Janssen is facing an Invokana lawsuit alleging that the plaintiff suffered from an amputated foot after taking the diabetes medication.

Plaintiff Michael M. has filed a lawsuit against Janssen Pharmaceuticals Inc, Janssen Research & Development LLC, Johnson & Johnson, and Janssen Other LLC after he suffered from an amputated foot. He argues that his amputated foot is a direct result of taking Invokana.

Michael says he started using Invokana on Jun. 5, 2017. Two days later, on Jun. 7, 2017, he had an right foot amputation above the ankle. He was hospitalized and required substantial medical treatment. He argues that he would not have suffered from an amputated foot if he did not take Invokana.

Invokana was approved for use as a treatment of type-2 diabetes in March 2013, becoming the first drug in its class to gain FDA approval. Before the drug’s release, it was aggressively marketed as a better alternative to other, similar diabetes medication. These marketing materials allegedly did not contain any warnings about ketoacidosis or serious infections.

Invokana is a SGLT2 inhibitor which inhibits glucose reabsorption in the kidneys to lower blood glucose. As a result, a significant portion of glucose is not metabolized and is instead secreted through the kidneys. The amputated foot lawsuit argues that this mechanism can be harmful to diabetes patients who are already at risk for kidney disease and injury.

The lawsuit argues that because Invokana prevents patients’ bodies from using glucose, the body’s primary fuel, their bodies break down fat as an alternative source of energy. When fat is broken down, the process releases acids called ketones into the blood stream, raising the acidity of blood.

This condition is called ketoacidosis. Normally, the body excretes excess ketones through the urinary tract but the lawsuit argues that the kidneys can not process and excrete the ketones because they are over encumbered by glucose processing.

In addition to the risk of ketoacidosis, which can be life threatening, the increased elimination via urination can reduce blood flow and thicken the blood plasma, creating circulation problems in lower extremities.

When a patient experiences circulation problems, the body is less able to heal and fight infections. In diabetic patients, this means that diabetic ulcers are less likely to heal and more likely to result in dangerous infection that may spread into the bones.

Should a diabetic ulcer lead to a serious infection, patients are at a risk for an amputated foot or toe. In June 2017, a study was published “which showed a [Invokana] had an amputation Hazard Ratio of 1.97, i.e. that patients taking [Invokana] were nearly twice as likely to suffer an amputation as those on placebo”.

Despite the startling odds of Invokana treatment leading to an amputated foot, the drug company “did not warn patients but instead continued to defend and aggressively promote INVOKANA, mislead physicians and the public, and minimize unfavorable findings,” the lawsuit states.

The Invokana Amputated Foot Lawsuit is Case No. 3:18-cv-03930-BRM-LHG in the United States District Court for the District of New Jersey.