Invokana Lawsuits Heating Up, Plaintiffs Allege Negligence

Mobile, ALA once-promising type 2 diabetes drug that’s only been on the market since 2013 is continuing to drive a series of lawsuits alleging that Invokana is linked with cardiovascular injuries and kidney failure.

A recent lawsuit was filed at the end of last year (Collie v. Janssen Research & Development, LLC et al, Case No. 1:15-cv-00636 filed December 15, 2015 in Alabama Southern District Court). According to court documents, the plaintiff in the case was unaware of the seriousness and the particulars of the Invokana side effects when she was prescribed the drug.

The Invokana adverse events lawsuit claims that the plaintiff began taking Invokana in December 2014 - about a year after Invokana hit the market. She alleges that within short order she developed diabetic ketoacidosis, alleged to be a serious, life-threatening condition about which the health care community has become increasingly aware as an emerging Invokana side effect in the basket of Invokana adverse events.

Not only does the plaintiff allege that she had no prior knowledge of the seriousness of the Invokana adverse events, but she has also taken Janssen to task for negligence by way of its alleged failure to properly warn consumers about the potential risks and drawbacks of Invokana. The Invokana lawsuit alleges that Janssen - a unit of pharmaceutical giant Johnson & Johnson - failed to properly study and vet the type 2 diabetes drug before bringing it to market in 2013.

And finally, the plaintiff alleges that Janssen improperly promoted Invokana off label for treatment of type 1 diabetes, as well as for the treatment of hypertension (high blood pressure). Doctors have always carried the blessing of the US Food and Drug Administration (FDA) in prescribing drugs for indications not necessarily approved by the FDA - the thinking being that doctors have the capacity to study and understand the formulation of drugs, and thus are in a position to undertake a medical judgment call on behalf of their patients. The FDA, in this way, defers to the doctor.

However, it is illegal for pharmaceuticals and manufacturers to market a drug off label, for uses and indications not specifically approved by the FDA.

Invokana (canagliflozin) is a member of the SGLT2 class of drugs that promotes the removal of sugars from the bloodstream by the kidneys through the urine. However, the emergence of Invokana side effects, including cardiovascular injuries and kidney failure, has become an increasing cause of concern for plaintiffs and health care advocates alike.

Especially, given that such Invokana side effects have emerged so soon after the drug was formally approved and brought to market. Industry experts are watching this file very carefully, given the aging American population and the propensity of type 2 diabetes amongst the older demographic.