Glaxo Settling Paxil Birth Defect Lawsuit. The maker of Paxil has settled nearly every birth defect lawsuit scheduled to go to trial in Philadelphia, PA over the next eight months. According to a report in the National Law Journal, only one lawsuit in the mass tort Paxil program has gone to trial so far.
Paxil belongs to a class of antidepressants called selective serotonin reuptake inhibitors, or SSRIs. Other drugs in this class include Celexa, Lexapro and Prozac. These drugs have been linked to a number of side effects, including birth defects.
In 2005, the U.S. Food and Drug Administration (FDA) issued a Public Health Advisory disclosing the results of two studies that examined the effects of Paxil when used by pregnant women during the first trimester of pregnancy. Both these studies concluded that women who used Paxil during the first trimester had a greater risk of delivering babies with a cardiac defect. The finding prompted the FDA to change the pregnancy warning on Paxil from C category to D category, which means that studies in pregnant women have demonstrated a risk of birth defects to the fetus.
FDA instructed the makers of SSRIs to revise their labels
In July 2006, the FDA instructed the makers of SSRIs to revise their labels to include information about the life-threatening birth defect of Persistent Pulmonary Hypertension or PPHN. PPHN is a rare and serious respiratory disorder that causes the newborn to not properly adapt to breathing in the outside world and the newborn is thereby unable to receive enough oxygen. That same year, a study in the New England Journal of Medicine showed that babies born to mothers who took SSRI during the second half of pregnancy had a significantly increased risk of being born with PPPHN.
GlaxoSmithKline lost the first Paxil birth defect lawsuit to go to trial last October, when a Philadelphia jury ordered the drug maker to pay $2.5 million to the family of a 3-year-old boy who was born with heart defects. The jury found 10-2 that Glaxo officials “negligently failed to warn” the doctor treating the child’s mother about Paxil’s birth defect risk. It also concluded the antidepressant was a “factual cause” of the child’s heart defects.
The case, known as Kilker v. SmithKline Beecham Corp. d/b/a GlaxoSmithKline, was seen as a leading indicator of the strength of more than 600 similar cases.
the cases that are settling involve cardiac defects
According to the National Law Journal, Glaxo has since chosen to settle the Kilker case, along with about 190 others. Most of the cases that are settling involve cardiac defects, but there are other minor plaintiffs alleging defects because of their mothers’ use of Paxil, the report said. The terms of the settlements so far remain confidential.
The local plaintiffs liaison counsel for the Paxil pregnancy mass tort program told the National Law Journal that up to another 100 cases, including cases that have not yet been filed, have settled. The litigation is two-thirds over.
The next cases in the litigation are scheduled for trial in the fall.
According to The National Law Journal, Glaxo continues to argue it acted appropriately regarding the drug in spite of the settlements. A spokesperson for the drug maker said it agreed to settle some of the Paxil cases “in order to avoid the costs, burdens and uncertainties of ongoing litigation.”