Several Invokana plaintiffs who sued Janssen Pharmaceuticals after they suffered severe kidney damage have filed a motion in federal court to consolidate all the claims into a multidistrict litigation docket.
The request to the Judicial Panel on Multidistrict Litigation is a critical first step in turning individual claims into a wide-reaching mass tort.
Currently, there are at least 56 actions pending in 11 different judicial districts alleging similar wrongful conduct on the part of defendants.
The movants propose the judge should be US District Judge Brian R. Martinotti in New Jersey, in part because Janssen and its parent company Johnson & Johnson are headquartered in the state. Judge Martinotti has supervised litigation involving Mirena, Yaz, Yasmin and the DePuy Hip, and has 36 of the Invokana cases already on his docket.
1.5 million prescriptions
The motion follows a safety warning by the FDA on June 17 strengthening the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). Based on recent reports, the FDA revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk.
Further warnings were added to the label in August 2016. The new warnings stated that fatal cases of ketoacidosis have been reported in patients taking Invokana. The FDA advised doctors to inform patients that ketoacidosis is a serious life-threatening condition.
In the year from October 2014 to September 2015, 1.5 million prescriptions were written for either canagliflozin or dapagliflozin.
“SGLT2 inhibitors, including Invokana, are designed to inhibit renal glucose reabsorption with the goal of lowering blood glucose. As a result, excess glucose is not metabolized but instead is excreted through the kidneys of a population of consumers already at risk for kidney disease,” the motion states. “Though Invokana is indicated for only improved glycemic control in type 2 adult diabetics, defendants have marketed and continue to market Invokana for off-label purposes, including but not limited to weight loss, reduced blood pressure, and improved glycemic control in type 1 diabetics.”
“Defendants engaged in aggressive, direct-to-consumer and physician marketing and advertising campaigns for Invokana. However, consumers of Invokana were misled as to the drug’s safety and efficacy, and as a result have suffered serious and dangerous injuries,” the motion states.
The motion was filed by Christopher A. Seeger and Jeffrey Grand of Seeger Weiss LLP in New York. Notices of appearance in the MDL are due by Oct. 5 and responses to the motion are due by Oct. 12.