Lawyer representing more than 90 plaintiffs went before the U.S. Judicial Panel for Multidistrict Litigation (JPML) yesterday to argue for the centralization of all federally-filed heart failure lawsuits involving Onglyza and Kombiglyze XR.
A group of Onglyza lawsuit plaintiffs petitioned the JPML for centralization in October. At the time, 40 product liability claims had been filed in federal courts on behalf of individuals who allegedly suffered heart failure due to their treatment with the Type 2 diabetes medications. However, their petition predicted that the litigation involving tOnglyza or Kombiglyze XR would eventually include hundreds of similar claims.
AstraZeneca and other defendants are opposed to centralization, and argued in their response to the plaintiffs’ petition that there were too few cases to warrant the creation of a multidistrict litigation.
In oral arguments presented yesterday at the Panel’s most recent Hearing Session in Miami, Florida, the plaintiffs’ attorneys asserted that consolidation in the U.S. District Court, Northern District of California, would improve judicial efficiency, as all currently pending claims share the same defendants, the same theory of liability and the same basic allegation of fact.
They also argued that current efforts to informally coordinate the federal Onglyza and Kombiglyze XR docket were not working.
Onglyza (saxagliptin) was approved by the U.S. Food & Drug Administration in 2009, while Kombiglyze XR (saxagliptin and metformin) was cleared the following year.
In April 2016, the FDA ordered that the labels for all saxagliptin-containing drugs be modified in to warn of the potential for heart failure, after interim data from the SAVOR-TMI clinical trial suggested that patients treated with Onglyza or Kombiglyze XR were 27% more likely to be hospitalized for heart failure compared to those who were not. Saxagliptin also appeared to be associated with a higher risk of all-cause mortality.
If the JPML agrees to centralize federally-filed Onglyza and Kombiglyze XR lawsuits in a single U.S. District Court, all pending and future cases will undergo coordinated discovery and other pretrial proceedings. At some point, a representative group of lawsuits will be selected for bellwether trials.
Verdicts in bellwether trials — which are intended to test the strength of plaintiffs’ claims – could provide insight into how other juries might rule in similar heart failure claims.
All Onglyza and Kombiglyze XR lawsuits included in the proposed multidistrict litigation will maintain their own individual identity. Any not resolved in the course of the proceeding will be returned to their court of original filing for trial.