Johnson & Johnson and its subsidiary Janssen Pharmaceuticals are facing mounting lawsuits after new evidence has demonstrated that Invokana, the popular diabetes drug, has been linked to an increased likelihood of below the knee amputations as well as other medical issues such as kidney failure.
The lawsuits contend that Janssen and Johnson & Johnson concealed their knowledge of the higher risks of lower limb amputations from the medical community and patients. The lawsuits also allege that Invokana’s defective nature caused patients to suffer additional severe or permanent injuries, including kidney failure, amputations, stroke, diabetic ketoacidosis and heart attack.
The FDA approved Invokana in 2013 for the treatment of type 2 diabetes. The European Medicines Agency allowed the drug to be sold in the EU that same year. Invokana has been one of the top-selling drugs in recent years, with sales of $1.31 billion in 2015 and $1.41 billion in 2016.
In 2017, the EMA issued information about the increased risk of lower limb amputation in patients taking SGLT2 inhibitors canagliflozin (Invokana), empagliflozin (Jardiance) and dapagliflozin (Farxiga) to treat type 2 diabetes. The review came after reported increases in lower limb amputations in patients taking Invokana in two clinical trials.
In the case of Invokana, 952 complaints alleging various injuries were pending as of Dec. 18, 2017, according to court records. The majority of the lawsuits involve injuries other than amputations, including ketoacidosis, infections, stroke and kidney injuries.
A federal court panel created the Invokana MDL on Dec. 7, 2016.
In May 2017, the FDA ordered the drug company to issue a black box warning for Invokana due to its increased risk of amputations. The FDA’s decision followed two large clinical trials that showed people who took the drug having twice as many leg and foot amputations as people given a placebo.
If you or a loved one has been injured or suffered a lower extremity amputation after taking the diabetes drug Invokana, call Attorney Joe Saunders for a free consultation.