A California MDL judge overseeing claims that four Type 2 diabetes drugs increased the risk of pancreatic cancer has dismissed at least 750 lawsuits under a rarely used analysis of the federal preemption doctrine.  In re Incretin-Based Therapies Products Liability Litigation, slip op. (S.D. Cal. Nov. 9, 2015) (the “Order”). In doing so, the opinion creates a favorable precedent for drug manufacturers defending similar failure to warn claims.

Plaintiffs are individuals with type 2 diabetes who were prescribed and consumed pharmaceutical drugs  marketed as Januvia, Janumet, Byetta, and Victoza. Order at 2. Defendants Amylin Pharmaceuticals, LLC, Eli Lilly and Company, Merck Sharp & Dohme Corp, and Novo Nordisk Inc are the pharmaceutical companies that manufacture and market the drugs at issue. Order at 2-3.

In his order granting Defendants’ motion for summary judgment, United States District Judge Anthony J Battaglia concluded that Plaintiffs’ state law failure to warn claims were preempted by federal law because Defendants demonstrated by “clear evidence” that the United States Food and Drug Administration (“FDA”) would have rejected a stronger warning on  pancreatic cancer in the product labeling, a standard set forth in the United States Supreme Court’s touchstone case of Wyeth v Levine, 555 US 555 (2009). Order at 34.

Levine’s “Clear Evidence” Standard:

In the context of pharmaceutical products liability litigation, Levine provides the relevant preemption standard: drug manufacturers must demonstrate “clear evidence” that the FDA would not have approved a change to the subject drug’s labeling to successfully argue that plaintiff’s state law failure to warn claims are preempted. 555 US at 572. The high court in Levine did not find “clear evidence” or define what could or would constitute “clear evidence” in future cases, leaving manufacturers to repeatedly argue “clear evidence,” without much success since Levine.

In finding “clear evidence,” Judge Battaglia was persuaded by the following facts: (1) the FDA was aware of a pancreatic safety signal for a number of years; (2) the FDA had meaningfully investigated the relationship between the drugs and pancreatic cancer; (3) the FDA had consistently concluded that a causal association between the drugs and pancreatic cancer was indeterminate; and (4) the FDA never took action with regards to the drugs’ labeling. Order at 15-20.

The Court summarized that “[w]hile FDA inaction is insufficient on its own to establish preemption, it is highly persuasive given the FDA’s comprehensive review of pancreatic safety and ability to mandate a labeling change if it concluded the regulatory standards were satisfied.” Order at 20. The Court further reasoned:

It is the FDA’s failure to act coupled with its substantial review of the issue posed by Plaintiffs’ claims that the Court finds persuasive. When considered in its entirety, and in connection with federal regulatory standards governing product labeling, the record establishes the FDA would have rejected a pancreatic cancer label change, having found on more than one occasion that scientific evidence did not support such a reference.

Order at 21.

Rejection of the Requirement for an Actual or Express Rejection by the FDA:

In reaching its holding, Judge Battaglia tossed several of Plaintiffs’ arguments, creating helpful precedent for drug manufacturers in future failure to warn lawsuits asserting a preemption defense. Plaintiffs had argued that absent “actual or express rejection” of a stronger warning on pancreatic cancer by the FDA, Defendants could not meet their burden of establishing “clear evidence.” Order at 21. But Judge Battaglia expressly rejected such a requirement. Id.

Such actual or express rejection would necessarily come after a drug manufacturer’s submission of a supplement under the Changes Being Effected (“CBE”) regulation or a prior approval supplement (“PAS”). And while a CBE or PAS submission and rejection would readily meet the clear evidence standard, Judge Battaglia noted it is not the only means by which a manufacturer can establish preemption. Id. Thus, under the Court’s ruling, a manufacturer is not required to submit a label change to the FDA to establish that a plaintiff’s claims are preempted by federal law.

FDA’s Ongoing Safety Review of Drugs Does Not Preclude Preemption:

Judge Battaglia likewise rejected Plaintiffs’ argument that the FDA’s ongoing review of pancreatic safety and the existence of an open pancreatic safety signal indicates the existence of some basis to believe there is a causal association, and therefore precludes a preemption defense. Order at 26-27. Instead, the Court observed that a safety signal, without more, is not indicative of a causal association warranting inclusion in a product’s labeling and does not undermine the FDA’s previously articulated conclusions with respect to a drug. Id.at 27. And importantly, the potential for the FDA to reach a different conclusion in the future in light of developing scientific evidence does not preclude a finding of preemption now. Id. at 28.

Buckman Applies to Plaintiffs’ Defense to the “Clear Evidence” Standard:

As an additional argument to rebut Defendants’ preemption defense, Plaintiffs alleged the existence of new safety information related to pancreatic cancer risk that Defendants withheld, misrepresented or underrepresented to the FDA. Id. at 29. And because the FDA has not considered this information, Plaintiffs argued that Defendants could not establish preemption. Id. But the Court rejected this argument under Buckman v. Plaintiffs’ Legal Committee, 531 US 341 (2001) (holding that fraud-on-the-FDA state law claims were preempted as they “inevitably conflict with the FDA’s responsibility to police fraud.”)

The MDL Judge observed that while Buckman is inapplicable to whether Plaintiffs’ state law failure to warn claims are preempted, Buckman is implicated by Plaintiffs’ fraud-on-the FDA defense to the “clear evidence” standard: “The Court maintains its earlier position that such arguments are preempted to the extent they are based on Defendants failure to comply with FDA reporting requirements.” Id. at 31.