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According to allegations raised in a product liability lawsuit brought by a Kansas man, side effects of the diabetes drug Invokana resulted in severe kidney problems, including chronic kidney disease, acute renal failure and other injuries.
The complaint (PDF) was filed by Terrence L. Tobler last week in the U.S. District Court for the District of New Jersey, indicating that Johnson & Johnson and it’s Janssen subsidiary knew or should have known about the Invokana kidney risks, yet failed to adequately warn patients or the medical community.
Tobler indicates that he began taking Invokana in February 2016, as a treatment for diabetes. However, the very next month he started to develop a host of injuries, indicating that Invokana resulted in kidney failure, acute kidney injury, chronic kidney disease and hyperkalemia.
“Defendants knew of the significant risk of severe injury caused by ingestion of Invokana. However, Defendants did not warn or did not adequately and sufficiently warn consumers, including Plaintiff, or the medical community of the severity of such risks,” the lawsuit states. “To the contrary, Defendants conducted nationwide sales and marketing campaigns to promote the sale of Invokana and willfully deceived Plaintiff, his/her health care professionals, the medical community, and the general public as to the health risks and consequences of the use of Invokana.”
Since the new-generation diabetes drug hit the market in the U.S. in 2013, a steady stream of serious health problems linked to Invokana 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.
Tobler’s complaint joins a growing number of diabetic ketoacidosis lawsuits, kidney failure lawsuits, heart attack lawsuits and amputation lawsuits filed against the drug makers in recent months, each raising similar allegations about label deficiencies.
Given the similar questions of fact and law raised in complaints filed throughout the federal court system, the Invokana litigation has been centralized before U.S. District Judge Brian Martinotti in the District of New Jersey for coordinated discovery and pretrial proceedings.
As part of the management of the federal multidistrict litigation (MDL), it is expected that Judge Martinotti will schedule a series of early “bellwether” trials involving each category of injury, which are designed to help the parties gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation.
While the outcomes of these early trial dates will not binding on Tobler and other plaintiffs not involved in the trials, they may influence eventual negotiations to reach Invokana settlements, which would be necessary to avoid the need for hundreds of separate trial in U.S. District Courts nationwide.