The federal court overseeing hundreds of Invokana lawsuits will convene “Science Day” next Thursday, July 19th. The litigation’s next Case Management Conference is scheduled for the following day.
Science Day will commence at 8:30 a.m. in the U.S. District Court, District of New Jersey. The event provides the parties with an opportunity to acquaint the Court with the medical and scientific issues central to their cases The Invokana presentations will be off-the-record and not subject to cross examination.
The Court will convene the Case Management Conference at 11:00 a.m., with lead and liaison counsel appearing at 10:00 a.m. The parties have been directed to submit a joint agenda to the Court no later than five days before the conference, which is to include an up-to-date list of Invokana lawsuits pending in the proceeding.
More than 440 Invokana lawsuits are currently pending in the District of New Jersey, where federally-filed product liability claims involving the drug’s alleged side effects have been centralized before a single judge for the purposes of coordinated pretrial proceedings.
Invokana belongs to a class of Type 2 diabetes medications known as SGLT2 inhibitors, which lower blood sugar levels by inhibiting absorption via the kidneys. Invokana was brought to market in March 2013, and was the first SGLT2 inhibitor to be approved for sale in this country.
Since coming to market, Invokana and other SGLT2 inhibitors have been embroiled in several safety controversies. In December 2015, for example, the U.S. Food & Drug Administration (FDA) ordered the drugs’ manufacturers to update their product labels to note 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. At the same time, the labels were updated with new information regarding serious urinary tract infections that could result in hospitalization.
Last June, the FDA ordered the manufacturers of several SGLT2 inhibitors, including Invokana, Invokamet, Farxiga and Xigduo XR, to strengthen warnings on potential kidney side effects, after the drugs were implicated in more than 100 reports of acute renal injury.
This past May, the prescribing information for Invokana and Invokamet was modified with a new black box warning regarding a risk of leg and foot amputations. A black box is the FDA’s most urgent safety notice, and is reserved for the very serious or life-threatening side effects.