Zofran Lawsuit

zofran lawsuitZofran, generically known as Ondansteron was created by GlaxoSmithKline and has been available in the market since the year 1992. Although Zofran was approved by the FDA for treating cancer patients, it was sold to pregnant women to relieve them of nausea. However, it came with drastic side effects which led the Zofran lawsuit and several claims. In the 2012, GlaxoSmithKline pleaded guilty to charges of illegal promotion and fraudulent claims on a number of drugs by the United States Department of Justice, which included Zofran. This Zofran lawsuit cost the multinational pharmaceutical company $3 billion in settlement and the company is still defending itself against the several allegations related to Zofran.

It has been considered as the largest lawsuit settlement ever done by any pharmaceutical company in the history of the nation. The Zofran lawsuit revealed that GlaxoSmithKline had marketed the drug for pregnant women without the approval of the FDA. Moreover, the drug makers have been also accused of paying the medical health professionals for prescribing Zofran to pregnant women without proper research. The pharmaceutical giant paid $1 billion by pleading guilty to 3 counts of criminal behavior. The fraud committed by GSK with the federal government and individual states mounted to $2 billion in settlement.

Zofran Lawsuit For Cross Branding and Illegal Marketing

The Food and Drug Administration Department of the United States had approved Zofran about two decades ago for treating patients who were undergoing chemotherapy. As chemotherapy can make the patient nauseous and induce vomiting, Zofran was prescribed to the patients to relieve the symptoms of nausea. However, GlaxoSmithKline decided to make Zofran even more profitable by introducing it to more patients who suffered from symptoms of vomiting and nausea – pregnant women with morning sickness. This would be fine, but the problem was that the FDA did not approve the drug Zofran to be used by pregnant women.

GlaxoSmithKline started pushing Zofran towards doctors and incentivized them to prescribe it to pregnant women who suffered from morning sickness. While doctors are permitted to prescribe Zofran to their patients, it was unethical and in fact illegal of GSK to promote the off-label use of their drug which was approved only for treating cancer patients. The drug maker had conducted no sizeable research to find out the effectiveness of the drug on pregnant women and its side effects on the mother as well as on the unborn child. After several number cases and studies it was revealed that women, who took the anti-nausea drug of Zofran during their pregnancy, were 30% more likely to conceive a baby with birth defects.

Why Are Zofran Lawsuit Being Filed By Former Users?

It was revealed in the documents presented before the Court that GlaxoSmithKline was cleary aware of there were risks associated with Zofran. Ever since its inception in the year 1992, Zofran posed an unidentified risk to the developing fetus as the drug passes through the human placenta. Moreover, research showed that the drug was present in the fetus for a longer duration than it was present in the mother’s system. The drug maker illegally marketed Zofran despite knowing the threats it posed to pregnant women and their child and many people round the world took the drug as most of them were unaware about the real facts. The large numbers of Zofran lawsuit that are being filed by the former users of the drug are based on the following claims.

  • It was the drug maker’s obligation to ensure that the medicine was safe for use before it was offered to the public and GSK were incompetent in determining the risks associated with their drug before they marketed it.
  • GlaxoSmithKline did not warn the horrendous side effects that came with Zofran.
  • The drug was marketed as safe for use for morning sickness as well as hyperemesis gravidarum in pregnant women, even though it was not approved for use by the FDA.
  • GSK represented the results of the drug testing on animals as safe, which was false as studies revealed signs of toxicity and bone growth abnormalities.
  • Glaxo did not analyze the data and did not provide the safety information on Zofran for it to be used by pregnant women.
  • GSK not only created a defective medicine, but promoted and publicized it as safe for use by pregnant women.

Zofran lawsuit is based on accusations being made by the former users towards GlaxoSmithKline for selling and marketing a drug as safe for use by pregnant women and even paying doctors to convince them in prescribing the drug. Zofran brought in millions of dollars to GSK with its sales and it has been reported that Zofran or its generic counterparts are consumed by more than a million women every year.

Medical Research Related To Zofran Lawsuit

It is medically known at about 80-85 percent of pregnant women suffer from the condition of nausea and vomiting known as morning sickness. There is a severe form of morning sickness which is known as hyperemesis gravidarum, due to which the unborn baby and the mother could be at risk of malnutrition. Due to this condition, pregnant women often ask their doctors to prescribe a drug to relieve the symptoms of morning sickness and put them at ease. One of the primary reasons that Zofran become instantly popular with pregnant women was because it provided the relief from the symptoms of nausea, and since their doctor prescribed it to them, women considered it to be safe for them as well as their unborn child.

Unfortunately, a large number mothers who were on Zofran during their pregnancy, conceived babies born with severe abnormalities and defects. These severe defects found in the infants not only caused facial deformities, but rendered them to be dependant forever on their parents. The rising number of abnormal births and rising number of mothers relating Zofran to their baby’s condition let to several studies and researches that brought back shocking results.

In the year 2013, a study was published by the New England Journal of Medicine which found that the birth defects were not related to the consumption of Zofran in any way. The study was conducted y evaluating the data of the pregnancy outcomes in the country of Denmark between the years 2004 and 2011. The study was inconclusive because most of the women who were prescribed Zofran during pregnancy did you take it until after the 10th week of their pregnancy. By the 10th week, the baby was safe from the risks of heart diseases and birth defects so consumption of Zofran did not pose a threat.

However, just six months later, an extensive research conducted by Dr. Jon A. Anderson used the same data from the previous research to conclude that Zofran was the cause of several side effects such as doubled risk of cardiovascular defects, along with a 30% increased chances of delivering a baby with birth defects. These results were based on a study that took into consideration a longer period of time (from the year 1997 to 2010) and included more than 900,000 pregnant women. It was concluded from the research that out of the 1,248 pregnant women who consumed Zofran, 5% of them give birth to a child with birth defects.

Australian researchers also published a study in BioMed Research International which related Zofran to an increase in the number of birth defects. It was concluded that women who took Zofran during the first three months of their pregnancy, were associated to a 20% increased chance of giving birth to a baby with birth defects. Although the study was too small to assess individual births, it was observed that Zorfan consumption during pregnancy increased the risk of kidney defects.

Birth Defects Connected To Zofran Lawsuit

The medical research and findings that have lead to the Zofran lawsuit include a large number of birth defects and abnormalities. Some of the most common birth defects that have been associated with the use of Zofran during pregnancy are:

  • Heart Diseases.
  • Defects related to the Cardiac septum.
  • Atrial Septal Defect (the condition of having a hole in the atria of the heart).
  • Ventricular Septal Defect (the condition of having a hole in the ventricle of the heart).
  • Cleft Lip.
  • Cleft Palate.
  • Congenital defects of the heart.
  • Club Foot.
  • Skull deformities (Craniosynostosis)

These are adverse side effects that are associated with the use of Zofran in pregnancy. This shows that all the mothers and their children who have been affected from the side effects of Zofran could have avoided if Zofran was marketed by GSK for the intended use.

Heart Defects from Zofran

There have been several reports and studies that point towards Zofran leading to 20% increase in the risk of heart diseases that could affect the unborn child. Some of these heart defects include:

  • Defect of the Atrial Septal: This condition causes the development of a hole like structure in the upper two chambers of the heart.
  • Heart Murmur: When the sound of the heart is heard with a stethoscope, the heartbeats sound abnormal (whooshing or clicking sounds)
  • Defect of the Venticle Septal: This condition causes the development of a hole like structure in the lower two chambers of the heart.

All of these heart conditions that are associated with Zofran can be fatal to the newborn if proper care is not provided immediately. Moreover, treating these severe heart conditions can take a long time out of the child’s life. Due to these defects, the child would have to refrain from physical activities, until the condition is cured with multiple surgeries.

Cleft Palate from Zofran

A study conducted and published by the Birth Defects Research Committee in the year 2012 revealed that Zofran consumption during pregnancy increases the risk of cleft palate in the baby by 2.4 folds. The research was extensively conducted over the data derived from 9,000 pregnant women. The birth defect of cleft palate occurs when the roof of the newborn’s mouth does not develop.

Although all babies are born with a cleft palate the tissue at the roof of the mouth slowly develops in the first 6 to 9 weeks. The babies born with this defect have an opening in the roof of their mouths which is directly connected to the upper lip, gums and the nose opening. This condition can not only interfere with feeding the child, but need extensive facial reconstructive surgery to treat the cosmetic condition.

Do You Have A Zofran Lawsuit?

If you and your child have been one of the several victims who have been affected by the side effects of Zofran, you can claim compensation for all the trauma, pain and inconvenience that has been caused to you with a Zofran Lawsuit. In order for you to get the justice you deserve, we stand right by your side and help you through the entire process with our expertise and experience in working with birth defect cases caused by Zofran all over the country. If you, or somebody you know who took Zofran during their pregnancy period and conceived a baby with a birth defect associated with the side effects of Zofran, reach out to our elite team of lawyers to file your Zofran lawsuit and make sure that justice is served.

Whether you have questions about the Zofran lawsuit procedure or any other queries, just give us a call to book a free consultation with our top notch legal advisors. We will help you understand your rights in the matter and how much compensation you should expect.Our seasoned lawyers will guide you through the entire process and make sure that you receive the compensation for your nightmarish trauma in full. You are just a phone call away from discussing and filing your potential Zofran lawsuit and making sure that you and your child will be satisfied by our dependable legal consultation services.



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