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Risperdal Gynecomastia Lawsuit Loans
Risperdall is the brand name of the antipsychotic drug, risperidone, which was developed and manufactured by a division of Johnson & Johnson, Janssen Pharmaceuticals, Inc. Recently, the drug has been linked to the development of gynecomastia, a disorder in which men grow large breasts.
History of Risperdall
Approved in 1993, the drug was the first that the United States Food and Drug Administration permitted for use on adults with schizophrenia, and ten years later, the FDA approved the drug for use in adults with bipolar disorder, then known as manic depression. In 2006 and 2007, the drug was approved to treat autistic children and teenagers, becoming the most commonly prescribed drug for children between the ages of 10 and 17 who showed early signs of schizophrenia and bipolar disorder.
Marketing of Risperdall
Because the drug was the first antipsychotic drug approved to treat pubescent and adolescent patients, Johnson & Johnson marketed the product heavily. Although the company was not approve to market the drug to doctors treating children until 2006, reports surfaced that Johnson & Johnson instructed sales representatives to visit child psychologists and facilities that focused on children prior to 2006. Even after the approval to use the drug on children exhibiting signs of bipolar disorders or schizophrenia, the company pushed doctors to use the drug to treat children with other disorders as well, such as attention deficit hyperactivity disorder (ADHD), although the drug was not approved for use on those patients. The company also actively pursued the use of the drug in elderly dementia patients, despite the fact that the FDA had rejected the company’s efforts to expand the use of the drug for those disorders. In fact, the company created a salesforce, ElderCare, to specifically promote the drug to doctors treating older patients.
Embarrassing Side Effect
In 2008, studies began to show that Risperall increased serum prolactin levels that led to the release of a hormone that could cause problems in patients, including:
- Galactorrhea – a milky nipple discharge unrelated to pregnancy or breastfeeding
- Amenorrhea – the cessation or absence of menstruation
- Gynecomastia – the growth of abnormally large breasts in males due to the growth of excess breast tissue, not fat tissue like that which occurs in obese men
- Erectile dysfunction – the inability to get or keep an erection that is firm enough for intercourse
Prolactin is a female hormone involved in the development of breasts in young girls and in the production of milk in pregnant and nursing women. Initially, Johnson & Johnson downplayed the risk of adverse events, claiming that they were extremely rare. Although the side effects were not life-threatening for patients, they could become embarrassing, especially in teenage boys who develop breasts. In addition, Risperdal gynecomastia can occur at any time once treatment commences. In one case, a child developed the disorder after taking the drug for five years.
Gynecomastia caused by Risperdal use is not reversible an stopping the drug does not cause the breasts to go away. The problem also does not resolve after a young man passes through puberty as the higher prolactin levels cause actual breast tissue to develop. In most cases, the only option to correct the condition is through liposuction and mastectomy.
Recent Lawsuit Settlement
In 2012, a 21-year old man filed a lawsuit against Johnson & Johnson after he developed breasts after taking Risperdal between 1999 and 2004, before it was approved for use on children. Court documents say that he suffered psychological trauma after developing gynecomastia and his lawyer said that he had seen boys who grew breasts as large as “D” cups after taking the drug. Johnson & Johnson settled the case with the 21-year old Pennsylvania man, but there are many more cases pending against them from young men who have suffered from gynecomastia after taking the drug.
In November 2013, Johnson & Johnson agreed to pay more than $2.2 billion in criminal and civil fines regarding their improper marketing of Risperdal. The settlement was the third-largest pharmaceutical settlement in the United States and the largest involving the marketing of antipsychotic drugs. Prosecutors say that the company recklessly risked the health of young children, the elderly and the disabled through their marketing efforts.
Gynecomastia is the result of a hormonal imbalance in boys in which glandular tissue, which is present in very small amounts in men, grows into large breasts. It is different than lipomastia, common in obese men, where fat tissue grows to give the appearance of breasts. All individuals, both male and female, possess estrogens, which are female hormones, and androgens, which are male hormones. Hormones fluctuate during puberty and, in some cases, the fluctuation can remain high longer than normal, leading to issues. This is the case in some males taking Risperdal. Unlike lipmastia, gynecomastia breast tissue is typically symmetrical to the nipple and may feel rubbery or firm. Tenderness and sensitivity may be present as well. Gynecomastia is normally diagnosed through physical examination by a doctor. Measurement of hormone levels is also recommended.
Treatment of Gynecomastia
Although normally-developing gynecomastia may go away on its own in about six months, Risperdal gynecomastia often does not diminish, even after stopping the drug. No drugs have been approved by the FDA for treatment of the disorder. After about 12 months, scarring occurs and once the tissue has become scarred, treatments are limited. In some cases, testosterone treatment has been effective as has the estrogen receptor, tamoxifen. Normally, men who develop gynecomastia must undergo breast reduction surgery.
Risks of Gynecomastia
Men with gynecomastia have five times the risk of developing male breast cancer. In addition, children who develop gynecomastia can suffer from psychological consequences if the enlargement is pronounced. Many who have developed the disorder report significant embarrassment due to the pronounced breasts.
What to Do
Parents whose sons have taken Risperdal who suspect the development of breasts should immediately contact their doctor for testing. Once gynecomastia has been diagnosed, you may be eligible for a lawsuit against the makers of the drug.
If you or a loved one has taken Risperdal and developed gynecomastia, contact our office either online or by telephone to determine if you are eligible for a product liability lawsuit. The initial consultation is free and we are here to answer your questions while guiding you through the process.