In the event you work on this enterprise lengthy sufficient, you’ll run into some legal professionals who test all of the packing containers: good, persuasive, humorous, and sartorially splendid.  One of the crucial proficient legal professionals we ever had the pleasure to work with was Peter Grossi.  He checked all of the packing containers, after which some.  When Peter was at Arnold & Porter, we co-tried a food plan drug case with him.  It was a beautiful 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 nice.  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 evaluation article — Grossi, “The Conservative Court docket on the Unacceptable Perils in Second-Guessing FDA Security Selections and Its Coming Evaluate of Alliance for Hippocratic Drugs v. FDA (The “Abortion Capsule Case”),” 31 Virginia J. of Social Coverage and Legislation (Forthcoming 2024) – is actually good and persuasive.  And you’ll not must 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 Drugs 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 remedy utilized by a whole lot of 1000’s of American girls annually).  That opinion poked at a political hornet’s nest.  The Fifth Circuit’s ruling would successfully restrict entry to mifepristone, not just for girls residing 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 court docket almost certainly to face a SCOTUS beatdown.  (Within the 35+ years since we clerked on the Ninth Circuit, we’ve grown a wee bit bored with listening to how the Ninth Circuit continually serves up reversal bait. The Fifth Circuit’s current monitor report ought to pour chilly water on that canard.) However, once more, that’s not why we suggest the article to you. 

The AHM case is now headed for SCOTUS evaluation subsequent yr.  The timing of this submit couldn’t be higher, inasmuch as SCOTUS as we speak granted cert. Will probably be attention-grabbing 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 decide or Justice ought to “second-guess” scientific judgments that FDA specialists make each day with respect to each drug the FDA regulates. And it’s the problem of deference to FDA choice making, expensive Reader, that makes us linger over the AHM choice and Grossi’s article.  That deference is the lynchpin for our favourite drug and machine regulation protection, preemption, in addition to different authorized theories (e.g., major jurisdiction) that ought to forestall 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 by way of SCOTUS precedents on abortion, such because the Dobbs choice.  However Grossi takes a special method.  He evaluations “what the Justices have stated on the overarching authorized problem in AHM – the extent to which any decide 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 important “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 number of days each few years contemplating such points.”  (The article is just 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 function in balancing the advantages and dangers of all medicine.” The article cites a number of situations the place SCOTUS Justices emphasised the necessity for deference to the FDA.  Our fellow protection hacks will seemingly 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 are actually normal with just about all medicine.  As can be true with lots of our drug and machine preemption arguments, the FDA’s therapy of a citizen’s petition is a helpful supply of proof. 

Naturally, the article has a viewpoint.  It argues that the district court docket and Fifth Circuit selections in AHM “have been decidedly non-deferential.”  Extra to the purpose, “[n]a kind of selections acknowledged any of the Supreme Court docket opinions addressing the correct method FDA security selections are to be reviewed and revered.”  The article particulars how the Fifth Circuit failed to think about the controlling Supreme Court docket circumstances; didn’t refute (and even acknowledge) the FDA’s evaluation of the related scientific and medical information; 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 powerful case that the district court docket and Fifth Circuit selections contradict SCOTUS precedent.  The article then engages in a bit 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, notably 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’ll discover it refreshing to learn a dialogue of an abortion case that’s steeped in authorized evaluation moderately than prejudice.