Lawsuit Alleges Invokana Makers Put Profits Ahead of Patient Safety

Published on August 18, 2016 by Sandy Liebhard

Yet another Invokana lawsuit has been filed on behalf of a patient who allegedly developed ketoacidosis as a result of the Type 2 diabetes medication. Among other things, the complaint claims that the drug’s manufacturers were aware that Invokana could cause this dangerous complication, but placed profits ahead of patient safety and failed to issue adequate warnings to the public and medical community.

According to a July 25th filing in the U.S. District Court, District of New Jersey, Sheryl Desalis of Arizona began taking Invokana in March 2014 to treat Type 2 diabetes. Within months, she was forced to end her treatment after being diagnosed with diabetic ketoacidosis and other injuries. Her complaint alleges that Johnson & Johnson and other defendants “negligently, recklessly and carelessly marketed, distributed and sold Invokana without adequate instructions or warning of its serious side effects and unreasonably dangerous risks.” Desalis maintains that she would not have used Invokana had the drug’s manufacturers properly disclosed the risks associated with its use.

This case is just one of the latest Invokana lawsuits filed in recent months on behalf o f patients who allegedly suffered ketoacidosis and kidney problems due to its use. In May, The Legal Intelligencer reported that at least 33 such claims were pending in Pennsylvania’s Philadelphia Court of Common Pleas. At the time, plaintiffs’ attorneys suggested that they would seek mass tort status for Invokana claims if the number of cases continued to grow.

A month earlier, The New Jersey Law Journal noted that at least three similar lawsuits had been filed in the U.S. District Court, District of New Jersey.

Invokana and Other SGLT2 Inhibitors

Invokana was brought to market in March 2013, and was the first SGLT2 inhibitor to be approved by the U.S. Food & Drug Administration (FDA) for the treatment of Type 2 diabetes. In December 2015, the FDA announced that the labels for all drugs in this class would be updated to reflect the potential for diabetic ketoacidosis. At that time, new information about life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that originate as urinary tract infections was also added to the labeling of all SGLT2 inhibitors.

In June, the FDA ordered the manufacturers of Invokana, Invokamet, Farxiga and Xigduo XR to strengthen label warnings regarding kidney complications potentially associated with their use. The announcement noted that these specific SGLT2 inhibitors had been implicated in more than 100 reports of acute kidney injury.