Invokana DKA Lawsuit Filed Against Johnson & Johnson, Janssen

An Alabama woman indicates that she developed diabetic ketoacidosis (DKA) from Invokana, a new-generation diabetes drug sold by Johnson & Johnson’s Janssen subsidiary. 

Luana Jean Collie filed a lawsuit against the drug makers on December 15, in the U.S. District Court for the Southern District of Alabama. The complaint (PDF) names Janssen, Johnson & Johnson, and Mitsubishi Tanabe Pharma Corp. as defendants.

Invokana (canagliflozin) is a new-generation diabetes treatment first introduced in March 2013, for treatment of type 2 diabetes. It was the first member of a new class of drugs, known as sodium-glucose co-transporter 2 (SGLT2) inhibitor, which work in a unique way by impacting some of the normal kidney functions to increase the amount of sugar excreted in the urine. However, serious concerns have emerged about the safety of Invokana amid reports that suggest it may increase the risk of diabetic ketoacidosis (DKA), severe kidney damage and kidney failure.

Diabetic ketoacidosis (DKA) is a serious condition involving a build up of acid within the blood, which is a medical emergency that results in the need for immediate medical treatment and may lead to long-term health complications if not promptly treated. Symptoms of DKA may include abdominal pain, nausea, vomiting, fatigue, shortness of breath or other complications.

Collie indicates that she began taking Invokana in December 2014, to treat her diabetes by reducing her blood glucose levels. Instead, she indicates that side effects of Invokana caused her develop DKA, resulting in severe and permanent physical and emotional injuries, including pain, suffering, emotional distress, loss of enjoyment of life and economic damages.

“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.”

The case joins a growing number of Invokana DKA lawsuits filed in recent weeks by individuals who indicate that the drug makers withheld information from consumers and the medical community about the risks associated with use of the new diabetes treatment.

Earlier this month, the FDA announced that new Invokana warnings about DKA will be added to the drug label, indicating that users should stop taking the drug and seek immediate medical attention if they develop symptoms. The new warnings also indicate that Invokana may cause urinary tract infections, kidney infections or blood infections, which could potentially lead to kidney infections and potentially to the development of kidney failure.

Similar warnings will also be added to other SGLT2 inhibitors introduced in recent years, including Invokamet, Farxiga, Xigduo XR, Jardiance and Glyxambi.

While ketoacidosis is commonly seen among type 1 diabetics, it is not often diagnosed among individuals with type 2 diabetes, which Invokana is designed to treat.

Collie’s lawsuit presents claims of negligence, fraudulent misrepresentation, negligent misrepresentation, fraudulent concealment, designing a defective drug, failure to warn, breach of warranty, negligent design and fraud. She is seeking both compensatory and punitive damages.