Plaintiffs around the country continue to file Invokana lawsuits in the U.S. District Court, District of New Jersey, where all federally-filed claims involving the drug’s alleged link to diabetic ketoacidosis and other serious side effects have been centralized before a single judge.
According to a report issued earlier this month by the U.S. Judicial Panel on Multidistrict Litigation, there were currently 952 cases involving either Invokana or Invokamet pending in the District of Jersey as of December 15th. That represents a slight increase since November 16th, when the Court reported 943 filings.
All of the currently pending claims were filed on behalf of individuals who experienced serious complications allegedly as a result of their exposure to canagliflozin, the active ingredient in Invokana and Invokamet, including:
Invokana and Invokamet are manufactured by Johnson & Johnson’s Janssen Pharmaceuticals unit. Both drugs belong to a class of Type 2 diabetes medications called SGLT2 inhibitors, which work by preventing the absorption of glucose by the kidneys, thereby allowing its elimination from the body through urine. Invokana – the first of the SGLT2 inhibitor class – was approved by the U.S. Food & Drug Administration (FDA) in March 2013 and was the first SGLT2 inhibitor to be cleared for sale in the U.S., while Invokamet was cleared in August 2014
Since coming to market, Invokana and other SGLT2 inhibitors have proven to be popular. According to data provided by the Institute for Safe Medication Practices last year, use of SGLT2 inhibitors has grown from 336,000 prescriptions dispensed in the first quarter of 2014 to more than 2 million prescriptions in the final quarter of 2016. However, the medications have been tied to a number of major side effects.
In December 2015, for example, the FDA required that the manufacturers of all SGLT2 inhibitors to add diabetic ketoacidosis warnings to 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 modified to warn of an increased risk for bone fractures and decreased bone density.
In June, 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.
According to Johnson & Johnson’s 3rd quarter earnings statement, at least 1,100 Invokana and Invokamet lawsuits have been filed in court’s nationwide as of October 1, 2017. In addition to the multidistrict litigation underway in the District of New Jersey, additional claims are pending in Pennsylvania, California and New Jersey state courts. Several claims have also been filed in Canada.