In the first jury verdict out of more 600 Paxil lawsuits pending against GlaxoSmithKline PLC, a Pennsylvania jury has found that use of the antidepressant during pregnancy resulted in birth defects for a three year old child and awarded $2.5 million in compensation.
The decision was handed down Tuesday in the Philadelphia Court of Common Pleas, in a lawsuit was brought by the family of Lyam Kilker, whose mother, Michelle David, alleged that GlaxoSmithKline failed to adequately warn about the risk of Paxil birth defects.
Paxil (paroxetine) is a selective serotonin reuptake inhibitor prescribed to treat depression. Approved in 1992, it has become one of the most commonly prescribed drugs in the United States, with sales of just under $1 billion in 2008.
The use of Paxil during pregnancy has been linked to an increased risk of persistent pulmonary hypertension in newborns (PPHN) and other heart problems. In lawsuits pending throughout the United States, plaintiffs allege that GlaxoSmithKline hid test data and misled doctors and consumers about the risk.
In December 2005, the FDA issued an alert about the risk of birth defects from Paxil after studies showed the drug could increase the risk of the heart defects when taken during the first three months of pregnancy. At that time, the agency also required GlaxoSmithKline to update the warning label to include information about the risk of birth defects from Paxil side effects.
At trial, the plaintiffs argued that GlaxoSmithKline’s handling of the drug was outrageous, presenting internal e-mails and memos that showed scientists and executives for the drug company were aware of the Paxil birth defect side effects, even as they minimized the risk to doctors. Evidence was also introduced that suggested Glaxo aggressively promoted Paxil for use in pregnant women even after suspecting the risk.
After deliberating for seven hours, the jury awarded $2.5 million in compensatory damages, but did not award any punitive damages.
Glaxo officials maintain that they do not believe a link has been established between Paxil and Kilker’s birth defects, and said they will appeal the verdict.