Court Overseeing Federal Invokana Lawsuits Finalizes Plans for Science Day

Published on March 22, 2017 by Sandy Liebhard

The federal court overseeing hundreds of injury lawsuits involving Invokana and Invokamet has finalized plans for Science Day. According to an Order issued in the U.S. District Court, District of New Jersey on March 21^st, Science Day is to be convened on June 19, 2017, at which time each side will have two hours to make their presentations to the Court.

Multidistrict litigations that involve complex matters routinely schedule Science Days. These events allow the parties to bring the Court up to speed on the medical and scientific issues central to their cases in a non-adversarial manner.

According to the Court’s May 21^st Order, topics to be addressed during the Invokana Science Day include:

• A background on diabetes
• A background on anti-hyperglycemic therapy, including SGLT-2 inhibitors
• Other diabetes treatments
• The mechanism of action of Invokana and approved indications
• The injuries alleged in the litigation.
• Medical literature and regulatory statements regarding the use of Invokana and/or SGLT-2 inhibitors
• Other matters the parties select to present on relative to the science behind Invokana

The lecture-style presentations may be made by the parties’ attorneys, by their experts, or by a combination of both. The presenters may use PowerPoint or other demonstrative aids. The parties’ attorneys will be able to lead the experts through a modified direct examination in order to focus the presentations.  Opposing counsel will not be able to question the presenters, though the Court will have the opportunity to do so.

A Court reporter will be supplied by the parties to transcribe the proceedings. However, the transcript is not to be used for any purpose other than the Court’s benefit to gather informal knowledge.

FDA Warns of Potential Invokana Side Effects

At least 126 lawsuits involving Invokana and Invokamet are currently pending in the District of New Jersey, where all federally-filed injury claims involving the Type 2 diabetes drugs have been centralized for the purposes of coordinated pretrial proceedings. Plaintiffs pursuing these claims are alleged to have suffered diabetic ketoacidosis, kidney damage and other injuries associated with the drugs.

Invokana and Invokamet belong to a class of Type 2 diabetes medications called SGLT2 inhibitors, which inhibit the absorption of sugar by the kidneys. In December 2015, the U.S. Food & Drug Administration (FDA) ordered the manufactures of all medications in this class to update their labeling with information about diabetic ketoacidosis, a serious complication that has the potential to result in diabetic coma and death.  At that time, the labeling was also updated with information about life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) originating as urinary tract infections.

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.