If you happen to work on this enterprise lengthy sufficient, you’ll run into some attorneys who test all of the containers: good, persuasive, humorous, and sartorially splendid.  One of the vital gifted attorneys we ever had the pleasure to work with was Peter Grossi.  He checked all of the containers, after which some.  When Peter was at Arnold & Porter, we co-tried a weight loss program drug case with him.  It was an exquisite alternative to look at a grasp on the job.  We by no means noticed anybody higher at maintaining out the unhealthy stuff and highlighting the great.  Peter retired from A&P a few years in the past, and is now a Lecturer at Harvard, Penn, and UVA Legislation Faculties.   He’s nonetheless good, persuasive, and humorous.  (We can not touch upon his post-retirement wardrobe.)  His most up-to-date regulation overview article — Grossi, “The Conservative Court docket on the Unacceptable Perils in Second-Guessing FDA Security Selections and Its Coming Overview of Alliance for Hippocratic Medication v. FDA (The “Abortion Tablet Case”),” 31 Virginia J. of Social Coverage and Legislation (Forthcoming 2024) – is actually good and persuasive.  And you’ll not should squint an excessive amount of between the strains to detect a eager wit.  Here’s a hyperlink to the article.  https://ssrn.com/summary=4560486 

The article examines the choice in Alliance for Hippocratic Medication v. FDA, 78 F.4^th 210 (5^th Cir. 2023) (hereinafter, “AHM”), which nullified the modifications the Meals and Drug Administration (FDA) made in 2016 and 2021 to its Danger Analysis and Mitigation Technique (REMS) governing the usage of mifepristone (the abortion treatment utilized by lots of of 1000’s of American ladies annually).  That opinion poked at a political hornet’s nest.  The Fifth Circuit’s ruling would successfully restrict entry to mifepristone, not just for ladies dwelling within the 17 states that successfully ban abortion inside their borders, but additionally within the 30 or so others that need their residents to have the choice of medicated abortion. However that’s not why we discover the AHM case and Grossi’s article so fascinating.  The AHM opinion additionally appears to solidify the Fifth Circuit’s standing because the outlier courtroom most definitely to face a SCOTUS beatdown.  (Within the 35+ years since we clerked on the Ninth Circuit, we’ve grown a wee bit uninterested in listening to how the Ninth Circuit continuously serves up reversal bait. The Fifth Circuit’s latest monitor file ought to pour chilly water on that canard.) However, once more, that’s not why we advocate the article to you. 

The AHM case is now headed for SCOTUS overview subsequent yr.  The timing of this submit couldn’t be higher, inasmuch as SCOTUS as we speak granted cert. Will probably be fascinating to see whether or not SCOTUS will observe a sequence of selections wherein SCOTUS — and particularly its extra conservative members (Justices Roberts, Alito, Kavanaugh and Thomas) — forcefully warned that no choose or Justice ought to “second-guess” scientific judgments that FDA consultants make on daily basis with respect to each drug the FDA regulates. And it’s the difficulty of deference to FDA choice making, pricey Reader, that makes us linger over the AHM choice and Grossi’s article.  That deference is the lynchpin for our favourite drug and gadget regulation protection, preemption, in addition to different authorized theories (e.g., main jurisdiction) that ought to stop loopy, inconsistent, runaway jury verdicts from wreaking havoc on the design and supply of life-saving medicine and medical units. 

Because the article factors out, most SCOTUS prognosticators discuss AHM when it comes to SCOTUS precedents on abortion, such because the Dobbs choice.  However Grossi takes a distinct method.  He opinions “what the Justices have mentioned on the overarching authorized difficulty in AHM – the extent to which any choose or Justice ought to defer to the scientific and medical judgments that FDA makes each time it approves or regulates any drug.”  The article examines the Supreme Court docket warnings on the hazards of such judicial second-guessing of FDA drug security determinations. Judicial deference is crucial “given the relative experience of the FDA scientists, who’ve devoted their complete careers to such questions, versus judges who, at most, could spend a couple of days each few years contemplating such points.”  (The article is simply too well mannered to distinction FDA experience with no matter it’s that prompts jurors to award eye-watering verdicts after fake bellwether trials marked extra by fairy tales than science.)  Recall that it was Justice Alito who authored the Bartlett choice, which grounded preemption on the deference warranted by FDA’s “distinctive position in balancing the advantages and dangers of all medicine.” The article cites a number of cases the place SCOTUS Justices emphasised the necessity for deference to the FDA.  Our fellow protection hacks will probably discover this a part of the article helpful for mining pertinent precedents.   

The article additionally particulars the historical past of the modifications FDA made to its mifepristone REMS in 2016 and 2021, (1) extending the deadline for utilizing the drug (from 7 weeks after gestation, which regularly expired earlier than a lady discovered she was pregnant, to a extra real looking 10 weeks), and (2) eliminating the requirement of three separate, in-person workplace visits to acquire and use mifepristone, thus allowing telehealth prescriptions that at the moment are commonplace with nearly all medicine.  As can be true with a lot of our drug and gadget preemption arguments, the FDA’s therapy of a citizen’s petition is a precious supply of proof. 

Naturally, the article has a viewpoint.  It argues that the district courtroom and Fifth Circuit choices in AHM “have been decidedly non-deferential.”  Extra to the purpose, “[n]a type of choices acknowledged any of the Supreme Court docket opinions addressing the right approach FDA security choices are to be reviewed and revered.”  The article particulars how the Fifth Circuit failed to contemplate the controlling Supreme Court docket circumstances; didn’t refute (and even acknowledge) the FDA’s evaluation of the related scientific and medical knowledge; and overturned the selections FDA made in 2016 and 2021, whereas ignoring the brand new January 2023 REMS which now governs use of the drug.  The article makes out a robust case that the district courtroom and Fifth Circuit choices contradict SCOTUS precedent.  The article then engages in just a little of its personal SCOTUS prognostication.  It ends with a query, or maybe it’s extra of a dare, as as to whether the SCOTUS Justices, significantly probably the most conservative ones, will find yourself contradicting themselves on the difficulty of FDA deference. 

Our little abstract can not do justice to the article’s scope and focus.  Furthermore, it’s an gratifying, invigorating learn. No matter your political leanings, if any speck of you is lawyerly, you can see it refreshing to learn a dialogue of an abortion case that’s steeped in authorized evaluation reasonably than prejudice.