Pfizer Not Liable for Birth Injuries Caused by Generic Zoloft, Judge Rules

Pfizer, the manufacturer of Zoloft, cannot be held liable for birth injuries allegedly caused by a generic version of the drug, a New York state judge ruled. New York County Supreme Court Judge Carol E. Huff issued the ruling, saying that a company does not have a duty regarding products and labels over which it has no control, even if they are based on the company’s own products.

The initial complaint was filed by a woman who claimed that her daughter was born with severe heart defects after she was prescribed sertraline, a generic version of Zoloft. The drug is a selective serotonin reuptake inhibitor, or SSRI, prescribed as a treatment for depression.

The case against Pfizer was based on the fact that federal law requires generic drugs to carry the same warning label as the medication on which they are based. The lawsuit alleged that Pfizer issued an inadequate warning label on the original Zoloft, resulting in an inadequate warning label on the generic equivalent.

Judge Huff said that New York courts have not addressed the issue of whether drug makers have a responsibility to ensure adequate labeling on generic versions of their products. She said that Pfizer had no role in providing the plaintiff with sertraline. The judge said that the sertraline was supplied by a third party, and that another third party, the federal government, created the labeling requirement.

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