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Johnson & Johnson and its Janssen subsidiaries failed to provide adequate label warnings about the potential side effects of Invokana, according to allegations raised in a lawsuit filed by an Alabama man who indicates that he suffered a stroke only a month after he started using the new-generation diabetes drug.
The complaint (PDF) was filed by Brian K. Armstrong in the U.S. District Court for the District of New Jersey on August 18, indicating that the drug makers knew or should have known about the Invokana stroke risk, yet withheld information from consumers and the medical community.
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 from other diabetes treatments, 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 that has encouraged doctors to switch diabetes patients to the new treatment.
Armstrong indicates that he began taking Invokana in July 2015. However, just a month later, in August 2015, he was hospitalized for dizziness, nausea, vomiting and vertigo. A diagnosis determined that he had suffered an ischemic stroke, which the lawsuit maintains was a direct result of his treatment with Invokana.
Since the new-generation diabetes hit the market in the U.S., 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.
“Defendant’s marketing campaign willfully and intentionally misrepresented the risks of Invokana and failed to warn about the risks of diabetic ketoacidosis, kidney failure, sepsis and other injuries,” the lawsuit states. “Defendants, both individually and in concert with one another, misrepresented that Invokana is a safe and effective treatment for type 2 diabetes mellitus when in fact the drug causes serious medical problems which require hospitalization and can lead to life threatening complications.”
The stroke case filed by Armstrong 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 Armstrong 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.