A British Columbia Supreme Court judge has ruled that a woman whose daughter was born with birth defects associated with taking a prescribed antidepressant during pregnancy can proceed with a class-action lawsuit against the drug's manufacturer.
The plaintiff, Faith Gibson, filed charges against GlaxoSmithKline (GSK), maker of the antidepressant Paxil (paroxetine), after her daughter, Meah Bartram, was born with a hole in her heart. At least a dozen other mothers have joined the suit so far. In the United States, GSK has paid out more than $1 billion to resolve more than 800 similar cases.
Paxil Use May Put Babies at Risk
Paxil is part of a class of drugs known as selective serotonin reuptake inhibitors (SSRIs), which affect brain chemistry to treat depression. Other SSRIs, like Zoloft and Prozac, have been associated with similar birth defects.
Gibson's daughter is just one of the many children who suffered birth defects after their mothers took Paxil during pregnancy. In Canada, around 6 million women of childbearing age filled prescriptions of Paxil from 1993 to 2009, according to a report in The Huffington Post of British Columbia.
"We estimate there are more than 200 children across Canada who were born with cardiovascular defects because their mothers were on Paxil during pregnancy," David Klein, one of Gibson's lawyers, told the Canadian Press.
Meah was born in September 2005, two weeks before GSK sent letters to doctors warning that taking Paxil during pregnancy could increase the risk of cardiovascular birth defects.
It wasn't until the winter of 2006 that the company updated the product label to include thorough labeling of all possible risks. Yet Klein claims GSK knew of birth defect reports from smaller case studies, making them aware of the dangers before they updated the label.
"It's been known for decades," Klein said. "The warnings could have and should have been much stronger."
Michelle Smolenaars Hunter, spokeswoman for GSK, defended the company, claiming that it appropriately updated pregnancy information once it was available, according to an email cited in the Edmonton Journal.
"The company properly shared documentation and submitted results from studies on Paxil to regulators," Smolenaars said, "and communicated important safety information to regulatory agencies, the scientific community and health-care professionals."
Klein maintains that "the information from GlaxoSmithKline was totally inadequate with respect to using the drug while pregnant."
Settlements in U. S. Paxil Cases
According to a 2010 report by Bloomberg News, GSK has paid out more than $1 billion to settle 800 Paxil birth defect cases in the United States -- an average of $1.25 million each. And more cases continue to be filed.
Some of the injuries encountered in newborns of mothers taking Paxil include atrial and ventricular septal defects (holes in the heart), persistent pulmonary hypertension of the newborn, abdominal defects and respiratory distress. In 2005, the U.S. Food and Drug Administration changed Paxil from a Class C drug to a Class D drug, which indicates that studies have demonstrated risk to the human fetus when taken during pregnancy.
Gibson's case is not expected to go to trial for a couple years, and when it was originally filed in February 2012, Meah was still suffering from her injuries with little hope of a full recovery.