Invokana Risks Include Ischemic Stroke, Lawsuit Claims

Amid a growing number of Invokana lawsuits filed nationwide by individuals who suffered diabetic ketoacidosis, kidney failure and other injuries, one of the latest cases indicates that side effects of the new-generation diabetes also increases the risk of ischemic stroke.

In a complaint (PDF) filed in the U.S. District Court for the District of New Jersey on June 20, James Routhe alleges that Johnson & Johnson and its Janssen Pharmaceuticals subsidiary failed to adequately warn consumers and the medical community about the stroke risk with Invokana.

Routh indicates that he began taking Invokana to treat his type 2 diabetes in March 2015. Only a few months later, Routh suffered an ischemic stroke, which occurs when the blood supply to the brain is blocked, potentially resulting in severe brain damage.

According to the complaint, Routhe was hospitalized due to the Invokana ischemic stroke, required substantial medical treatment and has been left with permanent injuries.

The lawsuit alleges that if Routhe or his doctor had known about the numerous Invokana risks, he never would have taken the controversial diabetes drug, as there are safer alternatives that do not carry the same health risks.

“Plaintiff agreed to initiate treatment with Invokana in an effort to reduce his blood sugar. In doing so, Plaintiff relied on claims made by Defendants that Invokana was safe and effective for the treatment of diabetes,” the complaint filed by Routhe states. “Instead, Invokana can cause severe injuries, including heart attack, stroke, renal failure, renal impairment, renal insufficiency, kidney injury and diabetic ketoacidosis. After beginning treatment with Invokana, and as a direct and proximate result thereof, on or about August 30, 2015, Plaintiff suffered from Ischemic Stroke/CVA.”

The complaint raises similar allegations to those presented in hundreds of other Invokana injury lawsuits filed in recent months, indicating that the drug makers knew or should have known about the Invokana risks, yet continued to market their new-generation diabetes drug without including appropriate warnings.

Since Invokana (canagliflozin) hit the market in March 2013, the manufacturers have aggressively promoted the drug as a superior diabetes treatment, which works in a different way than other diabetes drugs, inhibiting some kidney functions to increase the amount of sugar excreted in the urine. However, over the past few years, the FDA has required a number of Invokana warning updates, as new safety risks have been linked to the medication.

In December 2015, the FDA required Johnson & Johnson to add new diabetic ketoacidosis warnings to Invokana, indicating that the medication increases the risk of this serious condition, which typically results in the need for emergency treatment to avoid life-threatening injury. Prior to the update, the Invokana warnings failed to alert consumers about the importance of seeking immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting.

In June 2016, the FDA required additional label warnings about the link between Invokana and kidney risks, indicating that the medication may increase the risk of acute kidney injury and other severe health problems.

Given the similar questions of fact and law, Routhe’s case will be consolidated as part of an Invokana MDL (Multi-District Litigation), which is centralized before U.S. District Judge Brian Martinotti in the District of New Jersey for coordinated discovery and pretrial proceedings. However, if Invokana settlements or another resolution for the cases is not reached during the MDL process, Routhe’s claim and others involved in the litigation may later be remanded to U.S. District Courts nationwide for separate trial dates.