meant only to advise the public of how the agency understands, and is likely to apply, its binding statutes and legislative rules. . . .  [I]nterpretive rules, even when given Auer deference, do not have the force of law.

Kisor, 2019 WL 2605554, at *12 (citations and quotation marks omitted).  We’re not administrative lawyers, so we don’t know the extent to which the FDA issues non-notice-and-comment rules, but to the extent the FDA does, Albrecht’s force-of-law discussion calls their preemptive effect into question.

Finally, the opinion of the court part of Kisor concludes with a paean to stare decisis, pointing out that the Court has employed deference to administrative agencies “dozens” of times, and other courts have “thousands” of times.  Id. at *13.  As mentioned at the outset, those instances include Riegel and Mensing.  We find this somewhat ironic, as four of the five justices joining in this part of the opinion, have refused – so far, at least − to accord Mensing the dignity of stare decisis.  Since “deference decisions are balls tossed into Congress’s court,” id. at *14, then perhaps the deference that the Court in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), gave to the FDA’s questionable interpretation (but through notice and comment rulemaking) of 21 U.S.C. §360k(a), should be reconsidered – given that Congress has since responded with the Safe Medical Devices Act that, as we discussed here, applies the same safety and effectiveness standards to both PMA and 510(k) devices.  We note, however, that as Chief Justice Roberts’ short concurrence points out (2019 WL 2605554, at *15), deference to agency statutory interpretations is governed by Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984), and is not something that Kisor “touch[es] upon.”