The federal court overseeing hundreds of heart failure lawsuits involving Onglyza and Kombiglyze XR will allow new plaintiffs to file their cases directly in the multidistrict litigation.
According to an Order issued on October 3rd in the U.S. District Court, Eastern District of Kentucky, direct filing is intended to promote judicial efficiency and avoid delays associated with the transfer of cases filed in or removed from other federal courts.
Any Onglyza or Kombiglyze XR plaintiff whose case would be subject to transfer to the federal multidistrict may now file their lawsuit directly in the Eastern District of Kentucky.
“Filing a case directly in MDL No. 2809 will not determine the choice of law, including the statute of limitations;” the Order states “However, Defendants stipulate and agree that the filing of a complaint directly in MDL No. 2809 pursuant to this Order shall stop the running of any statute of limitations or prescriptive period, including statute of repose, as if the complaint had been filed in the district where it could otherwise have been brought absent this Order.”
The Order further stipulates that only lawsuits naming a single plaintiff (other than an additional consortium plaintiff, such as a spouse) may be filed directly in the Eastern District of Kentucky.
The Court is allowing direct filing of actions solely for the purposes of consolidated discovery and related pretrial proceedings. Once those proceedings have concluded, any Onglyza or Kombiglyze XR lawsuits that have not been resolved over the course of the multidistrict litigation will be returned to the appropriate U.S. District Court for a future trial date.
Onglyza and Kombiglyze XR are indicated to improve blood sugar levels in patients with Type 2 diabetes. While both contain saxagliptin as their active ingredient, Kombiglyze XR is a combination drug that also contains an older diabetes medication called metformin.
The multidistrict litigation underway in the Eastern District of Kentucky currently houses some 200 Onglyza and Kombiglyze XR lawsuits. Daniel C. Burke, a partner at the nationwide law firm of Bernstein Liebhard LLP, was recently appointed to the federal litigation’s 3-member Plaintiffs’ Executive Committee.
Plaintiffs pursuing saxagliptin lawsuits allege that their exposure to these two diabetes drugs resulted in heart failure and other cardiovascular complications. They further claim that AstraZeneca, Bristol-Myers Squibb, and other defendants were aware of the risks associated with saxagliptin, but failed to provide doctors and patients with adequate safety warnings.
Finally, plaintiffs assert that they could have avoided their injuries had they or their doctors been warned that exposure to saxagliptin might increase a patient’s risk of heart failure and other potentially life-threatening cardiovascular side effects.
Product liability lawsuits involving saxagliptin-containing diabetes drugs began to mount in 2014, shortly after the U.S. Food & Drug Administration (FDA) announced it was reviewing their possible association with heart failure. The agency’s investigation was prompted by interim results from the SAVOR-TMI clinical trial, which suggested that patients exposed to saxagliptin were 27% more likely to be hospitalized with heart failure. Saxagliptin also appeared to be associated with a higher risk of all-cause mortality.
In April 2015, an FDA advisory committee recommended that the labels for all saxagliptin products be updated to include warnings regarding a possible increased risk of heart failure. The FDA order those updates the following year.