Johnson & Johnson has once again been accused of concealing side effects allegedly associated with Invokana, one of the company’s most important Type 2 diabetes medications. According to lawsuits filed earlier this month in New Jersey federal court, those side effects include an increased risk of ischemic stroke, as well as a dangerous type of urinary tract infection called urosepsis.
The new filings are among more than 400 Invokana and Invokamet lawsuits now pending in the U.S. District Court, District of New Jersey, where all federal claims involving the drugs have been consolidated in a multidistrict litigation. In addition to urosepsis and stroke, plaintiffs participating in this litigation allege that treatment with Invokana or Invokamet can result in diabetic ketoacidosis, kidney failure and other serious complications.
Invokana Urosepsis Allegations
According to his June 12th filing, George Stomi, Jr. was prescribed Invokana in July 2013. In August of the following year, he was diagnosed with urosepsis (a urinary tract infection which has turned septic), resulting in his hospitalization. (Case 3:17-cv-04215)
“The development of Plaintiff’s injuries was preventable and resulted directly from Defendants’ failure and refusal to conduct proper safety studies, failure to properly assess and publicize alarming safety signals, suppression of information revealing serious and life-threatening risks, willful and wanton failure to provide adequate instructions, and willful misrepresentations concerning the nature and safety of Invokana,” the complaint states.
Invokana Ischemic Stroke Allegations
James Routhe began taking Invokana in March 2015, and experienced an ischemic stroke just a few months later. His lawsuit asserts that the stroke was preventable, alleging that it was the direct result of the Defendants’ “failure and refusal” to conduct proper safety studies of Invokana, as well as a failure to properly assess and publicize alarming safety signal associated with its use. (Case 3:17-cv-04497)
“Despite their knowledge of data indicating that Invokana use is causally related to the development of diabetic ketoacidosis, kidney failure, stroke, and heart attack, Defendants promoted and marketed Invokana as safe and effective for persons such as Plaintiff throughout the United States, including Iowa and New Jersey,” the lawsuit charges.
Invokana Safety Warnings
Invokana (canagliflozin) belongs to a class of Type 2 diabetes medications called SGLT2 inhibitors. Brought to market in March 2013, Invokana is now the market leader in this class. Johnson & Johnson also markets Invokamet, a medication that combines canagliflozin and metformin.
In December 2015, the U.S. Food & Drug Administration (FDA) ordered the manufacturers of Invokana, Invokamet and other SGLT2 inhibitors to add new information to their product labels regarding a potential risk of diabetic ketoacidosis. At that time, the labeling was also updated to include information about life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that originate as urinary tract infections.
Last June, the FDA ordered stronger kidney warnings for Invokana and certain other SGLT2 inhibitors, after the drugs were implicated in more than 100 reports of acute kidney injury. This past May, the labels for Invokana and Invokamet were updated with a new black box warning regarding a risk of leg and foot amputations.