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In 2023, lawsuits have been filed against the manufacturer of Invega by plaintiffs who developed enlarged breasts after taking the antipsychotic drug. If you are a male patient who took the paliperidone or other similar medications, and then developed gynecomastia, you may have a claim to request compensatory damages.
Invega (paliperidone) is a second-generation antipsychotic drug used to treat schizophrenia, schizoaffective disorder, and bipolar mania. It acts by blocking the activity of the D1 and D2 dopaminergic receptors found inside the prefrontal cortex limbic and mesolimbic pathways. The uncontrolled activity of these receptors is deemed somewhat responsible for causing many mental disorders such as anxiety and schizophrenia.
Risperdal (risperidone) is a drug manufactured by Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) that was approved by the U.S. Food and Drug Administration (FDA) in 1993. Paliperidone is one of the primary active metabolites of risperidone, another drug manufactured by the same pharmaceutical company.
A metabolite is one of the substances that start circulating in our blood after the body breaks the original molecule into smaller ones. In other words, risperidone gets transformed into paliperidone after the medication is administered, so they’ve got the same identical effects and, apparently, the same side effects. The FDA approved Invega in 2006, shortly before Risperdal’s patent expired.
The D2 receptors are also found in other regions of the brain, such as the pituitary gland. By blocking the otherwise normal activity of these groups of neurons, Invega causes many unwanted side effects ranging from tremors, restlessness, weight gain, increased salivation, and diarrhea.
On top of that, another adverse reaction that was not adequately disclosed by the manufacturer when paliperidone and risperidone hit the market is gynecomastia. By causing excess production of prolactin, the breasts start growing uncontrollably, even in male patients, and may even produce milk spontaneously (galactorrhea). An additional severe side effect is the demineralization of bones, which is associated with loss of bone strength and increased risk of fractures.
For years, J&J Both Invega and Risperdal have been marketed illegally. Although paliperidone received approval from the regulatory authorities only for adolescent schizophrenia in 2011, it was often prescribed to youths for a much longer time. Janssen and J&J falsely advertised their drug as safe when prescribed to the most vulnerable populations such as children and the elderly, and paid kickbacks to doctors and specialists to prescribe it for a much broader range of off-label indications.
Physicians were corrupted with lavish incentives and expensive gifts to use paliperidone for treating autism in children with developmental and personality disorders and elderly patients affected by dementia. Candies and toys were even offered with drug samples to look more appealing to young children. However, the threat of gynecomastia during adolescence wasn’t the only risk. Invega and Risperdal could worsen diabetes, stroke, and pneumonia, especially in the elderly.
The Department of Justice eventually cracked down on these unethical marketing practices, claiming that the manufacturer “made false and misleading statements about its safety and efficacy.” In 2013, J&J was pinned to the wall by the federal government and opted to resolve all civil and criminal allegations by paying a $2.2 billion fine. Even if this fine was one of the largest settlements in the history of pharmaceutical frauds, it was just breakfast money since the antipsychotic medications earned over $40 billion in sales to the pharmaceutical company.
Currently, the number of Invega lawsuits in 2023 is still insufficient to justify the creation of a multidistrict litigation (mass tort). However, in the recent past, many patients who suffered the dire consequences of the nearly-identical drug Risperdal have already been compensated for their pain and anguish.
For example, a jury from Philadelphia awarded Andrew Yount a staggering $70 million compensation back in 2016. The young plaintiff from Tennessee took risperidone since he was five years old, and had his life wrecked by the gynecomastia side effect. The court ruled against J&J, claiming that the pharmaceutical company not only failed to warn the family of the serious risks but even concealed key evidence related to the case.
During another case that eventually led to a $2.5 million settlement in favor of a plaintiff whose breasts grew to be size 46DD, even a former FDA official testified against J&J. According to former FDA chief David Kessler, the pharmaceutical company was aware of the risk of gynecomastia as early as 2001 and willfully waited another five years before adding a warning in 2006. If these (and all the other) settlements are any indication, any victim of Invega side effects has a good chance of receiving monetary compensation if a lawsuit is filed in 2023.
Because of the pharmaceutical companies’ widespread marketing efforts, a large number of children and adolescents were prescribed Invega for developmental and psychiatric issues such as ADHD, autism, and bipolar disorder. However, even that 3% chance of developing gynecomastia is more than enough to ruin the lives of countless teenagers.
Boys whose breasts enlarged abnormally after taking paliperidone had to suffer the shame of being mocked by their peers for their appearance. They had to deal with embarrassment, confusion, and bullying during such a delicate stage of development. If you or your kid had to cope with trauma and victimization because of Invega, it’s time to take action.
Filing an Invega lawsuit in 2023 is the only way to hold responsible those who harmed you. It’s not about revenge. It’s about justice. And we’re here to help you get the monetary compensation you justly deserve.