The Judicial Panel on Multidistrict Litigation established MDL No. 2776 in New York to hear claims of diabetic ketoacidosis and kidney damage caused by the Farxiga and Xigduo diabetes drugs.
The defendants in In Re: Farxiga (Dapagliflozin) Products Liability Litigation are Bristol-Myers Squibb Co., AstraZeneca Pharmaceuticals LP, AstraZeneca LP, AstraZeneca PLC, and AstraZeneca AB. There are 18 actions that involve allegations that ingestion of the drug Farxiga may cause a variety of injuries, including diabetic ketoacidosis and kidney damage.
The JPMDL assigned the cases to Judge Lorna G. Schofield of the Southern District of New York. She is already presiding over 13 constituent and tag-along actions pending in the district
Farxiga and its sister drug Xigduo XR belong to a class of diabetes drugs known as Sodium Glucose Cotransporter 1 2 (SGLT2) inhibitors. Other SLGT2 inhibitors include Invokana (canagliflozin) and Jardiance (empagliflozin). 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 actions thus implicate many common issues concerning the development, manufacture, testing, regulatory history, promotion, and labeling of the drugs.
As a result of ingesting Farxiga, the plaintiffs have suffered sudden onset of life-threatening diabetic ketoacidosis (often in the setting of normal blood glucose levels), and/or acute renal failure, and/or pyelonephritis (kidney infection) and/or urosepsis and continue to suffer from the sequelae of these injuries. Farxiga (dapagliflozin) is a pharmaceutical drug used to treat Type 2 Diabetes. All of these injuries were the subject of recent FDA safety advisories.
On January 8, 2014, the FDA approved Farxiga for use in treatment of type 2 diabetics.2 Farxiga is a part of the gliflozin drug class. The gliflozin class is referred to generally as SGLT2 (short for “Sodium Glucose Cotransporter 2”) inhibitors. Xigduo XR was (dapagliflozin combined with metformin) designed and made by the same defendants as Farxiga, and is an extension of the Farxiga product line. Xigduo XR was approved shortly after Farxiga, on October 29, 2014.
FDA safety warning
On December 4, 2015 the FDA issued a safety communication disclosing they had found 73 adverse events reported between March 2013 and May 2015 that required hospitalization due to ketoacidosis-related to SGLT2 inhibitors. The FDA noted adverse event reports “include only reports submitted to FDA, so there are likely additional cases about which we are unaware.”
The same safety communication also warned of “life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis). In light of the data disclosed in the December 4, 2015 safety communication, the FDA changed the label for Farxiga and Xigduo XR to include a warning “about the risks of too much acid in the blood” and urged patients taking SGLT2 inhibitors to stop taking the drug and seek immediate medical attention if they have any symptoms of ketoacidosis. The FDA also required a label change to warn of urosepsis and pyelonephritis. On June 14, 2016, the FDA issued a safety announcement which advised that the existing warning about the risk of acute kidney injury on the Farxiga and Xigduo labels would be strengthened.