JPML To Hear Oral Arguments Over Proposed Onglyza Multidistrict Litigation (MDL) Today
The U.S Judicial Panel on Multidistrict Litigation (JPML) will hear oral arguments today on whether to centralize all Onglyza lawsuits pending in U.S. District Courts nationwide before one judge for coordinated pretrial proceedings, as a growing number of complaints continue to be filed by individuals who developed congestive heart failure and other side effects from the diabetes drug.
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 heart side effects of Onglyza. Cases have also been filed on behalf of individual who used 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 about the risk of congestive heart failure and other cardiovascular complications.
Plaintiffs allege that AstraZeneca knew or should have known about the Onglyza heart risks 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 the Onglyza litigation 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.
The JPML agreed to consider oral arguments on the matter in December, which will be presented at a hearing set for today 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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