A man has filed a lawsuit against the makers of Invokana after he needed a below the knee amputation.

Plaintiff K.B. says he began taking Invokana (canagliflozin) in August 2014 to treat diabetes. In June 2017, he suffered a below the knee amputation of his right leg. He claims side effects of Invokana led to the below the knee amputation. 

Invokana, a drug from Johnson & Johnson subsidiary Janssen Pharmaceuticals, was approved by the FDA in 2014 to help normalize blood sugar levels in patients with type-2 diabetes.

Invokana made headlines in the medical world because it was the first in a new class of medications called SGLT2 inhibitors. These drugs are unique in that they rid the body of extra glucose (sugar) by routing it through the kidneys and out the urine. This action prevents the patient from suffering from high blood sugar because the extra sugar is prevented from re-entering the bloodstream.

Side Effects Allegedly Led to Below the Knee Amputation

A human’s primary source of fuel is sugar (glucose). Because Invokana redirects sugar away from the blood and out the urine, Invokana users have reported experiencing ketoacidosis. With not enough glucose to turn to for energy, the body then begins to burn fat. When fat is burned as the primary fuel source, acids known as ketones enter the bloodstream. Too much acid in the blood results in ketoacidosis.

Normally, a person suffering from ketoacidosis also has high blood sugar and frequent urination as telltale signs. Ketoacidosis in Invokana users allegedly is more difficult to diagnose because these patients already are urinating more frequently and their blood sugar levels will not indicate a high level of glucose.

As the Invokana patient urinates more often, the body can become dehydrated, leading to volume contraction in the blood. When the blood doesn’t have an adequate amount of moisture to move efficiently throughout the body, blood flow is reduced and the blood plasma thickens.

Thicker blood creates problems with circulation, particularly in the extremities. Imagine normal blood is the consistency of water, and the heart efficiently pumps it to all the tiny veins from the head to the toes. If moisture is taken away – say the blood is the consistency of molasses – you can imagine the heart having difficulty pumping molasses to reach all the tiny veins in the body, especially those all the way to the fingers and toes.

“As circulation in the extremities worsens, the body is less able to heal and fight infections, which increases the risk of ulcers, and can lead to dangerous infections that may spread into the bones,” says the below the knee amputation lawsuit.

Once infection invades the bones or gangrene sets in, the patient must endure an amputation to save his life.

K.B. alleges the side effects of taking Invokana led to his below the knee amputation in 2017.

The Below the Knee Amputation Lawsuit is Case No. 3:18-cv-10187-BRM-LHG and is part of the Invokana MDL, In re: Invokana (canagliflozin) Products Liability Litigation, MDL No. 2750, in the U.S. District Court for the District of New Jersey.