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In a new Zofran lawsuit, filed on October 3, 2016, a mother from Oneida, New York claims the drug’s active ingredient caused her son to develop cleft palate and cleft lip in the womb. The woman’s case, logged as number 1:16-cv-11980-FDS, was filed directly in the US District Court of Massachusetts, where over 280 additional Zofran lawsuits are now consolidated.

Zofran Lawsuits Filed Over Cleft Palate

Dozens of Zofran lawsuits have been filed over the drug’s potential link to cleft palate. In 2012, researchers at Harvard and Boston University found that women prescribed Zofran during pregnancy were more than twice as likely to deliver children with the condition. The drug’s warning label, however, bears no mention of a possible increased risk for cleft palate.

In this latest complaint, the mother says that she was prescribed a generic version of Zofran throughout her first and second trimesters. Her child, named as P.B. in court documents, was born with “a cleft hard palate [and] unilateral right cleft lip,” court records report. P.B. is now four years old.

She is demanding a total of $10 million in compensation, saying that she and her son have suffered “severe and permanent pain and suffering, mental anguish [and] medical expenses.”

Zofran And Pregnancy: Is The Drug Safe?

Zofran has become a popular choice among obstetricians, who turn to the drug’s potent anti-nausea effects to treat morning sickness. That may come as a surprise, since Zofran’s active ingredient has never been approved for use during pregnancy.

However, allegations leveled by the US Department of Justice suggest that GlaxoSmithKline may have promoted Zofran as an “off-label” morning sickness treatment – in violation of federal law. In more than 280 lawsuits, families from across the country have renewed this allegation, accusing GlaxoSmithKline of marketing a drug, one with links to birth defects, directly to obstetricians and gynecologists.


  1. Gravatar for Nicole Richardson-bessadok
    Nicole Richardson-bessadok

    I was prescribed zofran for anti nausea in my first trimester cvs pharmacy filled my prescription with generic zofran made by Mylan .my third kid a boy is born on August 2015 with cleft lip and palate he is one and missing teeth in top jaw.i live in west palm beach Florida

    1. Gravatar for Michael Monheit
      Michael Monheit

      Nicole, I am so sorry to hear what you and your son have been through. Unfortunately, we are not proceeding on matters involving generic ondansetron, except in the states of CA, VT, and IL, where we can sue the name brand manufacturer. There is a US Supreme Court ruling that we believe prevents us from successfully prosecuting cases against generic manufacturers.

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