The Ninth Circuit Court of Appeals has vacated a lower court win for Merck Sharp & Dohme Corp. and other drugmakers in a suit claiming that they failed to warn consumers about pancreas problems from Type 2 diabetes drugs. The class action was sent back by the Ninth Circuit to the district court. The panel said that court erroneously interpreted a U.S. Supreme Court ruling in a previous case.
In the decision, the panel agreed with the consumers that the trial judge misread Buckman Co. v. Plaintiffs’ Legal Committee – the Supreme Court decision that found that federal law bars private parties from pursuing state law tort claims that are predicated on alleged violations of the Food, Drug, and Cosmetic Act, or FDCA. The panel said:
The district court relied on Buckman to impermissibly circumscribe discovery. And second, the district court relied on Buckman to deem the plaintiffs’ newly discovered evidence ‘irrelevant’ to the court’s preemption analysis at the summary judgment stage. Either of these errors would independently warrant reversal.
Drugmakers Merck, Eli Lilly & Co., Novo Nordisk Inc. and Amylin Pharmaceuticals LLC defeated state law claims in the multidistrict litigation (MDL) in November 2015 when U.S. District Judge Anthony J. Battaglia ruled that the U.S. Food and Drug Administration (FDA) would have rejected labels warning patients of a potential connection between several drugs used to treat diabetes and pancreatic cancer.
The MDL, combined in August 2013, targets a class of Type 2 diabetes drugs known as incretin mimetics that has been under regulatory scrutiny since academic researchers suggested in early 2013 that they may lead to an increased risk of pancreatitis and precancerous changes in the pancreas. But the FDA and the European Medicines Agency found no firm evidence the drugs are connected to pancreas problems, according to a study released in February 2014.
The Plaintiffs in the MDL had contended that the FDA was not properly evaluating the evidence of a connection between prescription drugs Januvia, Janumet, Byetta and Victoza and that the agency’s failure to act should not mean the state law claims should be rejected. But the judge ruled that the FDA’s active work on the subject and its decision that a new warning label isn’t warranted were enough to close out the Plaintiffs’ claims.
While the case is not exactly like Buckman, Judge Battaglia had said in November 2015 the consumers were relying on “fraud-on-the-FDA-type allegations” that were preempted by Buckman. The panel disagreed, however, saying that the discovery the consumers sought was relevant to whether any causal connection existed between incretin use and pancreatic cancer. The panel said:
The plaintiffs did argue that it would not be unduly burdensome to produce the data they requested because the defendants were required to collect and submit it to the FDA, but the duty the plaintiffs claim the defendants breached was the parallel common law duty to warn, not a duty arising from the FDCA.
The panel also disagreed with the trial judge’s ruling that the consumers’ request for source files for each pancreatic cancer event known to the company was too burdensome. The panel said further:
Such files have been produced in pharmaceutical litigation of this sort, it is undisputed that the defendants already maintained these databases, and here, the volume of the requested data was limited.
Consumers are represented by David Frederick of Kellogg Hansen Todd Figel & Frederick PLLC. The case is Adams v. Merck Sharp & Dohme Corp. et al., (case number 15-56997) in the U.S. Court of Appeals for the Ninth Circuit.