VANCOUVER - A British Columbia mother whose daughter was born with a hole in her heart after taking prescribed anti-depressants during pregnancy will lead a class-action lawsuit against a pharmaceutical giant.
A B.C. Supreme Court judge has ruled that representative plaintiff Faith Gibson can proceed with her lawsuit against the maker of Paxil, GlaxoSmithKline Inc., alleging the drug causes birth defects.
"We estimate there are more than 200 children across Canada who were born with cardiovascular defects because their mothers were on Paxil during pregnancy," said David Klein, one of the lawyers representing Gibson.
"The information from GlaxoSmithKline was totally inadequate with respect to using the drug while pregnant."
Gibson's daughter, Meah Bartram, was born just two weeks before the company sent a letter to doctors in September 2005 warning that taking the drug during pregnancy could increase the chances of cardiovascular defects.
The cautionary letter cited early results of a study that found "ventricular septal defects" were possible in women who had taken Paxil during pregnancy. It suggested doctors heed that information when considering using it to treat pregnant women.
From the time the product was made available in Canada in 1993, it bore a generic product label that noted it should not be used during pregnancy "unless the potential benefit to the patient outweighs the possible risk factors."
In winter 2006, the company amended the product label to much more thoroughly outline the potential problems that might arise.
"The plaintiffs allege that GSK knew or ought to have known of the risk before then," says the court ruling released on Dec. 4.
Klein said that prior to the label change, there were reports of birth defects in smaller case studies, as well as in studies on similar products.
"It's been known for decades," he argued. "The warnings could have and should have been much stronger."
The suit must prove the drug caused the defect in the unborn child, which Klein said he doesn't believe will be a difficult feat.
"They wouldn't have changed the warning if there wasn't something there," he argued.
A few dozen individual lawsuits involving the same drug have been successful in the United States, Klein added. However, a similar suit filed in Saskatchewan did not go forward.
GlaxoSmithKline did not return a request for comment.
The plaintiffs want financial compensation for the harm caused to their babies. Klein said the amount will vary from child to child, as the problems that resulted ranged from complications requiring minor surgery to life-long disability.
Gibson's initial statement of claim contends Paxil increases the risks of damage to the heart and lungs of newborns, who are unable to breath properly due to constricted blood vessels. That in turn causes damage to other organs such as brain and kidneys.
At the time of the February filing, Meah had not fully recovered from her injuries and it was not expected that she would make a full recovery.
Klein said about a dozen women have come forward to join the lawsuit so far, and he expects many more now that is has been certified. The suit applies to women who took Paxil in Canada.
Evidence put forward during the application asking for approval of the class action says almost six million Paxil prescriptions were written for women of child-bearing age between 1993 and 2009.
A notice will go out across Canada notifying people of the lawsuit, although a trial isn't expected for a couple years.