New MDLs Requested for Farxiga, Mirena, Hip Implants and Sorin 3T Heater

farxiga320x320The US Judicial Panel on Multidistrict Litigation (JPMDL) will hear argument on March 30 on whether to create new multi-district litigation docket (MDL) No. 2776 for Farxiga and Xigudo diabetes medicines.

Oral argument is scheduled starting in the morning at the US Courthouse in Phoenix, Arizona. In addition, oral arguments will be held to create the following MDLs:

Ketoacidosis and kidney failure

Plaintiff’s attorney Holly Dolejsi of Robins Kaplan L.L.P. in Minneapolis moved to transfer currently filed Faxiga and Xigduo cases to either the Southern District of New York before Judge Lorna G. Schofield, the Eastern District of Pennsylvania before Judge Mitchell Goldberg, or the Southern District of Illinois before Judge Nancy J. Rosenstengel, who all have Farxiga cases assigned to them.

The motion involves 18 pending cases in 6 district courts, with 13 of the 18 filed in New York. The Defendants The Defendants in these cases are Bristol-Myers Squibb Co., AstraZeneca Pharmaceuticals LP, AstraZeneca LP, AstraZeneca AB, and AstraZeneca PLC.

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

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.

While a cross-motion to include Farxiga cases with Invokana MDL No. 2750 was raised, considered and ultimately denied by the Panel following the hearing in Charlotte, North Carolina, that request was opposed by both the Invokana Plaintiffs’ counsel and Defendants who claimed that the litigations were sufficiently different such that a joint SGLT2 MDL was improvident.

A total of 100 lawsuits have been filed in the MDL since the courts created it in December.

 


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