Johnson & Johnson and it’s Janssen subsidiary face hundreds of Invokana lawsuits, with a growing number of recently filed complaints involving individuals who allege that side effects of the diabetes drug resulted in amputations. 

Last week, at least five new amputation lawsuits were filed in the U.S. District Court for the District of New Jersey, including complaints brought on behalf of Joshua Blevins (PDF), Jeffrey and Amy Baker (PDF), Mildred Moore (PDF), Robin Pepper (PDF), and Robert and Acquanette Johnson (PDF).

Each of the cases raise nearly identical allegations that Invokana caused amputations, as well as other injuries, such as diabetic ketoacidosis, kidney failure and heart issues, claiming that the drug makers failed to provide adequate warnings for users or the medical community.

“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 public, and minimize unfavorable findings,” one of the complaints states. “Defendants knew of the significant risk of amputations caused by ingestion of Invokana.”

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 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.

Most recently, 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.

These latest complaint join more than 700 other Invokana cases centralized in the federal court system as part of a multidistrict litigation (MDL). While most of the cases have been pending for months, increasingly cases filed over the past 90 days involve allegations that users suffered an amputation from Invokana

The Invokana litigation 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, the claims may later be remanded to U.S. District Courts nationwide for separate trial dates.

Tags: Amputation, Diabetes, Diabetes Drug, Diabetic Ketoacidosis, Invokana, Johnson & Johnson, Kidney Failure