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A product liability lawsuit filed last week indicates that the side effects of Invokana caused an Alabama man to suffer severe injuries and complications from diabetic ketoacidosis.
The complaint (PDF) was filed by Mark Anderson in the U.S. District Court for the District of New Jersey on October 7, naming Johnson & Johnson, it’s Janssen subsidiary, and Mitsubishi Tanabe Pharma Corp. as defendants.
Invokana (canagliflozin) is was introduced in March 2013, and has been aggressively marketed as a new type of diabetes treatment, which works in a unique way by impacting the normal function of the kidneys. However, as more individuals have been switched to the new drug, a steady stream of serious health risks have been uncovered, resulting in dozens of Invokana lawsuits filed in courts nationwide, each raising similar allegations that the drug makers sold an unreasonably dangerous and defective product.
According to this recent case over Invokana, Anderson began taking the new-generation diabetes drug in April 2014, and later suffered diabetic ketoacidosis, which is a serious medical emergency involving an accumulation of blood acid that rises to dangerous levels, usually requiring hospitalization. Anderson stopped taking Invokana in September 2015.
Invokana diabetic ketoacidosis problems can cause low blood sugar, low potassium levels that can interfere with the functioning of the heart, muscles and nervous system, and can also cause swelling of the brain. If left untreated, ketoacidosis can result in loss of consciousness and even death.
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.
Like other plaintiffs, Anderson alleges that the drug makers knew or should have known about the diabetic ketoacidosis risk, yet withheld information from consumers and the medical community.
“Plaintiff would not have used Invokana had Defendants properly disclosed the risks associated with the drug,” the lawsuit states. “Thus, had Defendants properly disclosed the risks associated with Invokana, Plaintiff would have avoided the risk of developing the injuries complained of herein by not ingesting Invokana.”
In addition to concerns about ketacidosis, a number of lawsuits filed against the drug maker alleging that the drug makers knew or should have suspected that Invokana increases the risk of kidney failure.
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, the FDA released a new Invokana safety warning, indicating that the medication may increase the risk of acute kidney injury and other severe health problems.
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.