Wrongful Death Lawsuit Filed Over Invokana Ketoacidosis, Heart Failure Risk

An Alabama man claims that the side effects of Invokana resulted in the wrongful death of his wife, causing her to suffer diabetic ketoacidosis and congestive heart failure. 

The complaint (PDF) was filed by Scott Martin, on behalf of himself and his late wife, Sheila Martin, in the U.S. District Court for the District of New Jersey on June 2, naming Johnson & Johnson and it’s Janssen Pharmaceuticals subsidiary as defendants.

Sheila Martin began using the new-generation diabetes treatment Invokana in January 2015, on the advice of her doctor. After using the medication for less than six months, Martin died after developing dangerous levels of acid build up in the blood, known as diabetic ketoacidosis, as well as congestive heart failure.

The lawsuit claims that Janssen and Johnson & Johnson actively hid the Invokana risks from consumers and the medical community, providing false and misleading information on the warning label.

“Decedent would not have used Invokana had Defendants properly disclosed the risks associated with the drug,” the lawsuit states. “Defendants, through their affirmative misrepresentations and omissions, actively concealed from Decedent and his physicians the true and significant risks associated with taking Invokana.”

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.

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 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.

Martin’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, Martin’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.