A West Virginia man has filed a new lawsuit against Janssen Pharmaceuticals, alleging he suffered from serious complications, eventually leading to an Invokana toe amputation, after using the company’s diabetes medication.

The plaintiff, Harold P., says he began taking Invokana at the direction of his doctor in July 2014 in order to treat his type-2 diabetes. Unfortunately, in the months and years following, Harold claims he began to suffer from a number of side effects of the drug.

In December 2016, Harold says, these side effects were serious enough that he had to undergo an Invokana toe amputation on the fifth toe of his left foot.

According to the Invokana lawsuit, Janssen knew or should have known about the risk of amputation associated with Invokana, yet failed to warn Harold and others in his position, leading to his Invokana toe amputation.

Harold filed his Invokana toe amputation lawsuit on June 6, 2018, in the U.S. District Court for the District of New Jersey. The lawsuit was filed on multiple counts, including strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of express and implied warranties and fraud, among several others.

Background of Invokana

Invokana (also known by its generic name, canagliflozin metformin) is a popular type-2 diabetes medication, which works by ridding the bloodstream of glucose and lowering glucose production, ultimately lowering blood sugar levels. Invokana is part of a class of type-2 diabetes drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors. Other drugs belonging to the class include Invokamet and Invokamet XR.

Invokana is manufactured by Janssen, a subsidiary of pharmaceutical giant Johnson & Johnson. Invokana is a relatively new drug, approved by the U.S. Food and Drug Administration (FDA) in March 2013. Since its approval, Invokana has become one of the more popular diabetes drugs available.

Despite its widespread use, Invokana has been connected with a few severe side effects, some of which have prompted warnings from the FDA. The risk of Invokana toe amputation wasn’t added to the drug’s warning label until July 2017.

Invokana Toe Amputation Risk

Invokana users have reported a number of serious Invokana side effects, including Invokana toe amputation. Symptoms like pain, ulcers or infections in the legs or feet may lead to lower limb amputation.

The FDA released a safety announcement in May 2017 updating its information about the link between Invokana toe amputation risk.

The safety warning read, in part: “Based on new data from two large clinical trials, the U.S. Food and Drug Administration (FDA) has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations.”

Filing an Invokana Toe Amputation Lawsuit

Lawsuits allege that Janssen either knew or should have known about the risk of Invokana lower limb amputation, but failed to give adequate warning to the public and the medical community about these problems.

If you or someone you love has suffered from serious side effects after taking Invokana or a similar SGLT2 inhibitor, you may be able to file a lawsuit. Though filing a lawsuit cannot take away a patient’s pain and suffering, it may help to alleviate the financial burden incurred through medical bills and lost wages.

The Invokana Toe Amputation Lawsuit is Case No. 3:18-cv-10241-BRM-LHG, in the U.S. District Court for the District of New Jersey.