Invokana Caused Ketoacidosis, Kidney Failure, Urinary Tract Infections, Lawsuit Alleges

Less than a month after switching to Invokana, an Indiana woman indicates that the new-generation diabetes drug caused her to develop diabetic ketoacidosis, a urinary tract infection and severe kidney problems, which led to acute renal failure.

In a complaint (PDF) filed in the U.S. District Court for the District of New Jersey on May 15, Amanda Fox and her husband, Tim, indicate that Johnson & Johnson and its Janssen Pharmaceuticals subsidiary failed to adequately research the potential side effects of Invokana, and withheld information and warnings from consumers and the medical community.

Invokana (canagliflozin) is a controversial new diabetes treatment introduced in March 2013, which has been aggressively promoted by the drug makers in an attempt to convince doctors and patients to switch their medications. However, it has been linked to a steady stream of serious safety risks since it hit the market, which have led the FDA to require several warning label updates during the first few years Invokana has been on the market.

Jones indicates that she began taking Invokana in March 2014. As a direct result of the medication, Jones claims that she suffered diabetic ketoacidosis and acute renal failure on April 2, 2014. In addition, she suffered several urinary tract infections in 2014, and claims that she has been left with life-long complications due to health problems caused by Invokana.

“[Invokana was] defective due to inadequate warnings or instructions, as the Defendants knew or should have known that the product created a risk of serious and dangerous side effects, including stroke, heart attack, ketoacidosis, and severe kidney damage, as well as other severe and personal injuries which are permanent and lasting in nature, and the Defendants failed to adequately warn of said risk,” according to the complaint.

Over the past two years, the FDA has required the drug makers to add a steady stream of new warnings to the drug label, including new information added last week about the risk that Invokana may cause leg and foot amputations.

In December 2015, the FDA required Johnson & Johnson to add new diabetic ketoacidosis warnings to Invokana, indicating that the medication may cause a dangerous build up of acid levels in the blood, which typically results in the need for emergency treatment ot 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.

That same FDA warning included information about serious urinary tract infections from Invokana, indicating that at least 19 cases of life-threatening blood infections and kidney infections that started as urinary tract infections had been reported during the first 18 months Invokana was on the market. All of those cases required hospitalization, with many involving treatment in an intensive care unit and the need for dialysis to treat kidney failure.

In June 2017, 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.

“Defendants knew or should have known the risks associated with the use of Invokana, including the risks of acute renal failure, and urinary tract infections (among other injuries),” Fox indicates in the lawsuit. “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. This conduct, as well as the product defects complained of herein, was a substantial factor in bringing about and exacerbating Plaintiff’s injuries.”

Fox’s complaint joins a growing number of Invokana lawsuits filed by individuals nationwide, each raising similar allegations that suggest the drug maker placed the desire for profits before consumer safety when they introduced the new-generation diabetes treatment.

Given the similar questions of fact and law, Fox’s case will be consolidated as part of an Invokana MDL, 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, Fox’s claim and others involved in the litigation may later be remanded to U.S. District Courts nationwide for separate trial dates.