A California resident has joined in the litigation against type 2 diabetes drug Invokana (canagliflozin). The drug was first approved by the FDA in 2013 for the treatment of the disease, but manufacturers Janssen Pharmaceuticals and parent company Johnson & Johnson have been defending Invokana lawsuits lately because of health risks associated with the drug.
The plaintiff filed her case in the U.S. District Court for the Central District of California, where she seeks in excess of $75,000 in damages for injuries allegedly caused by her ingestion of Invokana.
Plaintiff Claims Invokana Caused Kidney Failure
According to her complaint, the plaintiff started taking Invokana for the treatment of her type 2 diabetes. She said her physician prescribed the medication for this purpose, and that she used it as intended, according to the instructions.
Plaintiff claims that after taking the drug, she was admitted to the hospital in April 2014 and May 2015 for acute kidney injury and acute kidney failure, respectively. Had the defendants properly disclosed the risks associated with the drug, she asserts that she would not have taken it, as there were safer alternatives available.
Invokana Warnings are Inadequate
Invokana belongs to a class of drugs called “sodium glucose co-transporter 2 (SGLT2) inhibitors, which are designed to work by blocking the reabsorption of glucose by the kidneys, thereby increasing its secretion through the urine. Clinical trials conducted to gain FDA approval of the drug showed that it did successfully reduce blood glucose levels in diabetics.
On May 15, 2015, however, the FDA released a drug safety communication warning the medical community that treatment with SGLT2 inhibitors, including Invokana, could lead to serious health complications, including diabetic ketoacidosis (DKA). This is a condition in which the patient’s blood becomes too acidic, and if left untreated, can lead to coma and even death.
Also in May 2015, the Institute for Safe Medication Practices released their QuarterWatch publication, in which they expressed concern about the safety of the drug. They reported that in the first year the drug was on the market, it was associated with 450 serious adverse event reports, many related to kidney impairment, kidney stones, and kidney failure.
The plaintiff in this case points out that thought the Invokana label mentions the kidneys, it does so only very generally, stating that a “possible side effect” is “kidney problems.” This warning, she adds, doesn’t adequately convey the dangers or address the real risk of kidney failure, which is often a life-threatening complication.
Plaintiff Seeks Punitive Damages for Invokana Kidney Failure
Like others who have alleged injuries because of Invokana, the plaintiff blames the manufacturers for failing adequately research on their product to determine its safety, and for aggressively advertising it as a safe treatment for type 2 diabetes while downplaying the serious risks. She claims that the product is more dangerous than the ordinary consumer would expect, and that the defendants knew or should have known that the drug warnings provided by the manufacturer regarding the risks were incorrect and misleading. She asserts counts of strict liability, design defect, failure to warn, negligence, breach of warranties, fraud, misrepresentation, fraudulent concealment, negligent misrepresentation, and violation of the Fair Business Practices Act of 1975, and seeks both compensatory and punitive damages.