The family of a Georgia man has filed a new lawsuit following his death from complications allegedly associated with Invokana, a Type 2 diabetes drug marketed by Johnson & Johnson’s Janssen Pharmaceutical’s subsidiary.
According to a complaint filed in the U.S. District Court, District of New Jersey, on October 27th, Raymond Jack, Sr., was prescribed Invokana in March 2015. The following June, he was hospitalized for an acute stroke. He was subsequently diagnosed with acute kidney injury, acute renal insufficiency, and diabetic ketoacidosis stroke.
The plaintiff was hospitalized again in September 2015, at which time he was diagnosed with renal insufficiency, acute stroke, acute toxic metabolic encephalopathy, acute kidney injury, dehydration, and hypokalemia.
Jack was hospitalized for a third time in October 2015, and diagnosed with acute kidney injury, urinary tract infection, chronic kidney disease Stage III, and volume depletion.
The plaintiff’s health continued to decline due to his complications, resulting in his death in November 2015.
The complaint charges that Jack’s injuries and subsequent death were a foreseeable consequence of his Invokana treatment. The lawsuit further claims that Johnson & Johnson and Janssen were aware that Invokana could cause potentially life-threatening side effects and complications, but failed to provide doctors and patients with adequate warnings of these risks.
“Defendants also, through their marketing materials, misrepresented and exaggerated the effectiveness of INVOKANA, both as to its ability to lower glucose, and its benefit for non-surrogate measures of health, such as reducing adverse cardiovascular outcomes,” the complaint states.
“Defendants’ marketing campaign willfully and intentionally misrepresented the risks of INVOKANA and failed to warn about the risks of diabetic ketoacidosis, kidney failure, sepsis, and other injuries,” it continues. (Case 3:17-cv-09809)
Invokana (canagliflozin) was approved by the U.S. Food & Drug Administration (FDA) in March 2013, and was the first SGLT2 inhibitor medication cleared by the agency to treat patients with Type 2 diabetes. Like other drugs in this class, Invokana works by preventing the absorption of glucose by the kidneys, resulting in its elimination from the body via urine.
In May 2015, the FDA announced it was reviewing all SGLT2 inhibitors for a possible link to diabetic ketoacidosis, a dangerous condition caused by the accumulation of toxic blood acids called ketones. In December of that year, the labels for Invokana and other SGLT2 inhibitor medications were updated with warnings about this potential side effect. The drug’s labels were also updated with warnings regarding serious urinary tract infections that can progress to life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis).
In September 2015, the labels for Invokana and Invokamet (canagliflozin and metformin) were modified to warn of an increased risk for bone fractures and decreased bone density.
The labels for several SGLT2 inhibitors, including Invokana and Invokamet, were updated yet again in June 2016, after the medications were linked to more than 100 reports of acute kidney injury.
In May 2017, information about an increased risk of lower limb amputations was added to the prescribing information for Invokana and Invokamet.