On August 24, 2012, a Nevada woman whose child was born with multiple congenital heart defects caused by her use of the antidepressant Zoloft filed a lawsuit against Pfizer, manufacturer of the drug. Filed in the U.S District Court for the Southern District of New York, the lawsuit claims that although Pfizer knew or should have known of the potential for Zoloft to cause such abnormalities, it failed in its responsibility to warn the woman or her doctor of the risks and are thus liable for her child’s medical bills and other damages.
During her pregnancy, the Nevada woman was prescribed Zoloft by her doctor as treatment for depression, in accordance with the dosage recommended by Pfizer. Her child was thereafter born with multiple birth defects, including ventricle septal defect, craniosynostosis, and a scaphoid cephalic head shape. Such birth defects have been widely linked to the use of Zoloft while pregnant.
Zoloft was first approved by the FDA in 1991 to treat depression, and was later approved to treat anxiety and OCD. This process went forward despite Pfizer’s knowledge that the drug caused birth defects in animal subjects. It thereafter became one of the most popular drugs used to treat depression. However, studies have continued to demonstrate that use of Zoloft by pregnant women dramatically increases the risk of birth defects in their children.
In 2005, the FDA issued a Safety Alert for Zoloft and other selective seratonin reuptake inhibitors (SSRIs) based on two studies showing that women who took Zoloft in the first trimester of pregnancy increased their child’s risk of heart defects by 100-150%. In 2006, the alert was followed with an FDA Public Health Advisory, following further studies confirming the drug’s link to birth defects.
By 2007, a study had linked Zoloft in pregnancy to a doubled risk of heart defects in the newborn, a risk about which the lawsuit alleges Pfizer knew or should have known. Furthermore, in 2009 and 2010 two major studies of thousands of births confirmed that Zoloft causes a greatly increased risk of birth defects, including heart abnormalities. On the basis of this information, which had been accumulating since even before the drug’s approval in 1991, the lawsuit alleges that Pfizer had both the ability and the duty to provide a stronger warning to patients and doctors by the time of the plaintiff’s pregnancy. Pfizer breached this duty, failing to notify the plaintiff of the drug’s full range of potential dangers.
The lawsuit alleges that despite this massing evidence, Pfizer has never made sufficient attempts to warn physicians and patients of these risks through changes to warning labels, physician education, or promotional materials. To this day, the Zoloft label does not adequately warn of these risks. The plaintiff in the case, filing on behalf of her minor child, thus alleges that Pfizer failed in its duty to adequately warn patients and doctors of the information it possessed regarding the drug’s risks, thus subjecting her child to major heart defects and birth defect injuries. The plaintiff’s complaint alleges counts for failure to warn, negligence, strict products liability, defective design, and fraud. The lawsuit seeks compensatory and punitive damages. The recent lawsuit joins many others filed against Pfizer due to birth defects caused by Zoloft use during pregnancy.
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