Product liability lawsuit filed over heart failure and other cardiovascular side effects allegedly associated with Onglyza and Kombiglyze XR continue to mount in courts throughout the United States.
According to an update issued June 15th by the U.S. Judicial Panel on Multidistrict Litigation, there are at least 207 Onglyza and Kombiglyze XR lawsuits pending in the U.S. District Court, Eastern District of Kentucky, where all such federally-filed claims are currently undergoing coordinated pretrial proceedings before a single judge.
That represents a significant increase since the creation of the multidistrict litigation in February, when 80 cases were initially transferred to the Eastern District of Kentucky.
All of the Onglyza and Kombiglyze XR lawsuits pending in the proceeding similarly allege that the use of saxagliptin (the active ingredient in both medications) caused plaintiffs or their loved ones to develop heart failure, congestive heart failure, myocardial infarction (heart attack). or other cardiovascular injuries. Plaintiffs further claim that the drugs’ manufacturers failed to provide doctors and patients with adequate warnings of these risks.
The federal docket – as well as any Onglyza and Kombiglyze XR cases filed in the future – was transferred to the Eastern District of Kentucky after the JPML determined that centralization would, among other things, eliminate duplicative discovery; prevent inconsistent pretrial rulings, and conserve the resources of the parties, their counsel, and the judiciary.
Each Onglyza and Kombiglyze XR lawsuit included in the federal multidistrict litigation will continue to retain its individuality and be decided on its own merits. In such proceedings, a small group of representative cases will usually be selected for bellwether trials. These trials are intended to test the strength of plaintiffs’ claims and provide insight into how other juries might decide similar lawsuits. Sometimes – though there is no guarantee – verdicts in bellwether trials can pave the way for a global settlement of all claims pending in a multidistrict litigation.
Onglyza and Kombiglyze XR are indicated to lower blood sugar levels in patients with Type 2 diabetes. Onglyza (saxagliptin) was approved by the U.S. Food & Drug Administration (FDA) in 2009, while Kombiglyze XR (saxagliptin and metformin) was cleared for sale in November 2010.
Product liability lawsuits involving the two medications began to mount shortly after a panel of FDA advisors recommended that their labels be updated with new heart failure warnings in April 2015. The panel made the recommendation after preliminary results from a clinical trial called SAVOR-TMI suggested that use of saxagliptin was associated with a 27% increase in hospitalizations for heart failure, as well as a higher risk of all-cause mortality
The FDA acted on the panel’s advice in April 2016, when it ordered the manufacturers of Onglyza and Kombiglyze XR to modify their labels’ “Warnings and Precautions” section to reflect the SAVOR-TMI findings.