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Zoloft Craniosynostosis Lawsuit Joins MDL

The makers of antidepressant Zoloft have been sued by a mother whose child was born with a birth defect. The woman blames the drug for causing her daughter’s craniosynotosis, a condition in which the fibrous joints connecting the bony plates in the skull close prematurely, inhibiting normal brain and skull growth. The Zoloft craniosynostosis lawsuit was filed in the U.S. District Court for the Eastern District of Pennsylvania, the venue for multidistrict litigation proceedings involving allegations of Zoloft birth defects overseen by Judge Cynthia M. Rufe (MDL no. 2342).

The plaintiff was first prescribed Zoloft in March 2010, prior to becoming pregnant. The plaintiff and her doctor were both unaware of a possible link between Zoloft and birth defects, so she continued to take it after learning of her pregnancy. In August 2011, she gave birth to her daughter at a Greensburg hospital, and was told the child had been born with craniosynostosis. In March 2012, a craniotomy was performed to correct the child’s skull defects. According to the Zoloft craniosynostosis lawsuit, the child still suffers physically and emotionally, continues to have regular testing and appointments, and “has been deprived of having a normal childhood and life.”

The family is seeking damages to cover medical costs and pain and suffering caused by the condition. The lawsuit claims that drug maker Pfizer should have known that their product could affect unborn children, citing animal studies that indicated a link between Zoloft and birth defects such as cleft lip and club foot.

FDA alert cited in Zoloft craniosynostosis lawsuit

Zoloft was approved by the FDA as a treatment for major depressive disorders in 1991, and was later approved for other conditions including obsessive-compulsive disorder, panic disorder, acute post traumatic stress disorder, premenstrual dysphoric disorder, and social anxiety disorder. By 2005, Zoloft had become the most prescribed antidepressant in the United States, with over 27 million prescriptions racking up $3.3 billion in sales for Pfizer.

But Zoloft and other selective serotonin reuptake inhibitors (SSRIs) have increasingly been associated with severe side effects ranging from suicidal thoughts to birth defects. Pfizer did not test the effect of their product on pregnant women or their unborn children and did not discourage the use of Zoloft by expectant mothers. Indeed, Pfizer actively encouraged doctors to prescribe Zoloft to women of childbearing age and marketed it directly to pregnant women.

Zoloft lawsuit cites clinical studies

According to the lawsuit, Pfizer knew of the link between Zoloft and birth defects as early as 1996. A study in the New England Journal of Medicine found that fetuses exposed to SSRIs late in pregnancy showed markedly higher rates of prematurity, significantly lower birth weights and persistent pulmonary hypertension of the newborn (PPHN). Another study published in the American Journal of Psychiatry in 2002 showed similar results, and in 2009, the British Medical Journal published a study of more than 493,000 patients that showed Zoloft carried an increased risk for congenital heart defects. The first bellwether cases in the Zoloft MDL are scheduled to begin by October 2014.