A proposed settlement has been reached in a lawsuit filed by a woman who alleges her daughter suffered a birth defect after she was prescribed the anti-depressant Paxil during pregnancy.
Rosenberg Law, a Vancouver firm that filed the class-action lawsuit involving about 50 mothers and their children, says it has reached a $6.2-million settlement with GlaxoSmithKline Inc.
In a statement on Wednesday, the pharmaceutical company says it has agreed in principle to settle the lawsuit but it does not admit to any liability or wrongdoing as part of the agreement, which must still be approved by the Supreme Court of British Columbia.
Faith Gibson of B.C. was named as the representative plaintiff in the suit after her daughter Meah Bartram was born with a hole in her heart in 2005.
Ms. Gibson's initial statement of claim filed in B.C. Supreme Court in 2012 alleged that Paxil increased the risks of damage to the heart and lungs of newborns, who it contends were unable to breath properly due to constricted blood vessels.
GlaxoSmithKline says patient safety is its "highest concern" and it continues to believe that it provided accurate and updated information on Paxil to regulators, and also communicated safety information to regulatory agencies, the scientific community and health-care professionals.
The company says it agreed to the proposed settlement "to avoid the time and expense associated with the trial and the subsequent steps in the class-action proceeding."
"We continue to be of the view that the scientific evidence does not establish that exposure to Paxil during pregnancy causes cardiovascular birth defects."
Rosenberg Law says as many as 200 children in Canada could benefit from the settlement.
In a decision released in 2013 upholding the class-action lawsuit, the B.C. Court of Appeal said the company sent a letter to health professionals in September, 2005, that referred to preliminary results about a study that showed an increased incidence of cardiovascular defects in babies born to women who took Paxil during the first trimester of pregnancy.
Ms. Gibson's daughter was born about two weeks before the company sent the letter to doctors.
In February, 2006, the company amended the product label to outline the potential problems that might arise.
The plaintiffs alleged in court that the company knew or ought to have known of the risk before then.