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A Louisiana man indicates that he needed to have his left foot amputated due to side effects of Invokana, claiming in a new lawsuit that the drug makers failed to adequately warn about the risk of problems linked to the controversial new-generation diabetes medication.
The complaint (PDF) was filed by Warren Prout, Sr. in the U.S. District Court for the District of New Jersey on May 14, alleging that Johnson & Johnson and it’s Janssen Pharmaceuticals subsidiary intentionally and fraudulently misrepresented the safety of Invokana.
Prout indicates that he was prescribed Invokana in June 2014, for the treatment of type 2 diabetes. However, between October 2015 and October 2016, he suffered a series of infections and diabetic ulcers on his left foot, resulting in several surgeries, including amputations of his toes and metatarsal bones of his left foot.
The lawsuit claims that the drug maker knew or should have known about the link between Invokana and amputations, yet failed to adequately warn consumers and the medical community about this important risk.
“Warren Prout, Sr.’s injuries were 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 and debilitating risks, willful and wanton failure to provide adequate instructions, and willful misrepresentations concerning the nature and safety of Invokana,” Prout’s lawsuit states. “The conduct and the product defects were a substantial factor in bringing about Plaintiff’s injuries.”
Prout notes that a number of studies published in recent years have led to a growing laundry list of Invokana side effects, which the drug makers should have discovered before introducing the drug.
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 June 2016, the FDA required additional label warnings about the link between Invokana and kidney risks, indicating that the medication may increase the risk of acute kidney injury and other severe health problems.
More recently, 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 lawsuit filed by Prout 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, Prout’s case and hundreds of others may later be remanded back to U.S. District Courts nationwide for individual trial dates.