Invokana Urosepsis Lawsuit Alleges Urinary Tract Infection Caused by Diabetes Drug

According to allegations raised in a product liability lawsuit recently filed against Johnson & Johnson and its Janssen subsidiary, side effects of Invokana caused a California man to suffer a severe sepsis infection in his urinary tract, known as urosepsis. 

The complaint (PDF) was filed by George Stomi, Jr. in the U.S. District Court for the District of New Jersey on June 12, indicating that the drug makers knew or should have known about the Invokana urosepsis risk, yet failed to adequately warn users of their new-generation diabetes drug or the medical community.

Stomi indicates that he was prescribed Invokana in July 2013, shortly after the medication was approved in the U.S. However, in August 2014 he was diagnosed with urosepsis, which is a urinary tract infection that turns septic. It is a severe infection that resulted in Stomi being hospitalized.

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“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 lawsuit states. “This conduct, as well as the product defects complained of herein, were substantial factors in bringing about and exacerbating Plaintiff’s injuries.”

Since Invokana (canagliflozin) hit the market 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.

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.

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 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.

Stomi’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, Stomi’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, Stomi’s claim and others involved in the litigation may later be remanded to U.S. District Courts nationwide for separate trial dates.


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