A consumer recently filed a lawsuit alleging that Invokana side effects caused her to suffer from diabetic ulcers resulting in an amputated leg.

Plaintiff Audrey P. recently filed a lawsuit against Janssen Pharmaceuticals and Johnson & Johnson, alleging that the manufacturers’ drug Invokana is associated with side effects which resulted in her suffering an amputated leg.

Audrey says she was prescribed Invokana and began using the drug in 2014. She took the drug as instructed to treat her type-2 diabetes in conjunction with exercise and diet. In the fall of 2015, Audrey began wound care and treatment for diabetic ulcers and their resulting infection. However, in December 2015, Audrey’s diabetic ulcers progressed to the point of needing amputation, leaving her with an amputated leg.

Invokana is a type-2 diabetes medication and is part of a class of drugs known as SGLT2 inhibitors. These drugs decrease blood sugar by inhibiting glucose reabsorption. This results in excess glucose being eliminated from the body through the kidneys.

According to the Invokana side effects lawsuit, processing glucose through the kidneys can put undue stress on the excretory system, placing Invokana users at a higher risk for decreased blood volume. When blood volume is decreased, patients can develop circulatory problems and a decreased ability to fight infection.

In May 2015, the U.S. Food and Drug Administration (FDA) announced that SGLT2 inhibitors can cause a life threatening condition known as diabetic ketoacidosis. Although this condition occurs frequently with type-1 diabetes, it is relatively uncommon with type-2 diabetes, leading to concern regarding the safety of Invokana and other SGLT2 inhibitors.

In May 2017, Invokana’s safety profile took another hit when the FDA announced that using the drug is associated with an increased risk of leg and foot amputations. This announcement required a black box label be added to Invokana’s label.

The Invokana side effects lawsuit argues that the undue stress placed on the kidneys is to blame for the increased risk of leg and foot amputations. When the kidneys are under stress and blood volume decreases, the resulting decreased ability to heal and fight infections means that diabetic ulcers can have problems healing. If these lesions do not heal, they can become severely infected and necessitate amputation.

Despite the known risk associated with Invokana side effects, drug manufacturers have allegedly continued to aggressively promote their product to patients. Their advertisement allegedly represents Invokana as a safe product, and encourages off-label uses for the drug.

“In an effort to increase sales and market share, Defendants have aggressively marketed and continue to aggressively market Invokana to doctors and directly to patients for off label purposes, including, but not limited to weight loss, reduced blood pressure, kidney benefits, cardiovascular benefits, and for use in type 1 diabetics,” the Invokana side effects lawsuit claims.

Audrey argues that the defendant’s conduct is unlawfully and deceptive. The Invokana side effects lawsuit seeks actual damages, economic damages, punitive damages, court costs, and attorneys’ fees.

The Invokana Side Effects Lawsuit is Case No. 3:18-cv-09318-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.