Invokana Case Filed By Seven Plaintiffs Over Ketoacidosis, Kidney Failure Injuries

A group of seven plaintiffs have filed a joint lawsuit against Johnson & Johnson and its Janssen subsidiary, alleging that the side effects of Invokana caused them to suffer various injuries; including diabetic ketoacidosis and kidney failure. 

The complaint (PDF) was filed in the U.S. District Court for the District of New Jersey on March 16, including plaintiffs Charles Pinkston, Pamela Gideon, Elia Lopez, Marie Luera, Opal Louise Simon, Anita Martinez and Janice Brana. All claim that the manufacturers failed to warn users of the new generation diabetes drug, as well as the medical community, about the risk of serious health problems linked to the use of Invokana.

Invokana (canagliflozin) was just 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 Invokana has hit the market, a growing number of serious health risks have been reported, leading to concerns over the lack of research before introducing the drug and decisions by the drug maker to withhold certain warnings from the initial label.

All of the plaintiffs are residents of Texas, and all began using Invokana before December 2015, when the FDA required Johnson & Johnson and the makers of other SGLT2 inhibitors, such as Farxiga and Jardiance, to add new diabetic ketoacidosis warnings to their medications. Those Invokana warnings urged users to stop taking the drug and 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 risks, indicating that the medication may increase the risk of acute kidney injury and other severe health problems.

The case joins a growing number of Invokana lawsuits filed in recent months, each raising similar allegations that the drug makers failed to adequately research the medication before marketing it as a new form of diabetes treatment, and withheld important safety warnings from consumers and the medical community.

“Defendants knew of the significant risk of severe injury caused by ingestion of SGLT2 Inhibitor,” the lawsuit states. “However, Defendants did not adequately and sufficiently warn consumers, including plaintiffs, or the medical community of the severity of such risks.”

The plaintiffs present claims of strict products liability, including design defect and failure to warn, negligence, willful and wanton conduct and/or gross negligence, breach of warranties, fraudulent misrepresentation, negligent misrepresentation, negligent design, fraudulent concealment, and fraud.

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.