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As Johnson & Johnson continues to face a growing number of Invokana lawsuits brought on behalf of individuals who developed diabetic ketoacidosis and kidney failure after using the new-generation diabetes drug, a number of former users are also filing complaints that indicate Invokana caused amputation of the leg, foot or toes.
One of the latest cases was filed by Michael Nickels and his wife, Mary, in the U.S. District Court for the District of New Jersey on August 11, indicating that Johnson & Johnson and its Janssen Pharmaceuticals subsidiary knew or should have known about the risk of amputations caused by Invokana side effects, yet failed to adequately warn consumers and the medical community.
According to the complaint (PDF), Mickels began taking Invonaka for the treatment of type 2 diabetes in August 2014, shortly after the medication was approved as a new type of treatment for diabetics. Two years later, Mickels underwent an amputation procedure, which he directly relates to the use of the medication.
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 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.
“Defendants knew of the significant risk of amputations caused by ingestion of Invokana,” the lawsuit filed by Mickels claims. “However, Defendants did not adequately and sufficiently warn consumers, including Plaintiff, or the medical community of the severity of such risks.”
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, Nickels’ 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 pretrial proceedings.
Following discovery and potential “bellwether” trials, which are designed to help the parties gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation, if Invokana settlements or another resolution for the cases is not, Nickels’ claim and hundreds of others may later be remanded to U.S. District Courts nationwide for separate trial dates.