(CNN) – Johnson & Johnson will have to pay $ 8 billion in punitive damages after a man denounced that the company had not warned young men that the Risperdal drug could grow breasts, a jury said Tuesday of agreement with Reuters.
Nicholas Murray, 26, previously won $ 680,000 in the case for the Risperdal antipsychotic medication at the Common Causes Court in Philadelphia.
Murray says he developed breasts after he started taking Risperdal in 2003, when a psychologist diagnosed him with an autism spectrum disorder, according to Reuters.RELATED
Murray's lawyers, Tom Kline and Jason Itkin said in a statement that the "jury told Johnson & Johnson that their actions were deliberate and malicious."
“The behavior that the jury saw in the courtroom was clear and convincing that J&J did not take into account the safety of the most vulnerable. This is an important moment, not only for this litigation, but also for J&J, which is a company that lost its way. ”
In a statement to CNN, Johnson & Johnson described the sentence as "extremely disproportionate to the initial compensatory judgment in this case, and the Company is confident that it will be revoked."
The company added that "the jury did not hear evidence on how the RISPERDAL® label clearly and adequately described the risks associated with the medication or the benefits that RISPERDAL® provides to patients with serious mental illness."
The case is the first of thousands in Pennsylvania where a jury could grant punitive damages, Reuters reported.
Earlier, a Pennsylvania judge ruled that New Jersey law, which prohibits punitive damages and is Johnson & Johnson's state of origin, must apply to all cases.
In 2018, a Pennsylvania Superior Court ruled that punitive damages were allowed, noting that the state where each plaintiff lives should be the determining factor, according to Reuters.
An ‘essential medicine’
The World Health Organization includes risperidone, the chemical name of Risperdal, on its list of "essential drugs," which means that it is "one of the minimum medications needed for a basic health system."
But since 1994, when J&J put Risperdal on the market, the drug has attracted a lot of attention and controversy, beyond the undisclosed side effects.
In 2013, in one of the largest health care fraud agreements in US history, the Department of Justice said that Risperdal and two other drugs manufactured by Johnson & Johnson were promoted for patients with dementia, despite the fact that the Risperdal was approved only to treat schizophrenia. This use was not approved as safe and effective by the Food and Drug Administration (FDA).
The drug was approved by the FDA in 1993.
"The conduct in question in this case endangered the health and safety of the patients and damaged the public's trust," said then Secretary of Justice Eric Holder.
The department also claimed that Janssen, a J&J company, promoted the drug for use in children and people with mental disabilities, despite knowing the health risks.
The agency also claimed that Janssen sales representatives told doctors they needed to increase their Risperdal prescriptions to receive the speech fees set by the company. Janssen accepted the agreement and the fines.
In a statement at that time, the company blamed the sales representatives.
Responding at the time to allegations that he marketed the drug inappropriately to children, J&J said Janssen “did not order sales representatives to promote Risperdal for use in children or adolescents and did not approve sales materials intended for treat children or teenagers. "
J&J insisted: "Risperdal is a safe and effective medication that has helped millions of people live better for more than two decades."
Evan Simko-Bednarski of CNN contributed to this report.