Gynecomastia Lawsuit Settles On Courthouse Steps
Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, paid a victim an undisclosed sum of money to avoid trial in a Risperdal lawsuit.
In December 2016, Judge Arnold L. New ruled that a jury could hear only two of the victim’s thirteen claims. Less than a month later, and three days before jury selection was to begin, the parties announced a settlement. According to court documents, doctors prescribed Risperdal to the victim off-label in 2002 while he was still a minor; at that time, the Food and Drug Administration had only approved the drug for use in adults with certain mental health conditions. After taking Risperdal for ten years, the young man developed gynecomastia (male breast enlargement), a condition that nearly always requires aggressive surgery to correct.
So far, plaintiffs have won four of the six Risperdal trials in the United States. In the most recent case, the victim won $70 million.
Experimental Drug Use
When the FDA first looks at a drug or device, the agency often approves it on a limited basis. Risperdal is a powerful anti-psychotic medicine, so when it approved the drug in 1993, the FDA carefully stated that it should only be used in certain situations. However, doctors could use Risperdal, and any other limited-approval drug any way they see fit.
Drug companies often take advantage of this loophole by aggressively marketing new drugs for experimental uses, a dangerous process euphemistically called off-label prescription. Many times, drug companies even sponsor seminars and workshops to train doctors in experimental techniques involving new drugs. Primarily, that’s because it costs a staggering $2.5 billion to bring a drug from the drawing board through the development process to FDA approval. Since generic alternatives become available after only a few years, drug companies have a very narrow window to recoup these costs and turn a profit.
In a nutshell, manufacturers have to sell a awful lot of pills in a very short time, and that often means some patients essentially become human guinea pigs.
This drug is a dopamine blocker designed to treat schizophrenia and other disorders. Dopamine blockers inevitably raise prolactin levels. Pregnant and nursing women have high levels of this hormone, because it stimulates breast enlargement and milk production. So, it is not surprising that as many as 90 percent of men who take Risperdal may experience gynecomastia.
Male breast enlargement has crippling psychological effects that are well-documented by researchers and scientists, which is one reason why juries often award these victims so much money. Furthermore, the aggressive surgery to fix Risperdal-induced gynecomastia has significant risks, including prominent scars, a high chance of infection, and permanent nerve damage.
Many drug companies are willing to put patients at risk to increase their profits. For a free consultation with an experienced defective drug lawyer in Glasgow, contact Attorney Gary S. Logsdon. We normally do not charge upfront legal fees in negligence cases.