Diabetic Ketoacidosis Lawsuit Filed Over Invokana Side Effects

Side effects of the diabetes drug Invokana caused diabetic ketoacidosis complications for a Texas man, who was hospitalized less than a month after switching to the new-generation treatment, according to allegations raised in a product liability lawsuit filed against the drug manufacturers.

The complaint (PDF) was filed by Ronney Lyons in the U.S. District Court for the District of New Jersey on July 21, indicating that Johnson & Johnson and it’s Janssen Pharmaceuticals subsidiary failed to provide adequate warnings for users or the medical community about the importance of monitoring for signs or symptoms associated with the dangerous build up of acid levels in the blood while using Invokana.

Lyons indicates that he began taking Invokana in late March 2015. However, only a few weeks later he was hospitalized with diabetic ketoacidosis, which he indicates was caused by side effects of Invokana.

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

Invokana (canagliflozin) is a new type of diabetes drug, which was introduced in March 2013, and has been aggressively marketed by the drug makers in an attempt to convince doctors to switch their patients to the medication. The drug works in a different way than other diabetes treatments, 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.

In December 2015, the FDA required Johnson & Johnson to add new Invokana diabetic ketoacidosis warnings, 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.

At the time Lyons used the medication, 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.

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