A Florida woman alleges, in a recent lawsuit brought against the makers of Invokana–Janssen Pharmaceuticals, and its parent company Johnson & Johnson (J&J)–, that the drug makers neglected to issue a proper warning about the connection between Invokana and ketoacidosis, a condition that occurs when too much acid builds up in a patient’s blood.
The plaintiff in the case alleges that patients who took Invokana (canagliflozin) for Type 2 diabetes have suffered severe and dangerous reactions including diabetic ketoacidosis, stroke, heart attack, and severe kidney damage. The woman began taking Invokana around August 2014 to manage high blood sugar related to her Type 2 diabetes. She maintains she then suffered an episode of diabetic ketoacidosis, which she claims was caused by Invokana. She believes the episode could have been avoided had the pharmaceutical companies properly evaluated the drug’s safety and effectiveness and provided adequate instructions and warnings.
Invokana was approved by the U.S. Food and Drug Administration (FDA) in March 2013 to treat Type 2 diabetes. Invokana is one of a class of diabetes drugs referred to as SGLT2 inhibitors, which are meant to lower excessive levels of blood sugar by inhibiting the sugar from being reabsorbed into the bloodstream within the kidneys. Excess sugar is excreted out in urine.
The plaintiff alleges that, according to the FDA’s adverse event reporting (FAERS) database, patients taking Invokana are more likely to suffer from diabetic ketoacidosis than are those taking non-SGLT2 diabetes drugs. Signs of ketoacidosis, according to the Mayo Clinic are: Excessive thirst, frequent urination, nausea and vomiting, abdominal pain, shortness of breath, fruity-scented breath, and confusion.
The woman alleges that Janssen Pharmaceuticals and J&J had knowledge of the risks associated with Invokana and ketoacidosis and failing to adequately warn consumers or the medical community about these risks. Allegations also include that the drug makers actively concealed information about Invokana’s risks and touted Invokana as a safe and effective treatment for diabetes. This influenced her choice of medication, the plaintiff alleges.
This lawsuit raises claims under New Jersey consumer protection laws for manufacturing defects, defective design, and failure to warn. The plaintiff also brings claims for breach of warranty, negligence, fraud, and misrepresentation.