According to a new Invokana lawsuit, Johnson & Johnson and its Janssen subsidiary concealed circulation problems and other complications associated with their controversial diabetes drug, leading to a New Jersey man having to undergo multiple toe amputations due to these side effects.
David Bottner filed the complaint in the District of New Jersey on June 12. He indicates that the manufacturers knew that Invokana’s defects present substantial risks of lower extremity circulation problems, hindering the ability to heal and fight infections, which can spread to the bones and eventually necessitate amputations. However, J&J and Janssen actively concealed these risks to maximize Invokana’s marketing value, putting “profits over the safety and well-being of the consumers of Invokana.”
Bottner began taking Invokana in May 2016 to treat type 2 diabetes. However, Invokana’s side effects allegedly led to him having to undergo a partial amputation of his fifth toe in January 2018. He would lose the rest of the toe about a month later.
Bottner’s Invokana lawsuit indicates that the very mechanism that makes Invokana work, eliminating excess glucose through urination, causes the increase in amputation risks.
“One of the effects of the increased elimination via urination is volume contraction in the blood, which can reduce blood flow and thicken the blood plasma, creating circulation problems in the lower extremities,” the lawsuit states. “As circulation in the extremities worsens, the body is less able to heal and fight infections, which increases the risk of ulcers, and can lead to dangerous infections that may spread into the bones.”
Invokana Lawsuit Background
Invokana (canagliflozin) received FDA approval in March 2013. It was the first member of a new class of diabetes drugs, known as sodium-glucose cotransporter 2 (SGLT2) inhibitors. These work in a unique way by altering normal kidney functions. Other SGLT2 inhibitors include Invokamet, Jardiance, Farxiga, Xigduo, and others. However, Invokana remains the biggest seller due to aggressive marketing.
In December 2015, the FDA required manufacturers to add new diabetic ketoacidosis warnings to Invokana. This serious condition typically requires emergency treatment to avoid life-threatening injuries. However, the previous labels failed to warn of the importance of seeking immediate medical attention for symptoms like abdominal pain, fatigue, nausea, respiratory problems, or vomiting.
In May 2017, the FDA mandated Invokana labels be updated once again to include leg and foot amputation risk warnings. Manufacturers of other SGLT2 inhibitors claim this risk is unique to Invokana.
Bottner’s Invokana lawsuit will join other similar claims pending in the ongoing federal multidistrict litigation (MDL) in New Jersey.