Follow him on 
The first of some 600 civil trials to be held alleging that GlaxoSmithKline's anti-depressant causes birth defects was put in the hands of a Philadelphia jury this morning.
Testimony in the state-court trial, which began in September, wrapped up yesterday. Jury deliberations have begun and a verdict is expected sometime in the coming days or week, court watchers said.
The lawsuit involves allegations from Michelle David, who claims drug maker GlaxoSmithKline concealed negative study results linking Paxil to a life-threatening heart malformation in newborns of women who took the drug during pregnancy. The company marketed Paxil for treating pregnant women with anxiety, despite knowing about the apparent connection to birth defects, David contends.
David took Paxil while pregnant with her son, Lyam Kilker, who was born with life-threatening heart defects. The boy is now four and has fully recovered after being hospitalized as a newborn and undergoing multiple surgeries to repair his heart.
The trial is considered a test case for 600 such lawsuits expected to be heard the coming months in Philadelphia, where Glaxo's US headquarters are located. Lawyers for several of those upcoming cases have been in Philadelphia monitoring the David/Kilker case as they prepare their own arguments.
In his closing statement, David's lawyer Sean Tracey said Glaxo intentionally ignored the possibility that Paxil caused birth defects.
Glaxo researchers never followed up on studies showing Paxil posed a birth-defect risk for fear of harming sales, Sean Tracey, lawyer for a family suing over the drug, told jurors yesterday in state court in Philadelphia.
The London-based drugmaker “made a concerted effort” not to study Paxil’s links to birth defects, Tracey said. Glaxo executives sought to “avoid doing studies that would have revealed the truth about their drugs,” he said.
The drug, approved for use in the U.S. in 1992, generated about $942 million (US) in sales last year.
In her closing statement, Glaxo lawyer Chilton Varner urged jurors to “set sympathy aside and decide this case fairly,” adding that arguments that Glaxo “has acted improperly or unethically” in its testing and marketing of Paxil “don’t ring true.”
She said the company isn't liable for Kilker's heart defects.
The company has set aside $2.8 billion to deal with legal and other non-tax disputes.
A second Paxil case, expected to begin next Tuesday, was settled out of court last weekend. The next is not scheduled to begin in mid-November.
This is going to be a difficult one. Run of the mill and these are hard!
Are there other cases? Rat trials? How is this mother going to show cause and effect?
Failing to disclose results or indeed not having tests is not a link. The fact that the tests were deliberately withheld because the company knew there was a link would have to be shown... Ah this is going to be hard!!!
Posted by: kenny | October 12, 2009 at 05:49 PM