Earlier this year, the U.S. Food and Drug Administration was sued in Pennsylvania
federal court. The suit claims that the FDA barred a law firm from turning
over confidential Risperdal documents, which were obtained through the
discovery process. This directly resulted in the denial of a citizen petition
asking that Johnson & Johnson publicize documents relating to the
dangers of the antipsychotic drug Risperdal. The petition in question
wanted Johnson & Johnson to publically release documents detailing
the connection between breast growth in adolescent boys and their popular
drug, Risperdal. They also wanted the FDA to change the labeling of Risperdal
and revoke its pediatric indication. None of that occurred, however, because
the FDA banned the use of specific documents obtained in discovery.
What were these documents? These documents were the analyses of a report by ex-FDA Commissioner David
Kessler that challenged a study commonly touted by Johnson & Johnson
regarding the correlation between their drug and adverse side effects.
In other words, the law firm had information that J&J and Janssen
knew of the data linking Risperdal to incidences of breast growth in adolescent
boys long before the medication’s label was updated to show the
risk - as early as 6 years before the label was changed.
Risperdal and Gynecomastia
Risperdal has been associated with an abnormal development of breast tissue
in men and young boys. This is known as gynecomastia and it can be traumatic
for young adolescent boys and young men. Many of these men have experienced
severe mental pain and anguish and embarrassment, as well as undergoing
Other Side Effects of Risperdal
Risperdal was believed to have a lower risk of movement disorders than
older antipsychotics, yet many Risperdal patients have experienced the
- Inability to move;
- Hesitant movements;
- Abnormal movement of face, shoulders, arms and legs;
- Parkinson's-like tremors, and
- Stiffening of the tongue, causing difficulty breathing.
Risperdal has also been associated with an increased risk of the development
of diabetes. In those who already have diabetes, Risperdal can cause a
worsening of symptoms. Mortality in elderly patients has also been associated
with the use of Risperdal, and, in fact, the FDA has mandated a Black
Box Warning on Risperdal related to use in the elderly.
Less severe side effects of Risperdal may nonetheless cause a decrease
in the quality of life. These symptoms include:
- Increased risk of falls;
- Nausea and vomiting;
- Drooling, and
- Difficulty swallowing.
All in all, Risperdal has one of the longest histories of problems of any
medication on the market. Injury related to Risperdal use was seen as
early as 2001, with the litigation still going on. While physicians are
allowed to prescribe medications for off-label, the manufacturer may not
promote medications for any indication other than those approved by the
FDA. Janssen and Johnson & Johnson have done just that, and may be
responsible for injury to thousands of American consumers.
National Risperdal Lawsuit Lawyers
Men, who have suffered from swollen or painful breasts, gynecomastia, mastectomy,
or liposuction after taking the dangerous drug Risperdal, may be able
to file a lawsuit against Johnson & Johnson. The
Philadelphia defective drug lawyers at Golomb & Honik are currently evaluating claims from men who were
prescribed Risperdal and have suffered serious side effects as a result.
We believe in holding negligent pharmaceutical companies responsible for
their actions and will fight aggressively for you and your family.
To learn more about your rights and legal options, call the Philadelphia
defective drug lawyers at Golomb & Honik today at
1-800-355-3300 or 1-215-985-9177 or fill out our
confidential Contact Form.