June 5, 2014 — Wyeth Pharmaceuticals and its parent company, Pfizer, have been hit with a lawsuit from a North Carolina couple who say their son’s birth defects were caused by Effexor (venlafaxine).
The boy’s mother, Amy Cornett, says she used Effexor during pregnancy but was unaware of the risk of birth defects. Her child was born with severe heart defects and other malformations, including Complex Total Anomalous Venous Return, Ventricular Septal Defect (VSD), Atrial Septal Defect (ASD), and Optic Nerve Atrophy. Treatment for these life-threatening conditions involves surgery and lifelong medical care.
Cornett is seeking compensation for his medical expenses and other damages, including punitive damages against Wyeth and Pfizer for failing to warn about the pregnancy risks of Effexor. According to her 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 case was transferred into federal court in the Eastern District of Pennsylvania, where approximately 58 Effexor lawsuits have been centralized in a Multi-District Litigation (MDL No. 2458). There are hundreds of similar lawsuits involving Zoloft pending in the same federal court. Plaintiffs accuse drug-makers of downplaying risk information linking antidepressants and Zoloft.
Pfizer has already provided 1.8 million pages of documents and they are still producing documents. On June 10, parties will meet with Judge Cynthia M. Rufe to discuss the current status of discovery, the expected number of cases, and other matters related to the litigation.
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