If you work in this business long enough, you’ll run into some lawyers who check all the boxes: brilliant, persuasive, funny, and sartorially splendid. One of the most talented lawyers we ever had the pleasure to work with was Peter Grossi. He checked all the boxes, and then some. When Peter was at Arnold & Porter, we co-tried a diet drug case with him. It was a wonderful opportunity to watch a master on the job. We never saw anyone better at keeping out the bad stuff and highlighting the good. Peter retired from A&P a couple of years ago, and is now a Lecturer at Harvard, Penn, and UVA Law Schools. He is still brilliant, persuasive, and funny. (We cannot comment on his post-retirement wardrobe.) His most recent law review article — Grossi, “The Conservative Court on the Unacceptable Perils in Second-Guessing FDA Safety Decisions and Its Coming Review of Alliance for Hippocratic Medicine v. FDA (The “Abortion Pill Case”),” 31 Virginia J. of Social Policy and Law (Forthcoming 2024) – is certainly brilliant and persuasive. And you will not have to squint too much between the lines to detect a keen wit. Here is a link to the article. https://ssrn.com/abstract=4560486
The article examines the decision in Alliance for Hippocratic Medicine v. FDA, 78 F.4th 210 (5th Cir. 2023) (hereinafter, “AHM”), which nullified the changes the Food and Drug Administration (FDA) made in 2016 and 2021 to its Risk Evaluation and Mitigation Strategy (REMS) governing the use of mifepristone (the abortion medication used by hundreds of thousands of American women each year). That opinion poked at a political hornet’s nest. The Fifth Circuit’s ruling would effectively limit access to mifepristone, not only for women living in the 17 states that effectively ban abortion within their borders, but also in the 30 or so others that want their residents to have the option of medicated abortion. But that’s not why we find the AHM case and Grossi’s article so fascinating. The AHM opinion also seems to solidify the Fifth Circuit’s status as the outlier court most likely to face a SCOTUS beatdown. (In the 35+ years since we clerked on the Ninth Circuit, we’ve grown a wee bit tired of hearing how the Ninth Circuit constantly serves up reversal bait. The Fifth Circuit’s recent track record should pour cold water on that canard.) But, again, that’s not why we recommend the article to you.
The AHM case is now headed for SCOTUS review next year. The timing of this post could not be better, inasmuch as SCOTUS today granted cert. It will be interesting to see whether SCOTUS will follow a series of decisions in which SCOTUS — and especially its more conservative members (Justices Roberts, Alito, Kavanaugh and Thomas) — forcefully warned that no judge or Justice should “second-guess” scientific judgments that FDA experts make every day with respect to every drug the FDA regulates. And it is the issue of deference to FDA decision making, dear Reader, that makes us linger over the AHM decision and Grossi’s article. That deference is the lynchpin for our favorite drug and device law defense, preemption, as well as other legal theories (e.g., primary jurisdiction) that should prevent crazy, inconsistent, runaway jury verdicts from wreaking havoc on the design and delivery of life-saving drugs and medical devices.
As the article points out, most SCOTUS prognosticators talk about AHM in terms of SCOTUS precedents on abortion, such as the Dobbs decision. But Grossi takes a different approach. He reviews “what the Justices have said on the overarching legal issue in AHM – the extent to which any judge or Justice should defer to the scientific and medical judgments that FDA makes every time it approves or regulates any drug.” The article examines the Supreme Court warnings on the dangers of such judicial second-guessing of FDA drug safety determinations. Judicial deference is essential “given the relative expertise of the FDA scientists, who have devoted their entire careers to such questions, versus judges who, at most, may spend a few days every few years considering such issues.” (The article is too polite to contrast FDA expertise with whatever it is that prompts jurors to award eye-watering verdicts after faux bellwether trials marked more by fairy tales than science.) Recall that it was Justice Alito who authored the Bartlett decision, which grounded preemption on the deference warranted by FDA’s “unique role in balancing the benefits and risks of all drugs.” The article cites several instances where SCOTUS Justices emphasized the need for deference to the FDA. Our fellow defense hacks will likely find this part of the article useful for mining pertinent precedents.
The article also details the history of the modifications FDA made to its mifepristone REMS in 2016 and 2021, (1) extending the deadline for using the drug (from 7 weeks after gestation, which often expired before a woman learned she was pregnant, to a more realistic 10 weeks), and (2) eliminating the requirement of three separate, in-person office visits to obtain and use mifepristone, thus permitting telehealth prescriptions that are now standard with virtually all drugs. As is also true with many of our drug and device preemption arguments, the FDA’s treatment of a citizen’s petition is a valuable source of evidence.
Naturally, the article has a point of view. It argues that the district court and Fifth Circuit decisions in AHM “have been decidedly non-deferential.” More to the point, “[n]one of those decisions acknowledged any of the Supreme Court opinions addressing the proper way FDA safety decisions are to be reviewed and respected.” The article details how the Fifth Circuit failed to consider the controlling Supreme Court cases; failed to refute (or even acknowledge) the FDA’s analysis of the relevant scientific and medical data; and overturned the decisions FDA made in 2016 and 2021, while ignoring the new January 2023 REMS which now governs use of the drug. The article makes out a strong case that the district court and Fifth Circuit decisions contradict SCOTUS precedent. The article then engages in a little of its own SCOTUS prognostication. It ends with a question, or perhaps it is more of a dare, as to whether the SCOTUS Justices, particularly the most conservative ones, will end up contradicting themselves on the issue of FDA deference.
Our little summary cannot do justice to the article’s scope and focus. Moreover, it is an enjoyable, invigorating read. Whatever your political leanings, if any speck of you is lawyerly, you will find it refreshing to read a discussion of an abortion case that is steeped in legal analysis rather than prejudice.