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A product liability lawsuit against Johnson & Johnson links the side effects of Invokana to yet another incident of kidney failure, little more than a year after a Florida woman switched to the new-generation diabetes drug.
The complaint (PDF) was filed by Flora Sanchez against Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, on February 16, in the U.S. District Court for the District of New Jersey, where nearly 1,000 similar claims have been consolidated.
According to the lawsuit, Sanchez began taking Invokana in June 2014, about one year after the type 2 diabetes drug was introduced. However, she indicates that after using the medication until August 2015, she developed kidney failure and other kidney problems, which she directly relates to side effects of the medication.
“Defendants knew of the significant risk of kidney failure caused by ingestion of Invokana,” the lawsuit states. “However, Defendants did not adequately and sufficiently warn consumers, including Plaintiff Flora Sanchez or the medical community of the severity of such risks.”
Sanchez raises allegations similar to those presented in a growing number of other Invokana lawsuits, which are currently centralized before U.S. District Judge Brian R. Martinotti in New Jersey, as part of a federal MDL, or multidistrict litigation.
Given similar questions of fact and law raised in the Invokana litigation, Judge Martinotti is coordinating pretrial proceedings to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings and to serve the convenience of the parties, witnesses and the judicial system.
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.
More 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.
As part of the coordinated pretrial proceedings in the federal court system, it is expected that a small group of “bellwether” cases will be prepared for early trial dates to help the parties gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation.
Following any bellwether trials, if Invokana settlements or another resolution for the cases is not found, Pitts’ claim and hundreds of others may later be remanded to U.S. District Courts nationwide for separate trial dates.