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Lawsuit in Pennsylvania Alleges Zoloft Caused Serious Birth Defects

Zoloft causes birth defects, according to a products liability lawsuit filed in federal court in Pennsylvania on July 5, 2013. The plaintiff, whose child was born with serious congenital birth defects, claims that Pfizer ignored the known risks to pregnant women inherent in selective serotonin reuptake inhibitors (SSRI) antidepressants, including Zoloft. The Zoloft lawsuit asks for an unspecified amount of compensatory damages, punitive damages and court costs.

The recent filing joins a growing list of lawsuits against Pfizer regarding Zoloft side effects in children, including a club foot, craniofacial defects, heart malformations, PPHN and other serious heart defects.  Like many other similar lawsuits against drug or device manufacturers,  the plaintiff’s lawsuit hinges on how much the drug manufacturer knew about the product’s safety, and the steps, if any, the manufacturer took to either correct or cover up the problem.

Zoloft lawsuit background

Since being approved by the Food and Drug Administration (FDA) in 1991, Zoloft has been a commonly-prescribed antidepressant; in 2011, American doctors wrote over 37 million prescriptions for Zoloft or sertraline, its generic equivalent. As early as 1996, however, evidence developed that SSRI drugs, including Zoloft, could be responsible for birth defects if taken in the third trimester. Such SSRI birth defects included premature delivery, respiratory distress and low birth weight. A 2009 study confirmed these findings, adding that SSRIs – particularly Zoloft – caused septal heart defects in newborn infants.

Pfizer’s response

Despite evidence to the contrary and a mounting number of lawsuits, Pfizer has consistently filed court papers denying that Zoloft causes birth defects. Basically, Pfizer challenges these plaintiffs to produce specific proof that Zoloft did in fact cause the complained-of birth defect, a common defense tactic in Zoloft lawsuits and many other personal injury lawsuits as well. The plaintiff always has the burden of proof in a civil case to prove the allegations in its lawsuit beyond a reasonable doubt, generally by means of expert testimony.

Plaintiff alleges defendant knew of Zoloft birth defects

In this case, the plaintiff’s lawsuit asserts that Pfizer knew about these risks, and nevertheless failed to warn pregnant mothers and their doctors about the hazards of taking Zoloft during pregnancy. The lawsuit includes allegations of:

  • Design defect: The lawsuit claims that Zoloft is a dangerous drug if administered to pregnant women. The plaintiff’s attorney goes on to say that Pfizer had the opportunity to correct the drug and make design changes, but refused to do so.
  • Failure to warn: According to the lawsuit, if Pfizer did not make Zoloft safer, Pfizer at least had a duty to warn both pregnant mothers and their doctors about the potential for Zoloft side effects in children. Instead, Pfizer aggressively marketed Zoloft as a safe and effective antidepressant for all patients.
  • Negligence: This Zoloft lawsuit claims that Pfizer breached its duty of reasonable care to both doctors and patients in a number of ways, including failing to conduct proper clinical trials, failing to disclose adverse test results, failing to warn about known risks and misrepresentation.

As in the other cases involving Zoloft side effects in children, Pfizer is expected to deny the plaintiff’s allegations and force her to prove them in court.