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.
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:
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.
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.