Invokana Lawsuit Filed Over Diabetic Ketoacidosis Injuries

The estate of a Texas woman has filed a product liability lawsuit over a case of Invokana-induced diabetic ketoacidosis, which allegedly caused her to suffer serious injury and hospitalization before her death. 

The complaint (PDF) was filed by the administrator for the estate of Cynthia Johnson on April 12, indicating that Johnson & Johnson and it’s Janssen Pharmaceuticals subsidiary failed to warn about the risk that their new-generation diabetes drug may cause users to develop diabetic ketoacidosis, kidney failure, sepsis and other injuries.

Johnson was prescribed Invokana to treat diabetes in March 2014. However, the lawsuit indicates that between December 2013 and January 2015, she twice suffered diabetic ketoacidosis, which is a dangerous medical emergency involving a build up of blood acid levels. As a result of the Invokana ketoacidosis problems, the lawsuit indicates that Johnson suffered serious injury and incurred significant medical expenses.

The case joins a growing number of other Invokana lawsuits filed throughout the federal court system, each involving similar allegations that the drug makers failed to properly research the potential risks, and withheld information from the medical community about safety problems.

“The design of Invokana was defective in that the risks associated with using Invokana outweighed any benefits of the design,” the lawsuit states. “Any benefits associated with the use of Invokana were either relatively minor or nonexistent and could have been obtained by the use of other, alternative treatments and products that could equally or more effectively reach similar results.”

Invokana (canagliflozin) was introduced in 2013, as the first member of new class of diabetes treatments, known as sodium glucose cotransporter 2 (SGLT-2) inhibitors. The drug works in a unique way, by altering some normal kidney functions to increase the amount of sugar excreted in the urine. However, since the drug hit the market, a growing number of serious Invokana health problems have been reported.

In December 2015, the FDA required Johnson & Johnson to add new diabetic ketoacidosis warnings to Invokana, warning users to seek immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting.

Less than a year later, in June 2016, the FDA required another warning label update to add information about the link between Invokana and kidney problems, indicating that the medication may increase the risk of acute kidney injury and other severe health complications.

Given similar questions of fact and law raised in lawsuits filed throughout the federal court system, the Invokana case will be consolidated as part of a federal MDL (multidistrict litigation), which is centralized before U.S. District Judge Brian Martinotti in the District of New Jersey to coordinate discovery and pretrial proceedings. However, if Invokana settlements or another resolution for the cases is not reached during the MDL process, the case and others involved in the litigation may later be remanded to U.S. District Courts nationwide for a separate trial dates.