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Birth Defects Linked To Zoloft Use Spur A Lawsuit

Zoloft is part of the selective serotonin reuptake inhibitor (SSRI) drug class of antidepressants. The FDA approved Zoloft for treatment of major depressive disorder (MDD) in 1991, for obsessive-compulsive disorder (OCD) in 1996, for panic disorder in 1997, and for social anxiety disorder in 2003.

In 2005, Zoloft was the most-prescribed antidepressant in the United States, with almost 27 million prescriptions filled that year. That year, Zoloft sales netted manufacturer Pfizer $3.3 billion.

Under U.S. law, manufacturer Pfizer is responsible for the warning label on their medications

On August 1, 2012, Lauri Serrano, individually and on behalf of her son Nehemiah Serrano, chose to file a birth defects lawsuit in the U.S. District Court for the Eastern District of Pennsylvania. According to her attorney, Serrano’s son was born with birth defects “as a direct result of [Serrano’s] ingestion of Zoloft during her pregnancy.” Birth defects, including persistent pulmonary hypertension of the newborn (PPHN), are one of several recognized side effects from the drug.

Under U.S. law, Pfizer at all times was responsible for the content of the warning label detailing side effects resulting from Zoloft use. Since the manufacturer was allegedly aware of published studies and research associating dangerous birth defects with Zoloft, Pfizer was therefore responsible for communicating this information to the public. According to Serrano’s lawsuit, Pfizer did not comply with this duty.

PPHN diagnosed and attributed to the mother’s use of Zoloft

Nehemiah Serrano was born on November 12, 2005 with PPHN, a birth defect attributed to Zoloft use during pregnancy. Lauri Serrano’s lawyer states that between 2002 and 2006, Pfizer knew that SSRI use during pregnancy “caused lower gestational age and birth weight, longer hospital stays and significantly lower APGAR scores” than children whose mother’s did not use SSRI medications during pregnancy.

Additionally, Serrano’s lawsuit states that Pfizer knew or should have known by 2005 that SSRI use after the 20th week of pregnancy “was significantly associated with PPHN.”

Serrano, through her attorney, requests punitive damages, as well as compensatory damages for past and future medical expenses, pain and suffering, mental anguish, ancillary associated expense, and legal costs.

Her lawsuit brings counts of negligence, breach of warranty, failure to warn, design defect, fraudulent misrepresentation and concealment, negligent misrepresentation, and unjust enrichment.

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