FDA Warning on Diabetes Drug Prompts Tennessee Lawsuit

Each year, dangerous drugs and defective medical devices injure thousands of Tennessee residents. When a pharmaceutical company releases a new drug into the market, it has a legal duty to ensure that product is safe and that consumers, most of whom lack sophisticated medical knowledge, are properly warned about any life-threatening side effects. Companies that fail to uphold this duty may face extensive litigation from injured patients.

Patient Says He Suffered Kidney Failure After Taking Invokana

In May 2015, the U.S. Food and Drug Administration issued a safety announcement regarding a number of medications used to treat type-2 diabetes. These drugs included canagliflozin, which is marketed in the United States under the brand name Invokana. According to the FDA warning, Invokana and similar drugs known as SGLT2 inhibitors “may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.”

A subsequent FDA investigation uncovered at least 73 cases of ketoacidosis in diabetes patients. There were also at least 19 cases of “life-threatening blood infections and kidney infections,” which required hospitalization, and in some cases dialysis was necessary due to kidney failure. Based on this new information, the FDA advised patients on December 4, 2015, to “stop taking their SGLT2 inhibitor and seek medical attention immediately if they have any symptoms of ketoacidosis.”

At least one Tennessee patient has sued the manufacturer and marketers of Invokana after suffering kidney failure. According to the patient’s lawsuit, filed in the U.S. District Court for the Western District of Tennessee, the defendants “concealed, and continue to conceal, their knowledge of Invokana’s unreasonable dangerous risks” from consumers. The patient said he was first prescribed Invokana in 2013, shortly after the FDA approved it for use in treating diabetes. But instead of reducing his blood sugar, as the defendants claimed, the patient said it led to “kidney failure, kidney damage, and reduced kidney function.”

The lawsuit alleges numerous violations of Tennessee law, including defective design, failure to warn, gross negligence, breach of express and implied warranties, fraudulent misrepresentation, and negligent design. The patient seeks $10 million in compensatory and punitive damages. Please keep in mind, the patient’s complaint is merely a statement of allegations. This case has yet to be tried before a jury.

Have You Been Injured by a Dangerous Drug?

There are many cases where a drug manufacturer manipulates or misleads regulators to prevent the true risks of their products from becoming known—at least until the drug is on the market and patients start to suffer. This is why patients cannot always rely on FDA approval or their doctor’s advice to ensure the safety of the drugs they take. Indeed, doctors are often just as much in the dark as patients when it comes to assessing these risks.

That is why if you have sustained any type of injury after taking a potentially dangerous drug, it is important you seek independent legal advice from an experienced Tennessee personal injury attorney. Contact the offices of Fox, Farley, Willis & Burnette, Attorneys at Law, in Knoxville or Clinton if you would like to speak with someone about your case right away.