The U.S. Judicial Panel on Multidistrict Litigation (JPML) has agreed to establish a centralized proceeding for product liability lawsuits involving Farxiga and Xigduo XR. Going forward, all federal cases alleging a link between the Type 2 diabetes drugs and ketoacidosis or kidney damage will be transferred to the U.S. District Court, Southern District of New York, for coordinated pretrial proceedings.
Farxiga and Xigduo XR belong to a class of diabetes drugs called SGLT2 inhibitors. According to the JPML’s April 6th Transfer Order, at least 18 lawsuits have been filed in federal courts on behalf of individuals who allegedly developed diabetic ketoacidosis, kidney damage, and other serious complications related to treatment with the two medications. Plaintiffs filed a petition with the JPML seeking centralization of the federal docket in February, asserting that consolidation in a single court would promote judicial efficiency. The Panel agreed.
““The actions share factual questions arising from allegations that taking Farxiga or Xigduo XR may result in patients suffering kidney related-injuries, such as diabetic ketoacidosis and kidney damage,” the Transfer Order stated. “The actions thus implicate numerous common issues concerning the development, manufacture, testing, regulatory history, promotion, and labeling of the drugs. Centralization will eliminate duplicative discovery, prevent inconsistent pretrial rulings on Daubert issues and other pretrial matters, and conserve the resources of the parties, their counsel, and the judiciary.”
Last year, the JPML created a separate multidistrict litigation in New Jersey federal court for similar claims involving Invokana and Invokamet, SGLT2 inhibitors marketed by Johnson & Johnson’s Janssen Pharmaceuticals unit. More than 120 cases are now pending in that proceeding.
SGLT2 inhibitors prevent the absorption of glucose by the kidneys, allowing for its elimination via urine. Invokana, the first of the class and was approved by the U.S. Food & Drug Administration (FDA) in March 2013. Farxiga was cleared for sale in January 2014.
In December 2015, the FDA required that the manufacturers of all SGLT2 inhibitors update their product labeling with information about diabetic ketoacidosis, a potentially fatal condition that occurs due to a buildup of toxic ketones in the blood. The drugs’ labels were also updated to include information about life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that originate as urinary tract infections.
In June 2016, the FDA ordered the manufacturers of Invokana, Invokamet, Farxiga and Xigduo XR to strengthen label warnings regarding kidney complications, after the drugs were cited in more than 100 reports of acute kidney injury.