Federally-filed Invokana lawsuits are continuing to move forward in the U.S. District Court, District of New Jersey. According to a Case Management Order dated June 1st, the Court will convene Science Day on July 19, 2017, at 9:30 a.m. State court judges presiding over other Invokana litigations will be invited to attend.
Science Days are common events in large, complex litigations. During Science Day, the parties to Invokana and Invokamet lawsuits will have an opportunity to apprise the Court of the medical and scientific issues central to their cases. Science Day presentations are generally off-the-record and non-adversarial in nature.
The June 1st Case Management Order further notes that 453 cases were pending in multidistrict litigation as of May 26, 2017. The federal Invokana litigation was established last December to allow claims of this nature to undergo coordinated pretrial proceedings. Initially, just 55 cases were centralized in the District of New Jersey.
Invokana and Invokamet are Type 2 diabetes medications known as SGLT2 inhibitors. Both contain canagliflozin, while Invokamet also contains an older diabetes drug called metformin. SGLT inhibitors inhibit the absorption of sugar by the kidneys, thereby lowering blood glucose levels by facilitating its removal from the body via urine. Invokana was brought to market in March 2013, and was the first SGLT inhibitor to be approved for sale in this country.
In December 2015, the U.S. Food & Drug Administration (FDA) ordered the manufacturers of Invokana, Invokamet and other SGLT2 inhibitors to add new information to their product labels regarding a potential risk of diabetic ketoacidosis. This condition occurs when toxic acids called ketones accumulate in the blood, and may lead to diabetic coma or death when not recognized and treated appropriately.
Last June, the FDA ordered the manufacturers of several SGLT2 inhibitors, including Invokana and Invokamet, to strengthen label warnings regarding renal complications, after the drugs were implicated in more than 100 reports of acute kidney injury.
Just last month, the labels for Invokana and Invokamet were updated with a new black box warning regarding a risk of leg and foot amputations. A black box is the most urgent label warning employed by the FDA, and is reserved for the very serious or life-threatening adverse events.