A toe amputee recently filed a diabetes amputation lawsuit alleging that Invokana increases the risk of an individual needing an amputation due to diabetic ulcer.

Toe amputee Billy L. recently filed a lawsuit against Janssen and Johnson & Johnson, alleging that the manufacturers’ diabetes medication Invokana increases the risk of diabetes amputation due to its affect on the body’s healing capabilities.

In January 2017, Billy says he was prescribed Invokana to treat his type-2 diabetes. In December 2017, Billy became a toe amputee when he suffered from an amputation of his left toe, which he claims is a direct result of taking Invokana.

Invokana was approved in March 2013 as a type-2 diabetes treatment. Invokana was the first drug in its class to be approved by the U.S. Food and Drug Administration (FDA), a class known as SGLT2 inhibitors.

These drugs work by inhibiting glucose reabsorption in the kidneys, lowering the blood glucose level. Due to this process, a significant portion of glucose is not metabolized and is instead processed out of the blood through the kidneys.

The diabetes amputation lawsuit argues that this process puts too much strain on the kidneys, diminishing their function. This can allegedly lead to ketoacidosis, circulation problems and a lowered ability to fight infections.

According to the lawsuit, this means that diabetes patients on Invokana are more likely to develop diabetic ulcers which are less likely to heal, increasing the risk of infection. If an ulcer progresses and becomes infected, the risk of diabetes amputation is increased.

“Individuals on INVOKANA are more likely to suffer injuries that cannot heal properly, and more likely to suffer infections that their body cannot fight, due to the dehydration induced hypovolemia,” the diabetes amputation lawsuit states. “Once an infection has spread to the bone or become gangrenous, the only safe medical treatment for the patient is amputation.”

Billy claims that the drug manufacturers knew or should have known that Invokana may increase the risk of diabetes amputation yet did not include a warning on the drugs label or warn patients and physicians of the risks.

Because the drug allegedly did not contain a warning for diabetic amputation, Billy was not prepared for the increased risk of infection and subsequent amputation.

“The development of [Billy’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 diabetic amputation lawsuit states.

Billy accuses the defendants of strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of warranties, negligent misrepresentation, fraudulent misrepresentation, unjust enrichment, fraud and violation of consumer protection laws. The diabetes amputation lawsuit seeks compensatory damages, punitive damages, court costs, and attorneys’ fees.

The Invokana Diabetes Amputation Lawsuit is Case No. 3:18-cv-09712-BRM-LHG and is part of the Invokana MDL, In re: Invokana (canagliflozin) Products Liability Litigation, Case No. 3:16-md-2750, in the United States District Court for the District of New Jersey.