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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” LevineAlbrecht, 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.

Albrecht, 139 S. Ct. at 1678.

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 relevant agency decision.  NPAM’s statement that “the manufacturer must have submitted a label change, and the FDA must have rejected it,” id., is thus way overbroad.  For years, pro-plaintiff organizations, usually in connection with litigation, have filed “citizen petitions” with the FDA concerning identical risks and demanding either warnings or to have the drug in question removed from the market.  FDA rulings on such petitions are final agency action.  21 U.S.C. §355(q)(1)(F); 21 C.F.R. §10.30(e)(3) (authorizing publication of the FDA’s decision in the Federal Register).  Citizen petitions also produce “an official administrative record for an FDA decision.”  Albrecht, 139 S. Ct. at 1680.  See 21 C.F.R. §10.30(i) (specifying the “record of the administrative proceeding”).

NPAM’s argument, 56-JAN JTLATRIAL 20, at *25-26, that courts should ignore FDA resolution of citizen’s petitions ignores Albrecht’s “like” Levine qualifier to the discussion of what “manufacturers” submit.  Essentially, plaintiffs are trying to have it both ways – so their fellow traveler organizations (and even plaintiffs’ counsel themselves) can petition the FDA about anything they want with no consequences when the FDA denies their petitions, formally and on the record.  As we’ve pointed out before, post-Albrecht cases involving FDA resolutions of identical issues in citizen’s petitions agree with us.  An on-point FDA ruling on a citizen’s petition is a “set of circumstances with a key difference.”  Cerveny v. Aventis, Inc., 783 F. Appx. 804, 808 n. 9 (10th Cir. 2019); accord State v. Purdue Pharma L.P., 2019 WL 3776653, at *2-3 (N.D. Dist. July 22, 2019).  We also note that, to the extent NPAM advocates serving intrusive discovery on the FDA concerning its internal deliberations, 56-JAN JTLATRIAL 20, at *25, that is unlikely to succeed under United States ex rel. Touhy v. Ragen, 340 U.S. 462 (1951).  For more about that, see here.

We also designated Albrecht as our #6 worst case of 2019, and one point NPAM discusses is the primary reason why.  “Lesser steps such as conversations with FDA employees, email exchanges, or internal FDA analyses of scientific data do not establish a federal requirement that can give rise to impossibility preemption.”  Id. at *22.  We think that’s probably correct, except when such “conversations,” exchanges,” or “analyses” produce some “other agency action carrying the force of law.”  Albrecht, 139 S. Ct. at 1679 (citing “e.g., 21 U.S.C. §355(o)(4)(A)”).  This arguable retreat is the primary reason for our designation.  Secondarily, are all the other, bogus arguments that plaintiffs will advance claiming support in Albrecht (in other words everything else in NPAM).

Albrecht stated, “[t]he Supremacy Clause grants ‘supreme’ status only to the ‘the Laws of the United States,’” 139 S. Ct. at 1679 (quoting U. S. Const., Art. VI, cl. 2.), so informal back-and-forth with the FDA by itself wouldn’t seem to qualify.  But preemption motions based on nothing more than that just aren’t very common.  The Third Circuit, for one, closed that door over a decade ago in Fellner v. Tri-Union Seafoods, L.L.C., 539 F.3d 237, 250 (3d Cir. 2008) (FDA “advisory and backgrounder” insufficient basis for conflict preemption).

Further, we think the converse is also true.  NPAM points out what falls short of Albrecht are “informal statements are not binding on the FDA.”  56-JAN JTLATRIAL 20, at *22.  Well, plaintiffs in both express and implied preemption situations (especially involving generic drugs) often seek to oppose preemption under “the Laws of the United States” with their own collection of FDA actions lacking the requisite “force of law.”  Albrecht, 139 S. Ct. at 1679.  Two prime examples are FDA warning letters and Forms 483.  This type of argument is particularly common in PMA preemption litigation, where the operation of an express preemption clause (21 U.S.C. §360k(a)), is frequently opposed by purported “parallel” claims also relying solely on “informal statements [that] are not binding on the FDA.”

Also, attention needs to be paid to Albrecht’s citation of §355(o)(4)(A) as an example of “other” preemptive “agency action carrying the force of law”:

If the [FDA] becomes aware of new information, including any new safety information or information related to reduced effectiveness, that the Secretary determines should be included in the labeling of the drug, the Secretary shall promptly notify the responsible person or, if the same drug approved under subsection (b) is not currently marketed, the holder of an approved application under subsection (j).

(Emphasis added).  Note, the reference to “subsection (j)” involves generic drugs.  This regulation cited by Albrecht nicely dovetails with the limitation of the FDA’s so-called “CBE regulation” authorizing unilateral changes to warnings only to” reflect newly acquired information.”  Albrecht, 139 S. Ct. at 1679.  FDA activity pursuant to this statutory power – whether affirmative or negative – should, if sufficiently formal, also support preemption in prescription drug cases.

Since the same “new information” both obligates the FDA to act unilaterally under §355(o)(4)(A) and allows the manufacturer to change warnings unilaterally under the CBE regulation, defendants desirous of the protections of preemption would be well advised to obtain formal FDA no-action letter under §355(o)(4)(A) to avoid the other side’s arguments outlined in NPAM.  NPAM concedes this as a valid reason for preemption, but describes it as “rare,” 56-JAN JTLATRIAL 20, at *23 n.12.  Albrecht provides reasons for our side to ensure that FDA decisions of this sort become much more common.

NPAM also urges plaintiffs to oppose preemption with intrusive discovery into the basis for any FDA’s decision rejecting the warning change at issue:

If the manufacturer establishes that the FDA denied the proposed label change, request discovery of all communications between the defendant and the agency pertaining to the risk at issue, and specifically request the drug manufacturer’s CBE or PAS submissions asking for the label change.

56-JAN JTLATRIAL 20, at *23.  That presents an obvious conflict with Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), as the article anticipates.  Id.  To argue that “Buckman should not be an obstacle to challenging a drug manufacturer’s deficient submissions to the FDA,” NPAM, 56-JAN JTLATRIAL 20, at *24, relies on the highlighted portion of the following discussion:

[I]f the FDA rejected a drug manufacturer’s supplemental application . . . on the ground that the information supporting the application was insufficient to warrant a labeling change, the meaning and scope of that decision might depend on what information the FDA had before it.  Yet in litigation between a drug consumer and a drug manufacturer (which will ordinarily lack an official administrative record for an FDA decision), the litigants may dispute whether the drug manufacturer submitted all material information to the FDA.

Albrecht, 139 S. Ct. at 1680.

The excerpt was from a discussion of why preemption is a legal, rather than a fact, question, and the Court doesn’t mention, let alone distinguish, Buckman.  Thus, it hardly stands for ignoring a unanimous Supreme Court decision.  It’s not the “litigants” who decide whether the FDA was fully informed.  Rather, under Albrecht, “the FDA, and only the FDA, can determine what information is “material” to its own decision to approve or reject a labelling change.”  In re Avandia Marketing, Sales & Products Liability Litigation, 945 F.3d 749, 759 (3d Cir. 2019) (emphasis original).  The obvious alternative is to ask the FDA.  We addressed the relationship between Albrecht and Buckman in more detail, here.

This can be done in several ways.  First, courts of the view that “only the FDA” can make the requisite determination could apply the doctrine of primary jurisdiction, which as we’ve discussed elsewhere, is the most reliable means to ensure that the FDA has requisite opportunity.  We haven’t seen a post-Albrecht decision addressing primary jurisdiction, but it’s the strongest option short of preemption itself to preserve the FDA’s decision-making power.  Second, as we discussed earlier in this post, another way is via citizen petition.  That was done recently in the Zofran, MDL, with the MDL judge telling the FDA he would express “no view as to the merits,” while urging the agency to “make its decision based on the relevant scientific and medical criteria, and according to the law, without regard to its potential impact on the litigation,” and to do so “without undue delay.”  Public letter to FDA, Zofran MDL PACER Docket #1773 (D. Mass. Dec. 13, 2019).

The NPAM article mentioned a third option, seeking an FDA amicus brief, something courts do from time to time (the last request we’re aware of happening in Albrecht itself).  The simple fact that the Supreme Court did precisely this in Albrecht substantially undercuts NPAM’s argument that FDA amicus briefs on “clear evidence” preemption questions:

[A]sk[] the court and the FDA to speculate about what the agency would have done in a counterfactual world in which the drug manufacturer fully informed the FDA.  Based on [Albrecht], such speculation has no place in a preemption analysis.

56-JAN JTLATRIAL 20, at *24.  This argument makes little sense.  First, courts routinely ask the FDA for amicus briefs in preemption cases, and even find such briefs persuasive in other cases.  E.g., Shuker v. Smith & Nephew, PLC, 885 F.3d 760, 774-75 (3d Cir. 2018) (relying on requested FDA amicus brief in preemption decision); Williams v. Mentor Worldwide LLC, 2019 WL 4750843, at *6 (N.D. Ohio Sept. 30, 2019) (preemption decision citing FDA amicus brief in prior case); In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation, 401 F. Supp.3d 538, 552, 554 (D. Md. 2019) (same as Williams, citing Shuker FDA amicus brief multiple times).  Second, there is nothing “counterfactual” or “hypothetical” about asking the FDA to state whether or not a specific decision that it has already made was “fully informed,” in light of whatever additional material the plaintiffs have brought forward.  This particular argument is based on one thing – plaintiffs’ fear of the prerequisites for preemption being decided by an independent, unbiased decision maker.

Finally, we’d like to point out all the preemption-related arguments NPAM avoids mentioning.  First and foremost, NPAM stays away from express preemption in PMA medical devices, as well as generic drug preemption.  As we’ve mentioned, the conclusion that preemption is a “legal question” and its emphasis on FDA decisions with “force of law” will have (and has already had) significant beneficial effects for defendants in all preemption cases:  (1) thumbs are now off the evidentiary scale – as we’ve discussed, the judge “simply ask[s]” who has the better of the argument, 139 S. Ct. at 1679; (2) precluding of expert testimony on questions of law; (3) Albrecht’s reiteration of the FDA’s CBE regulation as the basis for avoiding preemption, id., reinforcing the other, CBE-related bases for preemption, such as “newly acquired” information and other exceptions to that regulation; (4) Albrecht’s omission of any mention of a “presumption” against preemption from its restatement of Levine; (5) recognition of “overwarning” as a policy concern, id., at 1673 (“exaggeration of risk, or inclusion of speculative or hypothetical risks, could discourage appropriate use of a beneficial drug . . . or decrease the usefulness and accessibility of important information by diluting or obscuring it”); and (6) better arguments for interlocutory review.  There are good reasons we awarded Albrecht the # Best decision of 2019 that NPAM has no response to, and therefore remains mum.

We’re not just blowing smoke.  It’s still quite early, but we’ve already seen post-Albrecht decisions discussing overwarning.  McGrath v. Bayer HealthCare Pharm. Inc., 393 F. Supp. 3d 161, 169 (E.D.N.Y. 2019); Klein v. Bayer Healthcare Pharmaceuticals, Inc., 2019 WL 3945652, at *5 (D. Nev. Aug. 21, 2019).  Several courts have applied the “new evidence” limitation to the CBE exception and ruled in favor of preemption.  McGrath, 393 F. Supp.3d at 171; Goodell v. Bayer Healthcare Pharmaceuticals, Inc., 2019 WL 4771136, at *4 (D. Mass. Sept. 30, 2019); Pradaxa Cases, 2019 WL 6043513, at *3-4 (Cal. Super. Nov. 8, 2019); Roberto v. Boehringer Ingelheim Pharmaceuticals, Inc., 2019 WL 5068452, at *13 (Conn. Super. Sept. 11, 2019).