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A wrongful death lawsuit filed against Johnson & Johnson and it’s Janssen Pharmaceuticals subsidiary indicates that side effects of Invokana caused an Indiana man to suffer an acute kidney injury, which was eventually fatal.
The complaint (PDF) was filed earlier this week by Phyllis Craig in the U.S. District Court for the District of New Jersey, indicating that her husband, John Reuben Craig, died as a result of the drug makers’ failure to warn about the link between Invokana and kidney problems.
Craig indicates that her husband was prescribed the new-generation diabetes drug in September 2014, and continued to use Invokana until he suffered and acute kidney injury in February 2015. As a result of the kidney complications, Craig later died in October 2015.
Invokana (canagliflozin) was introduced in March 2013, only about 18 months before Craig’s husband was switched to the type 2 diabetes drug. The drug is part of a new class of medications, known as sodium glucose cotransporter 2 (SGLT-2) inhibitors, which work in a unique way, by altering some normal kidney functions to increase the amount of sugar excreted in the urine. However, since Invokana has hit the market, a growing number of serious health risks have been reported, including diabetic ketoacidosis, kidney failure and heart attacks.
Craig’s wrongful death case joins a growing number of similar Invokana lawsuits filed in recent months, each raising similar allegations that the drug makers withheld information from consumers and the medical community about the potential risks, and continued to aggressively market Invokana in an attempt to get diabetics switched to the new medication.
Plaintiffs allege that Invokana injuries could have avoided if the users and doctors had been properly informed of the potential side effects. Craig’s complaint also indicates that the very nature of how Invokana works may make such damage, including kidney injury and a dangerous build-up of acid in the blood, known as ketoacidosis, harder to detect and treat.
“Ketoacidosis can lead to organ failure, including renal failure if not treated quickly,” the lawsuit states. “Unfortunately for Invokana users, because the drug mimics a naturally occurring emergency process while lowering blood-glucose, key symptoms of ketoacidosis such as elevated blood-glucose and frequent urination are either not present or unrecognizable. Thus, Invokana users are often unaware they are suffering ketoacidosis until more severe injuries develop.”
In May 2015, the Institute for Safe Medication Practices (ISMP) conducted a detailed review of adverse event reports submitted to the FDA during the first year Invokana was on the market, and identified a potential risk of kidney damage with Invokana and other SGLT2 inhibitors, raising questions about whether the benefits provided by the medication justify the risk.
In June 2016, the FDA required the drug makers to add a new Invokana safety warning, indicating that the medication may increase the risk of acute kidney injury and other severe health problems.
In December 2015, the FDA required Johnson & Johnson and the makers of other SGLT2 inhibitors to add new diabetic ketoacidosis warnings to their medications, urging users to stop taking the drug and seek immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting.
As Invokana injury lawyers continue to review and file claims for individuals nationwide, it is widely expected that hundreds, if not thousands, of additional lawsuits may be filed in the coming months and years.
Given similar questions of fact and law raised in cases filed by individuals throughout the U.S., centralized federal pretrial proceedings have been established for the Invokana litigation before U.S. District Judge Brian Martinotti in the District of New Jersey. However, if Invokana settlements or another resolution for the cases is not reached following discovery and a series of early bellwether trials, each case may later be remanded back to the U.S. District Court where it was originally filed for a separate trial date.