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The side effects of Invokana pose an unreasonably dangerous risk for consumers, according to a recent product liability lawsuit that alleges the diabetes drug caused a Kentucky man to suffer a heart attack, kidney failure and other health problems.
The complaint (PDF) was filed by Forrest Swearingen in the U.S. District Court for the District of New Jersey on September 30, alleging that Johnson & Johnson, it’s Janssen subsidiary, and Mitsubishi Tanabe failed to adequately warn users and the medical community about the risks caused by Invokana.
Swearingen indicates that he was prescribed the new-generation diabetes drug in May 2015, alleging that Invokana caused him to develop acute kidney failure, myocardial infarction and other injuries.
Invokana (canagliflozin) was first introduced in the United States in March 2013, and was quickly adopted by the medical community amid aggressive marketing that suggested it was superior to other diabetes treatments. However, as more individuals have been switched to the new drug, a steady stream of serious side effects have emerged, including a potential risk of Invokana heart attacks, kidney failure, and diabetic ketoacidosis, which involves a dangerous build up of acid in the blood.
The case joins a growing number of similar Invokana lawsuits filed by individuals nationwide, each involving claims that severe and potentially life-threatening injuries may have been avoided if the drug makers had properly researched the side effects of their drug and warned about dangerous health risks.
“The development of Plaintiff Forrest Swearingen’s injuries was preventable and resulted directly from Defendants’ failure and refusal to conduct proper safety studies, failure to properly assess and publicize alarming safety signals, suppression of information revealing serious and life-threatening risks, willful and wanton failure to provide adequate instructions, and willful misrepresentations concerning the nature and safety of Invokana,” the lawsuit states. “This conduct and the product defects complained of herein were substantial factors in bringing about and exacerbating Plaintiff Forrest Swearingen’s injuries.”
Invokana was the first member of a new class of diabetes drugs introduced in recent years, known as sodium-glucose co-transporter 2 (SGLT2) inhibitors, which work in a unique way from other diabetes treatments. Other members of this class include Invokamet, Farxiga, Xigduo XR, Jardiance and Glyxambi.
Only two years after the drug was approved, the Institute for Safe Medication Practices (ISMP) highlighted serious concerns after analyzing FDA adverse event data in May 2015. Based on problems reported during the first full year the drug was on the market, ISMP identified a risk of kidney damage with Invokana, raising questions about whether the side effects may outweigh the benefits provided by the medication.
In June 2016, the FDA required the drug makers to provide new Invokana warnings, indicating that the medication may increase the risk of acute kidney injury and other severe health problems.
In addition to concerns about kidney failure, a number of lawsuits filed against the drug maker alleging that the drug makers knew or should have suspected that the drug could cause diabetic ketoacidosis, which the FDA required the drug makers to add to the warning label in December 2015. The updated diabetic ketoacidosis warnings now urge users to stop taking the drug and seek immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting.
Amid a mounting number of complaints filed nationwide, a motion was filed last month with the U.S. Judicial Panel on Multidistrict Litigation, seeking to centralized and consolidate all Invokana cases pending throughout the federal court system. There are currently about six dozen complaints pending nationwide, but as Invokana injury lawyers continue to review and file claims for individuals who experienced problems, it is widely expected that hundreds, if not thousands, of additional lawsuits may be filed in the coming months and years.