A woman has filed an Invokana death lawsuit against Johnson & Johnson and its Janssen Pharmaceuticals subsidiary after her husband died upon suffering acute kidney injury.

Phyllis C.’s husband started taking Invokana in September 2014 to control his type 2 diabetes. He took the drug as directed until suffering acute kidney injury in February 2015. He subsequently died in October 2015 as a result of the kidney failure complications.

The Invokana death lawsuit is among several suits filed recently alleging that the diabetes medication causes kidney damage. Invokana (canagliflozin) came on the market in March 2013 and is one of a new class of medicines known as sodium glucose cotransporter 2 (SGLT-2) inhibitors.

The drugs basically work by redirecting sugar away from the bloodstream and releasing it from the body through urine. While this appears like a sound theory, many serious adverse events have been reported, including kidney failure, diabetic ketoacidosis and heart attacks.

Invokana Death Lawsuit Says Drug Effect Mimic Those of Illness

“Ketoacidosis can lead to organ failure, including renal failure if not treated quickly,” the Invokana death lawsuit states.

“Unfortunately for Invokana users, because the drug mimics a naturally occurring emergency process while lowering blood-glucose, key symptoms of ketoacidosis such as elevated blood-glucose and frequent urination are either not present or unrecognizable. Thus, Invokana users are often unaware they are suffering ketoacidosis until more severe injuries develop.”

Ketoacidosis means the body has produced an abnormally high level of blood acids, which can lead to brain swelling and kidney failure.

When the body’s cells don’t receive the glucose they need for energy, the body begins to burn fat for energy, a process that produces ketones. These ketones break down the fat to turn it into energy. When the ketones build up in the blood, the resulting ketoacidosis can make a person extremely ill.

Dry mouth or excessive thirst, frequent urination and high blood sugar are early symptoms of ketoacidosis.

Constant fatigue, dry or flushed skin, abdominal pain, vomiting, difficulty breathing and a fruity breath odor are signs of advanced ketoacidosis.

The FDA ordered all manufacturers of SGLT2 inhibitors to include warning labels about the risk of ketoacidosis in December 2015.

In June 2016, the FDA strengthened warnings for Invokana linked to kidney failure. The revised warnings in the drug labels include information about acute kidney injury and recommendations to minimize the risk.

This Invokana death lawsuit is based in part on the assumption that Johnson & Johnson allegedly knew of the risks of kidney failure and ketoacidosis, but concealed these risks from doctors and the public.

“Prior to ingesting Invokana, Decedent exhibited no indication that he was at risk of acute kidney injury, including but not limited to kidney failure, renal failure or complications arising therefrom,” clarifies the lawsuit.

The FDA advises patients to seek medical attention immediately if they experience signs of Invokana linked to kidney failure such as decreased urine output or swelling in the legs or feet.

The Invokana Death Lawsuit is Case No. 3:17-cv-00697, in the U.S. District Court District of New Jersey.