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Johnson & Johnson and its Janssen subsidiary face another lawsuit over their controversial diabetes drug Invokana, alleging that the drug makers failed to adequately warn about the risk of circulation problems and other complications, indicating that a New Jersey man had to undergo several toe amputations due to the Invokana side effects.
The complaint (PDF) was filed by David Bottner in the U.S. District Court for the District of New Jersey on June 12, indicating that Invokana creates a risk of circulation problems in the lower extremities, which impacts the ability to heal and fight infections, which may spread to the bones and lead to the need for amputations.
Bottner was prescribed Invokana in May 2016 for the treatment of type 2 diabetes. However, side effects of Invokana allegedly caused him to undergo a partial amputation of the fifth toe in January 2018, and the rest of the toe was amputated about a month later.
Invokana (canagliflozin) was introduced in March 2013, as the first member of a new class of diabetes drugs, known as sodium-glucose cotransporter 2 (SGLT2) inhibitors, which works in a unique way by impacting some normal kidney functions. Other members of this class include Invokamet, Jardiance, Farxiga, Xigduo and others, but Invokana has remained the biggest seller, amid aggressive marketing.
The lawsuit indicates that the mechanism of action for Invokana, eliminating excess glucose through urination, is to blame for increased 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,” Bottner’s lawsuit states. “As circulation in the extremeties 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.”
In December 2015, the FDA required Johnson & Johnson to add new diabetic ketoacidosis warnings to Invokana, indicating that the medication increases the risk of this serious condition, which typically results in the need for emergency treatment to avoid life-threatening injury. Prior to the update, the Invokana warnings failed to alert consumers about the importance of seeking immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting.
In May 2017, the FDA required an Invokana warning update regarding the risk of leg and foot amputation, which manufacturers of other similar diabetes drugs claim is a unique risk with Invokana.
The lawsuit filed by Bottner will be consolidated with other Invokana lawsuits pending in the federal court system, which are currently consolidated for pretrial proceedings before one judge in New Jersey.
Following coordinated discovery and any bellwether trials held to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation, if Invokana settlements or another resolution for the claims is not reached, Bottner’s case and hundreds of others may later be remanded back to U.S. District Courts nationwide for individual trial dates.