Pfizer Executives Warned about the Link Between Zoloft and Birth Defects

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.”

About Zoloft

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 after birth.

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 Legal 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 Legalhave successfully represented individuals in Philadelphia, Pennsylvania, New Jersey, and throughout the United States.