The U.S. Food and Drug Administration (FDA) approved Zofran to help alleviate nausea for cancer patients after chemotherapy or surgery. Shortly thereafter, the pharmaceutical company GlaxoSmithKline (GSK), responsible for Zofran, began marketing the drug for an illegal “off-market” use. They promoted the drug for pregnant women suffering from morning sickness despite having knowledge of potential dangers and despite the fact that the FDA had never approved this use for Zofran. Approximately one million women a year took Zofran for morning sickness, never suspecting the drug could cause significant harm to their unborn children.
The attorneys at Wagner Reese, LLP are currently working on behalf of families whose babies were born with Zofran-related birth defects, such as cleft palate. If you or anyone you know took this drug for morning sickness while pregnant and gave birth to a child with a cleft palate, heart defect, or any of the below birth defects, you may have a Zofran lawsuit case against GlaxoSmithKline.
Who Is GlaxoSmithKline?
GSK is a very large British pharmaceutical company with some even bigger challenges. The drug company, the sixth largest in the world as of 2015, has annual profits of over 20 billion pounds ($28,662,000,000 USD). In 2012, GSK paid a three billion dollar settlement after pleading guilty to federal charges of fraud and illegal marketing of several drugs, including Zofran. In February 2016, GSK was fined more than 37 billion pounds ($53,024,700,000 USD) in a UK antitrust suit in which the drug company was found to have prevented competition for generic drugs.
What Is Zofran?
Zofran was developed in 1991 and in known in generic form as ondansetron. As mentioned previously, it was approved for use in preventing nausea in chemotherapy patients. Despite not having approval for use in pregnant women, GSK heavily marketed Zofran to women experiencing morning sickness in their first trimester. It is available in oral and injectable form.
What Are the Claims Against GSK?
Documentation from court proceedings shows that the company knew in the early 1990s that the drug passes through the human placenta to a fetus. This makes clear they knew there was an “unreasonable risk of harm” to fetal development.
The claims currently being made include the following:
- GSK fraudulently stated to patients that Zofran was safe for pregnant women.
- GSK did not properly evaluate data and safety information on Zofran.
- GSK produced a defective product.
- GSK misrepresented animal studies that showed abnormal results.
- GSK advertised the drug as a safe treatment for pregnant women.
- GSK did not provide an appropriate warning to the public about the seriousness of its potential side effects.
What Birth Defects Can Be Caused by Zofran?
The below is not an exhaustive list, but includes some of the most commonly reported or studied defects that are likely to be tied to use of Zofran during pregnancy:
- Heart defects: Zofran has been linked to defects and structural abnormalities of the heart, such as atrial septal defect, ventricular septal defect, hole in the heart, and heart murmurs.
- Facial and oral malformations: These types of defects, including cleft lip and cleft palate, occur very early in a pregnancy and are one of the most common defects tied to Zofran use. The Center for Birth Defects Research and Prevention published research indicating that mothers who took Zofran during the first trimester were twice as likely to have a baby with a cleft palate.
- Congenital kidney and bladder defects: Another serious group of potential side-effects includes defects in the kidneys. Zofran is believed to cause structural defects but can also cause hydronephrosis.
- Gastrointestinal defects: FDA data shows dozens of references to gastrointestinal defects such as gastroschisis, anal atresia, and intestinal obstruction.
- Congenital respiratory defects: The most common respiratory defects linked to Zofran include neonatal respiratory distress syndrome and neonatal apnea.
- Limb defects: There have been nearly two dozen reports of congenital limb defects, including cases of “talipes” or clubfoot.
File Your Claim Now
Drug lawsuits are extremely complex and slow-moving. At this time, there have not been large settlements in Zofran lawsuits, as lawyers collaborate in the sharing of information and resources. If you believe your child was affected by Zofran, it is critical to file a claim as soon as possible. The statute of limitations depends upon when you first knew of the injuries related to the drug, as well as the state in which you live. This is not as simple as it sounds, but an experienced attorney, such as those at Wagner Reese, can help. If your claim against GSK is not filed within the statute of limitations, you will lose your right to compensation for your baby’s injuries.
Wagner Reese offers a free consultation about your case, and even better, we do not take payment unless there is a verdict or settlement in your favor. Going to court against a billion-dollar pharmaceutical company can be daunting, and it is a grueling process; however, with the help of our experienced Indianapolis product liability attorneys, you can fight against the drugmaker who knowingly put you and your baby at risk, and you can win. Though nothing can undo the damage that has been done, you can still gain the compensation you need to help your child live as close to a normal life as possible.
Call us now for your free consultation at (888) 204-8440.