A woman is suing the makers of a popular, new diabetes drug, claiming she incurred kidney injury caused by Invokana.

Gloria U. claims she developed kidney failure or serious kidney injury caused by Invokana in December 2014 and was hospitalized with serious complications for several days.

Janssen Pharmaceuticals, Inc., Johnson & Johnson Co. and Mitsubishi Tanabe Pharma Corp. are among the drug’s manufacturers named in the lawsuit.

The Invokana lawsuit contends that the companies “with the exercise of reasonable care should have known of the hazards and dangerous propensities” of Invokana.

Kidney Injury Caused by Invokana Was Predictable

Invokana has been heavily marketed as a safe and effective drug for the treatment of Type 2 diabetes. The lawsuit contends that the kidney injury caused by Invokana was a risk that the defendants knew or should have known at the time.

Among the information available at the time regarding Invokana:

1. Animal studies demonstrating increased ketones when given Invokana;
2. Studies of Invokana component phlorizin indicating a propensity to cause ketoacidosis;
3. Clinical studies, adverse event reports and case reports demonstrating increased ketones in people taking Invokana;
4. Adverse event report analysis demonstrating an increased rate of reports for ketoacidosis in people taking Invokana compared with other glucose-lowering medications.

Kidney injury caused by Invokana is more likely because Invokana usually will keep blood sugar below 250 mg/dl, a marker normally used in helping diagnose diabetic ketoacidosis. Undiagnosed ketoacidosis can progress, increasing the possibilities of kidney injury caused by Invokana.

Gloria’s lawsuit alleges that the drug’s manufacturers “were aware of the mechanism of action for Invokana places extraordinary strain on the kidneys and renal system.”

The complaint goes on to say, “Despite Defendants’ knowledge of the increased risk of severe injury among Invokana users, Defendants did not warn patients but instead continued to defend Invokana, mislead physicians and the public, and minimized unfavorable findings.”

Invokana Makers Accused of Fraudulent Misrepresentation

Among the counts in the Invokana lawsuit is one for fraudulent misrepresentation. The drug’s manufacturers are accused of failing to adequately warn of the risk of ketoacidosis, and of failing to provide complete information to the FDA about Invokana.

Product labels to physicians and to consumers allegedly stopped short of disclosing all the risks that the manufacturers knew of at the time.

Invokana’s makers are accused of overstating the drug’s benefits and of marketing the drug for unapproved uses such as weight loss and lowering blood pressure.

The Defendants also are accused of advertising that Invokana “was generally well tolerated and safe for use, and was not likely to cause side effects other than the ones listed – these listed side effects did not include diabetic ketoacidosis, renal injury or renal failure, bone fractures, etc.”

If you have suffered kidney injury caused by Invokana, you could benefit from legal counsel.

The Kidney Injury Caused by Invokana Lawsuit is Case 1:16-cv-04687-SCJ in the U.S. District Court for the Northern District of Georgia.