Gynecomastia is attributed to several different causes, and some remain unknown. Dr. Delgado tells his California male breast reduction patients from San Francisco, Sacramento, San Jose and beyond, that most are due to an imbalance of hormones, in particular increased levels of prolactin. Legal and illegal drugs are known to cause the development of male breasts.
In one of the country’s largest health care related settlements, Johnson and Johnson agreed to a settlement of $2.2 billion for the marketing of Risperdal “off-label.” “Off-label” use means a doctor can legally prescribe a drug for uses other than what the FDA approved it for, but the drug companies are not allowed to promote their drug for anything other than what it was approved for.
Risperdal is an anti-psychotic drug that was developed to treat schizophrenia and bipolar disorder in adults and adolescents. However, sales reps were rewarded large bonus’ for promoting the drug to pediatricians and other physicians for “off-label” use. They promoted Risperdal for; attention deficit hyperactivity disorder (ADHD), depression, sleeps difficulties and anxiety. Additionally, claims were made that j & j paid for doctors’ golf outings, and financially rewarding consulting deals.
Omnicare, which is the nation’s largest long-term care pharmacy, was implicated by a “whistle-blower,” one of their previous pharmacists, of being involved in “kickback for switches.” This is where pharmacists were “encouraged” to switch patients from approved drugs to Johnson and Johnson medications, which included Risperdal.
Some feel that the $2+ billion in fines is just a slap on the wrist. In a survey done by Stanford University and the University of Chicago, 54% of prescriptions for anti-psychotic drugs were for “off-label” uses and determined this was the result of good marketing.
Including global sales, between 2003 and 2010, Risperdal generated $24 billion in sales for johnson & johnson. Federal investigators state that j & j was aware that Risperdal could increase the risk of developing diabetes, stroke in the elderly, and development of breasts in boys, but chose to keep quiet about it.
As new evidence emerges, more individual and class actions lawsuits are being filed.