A number of lawsuits have been filed against Janssen Pharmaceuticals and Mitsubishi Tanabe Pharmaceuticals, nationwide and in Pennsylvania involving allegations the Diabetes drug Invokana causes kidney failure and a condition called diabetic ketoacidosis. The suits claim the diabetes drug Invokana causes kidney failure and a condition called diabetic ketoacidosis, which is caused by a build-up of acids in the blood.

Along with alleging that Janssen Pharmaceuticals and Mitsubishi Tanabe Pharmaceuticals failed to warn and improperly marketed the drug, plaintiffs are also alleging Invokana was defectively designed because it prevents the body from metabolizing excess glucose by directing it to be excreted through the kidneys.

In December the Food and Drug Administration announced it added safety warnings on labels about the risks of urinary tract infections and too much acid in the blood. According to the FDA’s website, the warnings updated the prescribing and monitoring information and included a requirement for a post-marketing study.

Since the spring of 2013 the drug has produced more than 1 Billion in sales. There are also claims that Invokana has been linked to urinary tract infections, and cardiovascular problems, like heart attack and stroke.