An hour south of Houston, in Brazoria, Texas, one family tells their troubling story. Sarah and William Hill learned they were having a baby in November of 2000, and ultrasound showed the baby to be healthy. But to deal with her continued morning sickness, Sarah’s doctor prescribed her Zofran. She trusted that a drug like Zofran wouldn’t be prescribed to her (and a million other pregnant women every year) if it hadn’t been found safe for pregnant women and their unborn children, so she started taking it according to her doctor’s directions.
After that, everything changed.
Later testing brought Sarah and William the news no parents want to hear: their unborn child was suffering from severe physical malformations, including life-threatening heart defects. To try to save the baby’s life, Sarah’s medical team conducted a C-section in July 2000 and hurried her newborn daughter away to an intensive care unit. The baby stayed there the rest of her life. Despite multiple surgeries on her heart, Sarah and William’s daughter died in early August.
Sarah had no idea that heart defects like the one that killed her daughter had been linked to the drug Zofran. So two years later, when she became pregnant again, and was again prescribed Zofran to treat her morning sickness, Sarah once more complied with the doctor’s orders. Tragically, her second daughter was also classified as a high-risk birth. The brand-new baby was subjected to extended hospitalization and a slew of testing before she was diagnosed with congenital kidney defects and other digestive problems. Though Sarah and William’s daughter survived, she will be dealing with these problems for the rest of her life.
Since then, Sarah and William have learned their family’s story is not unique. Thousands of mothers who took Zofran to treat morning sickness are now sickened by news revealing the drug’s ties to birth defects like heart malformations and cleft palate, as well as other health problems including fetal growth restriction, low birth weight, jaundice, spontaneous abortion or stillbirth.
Now many – including Sarah – are filing lawsuits against the drug manufacturer, GlaxoSmithKline (GSK). If you or a loved one have also given birth to a child with severe birth defects after taking Zofran, learn about your options today by talking with a Patient Advocate. Call (844) 314-0777 or fill out an information form to get help today.
Taking it to the courts
Families who believe they and their children have been harmed by Zofran are taking their stories to the courts in the search for justice. These are some of their stories:
• A Massachusetts mother named Tomisha was prescribed Zofran for her nausea and vomiting during pregnancy, and took the pill without suspicion that it could cause damage to her child. Sadly, her daughter was born with several heart defects, facial and body deformities, and hernias which required ten surgeries during her first years. Tomisha filed one of the first lawsuits against Zofran manufacturer GSK in February 2015.
• A Pennsylvania mother named Cheri gave birth to two children with birth defects following the prescribed use of Zofran. Cheri’s first child had a hole in the heart that required surgery, while the second child was born prematurely and still suffers developmental delays, such as an inability to breathe adequately.
• An Alabama mother named Julie took Zofran in her first trimester of pregnancy following her doctor’s orders and then gave birth to a son with facial deformities, extra digits, glaucoma, distended kidney and other disorders. Her son began to experience seizures when he was only nine months old, and remains nonverbal and with delayed reactions – disabilities which doctors say he did not inherit from his parents.
• A Louisiana family filed a lawsuit against GSK in July 2015, after taking the drug and giving birth to a son with several defects – including heart problems that have already required two surgeries. The boy’s mother notes that clear back in the year 2000, GSK had already received 200 reports of birth defects following Zofran use, and states that if she had been aware of this information she never would have risked using the drug.
• And nearly fifty additional families nationwide, with more joining all the time. These families claim that GSK negligently failed to warn of the risks of their drug, fraudulently concealed information, and still aggressively promoted their drugs to doctors to prescribe off-label to pregnant women for morning sickness.
As the list of complaints against Zofran and its manufacturer GSK grows longer, a Judicial Panel recently consolidated these lawsuits into multidistrict litigation, or MDL. This action is seen as a step forward for victims of the drug, as it makes filing claims against the GSK easier, and speeds up entering the lawsuit process for new families.
Do I qualify for compensation?
If you took Zofran during pregnancy and your child was born with birth defects, you may be eligible to seek compensation.
Several scientific studies have tied the use of Zofran in early pregnancy with heart defects, particularly ‘hole-in-heart’ defects (such as atrial septal defect, ventricular septal defect, and atrioventricular septal defect). There is also significant evidence linking the drug and cleft palate or cleft lip in newborns.
Other birth defects mentioned in Zofran lawsuits include:
• Club foot
• Skull and facial deformities
• Extra digits
• Hearing loss
• Vision problems, such as glaucoma
• Abnormal blood pressure
• Stomach problems
• Kidney problems
• Mental problems
• Webbed toes
• Developmental delays
• Delayed reactions
In most cases, the newborns suffering from these complications have had to undergo extensive medical treatment, including extended stays in the hospital and follow-up treatments. In some cases, the complications have cost the children their lives.
If you believe Zofran has affected the health of your child, you are not alone. Join others who are seeking compensation and an end to harmful pharmaceutical practices by filling out an information form, or contacting a Patient Advocate directly at (844) 314-0777.
What kind of compensation can be sought?
Drug-linked birth defects often result in massive medical bills, as well as immense psychological and emotional pain for children and parents alike. Victims and their parents may qualify for compensation to cover a variety of expenses, including:
• past, present, and future medical bills
• emotional suffering
• psychological distress
• legal expenses
• funerary expenses
At times, judges or juries also choose to award punitive damages, which are intended to punish companies who harm patients, and deter them and others from behaving illegally and unethically in the future.
Many lawsuits also demand that GSK change the wording on their warning labels, to provide information of the potential dangers to pregnant women and reduce the likelihood of future parents experiencing the same tragedies.
What will your legal team need to prove?
A strong cases against drug manufacturer GSK would include the following allegations:
• A doctor prescribed Zofran to you, knowing you were pregnant, and you took it properly.
• After taking Zofran, you gave birth to a child with a severe defect, that wasn’t caused by heredity or other known factor.
• You did not know about the risk of birth defects before taking Zofran.
• The drug makers knew or should have known about these risks, but did not include adequate warning on the product label.
To prove the above, in the early stages of the lawsuit your legal team will compile:
• Documents like medical bills and other expenses
• Testimony from medical experts and scientific researchers
• Information from FDA investigations, leaked internal documents, or other material that show the corporation’s wrong-doing.
How long does a lawsuit take?
Lawsuits against drug manufacturers and marketers can take two years or more to go to trial. However, most cases are resolved before they go to trial. Your legal team can help you understand what the time requirements might be for your specific case.
Now that claims against GSK dealing with Zofran have been consolidated, filing a claim will likely be easier for new plaintiffs. This is because a ‘short form’ complaint can be used. The resolution of the first cases, called ‘bellwether trials,’ will often set the tone for future settlements. Often, companies reach settlements before the bellwether trials start or shortly afterward.
Though the legal process can be slow, it is important to begin filing a complaint as soon as possible. This will not only protect you against the legal deadline (called the statute of limitations), it will also increase the ease of locating important documents and remembering details.
Why might the drug companies be held responsible?
Health complications resulting from drugs are traumatic enough – especially when the ones affected are newborn babies. But what makes the story of Zofran particularly troubling is the evidence that drug manufacturer GSK knew all along about the risks its drug posed to children, and still promoted its use to pregnant women.
Zofran (and its generic equivalent ondansetron) is not approved by the FDA for use by pregnant women, since it is known to easily cross the placental barrier to the fetus. Because GSK never carried out studies on the effects Zofran might have on unborn children, they claim they have no evidence that it is risky, meaning it is labeled as Pregnancy Risk Category B.
Since GSK never proved their drug was safe for pregnant women, the FDA never gave them approval to market the drug to women experiencing morning sickness. All the same, doctors have been increasingly prescribing the drug off-label to pregnant women dealing with severe morning sickness – and without any warning on the label, pregnant women have assumed the drug must be safe.
Off-label drug prescription is controversial, but legal. What isn’t legal is drug companies lobbying doctors to prescribe their drugs for unapproved uses.
But GSK has been successfully prosecuted for doing just that. Three years ago, the US Government brought criminal charges of fraud against GSK, for promoting unapproved uses for its drugs and failing to report crucial safety data. One of these drugs was Zofran. The Department of Justice alleged that GSK knowingly:
• “promoted the sale and use of Zofran for a variety of conditions other than those for which it was approved as safe and effective by the FDA (including hyperemesis or pregnancy-related nausea).”
• “made and/or disseminated unsubstantiated and/or false representations or statements about the safety and efficacy of Zofran” for morning sickness.
• “offered and paid illegal remuneration to health care professionals to induce them to promote and prescribe Zofran, in violation of the Federal Anti-Kickback Statute.”
As part of the settlement, GSK had to pay a hefty fine, but didn’t have to admit to any wrong-doing with Zofran.
But it seems this settlement wasn’t enough to teach GSK a lesson. Court documents assert that between April 2009 and December 2013, GSK voluntarily self-reported that it paid nearly half a billion dollars to doctors in the United States for “speaking fees, consulting fees, research, travel fees and meals.” These controversial payments can easily cross the line into flat-out bribery, as GSK seeks to cajole doctors to prescribe Zofran in cases where it isn’t approved by the FDA.
Some feel it’s time for GSK to finally be accountable for inappropriate promotion of a dangerous drug. Court documents show that as early as 1992, GSK knew Zofran presented an “unreasonable risk of harm to babies who are exposed to the drug during pregnancy.” Despite this information, the drugmaker failed to provide any warning to doctors or patients and continued to encourage doctors to prescribe its drug off-label – in the meantime making millions off of pregnant women.
Some of the claims being made against GSK in the lawsuits are:
• GSK failed in its duty to ensure Zofran was safe or determine health risks before offering it to the public.
• GSK failed to warn about dangerous side effects.
• GSK fraudulently claimed Zofran was safe for pregnant women and advertised the drug as a treatment for morning sickness, without FDA approval.
• GSK misrepresented its animal studies, claiming they showed the drug was safe when they actually revealed signs of toxicity.
• GSK produced a defective drug.
If you’ve suffered from Zofran, you are likely to feel that the company’s pursuit of profit has come at the expense of careful preclinical research, truth in advertising, and accountability to address severe birth-defect risks when they came to light. Successful lawsuits against GSK will not only provide victims with compensation, but will also send the message that drug companies must prioritize their legal and ethical duties to patients over their thirst for profits.
Should you join?
Medical trauma is emotionally exhausting – especially when it involves a newborn baby. It is also financially taxing. The thought of adding legal action to one’s life can appear overwhelming. At the same time, each state has a different deadline for legal action (called the statute of limitations), meaning it’s important to file legal claims quickly.
Our Patient Advocates are here to ease the process for those who have been hurt by this drug, carefully assessing your situation to determine whether you are eligible to file a claim for legal compensation, and providing clear guidance for continuing legal action.
To understand whether you have a strong potential case or not, a Patient Advocate can set you up with a free consultation with an experienced attorney. If you decide to hire the attorney to represent you, he or she will help guide you through the lawsuit process. There are usually no upfront, out-of-pocket costs for the duration of the lawsuit. Typically, payment for attorneys for cases like these comes from a percentage of the award or settlement you receive. Be certain to clarify fee arrangements with a law firm before deciding to hire them.
Lawsuits can provide much-needed compensation to those who have suffered from illegal behavior, but they also go a step further. Currently, lawsuits are the most effective way to hold drug giants responsible for the harm they have caused through negligence, medical fraud, making false and misleading statements, and other illegal behavior that harms those they are supposed to serve. When a powerful company breaks the law, it’s important for those who have been harmed by them to step forward and demand justice.
It’s possible that GSK will be found innocent of wrong-doing, even after all the evidence comes to light. However, if allegations are true that GSK knowingly endangered the lives of newborns for the sake of higher profits, it is imperative that they face legal consequences for their behavior. If no one stands up on behalf of themselves and their children, GSK will be able to avoid accountability for actions that have placed millions of innocent people at risk.
GSK will be dedicating significant resources to the trial process in order to avoid responsibility. But ordinary people can still find justice, provided they have an experienced and trusted legal team on their side. If you or a loved one have suffered from Zofran side-effects, don’t delay in seeking legal help. Fill out an information form here, so a Patient Advocate can contact you. For faster help, call (844) 314-0777.
What should I ask my Patient Advocate?
Patient Advocates are trained to evaluate your situation and help you find a trustworthy legal team, who can give you individualized attention.
Questions to ask them might include:
• Which legal firms have experience with cases like mine?
• What documents or information should I be gathering now?
• What is it like to be part of a lawsuit? What will I be expected to do?
• What kind of fee arrangement do law firms have for cases like mine?