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Ohio Mom Sues Both Name Brand and Generic Manufacturers of Zoloft

Zoloft and Birth Defects An Ohio mom recently filed one of the many new Zoloft lawsuits pending in the U.S. District Court for the Eastern District of Pennsylvania, the location of the current Zoloft MDL. The plaintiff files individually and on behalf of her child, and brings claims against Zoloft manufacturer Pfizer, Inc.

According to the complaint, Pfizer failed to provide adequate warnings about the link between Zoloft and birth defects. The plaintiff took the antidepressant during her pregnancy, unaware that it could increase her risk of giving birth to a child with birth defects. Her baby was born on December 12, 2008, and suffered serious injuries. The plaintiff seeks in excess of $75,000 in damages.

Pfizer failed to warn of Zoloft and birth defects

Pfizer knew or should have known about the long-term side effects of Zoloft, the plaintiff states, including the fact that it can cross the placenta and affect the development of the fetus. Under the direction of her doctors, which were also not warned of these possible risks, the plaintiff took Zoloft (sertraline) during her pregnancy.

After her child was born, the plaintiff discovered that the baby suffered from a cleft lip, a cleft palate, and other associated malformations. The plaintiff alleges these injuries are a direct result of the child’s exposure to sertraline in utero. As a result of these injuries, the child has suffered physical pain and suffering, as well as and emotional distress.

Had Pfizer provided adequate warnings, the plaintiff states that she would not have taken it.

Claims against the generic manufacturer

The plaintiff in this case also brings counts against Greenstone LLC, a New Jersey Corporation. In her complaint, she states that Greenstone became a wholly owned subsidiary of Pfizer, Inc. in April 2003. In 2006, when the patent for Zoloft was expiring, Pfizer announced that Greenstone would release an authorized generic version of Zoloft.

“In this way,” the complaint reads, “Pfizer sought to establish a strong presence in the generic marketplace even before other manufacturers could gain approval for their generics.”

The plaintiff goes on to state that Greenstone manufactured and sold sertraline “pursuant to a contractual agreement with Pfizer,” and Pfizer and Greenstone engaged “in joint efforts to manufacture, market, promote, distribute, and sell sertraline.”

Greenstone relied on Pfizer concerning any warnings and precautions associated with the product, and therefore also failed to warn doctors and parents about Zoloft and birth defects.

Scientific studies indicate the long-term side effects of Zoloft

The FDA approved the use of Zoloft as a selective serotonin reuptake inhibitor (SSRI) antidepressant in 1991. The plaintiff claims that before she started taking the drug, Pfizer was aware of scientific studies that indicated an association between Zoloft and birth defects among children whose mother take it during pregnancy.

A 1996 study, for example, published in the New England Journal of Medicine, showed that medications in the same class of SSRI drugs as Zoloft, when given to mothers during pregnancy, increased risk of babies born with low mean birth weight and length, and persistent pulmonary hypertension of the newborn (PPHN).

In 2006, the same journal published a study linking the use of Zoloft after the 20th week of pregnancy with a significant increased risk of giving birth to a baby with PPHN. In 2007, two other studies indicated the drug was associated with cranial and abdominal birth defects, as well as heart defects.

The plaintiff brings counts of defective design, failure to warn, negligence, breach of warranties, negligent and fraudulent misrepresentation, and unjust enrichment.