Unfortunately, the Third Circuit now seems to have a fetish with the presumption against preemption.  Not long after the Supreme Court abolished that presumption in express preemption cases in Puerto Rico v. Franklin-California Tax-Free Trust, 579 U.S. 115 (2016), the Third Circuit refused to go along.  See Shuker v. Smith & Nephew, PLC, 885 F.3d 760, 771 n.9 (3d Cir. 2018) (finding Puerto Rico v. Franklin not controlling because it was not a product liability case).  Since then, as we discussed here, every other circuit court to address the issue has recognized the demise of the presumption against preemption in express preemption cases – several of them doing so in product liability litigation.  The Third Circuit stuck out like a sore thumb.

Then along came Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299 (2019).  In our initial “breaking news” post when Albrecht was first decided, we pointed out an interesting fact.  Among other things, Albrecht spent several pages restating and reworking the Court’s poorly reasoned Wyeth v. Levine, 555 U.S. 555 (2009), decision.  See Albrecht, 587 U.S. at 310-13 (“describing” Levine for four pages).  Levine, of course, had been the high water mark of the presumption against preemption, which it called a “cornerstone” of “pre-emption jurisprudence” generally.  555 U.S. at 565.  But nowhere in Albrecht’s discussion of Levine – indeed, nowhere in the Albrecht decision anywhere – did the Court even mention any presumption against preemption.  (If you don’t believe us, search Albrecht for “presum!”)  As we said then, “conspicuously absent from that description is any express reference to any ‘presumption’ (as opposed to the older ‘assumption’) against preemption.”  So on that issue, be believe that the Court in Albrecht actually pulled back from that presumption.

That’s not surprising.  In PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), an implied conflict preemption case, four justices sought to jettison the presumption against preemption altogether, id. at 621-23, and argued that the Supremacy Clause operated as a “non obstante” clause that “plainly contemplates conflict pre-emption by describing federal law as effectively repealing contrary state law.”  Id. at 621 (citations omitted).

To consider in our pre-emption analysis the contingencies inherent in these cases − in which the Manufacturers’ ability to comply with state law depended on uncertain federal agency and third-party decisions − would be inconsistent with the non obstante provision of the Supremacy Clause.  The Manufacturers would be required continually to prove the counterfactual conduct of the FDA and brand-name manufacturer in order to establish the supremacy of federal law. We do not think the Supremacy Clause contemplates that sort of contingent supremacy.

Id. at 623 (Thomas, J., for Roberts, C.J., Scalia, and Alito, JJ.).  Without explanation, Justice Kennedy declined to join this section of the Mensing decision.  Id. at n.*.  The dissent in Mensing, relied – as in Levine – on a presumption against preemption.  Id. at 641-43 & n.14 (Sotomayor, J., for Ginsburg, Breyer, and Kagan, JJ.).  Our readers know which of these justices are, and are not, still on the Court.

Which brings us to In re Fosamax (Alendronate Sodium) Products Liability Litigation, ___ F.4th ___, 2024 WL 4247311 (3d Cir. Sept. 20, 2024), in which the Third Circuit had to redo its prior preemption decision in the Fosamax MDL, which the Supreme Court unanimously reversed in Albrecht.  We thoroughly discussed Fosamax here, in our appropriately named “Has Albrecht Been Undone?” post.  We recommend that post to anyone who has not read it yet.  Today, we’re only interested in Fosamax in the context of the aforementioned Third Circuit fetish for the otherwise dying presumption against preemption.

As we described in our earlier Fosamax post, after Albrecht, the matter was remanded to the MDL judge, who then produced a lengthy, detailed decision holding that the plaintiffs’ warning-related claims were preempted.  In re Fosamax (Alendronate Sodium) Products Liability Litigation, 593 F. Supp.3d 96, 145 (D.N.J. 2022) (for anyone interested, our post on the district court decision is here).  The Third Circuit first held that the trial court’s factual findings concerning preemption were subject to deferential “clearly erroneous” review.  2024 WL 4247311, at *16.  The Third Circuit panel then agreed with the trial court on several significant issues:

• That the defendant did not withhold information from, or provide misleading information to, the FDA.  Id. at *19.
• That the FDA having “full information” is measured as of the point at which the FDA acted on the warning at issue.  Id. at *20.
• That the defendant was not under any duty to provide more information after receiving an FDA “complete response letter” that did not ask for any more information.  Id.
• That the rejected warning involved the specific type of injury at issue in the MDL, not merely a “garden variety” risk.  Id. at *21.
• That an FDA complete response letter is a formal action with force of law that has preemptive effect.  Id. at *22.

Thus, Fosamax arrived at the FDA’s complete response letter.  The district court, after concluding that the FDA letter allowed for “competing inferences,” had conducted a detailed analysis of other FDA-related evidence, including what the FDA had told the United States Supreme Court in an amicus brief, in order to determine what the agency had actually intended.  We discussed that in detail in the “fifth” section of our post on the district court’s decision, as does the Third Circuit, 2024 WL 4247311, at *23-24, so we won’t repeat it here.

The Third Circuit, however, held that no such analysis was permitted – deciding, in effect, that “we don’t need no stinkin’ [administrative] facts.”  Rather, what the FDA actually intended to do didn’t matter once its only formal document was “ambiguous.”  Instead, the presumption against preemption trumped any and all real facts – so whether the District Court correctly determined that the FDA’s decision rejected the plaintiffs’ contentions didn’t matter.

We acknowledge that this is a close case, but, in a close case, the strong presumption that the Supreme Court has established will likely be determinative.  The “difficult” and “demanding” clear-evidence standard is one that “a drug manufacturer will not ordinarily be able to show[.]”  Albrecht, 587 U.S. at 313.  Congress’s intent to preserve state law claims in the drug labeling context would be undermined, and the presumption against pre-emption that exists in that context would have diminished effect, if the kinds of informal communications the District Court relied on here could readily serve as the determinative evidence in answering the pre-emption question.

Fosamax, 2024 WL 4247311, at *24 (emphasis added).  “In short, we are bound to consider the ‘presumption against pre-emption’ when analyzing the particular Complete Response Letter in this case.  We actually “have a duty to accept the reading that disfavors pre-emption.”  Id. at *52.  Since no such “presumption” was mentioned in Albrecht, for this proposition Fosamax followed an earlier, non-FDCA decision, Bates v. Dow Agrosciences LLC, 544 U.S. 431, 449 (2005).

Still, Fosamax misrepresented this result as supposedly mandated by Albrecht – despite Albrecht expressly refusing to decide the preemption question, and the prior panel mandate requiring the District Court to make the preemption determination in the first instance:

[E]xtrinsic evidence [that is, actual FDA administrative facts] . . . cannot be determinative in a case like this, where the ambiguities in the FDA’s Complete Response Letter are swept away by the heavy Albrecht presumption.  Given how emphatically the Supreme Court has directed our attention to the weight of that presumption, it appears that ambiguity alone will seldom, if ever, be enough to overcome the presumption.

2024 WL 4247311, at *26 n.27 (emphasis added).

That’s not only wrong, that’s loud wrong.  As we pointed out above, and as any reader can quickly and independently determine, Albrecht did not rely on any presumption against preemption at all – let alone “emphatically.”  To the contrary, Albrecht rewrote Levine to remove any mention of any “presumption” against preemption.  The Third Circuit’s fetish with that purported presumption reached new heights in Fosamax just as the United States Supreme Court has moved in the opposite direction.  “Presumptions have their place . . ., but only to the extent that they approximate reality.”  Loper Bright Enterprises v. Raimondo, 144 S. Ct. 2244, 2265, (2024).  Fosamax, however, employed its presumption against preemption specifically in place of determining what the FDA was really doing, thereby avoiding, not “approximating,” reality.

As far as regulated product manufacturers’ ability to rely on what the FDA actually did – or might actually do in future cases – Fosamax tells defendants, “tough luck.”

Whether it seems fair or not, the FDA can take its time, but [defendant] is responsible for the content of its label at all times. . . .  Thus, since the FDA had not formalized a decision on whether to include [the at-issue] fracture language in the Precautions section of [the drug’s] label, it is not dispositive that the Agency did not invoke its power . . . to require manufacturers to change its label.

Id. at 28 (citations omitted).

So we come full circle.  The presumption against preemption, as created and applied by the Fosamax panel, results in a judicial view of the FDA regulatory scheme that is the complete opposite of the approach taken by the aforementioned 4-justice plurality in Mensing that would have done away with that same presumption altogether.  We re-quote it.

To consider in our pre-emption analysis the contingencies inherent in these cases − in which the Manufacturers’ ability to comply with state law depended on uncertain federal agency and third-party decisions − would be inconsistent with the non obstante provision of the Supremacy Clause.  The Manufacturers would be required continually to prove the counterfactual conduct of the FDA and brand-name manufacturer in order to establish the supremacy of federal law.  We do not think the Supremacy Clause contemplates that sort of contingent supremacy.

564 U.S. at 623.  The Mensing plurality rejected any “presumption” that that would have a manufacturer defendant’s “ability to comply with state law,” and thus its ability to assert preemption “depend[] on uncertain federal agency and third-party decisions.”  The Fosamax panel, in contrast, revels in precisely that:  “Whether it seems fair or not, the FDA can take its time, but [defendant] is responsible for the content of its label at all times.”  2024 WL 4247311, at *28.

Fosamax, of course, had no more use for Mensing than it did for what the Supreme Court actually held in Albrecht, disposing of it in a footnote:  “Our opinion today analyzes drug labeling in the brand-name drug manufacturer context.  The statutory and regulatory regime is different for generic drug manufacturers.”  2024 WL 4247311, at *29 n.34.  That back of the hand put-down is no more viable than the Fosamax opinion’s just-discussed distortion of Albrecht.  Implied preemption principles are universal, and apply across “statutory and regulatory regimes.”  Mensing based its “independence principle” finding preemption where state-law compliance turned on “independent” FDA activity, on Levine’s analysis of unilateral “CBE” label changes, notwithstanding, indeed because of, the differing regulatory regime.  Moreover, Fosamax itself reached out to an entirely non-FDCA decision (Bates) to justify its presumption-against-preemption-on-steroids rationale, notwithstanding an even greater difference in statutory context.

Could a second Fosamax appeal result in the Mensing plurality’s anti-presumption against preemption analysis now commanding five votes?  Adding Justices Kavanaugh and Coney-Barrett to the three still-sitting justices from that 2011 plurality would do that.  Conversely, Justice Thomas, who wrote Mensing, was the only justice in Albrecht to opine adversely on preemption in the same litigation.  587 U.S. at 321.  Would he vote to reverse a no-preemption result because of disagreement – however strong – over whether a presumption against preemption did, or should, exist?  If not, a pro-preemption result would require winning the vote of Justice Gorsuch, who (notwithstanding an excellent opinion from when he was on the Tenth Circuit) seems so opposed to anything that administrative agencies do as to be a wildcard.

It’s hardly a sure thing, but a solid legal basis exists for the defendant in Fosamax to seek an up-or-down Supreme Court decision on the presumption against preemption, a presumption the we believe is long past its expiration date.