Just last year one of Pfizer’s own scientists warned top executives
about a possible link between birth defects and the anti-depressant drug
Zoloft. At that time, changes were recommended regarding changes to the
safety warnings on the drug. The document clearly shows Pfizer was warned
of Zoloft’s potential risks and would seem to complicate the more
than 1,000 lawsuits brought by parents whose children were born with malformed hearts.
Pfizer maintains the document was taken out of context and that Zoloft is
not responsible for newborn birth defects. The first lawsuit against Pfizer
for harm alleged by Zoloft went to trial in April, with a decision in
favor of the defendants. At that time, the document showing Pfizer executives
may have known about the dangers of Zoloft had not yet surfaced. One California
lawyer who has gone head to head with Pfizer in the past put the issue
succinctly: “A jury could easily find it to be a bald-faced lie to say there’s
no credible ties between Zoloft and birth defects when you own people
are citing studies and adverse event reports highlighting those links.”
Zoloft was, at one time, the most-prescribed antidepressant in the United
States, bringing in billions of dollars for Pfizer. Zoloft was manufactured
and released in the U.K. in 1990, marketed as a safer alternative to the
antidepressant Prozac, manufactured by Eli Lilly. Nine years after the
release of Zoloft in the U.K., the drug was released in the U.S., and
by 2005, more than 30 million prescriptions per year were being written
for the drug.
Also in 2005, Zoloft was the sixth most-prescribed brand name prescription
medicine, grossing almost $2.6 billion in that year alone. Zoloft is in
a class of antidepressants known as selective serotonin reuptake inhibitors
(SSRI), used to control depression and other mental illnesses. Zoloft
and other SSRIs work by regulating serotonin in the brain—a neurotransmitter
which affects sleep, mood and learning.
Studies Associating Zoloft with Birth Defects
The FDA classifies Zoloft as a Class C drug for pregnant women. This means
that while animal studies have shown harm to the fetus, there have not
been adequate studies in human subjects. Research has shown, however,
that mothers who take Zoloft after the 20th week of pregnancy are much more likely to deliver a baby who suffers from
persistent pulmonary hypertension, which is fatal in at least ten percent of cases.
One study showed mothers who took Zoloft while pregnant had twice the risk
of delivering a baby with a heart defect. Further, the use of SSRIs while
pregnant has been linked to an anencephaly, a fatal birth defect in which
a large part of the skull and brain do not develop. Babies born to mothers
who took SSRIs such as Zoloft while pregnant are also more likely to be
born with cleft lip or cleft palate, and can suffer withdrawal symptoms
Second Trial Results in a Win for Pfizer Despite New Evidence
A 1998 report by Pfizer researchers was introduced into evidence in a recent
Zoloft Philadelphia trial which acknowledged that the effects of Zoloft “could not be ruled out” in more than a dozen reports regarding babies’ birth defects.
Last year’s document from a Pfizer scientist was also introduced.
Despite this, Pfizer once again triumphed in the second trial which alleged
links between Zoloft and birth defects. In the Philadelphia trial, eight-year
old Mia Robinson, who suffered a hole in her heart after being born to
a bipolar mother who took Zoloft during her pregnancy, asked for $2.4
million in damages. Following the jury’s decision, Rachel Robinson,
Mia’s mother, wept in the arms of her attorney.
Many find the past two decisions in favor of Pfizer ludicrous in light
of the internal Pfizer memo by Francesca Kolitsopoulous, associate director
of Pfizer’s Worldwide Safety Strategy. The document reported that
after reviewing published studies showing an association between Zoloft
and cardiac malformations, Kolitsopoulous determined the association was
“causal”. At that time Kolitsopoulous proposed a modification
of the warning label on Zoloft to include potential links between the
drug and birth defects.
Contact Our National Dangerous Drug Lawyers
If you took Zoloft during pregnancy and your baby was born with a congenital
defect, it is important to speak one of the experienced national dangerous
drug attorneys at Golomb & Honik immediately. Our lawyers can answer
all your questions regarding the current Zoloft litigation and determine
if you are eligible to file a lawsuit against the manufacturers of Zoloft.
The national dangerous drug lawyers at Golomb & Honik, P.C. have successfully
represented individuals in Philadelphia, Pennsylvania, New Jersey, and
throughout the United States.