JPML To Hear Oral Arguments Over Onglyza Lawsuit Consolidation
A panel of federal judges will hear oral arguments next month, to consider whether all Onglyza lawsuits filed in U.S. District Courts nationwide should be consolidated before one judge for coordinated pretrial proceedings, as a growing number of complaints continue to be filed by individuals who allege that the diabetes drug caused heart failure and other medical problems.
There are currently at least 42 product liability lawsuits pending in the federal court system, each raising similar allegations that the manufacturer failed to adequately warn about the potential side effects of Onglyza on the heart.
Claims have been brought by users Onglyza, as well as the combination drug Kombiglyze XR, which includes the 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. Plaintiffs allege that AstraZeneca knew or should have known about the risk 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 all Onglyza cases before one judge for coordinated discovery and pretrial proceedings in the Northern District of California.
AstraZeneca opposes consolidation, maintaining that there are not enough cases at this time to justify centralization.
According to a Notice of Hearing Session (PDF) recently issued by the U.S. JPML, oral arguments will be considered on January 25, at the Wilkie D. Ferguson, Jr. U.S. Courthouse in Miami, Florida.
Onglyza Heart Failure Risks
The Onglyza litigation emerged after a series of steps taken by federal drug regulators to review the heart failure risks associated with the medication.
The FDA launched an investigation into the potential heart problems with Onglyza in 2014, following the publication of the a 2013 study in the New England Journal of Medicine.
In April 2015, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 to recommend stronger warnings about the potential Onglyza heart risks, after a review of data from clinical trials suggested that users may face a higher than expected risk of hospitalization for heart failure and all-cause mortality.
The review 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.
The FDA now recommends that health care professionals consider a different medication if an individual develops heart failure on Onglyza or Kombiglyze XR.
As Onglyza lawyers continue to review and file additional cases over the coming months, it is widely expected that a steadily increasing number of claims may be filed in U.S. District Courts nationwide.
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