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The U.S. District Judge presiding over all federal Onglyza heart failure cases has decided to bifurcate the litigation, establishing two phases for discovery, with the first focusing on general causation and whether plaintiffs can establish that the diabetes drug causes heart failure.
There are currently more than 220 product liability lawsuits pending in the federal court system, each involving common allegations that the drug maker knew or should have known about the link between Onglyza and heart failure for years, yet failed to adequately warn users and the medical community.
The litigation emerged after the FDA required new Onglyza warnings in 2016, indicating that users of the drug may face a higher-than-expected risk of hospitalization for heart failure.
Given common questions of fact and law presented in cases filed in U.S. District Courts nationwide, the litigation has been centralized in the Eastern District of Kentucky before U.S. District Judge Karen Caldwell, who is overseeing the coordinated discovery and pretrial proceedings.
Earlier this month, drug maker proposed that the litigation be split into two phases. Although plaintiffs opposed the plan, arguing that it would unnecessarily delay the cases, Judge Caldwell issued a case management order (PDF) last week establishing the bifurcated discovery schedule.
“General causation is a critical issue in this case, common to all actions,” she wrote in the order. “If the plaintiffs are unable to establish that Onglyza and Kombiglyze XR is capable of causing any person to develop heart failure or other conditions alleged by the plaintiffs, then the parties will not be required to undergo the time and expense of further discovery and litigation.”
According to the order, the parties must submit a proposed discovery plan by January 15, including various deadlines for the exchange of information and challenges to the admissibility of expert witness testimony on the issue of general causation.
In April 2016, the FDA felt there was enough proof of causation to issue Onglyza heart failure warnings. The risk information was also added to other drugs that belong to the same class of diabetes medications, known as dipeptidyl peptidase-4 (DPP-4) inhibitors, such as Kombiglyze XR, Nesina, Kazano and Oseni.
The warnings were issued after a review that looked at two large clinical trials involving patients with heart disease. In both trials, patients given drugs containing saxagliptin or alogliptin were at a higher risk of being hospitalized for heart failure than those given a placebo.
Lawyers involved in the Onglyza heart failure cases are next scheduled to meet with the Court for a quarterly status conference on December 18, 2018, at which time the future of the litigation is likely to be addressed.