Give Textualism A Try

• Published date: 23 June 2020
• Subject Matter: Litigation, Mediation & Arbitration, Food, Drugs, Healthcare, Life Sciences, Trials & Appeals & Compensation, Food and Drugs Law, Biotechnology & Nanotechnology
• Law Firm: Reed Smith
• Author: Mr James Beck

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 Lohr. See 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)).

First:

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...