Onglyza Lawsuits Move Forward, As Federal Litigation Issues Initial Practice and Procedure Order

Published on February 20, 2018 by Sandy Liebhard

Onglyza lawsuits have begun to move forward in the U.S. District Court, Eastern District of Kentucky, where all federally-filed claims involving the alleged link between saxagliptin and heart failure were recently centralized for the purpose of coordinated pretrial proceedings.

Onglyza Lawsuit Parties Ordered to Submit Brief Summaries

The judge overseeing the litigation issued an Initial Practice and Procedure Order on February 9th, which, among other things, directs the parties in each Onglyza and Kombiglyze XR lawsuit transferred to the Eastern District of Kentucky to submit a summary to the Court that includes:

  • A brief synopsis of the factual allegations involved in the case.
  • A brief summary of the legal issues involved in the case.
  • A brief description of any discovery that has been completed, including any depositions that have been taken.
  • If the case has been filed as a proposed class action, a description of the proposed class and an indication of any discovery that will be necessary before the class certification issue can be briefed, along with an anticipated schedule for that discovery.
  • A list of pending motions, with an indication regarding whether they are fully briefed.
  • Any other matter that counsel believe requires the immediate attention of the Court.

The submissions must be completed within 21 days from the date of the order, or within 21 days from the date that a case is transferred to the Court, whichever is first.

Onglyza Lawsuit Overview

More than 80 lawsuits filed against the manufacturers of Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin and metformin) are currently pending in the Eastern District of Kentucky. The centralized proceeding was established earlier this month, after the U.S. Judicial Panel on Multidistrict Litigation (JPML) determined that consolidation of the federal docket would improve judicial efficiency and preserve the resources of the courts, witnesses and parties involved in the lawsuits.

Onglyza and Kombiglyze XR are indicated to treat adults with Type 2 diabetes. Both are marketed and sold by AstraZeneca PLC.

Saxagliptin, the active ingredient in both Onglyza and Kombiglyze XR, belongs to a class of Type 2 diabetes medications called DPP-4 inhibitors. DPP-4 is an enzyme that breaks down GLP-1, an incretin hormone that stimulates the body to release insulin in response to a meal.

Type 2 diabetics secrete less GLP-1 than normal, which causes the pancreas to release inadequate amounts of insulin. By inhibiting DPP-4, saxagliptin allows GLP-1 to remain in the body longer, which causes the pancreas to produce more insulin.

The litigation involving Onglyza and Kombiglyze XR began to gain momentum in April 2016, shortly after the  FDA ordered new heart failure warnings for the labels of Onglzya and other saxagliptin-containing drugs. The agency acted in response to clinical trial data linking saxagliptin to a 27% increased risk of heart failure. The drug also appeared to be associated with a higher risk of all-cause mortality.

Plaintiffs who have filed Onglyza and Kombiglyze XR lawsuits claim that they were never warned of the potential for saxagliptin to cause heart failure and other cardiac injuries.

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