Johnson & Johnson’s subsidiary Janssen Pharmaceuticals, Inc., manufactures the diabetes drug Invokana. Janssen is facing a products liability lawsuit over an alleged claim of Invokana renal (kidney) failure. Invokana (canagliflozin) is used along with a proper exercise program and diet, in the treatment of type 2 diabetes to control high levels of blood sugar. The control of high blood sugar levels helps prevent kidney damage, nerve problems, loss of limbs, and blindness.
A new study published recently in the New England Journal of Medicine regarding the potential for diabetic ketoacidosis (DKA) reveals that type 2 diabetes patients on sodium-glucose cotransporter 2 (SGLT2) inhibitor drugs seem to have double the risk for DKA when compared with patients using dipeptidyl peptidase-4 (DPP-4) inhibitors. Invokana is part of the SGLT2 class, and significant concern has been expressed over Invokana associated with cardiovascular injuries and kidney failure.
Allegations Concerning Invokana
Johnson & Johnson (J&J) hid their knowledge of the drug’s adverse side effects and dangerous risks involved in its use from consumers and the medical community, according to the plaintiff from Ohio. In the man’s renal failure lawsuit, the plaintiff says that the defective nature of Invokana caused his severe and permanent personal injuries, including acute renal failure.
Due to the alleged personal injuries suffered as a result of taking Invokana, the plaintiff seeks punitive and compensatory damages and monetary restitution. He maintains had he known of the risks involved in taking Invokana, he never would have used the medication, the lawsuit states.
“As a direct and proximate result of defendants’ negligence, wrongful conduct, and the unreasonably dangerous and defective characteristics of Invokana, plaintiff… suffered severe and permanent physical and emotional injuries,” the Invokana renal failure lawsuit states.
In addition, it is contended that he “has endured pain and suffering, emotional distress, loss of enjoyment of life, and economic loss, including significant expenses for medical care and treatment which will continue in the future,” according to the lawsuit. The Invokana Renal Failure Lawsuit will take place in the U.S. District Court for the District of New Jersey.
National law firm Parker Waichman LLP has extensive experience and success representing clients in pharmaceutical litigation. Attorneys at the firm are available to answer questions for any individuals seeking legal information for a potential lawsuit.
In March 2013, Invokana was approved by the U.S. Food and Drug Administration (FDA). It is one of J&J’s top selling drugs, with revenue in excess of $278 million in the first quarter of 2015.
Invokana works by passing excess sugar out of the body through the excretion of urine. Invokana lowers blood sugar levels in the bloodstream by inhibiting renal glucose reabsorption. However, as contended in the Invokana renal failure litigation, because of this inhibition, the excess glucose is “excreted through the kidneys of a population of consumers already at risk for kidney disease.”
FDA Warnings Increase
The U.S. Food and Drug Administration (FDA) has recently issued more severe warnings about the popular diabetes medication. There has been an increased risk of amputation and other serious side effects including severe urinary tract infection, and heart attack, as well as kidney failure.
Some of these injuries have resulted in a need for hospitalization and may have been life-threatening or resulted in permanent disability. Multiple Invokana lawsuits have been filed against Janssen Pharmaceuticals and the parent company, Johnson & Johnson. These lawsuits claimed that the drug company failed to warn patients and medical professionals about the dangers of the drug, according to drugwatch.com.
The FDA warned Invokana could cause a buildup of acid in the blood called ketoacidosis, a condition that can be fatal. 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 FDA updated the warning label in May 2015 on SGLT2 inhibitors to warn of ketoacidosis. The label update affected Farxiga, Jardiance, and three combination products that include an SGLT2 inhibitor with metformin: Invokamet, Xigduo XR and Glyxambi. Between March 2013 and June 2014, regulators reported 20 cases of ketoacidosis linked to an SGLT2 inhibitor. Hospitalization was necessary in all cases.
Then, in December of the same year, the agency announced the diabetes drug could also lead to blood infections and kidney injuries, reports drugwatch.com
The FDA has since 2016, strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). Based on recent reports, the FDA has revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk, reports FDA MedWatch.
Legal Help Regarding Diabetes Medications’ Side Effects
If you or someone you know has been injured by Invokana or other diabetes medications, you may be eligible for valuable compensation. The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).