A woman has filed an Invokana urosepsis lawsuit against drug manufacturer Janssen Pharmaceuticals, parent company Johnson & Johnson and Mitsubishi Tanabe Pharma Corp. alleging their diabetes drug led to the wrongful death of her mother.

Plaintiff Tracey F. filed this lawsuit on behalf of her deceased mother, Helen S. in California federal court. Tracy alleges that Invokana “is defective, dangerous to human health and suitable to be marketed and sold in commerce and lacked proper warning to the dangers associated with its use.”

Invokana (canagliflozin) is a prescription drug used as an oral treatment of type-2 diabetes. It was initially released into the market in January 2014 following FDA approval and is one of several drugs in a class known as SGLT-2 inhibitors.

This class of drugs works by decreasing glucose levels in the blood by inhibiting glucose reabsorption into the kidneys. The additional glucose is then eliminated through the urine.

In May 2015, the FDA released a safety communication that warned patients and physicians that SGLT-2 inhibitors could be responsible for causing diabetic ketoacidosis, which may prove to be fatal.

Diabetic ketoacidosis is a common concern with type-one diabetic patients, but is rarely seen in patients with type-2 diabetes. The FDA also received reports that patients were suffering from urosepsis.

In addition to diabetic ketoacidosis and urosepsis, the FDA has also warned about premature bone loss, bone fractures, kidney infections, renal impairment, angioedema, anaphylaxis and an increased risk of amputations, the Invokana urosepsis lawsuit states.

In cases of diabetic ketoacidosis, the patient’s body develops a high amount of ketones, which are the byproduct of fat metabolism.

These byproducts are very acidic, and when enough of them built up, they cause acidity in the body. A person’s body is healthiest in a slightly alkaline state, so when the body turns acidic, major health issues can ensue.

Urosepsis is a bacterial blood infection (sepsis) that happens systemically in the body that is caused by a urinary tract infection. The lawsuit states that Helen developed Invokana urosepsis after taking the drug, and this ultimately led to her untimely death on March 14, 2015.

She ultimately went into septic shock, leading to a myocardial infarction, and these caused “a fatal exacerbation of congestive heart failure which ultimately caused her death.”

According to the Invokana urosepsis lawsuit, Helen has endured “pain and suffering, emotional distress, loss of enjoyment of life, and economic loss, including civic ticket expenses for medical care and treatment.”

Her daughter is seeking actual, compensatory and punitive damages as well as for loss of relationship with her mother.

“Helen [S.’s] death 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 you with instructions, and willful misrepresentations concerning the nature and safety of Invokana,” the Invokana urosepsis lawsuit states.

Tracey has brought forth a number of allegations against the defendants including failure to warn, negligence, breaches of express and implied warranties, fraudulent misrepresentation and punitive damages.

The Invokana Urosepsis Lawsuit is Case No. 2:17-cv-JFW-E, in the U.S. District Court for the Central District of California.