Thousands of lawsuits have been filed in several states against Johnson & Johnson on behalf of injured boys and young men. They are alleging that Risperdal, an atypical antipsychotic drug, made them develop breasts. State and federal attorneys general allege the company disregarded the FDA’s warnings as early as 1994 not to promote the drug for childhood use.
Plaintiffs allege that the breast growth caused by the drug, which often requires surgical reduction, forced them to suffer psychological harm. Additionally, that they were not warned about gynecomastia as a potential side effect. Risperdal has been prescribed by physicians to treat bipolar disorder, schizophrenia, autism, ADHD, depression, Alzheimer’s disease, anxiety, obsessive compulsive disorder, and other psychiatric disorders. It has several side effects including diabetes, substantial weight gain, and stroke. However, the side effects at the core of recent litigation is Risperdal gynecomastia. This is the development of breasts caused from a hormonal imbalance triggered by the drug. Risperdal allegedly increases a hormone called Prolactin, which activates breast development in women.
In February 2015, a victim of Risperdal gynecomastia was the first to win a jury trial against Johnson & Johnson, which allegedly paid and incentivized doctors to recommend the drug and prescribed it to children. The Plaintiff was eight when he began taking the drug. He developed size 46DD breasts and was subsequently awarded $2.5 million dollars in damages. U.S. Attorney General Eric Holder stated Johnson & Johnson “recklessly put at risk the health of some of the most vulnerable members of our society,” as youths are especially vulnerable to psychological trauma brought on by embarrassment, bullying, the stigma of mental illness, and undergoing surgery.
As of last December, 1600 lawsuits associated with gynecomastia have been filed in Philadelphia. One plaintiff was awarded $1.75 million by a jury. However on March 10, 2016 that verdict was reduced to $680,000 due to state laws capping damages. The judge presiding over the case refused to overturn the verdict. He believed enough evidence was offered to show the company was negligent.
Plaintiffs used several expert witnesses during that trial including pediatrician, David Kessler, M.D., J.D., David E. Goldstein, M.D., pediatrician and endocrinologist, and Paul J. Ambrosini, M.D., a psychiatrist. Kessler previously served as Administrative Commissioner of the FDA. He was used in this case to report on regulatory mandates for pharmaceuticals. He stated the “FDA warned Johnson & Johnson, who in turn did nothing.”. His testimony was able to establish the defendant’s negligence during the period when the plaintiff began taking the drug.
Pediatrician and endocrinologist, David Goldstein, reported use of risperdal “creates a ‘perfect storm,’ [of hormonal conditions] combining normal puberty, obesity, and drug related elevated serum prolactin, all of which are known to increase risks for the development of gynecomastia.”. He concluded that risks for developing of gynecomastia in children are far greater than the company claimed in its marketing. The defense called expert Janet B. Arrowsmith, M.D., an epidemiologist, internist, and expert as a government investigator. She opined that the defendants “openly shared accurate data with FDA regarding Risperdal’s effects.”. Johnson & Johnson continues to stand by their claim that physicians were warned of the risks associated with the use of Risperdal.