Janssen faces another lawsuit as part of a multidistrict litigation, alleging that consumers were not warned about the amputation risk posed by the diabetes medication Invokana.

Plaintiffs Teresa J. and her husband Paul J. recently filed a lawsuit against Janssen Pharmaceuticals Inc. and Johnson & Johnson Co., alleging that they and other consumers were not sufficiently warned about the Invokana amputation risk before taking the medication.

The couple claims Teresa began taking Invokana in February 2014; allegedly both she and her doctor were not warned about Invokana’s amputation risk. After taking the medication, Teresa allegedly suffered from an amputation she claims was directly related to her usage of Invokana. She adds that she is now subject to other risks associated with the medication including heart attack, stroke, and ketoacidosis.

Overview of Invokana Lawsuit

Invokana is a medication used to treat type-2 diabetes by lowering blood sugar in conjunction with diet and exercise. The drug is an SGLT2 inhibitor, meaning that it lowers blood sugar by inhibiting glucose absorption through the kidneys. Instead of being metabolized, the glucose is excreted through the kidneys, a mechanism which can allegedly cause other problems.

While the drug is meant for type-2 diabetes treatment, the plaintiff argues that Janssen wrongly advertises use of Invokana for off-label, unapproved conditions.

Her Invokana amputation risk lawsuit claims, “Though Invokana is indicated for only improved glycemic control in type 2 adult diabetics, Defendants have marketed and continue to market Invokana for off label purposes, including but not limited to weight loss, reduced blood pressure, and improved glycemic control in type 1 diabetics.” 

The complaint argues that these actions, along with repeated defense of the drug, have created a perception that Invokana is safe and effective. As a result, consumers are allegedly not aware of the Invokana amputation risk and cannot make an informed decision when deciding to take the drug.

“Defendants were actually, subjectively aware of the risk involved, but nevertheless proceeded with complete indifference to or a conscious disregard of the rights, safety, or welfare of others,” states the Invokana amputation risk lawsuit. “Moreover, Defendants made material representations that were false, with actual knowledge of or reckless disregard for their falsity, with the intent that the representations be acted on by [Teresa] and her healthcare providers.”

Teresa further argues that these allegedly negligent and fraudulent actions violate the defendant’s’ duty to provide accurate warnings and representations about their drug and the Invokana amputation risk. Instead of providing truthful information, the manufacturers allegedly chose to conceal risks and dangers in order to profit off of their product at the expense of Teresa and other consumers.

The Invokana amputation risk lawsuit accuses the defendants of manufacturing defect, defective design, failure to warn, breach of warranties, negligence, fraudulent misrepresentation, negligent misrepresentation, fraudulent concealment, and fraud. 

The Invokana Amputation Risk Lawsuit is Case No. 3:18-cv-11554-BRM-LHG and is part of the Invokana MDL, In re: Invokana (canagliflozin) Products Liability Litigation, Case No. 3:16-md-2750, in the United States District Court for the District of New Jersey.