Onglyza Lawyers Appointed to Leadership Roles in Federal MDL Over Heart Failure Risk

With more than two hundred Onglyza lawsuits pending in the federal court system, each involving similar allegations that the diabetes drug caused users to develop heart failure, the U.S. District Judge presiding over the litigation has appointed a small group of plaintiffs’ attorneys to serve in various leadership roles in the recently established multidistrict litigation (MDL).

Onglyza (saxagliptin) was introduced for treatment of type 2 diabetes in 2009, but heart safety concerns have emerged in recent years, leading the FDA to require stronger label warnings about the risk of congestive heart failure and other cardiovascular complications.

As a result, a growing number of product liability complaints have been filed by individuals nationwide, presenting similar claims that AstraZeneca knew or should have known about the Onglyza heart failure risks for years, yet failed to adequately warn users and the medical community.

Given similar questions of fact and law presented in the cases, U.S. District Judge Karen Caldwell has been appointed to preside over the consolidated pretrial proceedings and coordinated discovery in the Eastern District of Kentucky.

In an order (PDF) issued on September 6, Judge Caldwell appointed different plaintiffs’ attorneys to serve 16 different leadership roles in the litigation. These attorneys will take certain actions during the MDL proceedings that will benefit all plaintiffs who are pursuing cases.

The appointments include two Onglyza lawyers who will serve as Plaintiffs’ Co-Lead Counsel, one as Plaintiffs’ Liaison Counsel, a three-member Plaintiffs’ Executive Committee, a Plaintiffs’ Federal-State Court Liaison Counsel, and a nine-member Plaintiffs’ Steering Committee.

The establishment of a leadership group for plaintiffs counsel is common in complex medical device litigation, where a large group of cases present similar claims. The lawyers will conduct general discovery into common issues, argue motions before the court and coordinate with individual attorneys with cases in the MDL. However, each plaintiff will still maintain their own lawyer, who will be responsible for case-specific deadlines and establishing causation between that plaintiffs use of Ongylza and heart failure injury.

As part of the coordinated pretrial proceedings, it is expected that Judge Caldwell will establish a bellwether process, where a small group of cases will be scheduled for early trial dates to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation

If Onglyza heart failure settlements are not reached following the coordinated MDL proceedings, each case may ultimately be remanded back to the U.S. District Court where it was originally filed for an individual trial date in the future.

Judge Caldwell issued a preliminary scheduling order (PDF)¬†on September 7, giving the plaintiffs’ co-lead counsel 14 days to submit a brief regarding a request by the defense to bifurcate the pretrial proceedings into two phases, with the first phase dedicated to general causation. The next conference is scheduled for December 18, 2019.


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