Over the past 20 years, the use of antidepressants such as Paxil and Zoloft
have increased by nearly 400 percent among patients between the ages of
18 and 44. The most commonly prescribed antidepressants contain serotonin
reuptake inhibitors (SSRIs), which have been shown to increase the risk of
birth defects. These birth defects include heart malformations, spina bifida, and persistent
pulmonary hypertension (PPHN).
Recent lawsuit alleges heart defects in newborn resulting from mother’s
use of Zoloft during pregnancy.
On June 13, 2013, a federal lawsuit was initiated against Pfizer, Inc.
the manufacturers of the antidepressant, Zoloft. The lawsuit alleges that
the antidepressant caused harm to the plaintiff’s unborn child.
The woman took Zoloft as prescribed by her doctors as treatment for depression.
She believed the product to be safe based on the advice of medical professionals
as well as, the manufacturer’s marketing materials and warning labels.
However, her child was born with congenital heart defects, which have
required multiple heart reconstructive surgeries and other ongoing medical
According to the lawsuit, Pfizer manufactured and sold a defective product,
and failed to warn consumers of the product’s known dangers. The
lawsuit specifically points to studies linking the medication to a variety
of birth defects including heart abnormalities and PPHN.
FDA has issued numerous warnings regarding the risks associated with taking
SSRI antidepressants during pregnancy.
In 2005, the Food and Drug Administration (FDA) issued a safety communication
that sought to educate the public regarding the increased risk of congenital
heart defects among newborns when mothers took Paxil during the first
three months of pregnancy. According to studies cited in the FDA’s
safety communication, taking Paxil during the first trimester of pregnancy
doubled newborns’ risk of heart defects, as compared to other types
of antidepressants. Accordingly, the FDA asked GlaxoSmithKline, Paxil’s
manufacturer, to change the drug’s warning label to indicate that
it carried a known risk of birth defects to the human fetus.
In 2006, the
FDA issued another public health advisory regarding birth defects, namely neonatal PPHN, linked to SSRI antidepressants.
It cautioned medical providers and patients to consider the risks of SSRIs
and to weigh them against stopping the patient’s treatment for depression
during pregnancy. The advisory was based on a study published by the New
England Journal of Medicine, which indicated that babies were six times
more likely to be born with PPHN when the mother took SSRIs after the
20th week of pregnancy.
If you took an antidepressant during your pregnancy and your child was
born with a birth defect, you should
contact Goldstein & Hayes immediately. An attorney will be able to review the facts of your case
and determine whether the drug manufacturer’s negligence, fraud,
breach of warranty, or other misconduct caused your child’s injuries.
If so, an attorney can help you seek the compensation you deserve, both
for the cost of your child’s past and future medical expenses as
well as, you and your child’s pain and suffering.