Prescription drugs are usually subject to several rounds of testing and trials before they can be sold to consumers, but all too often we have seen dangerous drugs come to market that have harmful or even deadly side effects. Some prescription drugs even come to be used outside their original scope of approval in areas that they have not been tested for nor approved for usage.
Zofran is one such drug that was originally approved as an anti-nausea drug for use in treating the side effects of chemotherapy, but which came to be used widely among pregnant women struggling with morning sickness. Zofran was manufactured by GlaxoSmithKline (GSK) and first entered the market in 1991. It was only in the last decade or so that Zofran became a popular “off-label” treatment for morning sickness, and by 2013 the drug was being used by an estimated one million pregnant women per year. This widespread adoption may also be partly due to the fact that there was no FDA approved drug for the treatment of morning sickness for more than 30 years, so Zofran became the go-to option.
Zofran works by blocking serotonin, a natural substance in the body which causes vomiting, however, serotonin has many other roles in the human body, particularly during pregnancy where it serves in the development of the fetal heart and organs. Women who took Zofran while pregnant have reported a number of medical complications upon the birth of their babies, including a wide range of birth defects.
Studies have found that the drug Zofran passes from the mother to the fetus through the placenta, and that it does so both rapidly and in significant amounts. More troubling is that the active compounds remain in the fetus much longer than they do in the mother. While one study published in the New England Journal of Medicine in 2013 found that were no associated risks between Zofran and birth defects, numerous subsequent studies have disputed those results.
In 2013, researchers in Denmark found that Zofran was associated with a doubled risk of heart defects and was associated with a 30% overall increased risk of birth defects. Of the more than 1,200 women who were part of the study, some 4.7% experienced birth defects, compared to 3.5% of women who did not use the drug. In the same year, Australian researchers found a 20% increased risk of birth defects associated with the use of Zofran.
Alarming statistics and research continued to mount in subsequent years, such as the 2014 study in Sweden which found that Zofran doubled the risk of so-called “hole in the heart defects” (septal defects) and increased the risk of heart defects by more than 60%. This study was based on data collected from more than 1,300 infants whose mothers took the drug early in their pregnancy. By the middle of 2015, the Food and Drug Administration had received 475 reports of birth defects related to the use of Zofran.
The range of reported birth defects include mental deficiencies, cleft lip or palate, heart problems, club foot, kidney malformation, skull deformities, hearing loss, and more.
In 2003, two former employees of GlaxoSmithKline stepped forward to claim that the company was actively promoting Zofran for off-label use to treat morning sickness. Ultimately, the Justice Department took the manufacturer to court and GlaxoSmithKline agreed to settle the case for $3 billion, which is the largest settlement for health care fraud in U.S. history.
In early 2015, the first private lawsuit emerged when a Minnesota mother filed a lawsuit on behalf of her two daughters that were born with congenital heart defects. Further lawsuits continued to emerge across the country as word spread and mothers realized what may have caused their baby’s birth defect, and the total swelled to nearly 500 lawsuits pending in federal courts. The affected families allege that GlaxoSmithKline marketed the drug to pregnant women without FDA approval, that it paid doctors to prescribe the drug, and that it failed to warn about the associated risks of use while pregnant. A number of these cases were consolidated into multi-district litigation (MDL) in late 2015 in order to improve the speed and efficiency of the proceedings.
Court documents show that as early 1992, the manufacturer may have known that Zofran was associated with an increased risk of harm to unborn babies, and that despite this knowledge, the company continued to actively promote the drug to doctors for this off-label use.
The widespread use of Zofran for morning sickness changed in 2013 when the drug Diclegis was approved for morning sickness. Health experts now say that Zofran should only be prescribed to women as a last resort when other medications and treatments have failed, and the American Journal of Obstetrics & Gynecology said of Zofran: “Now that a safe and effective drug is available in the United States, there is no reason for women to be exposed to a drug of unproven maternal and fetal safety.”
While the current advice and warnings about using Zofran while pregnant will undoubtedly prevent future health complications and birth defects in future pregnancies, those recommendations are too little, too late for families that have already been affected by this pharmaceutical drug.
Whether it’s a cleft palate, a heart murmur, or other complications, any birth defect is devastating news for families. But that pain isn’t just emotional, it is also financial.
The cost of medical care in the United States is never cheap, but the treatment of some of the medical conditions associated with Zofran can be absolutely staggering. It is not fair that a drug manufacturer has released a dangerous drug to the marketplace, promoted the off-label use of the drug, and caused long-term damage and complications to the lives of so many families, all while making millions of dollars in the process. You and your family shouldn’t have to shoulder this financial burden alone.
An attorney can file a lawsuit against the manufacturer on behalf of you and your family in order to help you get the compensation you need and deserve. While we know that no lawsuit or compensation will change the past, it can help pave the way to a better future for your family and will ensure that your child gets the best medical care they can when going forward. A lawsuit will help hold the corporation responsible and may also be the best way to move your family past this terrible ordeal.
The attorneys at Fears Nachawati understand the tragic nature of a birth defect and while we know that some families may be reluctant to face another battle, particularly one against a major pharmaceutical corporation, it may be the only way that they find some semblance of justice in this ordeal and may be the only way to recover financially from the costs associated with surgical procedures, hospital stays, rehabilitation, past and future medical expenses, and even pain and suffering.
If you or someone you know has given birth to a baby with birth defects as a result of using Zofran, then the legal team at Fears Nachawati may be able to help you hold the responsible parties accountable. Contact our experienced legal team for a free, no obligation legal consultation to discuss the specifics of your case. Our team is fully prepared to fight on behalf of families who have suffered as a result of using Zofran during their pregnancy and having a compassionate and knowledgeable legal team on your side can make all the difference during this trying time.