According to a report in The Philadelphia Enquirer, GlaxoSmithKline, manufacturer of the antidepressant Paxil, must pay $2.5 million to settle a claim that the drug caused severe heart defects in 3-year-old Bensalem, PA boy.
The verdict is the first in 600 similar cases, which allege that Glaxo knew Paxil causes birth defects, but hid that knowledge in order to protect their profits.
Paxil generated about $942 million in sales last year, accounting for 2.1% of Glaxo's total revenue.
The boy's mother, Michelle David, claimed that her son, Lyam Kilker, suffered from life-threatening heart defects because she had used the drug during her pregnancy. There was no previous history of heart defects in her family, according to David.
By a 10-2 margin, the jury found Glaxo had "negligently failed to warn" David's doctor about Paxil's risks and that the drug was a "factual cause" of the boy's heart defects. They also found that Glaxo's handling of the drug was not "outrageous", meaning that the family could not seek punitive damages.
The jurors awarded the family more than double the $2.1 million that had asked for in order to provide for Lyam's past and future medical expenses related to the heart defects.
The verdict arrives at a time when the medical community is seeking to reevaluate how to treat pregnant women. An August report from the American Psychiatric Association and American College of Obstetricians and Gynecologists recommended that pregnant women should consider psychotherapy before taking antidepressants. It further stated that women with moderate to severe depression should probably remain on their medication, but the risks might outweigh the benefits for women with mild depression.
Selective serotonin reuptake inhibitors, which is the class on antidepressant which Paxil belongs to, have been linked to various problems, including a higher incidence of pulmonary hypertension, a condition in which increased lung pressure can lead to heart failure. In 2005, the FDA reclassified Paxil as a drug with some evidence of risk of the human fetus, but allowed doctors to continue prescribing it to pregnant women if the benefits outweighed the risks.
Glaxo issued a statement saying that they planned to appeal the verdict.
"While we sympathize with Lyam Kilker and his family, the scientific evidence does not establish that exposure to Paxil during pregnancy caused his condition. Very unfortunately, birth defects occur in 3 to 5% of all live births, whether or not the mother was taking medication during pregnancy," the company's statement said.
