June 5, 2014 — A couple from North Carolina have filed a lawsuit claiming that the antidepressant drug Effexor (venlafaxine) caused their infant son’s birth defect.
According to the Pennsylvania Record, plaintiffs Amy Cornett and Luke Dean accuse Wyeth Pharmaceuticals and its parent company, Pfizer, of failing to disclose risk information linking Effexor and birth defects. They are seeking compensation for the child’s medical expenses and other damages, including punitive damages.
The infant was born with a number of serious birth defects, including Complex Total Anomalous Venous Return, Ventricular Septal Defect (VSD), Atrial Septal Defect (ASD),Optic Nerve Atrophy, and more. He has required surgery and ongoing treatment.
According to the complaint (PDF):
“Despite having extensive knowledge of the extreme risks associated with Effexor, as well as the absolute duty to properly and adequately warn foreseeable users, the Manufacturing Defendants never approached the FDA to alter the label for Effexor so that it properly and adequately warned of the risks of birth defects associated with the drug.”
The lawsuit was filed in the U.S. District Court for the Eastern District of Pennsylvania, where at least 59 other lawsuits blaming birth defects on Effexor have been centralized. The Multi-District Litigation (MDL No. 2458) was established in August 2013.
Just a few months before the MDL was created, a study found that Effexor could significantly increase the risk of several birth defects, including anencephaly, atrial septal defect, coarctation of the aorta, cleft palate, and gastroschisis.
Next week, the parties involved in the MDL are scheduled to meet with Judge Cynthia M. Rufe on June 10 to discuss the current status of the litigation, including discovery and the expected number of cases. Pfizer turned over about 1.8 million pages of documents before the MDL was established and has continued to produce documents.