As Zoloft birth injury lawsuits mount, news reports cite a communication from the FDA to drug manufacturer Pfizer seeking to include the risk of infant heart defects in label warning. Many mothers on behalf of their children have filed a Zoloft birth injury lawsuit claiming serious and fatal heart defects filed across the United States. Plaintiffs claim that they and their innocent children turned victims of the drug side effect in the absence of any pregnancy-linked adverse event warning. Recent court submission by a Zoloft attorney highlights Pfizer was aware of birth injury side effects as early as 1998, but never made it public.
As reported by Bloomberg News, the FDA asked Pfizer in August 2015 to modify safety warnings and add information to Zoloft label warning that “some researchers have discovered risk of congenital cardiac problems in children born to women treated with the antidepressant during pregnancy. The present label talks about “absence of adequate and well-controlled studies involving pregnant women.” The FDA stepped in after a Zoloft birth injury lawsuit quoted some internal memos (between 1998 and 2014) citing how the manufacturer’s staff scientists periodically warned about the potential link between heart defects in newborns and pregnancy side effects of the drug.
The changes to the rules governing pregnancy and lactation labeling information incorporated in 2014 empowers the FDA to request for necessary label changes in the view of perceived health risks for pregnant women. Pfizer sources have confirmed that the FDA request is under consideration. Though the manufacturer still claims that “there is no reliable scientific evidence linking Zoloft and birth defects,” the FDA request underlines what many consumer groups, research reports, and plaintiffs have been highlighting so far.
Internal Memos Cite Heart Defect Birth Injury Risk from Zoloft; Leads to Zoloft Birth Injury Lawsuit
A few weeks ago, a Zoloft attorney representing a $2.4 million claim in a Philadelphia court submitted some portions of a Pfizer internal memo that warns about the possibility of “hole in heart, persistent pulmonary hypertension, and congenital heart disorders” in children born to women ingesting the drug while pregnant. It was taken from a 1998 report prepared by researchers employed by the manufacturer. The report studied 50 Zoloft pregnancy adverse events to conclude that the drug side effects “could not be ruled out” for causing birth injuries, the Zoloft lawyer claims.
Another internal report prepared by Pfizer’s associate director for epidemiology at Worldwide Safety Strategy department and dating back to April 2014 also hinted at Zoloft heart defects in infants. Primarily a review report, it talks about birth deformities impacting heart and other vital organs due to prenatal expose to the antidepressant.
For long, Pfizer is rejecting charges of association between Zoloft antidepressant and birth injury in infants, including heart defects. There are over 1,000 Zoloft lawsuits and more than a dozen research reports claiming various types of congenital birth defects in babies born to mother taking the drug during pregnancy. These documents are support for injured children in a Zoloft birth injury lawsuit.
Zoloft Heart Defects
Research studies and litigant claims associate Zoloft pregnancy side effects to congenital heart defects in new born, including
- persistent pulmonary hypertension
- non-fatal pulmonary hypertension
- plumonary atresia
- hypoplastic heart
- pulmonary stenosis
- heart valve defects
- arota compression
- opening between right and left atria
- fallot tetralogy
- arterial defects
Zoloft Birth Injury Lawsuit Updates
The latest FDA suggestion for label changes is viewed as existence of credible link between Zoloft and heart defects in newborns. It could be a potential boost to hundreds of such claims in the court and induce a jury to rule that Pfizer is guilty of hiding safety data to further commercial gains. The manufacturer was successful in defending two Zoloft lawsuits in St. Louis and Philadelphia earlier this year well before the FDA suggestions came into the fore. However, the first federal bellwether trial for a Zoloft birth injury lawsuit is expected in January 2016. I would expect that trial to be influenced by the news.
If you have a claim involving Zoloft birth defect in children, please contact us or call on 1-800-632-1404 for a free evaluation of your potential lawsuit.