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Since we were involved in the Medtronic Infuse wars, we’ve been quite aware of Justice Gorsuch’s textualist views towards statutes since he wrote Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015).  In Caplinger he got a close look at the damage the Supreme Court had done to the plain meaning of the Medical Device Amendments’ preemption clause, 21 U.S.C. §360k(a) in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).  Suffice it to say that he didn’t like it one bit, but because he was then a mere member of the Tenth Circuit, he had to attempt to apply it.  We’ve been through all the details twice, first in our February, 2017 post on then-nominee Gorsuch’s views on preemption, and again in our “Lohr Has Two Shadows” post the following October.  We’ll just jump right to the conclusion that then-Judge Gorsuch reached in Caplinger:  he couldn’t “help but wonder if perhaps some of those rules [in Lohr] warrant revisiting and reconciliation.”  Caplinger, 784 F.3d at 1340.

Then, in the interim, the Supreme Court abolished the “presumption against preemption” in express preemption cases, upon which the Lohr majority so strongly relied.  See Puerto Rico v. Franklin California Tax-Free Trust, 136 S. Ct. 1938, 1946 (2016).

Gorsuch the textualist has shown forth bright and clear recently – in an opinion that, oddly, was joined by all the quondam defenders of Lohr in preemption cases.  In determining that “sex,” as used in Title VII of the 1964 Civil Rights Act meant exactly what it said, we had a heaping helping of the textualist principles that we hope the Supreme Court will apply whenever it finally takes another look at LohrSee Bostock v. Clayton County, Georgia, ___ S. Ct. ___, 2020 WL 3146686 (U.S. June 15, 2020).  If readers want the scoop on the substantive impact of Bostock, here’s a good link.  Our interest, as drug/device defense lawyers, is in what the Court had to say about the proper way to interpret statutes (such as §360k(a)).


When the express terms of a statute give us one answer and extratextual considerations suggest another, it’s no contest.  Only the written word is the law, and all persons are entitled to its benefit.

Bostock, 2020 WL 3146686, at *3.  Second:

You can call the statute’s but-for causation test what you will − expansive, legalistic, the dissents even dismiss it as wooden or literal.  But it is the law.

Id. at *11.  Third:

Nor is there any such thing as a “canon of donut holes,” in which Congress’s failure to speak directly to a specific case that falls within a more general statutory rule creates a tacit exception.  Instead, when Congress chooses not to include any exceptions to a broad rule, courts apply the broad rule.

Id. at *11.  Fourth:

This Court has explained many times over many years that, when the meaning of the statute’s terms is plain, our job is at an end.  The people are entitled to rely on the law as written, without fearing that courts might disregard its plain terms based on some extratextual consideration.

Id. at *14 (citations omitted).  Fifth:

[T]that a statute has been applied in situations not expressly anticipated by Congress’ does not demonstrate ambiguity; instead, it simply demonstrates [the] breadth of a legislative command. . . .  [U]nexpected applications of broad language reflect only Congress’s presumed point [to] produce general coverage − not to leave room for courts to recognize ad hoc exceptions.

Id. (citations and quotation marks omitted).  Sixth:

Ours is a society of written laws. Judges are not free to overlook plain statutory commands on the strength of nothing more than suppositions about intentions or guesswork about expectations.

Id. at *18

The preemptive language of §360k(a) is about as broad in the prescription medical product liability litigation context as “sex” is in the context of Title VII.

[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement − (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

Or, as then-judge Gorsuch put it in Caplinger, “Given this expansive language one might be forgiven for thinking all private state law tort suits are foreclosed.”  784 F.3d at 1337.  Thus, we look forward to the Court taking a Bostock/Caplinger textualist approach to §360k(a) the nest time it encounters medical device preemption.

And the same goes for “snap removals” – another instance where plaintiffs (less successfully than in Lohr) have sought to induce courts to ignore the plain language of a federal statute.

Oh, and one last thing.  Here’s a Bostock quote for Wyeth v. Levine, 555 U.S. 555 (2009), and that Court’s result-oriented analysis of implied preemption and the history of the FDCA:

All we can know for certain is that speculation about why a later Congress declined to adopt new legislation offers a “particularly dangerous” basis on which to rest an interpretation of an existing law a different and earlier Congress did adopt.

Bostock, 2020 WL 3146686, at *12 (citations omitted).