Invokana Lawsuits Move Forward, As Federal Court Approves Plaintiff Fact Sheet

Published on July 20, 2017 by Sandy Liebhard

Hundreds of Invokana lawsuits continue to move forward in the U.S. District Court, District of New Jersey. A Case Management Order dated June 16^th indicates that the Court has approved a Plaintiff Fact Sheet, as well as protocols for its use.

The Plaintiff Fact Sheet is to be used by all claimants with pending cases, as well as any who file lawsuits or have cases transferred to the District of New Jersey in the future. Plaintiffs’ whose Invokana lawsuits were assigned to the multidistrict litigation as of May 3, 2017 were to complete and serve their Fact Sheets by July 7, 2017. All others must do so no later than 45 days after the Defendants file a Notice of Answer and Affirmative Defenses.

Fact Sheets are used in large, complex litigations to streamline discovery by replacing formal interrogatories.

At least 440 Invokana lawsuits are pending in the District of New Jersey, all of which were filed on behalf of individuals who suffered diabetic ketoacidosis, kidney damage and other side effects allegedly related to treatment with the Type 2 diabetes medication. Plaintiffs with cases pending in the litigation claim that they were not adequately warned about the potential for serious Invokana side effects and accuse the drugs’ manufacturers of concealing its risks.

What is Invokana?

Invokana was the first SGLT2 inhibitor approved by the U.S. Food & Drug Administration (FDA) to treat Type 2 diabetes. These drugs lower blood sugar levels by inhibiting its absorption via the kidneys, thus allowing glucose to be eliminated from the body via urine.

In December 2015, the FDA ordered manufacturers of Invokana and other SGLT2 inhibitors to update their product labels with warnings regarding diabetic ketoacidosis, a dangerous condition related to the accumulation of toxic acids called ketones in the blood. If not recognized and treated immediately, ketoacidosis can progress to diabetic coma or death.

At the same time, the labels for all SGLT2 inhibitors were updated with information regarding serious urinary tract infections that could result in hospitalization.

The FDA ordered another label update in May for Invokana and several other SGLT2 inhibitors, after the drugs were implicated in more than 100 reports of acute renal injury.

In May, the Invokana label was updated yet again, this time with a new black box warning – the FDA’s most urgent safety warning – regarding a risk of leg and foot amputations.