Diabetes Drug Lawsuits Over Pancreatic Cancer Risk Dismissed, Again

The U.S. District Judge presiding over all federal lawsuits involving pancreatic cancer diagnosed among users of Byetta, Januvia, Victoza and other incretin mimetic-based diabetes drugs has granted a motion for summary judgment brought by the manufacturers, dismissing the claims again, after a similar ruling issued several years ago was overturned on appeal.

There are currently about 1,000 Byetta lawsuits, Januvia lawsuits, Janumet lawsuits, and Victoza lawsuits pending in the federal court system, which have been centralized in the U.S. District Court for the Southern District of California since 2013, as part of a multidistrict litigation (MDL).

The drugs are all part of a popular class of diabetes medications, known as incretin mimetics, which were linked to a potential risk of pancreatitis about a decade ago. The pancreatic cancer litigation emerged as a growing number of former users filed lawsuits alleging that the failure to warn about the side effects associated with Byetta, Januvia and other incretin mimetics resulted in the development of pancreatic cancer, which may have been avoided if earlier warnings and information had been provided to consumers and the medical community.

Given common questions of fact and law raised in complaints filed throughout the federal court system, the litigation was centralized before U.S. District Judge Anthony Battaglia for coordinated discovery and pretrial proceedings.

In 2015, Judge Battaglia issued an order that dismissed all claims in the MDL, after determining the lawsuits were preempted by federal law. The Court found at that time there was sufficient evidence to establish the FDA would not have approved any request by the drug makers to add an earlier pancreatic cancer warnings to the drug labels, which allowed the drug makers to escape liability in state-law based failure to warn claims.

Following a lengthy appeal process, the U.S. Court of Appeals for the Ninth Circuit overturned that ruling in December 2017, reinstating the diabetes drug lawsuits, and returning the cases back to Judge Battaglia for further discovery and proceedings.

Over the past few years, hundreds of additional cases have been added to the litigation and Judge Battaglia established a pretrial schedule that resulted in another round of motions for summary judgment on the pre-emption issue before any individual cases were prepared for trial.

In an omnibus order (PDF) issued on March 9, Judge Battaglia determined one again that the cases should be dismissed, granting defendants summary judgment, indicating plaintiffs could not bring substantial and reliable arguments showing that the drugs caused pancreatic cancer.

“As previously analyzed, the opinions of Plaintiffs’ experts are unreliable and therefore do not constitute admissible evidence,” he wrote. “With no expert evidence to show a causal relationship between incretin-based therapies and pancreatic cancer, Plaintiffs cannot demonstrate a genuine dispute of material fact as to the element of general causation.”

Unless plaintiffs can mount another success appeal, this ruling is likely to mean the end of the litigation.