Manufacturers of the type 2 diabetes drug Invokana (canagliflozin) are facing another Invokana lawsuit recently filed in the Eastern District of California. The plaintiff, a resident of California, brings claims against Janssen Pharmaceuticals and parent company Johnson & Johnson for failing to warn of the serious side effects that are possible with Invokana use.
She seeks in excess of $75,000 in compensatory and punitive damages.
Invokana Blamed for Plaintiff’s Development of Diabetic Ketoacidosis
According to her complaint, the plaintiff was prescribed Invokana by her physician to treat her type 2 diabetes. She states that she took it as directed to improve her blood sugar control.
Then, on October 30, 2013, she was hospitalized for diabetic ketoacidosis (DKA). This is a condition in which the blood becomes too acidic, and can lead to serious health complications including death. It causes symptoms like nausea and vomiting, severe abdominal pain, severe dehydration, labored breathing, low blood pressure, and tachycardia (racing heartbeat).
In May 2015, the FDA warned doctors and patients about a possible link between Invokana and DKA in May 2015. They had received at least 20 reports of patients with type 2 diabetes who were taking the drug and were hospitalized for DKA. The situation caused alarm because it is very rare for type 2 diabetes patients to suffer from DKA—it is more common in type 1 diabetes patients.
DKA More Common in Type 1 Diabetes Patients
“DKA,” the FDA stated, “is a type of acidosis that usually develops when insulin levels are too low or during prolonged fasting.” This is why it’s more common in type 1 diabetes patients, who often lack the insulin they need to properly metabolize glucose. Accordingly, when they suffer DKA, it is often accompanied by high blood sugar levels.
Type 2 diabetes patients, though, usually have sufficient levels of insulin—they are just not able to utilize it as well. The FDA noted that the reports they received of type 2 diabetes patients suffering DKA “were not typical” because most of the patients had type 2 diabetes, and their blood sugar levels were only slightly increased compared to the greater increases normally seen in typical cases of DKA.
The FDA urged doctors and patients to report side effects like DKA to the FDA’s MedWatch program, and to watch out for the symptoms of the condition in patients taking Invokana.
Plaintiff Regrets Taking Invokana
The plaintiff states that she was unaware that Invokana could cause DKA. Indeed, neither the product label nor the accompanying information listed it as a possible side effect. Had she known, she says, she would not have taken it, or at the very least, would have been more careful to monitor herself for changes that would indicate she was in danger.
Invokana was the first drug in the SGLT2 inhibitor class to be approved by the FDA. It works by preventing the kidneys from reabsorbing all glucose, allowing some of it to be flushed away via the urine. The drug has also been associated with other side effects like urinary tract infections and kidney failure. The plaintiff notes in her case that DKA, as well, can lead to other complications like cerebral edema, pulmonary edema, heart attack, and severe dehydration and coma.
The plaintiff brings counts of failure to warn, negligence, breach of warranties, negligent misrepresentation, design defect, and unjust enrichment.