Invokana Amputation Lawsuit Filed Over Loss of Right Leg from Diabetes Drug

Diabetes patients and the medical community were not adequately warned about the risk of amputations caused by Invokana, according to allegations raised in a product liability lawsuit filed last month on behalf of a woman who had her right leg removed about a year after switching to the new-generation treatment.

The complaint (PDF) was filed by Polley Dailey in the U.S. District Court for the District of New Jersey on July 6, indicating that Johnson & Johnson and it’s Janssen Pharmaceuticals subsidiary knew or should have known about that potential side effects of Invokana, yet withheld and concealed information about the severity of the risks.

Dailey indicates that she began taking Invokana in December 2014, which is a new type of treatment for type 2 diabetes that works in a different way than most diabetes treatments. About a year later, Daily had to undergo surgery to amputate her right leg, which she indicates was caused by the use of the drug.

Invokana (canagliflozin) was introduced in March 2013, as the first member of a new class of diabetes drugs, known as sodium-glucose cotransporter 2 (SGLT2) inhibitors, which works in a unique way by impacting some normal kidney functions. Other members of this class include Invokamet, Jardiance, Farxiga, Xigduo and others, but Invokana has remained the biggest seller, amid aggressive marketing.

As more and more diabetics have switched to Invokana, a steady stream of serious health concerns have emerged from post-marketing adverse event reports, leading the FDA to require several warning label updates over the past few years. In addition to the Invokana amputation risks, the medication has also been linked to reports of diabetic ketoacidosis, kidney failure, heart attacks and other injuries.

In May 2017, the FDA required an Invokana warning update regarding the risk of leg and foot amputation, which manufacturers of other SGLT2 inhibitors claim is a unique risk with Invokana, not seen with their competing drugs.

Dailey’s complaint joins a growing number of Invokana lawsuits filed by plaintiffs nationwide who suffered amputations, kidney failure, diabetic ketoacidosis and other injuries linked to the drug, which were not adequately disclosed by the drug maker. The lawsuits indicate that many plaintiffs would have never taken Invokana had they known the true extent of the potential health risks.

“Despite Defendants’ knowledge of the increased risk of severe injury among Invokana users, Defendants did not warn patients but instead continued to defend Invokana, mislead physicians and the publick, and minimize unfavorable findings,” the lawsuit filed by Dailey states. “Consumers, including Plaintiff, who have used Invokana for treatment of diabetes, have several alternative safer products available to treat the conditions.”

In December 2015, the FDA required Johnson & Johnson to add new diabetic ketoacidosis warnings to Invokana, indicating that the medication increases the risk of this serious condition, which typically results in the need for emergency treatment to avoid life-threatening injury. Prior to the update, the Invokana warnings failed to alert consumers about the importance of seeking immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting.

In June 2016, the FDA required additional label warnings 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.

Given the similar questions of fact and law, Dailey’s complaint will be consolidated as part of an Invokana MDL, which is centralized before U.S. District Judge Brian Martinotti in the District of New Jersey for coordinated discovery and pretrial proceedings. However, if Invokana settlements or another resolution for the cases is not reached during the MDL process, Dailey’s claim and others involved in the litigation may later be remanded to U.S. District Courts nationwide for separate trial dates.