Jon Campisi Oct. 3, 2012, 8:43am

Pfizer is facing a product liability complaint initiated by two New York State residents

who claim that their son was born with birth defects as a result of the mother taking the anti-depression drug Zoloft during pregnancy.

Jeremy and Emily Favata, of Rome, N.Y., are suing Pfizer Inc. and Greenstone LLC, a wholly-owned subsidiary of Pfizer that produces generic drugs, over claims that their child was born in December 2009 with multiple congenital birth defects and malformations, including cardiac non compaction syndrome and complex congenital heart disease, including an abnormal aortic valve and a left ventricle to upper aorta tunnel.

The claim is that the birth defects were directly caused by Emily Favata ingesting Zoloft, which is used to treat depression and mental illness, during pregnancy.

The lawsuit, which was filed Oct. 1 at the U.S. District Court for the Eastern District of Pennsylvania by Philadelphia attorneys Jack Meyerson and Debora O’Neill, states that on Dec. 7, 2009, immediately after his birth, the plaintiff’s son underwent surgery to repair the tunnel in his heart.

The newborn spent two weeks in the hospital, after which he was quarantined for six to seven months.

The boy continues to suffer significant delays in his physical and mental development, the suit claims.

The plaintiffs allege that the child’s injuries were a direct result of the defendants’ wrongful conduct relating to the design, development, manufacture, testing, distribution, labeling, advertising, marketing, promotion and sale of what the suit calls an “unsafe prescription drug.”

At the heart of the plaintiffs’ lawsuit is the allegation that the drug makers failed to warn pregnant women that Zoloft was unsafe for mothers-to-be since it could increase the risk of birth defects in children.

“Defendants knew or should have known that SSRI  [serotonic reuptake inhibitor] use, including Zoloft/Setraline, during pregnancy caused lower gestational age and birth weight, longer hospital stays, and APGAR scores being significantly lower than in non-exposed infants in control groups,” the lawsuit states.

Zoloft is an SSRI that is marketed as a medication for depression, anxiety and other mental health conditions including obsessive-compulsive disorder, panic attacks and post-traumatic stress disorder.

The lawsuit states that many observational studies have been conducted showing a statistically significant increase in birth defects associated with the use of Zoloft.

The complaint alleges that the drug’s manufacturers suppressed information about the drug’s adverse side effects, which prevented physicians and the public from fully understanding the risks associated with the pharmaceutical.

“Instead of discouraging Zoloft/Sertraline use in pregnant women, Defendants marketed the drug to women of childbearing age, women who were trying to conceive, and women who already were pregnant,” the lawsuit states. “Defendants did not reveal information pertaining to the associations between Zoloft/Sertraline and birth defects and actually sought to limit health care providers’ access to negative data by misrepresenting the efficacy and safety of the drug.”

The lawsuit says that Emily Favata, who became pregnant with her child in the spring of 2009, took Zoloft during the entire term of her pregnancy since she was unaware of its dangers.

The suit claims that the minor child will have to be monitored by specialists for the rest of his life.

The complaint states that Emily Favata would not have taken Zoloft during pregnancy if she had been made aware of its dangers by her doctor, who the suit claims was mislead by the defendants.

The complaint contains counts of strict products liability, negligence, breath of implied and express warranties and fraud.

The lawsuit claims that the plaintiffs have suffered severe pecuniary injury and loss, including medical expenses, lost wages and other incidental expenses relating to the treatment and care of their child.

The plaintiffs seek unspecified compensatory damages, exemplary damages, attorney’s fees, interest and costs.

A jury trial has been demanded.


The federal case number is 2:12-cv-05622-CMR.

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