Corporate greed leads to Paxil birth defects

In hindsight, it looked like a corporate dream. Flood the market with a product bound to be popular. Hide the side effects. Make money.

Those are the charges against GlaxoSmithKline (GSK), the maker of Paxil, an anti-depressant drug approved by the U.S. Food and Drug Administration (FDA) in 1992. It’s estimated that GSK made $942 million in 2008 from sales of Paxil, a full 16 years after it went on the market and 13 years after warnings about its connections to life-threatening birth defects first surfaced.  All told, Paxil is said to generate close to $3 billion in annual sales for GSK, according to consumer affairs.com.

In 2009, the family of a child born with three holes in his heart won $2.5 million from GSK in a Paxil lawsuit after a jury ruled that the company “withheld information from consumers and regulators about the risk of birth defects and failed to properly test Paxil.” The child’s mother took the antidepressant Paxil while she was pregnant. Normal hormonal changes in pregnancy can trigger depression.

Since Paxil was on the market for 13 years before the federal government posted warnings about its link to birth defects, there may be many more families with children who were born with life-threatening conditions or had babies who died from these Paxil side effects.

In June 2010, more than 600 cases against GSK had been filed on grounds that Paxil was responsible for heart-related birth defects.  By then, the company had agreed to settle 200 cases.

Houston personal injury attorney Jim Adler, who has long held that Americans are being used as guinea pigs by big pharmaceutical companies, is particularly offended by GSK’s treatment of pregnant women and their fetuses – babies who were scarred even before they had a chance at life.

“I’ve seen a lot of abuse caused by big companies after 30 years of standing up for victims," Adler says. "Corporate greed is nothing new. But this takes the cake. Taking a chance that you could ruin the life of an unborn child just to make a profit is worse than anything I’ve ever heard of.”

In 2005, when the FDA ruled that Paxil birth defects posed potential danger to fetuses, especially during the first three months of pregnancy, the federal agency said “…two studies showed that women who took Paxil during the first three months of pregnancy were about one and a half to two times as likely to have a baby born with a heart defect as women who received other antidepressants or women in the general population.”

“Moms all over this country need to look back and make sure they weren’t taking Paxil when they were pregnant, especially during the first trimester.," Adler says. "If they did, and their child was born with heart problem, they should call an attorney.”