Plaintiff Gail S. has filed a lawsuit against Janssen Pharmaceuticals, Inc. and Johnson & Johnson Co., after she allegedly developed the condition of diabetic ketoacidosis from taking Invokana.

Gail, who requests a jury trial, seeks action for damages resulting from Janssen’s “negligent and wrongful conduct” in connection to the sale and distribution of Invokana.

Invokana, also known as canagliflozin, is a medication prescribed for treating patients with type-2 diabetes. According to reports, it is classified within the gliflozin class or the subtype 2 sodium-glucose transport inhibitors class.

According to the Invokana and diabetic ketoacidosis lawsuit, the plaintiff alleges that she “suffered and may continue to suffer severe and permanent personal injuries, including diabetic ketoacidosis.”

Gail alleges she had started taking Invokana in April 2015 and took it until May 2015. However, she developed diabetic ketoacidosis in May and was then admitted into the Ransom Memorial Hospital in Ottawa, Kan. that month.

Invokana and Diabetic Ketoacidosis Facts

According to the Invokana and diabetic ketoacidosis lawsuit, Invokana is Janssen’s and Johnson & Johnson’s top selling drug, with revenues around $278 million in the first quarter of 2015 alone. Janssen is a wholly owned subsidiary of Johnson & Johnson.

The drug was approved by the U.S. Food and Drug Administration (FDA) in March 2013 for its treatment of type-2 diabetes. The drug is classified as a sodium-glucose cotransporter 2 (SGLT2); it specifically works by inhibiting “renal glucose reasbsorption with the goal of lowering blood glucose.”

However, “as a result, excess glucose is not metabolized, but instead is excreted through the kidneys of a population of consumers already at risk for kidney disease,” the Invokana and diabetic ketoacidosis lawsuit maintains.

And so, although the defendants have allegedly continued to market the drug for “off label purposes,” the drug is being contended to only improve the blood sugar levels in patients with type-2 diabetes. The defendants allegedly continue to market the drug for purposes such as reduced blood pressure, improved glycemic control in type-1 diabetes, and weight loss.

Moreover, the Invokana and diabetic ketoacidosis lawsuit reports a “significant number of reports of severe kidney damage among users of Invokana.”

The Invokana and diabetic ketoacidosis lawsuit states that an FDA adverse event database concludes that Invokana patients are at an increased risk or “several times more likely” to develop severe kidney damage than other medications within Invokana’s class.

The Invokana and diabetic ketoacidosis lawsuit maintains that the defendants failed in sufficiently and adequately informing the public, including the medical community and patients, of these increase risks.

Gail alleges that she would have not taken the drug had she known of the “properly disclosed” risks in taking Invokana.

The Invokana and Diabetic Ketoacidosis Lawsuit is Case. No. 3:17-cv-05376-BRM-LHG, in the U.S. District Court for the District of New Jersey, Trenton Division.