The California state court consolidated Incretin litigation has closely followed its MDL counterpart. We reported on the trial court’s preemption-based dismissal here. But, after reporting on the Ninth Circuit’s undoing of the federal dismissal, we opted not to explore the California Court of Appeals decision essentially doing the same thing at the state level. See Rotondo v. Amylin Pharmaceuticals, Inc., 2018 WL 5800780 (Cal. Ct. App. Nov. 16, 2018). Suffice it to say that the state court Incretin plaintiffs were provided the same opportunity to poke around for “newly acquired evidence” that would support an unpreempted warning based claim.
But, as with the federal court decisions, we are now in a post-Albrecht world. So, if at first you don’t succeed . . . .
Here we are two and a half years later, and the Incretin defendants again moved to dismiss the action, and once again they succeeded. And, once again the state court followed the federal court’s lead using the same one-two punch – Daubert and preemption. In re Byetta Cases, Case No. JCCP 4574, slip op. (CA. Super. Apr. 6, 2021). It’s also a lengthy decision and so today you are getting the preemption portion with Daubert to follow.
The court started by addressing the conflict between the state appellate ruling in Rotondo and the Supreme Court ruling in Albrecht – Albrecht controls. And as pointed out yesterday, that’s generally a good thing for defendants.
[T]he issue of FDA preemption presents a question of law for decision by the Court and that in the course of doing so, the Court is authorized to decide all predicate factual questions necessary to the resolution of the ultimate legal question of whether or not “impossibility” preemption applies in a given case.
Slip op. at 24. Not wanting to completely ignore Rotondo, the Incretin court offered to conduct a bench trial before deciding the preemption issue, but the parties stipulated that all the necessary evidence to address the issue was before the court and no trial was needed. Slip op. at 24. So, having satisfied any obligation that still existed under Rotondo, the court moved on to those “predicate factual questions.”
First up, what “new safety evidence” should the FDA have considered before deciding the drug’s labeling need not include the risk of pancreatic cancer? While preemption is considered an affirmative defense, it was plaintiffs arguing more information needed to be sent to the FDA. So, plaintiffs bore the burden of identifying the allegedly missing information and also demonstrating how and why such information “would have made a difference in the FDA’s deliberative process.” Slip op. at 25.
The court enumerates seventeen categories or types of data plaintiffs contended were “new safety evidence.” Slip op. at 27-36. As noted yesterday, plaintiffs “nitpicked” practically everything that was ever submitted to the FDA. The state court’s conclusion was that the “information” (i) was outdated and unreliable, slip op. at 27; (ii) didn’t support plaintiffs’ position as to the risk of pancreatic cancer, slip op. at 28, 31; (iii) was in fact reported to the FDA, slip op. at 29, 34-35; (iv) was litigation-driven science that the court found unreliable, slip op. at 30; (v) was publicly available and therefore available to the FDA, slip op. at 33; or (vi) involved a different drug, slip op. at 34.
Plaintiffs’ nitpicking was viewed by the court as “trying to get the Court to decide the science.” Slip op. at 30. That’s not the court’s job. Nor is it the court’s job to second-guess FDA submissions. But, like the federal court, the state court took a once-bitten approach and stayed away from Buckman this time around too. Instead, after
[S]eriously consider[ing] each piece of plaintiffs’ proposed “new safety evidence,” the Court makes the predicate finding of one of the “brute facts” needed to resolve this legal question: plaintiffs have failed to show that defendants failed to provide the FDA in a timely fashion with one or more piece of additional safety evidence which might have a tendency to change the FDA’s behavior.
Slip op. at 37.
The next predicate fact that needed deciding was whether the defendants have met their burden as to “clear evidence” that a unilateral label change would have been rejected by the FDA. Tied up in that question is the threshold question of what constitutes “agency action carrying the force of law.” Id. In other words, what could the court consider as proof of the FDA’s position to support that it would have rejected the adding of a warning. Relying on the concurrence in Albrecht, the court noted that the FDA’s failure to act may be an “official action” disapproving of a warning. Slip op. at 38.
The court’s primary focus was on a 2014 article published in the New England Journal of Medicine (“NEJM”) by four FDA officials concluding that upon examination of the data regarding a “pancreatic safety signal,” the FDA believed that the product labeling “adequately reflected” current knowledge. Slip op. at 38-39. For several reasons the court concluded that the article was “not necessarily” the formal position of the FDA and did not bind the agency. Id. at 40. However, the article was “highly relevant” as evidence of the bases for the FDA’s “consistent” exercise of its labeling authority, “which does constitute official agency action.” Id.
The FDA’s consistent evaluation and reevaluation of a product, coupled with its obligation to raise new safety information with the manufacturer when such information independently comes to the agency’s attention, constitute “official action” for purposes of preemption. The FDA has treated with the subject of suitable labels for incretin-based mimetic products repeatedly over the last five-plus years. Its consistent declination of addition of a pancreatic cancer warning when it is otherwise officially approving such label changes does show “agency action” under its delegated authority sufficient to support application of the Supremacy Clause.
Id. at 40-41.
Between the FDA’s inaction in requiring a warning while making labeling decisions and “[n]o recall, recanting, or questioning of the NEJM article” from any corner, defendants proved by “clear evidence” that the FDA would have rejected the warning put forth by plaintiffs. Therefore, it was impossible for defendants to comply with both federal and state requirements. Id. at 41.
Stay tuned for a future post on the Daubert rulings.
This article was written by Michelle Yeary of Dechert LLP.