Court Overseeing Federal Invokana Lawsuits Eyes September 2018 for First Bellwether Trial

Published on April 4, 2017 by Sandy Liebhard

The federal court overseeing dozens of products liability lawsuits is involving Invokana and Invokamet is already looking ahead to the litigation’s first bellwether trials. According to a Case Management Order issued in U.S. District Court, District of New Jersey, on March 30^th, the first such trial could be convened as early as September 2018.

Court documents indicate that 168 claims are currently pending in the District of New Jersey, all of which were filed on behalf of plaintiffs who experienced diabetic ketoacidosis or kidney injuries allegedly related to treatment with Invokana or Invokamet.  Similar cases filed in federal courts around the country continue to be transferred to the multidistrict litigation in New Jersey. The proceeding’s bellwether trials will act as test cases, and could provide insight into how juries might decide similar lawsuits.

The March 30^th Case Management Order directs the parties to use the September 2018 proposed trial date when scheduling discovery and pre-trial orders. The Court has also ordered that they meet and confer on several issues, including:

• Plaintiffs’ and Defendants’ fact sheets
• Scope of discovery informally served on Defendants
• Discovery plan and pre-trial schedule (including the selection of bellwether cases)
• An order addressing “bundled” cases
• A proposed order regarding Defendants’ requirement to answer individual complaints and process for service of complaint

Counsel are to  file a submission with the Court setting forth their positions with regard to any areas agreement/disagreement at least 10 days prior to the next case management conference. That conference is scheduled for April 27th at 10:00 a.m.

Invokana and Invokamet: What Are the Potential Risks?

Invokana (canagliflozin) and Invokamet (canagliflozin and metformin) belong to a class of Type 2 diabetes medications called SGLT2 inhibitors. These drugs lower blood sugar levels by inhibiting the absorption of glucose by the kidneys, resulting in its elimination via urine. Invokana was brought to market in March 2013, and was the first SGLT inhibitor to be approved for use in this country. Other diabetes drugs in the SGLT2 inhibitor class include:

• Farxiga (dapagliflozin)
• Xigduo XR (dapagliflozin and metformin extended-release)
• Jardiance (empagliflozin)
• Glyxambi (empagliflozin and linagliptin)

In December 2015, the U.S. Food & Drug Administration (FDA) announced that the labels for all SGLT2 inhibitor drugs would be updated with information about diabetic ketoacidosis, a dangerous condition related o the accumulation of toxic acids (ketones) in the blood. Diabetic ketoacidosis can 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.