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A woman who was prescribed the new-generation diabetes drug Invokana shortly after it was introduced indicates that side effects associated with use of the medication caused her to develop kidney failure and suffer a stroke, according to a lawsuit filed last week against the drug makers.
The complaint (PDF) was filed filed by Brenda Lozano in the U.S. District Court for the District of New Jersey on May 26, indicating that Johnson & Johnson and its Janssen subsidiary manufactured and sold a defective and unreasonably dangerous diabetes drug, withholding warnings from consumers and the medical community.
Lozano was prescribed Invokana in early 2013, shortly after it was approved by the FDA for treatment of type 2 diabetes. She continued to use the drug through June 2015, indicating that Invokana side effects were the cause of her subsequent kidney failure and stroke.
Since Invokana (canagliflozin) was introduced in March 2013, the drug makers have aggressively marketed the drug in an attempt to convince doctors to switch their patients to the medication, 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.
“Since Invokana’s release, the FDA has received a significant number of reports of severe kidney damage among users of Invokana,” the lawsuit states. “”An analysis of the FDA adverse event database shows that patients taking Invokana are several times more likely to report severe kidney damage than those taking non-SGLT2 diabetes drugs to treat diabetes. Despite Defendants’ knowledge of the increased risk of severe injury among Invokana users, Defendants did not warn patients but instead continued to defend Invokana, mislead physicians and the public, and minimize unfavorable findings.”
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 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.
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.
Lozano’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, Lozano’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, Lozano’s claim and others involved in the litigation may later be remanded to U.S. District Courts nationwide for separate trial dates.