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According to allegations raised in a recently filed product liability lawsuit, the side effects of Invokana resulted in a double amputation below the knee for a Texas man, as well as life-threatening cases of kidney failure and diabetic ketoacidosis.
The complaint (PDF) was filed by Arthur Trevino, Jr. in the U.S. District Court for the District of New Jersey on July 23, naming Johnson & Johnson and its Janssen Pharmaceuticals subsidiary as the defendants.
Trevino indicates that he was prescribed the new-generation diabetes drug Invokana to improve glycemic control in November 2014, and continued to use the drug until April 2017, not knowing about the growing number of health risks linked to the medication since it was introduced by the manufacturers.
“While taking Invokana, Plaintiff developed kidney injury, and have below the knee amputations on both legs as a result of treatment with Invokana,” the lawsuit states. “As a result of his development of diabetic ketoacidosis, Plaintiff developed serious complications, such as acute kidney failure, which required multiple days of hospitalization.”
Invokana (canagliflozin) was introduced in March 2013, as the first member of a new class of diabetes drugs, known as sodium-glucose cotransporter 2 (SGLT2) inhibitors, which works in a unique way by impacting some normal kidney functions. Other members of this class include Invokamet, Jardiance, Farxiga, Xigduo and others, but Invokana has remained the biggest seller, amid aggressive marketing.
In December 2015, the FDA required Johnson & Johnson to add new diabetic ketoacidosis warnings to Invokana, indicating that the medication increases the risk of this serious condition, which typically results in the need for emergency treatment to avoid life-threatening injury. Prior to the update, the Invokana warnings failed to alert consumers about the importance of seeking immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting.
In May 2017, the FDA required an Invokana warning update regarding the risk of leg and foot amputation, which manufacturers of other similar diabetes drugs claim is a unique risk with Invokana.
The amputation case filed by Trevino will be consolidated with other Invokana lawsuits pending in the federal court system, which are currently consolidated for pretrial proceedings before one judge in New Jersey.
Following coordinated discovery and any bellwether trials held to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation, if Invokana settlements or another resolution for the claims is not reached, Bottner’s case and hundreds of others may later be remanded back to U.S. District Courts nationwide for individual trial dates.