The Third Circuit has affirmed the finding of extensive preemption in the Colacicco/McNellis suicidality litigation. Here’s a copy of the opinion. Judge Sloviter wrote the opinion. There is a dissent, by Judge Ambro. This is the first federal court of appeals decision to address preemption following the FDA’s 2006 Preemption Preamble.
The high points:
1. The “direct and positive conflict” language in the 1962 FDCA amendments “merely states that conflict preemption applies.” Slip op. at 17 n.8.
2. In a case “of conflict preemption, the lack of a Congressional directive expressly approving or rejecting preemption in the context of drug labeling regulations is not determinative. Rather, the conflict preemption analysis is designed to determine the propriety of preemption where Congress has not explicitly stated its intent.” Slip op. at 22.
3. While the court allows a presumption against preemption in conflict preemption cases, it finds that presumption in “tension” between the presumption, which is based on congressional “intent,” and the nature of conflict preemption, “which analyzes preemption in the absence of any explicit intent.” Slip op. at 22.
4. “[B]efore we can hold that a federal regulation or…the failure to regulate as extensively as plaintiffs sought, has preemptive force, we must review the record of the FDA’s treatment of the desired warning at issue.” Slip op. at 26.
5. “The FDA has actively monitored the possible association between SSRIs and suicide for nearly twenty years and has concluded that the suicide warnings desired by plaintiffs are without scientific basis and would therefore be false and misleading.” Slip op. at 28-29.
6. Deference to the FDA is different depending on whether the Agency is discussing facts or law. “The FDA’s summary of its scientific determinations must be distinguished from the agency’s construction of a statute, as the review of scientific information is strictly within its expertise. The FDA asserted facts in support of its legal position, and we take notice of its statement of those facts, rather than its legal position.” Slip op. at 30 n.15.
7. Suicidality claims are preempted. “Because the standard for adding a warning to drug labeling is the existence of “reasonable evidence of an association of a serious hazard with a
drug,” 21 C.F.R. § 201.57(e), and the FDCA authorizes the FDA to prohibit false or misleading labeling, a state-law obligation to include a warning asserting the existence of an association
between SSRIs and suicidality directly conflicts with the FDA’s oft-repeated conclusion that the evidence did not support such an association.” Slip op. at 32.
8. The decision is relatively limited. The court “need not decide whether preemption would be appropriate under different facts–such as where the FDA had not rejected the substance of the warning sought or where the FDA only stated its position after a lawsuit had been initiated–or under the broader theories of preemption argued by the parties.” Slip op. at 33.
8. There is no prerequisite of an FDA “formal rejection of a CBE supplement” prior to a finding of preemption. Slip op. at 34. The court does not “favor encouraging regulated parties to submit CBE supplements for the sole purpose of insulating themselves from potential liability.” Id.
9. Any claim that the a defendant “manipulated or withheld information from the FDA…should be brought before the FDA.” Slip op. at 35.
10. “In light of the FDA’s continued review of existing scientific studies, we reject plaintiffs’ arguments that the FDA lacked information that would have dissuaded it from rejecting an adult
suicidality warning.” Slip op. at 37.
11. The FDA’s preemption positions are entitled to Skidmore deference. “[W]e conclude (1) that an agency’s position concerning preemption need not be contained in a formal regulation in order to be considered, and (2) that such a position is subject to a level of deference approximating that set forth in Skidmore v. Swift & Co., 323 U.S. 134 (1944).” Slip op. at 38.
12. The FDA’s positions about what might happen in the context of a particular drug warning claim might be entitled to “more” deference. “The FDA’s view that “the imposition of liability under state law for defendants’ alleged failure to warn would interfere with FDA’s accomplishment of regulatory objectives,” id. at 22, is in our view entitled to at least as much deference, if not more, as the FDA’s view of its preemption authority.” Slip op. at 38-39.
13. “We see no inconsistency between the FDA’s preamble to the 2006 amendments and its long-held position that it has the responsibility to determine whether a warning is required.” Slip op. at 40. But the court does not decide any other agency inconsistency claim. Id. at 40-41.
The court’s rationale appears to be applicable to any and all SSRI suicide cases. Hear Hear!