Metropolitan News-Enterprise


Thursday, November 8, 2018


Page 3


Court of Appeal:

Failure-to-Warn Action Against Drug-Makers Can Continue


By a MetNews Staff Writer


The Court of Appeal for this district has revived the state court’s portion of a case being litigated before cooperating state and federal trial judges, holding that the plaintiff’s claim that a group of pharmaceutical companies should have warned about certain diabetes drugs’ pancreatic cancer risk is not preempted by the Food and Drug Administration’s rules.

Justice Laurie D. Zelon of Div. Seven wrote the unpublished opinion, filed Tuesday. It reverses a summary judgment granted by Los Angeles Superior Court Judge William F. Highberger to the defendants.

The Ninth U.S. Circuit Court of Appeals in 2017 likewise reversed a summary judgment in favor of the drug companies.

More than 300 cases brought by users of the drugs or their heirs were consolidated and assigned to Highberger. Cases filed in U.S. district courts in California were bunched together and routed to Judge Anthony Battaglia of the Southern District of California.

Highberger and Battaglia both concluded that there was no chance of the Food and Drug Administration (“FDA”) approving a warning label change for the medicines in light of an article published in the February 2014 issue of New England Journal of Medicine reporting its findings, and those of the European Medicines Agency, that the drugs likely do not carry a cancer risk.

The plaintiffs alleged that the drugs—sold under the names Byetta, Victoza, Januvia and Janumet—should have carried a cancer risk warning, and that new research conducted after the report of the FDA’s study render it likely that the agency would, indeed, approve the label change.

Cross-Sovereignty Cooperation

Highberger and Battaglia agreed to work together on the cases during discovery, due to the substantial similarity between the claims and a desire to avoid conflicting rulings and redundancy. Battaglia was assigned to preside over a multi-district federal failure-to-warn lawsuit regarding the drugs, which work by increasing the hormone incretin, stimulating the pancreas’s insulin production.

The judges held a joint hearing on the defendants’ summary judgment motions.

The defendants relied on the 2009 U.S. Supreme Court decision in Wyeth v. Levine. It was held there that a state claim against a drug manufacturer for a failure to include a warning was not preempted by the FDA’s regulations because there was no “clear evidence that the FDA would not have approved a change to” the drug’s label.

In the present case, they argued, the “clear evidence” was there in the form of the 2014 FDA study.

Battaglia granted the motion before him in November 2015, while Highberger granted the defendants’ motion a week later, incorporating Battaglia’s decision (excepting only a section addressing federal summary judgment procedure).

Jurists’ Controlling Precedent

The jurists relied on a 2001 U.S. Supreme Court case, Buckman Co. v. Plaintiffs’ Legal Committee, in which then-Chief Justice William H. Rehnquist delivered the high court’s holding that “state-law fraud-on-the-FDA claims conflict with, and are therefore impliedly pre-empted by, federal law.”

Battaglia indicated that the policy underlying Buckman precluded him from considering the new research, because to do so would “inevitably conflict with the FDA’s responsibility to police fraud.”

Highberger, agreeing, added:

“The Court gives no proffered items which were not in the public domain or not shown to be information submitted to the FDA some time prior to the February 2014 issuance of the NEJM article based on [Buckman.]”

He emphasized that he “fully agree[d] with Judge Battaglia’s analysis that there was ‘clear evidence’ that the FDA would not have approved plaintiffs’ desired label change.”

Ninth Circuit Opinion

In a memorandum opinion filed in December 2017, the Ninth Circuit reversed Battaglia’s decision. That opinion says:

“[W]e disagree with the district court’s characterization of the plaintiffs’ state-law claims as ‘fraud-on-the FDA type allegations.’ The plaintiffs asserted common-law failure-to-warn claims arising from a state-law duty.…Neither Buckman’s holding nor what the district court termed the ‘policy underlying Buckman’ can be read to preclude discovery of evidence relevant to the plaintiffs’ state-law failure-to-warn claims.”

It continues:

“The district court also relied on Buckman to preclude its consideration of ‘new safety information’ the plaintiffs uncovered in the discovery they were allowed to conduct, including a signal assessment completed by Health Canada and evidence from animal studies and clinical trials….Uncertainty about whether the FDA considered the ‘new safety information’ and whether it would have altered the FDA’s conclusion establishes that a disputed issue of material fact should have prevented entry of summary judgment on the defendants’ preemption claim. As the district court correctly noted, the parties’ experts disputed whether the ‘new safety information’ would have been material to the FDA’s analysis.”

Zelon’s Opinion

Zelon agreed with the Ninth Circuit. She wrote:

“Acknowledging that Buckman does not preclude the type of claim at issue in this case, defendants nonetheless contend that Buckman limits the type of evidence that may be considered when evaluating Wyeth’s ‘clear evidence’ standard. Defendants contend Buckman bars consideration of any evidence that manufacturers are alleged to have misreported or intentionally withheld from the FDA. We reject this argument.

“First, only a portion of plaintiffs’ ‘new safety evidence’ consists of information that defendants allegedly had in their possession, but failed to disclose, or otherwise misreported, to the FDA….

“The second problem with defendants’ application of Buckman is that the California Court of Appeal and numerous federal circuit courts have concluded that Buckman’s preemption principles do not apply to product liability claims alleging the defendant breached its state-law duty of care by withholding information from the FDA. Given that Buckman has been found not to apply to failure-to-warn claims that are predicated on defendant’s withholding of information from the FDA, we fail to see why it would preclude consideration of evidence that defendants allegedly failed to report to the FDA in this case.”

The case is Rotondo v. Amylin Pharmaceuticals, Inc., B275314.


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