A man claims he could have avoided a diabetes toe amputation had he been given an adequate Invokana warning.

Plaintiff Stephen W. has filed a lawsuit against Johnson & Johnson and its subsidiary Janssen Pharmaceuticals, alleging that Invokana caused him to lose his big toe.

Invokana was approved by the FDA in 2014 to help maintain normal blood sugar levels in type-2 diabetics. It was the first in a new class of medications called SGLT2 inhibitors that eliminate excess glucose (sugar) by sending it through the kidneys and out the urine instead of allowing the glucose back into the bloodstream.

Plaintiff: No Invokana Warning Issued Regarding Adverse Effects

A person with diabetes is already at greater risk of kidney ailments. Invokana purportedly makes the kidneys work even harder by sending sugar out through the urine, as opposed to allowing the sugar to be reabsorbed into the blood. As a result, Invokana patients can suffer dehydration, which further hinders the kidneys.

Janssen allegedly concealed the fact that the medication could cause kidney failure, ketoacidosis and risks of amputations by issuing no Invokana warning regarding any of the potential side effects.

“In particular, the product is not safe, has numerous and serious side effects, and causes severe and permanent injuries, including, but not limited to, amputation,” says Stephen’s diabetes toe amputation lawsuit. Any Invokana warning that did exist was “not accurate, clear and/or were ambiguous,” he says.

According to the lawsuit, the drug companies had a duty to tell doctors and health professionals about the possibilities of Invokana causing the injuries Stephen suffered. With no Invokana warning of amputation, Stephen trusted the medication was safe.

Janssen and Johnson & Johnson are accused of failing to properly and completely test Invokana prior to releasing it into the U.S drug market. They also allegedly failed to properly and thoroughly analyze the data resulting from the drug’s premarketing tests and neglected to follow up on post-market testing and surveillance of the drug.

Stephen says the drug companies knew that doctors would write prescriptions for Invokana and would rely on the information that Janssen provided about the drug. Invokana’s makers should have known that potentially life-threatening injuries could occur if they provided information that “was materially inaccurate, misleading, or otherwise false.”

Attempts to conceal, downplay or misrepresent the inherently dangerous side effects meant that no Invokana warning was issued that would give a doctor or the patient cause for concern.

Stephen’s lawsuit alleges that Invokana is a dangerous drug that resulted in injuries–including diabetes toe amputation–that he could have avoided and would have avoided had he known the risks.

The Invokana Warning Lawsuit is Case No. 3:18-cv-01136-BRM-JHG in the U.S. District Court for the District of New Jersey.