A man has filed a products liability lawsuit against Janssen Pharmaceuticals, Inc., alleging negligence and wrongful conduct for purportedly causing kidney failure from Invokana, a popular diabetes drug.

Plaintiff Troy P. files the lawsuit against Janssen, the maker and marketer of Invokana, in New Jersey federal court. According to the complaint, Troy allegedly suffered harm as a result of ingesting Invokana.

The lawsuit states that Troy “suffered various injuries, physical pain and suffering, medical, hospital, and surgical expenses as a direct result of using Invokana.”

According to the lawsuit, Invokana is purportedly the first in its class to gain approval from the U.S. Food and Drug Administration. It is prescribed for the treatment of type-2 diabetes and is known as a sodium-glucose contransporter2 (SGLT2) inhibitor.

In the first quarter of 2015, sales of Invokana reached $278 million, making it one of the defendant’s top selling drugs.

According to theInvokana lawsuit, however, the promotion and sale of Invokana was solely for the treatment of type-2 diabetes. But Troy alleges the defendants have even marketed Invokana for “off-label purposes,” such as for weight loss and lowering blood pressure.

The lawsuit states that “SGLT2 inhibitors, including Invokana, are designed to inhibit renal glucose reabsorption with the goal of lowering blood glucose.”

“As a result, a significant portion of glucose is not metabolized, but instead excreted through the kidneys of a population of consumers already at risk for kidney disease, and exposes the drug’s users to an increased risk of the injuries complained of herein.”

The Invokana lawsuit maintains that when patients are prevented from using glucose as a primary fuel, the body turns to fats as an alternative source of energy. Acidic compounds known as ketones form as the body breaks down the fat. The higher amount of ketones in the blood then causes the potential for “acidosis-excessive blood acidity,” or ketoacidosis.

According to the Invokana lawsuit, “ketoacidosis-excess ketones” in the blood may then cause patients to suffer from kidney failure from Invokana, as was the case with plaintiff Troy.

The Invokana lawsuit maintains that the U.S. Food and Drug Administration had also issued a Public Health Advisory, in March 2015, “linking SGLT2 inhibitors, including Invokana, to diabetic ketoacidosis, a condition which can result in organ failure and even death.”

The U.S. Food and Drug Administration has also received reports of kidney failure from Invokana, as well as other kidney injuries and renal impairment.

Troy’s Invokana lawsuit, further purports that, “on December 4, 2015, the FDA required defendants to change the Invokana warning label to warn of ketoacidosis, and urosepsis- a severe, life threatening bacterial infection of the blood which can injure the kidneys.”

This Invokana Lawsuit is Case No. 3:17-cv-04764, in the U.S. District Court for the District of New Jersey.