April 26, 2016 — A woman from Texas who was diagnosed with ketoacidosis after using Invokana has filed a lawsuit accusing drug-makers of failing to warn about the risk.
The lawsuit (PDF) was filed in the U.S. District Court for New Jersey on November 13, 2015 (Case No. 3:15-cv-08070) against Janssen Pharmaceuticals, Johnson & Johnson, and Mitsubishi Tanabe Pharma Co.
The plaintiff, Maria Puente, used Invokana in October and November 2013 before being diagnosed with diabetic ketoacidosis (DKA), a life-threatening condition involving too much acid in the blood. Her husband has joined the lawsuit claiming loss of consortium.
They accuse drug-makers of negligence for concealing their knowledge about side effects of Invokana. As a result, many people who were prescribed Invokana suffered severe and permanent injuries, including ketoacidosis, stroke, heart attack, and kidney damage.
Mrs. Puente says she never would have used Invokana if she had known about its risks. According to the complaint:
“Defendants… recklessly and carelessly marketed, distributed and sold Invokana without adequate instructions or warning of its serious side effects and unreasonably dangerous risks.”
The plaintiffs are seeking compensation for their pain and suffering, medical expenses, diminished quality of life, aggravation of pre-existing health problems, increased risk of premature death, and other damages.
In a Safety Communication in December 2015, the FDA warned that patients should stop taking Invokana and seek medical attention immediately if they develop symptoms of ketoacidosis, such as nausea, vomiting, abdominal pain, tiredness, and trouble breathing.
The problem is that patients on Invokana may not realize they have ketoacidosis because it is not usually seen in people with type-2 diabetes. Furthermore, blood-sugar levels may be relatively normal in patients on Invokana with ketoacidosis. Without treatment, ketoacidosis can lead to diabetic coma or even death.
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