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According to allegations raised in a product liability lawsuit filed last week by a Massachusetts woman, side effects of the diabetes drug Invokana caused her to be hospitalized with diabetic ketoacidosis, a serious medical emergency associated with a buildup of blood acids, which results in severe abdominal pain, shortness of breath, nausea and other complications.
The complaint (PDF) was filed by Karyn Norris and her husband, Paul, in the U.S. District Court for the District of New Jersey on October 10, naming Johnson & Johnson and it’s Janssen subsidiary as defendants.
Norris indicates that she was prescribed Invokana in June 2014, shortly after it was approved in the U.S. as a new-generation diabetes treatment that works in a unique way, by impacting some normal kidney functions. However, within about five months, she began to experience symptoms of diabetic ketoacidosis, which ultimately led to her hospitalization and left her with permanent injuries.
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 agressive 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.
Norris indicates that the drug makers failed to adequately research the medication or provide adequate warnings to users and the medical community.
“Defendants, both individually and in concern 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, including but not limited to diabetic ketoacidosis and its sequelae and kidney failure and its sequelae,” the lawsuit states.
Amid a growing number of adverse event reports involving diabetic ketoacidosis hospitalizations, the FDA required an Invokana warning update in December 2015, adding indication for the first time about the importance of seeking immediate medical attention if users experience abdominal pain, fatigue, nausea, vomiting, respiratory problems or other symptoms.
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.
“Defendants were aware that the mechanism of action for Invokana places extraordinary strain on the kidney and renal system,” according to the complaint. “Despite Defendants’ knowledge of the increased risk of severe injury among Invokana users, Defendant did not warn patients but instead continued to defend Invokana, mislead physicians and the public and minimize unfavorable findings.”
Norris’s case joins a growing number of other Invokana lawsuits filed by users nationwide, each raising similar questions of fact and law.
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.