Janssen, the manufacturer of the diabetic drug Invokana is now facing a Canadian class-action lawsuit, according to court documents filed at the Ontario Superior Court of Justice. These documents allege Invokana could be responsible for kidney damage or death among those taking the drug. Under Canadian law, the action must be certified as a class action before it can proceed, which typically takes six to seven months. Invokana was approved by Health Canada in May 2014, but by June 2015, an investigation into the safety of the drug had been instigated.
At that time Health Canada found diabetic ketoacidosis—which is more commonly seen in those with Type 1 diabetes—was occurring more and more among those with Type 2 diabetes taking an SGLT-2 inhibitor drug like Invokana. Health Canada expected to determine whether changes in prescribing information were required for Invokana. The Canadian courts are also hearing arguments for the certification of a class action lawsuit against another Type 2 diabetic drug, Avandia. Avandia is not in the same class of drugs as Invokana, rather is an insulin sensitizer.
The Woman at the Center of the Canadian Class-Action Lawsuit
One woman, Rosalba Joudry, is at the center of the Canadian Invokana class-action lawsuit. Joudry used Invokana for eight months, stopping only after she heard there was an Invokana class-action lawsuit in the U.S. Tests showed Joudry was experiencing kidney failure after taking Invokana. The lawsuit is claiming $1 billion in damages on behalf of all Canadian consumers harmed by Invokana. The lawsuit alleges Janssen failed to adequately test Invokana, and failed to warn doctors and patients of potentially serious side effects. While some are calling for Invokana to be removed from the Canadian market, a consultant for Janssen, Dr. Debbie Knight, is confident there is no harm to kidneys from Invokana. The Canadian class-action suit also claims there is an increased risk of ketoacidosis among patients taking Invokana.
What is Diabetic Ketoacidosis?
Diabetic ketoacidosis is an extremely serious condition, which can result in extreme dehydration, swelling of the brain, diabetic coma, or even death. When the cells in the body don’t receive the glucose needed for energy, the body burns fat which produces ketones. This occurs when there is insufficient insulin produced by the body. The ketones build up in the blood, making it more acidic. SGLT-2 drugs like Invokana do not metabolize insulin the same way as older diabetic drugs, rather they target the kidneys. The excretion of sugar through the urine is increased, and those sugars are prevented from reabsorbing into the kidneys. This process created by Invokana is considered by many doctors to be an unnatural process for the kidneys. Early symptoms of ketoacidosis include excessive thirst, frequent urination, dry mouth, stiff muscles, unusual aches and pains, rapid breathing, decreased alertness, dry skin, vomiting which lasts more than two hours and fruity-smelling breath.
Did Janssen and Johnson & Johnson Exhibit a Failure to Warn?
Janssen is a subsidiary company of giant Johnson & Johnson. Many are asking whether the potentially dangerous side effects of Invokana were not communicated to consumers by the manufacturers. If it is found the manufacturers were aware of the dangers associated with Invokana, yet continued to market the drug without warnings, they may be held liable for consumer injuries. Even if Janssen and J & J claim they were unaware of these dangers, they were aware of the adverse event reports related to Invokana collected by the FDA. If you feel you have suffered injury or harm after taking Invokana, speaking to a knowledgeable product liability attorney could be helpful. You may have serious injuries as a result of the drug, and need time to heal while your attorney advocates for your rights.