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The U.S. Judicial Panel on Multidistrict Litigation (JPML) has determined that all federal Onglyza lawsuits filed on behalf of individuals nationwide who suffered heart problems allegedly caused by the diabetes drug will be consolidated before one judge in Kentucky, for coordinated discovery and pretrial proceedings.
There are currently at least 84 product liability lawsuits pending in the federal court system, each raising similar allegations that the manufacturer failed to adequately warn about the potential heart failure side effects of Onglyza.
Cases have also been filed on behalf of individual who used the combination drug Kombiglyze XR, which includes the same active ingredient in Onglyza, together with the older diabetes drug metformin.
Onglyza (saxagliptin) was introduce 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.
Plaintiffs allege that AstraZeneca knew or should have known about the Onglyza heart risks for years, yet failed to adequately warn users and the medical community about the diabetes drug’s heart failure risks.
In October, a group of plaintiffs filed a request with the U.S. Judicial Panel on Multidistrict Litigation (JPML), seeking to consolidate the Onglyza litigation before one judge for coordinated discovery and pretrial proceedings in the Northern District of California.
AstraZeneca opposed consolidation, arguing that there are not enough Onglyza cases pending at this time to justify centralization and formal coordination in an MDL.
However, in a transfer order (PDF) issued on February 2, the JPML agreed with plaintiffs, transferring cases pending in U.S. District Courts nationwide to the Eastern District of Kentucky, where U.S. District Judge Karen K. Caldwell will preside over the litigation.
The Eastern District of Kentucky was selected as the most suitable venue, since it is relatively accessible and the longest-pending action is proceeding in that district.
The Panel rejected AstraZeneca’s arguments that there were too few cases and that they were likely to be dismissed.
“To date, there are 84 cases pending in over 30 districts. Informal coordination among 84 cases scattered across the nation does not seem feasible,” the JPML noted in its decision. “If defendants are convinced that plaintiffs’ claims regarding heart failure or other injuries lack scientific support, then centralization affords them a single forum in which to seek summary judgment, which might be applied to other similar cases.”
Known as an MDL, or multidistrict litigation, such consolidation is common in complex product liability litigation, where a large number of individuals claim they suffered similar injuries following use of the same medication. Consolidating the cases is designed to reduce duplicate discovery into common issues, avoid conflicting pretrial rulings from different courts and to serve the convenience of the parties, witnesses and the courts.
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.