Jury: Glaxo's Paxil caused birth defects

The jury has spoken, and it's not good news for GlaxoSmithKline. In the first trial [1] of claims that the antidepressant Paxil caused birth defects, a Pennsylvania jury awarded $2.5 million to the plaintiffs. And in doing so, the jurors found that Glaxo didn't adequately warn doctors and Paxil patients about the risks of use during pregnancy.

Some 600 other cases are working their way through various courts, so lawyers for both sides were closely watching this first trial, over 3-year-old Lyam Kilker's congenital heart defects. Other plaintiffs' lawyers may craft their cases along the same lines, hoping for similar success.

Glaxo says it disagrees with the verdict and plans to appeal. The company's attorney believes the jury didn't pay enough attention to a September 2005 addition to Paxil's package insert, which mentioned an increased risk of birth defects when mothers took Paxil during their first trimesters. "Clearly the jury thought the information was suppressed," Panmure Gordon told Sharecast. Meanwhile, Glaxo said in a statement that it sympathizes with the Kilker family, but "the scientific evidence does not establish that exposure to Paxil during pregnancy caused his condition." 

The lack of scientific evidence, it appears, is one reason why the jury ruled against the company. Sean Tracey, lawyer for the Kilker family, told The American Lawyer that he had asked jurors why they decided as they did. "They said the fact that GSK never adequately studied their own drug was a big deal," Tracey said. "The animal testing they did showed that they had a potential problem, and they didn't follow up with adequate studies on animals of humans." Stay tuned; there are more trials to come.

- read the Glaxo statement [2]
- check out the story [3] from Bloomberg
- get the news [4] from American Lawyer
- see Sharecast's take [5]

Related Articles:
Test Paxil case hits court [1]
Glaxo promises a public airing of all trial data [6]
Judge reverses Paxil preemption ruling [7]
U.S. Paxil probe broadens [8]
Grassley asks FDA for Paxil review [9]