GlaxoSmithKline (GSK), the manufacturer of Zofran, has agreed to a $3 billion settlement to the Justice Department for marketing Zofran to pregnant women.

$3 Billion Zofran Settlement

July 2, 2012 — The U.S. Department of Justice (DOJ) has announced a $3 billion settlement with GSK to resolve a number of civil and criminal allegations, including illegal “off-label” (unapproved) promotion of Zofran.

According to the Office of Public Affairs:

“It further resolves allegations that GSK promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women.”

Doctors are allowed to prescribe drugs for whatever purpose they see fit, but pharmaceutical companies are only allowed to market their drugs for the treatment of diseases that have been approved by the FDA.

What is the problem?

Zofran is not FDA-approved for the treatment of morning sickness in pregnant women. It is intended for the treatment of nausea associated with chemotherapy. Its use during pregnancy has never been evaluated in clinical trials and no one knows if it is safe for a developing baby.

Pregnancy Category B

Zofran is a Pregnancy Category B medication, meaning studies in animals have found no evidence of fetal risk, but this does not rule out the risk of birth defects in humans.

According to the Prescribing Information for Zofran:

“Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.”

Zofran Birth Defect Settlement

The $3 billion settlement did not include payments for birth defects in babies who were exposed to Zofran during pregnancy. However, it adds evidence for women pursuing claims of negligence against GSK for failing to warn about the possible danger to an unborn baby. Women who are seeking settlements may eventually join together in a class action or another consolidated litigation.

If you decide to file a lawsuit, you and your child may be eligible for compensation, including:

  • Pain and suffering
  • Medical expenses
  • Disability
  • Decreased quality of life
  • Lost income
  • And more


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