Two and half years ago we posted about a favorable California Superior Court ruling in the Risperdal and Invega Product Liability Cases litigation finding plaintiffs’ claims were preempted because there was no newly acquired information on which to base a CBE label change and because the FDA had rejected the proposed label change already. We titled that post Never Too Late to Celebrate Preemption. Apparently it’s also never too late for the California Court of Appeals to be a party pooper, a killjoy, a spoilsport, a wet blanket, a sourpuss, a downer, a real drip. We’re sure you can see which way this is headed – reversal.
In what appears to be a de novo review in Risperdal and Invega Product Liability Cases, 2020 WL 2300213 (Cal. Ct. App. May 8, 2020) the court traces the history of pediatric labeling for Risperdal up through the FDA’s October 2006 approval for use in children and adolescents to treat autism. The 2006 label that plaintiffs claim is inadequate included language about prolactin elevation and the reported rate of gynecomastia (enlargement of male breasts) among Risperdal users. Id. at *1-3. Because this is a well-known side effect of the drug that is warned about, you can search our blog and find a multitude of decisions granting summary judgment in defendant’s favor on causation grounds and indeed the last part of this decision upholds the dismissal of one plaintiff’s claims because his prescriber testified a changed warning would not have changed her decision to prescribe the drug. See id. at *11-13.
Plaintiffs argue that the defendant could have used the CBE process to add a warning of a direct correlation between the drug and gynecomastia and to add a recommendation for regular monitoring of prolactin levels. Id. at *9. A CBE label change however must be based on newly acquired information. The court agreed with defendant that there were no new studies or previously undisclosed studies that constituted newly acquired information. Id. Plaintiffs’ entire argument came down to a single table that was in a draft of study but not the final published results and therefore was not included when the study was provided to the FDA. Defendant argued that the table could not be newly acquired information because “it did not reveal risks of a different type or greater severity or frequency and the analysis was based on the studies submitted to the FDA.” Id. In fact, the table did not change the overall rate of gynecomastia that was reported on defendant’s label. But, it did show different rates at different time periods after use at least one of which was higher and which was not reported on the label. This was enough for the court to conclude that the table “demonstrated a risk of greater frequency” and therefore could support a CBE label change. Id.
Defendant argued that the table could not support a label change because the FDA would not have allowed it. First, defendant pointed to a statement by the FDA in a brief filed in a different case in which it said that defendant had “submitted all the necessary data and information to conclude that risperidone was appropriately labeled.” Id. at *10. It is important to note that in that other case, the FDA was a defendant, not writing as an amicus. Because the brief was “made in a wholly different context” and was not an “agency action taken pursuant to the FDA’s congressionally delegated authority,” it could not be used as “clear evidence” that the FDA would have rejected the label change. Id.
But that was not defendant’s only evidence. In 2012, the FDA denied a citizens petition filed by plaintiffs’ counsel challenging that the Risperdal label did not adequately address elevated prolactin levels, the need to monitor for elevated prolactin levels, or the rates of gynecomastia. For the trial court, this was clear evidence that the FDA considered and rejected the argument that the Risperdal label was deficient with respect to prolactin levels and gynecomastia. The appellate court parsed the issue differently. It was important to the court that the FDA did not have the above-mentioned table when it denied the citizens petition. Then, in denying the petition, the FDA found “there was no evidence that risperidone was unsafe or anything else that warranted revoking the pediatric indication of the drug,” and “no basis for requiring a black box warning about the lack of long-term safety data associated with pediatric use of risperidone.” Id. at *4. The denial also said that because the petition’s only specific labeling request was for a boxed warning, that was the only labeling request to which the FDA was responding, despite the petition “includ[ing] an extensive discussion of the current labeling.” Id. That was key for the appellate court. It viewed the citizens petition as making a “broader request” to either take the drug off the market or include a black box warning as compared to plaintiffs’ argument that the unconsidered table supports a label change to include prolactin monitoring at certain periods of time. Id. at *10. For this court, the charges in the citizen petition while similar to plaintiffs’ allegations were distinct enough to not be “clear evidence” to support a preemption defense. Never mind that the petition put the adequacy of the drug’s labeling specific to prolactin levels and gynecomastia before the FDA who determined that no changes were required.
We were enjoying our Risperdal preemption party and while this uncitable decision has put a damper on the celebration, as we note the litigation as a whole has much more good than bad. Enough to keep us smiling.