The U.S. Judicial Panel on Multidistrict Litigation (JPML) will hear oral arguments in December regarding a proposal to centralize all federally-filed Invokana lawsuits in a single U.S. District Court for the purposes of coordinated pretrial proceedings.
Court documents indicate that at least 57 product liability lawsuits have been filed in federal courts on behalf of individuals who suffered diabetic ketoacidosis, kidney problems, heart attacks and other injuries allegedly related to the use of Invokana. All of the plaintiffs similarly allege that they were not adequately warned about the side effects associated with the drug, which was the first of a new class of Type 2 diabetes medications called SGLT2 inhibitors to be approved for use in the U.S.
Invokana plaintiffs filed a Motion for Transfer with the JPML last month, seeking consolidation of all federally-filed claims of this type in the U.S. District Court, District of New Jersey. Johnson & Johnson and its Janssen’s Pharmaceuticals unit have also voiced support for this proposal.
The JPML has indicated that it will hear oral arguments on the matter during its next Hearing Session, which has been scheduled for December 1st in Charlotte, North Carolina.
Invokana was approved by the U.S. Food & Drug Administration (FDA) in March 2013. Since coming on the market, it and other SGLT2 inhibitors have been the subject of serious safety concerns as reports of their potential side effects have mounted. In December 2015, the FDA required that the manufacturers of all SGLT2 inhibitors implement label changes to reflect the potential for diabetic ketoacidosis. At that time, 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, the FDA ordered the manufacturers of Invokana and several other SGLT2 inhibitors to strengthen label warnings regarding kidney complications, after the drugs were cited in more than 100 reports of acute kidney injury. In September 2015, Invokana’s label was updated to note a potential risk of bone fractures. The FDA is also currently investigating a possible association between the use of Invokana and leg and foot amputations, especially those involving the toes.