Drug Makers Want Plaintiffs To Prove Link Between Onglyza and Heart Failure Before Claims Proceed

AstraZeneca is pushing for the U.S. District Judge presiding over all federal Onglyza lawsuits to institute a phased pretrial schedule, which prioritizes discovery into the “general causation” issue of whether the diabetes drug causes heart failure, before allowing any case-specific discovery in individual claims.

There are currently more than 220 product liability lawsuits pending in the federal court system, each involving common allegations that the drug maker knew or should have known about the link between Onglyza and heart failure for years, yet failed to adequately warn users and the medical community.

The litigation emerged after the FDA required new Onglyza warnings in 2016, indicating that users of the drug may face a higher-than-expected risk of hospitalization for heart failure.

Given common questions of fact and law presented in cases filed in U.S. District Courts nationwide, the litigation has been centralized in the Eastern District of Kentucky before U.S. District Judge Karen Caldwell, who is overseeing the coordinated discovery and pretrial proceedings.

Plaintiffs have proposed that case-specific discovery and general causation discovery proceed concurrently, to avoid delays and move the cases toward a resolution. This would involve the selection of a small group of “bellwether” case to go through the full discovery process in preparation for a series of early trial dates, which would help gauge the strengths and weaknesses of the cases, as well as how juries will respond to evidence that is likely to be repeated throughout the litigation.

In a response (PDF) filed earlier this month, the drug maker claims that the court should not provide plaintiffs with “unfettered discovery” until the Court determines whether they can support their claims with reliable evidence that Onglyza causes heart failure, indicating that the proceedings should be bifurcated.

“The Court should prioritize general causation because it is pivotal to every case in this proceeding and because Plaintiffs’ allegations on their face fail to support many of their causation claims,” the response states.

Plaintiffs indicate that such an approach would unnecessarily delay the litigation, and result in duplicative discovery, arguing that the issues of general causation are “inextricably interwoven” with other liability discovery in the possession of the drug maker. Under the Defendant’s proposal, discovery into all other issues in the litigation would largely be stayed until at least May 2020.

The parties are next scheduled to meet with the Court for a quarterly status conference on December 18, 2018, at which time the future of the Onglyza litigation is likely to be addressed.