Paxil And Babies

GlaxoSmithKline announced it expects legal charges of approximately $2.4 billion for the second quarter of 2010.  The reports are that the $2.4 billion legal bill includes charges related to product liability lawsuits over Paxil, mothers and babies. “The charge we have announced today reflects the company’s ongoing efforts to resolve certain longstanding legal cases,” according to its main corporate lawyer in a statement quoted in the New York Times. “This represents a substantial proportion of GSK’s outstanding litigation.”

GlaxoSmithKline settled more than a hundred Paxil birth defect lawsuits in June 2010.  The Fitzgerald Law Firm has cases alleging GSK deliberately chose against adequately warning physicians and expectant mothers about the risk of birth defects when those pregnant mothers took Paxil.  Those birth defects include persistent pulmonary hypertension in newborn babies (PPHN) and heart defects, including holes in the heart and malformations.

Many law firms claim to have success in Paxil cases but only two lawsuits have ever resulted in a verdict against GSK for a birth injury, or death from suicide. One of those two successful cases against GSK over its Paxil product resulted in a verdict in which Jim Fitzgerald was privileged to serve as trial co-counsel for the family.

A Danish study published in September 2009, entitled “Selective serotonin reuptake inhibitors in pregnancy and congenital malformations: population based cohort study” resulted in an important conclusion. It is cited at BMJ 2009;339:b3569.  Medical experts in the Departments of Epidemiology, Pediatrics and General Practice at the Institute of Public Health, Aarhus University, Denmark, and the UCLA School of Public Health, Department of Epidemiology, collaborated in the study.

The study’s Objective was “to investigate any association between selective serotonin reuptake inhibitors (SSRIs) taken during pregnancy and congenital major malformations.”  It included 493,113 children born in Denmark from 1996-2003.  It found that SSRIs “were associated with septal heart defects.”

The doctors and researchers concluded that there “is an increased prevalence of septal heart defects among children whose mothers were prescribed an SSRI in early pregnancy.”

There are potential dangers to the developing baby of women who get pregnant while taking paroxetine, or who start it after getting pregnant.  We are involved in cases where women took Paxil in various trimesters of pregnancy.  The cases usually involve allegations of fetal heart damage when the mother took Paxil early in the pregnancy.

However, Glaxo’s www.gsk.com own literature shows that newborns who were exposed to Paxil and other SSRIs or SNRIs (selective serotonin and norepinephrine reuptake inhibitors) late in pregnancy have at times developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.

Paxil related complications in newborns may include respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability and constant crying.

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