Another lawsuit has been filed against Janssen Pharmaceuticals and its parent company Johnson & Johnson, alleging that the companies’ type 2 diabetes drug Invokana (the trade name for canagliflozin) caused a user to suffer a stroke. The lawsuit was filed in federal court in the federal district court in New Jersey.
According to the lawsuit, the plaintiff, a Kentucky woman, was prescribed to take Invokana in 2015 for treatment of diabetes. Not long after she started using the pharmaceutical product, she suffered a debilitating stroke. She alleged that both companies knew of the potential risk for stroke, but provided no warning in any of the packaging materials or on the label. She also alleges that Janssen/Johnson and Johnson knew as early as 2013 that there were concerns about the potential safety of the drug.
When the U.S. Food and Drug Administration (FDA) approved the drug that year, two members of the panel, both cardiologists, expressed reservations about the drug, citing concerns about the risk of stroke or heart attack. The FDA then issued conditional approval, mandating post-marketing studies to assess the risks of injury to the cardiovascular system. That study found that nearly half of all users (46%) had an increased risk of stroke within the first month after starting treatment with Invokana.
The lawsuit comes on the heels of a similar suit filed in New Jersey federal court in April by a couple from Illinois, citing similar factual circumstances. Other lawsuits have been filed alleging that Invokana led to kidney failure or impairment and that it caused a condition known as diabetic ketoacidosis (DKA), a process that introduces poisons into the body.
The lawsuit filed by the Kentucky woman alleges that Invokana has both manufacturing and design defects, that the companies failed to adequately warn of known dangers, that the companies fraudulently misrepresented and concealed information, and that the companies were negligent. The lawsuit seeks compensatory and punitive damages.