A diabetes patient claims that Johnson and Johnson, makers of the diabetes medication Invokana, failed to warn him of possible severe Invokana side effects, causing him serious injury.

Plaintiff Donald L. joins a consolidated master order of lawsuits against Johnson and Johnson and its family of companies over alleged Invokana side effects. In his Invokana lawsuit, Donald claims that he had to have the second toe on his right foot amputated as a result of his use of Invokana. He seeks damages for physical injury and for emotional and financial injury incurred due to medical bills, lost work, and trauma.

Donald claims that Johnson and Johnson knew that there is a high risk of amputations associated with Invokana use, but intentionally concealed this risk from consumers and medical professionals. Donald claims that he would have never used Invokana to treat his diabetes had he known of the high risk of lower-extremity amputation posed by the drug.

Diabetes patients in general have a higher risk of amputations than the general public. Ideally, diabetes medications and treatments should reduce a patient’s risk of possibly needing an amputation. The most common forms of amputation associated with diabetes are those of the lower extremity — toes and feet, though sometimes extending to the knee.

The Invokana side effects class action lawsuit claims that a study showed that diabetes patients that took Invokana had twice the risk of requiring an amputation than a patient with untreated diabetes. In his class action lawsuit, Donald claims that the drug is not safe or effective, given that in this way, the drug causes more harm to patients than not treating their diabetes at all.

Donald claims that because the company did not warn him of the potential and serious risk of amputations as one of the many Invokana side effects, he was subjected to “risks that exceed the benefits” of taking the drug.

In addition to failing to warn consumers, Donald’s Invokana amputation lawsuit claims that Johnson and Johnson did not conduct sufficient testing on the drug before releasing it into the market, and did not provide patients and medical professionals with sufficient instructions for how to use the drug safely.

Allegedly, Invokana has a number of serious side effects besides lower extremity amputation, including diabetic ketoacidosis, kidney failure, sepsis, cardiovascular problems, and stroke. Johnson and Johnson allegedly market Invokana as a safe and effective drug, in many ways preferable to alternatives. However, Donald claims that other treatments for diabetes do not pose the same risks as Invokana, so its marketing as a safe and effective treatment is a false claim, intended to mislead patients into choosing to take the drug.

Allegedly, Johnson and Johnson failed to properly assess the safety of Invokana at every step of the process. Donald’s Invokana side effects lawsuit claims that the drug was insufficiently tested before it was sold, that the data from what pre-marketing tests there were was insufficiently analyzed, and that Johnson and Johnson did not conduct sufficient post-marketing testing and surveillance of how the drug performed once it was on the market.

The Invokana Side Effects Lawsuit is Case No. 3:18-cv-09701-BRM-LHG, in the U.S. District Court in the District of New Jersey.