MEDICAL MALPRACTICE-DRUG MANUFACTURERS-PHARMACEUTICAL

In re Fosamax (Alendronate Sodium) Prods. Liab. Litig., U.S. App. LEXIS 23950, (U.S. Ct. of App., 3d Cir., March 5, 2024)(Jordan, J.)
JORDAN, Circuit Judge.
Drug manufacturers have the primary responsibility to ensure that the labels on their products comply with federal and state law. In this case, hundreds of Plaintiffs accuse drug manufacturer Merck Sharp & Dohme (“Merck” or the “Company”) of failing to comply with drug labeling requirements under state law. According to the Plaintiffs, they were injured by the drug Fosamax and would not have taken it had they been properly warned. The District Court concluded at the summary judgment stage that the Plaintiffs’ state law claims are preempted because Merck in fact proposed a label change that would have addressed the risk with Fosamax that the Plaintiffs complain of, but the Food and Drug Administration (the “FDA” or the “Agency”) rejected the proposed change as lacking sufficient scientific support.
With real respect for the thorough and thoughtful work the District Court did in this complex case, we nonetheless conclude that it erred in its pre-emption analysis by giving too little weight to the required presumption against pre-emption. Applying that presumption, and considering the record here, we conclude that Plaintiffs’ state law claims are not preempted. Accordingly, we will vacate the District Court’s judgment for Merck and remand for further proceedings.
we undertake a de novo review of the District Court’s conclusion that the Plaintiff’s state law claims were preempted by federal law, while giving clear-error deference to subsidiary factual findings.
The parties dispute whether Merck “fully informed the FDA of the justifications for the warning required by state law[.]” Albrecht, 587 U.S. at 314. Resolving that dispute requires a fact-intensive analysis, as is evident by the parties’ disagreement about how the information provided to the FDA was portrayed. Indeed, the Supreme Court’s examples of “contested brute facts” in Albrecht – “what information the FDA had before it” and “whether the drug manufacturer submitted all material information to the FDA” – are among the central issues in this case. Id. at 317.
The Plaintiffs contend that the District Court improperly “credited Merck’s 2008 safety update,” which “downplayed the risk of atypical femoral fractures.” (Opening Br. at 40 (emphasis omitted).) They also claim that, by including misleading risk factors, Merck “blurred the relationship between Fosamax and atypical femoral fractures” in its Prior Approval Supplement. (Opening Br. at 49.) They contend that our holding in In re: Avandia Marketing, Sales and Products Liability Litigation, 945 F.3d 749 (3d Cir. 2019), compels us to rule for them on this prong. Merck, on the other hand, asserts that the District Court did not err because the record is clear that the FDA was fully informed and because In re Avandia does not support the Plaintiffs’ argument.
The District Court did not clearly err in rejecting the Plaintiffs’ argument that Merck failed to provide necessary and available additional information to the FDA.
The upshot of [Albrecht] is that a drug manufacturer must show that the FDA made a fully informed decision to reject a change to a drug’s label in order to establish the demanding defense of impossibility preemption. If the question of whether the FDA was fully informed was not tethered in time to the question of whether the FDA indeed rejected the proposed warning, the fully informed prong of the test espoused in [Albrecht] would be rendered superfluous.
Thus, if GSK wishes to rely on the [complete response] [l]etter as proof that the FDA rejected its proposed label change, it must also demonstrate that the FDA possessed all the information it deemed necessary to decide whether to approve or reject the proposed warning at the time it issued the [l]etter. By arguing that it did not have the FDA’s requested data and information until after the FDA issued its letter, however, GSK is, in effect, conceding that the FDA was not fully informed at the time of the [l]etter’s issuance. For that reason, among [] others …, GSK cannot satisfy the first prong of the test espoused in [Albrecht].
The question is not whether the FDA agrees with the drug manufacturer; the question is whether the manufacturer provided the FDA with all the relevant data and information for the FDA to make a fully informed decision. Here, the FDA did not tell Merck that it failed to provide necessary data, as it told the drug manufacturer in Avandia. 945 F.3d at 758. Thus, Avandia does not control the outcome of this case.
For all of the forgoing reasons, the District Court did not err in finding that Merck fully informed the FDA of the justifications for adding to the Fosamax label a warning about atypical femoral fractures.
The Supreme Court “has recognized that an agency regulation with the force of law can pre-empt conflicting state requirements.” Wyeth, 555 U.S. at 576. In Albrecht, the Court stated that “[f]ederal law permits the FDA to communicate its disapproval of a warning” “by formally rejecting a warning label that would have been adequate under state law[.]” Albrecht, 587 U.S. at 315-16. The Court cited § 314.110(a), the regulation setting forth the rules regarding complete response letters, for that statement. Id. at 316. Although the Supreme Court’s statement was dicta because, as it recognized, “[t]he question of [a] disapproval ‘method’ [was] not … before [it,]” we do not take lightly the Court’s citation to the regulation governing complete response letters as an example of an “agency action[] that can determine the answer to the pre-emption question[.]”23 Id. at 315-16. The bottom line is that a complete response letter may have preemptive effect, but whether it does depends upon the specific language it uses. The outcome of this case thus largely depends on the interpretation of the Complete Response Letter the FDA issued to deny Merck’s Prior Approval Supplement.
There is no legitimate basis to believe that the FDA did not understand that Merck was proposing a warning about atypical femoral fractures. The language of Merck’s Prior Approval Supplement supports its position, and the plain text of the Complete Response Letter confirms that the FDA understood Merck’s proposal to be one about atypical femoral fractures.
Undertaking our own review of the Complete Response Letter in the context of the pre-emption question presented here, we conclude that the District Court erred by placing too much weight on informal FDA communications and the Agency’s amicus brief to decide that the Letter preempted the Plaintiffs’ state law claims. 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, 315. 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.
Again, “the purpose of Congress is the ultimate touchstone in every pre-emption case.” Wyeth, 555 U.S. at 565. In the drug labeling context, Congress has repeatedly “[taken] care to preserve state law” because it “determined that widely available state rights of action provide[] appropriate relief for injured consumers” and because “state-law remedies further consumer protection by motivating manufacturers to produce safe and effective drugs and to give adequate warnings.” Id. at 567, 574. And the Supreme Court, after undertaking “a careful review of the history of federal regulation of drugs and drug labeling[,]” “found nothing within that history to indicate that the FDA’s power to approve or to disapprove labeling changes, by itself, pre-empts state law.” Albrecht, 587 U.S. at 311.
Rather, [the Court] concluded that Congress enacted the FDCA “to bolster consumer protection against harmful products;” that Congress provided no “federal remedy for consumers harmed by unsafe or ineffective drugs”; that Congress was “aware of the prevalence of state tort litigation;” and that, whether Congress’ general purpose was to protect consumers, to provide safety-related incentives to manufacturers, or both, language, history, and purpose all indicate that “Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.” Id. (cleaned up) (quoting Wyeth, 555 U.S. at 574-75).
The statutory and regulatory regime in that case is thus quite different from the one we are dealing with here. As noted previously (see supra Section I.A.1.), Congress has not set forth an express pre-emption provision in the drug labeling context. And the Supreme Court has said that nothing in the legislative history of the FDCA shows “that the FDA’s power to approve or to disapprove labeling changes, by itself, pre-empts state law.” Albrecht, 587 U.S. at 311. Unlike in the pesticide labeling context, drug manufactures may have opportunities to unilaterally change their products’ labels prior to receiving agency approval. Thus, our decision in Schaffner does not dictate the pre-emption analysis in this case.
We are not deciding whether “there is sufficient evidence to find that Merck violated state law by failing to add a warning about atypical femoral fractures to the Fosamax label.” Albrecht, 587 U.S. at 314. That conclusion must be determined at trial. Nor are we implying anything about the evidence that will be admissible at trial. Our holding is solely that the Plaintiffs’ state law claims are not preempted.
Merck relies on § 355(o)(4)(A), which, in his concurring opinion in Albrecht, Justice Alito noted we would do well to consider on remand. (See supra note 14.) We do so now. Under that provision, the FDA has a duty to notify drug manufacturers if it “becomes aware of new information” that “should be included in the labeling[.]”31 § 355(o)(4)(A). After discussions with the manufacturer, the Agency “may issue an order directing” the manufacturer “to make such a labeling change as the [FDA] deems appropriate to address the new safety or new effectiveness information.” § 355(o)(4)(E). Merck argues that it “strains credulity to claim the FDA did not agree with Merck’s use of ‘stress fracture’ terminology and therefore did nothing — even at the expense of patient safety.” (Answering Br. at 40.) That echoes Justice Alito’s comment that § 355(o)(4)(A) “arguably affect[s] the pre-emption analysis” “because, if the FDA declines to require a label change despite having received and considered information regarding a new risk, the logical conclusion is that the FDA determined that a label change was unjustified.” Albrecht, 587 U.S. at 324 (Alito, J., concurring). He suggested that FDA inaction could communicate disapproval of a warning because § 355(o)(4)(A) does not “require the FDA to communicate to the relevant drug manufacturer that a label change is unwarranted; instead, the FDA could simply consider the new information and decide not to act.” Id. at 325.
While § 355(o)(4)(A) is relevant to the pre-emption analysis when the FDA has fully considered the information submitted by a drug manufacturer, it does not change our analysis in this case because the FDA was in the process of deciding whether a change to the Precautions section of the label was needed at the time it issued the Complete Response Letter.
For the foregoing reasons, we will vacate the District Court’s judgment and remand the case for further proceedings.
Our opinion today analyzes drug labeling in the brand-name drug manufacturer context. The statutory and regulatory regime is different for generic drug manufacturers. See PLIVA, Inc. v. Mensing, 564 U.S. 604, 626, 131 S. Ct. 2567, 180 L. Ed. 2d 580 (2011) (“[T]he federal statutes and regulations that apply to brand-name drug manufacturers are meaningfully different than those that apply to generic drug manufacturers.”). We do not opine on the principles to be applied in that different context.