GlaxoSmithKline (GSK), the manufacturer of Zofran, has agreed to a $3 billion settlement to the Justice Department for marketing Zofran to pregnant women.
Need a Texas Zofran Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one took Zofran during pregnancy and had a baby with a birth defect, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
$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
- Decreased quality of life
- Lost income
- And more
Need a Zofran Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Zofran lawyers for a free lawsuit review.