Number of Birth Defect Lawsuits Rise; FDA Strongly Urges Pfizer to Update Zoloft Label

zoloft birth defect attorney

The author of this post believes there has been a widespread increase in the number of Zoloft birth defect lawsuits. Research reveals that there is an increased risk of congenital defects in infants whose mothers had taken the antidepressant during pregnancy. The Food and Drug Administration has strongly urged Pfizer to change the label warnings on the drug to indicate the risk of birth defects. Unfortunately, the drug company continues to hold its ground, rubbishing claims that the antidepressant drug causes birth defects in women that take the drug during pregnancy. The company sticks to its line that the drug is not proven to cause congenital heart problems.

Rising Number of Cases

Over 1,000 Zoloft birth defect lawsuits have already been filed against Pfizer, accusing the drug maker of knowing that the drug caused heart defects and abnormalities in newborns whose mothers took the Zoloft in pregnancy. The lawsuits accuse Pfizer of failure to warn patients and doctors that the drug could trigger heart abnormalities in infants born to women who used the drug while pregnant.

Hundreds of Zoloft lawsuits have been joined to the multidistrict litigation no. 2342. The first Zoloft side effects lawsuit goes to trial in April 2016.

Plaintiffs allege that Zoloft causes birth defects, which require extensive repair surgeries, including complex congenital heart disease, pulmonary stenosis, ventricular septal defect, and right ventricular hypoplasia. The plaintiffs allege that the drug maker failed to place strict warning labels despite knowing of the risks of using the antidepressant during pregnancy. Zoloft is prescribed as an antidepressant to treat major depressive disorders, which works by controlling serotonin levels in the brain.

The lawsuits filed by parents of children born with birth defects accuse Pfizer of hiding the potential risk of Zoloft side effects and that if the defendant had placed a strong warning label on the drug, the plaintiffs would have never would used the antidepressant during pregnancy.

Some of the Pfizer birth defects include:

  • Spinal malformation
  • Cardiac defects
  • Lung, abdominal & cranial defects
  • Pulmonary hypertension
  • Septal defects

Pfizer Report Warns of Potential Risk

The risk of cardiac and septal birth defects increases when women take the drug in the first trimester. A Pfizer Inc. report shows that its own scientists have been warning the executives about the potential risk of heart defects and omphalocele defects in kids born to women taking Zoloft during pregnancy and suggesting changes to the safety warning label on the drug. However, the manufacturer decided to ignore the warning despite knowing that the drug could cause heart abnormalities in children, claiming that no credible link has been found between Zoloft and birth defects.

In a Zoloft birth defects lawsuit filed against Pfizer in 2011, the plaintiff blames the defendant’s failure to place risk warnings for her cardiac defects and seeks $2.4 million in damages to cover her future medical expenses. The plaintiff asserts that had the drug maker placed a stringent drug label warning, her bipolar mother would not have used Zoloft during pregnancy.

The FDA issued a ruling that Pfizer must enlist more clearly the risks of Zoloft during pregnancy, with “detailed subsections that describe risks within the real-world context of caring for pregnant women who may need medication.”

If you or a loved one has suffered from Zoloft birth defects, you have a potential claim against Pfizer, seeking compensation for damages. Please contact us or call on 1-800-632-1404 for a free consultation with our Zoloft attorney.

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