An Invokana lawsuit has been filed by a consumer alleging that the diabetes medication caused her to need a toe amputation, allegedly a known outcome of Invokana treatment.

Plaintiff Florence P. recently filed a lawsuit against Janssen Pharmaceuticals Inc., Johnson & Johnson, and other Invokana-related companies, alleging that the diabetes medication caused her to suffer an amputated toe.

In November 2014, Florence says she began taking Invokana to treat type-2 diabetes. In December 2015, Florence suffered from a partial amputated toe on the first toe of her left foot. In August 2017, she alleges had the remaining portion of her toe amputated. Her toe amputation, which she claims was a direct result of taking Invokana, required her to pay the costs associated with hospitalization and substantial medical treatment.

Invokana is a type-2 diabetes medication which was approved by the U.S. Food and Drug Administration (FDA) in March 2013. The drug was the first SGLT2 inhibitor to be approved and works by excreting excess glucose through the kidneys. In her lawsuit, Florence argues that this mechanism puts too much strain on kidneys in a population of patients already at risk for kidney issues, leading to complications including toe amputation.

When the kidneys excrete excess glucose, the process allegedly excretes large amounts of water, leading to dehydration and a condition known as hypovolemia. Hypovolemia involves a thickening of the blood and decreased blood flow. This decreased blood performance can allegedly limit the body’s ability to heal wounds and fight infections.

The overworked kidneys can also allegedly experience further problems in regulating blood-acid levels. If the kidneys cannot filter out blood acids known as ketones, an Invokana patient can reportedly develop ketoacidosis. Ketoacidosis is a serious condition which must be treated in a medical setting. The condition can cause circulatory problems which, like other alleged Invokana side effects, can cause a decreased ability to heal and fight infections.

Florence argues that when a person with type-2 diabetes on Invokana gets a diabetic ulcer, which are common for diabetic patients, they are less capable of healing and fighting infection. This can allegedly increase the chance that they will need a toe amputation due to an uncontrolled infection.

The lawsuit claims that Invokana manufacturers knew or should have known about the risk of toe amputation associated with the diabetes medication. Patients on Invokana were allegedly not warned about the potential of an amputated toe while on the diabetes medication, the lawsuit claims.

“Defendants failed to provide the FDA, physicians and consumers with available materials, information and warnings that would have ultimately dissuaded physicians from prescribing Invokana to consumers, from purchasing and consuming Invokana, thus depriving physicians and consumers from weighing the true risks against the benefits of prescribing and/or purchasing and consuming Invokana,” the lawsuit states.

Florence accuses the defendants of strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of warranties, negligent misrepresentation, fraudulent misrepresentation, unjust enrichment, fraud, and violation of consumer protection laws. The Invokana toe amputation lawsuit seeks compensatory damages, punitive damages, court costs, and attorneys’ fees.

The Invokana Toe Amputation Lawsuit is Case No. 3:18-cv-10462-BRM-LHG and is part of the Invokana MDL, In re: Invokana (canagliflozin) Products Liability Litigation, MDL No. 3:16-md-2750, in the United States District Court for the District of New Jersey.