Doctors prescribe Zofran (ondansetron) to pregnant women as a treatment for nausea and vomiting during pregnancy. Unfortunately, studies link the medication to birth defects, and families are taking drugmaker GlaxoSmithKline to court, saying it marketed the drug to pregnant women without FDA approval.
The U.S. Food and Drug Administration approved Zofran to help cancer patients with nausea after treatments or after surgery. It helped people who vomited as a side effect from chemotherapy or who grew sick after taking post-op meds to help with pain or other complications.
But drugmaker GlaxoSmithKline soon found other patients to take the drug – pregnant women suffering from morning sickness. There was just one problem. The FDA never approved Zofran for use by pregnant women.
In 2012, Glaxo pleaded guilty to federal charges of fraud and illegal promotion of several drugs, including Zofran, and paid $3 billion as part of the legal settlement. Now the company is going back to court to defend more specific allegations about Zofran (ondansetron).
That Glaxo had a duty to ensure its drug was safe before offering it to the public and failed to determine safety risks before selling it.
That Glaxo failed to warn the public about dangerous side effects.
That Glaxo advertised the drug as a safe treatment for morning sickness and hyperemesis gravidarum even if it was not approved for this use.
That Glaxo misrepresented that animal studies showed the drug was safe, when in actuality the results showed abnormal bone growth and signs of toxicity.
That Glaxo failed to properly evaluate all data and safety information on Zofran for use in pregnant women.
That Glaxo produced a defective drug.
That Glaxo falsely and fraudulently claimed Zofran was safe for pregnant women.
Zofran is not approved for use in pregnant women, and lawsuits accuse GlaxoSmithKline of marketing the drug to expectant mothers as well as paying doctors to prescribe it. The drug brought in millions of dollars for Glaxo, and roughly 1 million women take the medication or its generic counterpart each year.
About 80 percent of women suffer from some form of nausea or vomiting during pregnancy (NVP), commonly referred to as morning sickness. The most severe form of NVP is called hyperemesis gravidarum and can cause malnutrition and endanger the mother and unborn baby.
Several women turned to Zofran to keep them and their babies safe from complications. Instead their babies suffered from severe birth defects that render them forever dependent on their parents for care.
Birth defects mentioned in lawsuits include:
- Heart defects, including septal defects (holes in the heart)
- Cleft lip
- Cleft palate
- Club foot
- Craniosynostosis (skull deformities)
LeClair v. GlaxoSmithKline
Tomisha LeClair of Massachusetts filed one of the first birth defect lawsuits in February 2015. Like many other expectant mothers, LeClair took Zofran to treat severe nausea and vomiting that was interfering with going to work and performing other daily tasks. She never suspected anything was wrong because she was told it was safe.
Unfortunately, her daughter – identified as A.S. in court documents – was born with several congenital defects, including: several heart defects, facial dysmorphia, low set ears, hearing loss, webbed toes, sensitivity to light and an inguinal hernia. A.S. had 10 surgeries in 12 years to try and correct several abnormalities.
LeClair’s lawsuit claims if she had known the risks, she would never have taken Zofran and says Glaxo concealed the truth about the drug. She is claiming compensatory as well as punitive damages and hopes to warn other mothers-to-be about the dangers of the medication.
- LeClair v. GlaxoSmithKline. (2015, February 16). United States District Court of the District of Massachusetts. Complaint and Jury Demand. Case No. 1:15-cv-10429.
- Koren, G. (2014, December). Treating morning sickness in the United States—changes in prescribing are needed. American Journal of Obstetrics & Gynecology. Retrieved from http://www.ajog.org/article/S0002-9378(14)00853-9/fulltext
- Department of Justice). (2012, July 2). GlaxoSmithKline to plead guilty and pay $3 billion to resolve fraud allegations and failure to report safety data. [Press Release]. Retrieved from http://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report