A California judge overseeing the JCCP for diabetes drugs recently made a significant ruling, dismissing more than 500 claims in the coordinated proceeding that alleged the drugs were linked to pancreatic cancer. In Re Byetta Cases, No. JCCP4574, 2021 WL 2462800 (Cal.Super. Apr. 06, 2021). The Court made both evidentiary rulings regarding plaintiffs’ experts and a decision on preemption in this long-running litigation.
Regarding experts, the court found the unwillingness or inability of the experts (particularly Drs. Madigan, Wells, and Gale) to grapple with all the available epidemiological evidence to be “troubling.” 2021 WL 2462800, at *1. The court emphasized that the issue was not, as plaintiffs argued, whether an expert can offer an opinion that a substance can cause a disease in the absence of epidemiology, but whether the expert can offer an opinion without taking into account all the existing epidemiology. “The plaintiffs here would have a much more procedurally respectable expert opinion on the essential issues of general causation if the opinions had considered all the available epidemiological evidence and not just the state of research as it existed in 2015 with limited consideration of studies done thereafter,” the judge reasoned. Even worse, plaintiffs’ counsel provided a two-hour overview of the scientific evidence and documents they believe support causation including references to numerous studies, documents and analyses that, in large part, never were considered by their experts and, in some cases, were created by plaintiffs’ counsel. Id. at *2. The judge also noted that one expert’s conclusions in this case were undermined by a peer-reviewed article he published in 2016, which does not repeat his conclusions about the alleged link between the medications and pancreatic cancer, but instead that a potential link requires “further study.”
Without admissible expert opinions, the judge granted summary judgment, but continued to analyze whether the claims were preempted under federal law. The court perceived the key issue to be whether the product label could have been amended by the unilateral action through a Changes Being Effected (“CBE”) label change to add disclosure of a risk of pancreatic cancer without running afoul of the FDA and its supervisory authority over prescription drug labels. 2021 WL 2462800, at *12. The court noted that plaintiffs—as the parties urging that the FDA should have been presented with additional information by the manufacturers—have the burden of persuasion as to what that information was. The court lists and assess 17 categories of information that the FDA allegedly did not have, concluding that the information did not constitute newly acquired evidence, because the FDA had it, or it was not scientifically significant, or was out of date and superseded by newer, better data. For example, plaintiffs referred to a Health Canada view of causation, but defendants have persuasively shown that Health Canada, the Canadian counterpart to the FDA, has swung around to express the view that no association of these drugs with pancreatic cancer is shown. Regarding allegedly unreported data, for example, there have been a number of new studies of the possible connection between pancreatic cancer and incretin-based therapies—to name just a few, the TECOS, LEADER, and EXSCEL studies contained thousands of patients who received defendants’ drugs. The presence of a mountain of new data at the present indicates that the prior pooled data analysis—standing alone—is now out of date and unreliable, and thus its supposed effect on the FDA would be irrelevant in light of the new data.
So, while the Court has seriously considered each piece of plaintiffs’ proposed “new safety evidence,” the Court made 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.
Turning to the second prong of preemption analysis, the court stated that 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 the purpose 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. 2021 WL 2462800, at *21.