A new Invokana amputation lawsuit was filed in U.S. District Court, District of New Jersey on May 11, 2018. The complainant, Michael T., has named Janssen Pharmaceuticals Inc., Janssen Research and Development LLC, Johnson & Johnson Inc., and Janssen Ortho LLC as defendants in his case.

Michael is a citizen and resident of Pensacola, Fla. who joins multidistrict litigation (MDL) No. 2750 with this legal action.

According to the factual background section of the Invokana amputation lawsuit, Michael began taking Invokana, a sodium glucose cotransporter 2 (SGLT2) inhibitor, to treat his type-2 diabetes under the prescriptive direction of his physician in May 2014.

Michael says that both he and his physician relied upon the advertisements, presentations, and labeling ensuring product safety when making the decision to start this treatment regimen.

Within a month of starting to take the drug, however, the plaintiff says he required amputation of the great toe on his right foot. The narrative of the Invokana amputation lawsuit then indicates that six months later on Jan. 6, 2015, Michael required an amputation of the left leg below the knee joint.

Through his counsel, the complainant attributes the loss of both his right great toe and left lower leg and foot entirely to the ingestion of Invokana.

Invokana’s History in the U.S.

The drug compound sold under the brand name Invokana is known as canagliflozin. It was approved by the U.S. Food and Drug Administration (FDA) as the first SGLT2 inhibitor for use in controlling glycemic levels in Type 2 diabetics in March 2013.

According to the Invokana amputation lawsuit, this approval was followed by excessive advertisements and press releases by the defendants which promoted Invokana as a glorified panacea to treat diabetes with little to no mention of the dangers of developing ketoacidosis, kidney damage and even failure, or infections and loss of limbs from amputation.

In addition to promoting the intended use of the new drug application as approved by the FDA, the defendants allegedly directly promoted the SGLT2 inhibitor to physicians and patients for other purposes such as hypertension, weight loss, health benefits for the heart and kidneys and for treatment of type-1 diabetes.

According to the timeline presented in the Invokana amputation lawsuit, the FDA started issuing warnings regarding reported adverse medical events with Invokana beginning in mid-May 2015.

The first condition linked to this and other SGLT2 inhibitors was ketoacidosis—a condition caused by too many acids in the blood. Ketoacidosis can also cause organ systems to fail and death to follow. By December of that year, the FDA made the defendants change their label to warn of this condition.

By June 2016, the defendants were forced by the drug oversight agency to change their label once again to reflect growing concerns regarding the drug’s ingestion and kidney failure.

In July 2017, Invokana’s label had to have a black box warning added to the label regarding increased risk of amputation. A month earlier, a study had been published and the public warned in an FDA Safety communication that Invokana patients had twice the risk level of those taking a placebo to need an amputation.

Plaintiff Michael T. is bringing 12 causes of action against the defendants in his Invokana amputation lawsuit. Among those causes are allegations of fraud, failure to warn, negligent misrepresentation, and breach of implied warranty.

Michael seeks compensatory damages for his pain and suffering, economic loss through medical bills and loss of earning capacity. He also hopes for punitive damages to be assessed against Janssen and related companies.

The Janssen Pharmaceuticals Lawsuit is Case No. 3:18-cv-09137-BRM-LHG in U.S. District Court, District of New Jersey.