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Parents Say Zoloft Caused Death of Newborn

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Susan and James Hodge filed a lawsuit against Pfizer and Cardinal Health in Cuyahoga Court of Common Pleas in Ohio, saying that the anti-depressant Zoloft cause their newborn son to die of anencephaly 18 hours after his birth. The lawsuit alleges that Pfizer covered up studies that documented the fatal side effect of the drug.

According to the lawsuit, anencephaly is a fatal neural tube defect, “generally described as the absence of a large part of the brain and skull.” The lawsuit also says that before Susan became pregnant, the drug maker knew or should have known about the risks the drug posed to the unborn fetus. “Prior to the time that the mother plaintiff ingested Zoloft during her pregnancy, Pfizer knew of the dangerous birth defects associated with Zoloft’s use during pregnancy from the preclinical studies and the subsequent published studies confirming these risks. Pfizer took no action to adequately warn or remedy the risks, but instead, concealed, suppressed and failed to disclose the dangers.”

The lawsuit says, “During the entire time Zoloft has been on the market in the United States, FDA regulations have required Pfizer to issue stronger warnings whenever there existed reasonable evidence of an association between a serious risk and Zoloft…The regulations specifically state that a casual link need not have been proven to issue the new warnings. Further, the regulations explicitly allowed Pfizer to issue such a warning without prior FDA approval.

“Thus, prior to the mother plaintiff’s pregnancy, Pfizer had the knowledge, the means, and the duty to provide the medical community and the consuming public with a stronger warning regarding the association between Zoloft and congenital birth defects … through all means necessary, including, but not limited to, labeling, continuing education, symposiums, posters, sales calls to doctors, advertisements, and promotional materials, etc. Pfizer breached this duty,” Courthouse News reported the suit as saying.

The lawsuit seeks punitive damages for negligence, fraud, breach of warranty, product liability, false advertising, unjust enrichment, and wrongful death. disclaimer: This article: Parents Say Zoloft Caused Death of Newborn was posted on Wednesday, October 5th, 2011 at 8:18 pm at and is filed under Defective Drug Lawsuits.

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