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Are There any Class Action Lawsuits Against GlaxoSmithKline, the Manufacturer of Zofran, for Children who Have Birth Defects Following Zofran Usage During Pregnancy?

GlaxoSmithKlineCurrently, there is no class action lawsuit against GlaxoSmithKline for the manufacture and distribution of Zofran. This means you will personally bring an action against them. This is significant because, like many other pharmaceutical companies, they have significant resources that they can bring against you including money, information, and legal talent. This is also important because details of your specific situation will become very important such as your medical history, circumstances of your prescription, genetic makeup, or any other medications or treatments you were receiving in conjunction with Zofran.

Rosenfeld Injury Lawyers LLC represents victims who have been heard after taking a prescription medication and other types of professional negligence. Our law firm has successfully prosecuted cases for our clients who were injured by bad drugs. Our attorneys are available to answer any legal questions on how to receive the monetary compensation you deserve if your injuries were a result of a pharmaceutical company's negligence. Should you have additional questions, we invite you to contact our office for a free review of your legal rights.

The Problem of Zofran

Ever since the FDA (Food and Drug Administration) first approved Zofran to treat nausea and vomiting in cancer patients, there have been a significant number of problems. Many doctors began prescribing the medication for off-label use to pregnant mothers to treat morning sickness. However, the medication has been shown to double the potential risk of birthing a baby with a “hole in the heart” congenital disability and other congenital disabilities including cleft palate and cleft lip.

Doctors often find it challenging to treat severe morning sickness but have found that Zofran (ondansetron) worked well because it blocks the action of specific chemicals in the body that produce vomiting and nausea. However, the drug was never designed to be used in expectant mothers but instead for cancer patients who undergo chemotherapy, radiation therapy, and surgery.

Zofran and Pregnancy

Recent statistics maintained by the CDC (Centers for Disease Control and Prevention) shows that more than one million pregnant women are given a Zofran prescription each year. Obstetricians continue to prescribe the medication even though the NCBI (National Center for Biotechnology Information) has revealed that using Zofran (ondansetron) is unhealthy for expectant mothers because the drug causes electrolyte imbalances.

Also, the study revealed that taking the drug when pregnant doubles the potential risk for major congenital heart defects and facial deformities. During the first trimester pregnancy, the fetus can develop:

  • Cranial defects including a cleft lip or cleft palate,

  • Part abnormalities including atrial septal defect (ASD), ventricular hypertension, and aortic arch hypoplasia,

  • Kidney malformation,

  • Hearing loss,

  • Webbed toes,

  • Inguinal hernia involving protrusion of the intestines and stomach through the abdominal cavity,

  • Skull deformity including facial dysmorphia,

  • Clubfoot

  • Other congenital disorders including Down syndrome, Turner syndrome, Patau syndrome, and Cri du chat syndrome.

During a negotiated settlement with the US Department of Justice, GlaxoSmithKline repeatedly admitted that taking the medication to treat vomiting and nausea in pregnant women had not been tested. Even so, admitting there was a problem for expectant mothers using the medication, they never stopped promoting the drug for off-label use.

A representative for GlaxoSmithKline stated in a press release that “the safety of ondansetron for use in human pregnancy has not been established.” The spokesman continued to say that the company continues to monitor and report all adverse events and “… works closely with regulatory agencies in Canada to include relevant safety information for physicians and patients within our product labels.”

Many women have filed a GlaxoSmithKline lawsuit claiming that in addition to their child being harmed, they also suffer serious side effects that involve:

  • Difficulty breathing,
  • Fainting,
  • Dizziness,
  • Constipation,
  • Irregular heart rate,
  • Difficulty swallowing,
  • Swelling all over the body,
  • Itching, hives, and rashes,
  • Shortness of breath.

Mass Tort Lawsuit Involving Zofran (Ondansetron)

Even though no class action suit has been filed against GlaxoSmithKline to resolve cases involving Zofran (ondansetron), many women in the US have filed Zofran lawsuits. Many of these cases have been consolidated in multidistrict litigation (MDL – mass tort) in a federal Massachusetts district court. To date, there are hundreds of claims that have been centralized to ensure all injured victims receive compensation for their damages. The case (MDL 2657) involved “allegations regarding Zofran and its generic equivalent [ondansetron], a prescription medication.” These cases have been assigned to Judge F. Dennis Saylor.

In addition to lawsuits filed against Glaxo SmithKline, as of March 23, 2015, Novartis, another leading pharmaceutical manufacturer has also been named by plaintiffs and lawsuits concerning the taking of Zofran (ondansetron). Even though many of these cases have been consolidated up to October 2015, other similar cases that share identical evidence have been added to the multidistrict litigation case. These cases will be heard as a “master complaint” to help reduce the amount of time it will take to resolve thousands of cases.

Many of these lawsuits are based on similar complaint stating that GlaxoSmithKline, and now Novartis also, never warned medical providers, patients, or the public that the drug had the potential dangers when prescribed to expectant mothers. These documents reveal that the Food and Drug Administration never approved the medication for the treatment of morning sickness and yet both companies continue to violate Federal rules and regulations when promoting their medications.

Numerous court documents reveal that GlaxoSmithKline knew as early as 1992 that Zofran increase the potential risk of harming unborn children because the drug passes through the human placenta. Even knowing this, GlaxoSmithKline continues to promote their medication to pregnant women and doctors for the treatment of nausea and vomiting associated with morning sickness.

These documents alleged that:

  • The pharmaceutical manufacturers failed in their legal obligation to ensure pregnant women that taking Zofran (ondansetron) was safe before they released, marketed, and promoted in the medical marketplace.

  • The drug makers failed to warn the medical community and public of the known serious side effects of taking Zofran (ondansetron).

  • The drug companies continue to market Zofran (ondansetron) as a safe and effective treatment for off-label use, including treating hyperemesis gravidarum and morning sickness.

  • The pharmaceutical manufacturers misrepresented animal studies that supposedly proved that taking Zofran (ondansetron) was safe.

  • The drug makers never properly analyzed safety information and data concerning Zofran use during pregnancy.

  • The drug companies fraudulently and falsely claimed that taking Zofran (ondansetron) was safe during pregnancy.

  • Both drug companies manufactured a defective medication.

By the summer of 2018, there were nearly 500 lawsuits filed by plaintiffs against GlaxoSmithKline and Novartis that had been consolidated in multidistrict litigation (MDL 2657) court. However, the judge has yet to schedule a trial date for numerous bellwether cases that will serve as a guideline for plaintiffs and defendants to resolve the remaining individual cases through negotiated settlements.

Open GlaxoSmithKline Lawsuits

The four lawsuits detailed below have yet to be heard in open court or settled between the plaintiffs and defendants. However, the suits represent common allegations involved in hundreds of lawsuits filed across the United States.

  • Flynn V. GlaxoSmithKline – In February 2015, the US District Court, Eastern District of Pennsylvania accepted the first Zofran lawsuit. This case was filed by a Minnesota plaintiff claiming she gave birth to two children with severe heart abnormalities. The expectant mother's doctor prescribed Zofran to treat her morning sickness she experienced during the first few months of pregnancy.

The plaintiff gave birth to her first daughter in 2004. The child was developmentally delayed and needed a surgical procedure in 2012 to repair a congenital (hole in the heart) defect. The woman gave birth to her second daughter in 2006 who was also diagnosed with a congenital heart defect.

  • LeClaire v. GlaxoSmithKline – Less than a week after the first case was filed in US District Court, a second lawsuit was filed by a Massachusetts plaintiff who was prescribed Zofran to treat vomiting and nausea associated with her pregnancy. The expectant mother gave birth to a daughter in 2000 who was born with numerous congenital disabilities including facial dysmorphia, heart defect, hearing loss, webbed toes, sensitivity to light, low set ears and an inguinal hernia. The daughter has undergone ten surgical repairs over a dozen years in an attempt to correct her congenital defect-associated abnormalities.

  • Kutzer v. GlaxoSmithKline – A family with an expectant mother who had been prescribed Zofran filed a lawsuit against GlaxoSmithKline in 2015 claiming that the drug manufacturer had paid doctors to promote the medication to treat morning sickness during pregnancy. The family claims that the drug manufacturer made “false representations about the safety and efficacy” of their medication. The expectant mother gave birth to a son, who was born with multiple defects including an incomplete vas deferens, a necessary duct that goes from the urethra to the testicle. The child was also born with only one kidney.

  • Davis and Hanke v. GlaxoSmithKline – In 2016, a husband and wife filed a lawsuit against GlaxoSmithKline claiming that their son's congenital disabilities are the result of an expectant mother taking Zofran in the first three months of pregnancy. The child was born in 2007 and diagnosed with a cleft lip and cleft palate. Since then, the family says that the son has experienced “a delay in his physical, language, and psychological development and interference with speaking and dental development.”

I am Taking Zofran (ondansetron). What Should I do?

If your doctors prescribe Zofran or its generic form ondansetron, and you are pregnant or plan to become pregnant, it is important to discuss the problem with your doctor right away. The obstetrician or gynecologist can inform you of other options to treat your symptoms involving nausea and vomiting. Failure doctor you are concerned about birthing children with heart malformations, cleft palate, cleft lip, or another severe congenital disability.

Taking the First Legal Step

The bad drug injury attorneys at Rosenfeld Injury Lawyers LLC understand that the injuries that were caused by the defective medication were not your fault. We have successfully obtained millions on behalf of the victims and their family members to ensure they were adequately compensated to cover their medical expenses, household bills, lost wages, loss of future earnings, pain, suffering, and emotional damage and we can help your family too.

Our legal team encourages you to contact our attorneys today to schedule a free, no-obligation case consultation to discuss the merits of your monetary recovery claim. We accept all personal injury cases, wrongful death lawsuits, and defective medication injury claims through contingency fee arrangements. This legal contract postpones the payment of legal services until after we have successfully completed your case through a negotiated settlement or a jury verdict.

Our law firm gets results quickly because we understand you need money now to resolve the financial burden Zofran has caused your family. We proudly offer every client a “No Win/No-Fee” Guarantee, meaning if we are unable to secure financial compensation on your behalf you owe us nothing. All information you share with our law office will stay confidential. Let us begin working for you today.


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