When we go to the doctor and get medication for an illness or medical condition, we expect these medications to be safe and to help us feel better. Unfortunately, sometimes medications have dangerous side effects that can cause more problems and even end up making us worse than before we received the medication. According to a recent lawsuit filed on December 15th of 2015, the plaintiff claims that they did not know about the seriousness and particulars of the dangerous side effects of Invokana when she was prescribed the medication. She began taking the medication in December of 2014, when it had been on the market for about a year. She claims that soon after taking the medication, 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 among the many adverse events of Invokana.
The plaintiff, while alleging that she did not previously know about the seriousness of the Invokana side effects, has also claimed that Janssen, a unit of pharmaceutical giant Johnson & Johnson, failed to properly warn consumers about the possible risks and drawbacks of Invokana. The lawsuit claims that the Johnson &Johnson company failed to properly study and vet the type 2 diabetes drug before bringing it to market in 2013.
The lawsuit’s final claim is that Janssen improperly promoted Invokana off label for treatment of type 1 diabetes, as well as for the treatment of hypertension. Doctors have always carried the blessing of the US Food and Drug Administration 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.