In a recent ruling handed down by the Supreme Court of British Columbia, the makers of Paxil, GlaxoSmithKline, will not be getting the medical records of the mother who is suing the drug maker after she claims that taking Paxil during pregnancy caused her daughter to be born with a heart defect.
Faith Gibson of Surrey filed her lawsuit against Glaxo in British Columbia three years ago. In it, she claims that Glaxo didn’t properly warn her of the birth defects risks involved when taking Paxil during pregnancy. Because of this her daughter, born six years ago, was born with a hole in her heart that needed surgery and a seven-month stay in the hospital. It wasn’t until three months after the girl was born that the FDA issued a warning on Paxil labels that included the increased risk of cardiovascular defects in newborns.
Gibson is also saying that Glaxo should have known that the drug could cause birth defects as early as June 2003. There are also claims that Glaxo didn’t make the birth defects concerns available for the public and because of that Gibson says that neither she, nor her doctor, knew the birth defects risks when she was prescribed Paxil during her pregnancy. She believes that Paxil should have been recalled once this information was known.
The goal of the lawsuit is to find out how much data Glaxo had on Paxil’s effects before Gibson’s daughter was born. She is hoping to have her lawsuit accepted as a class action, but the court hasn’t heard it yet. The class-action certification application is hoping that Gibson will be the representative plaintiff. The goal is to define the class as “any person in Canada, born with cardiovascular defects, to women who ingested Paxil while pregnant, and the mothers of those persons.”
It was when Glaxo applied in court to have copies of Gibson and her daughter’s medical records as well as their pharmaceutical records that the judge decided not to allow it. Glaxo was hoping to get the records from as far back as two years before Gibson’s daughter was born. In its argument, Glaxo said that “their experts require these records in order to fully respond to the issues on the certification application.” It’s nice to see that there is a ruling that benefits the plaintiffs before the drug companies.