When we have an ailment, we often turn to prescription medication to alleviate or cure our symptoms. Unfortunately, those prescription medications can sometimes cause other symptoms, ailments, and issues.
One of the most common complaints about early pregnancy is morning sickness. According to the American Pregnancy Association, more than half of pregnant women experience morning sickness – nausea and vomiting caused by an increase in the body’s hormones – during the first trimester of a pregnancy.
To quell the symptoms of morning sickness, doctors started prescribing Zofran or ondansetron, which quickly became number the one treatment for morning sickness here in the United States.
The problem with this, however, is that Zofran was never approved by the Food and Drug Administration (FDA) for these purposes. As a result, numerous pregnant women who used Zofran claim that their children have suffered birth defects. They are now suing GlaxoSmithKline, the drug’s manufacturer, for marketing the drug to pregnant women without FDA approval and failing to warn them about potential risks.
How Did Zofran Become the Go-To Drug for Morning Sickness?
In 1956, the FDA approved the use of Bendectin for nausea and vomiting during pregnancy. The drug then became the leading treatment for morning sickness in the United States and other countries of the world.
In the late 1970s, Bendectin saw its first claim of causing birth defects. Numerous studies and reviews were conducted to determine if there was an association between Bendectin and birth defects. The FDA along with the many legal cases were unable to determine that link. But Merrell Dow Pharmaceuticals decided to stop manufacturing the drug in 1983, due to their rising legal and liability insurance costs.
Eight years later, GlaxoSmithKline came out with Zofran. Zofran is an anti-nausea drug developed to help symptoms of nausea and vomiting in cancer patients who have undergone radiation, chemotherapy, and surgery. When doctors saw how well it worked, they started prescribing it as an off-label medication to their pregnant patients.
Doctors are allowed to prescribe off-label drugs to their patients, but pharmaceutical companies are only allowed to market their products for approved uses. For this reason, in 1999, the FDA issued GlaxoSmithKline a warning letter ordering them to stop distributing its marketing material because it didn’t include Zofran’s risks.
What Type of Birth Defects Does Zofran Cause?
Since morning sickness typically occurs during the first trimester of pregnancy, when women take the drug, they are taking it during one of the most critical development periods for a baby.
Mothers who used Zofran during pregnancy allege that their babies suffered birth defects including:
- Congenital heart defects, including septal defects or holes in the heart
- Cleft palates
- Cleft lips
- Malformed kidneys
- Craniosynostosis or skull deformities
Zofran and Lawsuits
GlaxoSmithKline is currently the subject of over 500 federal court actions.
A Minnesota mother filed the first Zofran lawsuit in February 2015. The mother took Zofran during her pregnancy and claims her two daughters were born with congenital heart defects. After this lawsuit was filed, multiple other lawsuits popped up across the country in New Jersey, Texas, Alabama, Ohio, Montana, Louisiana, Arkansas, and Massachusetts.
Twelve of these lawsuits were transferred to the District of Massachusetts as a multidistrict litigation – case MDL 2657 – in October 2015. Specific claims in the lawsuit allege that GlaxoSmithKline:
- Failed to determine Zofran’s safety risks before promoting the drug
- Failed to provide appropriate warning of Zofran’s side effects
- Marketed Zofran as a morning sickness drug even though the FDA hadn’t approved it for that purpose
- Misrepresented animal studies designating Zofran was safe when it actually showed toxicity and abnormal bone growth
- Manufactured a defective drug
- Fraudulently and falsely claimed Zofran was safe for pregnant women
As of March 2017, no trial date has been scheduled for MDL 2657 and GlaxoSmithKline has not offered any settlements.
Despite the abundant claims of birth defects and the multitude of pending lawsuits, monthly prescriptions for Zofran continue to increase. In 2008, there were around 50,000 monthly prescriptions. In 2013, there were 110,000.
Every year, there are about four million pregnancies here in the United States. Nearly a quarter of those pregnant women and their unborn babies are exposed to Zofran.
If you were prescribed Zofran for morning sickness during your pregnancy and your child suffered birth defects, reach out to an experienced New York pharmaceutical liability attorney today. A qualified attorney will be able to help you seek the justice and compensation you deserve for your injuries.