Invokana Wrongful Death Lawsuit Filed in Louisiana

Published on July 5, 2016 by Sandy Liebhard

A wrongful death lawsuit has been filed on behalf of five plaintiffs who allegedly lost their mother to serious Invokana side effects, including diabetic ketoacidosis and kidney damage. The complaint claims that Johnson & Johnson and its Janssen Pharmaceuticals unit knew or should have known about the risks associated with Invokana, yet withheld this critical information from patients and doctors.

According to the May 10th filing in the U.S. District Court, Eastern District of Louisiana, the Decedent began taking Invokana as directed by her doctor in July 2014 to treat Type 2 diabetes. She subsequently suffered from diabetic ketoacidosis, heart problems, kidney damage, stroke, and eventual death.

In using the medication, the lawsuit asserts that the Decedent relied on information in Invokana marketing materials that represented the drug as safe and effective. The plaintiffs also claim that Johnson & Johnson and Janssen should have conducted more extensive testing before releasing Invokana on the market.

“The development of the injuries at issue herein were preventable and resulted directly from Defendants’ failure and refusal to conduct proper safety studies, failure to properly assess and publicize alarming safety signals, suppression of information revealing serious and life-threatening risks, willful and wanton failure to provide adequate instructions, and willful misrepresentations concerning the nature and safety of Invokana,” the complaint states.

Invokana Safety Alerts

Invokana was brought to market in March 2013, and was the first SGLT2 inhibitor approved to treat Type 2 diabetes. These drugs work by preventing the reabsorption of glucose by the kidneys, thereby facilitating its removal from the body via urine.

In December 2015, the FDA announced that information regarding a possible association with diabetic ketoacidosis would be added to the “Warnings and Precautions” section of all SGLT2 inhibitors labels. The labels were also modified with information about life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that originate as urinary tract infections.

Diabetic ketoacidosis occurs when toxic acids called ketones accumulate in the blood. Untreated, the condition may lead to diabetic coma or death. According to the FDA, patients should stop taking their SGLT2 inhibitor and seek medical attention immediately if they develop any symptoms of the condition including: nausea, vomiting, abdominal pain, tiredness, and trouble breathing.

Just last month, the labels for Invokana and several other SGLT2 inhibitors were updated with stronger kidney safety warnings, after the medications were tied to reports of acute kidney injury. Invokana has also been linked to an increased risk of bone fractures, and the FDA is currently investigating a potential link to foot and toe amputations.

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