Two new Invokana lawsuits were recently filed in U.S. courts on behalf of patients who suffered serious side effects allegedly related to their use of the Type 2 diabetes medication. A plaintiff at the center of one of the cases claims that Invokana caused her to suffer a potentially fatal disorder called diabetic ketoacidosis, while the other blames the drug for kidney damage.
The Invokana ketoacidosis lawsuit was filed on October 26th in the U.S. District Court, Eastern District of California, by a woman who was hospitalized for the condition in October 2013. Diabetic ketoacidosis occurs when toxic acids called ketones accumulate in the blood. The condition, which can lead to diabetic coma and death, is generally seen in patients with Type 1 diabetes. But in recent months, concerns have mounted over reports of ketoacidosis among patients taking SGLT2 inhibitors like Invokana to control Type 2 diabetes.
“Despite their knowledge of data indicating that Invokana use is causally related to the development of Diabetic Ketoacidosis and kidney failure, Defendants promoted and marketed Invokana as safe and effective for persons such as Plaintiff throughout the United States, including this judicial district,” the lawsuit states. “Defendants failed to adequately warn physicians about the risks associated with Invokana and the monitoring required to ensure their patients’ safety.”
Just a few days earlier, an Invokana lawsuit was filed in the U.S. District Court, Southern District of Illinois, by a man who claims to have suffered severe kidney damage due to his treatment with the SGLT2 inhibitor. The October 23rd complaint alleges that Johnson & Johnson and certain of its subsidiaries were aware that Invokana was associated with a significant risk of kidney damage, but did not adequately warn consumers or the medical community of the severity of this risk. Among other things, the filing cites a recent analysis of the U.S. Food & Drug Administration (FDA) adverse event database that purportedly suggested Invokana patients were more likely to report kidney damage than users of other SGLT2 inhibitor medications.
Invokana was introduced by Johnson & Johnson and Janssen in March 2013, and was the first SGLT2 inhibitor medication approved for the treatment of Type 2 diabetes. In a few short years, it has become one of Janssen’s top-selling drugs, generating $278 million in sales during the first quarter of 2015.
In March 2015, the FDA announced its adverse events database had received 20 reports of diabetic ketoacidosis in patients taking SGLT2 inhibitors from March 2013 to June 6, 2014. The agency is currently reviewing these reports to determine whether changes are needed in the prescribing information for this class of medications.
An analysis of FDA adverse event reports issued that same month by the Institute for Safe Medicine Practices (ISMP) noted that the agency had received 457 adverse event reports associated with Invokana during its first year on the market, including more than 50 that tied Invokana to kidney failure or renal impairment. The ISMP said that these issues were not surprising, given that the medication directly impacts the kidneys. The group also pointed out that the Invokana prescribing information already contains information regarding the potential for kidney failure or impairment.
The nationwide law firm of Bernstein Liebhard LLP is now investigating potential product liability claims involving Invokana and other SGLT2 inhibitors. If you or a loved one were hospitalized with diabetic ketoacidosis while using one of these medications to treat Type 2 diabetes, please call to learn more about your legal options.