Poor impulse control (particularly compulsive gambling) is one of the main side effects of the “new generation” neuroleptic medication Abilify. That has been the cause of action in recent lawsuits against drug manufacturers Otksuka Pharmaceuticals and Bristol-Meyers Squibb. However, it is not the most serious side effect. Two years ago, a lawsuit was filed against the manufacturers in Louisiana by a plaintiff claiming that he developed a condition called tardive dyskinesia because of Abilify.

In 2010, the plaintiff, Cory Jenkins, was prescribed Abilify for the treatment of his bipolar disorder. After three years of taking two milligrams a day, he began developing unusual and uncontrollable tics and twitching in his hands and feet. These were followed by facial tics, that included jaw clenching, clucking noises and frequent blinking. A few months later, he was diagnosed with tardive dyskinesia, and was told that the condition was due to taking Abilify.

Unlike the compulsive behavior patterns associated with Abilify, tardive dyskinesia (TD) is irreversible – the symptoms do not go away once the medication has been discontinued. Other symptoms of TD include uncontrollable facial tics such as chewing motions, lip smacking, and tongue movements. It can also involve actual vocalizations and is known to interfere with breathing and swallowing – making it a potentially life-threatening condition.
In most cases, this is caused by neuroleptic (psychoactive) medications that work to block dopamine receptors. Among other things, these receptors control voluntary muscle movement. Oddly, Abilify actually works to open dopamine receptors, and has been used to treat tic disorders. Nonetheless there have been case studies to show a connection between the use of Abilify and the development of TD. It appears to happen when the drug is used in an off-label manner to treat depression that has not responded to other medications, as well as when Abilify is used in combination with other prescriptions.

TD is an embarrassing condition that can negatively affect the victim’s social life, relationships and even the ability to engage in employment – and there is no cure.

Jenkins’ attorney asserted that the drug was defective in design, and that Otsuka failed to warn doctors and patients about the TD risk. In response, the defendants claimed that there was not a safer version of the medication. They also moved to have the failure to warn claim dismissed because the plaintiff did not mention that his doctor would not have written the prescription if there had been a different warning.

As it was, the judge dismissed the claim of defective design, but allowed the case to proceed on grounds of failure to warn. According to the judge presiding over the case, “[The] Plaintiff is merely required to allege that Defendants did not adequately warn Plaintiff’s treating physician and that the inadequate warning constituted the proximate warning of Plaintiff’s injuries.”

A similar case was also filed in a federal court in Louisiana. However, in that case, the judge rejected the failure to warn claim, but allowed the defective design claim to go forward. That case is still pending. Unfortunately, the Jenkins case was ultimately dismissed because it was outside of the statute of limitations, since he had known of his condition and its causes in April of 2013.

K.J. McElrath is a former history and social studies teacher who has long maintained a keen interest in legal and social issues. In addition to writing for The Ring of Fire, he is the author of two published novels: Tamanous Cooley, a darkly comic environmental twist on Dante's Inferno, and The Missionary's Wife, a story of the conflict between human nature and fundamentalist religious dogma. When not engaged in journalistic or literary pursuits, K.J. works as an entertainer and film composer.