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The family of a Georgia man has filed a wrongful death lawsuit against Johnson & Johnson and it’s Janssen Pharmaceutical’s subsidiary, alleging that the type 2 diabetes drug Invokana caused the development of severe kidney problems, diabetic ketoacidosis and a stroke.
The complaint (PDF) was filed by Loretta Jack in the U.S. District Court for the District of New Jersey on October 27, on behalf of herself and her late husband, Raymond Jack, Sr., who died in November 2015.
Raymond Jack was prescribed Invokana for treatment of his diabetes in March 2015. According to the lawsuit, he was hospitalized just months later in June 2015, after suffering an acute stroke. He was subsequently diagnosed with an acute kidney injury and acute renal insufficiency, which his wife indicates was directly caused by side effects of Invokana. In October 2015, he was again hospitalized and diagnosed with additional injuries, including a urinary tract infection, stage III chronic kidney disease and volume depletion.
“The development of Decedent’s injuries and subsequent death was preventable and resulted directly from Defendants’ failure and refusal to conduct proper safety studies, failure to properly assess and publicize alarming safety signals, suppression of information revealing serious and life-threatening risks, willful and wanton failure to provide adequate instructions, and willful misrepresentations concerning the nature and safety of Invokana,” the lawsuit states. “This conduct, as well as the product defects complained of herein, were substantial factors in bringing about and exacerbating Decedent’s injuries and subsequent death.”
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. Other members of this class include Invokamet, Jardiance, Farxiga, Xigduo and others, but Invokana has remained the biggest seller since it hit the market in March 2013.
Amid aggressive marketing by Janssen, Invokana quickly grew to become a blockbuster treatment. However, as more users began to switch to the drug, a serious of serious safety problems have emerged, resulting in a number of warning label updates over the past few years.
In December 2015, after a number of adverse event reports were identified involving involving diabetic ketoacidosis from Invokana, the FDA required a warning label update. At that time, the drug makers were forced to provide information for the first time to consumers and the medical community about the importance of users seeking immediate medical attention if users experience abdominal pain, fatigue, nausea, vomiting, respiratory problems or other symptoms while taking Invokana.
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.
In May 2017, FDA required a warning update about the Invokana amputation risks, placing information about the increased incidence of leg, foot and toe amputations in a prominent black box on the label, which is one of the strongest warnings the agency can require a prescription medication to carry.
The wrongful death lawsuit joins a growing number of other Invokana lawsuits filed by users nationwide, each raising similar allegations that the drug makers withheld critical safety information about their type 2 diabetes treatment.
As part of the coordinated pretrial proceedings in the federal court system, which are centralized before U.S. District Judge Brian Martinotti in the District of New Jersey, 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, Norris’s claim and hundreds of others may later be remanded to U.S. District Courts nationwide for separate trial dates.