New York Lawyers for Injuries Related to the Prescription Drug Risperdal
Sullivan & Brill, LLP is representing clients that have been diagnosed
with gynecomastia, a condition wherein young males develop breast tissue,
as a result of using the prescription drug Risperdal. If you or a family
member suffers from this condition,
contact us to see how we may be able to help.
What is Risperdal?
The antipsychotic medication, Risperdal (risperidone), which is manufactured
by Johnson & Johnson's Janssen Pharmaceutical unit, has been blamed
for young boys developing gynecomastia, more commonly known as male breasts.
Lawsuits continue to mount and allege that the drug maker did not provide
sufficient warnings about this serious, potential side effect and also
allege that the drug was not appropriately researched before being released
to the market.
Risperdal is an atypical antipsychotic that received U.S. Food and Drug
Administration (FDA) approval in 1993 to treat schizophrenia and bipolar
disorder in adults and adolescents. The drug was also approved to treat
irritability in children who are 5-to-16 years of age and diagnosed with
autistic disorder. In some cases, Risperdal is prescribed off-label to
treat attention deficit with hyperactivity disorder (ADHD).
Risperdal Research Points to Serious Injuries
Atypical antipsychotics, including Risperdal, target the brain's serotonin
and dopamine receptors. Risperdal has been associated with a number of
serious side effects, including gynecomastia, diabetes, and movement disorders,
and may also increase the body's prolactin levels. Prolactin is a
hormone that stimulates female breast development and is associated with
breast development in girls undergoing puberty, as well as the breast
development seen in lactating mothers. When young boys experience increased
prolactin levels, they may develop male breasts that also may cause pain
and nipples that discharge.
Studies have tied Risperdal with breast development in young males. In
fact, a study published in 2006 in the
Journal of Clinical Psychopharmacology, indicated that some children who took Risperdal developed increased prolactin
levels. According to the research, risperidone, "administered to
adolescents at doses commonly used for the treatment of psychotic symptoms
can strongly increase prolactin levels, with clinical consequences such
as gynecomastia." The research also revealed that long-term Risperdal
effects are not well-documented concerning growth and puberty delays and
should be prescribed with caution to children and adolescents.
Another study, published in the
Journal of Child and Adolescent Psychopharmacology in 2009 revealed that the increased prolactin levels seen in Risperdal
patients might persist for about two years.
Risperdal Gynecomastia Plagues Patients
Gynecomastia is much more than a source of shame for victims of Risperdal
gynecomastia. The growing of male breasts has significant effects on physical
health, as well. In clinical trials that involved 1,885 children who had
been prescribed Risperdal, 43 were diagnosed with abnormal breast tissue growth.
The symptoms of Risperdal gynecomastia are not reversible, even if the
medication is stopped, and may include:
- Swollen breast tissue
- Tenderness of the breasts
- Breast pain
- Breast growth, up to size D breast cup
- Discharge from one or both nipples
- Galactorrhoea (spontaneous breast milk production)
Adverse side effects associated with Risperdal may happen at any time once
treatment starts. In one case, for example, a patient developed gynecomastia
after taking the drug for five years. In other cases, symptoms may occur
earlier. Because there is no reversal of symptoms, even if the medication
is stopped and following puberty, mastectomy or liposuction may be required
to remove male breasts. Mastectomy may be needed when the breasts are
larger and liposuction is, or would be, ineffective. Mastectomy, "the
surgical removal of breasts tissue and fat," is a significant and
risky surgery, as is liposuction. There are no medications that reverse
Risperdal Targeted to Children
There is an ongoing trend in which children are being treated with strong
antipsychotic drugs, including Risperdal. A recent
Consumer Reports article revealed that the increase in Risperdal prescriptions, as well
as other medications, does not mean that there is an increased in schizophrenia
and bipolar disorder diagnoses. It seems that economically disadvantaged
and minority children who are as young as two years of age are being treated
While use of Risperdal has increased and broadened, and related injury
reports and litigation has mounted, as well, some health industry organizations
have worked to correct the situation. For example, the American Psychiatric
Association announced that Risperdal and other medications should not
be prescribed for off-label uses – uses not approved by the FDA.
"What's not known about the long-term effects is very troubling,"
an assistant professor at Tufts University School of Medicine in Boston
also said, adding that, "The younger you go, the more you can affect
the developing brain."
Risperdal Injury Lawsuits Continue to Mount
There are no exact numbers indicating how many men and boys have developed
gynecomastia due to their having taken Risperdal; however, lawsuits continue
to mount over the matter. Of the pending Risperdal lawsuits brought against
Janssen Pharmaceuticals, at least 130 allege that Risperdal led to male
teenagers developing breasts. In fact, one teenaged boy alleged that he
developed male breasts after taking Risperdal for five years from when
he was nine years of age. He also alleged that his gynecomastia caused
him psychological trauma and his having to undergo surgery to have the
breast tissue removed. In this case, Johnson & Johnson agreed to a
settlement on the first day of trial, which was scheduled in mid-September 2012.
Many claims indicate that Risperdal gynecomastia victims allege having
suffered shame in addition to enduring significant breast removal medical
treatment. In many similar cases, physicians have recommended that teenage
boys undergo surgery to have the breasts removed due to the potential
for significant trauma. Some cases may be handled with liposuction; however,
more severe cases, even moderate cases, typically require patients to
undergo double mastectomy
Numerous Risperdal lawsuits have also been filed nationwide alleging that
Johnson & Johnson and Janssen knew that Risperdal might lead to gynecomastia,
but hid this information from the public. According to an October 12
Bloomberg News report, the drug makers started to settle Risperdal lawsuits that had
been consolidated in Pennsylvania State Court in Philadelphia. That same
year, Johnson & Johnson reportedly agreed to settle charges with the
federal government over the way in which it had marketed some of its medications,
In a consolidated proceeding established in the Philadelphia Court of Common
Pleas, court documents reveal that some 275 claims have been filed on
behalf of men and young boys who allege they suffer from Risperdal gynecomastia.
The lawsuits also allege that Risperdal was inappropriately promoted off-label.
In later 2013,
The Wall Street Journal reported that the drug maker was planning on removing itself from a $212
million deal when the U.S. Department of Justice sought to have Johnson
& Johnson admit it downplayed Risperdal-related side effects, including
its alleged potential to raise prolactin levels in children. The government
also accused the drug maker of illegally promoting Risperdal to children
before the drug was approved for any pediatric uses.
The Wall Street Journal reported that Johnson & Johnson argued that the admission the government
wanted would damage its position in lawsuits alleging Risperdal gynecomastia.
Ultimately, the drug maker agreed to settlements exceeding $2.2 billion
to resolve federal charges that it improperly marketed a number of drugs,
including Risperdal. That deal was part of a settlement with the U.S.
Department of Justice under which Johnson & Johnson agreed to plead
guilty to a criminal misdemeanor charge over the way in which the drug
maker illegally marketed Risperdal for the treatment of elderly dementia
patients. Johnson & Johnson and its Janssen Pharmaceuticals unit did
not admit to any wrongdoing in settling the civil charges brought by the
Justice Department over allegations the drug makers improperly marketed
Risperdal for use in children. The settlement included criminal fines,
as well as forfeiture of $485 million and $1.72 billion in civil penalties.
The settlement also resolves similar accusations brought by 45 states,
according to a
New York Times report
. The civil charges allege that Risperdal was marketed for use in children
before the drug received agency approval for pediatric treatment in 2006
and that Johnson & Johnson knew that Risperdal posed significant risks
to pediatric patients, including gynecomastia. When the settlement was
announced, U.S. Attorney General Eric Holder said that J&J had "recklessly
put at risk the health of some of the most vulnerable members of our society,
including young children, the elderly, and the disabled."
Johnson & Johnson also agreed to settle Risperdal lawsuits that were
brought over claims that the antipsychotic medication increased breast-tissue
growth in boys, according to a
Bloomberg News report. The settlement terms were not released, but five cases of more
than 500 were planned to be tried in Philadelphia, Pennsylvania, according
to Janssen spokeswoman, Teresa Mueller, in an emailed statement; the drug
maker denies any wrongdoing. The five Risperdal lawsuit settlements involved
cases that accuse Johnson & Johnson and Janssen of injuries tied to
Risperdal use, the drug makers indicated in a regulatory filing.
More than 100 Risperdal lawsuits allege gynecomastia (male breast growth)
injuries, according to the
Bloomberg News report.
Bloomberg News was told by one of the patient's attorneys that Johnson & Johnson
hid Risperdal's ties to increased hormone levels that lead to breast
development in males and that the drug maker trained its sales staff to
minimize adverse event information when speaking to physicians. For its
part, the drug maker's attorneys argue that the boy's breast development
was a normal aspect of puberty, denying that the drug maker illegally
Dozens of lawsuits alleging gynecomastia injuries following use of Risperdal
are pending in courts nationwide. Of these, 77 plaintiffs in some of these
claims, which had been filed in a consolidated litigation underway in
Pennsylvania State Court in Philadelphia, motioned the Court seeking to
have an agreement enforced which, they state, was previously reached with
the drug maker. J&J threatened to walk away from the Risperdal lawsuit
settlements agreement, according to the motion, if the agreement was not
expanded to include claims filed against specific third-party defendants.
The plaintiffs allege that Johnson & Johnson had known from the start
that the settlement would not extend to these defendants.
Considering a Risperdal lawsuit?
If you experienced gynecomastia as a result of taking Risperdal, you may
want to consider filing a lawsuit to seek compensation for any alleged
injuries, medical care, and lost wages, among other losses. To learn more,
contact our Risperdal lawyers today. Sullivan & Brill, LLP
offers free consultations and, if we cannot get a recovery for you, you do not owe us any attorney fees.