An Ohio couple has sued pharmaceutical manufacturer Pfizer, alleging that the antidepressant Zoloft, a drug made by the company, caused their son to die from a birth defect. The boy was born with anencephaly, a condition in which an individual lacks a large portion of his or her brain, causing him to die 18 hours after his birth.
In additition to causing the wrongful death of the couple's newborn son, the lawsuit also accuses Pfizer of covering up evidence that proved Zoloft could lead to the condition her son was born with. The mother took the medication during her pregnancy to cope with depression. She claims that Pfizer knew that use of the drug could cause the birth defect, but concealed the results from the public in order to continue selling the medication. The lawsuit claims that Zoloft crosses the placenta after use, and argues that Pfizer knew this and should have informed patients to stop taking the drug while pregnant.
The lawsuit contends that even if no research has linked Zoloft to anencephaly, FDA regulations require pharmaceutical companies to issue a warning if there is reason to believe that a product could pose a serious risk. In failing to provide sufficient notice of a possible serious side effect, the couple argues, Pfizer breached its duty to its customers. Additionally, FDA regulations do not require pharmaceutical manufacturers to obtain official approval before issuing a tentative warning regarding potential risks or side effects.
The couple is seeking unspecified damages for the wrongful death of their child in addition to negligence, breach of warrant, fraud, product liability, false advertising and unjust enrichment.
Source: Opposing Views, "Did Pfizer Cover-Up Evidence of Birth Defects with Zoloft?," Oct. 4, 2011