According to court documents, one such lawsuit was filed in New Jersey by Maria and Carlos Puente. In October 2013, Maria began taking diabetes medication - known as an SGLT2 inhibitor - Invokana, but only took the drug for a month. In that short time, Maria suffered diabetic ketoacidosis and severe kidney damage. Ketoacidosis is a serious condition in which the patient’s blood has dangerously high levels of acidity. The American Diabetes Association warns that diabetic ketoacidosis can lead to diabetic coma or death. Symptoms of diabetic ketoacidosis can reportedly develop quickly, giving patients little time to react.
Maria argues that she would not have taken Invokana if she had known all the risks associated with the drug. The lawsuit alleges that Janssen Pharmaceuticals - a subsidiary of Johnson & Johnson - negligently marketed and sold Invokana without proper warnings about the unreasonably dangerous risks.
“The development of Plaintiff’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 [capitals in original],” the lawsuit alleges.
Maria says she has suffered severe and permanent physical and emotional injuries, and suffered financially due to significant costs associated with medical care.
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In December 2015, the US Food and Drug Administration (FDA) issued a warning about the risk of ketoacidosis in patients taking Invokana. Other drugs in the SGLT2 class were included in the warning. At the time, the FDA urged doctors to consider patient history that may predispose the patient to ketoacidosis before prescribing drugs in that class.
The Puente lawsuit is Maria Puente and Carlos Puente, v. Janssen Pharmaceuticals Inc., et al, case number 3:15-cv-08070, in US District Court, District of New Jersey.