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Joint Invokana Lawsuit Filed Over Failure to Warn About Kidney Failure Risk

In mid-March, a joint lawsuit was filed against the manufacturers of Invokana alleging that the side effects of the drug caused diabetic ketoacidosis and kidney failure. The suit also alleges that the manufacturers, Johnson & Johnson and its subsidiary Janssen, failed to warn both patients and healthcare practitioners about the risks posed by Invokana’s side effects.

The lawsuit was filed in the U.S. District Court for the District of New Jersey. There are seven plaintiffs: Charles Pinkston, Pamela Gideon, Elia Lopez, Marie Luera, Opal Louise Simon, Anita Martinez and Janice Brana. All reside in Texas.

Each plaintiff used the drug prior to December 2015, when the U.S. Food and Drug Administration (FDA) mandated that warnings be added to the labels of sodium glucose cotransporter 2 (SGLT2) inhibitors about the potential danger of diabetic ketoacidosis as a side effect. The warnings say that patients should stop taking the medication if they have symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting. Patients are also urged to get immediate medical attention if they have these symptoms.

Invokana is an SGLT2 inhibitor, so Johnson & Johnson was required to add the warning at that time, as were the manufacturers of fellow SGLT2 inhibitor medications Farxiga and Jardiance.

Invokana linked with serious health risks by plaintiffs

Invokana (canagliflozin) was rolled out in 2013. It was marketed as the initial member of the new class of drugs for diabetes that inhibit SGLT-2. In this class, some normal kidney functions are altered so that the amount of sugar excreted via urine rises.

However, since its initial launch, the number of serious health concerns reported has been steadily climbing.

Six months after the diabetic ketoacidosis warning was added, the FDA required another warning be added to the label. This one indicated that Invokana could heighten the risk of acute kidney injury and other serious health problems.

Number of Invokana lawsuits growing

The joint case recently filed is one in a steadily rising number of claims filed against the makers of Invokana. The cases commonly allege that the drug manufacturers failed to research the drug adequately before it was launched as a new class of diabetes medication. The lawsuits also allege that the manufacturers kept important warnings regarding the safety and side effects of the drug from both patients and medical practitioners.

The joint filings claim strict products liability, including:

  • Design defect
  • Failure to warn
  • Negligence
  • Willful and wanton conduct and/or gross negligence
  • Breach of warranties
  • Fraudulent misrepresentation
  • Negligent misrepresentation
  • Negligent design
  • Fraudulent concealment
  • Fraud

Because the questions of fact and law are similar to Invokana cases previously filed, the recent case will be centralized under the federal MDL (multidistrict litigation) already established under U.S. District Judge Brian Martinotti in the District of New Jersey. MDLs frequently consolidate cases so that discovery and pretrial proceedings can be coordinated effectively. It is possible that if settlements or other resolution for the Invokana lawsuits are not reached during the MDL, the cases may be remanded to the U.S. District Courts across the country.

  1. FDA, Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Clinical Trial Results Find Increased Risk of Leg and Foot Amputations,

  2. Medscape, FDA Warns About Amputation Risk With Canagliflozin,