A plaintiff has filed an Invokana leg amputation lawsuit against Janssen Pharmaceuticals and Johnson & Johnson, the makers of the popular medication.

The plaintiff alleges in the Invokana leg amputation lawsuit that the diabetes medication Invokana is dangerous to human health and defective because of a lack of proper warning about the dangers linked with its use. The Invokana leg amputation lawsuit is being incorporated with the larger Invokana MDL number 2750.

The FDA initially approved Invokana in early 2014 as one of the newest types of diabetes medications referred to as SGLT2 inhibitors. These medications work by decreasing the patient’s sugar in the bloodstream, and then that extra sugar is eliminated from the body through the user’s kidneys. Unfortunately, this can put extra strain on the patient’s kidneys.

Invokana leg amputation is one serious and troubling side effect of using this drug, but many other patients report an array of additional side effects. Avoiding an amputation risk is a common concern for most people taking any diabetes drug, and it’s well worth talking through your options with your doctor before committing to a medication that may be dangerous for your individual use. Knowing the pros and cons in advance helps consumers to make informed decisions, but if the makers of the drugs never warned patients, problems may ensue.

A 2015 warning from the FDA indicated that there were life-threatening risks linked to the use of Invokana, including diabetic ketoacidosis, after more than 20 cases were included in the adverse event reporting system captured by the FDA.

Furthermore, the risk of Invokana leg amputation was documented in a 2017 safety communication from the FDA after two major clinical studies indicated a higher risk of leg and foot amputation for Invokana users. A black box warning regarding the Invokana leg amputation risk was then added to the medication.

Other SGLT-2 inhibitors were not included in this Invokana leg amputation risk black box warning. Safety outcomes reported in the New England Journal of Medicine and other studies were used to develop the rationale behind the black box warning for Invokana. This showed a higher risk of amputations for those patients using this particular medication.

The 2017 study identifying the risk with Invokana leg amputation involved trials with more than 10,100 patients and found that the risk for amputation was higher with Invokana than with a placebo.

The plaintiff in this Invokana leg amputation lawsuit says that she was severely physically harmed after ingesting Invokana and wants to hold the manufacturers responsible for failing to warn her about the serious risks linked with taking this medication.

Many other patients have already come forward to allege that the risk of Invokana leg amputation was hidden from them or never disclosed and that the defendants, Janssen Pharmaceuticals and Johnson & Johnson, had a legal responsibility to inform patients about the risks so that patients and their doctors could make appropriate determinations about whether or not Invokana was the right choice for diabetes treatment.

The Invokana Leg Amputation Lawsuit is Case No. 3:18-CV-09318-BRM-LHD filed in the United States district court for the district of New Jersey