One the latest in a growing number of Invokana lawsuits filed in the federal court system alleges that side effects of the new-generation diabetes drug caused an Indiana woman to develop severe dehydration and a medical condition known as Starvation Ketosis, resulting in serious health problems.

The complaint (PDF) was filed by Teresa Ross in the U.S. District Court for the District of New Jersey on March 29, naming Johnson & Johnson, it’s Janssen subsidiaries, and Mitsubishi Tanabe Pharma Corp. as defendants.

Ross indicates that she was prescribed Invokana in September 2013, for glycemic control as an adjunct to diet and exercise. In late March 2015, Ross developed Starvation Ketosis and dehydration, indicating that the health problems resulted from Invokana treatment.

Starvation ketosis occurs when high levels of ketones are present in the body, and is usually caused by starvation, low levels of carbohydrates, intense and prolonged physical activity or uncontrolled type 1 diabetes. It can ultimately develop into ketoacidosis, where high blood acid levels lead to organ damage and typically result in hospitalization.

Ross’s complaint joins a growing number of other product liability lawsuits filed against the drug makers, each of which allege that inadequate warnings about the potential side effects of Invokana were provided to consumers or the medical community.

“Defendants, both individually and in concert with one another, misrepresented that Invokana is a safe and effective treatment for type 2 diabetes mellitus when in fact the drug causes serious medical problems which require hospitalization and can lead to life threatening complications, including but not limited to diabetic ketoacidosis and its sequelae, kidney failure and its sequelae, as well as serious cardiovascular problems,” Ross’s lawsuit indicates. “Plaintiff’s injuries 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.”

Invokana (canagliflozin) was introduced in 2013, as the first member of new class of diabetes treatments, known as sodium glucose cotransporter 2 (SGLT-2) inhibitors. The drug works in a unique way, by altering some normal kidney functions to increase the amount of sugar excreted in the urine. However, since the drug hit the market, a growing number of serious Invokana health problems have been reported.

In December 2015, the FDA required Johnson & Johnson to add new diabetic ketoacidosis warnings to Invokana, warning users to seek immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting.

Less than a year later, in June 2016, the FDA required another warning label update to add information about the link between Invokana and kidney problems, indicating that the medication may increase the risk of acute kidney injury and other severe health complications.

Ross presents claims of defective design, failure to warn, negligence, gross negligence, breach of warranty, fraudulent misrepresentation, negligent misrepresentation, fraudulent concealment, fraud, unjust enrichment and violation of consumer protection laws. She is seeking both punitive and compensatory damages.

Given similar questions of fact and law raised in lawsuits filed throughout the federal court system, the Invokana case will be consolidated as part of a federal MDL (multidistrict litigation), which is centralized before U.S. District Judge Brian Martinotti in the District of New Jersey to coordinate discovery and pretrial proceedings. However, if Invokana settlements or another resolution for the cases is not reached during the MDL process, the case and others involved in the litigation may later be remanded to U.S. District Courts nationwide for a separate trial dates.

Tags: Diabetes, Diabetes Drug, Farxiga, Heart Attack, Invokana, Jardiance, Johnson & Johnson, Ketoacidosis, Kidney Failure