Personal injury lawsuits filed on behalf of individuals who suffered diabetic ketoacidosis and other serious side effects allegedly related to the use of Invokana or Invokamet continue to move forward in the U.S. District Court, District of New Jersey. According to a Case Management Order dated May 1st, the Court has established a discovery schedule that, among other things, addresses the selection of cases for the litigation’s bellwether trials.
At least 230 Invokana and Invokamet lawsuits are currently undergoing coordinated pretrial proceedings in the District of New Jersey. In March, the Court had indicated its intention to convene a series of bellwether trials beginning in September 2018. These trials will act as test cases, and could provide insight into how juries might rule in similar claims involving the Type 2 diabetes drugs.
The Court’s May 1st Order directs the parties to submit a proposed Case Management Order by June 1, 2017 that sets forth the process and parameters for selecting bellwether plaintiffs, as well as the case categories that should be the first to proceed. By August 31st, they are to identify in writing an agreed to number of bellwether candidates per side that will serve as the bellwether discovery pool.
Bellwether discovery is to take place between September l, 2017 and December 15, 2017. A maximum of four (4) case-specific depositions will be permitted per side for each case, unless otherwise agreed by the parties or ordered by the Court for good cause. No case-specific depositions will proceed outside of the cases selected for the bellwether pool.
By January 5, 2018, each side is to furnish the Court with their recommendations for the bellwether trial pool. By January 19th, the Court will select three (3) bellwether cases for the first three trials and designate the order of such trials. Additional discovery on the final bellwether trial cases may be conducted from January 22, 2018 through March 16, 2018.
Invokana (canagliflozin) was approved by the U.S. Food & Drug Administration (FDA) in March 2013 and was the first SGLT2 inhibitor cleared by the agency to treat Type 2 diabetes. Invokamet (canagliflozin and metformin) was approved by the FDA the following year.
In September 2015, the labels for Invokana and Invokamet were updated to include information about a possible increased risk of bone fractures. That December, the FDA announced that the labels for all SGLT2 inhibitor drugs would be modified with information about diabetic ketoacidosis, a dangerous condition that can lead to diabetic coma or death when not recognized and treated appropriately.
In May 2016, the FDA announced it was investigating a possible association between canagliflozin and an increased risk of lower limb amputations (mostly involving the toes). Just a month later, the agency ordered the manufacturers of several SGLT2 inhibitors, including Invokana and Invokamet, to strengthen kidney side effect warnings included on the labels, after the drugs were implicated in more than 100 reports of acute kidney injury.