$2.5 Million Awarded in Paxil Case

A Philadelphia jury has ordered drug manufacturer GlaxoSmithKline to pay $2.5 million to settle a claim that its anti-depressant drug, Paxil, caused a severe heart defect in 3-year-old Lyam Kilker. The verdict is the first in 600 cases and alleges that the drug giant knew Paxil caused birth defects but ignored the risks in favor of profits. The drug was approved in 1992 for use in the United States and generated over $940 million in sales in 2008.

Michelle David claimed that her son, Lyam, suffers from a life-threatening heart defect due to her use of Paxil during her pregnancy. The U.S. Food and Drug Administration initially classified Paxil as a drug with no known connections to birth defects. However, in 2005, the drug was reclassified with some evidence of risk to human fetuses, but the FDA continued to allow doctors to prescribe it to pregnant women if the benefits outweighed the risks.

The verdict arrives as the medical community is reassessing how to treat depression in pregnant women. An August report from the American Psychiatric Association and American College of Obstetricians and Gynecologists said depressed pregnant women should consider psychotherapy before taking anti-depressants. The report also stated that women with moderate to severe symptoms should remain on their medications while pregnant, and that the medication decision was especially challenging for expectant mothers with milder depression because the risks might outweigh the benefits.

Jurors awarded the family more than double the $1.2 million they had sought for Lyam's past and future medical care and other damages caused by the heart defects. David said the money would help pay for Lyam's future health care and other needs.

Glaxo issued a statement saying it disagreed with the verdict and would appeal. The case was heard by Judge Stephen Levin in Common Pleas Court.