In a new Invokana lawsuit, a woman from Florida says Janssen Pharmaceuticals and its parent company Johnson & Johnson failed to issue a proper warning about the link between Invokana and ketoacidosis.

Plaintiff Laura W. contends that patients who took Invokana for type 2 diabetes have suffered excessively dangerous reactions including “diabetic ketoacidosis, stroke, heart attack and severe kidney damage.”

She says the risks of these complications make Invokana “defective in design and formulation” and more dangerous than an ordinary consumer would expect.

Laura alleges she started taking Invokana around August 2014 to control high blood sugar related to her type 2 diabetes. She says she then suffered an episode of diabetic ketoacidosis.

Laura now claims her ketoacidosis was caused by the Invokana she took. She believes this episode could have been avoided if it weren’t for the defendants’ failure to properly evaluate the drug’s safety and effectiveness and to provide adequate warnings and instructions.

Had the defendants properly warned her about risks like the link between Invokana and ketoacidosis, she says, she would have avoided her alleged injuries by declining to take Invokana in the first place.

Linking Invokana and Ketoacidosis

According to Laura’s Invokana lawsuit, the drug was originally developed by Japanese pharmaceutical manufacturer Tanabe in collaboration with Johnson & Johnson. It’s also known by the generic name canagliflozin.

Invokana was approved by the FDA in March 2013 for the treatment of type 2 diabetes.

Invokana is one of a class of diabetes drugs known as SGLT2 inhibitors. It is the first of that class to gain FDA approval, Laura says.

These drugs are designed to lower blood excessive levels of blood sugar by inhibiting it from being reabsorbed into the bloodstream within the kidneys. The excess sugar is then excreted out in the urine.

Laura says that since the drug’s entry into the market, the FDA has received a “significant number” of reports about Invokana and ketoacidosis.

She says that an analysis of records in the FDA’s adverse event reporting database shows that patients taking Invokana are “several times more likely” to report diabetic ketoacidosis than are those taking non-SGLT2 diabetes drugs.

Laura says that defendants Janssen Pharmaceuticals and its parent company Johnson & Johnson knew about the risks associated with Invokana and ketoacidosis. Yet, the companies failed to adequately warn consumers or the medical community about those risks, she says.

In fact, Laura accuses the defendants of actively concealing information about the drug’s ketoacidosis risk and instead conducting nationwide promotional campaigns that held Invokana out as a safe and effective treatment for diabetes.

Laura herself relied on these representations in deciding to take Invokana, she claims.

Laura’s Invokana lawsuit raises claims under New Jersey consumer protection laws for manufacturing defects, defective design, failure to warn. She also brings claims for breach of warranty, negligence, fraud and misrepresentation.

She seeks damages in excess of $75,000 to cover economic harm like medical expenses and non-economic harm like pain and suffering and the increased risk of future complications. She also seeks reimbursement for attorneys’ fees and other costs of litigation.

The Ivokana Lawsuit is Case No. 3:16-cv-04024 in the U.S. District Court for the District of New Jersey, Trenton Division.