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A product liability lawsuit filed against Janssen Pharmaceuticals and it’s parent company, Johnson & Johnson, indicates that side effects of Invokana caused a Tennessee woman to suffer acute renal failure, a urinary tract infection and other health complications, which were not initially included on the warning label for the new-generation diabetes drug when it was introduced.
Invokana (canagliflozin) hit the market in March 2013, and has been aggressively marketed by the drug makers in an attempt to convince doctors to switch their diabetes patients to the medication, which works in a different way than other diabetes drugs by inhibiting some normal 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.
According to a complaint (PDF) filed by Martha J. Williams in the U.S. District Court for the District of New Jersey on July 3, the drug makers failed to adequately research the medication or warn users and the medical community about the potential health risks with Invokana.
Williams indicates that she was prescribed Invokana in April 2015, to treat her diabetes. However, on May 3, 2015, less than a month later, she suffered acute renal failure, dehydration, urinary tract infection and hypokalemia; which occurs when the body’s potassium levels drop dangerously low. As a result, Williams was hospitalized and required substantial medical treatment, according to the lawsuit.
“Consumers of Invokana and their physicians relied on the Defendants’ false representations and were misled as to the drug’s safety, and as a result have suffered injuries including diabetic ketoacidosis, kidney failure, sepsis, cardiovascular problems, stroke, and the life-threatening complications thereof,” her lawsuit states. “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 lifethreatening risks, willful and wanton failure to provide adequate instructions, and willful misrepresentations concerning the nature and safety of Invokana.”
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.
Williams’ 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, William’s complaint 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, William’s claim and others involved in the litigation may later be remanded to U.S. District Courts nationwide for separate trial dates.