Zofran Lawsuit Settlement Birth Defects

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Plaintiffs from all over the nation filling lawsuit against Zofran allege that GlaxoSmithKline’s failure to adequately warn about the potential Zofran side effects on unborn babies. As of now more than 280 Zofran lawsuits are pending in the U.S. District Court; District of Massachusetts alleging Zofran medication during Pregnancy to treat morning sickness can lead to newborns having cleft palate, cardiac malformations and kidney malfunctions. The lawsuits are being consolidated in the U.S. District Court of Massachusetts. Mothers are accusing GlaxoSmithKline of marketing Zofran to obstetricians and gynecologists as a morning sickness treatment – despite proper scientific evidence that the nausea drug may cause child birth defects.

A recent Zofran lawsuit was filed on behalf of a mother from Utah who gave birth to a girl child suffered from hip birth defect. She claims that GlaxoSmithKline’s anti-nausea drug caused her child to develop bilateral hip dysplasia, is an abnormal formation of the hip socket can eventually cause crippling lameness and painful arthritis of the joints. There are several U.S families who are suffering from the severe Birth defect cause by Zofran. In 2012, the U.S. Justice Department announced that GlaxoSmithKline had crossed the line. It is illegal for physician to prescribe an off label medication for unapproved uses.

Zofran Birth Defects

Zofran is the brand name for the generic medication, ondansetron hydrochloride. Zofran was approved in 1991 by the U.S. Food and Drug Administration to treat nausea and vomiting in chemotherapy, radiation and surgery patients. The medication has never been approved for the treatment of morning sickness in pregnant women. The drug has been prescribed to pregnant women suffering from morning sickness by the physicians without FDA approval, which is considered as “off-label. It is available as an oral tablet, oral solution, and oral disintegrating tablet and as an injection for intravenous use.

Zofran has been given an FDA rating of “Pregnancy Category B.”. Pregnancy Category B indicates that the medication has not been proven safe for uses in pregnancy but many women have been prescribed Zofran for morning sickness. As per a register based nationwide cohort study, Ondansetron medications have adverse effects on the fetus during early pregnancy which causes “Congenital Malformations”. The possible birth defects caused by Zofran may include:

  • Cleft Palate
  • Kidney malformation
  • Congenital heart defects
  • Facial Dysmorphia
  • Skeletal defects
  • Stillbirth
  • Hearing Loss
  • Fetal growth restriction
  • Webbed Toes
  • Inguinal Hernia

Zofran Lawsuits Settlement Factors

In 2012, GlaxoSmithKline has been fined $3bn in criminal and civil penalties to settle Department of Justice allegations that the company had promoted Zofran for off-label use in pregnant women and had bribed physicians and encouraging the prescription of unsuitable antidepressants to children. It also alleged that GlaxoSmithKline was paying kickbacks to doctors who prescribed Zofran. The lawsuit will consider numerous factors for settlement. Despite the fact that all the lawsuits associates with similar allegations, each case is different. The compensation amount awarded will be based on what the jury settles. However, the following are key factors that will possibly be considered:

  • The birth defect from Zofran has reaction on the overall physical and mental health of the child.
  • The medical costs or treatment required because of the injury.
  • Zofran birth defect or injury extent and duration.
  • Any mental and physical pain will likely be suffered by child cause by Zofran medication.
  • The plaintiff’s future health, potential for employment or success, and quality of life affected by any Long-term injuries or defects associated with Zofran

Potential Allegations against the Manufacturers

  • Plaintiffs alleges that manufacturer failed to determine safety risks before selling Zofran and did not have safety concern before offering the drug to the public .
  • The drug was not approved by FDA to treat morning sickness and hyperemesis gravidarum but the manufacturer (GlaxoSmithKline) published advertisements for its use in pregnancy.
  • The actual reports of the animal studies showed abnormal bone growth and signs of toxicity but the manufacturer withheld it and misrepresented the result of the study.
  • Plaintiff claims that manufacturer failed to properly figure out all data and safety information on Zofran for use in pregnant women.
  • According to several lawsuits manufacturer produced a defective drug and failed to warn the public about dangerous side effects of Zofran.
  • The manufacturer withheld mounting evidence of the drug’s potential to harm developing babies from doctors, patients and the general public.

Plaintiffs are claiming that GlaxoSmithKline was aware of the life threatening danger that Zofran could pose to a developing fetus and to a new born but they were flop to warn physicians and patients about the risks associated with the drug. The manufacturers placed their desire for profits before consumer safety. If you or someone you love has been injured by using Zofran medication, contact the Zofran lawsuit lawyers at to schedule a free initial consultation.

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