In 2012 GlaxoSmithKline (GSK) settled claims brought forth by the United States Government, where the pharmaceutical company paid a record breaking $3 billion fine. This fine settled claims over GSK promoting “off label” drugs and giving kick backs to medical professionals who would prescribe their drugs. Part of this settlement included the marketing of the drug Zofran to pregnant women experiencing severe morning sickness, as well accusations of paying physicians to prescribe Zofran for morning sickness.
Food & Drug Administration Approval Of Zofran
The drug Zofran was approved in 1991 by the Food and Drug Administration (FDA). Approval of the drug was to medicate patients experiencing symptoms of nausea and vomiting induced by chemotherapy, radiation therapy, and surgical procedures. Here are the exact uses Zofran was originally approved for:
- Preventing nausea and vomiting brought on by highly emetogenic cancer chemotherapy.
- Prevention of nausea and vomiting related to initial and repeat courses of moderately emetogenic cancer chemotherapy.
- Preventing nausea and vomiting associated with radiotherapy in patients getting total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
- Prevention of postoperative nausea or vomiting.
The FDA never approved Zofran for use in alleviating morning sickness in pregnant women. The FDA found out that GSK were marketing Zofran to doctors for pregnant women experiencing severe morning sickness, and directed the company to issue label warnings of the risks associated with taking Zofran while pregnant. The FDA further directed the company to stop all marketing related to Zofran for morning sickness. Consequently, epidemiology studies have been undertaken in several countries including the United States that have linked the drug usage in the first trimester of pregnancy to birth defects like cleft palate and congenital heart defects. Find out more about the studies here.
Maryland: Inborn Birth Deformities
The Maryland Health Department states that birth defects are estimated to affect more than 120,000 children in the U.S. every year. According to the CDC that’s one in every 33 children born with birth defects. Birth deformities can be the result of genetic disorders, even medical misconduct.
Maryland’s 2014 census data estimates 5,976,407 people in the state. The five biggest cities in Maryland are:
- Baltimore- 622,104 population
- Columbia- 105,000 population
- Germantown- 86,395 population
- Silver Spring- 71,452 population
- Waldorf- 67,752 population
Since its market emergence in 1991, Zofran rapidly gained popularity with a 99% market gain by 2005.The Zofran litigation team has put together data about the likelihood of a baby being born with deformities due to Zofran, by utilizing data from the epidemiological studies, state population figures, and cleft lip/palate and congenital heart defects ratios. It’s possible that 3,300 births since 1991 were affected by the consumption of Zofran- thereby leading to heart defect or cleft palate in Maryland.
Predicted Cleft Defects & CHD In Maryland & Its Populous Cities
From the reported figure of 3,000 possible child birth deformities, we have further calculated that 560 resulted in a cleft abnormality and 2,740 are a form of a congenital heart defect. Using the five largest city population data of Maryland, we believe the defects were as follows:
- Baltimore- total possible birth defects were 340, with 60 being cleft palate, and 280 resulting in chd
- Columbia- total possible birth defects were 100, with 10 being cleft palate, and 90 resulting in chd
- Germantown- total possible birth defects were 90, with 8 being cleft palate, and 82 resulting in chd
- Silver Spring- total possible birth defects were 85, with 5 being cleft palate, and 80 resulting in chd
Reported Secondary Effects Of Taking Zofran When Pregnant
Lawsuits that have already started being filed cite that Zofran, taken during the first trimester for morning sickness as per their physician’s direction, caused their child or children to be born with deformities. Complainants allege that their doctor gave no warnings about the effects of Zofran on their unborn child. Reported adverse effects of Zofran include:
- ASD (atrial septal defect)
- congenital heart defects
- facial dysmorphia
- webbed toes
- VSD (ventricular septal defect)
- low set ears
- kidney malformations
- cleft palate
Can I File A Zofran Lawsuit?
If you have been reading this information and it resonates with you because you or someone you know was administered Zofran for severe morning sickness, and was taken in the first trimester of pregnancy, eventually giving birth to a child with one of the abnormalities stated above, you may have a right to a settlement.
Our Zofran attorneys are here to talk about your individual case at any time. Our consultations are free. For more information about our team click here.
If you are not sure if your child’s defect was related to Zofran you can still call us as we are looking further at various defects and we may be able to help you one way or the other.
Who Are The Maryland Zofran Attorneys?
Maryland Zofran lawsuits are being filed by the Janet, Jenner & Suggs’ legal and medical experts practice in Maryland.Our lawyers are licensed to practice law in the state of Maryland. Contact us here to discuss your case details.
Where Can I Learn More About Birth Defects?
If you are looking for more information about birth defects in Maryland, feel free to look at the list below where you can learn more about child birth defects.