Paxil Birth Defects Class Action in Canada


. By Jane Mundy

A Canadian woman’s Paxil birth defects case against the pharmaceutical giant GlaxoSmithKline (GSK) has been certified as a class action in early December. “We have been contacted by at least 20 potential class members across Canada since the case was certified,” says Paxil attorney David Klein.

The plaintiff in the Paxil birth defects case, Faith Gibson, took Paxil throughout her pregnancy. She was told by her doctor that “It's the only drug approved to take for anxiety while you're pregnant," according to The Province newspaper (March 2008).

Gibson’s class action alleges that Paxil caused her daughter to be born with a hole between the ventricular chambers of her heart. In an affidavit, Gibson said that, had she known of Paxil’s potential risk to her child, she would have taken another antidepressant or none at all.

“My client, Meah Bartrum [Gibson’s daughter], has a septal defect which is essentially a hole in her heart and she will require ongoing specialized treatment and care,” says attorney David Klein of Klein Lyons, Vancouver.

Just two weeks after Meah was born on September 14, 2005, the drug company published information suggesting an association between Paxil taken during pregnancy and cardiovascular defects in newborns. Gibson’s lawsuit argues that GSK "knew or ought to have known . . . that there was a significant risk of serious adverse cardiovascular complication for newborns from pregnant mothers ingesting Paxil" and that the hole in Meah's heart was caused or contributed to by the use of Paxil. Furthermore, GSK failed to provide adequate and timely warning to doctors and the public.

“The evidence we have seen indicates that GSK knew about Paxil problems since the day it was sold in Canada??"back in 1993-- but they failed to issue adequate warnings until 2005,” says Klein. (Health Canada in September 2005 issued warnings that paroxetine (Paxil) causes malformations to the fetus.)

Klein says this is the only such class action that he is aware of in North America. “The BC case was put on hold pending the outcome of a class action that had been filed in Saskatchewan,” he explains. "The Saskatchewan plaintiff decided not to proceed, so the BC suit ramped up and proceeded to certification.”

“Although the class action awards in Canada are not as high as those in the US and we rarely receive punitive damages, proceeding through a class action makes more sense for our client going forward than an individual lawsuit,” Klein explains. “And it is unlikely that an attorney in Canada would take her case.”

The next step is a “common issues trial” in which a judge decides for the entire class certain common issues, such as “Did Paxil increase likelihood of birth defects?” and “Did GlaxoSmithKline fail to adequately warn Health Canada of the risks?”

GlaxoSmithKline has 30 days to appeal the decision.


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