AstraZeneca Opposes MDL for Onglyza Heart Failure Cases
Although a number of Onglyza lawsuits have been filed in various different U.S. District Courts nationwide, AstraZeneca is opposing a recent request to consolidated the cases before one judge for coordinated pretrial proceedings, indicating that informal coordination would be more effective.
Onglyza (saxagliptin) was introduce for treatment of type 2 diabetes in 2009, and is also marketed under the brand name Kombiglyze XR, which is a long-acting version of the active ingredient combined with metformin, an older, front-line diabetes drug.
Following the emergence of safety concerns in recent years, the FDA required stronger label warnings for Onglyza and Kombiglyze XR last year, adding information to the drug label about the risk of serious heart problems.
Since then, a steadily mounting number of product liability lawsuits have been filed by individuals nationwide, alleging that the drug makers failed to adequately warn consumers and the medical community about the heart failure side effects of Onglyza and Kombiglyze XR.
Last month, 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.
In complex pharmaceutical litigation, where a large number of complaints are brought by individuals who suffered the same or similar injuries from the same medication, it is common for the cases to be coordinated as part of a federal multidistrict litigation (MDL) to reduce duplicative discovery into common issues raised in the cases, avoid contradictory pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the judicial system.
AstraZeneca filed a response in opposition (PDF) on November 2, indicating that there are not enough cases at this time to justify a formal multidistrict litigation for the lawsuits over Onglyza and Kombiglyze XR.
The drug maker indicates that there are currently fewer than 40 active cases, with a limited number of law firms involved in the litigation. The company also argues that there is no evidence that the number of cases will grow significantly in the coming months and years, and that the parties are already coordinating to maximize efficiency.
“At the same time, an MDL could frustrate resolution of these cases. Determinative merits issues will overwhelmingly focus on varying plaintiff-specific facts,” AstraZeneca argues. “For example, unlike other MDLs that focus exclusively on a narrowly-defined injury type, these cases involve a range of claimed injuries not well suited for consolidation, including heart failure, unrelated forms of cardiovascular injury, and a form of lung injury.”
The U.S. JPML is expected to consider oral arguments on the motion during an upcoming hearing in January 2018.
Onglyza Heart Failure Risks
The Onglyza litigation emerged following 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 should 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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