Plaintiffs who allegedly suffered diabetic ketoacidosis and other serious side effects allegedly associated with Invokana and Invokamet continue to file lawsuits against the drugs’ manufacturers.
According to a Case Management Order dated January 11th, there are at least 1,001 Invokana and Invokamet lawsuits pending in the federal multidistrict litigation currently underway in the U.S. District Court, District of New Jersey.
The number of filings has increased by 43 since November 7, 2017, when the Court reported 943 pending cases.
Among other things, the Order noted that the parties continue to meet and confer regarding discovery and a proposed revised scheduling order. The proposed order is to be submitted to the Court prior to the next case management conference.
The Court also indicated that it still expects to have the first Invokana lawsuit trial scheduled for September 2018. The parties are ordered to use this proposed trial date when scheduling discovery and pre-trial orders.
The Invokana litigation will convene its next Status Conference on February 8th at 11:00 a.m.
“Counsel is required to submit via email a joint agenda five (5) days prior to the next scheduled conference, which shall include an up to date list of Invokana cases pending in this Court,” the Order states. “If there are any disagreements as to the agenda, counsel shall set forth each party’s position.”
Invokana (canagliflozin) was approved by the U.S. Food & Drug Administration (FDA) in March 2013 to treat adults with Type 2 diabetes. Invokamet (canagliflozin and metformin) was cleared in August 2014.
Canagliflozin belongs to a class of Type 2 diabetes drugs called SGLT2-Inhibitors, which lower blood sugar levels by inhibiting the absorption of glucose by the kidneys. Since Invokana – the first in the class – came to market, SGLT2 inhibitors have been tied to a wide range of side effects.
In December 2015, for example, the FDA required that the manufacturers of all SGLT2 inhibitors including diabetic ketoacidosis warnings on their product labels. The labels were also modified at that time to include information about life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that originate as urinary tract infections.
In September 2015, the labels for Invokana and Invokamet were updated to note a possible association with an increased risk for bone fractures and decreased bone density.
In June 2016, the FDA ordered the manufacturers of Invokana, Invokamet, Farxiga and Xigduo XR to strengthen their labels’ existing kidney warnings, after the drugs were cited in more than 100 reports of acute kidney injury.
In May 2017, information about an increased risk of lower limb amputations (mostly involving the toes) was added to the prescribing information for Invokana and Invokamet.
Early clinical trial results for canagliflozin also suggested that patients using these drugs face a higher risk for suffer heart problems – including heart attack and stroke – during the first 30 days of treatment.