Not too long ago, our search keyed to Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019), picked up the following article in Trial Magazine: Abaray & Harman, "Navigating Preemption After Merck," 56 Trial 20 (Jan. 2020). For anybody who doesn't know, Trial is the house organ of the American Ass'n for Justice - the rebranded name for ATLA - and thus a thought leader for the other side of the "v."
Cognizant of the limits of fair use, we thought we'd provide our views on those arguments. We'll start with trivia - we prefer using plaintiff names to describe cases where, as here, there are many cases out there against the named defendant, so we'll continue calling it Albrecht, except possibly in formal briefing. That's the same rule we use for Bauman, Levine, Lohr and a number of other cases we cite frequently where the sides of the "v." were flipped by the vagaries of the appellate process (usually signifying that the defendant lost in an intermediate appellate court). Speaking of naming conventions, we'll refer to the article in this post as "NPAM."
First off, we agree with the other side that "[a] court's decision whether state law failure-to-warn claims are federally preempted is a pivotal, sometimes dispositive point in pharmaceutical litigation." NPAM, 56-JAN JTLATRIAL 20, at *21 (we're using Westlaw cites and pagination, since we don't subscribe). In fact, for precisely that reason, we've supported Lawyers for Civil Justice in its not-yet-successful quest to have certain MDL decisions, including preemption, become eligible for immediate interlocutory review. As for the Albrecht angle to this, we've mentioned before that the Court's main holding in Albrecht - that preemption is a question of law to be decided by the court - should make the case for interlocutory appeals easier, both before the Rules Committee and under current standards:
[O]ne type of MDL ruling that everyone agrees qualifies as "important" is preemption. Now that Albrecht has disconnected preemption decisions from factual disputes that require jury resolution, preemption rulings thereby become much more discrete, and thus collateral. . . . Thus, Albrecht makes it much easier for the defense side to argue that MDL preemption decisions . . . are not only important, but procedurally severable, so as to facilitate interlocutory appeal.
In the same paragraph, and indeed throughout the NPAM article, the authors refer to "impossibility" preemption. They're right that Albrecht was an impossibility case, but wrong if they think its holdings are so limited. In particular, the key holding that made Albrecht our #1 good case for 2019 is that preemption is a legal issue applies to all preemption cases. That is how post-Albrecht decisions have treated it. See Delfino v. Medtronic, Inc., 2019 WL 2415049, at *10 (Minn. App. June 10, 2019), review denied (Minn. Aug. 20, 2019) (express preemption case; "the issue of whether [something] constituted a federal requirement is a question of law to be decided by a judge"). Delfino went on to hold that, given the Albrecht holding that preemption was an issue of law, it was proper to exclude plaintiff's expert, since experts may not opine on questions of law. Id. at *12 ("we explained in the preceding section, 'determining compliance with a regulation . . . is a question of law"; "expert opinion as to a legal matter is generally inadmissible," so the district court did not abuse its discretion by prohibiting [plaintiff's expert] from opining on a legal question").
Even though the Albrecht Court only decided the legal/factual question point, and with it the collateral proposition that there is no heightened evidentiary standard in preemption cases, the majority did reach out and alter the criteria for "clear evidence" of impossibility preemption in cases "like" Levine. Albrecht, 139 S. Ct. at 1678. Levine (which the Court calls "Wyeth") had stated: "absent clear evidence that the FDA would not have approved a change to [the drug's] label, we will not conclude that it was impossible for [defendant] to comply with both federal and state requirements." Wyeth v. Levine, 555 U.S. 555, 571 (2009). Albrecht turned Levine's holding into something resembling a multi-part test:
[I]n [Levine], we confronted that question in the context of a particular set of circumstances. . . . In a case like [Levine], showing that federal law prohibited the drug manufacturer from adding a warning that would satisfy state law requires the drug manufacturer to show that it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug's label to include that warning.
Almost all of NPAM focuses on various parts of this language - except it ignores the Albrecht majority's "like" Levine qualifier entirely. Indeed, the word "like" appears nowhere in NPAM. That has a number of consequences that we will point out.
NPAM interprets Albrecht as eliminating any consideration of what FDA "would not have" done under the Levine standard. NPAM, 56-JAN JTLATRIAL 20, at *22. However, that is only true in cases "like" Levine. In Levine, there was no claim or evidence that anyone other than the manufacturer had sought any...
