Studies have shown Zofran, a commonly used anti-nausea drug can cause birth defects in children. Lawsuits were filed in these cases because the drug’s maker, GlaxoSmithKline, did not warn women that this drug could cause injuries to their unborn child if taken while pregnant.
2023 Zofran Lawsuit Update: Judge F. Dennis Saylor ruled that the FDA would not have allowed a pregnancy warning on Zofran’s label, citing the FDA’s recent rejection of a request to add a warning. This ruling dismissed 425 Zofran lawsuits in the MDL class action lawsuit.
In January 2023, the 1st Circuit Court of Appeals agreed with Judge Saylor, effectively ending every Zofran lawsuit in the country (unless the Supreme Court takes up the appeal, which our lawyers think is unlikely.
Most of this post was written many years ago and much of the science cited is outdated.
Zofran (generically called ondansetron) is a prescription drug belonging to the class of drugs known as antiemetic and selective 5-HT3 receptor antagonists. These drugs are for the treatment of nausea or vomiting from chemotherapy or surgery.
Zofran is not a good drug for nausea. It is a great drug. For people taking chemotherapy in the early 90s — you can count one of our lawyers among this group — it was a total game changer. If you are getting chemotherapy or radiation — particularly to your abdomen — it can cause awful nausea. Since the FDA approved it in 1991 for nausea and vomiting for patients recovering from surgery or chemotherapy, it has made a tremendous impact on a large number of people.
So no one is arguing that GlaxoSmithKline did an awesome thing for human suffering when it invented Zofran. That is what drug companies are supposed to do, right? It is why successful ones, like GlaxoSmithKline, make billions and billions of dollars every year.
But if you have a child that has been harmed because no one told you taking Zofran while you were pregnant could cause your child pain and suffering that could kill the child or cause them a lifetime of pain and challenges, you could not possibly care less about how the drug made you feel a little better when you were sick.
Sure, this drug has done and will continue to do amazing things for people. But what inventing a great drug cannot be is a license to push the drug to people that you know or should know may be badly harmed by the drug.
A $3 Billion Fine
When drug companies see that they have a drug that is selling, that is making them money hand over fist, they almost invariably have a single reaction: how can we sell this drug to more people? Greed takes over. Does this sound like the plaintiffs’ lawyer’s hysteria? Well, keep in mind Glaxo was fined $3 billion — billion with a B — to settle charges from the federal government that it committed fraud and failed to report safety data. Among other things, GSK was charged with promoting many of its best-selling drugs, including Zofran, off-label.
The crazy thing is that GSK did not need to do it. The company hit the jackpot with this drug. They even got some unbelievably serendipitous luck with this drug that had to astound even them.
In 2006, a study showed the drug might treat schizophrenia. Another study showed it might be useful in treating antipsychotic-induced tardive dyskinesia. Then evidence came out that it might help with Parkinson’s Disease. (Our firm is handling Paraquat lawsuits regarding Parkinson’s Disease). There was even some evidence at one point that it helped people that were obsessive-compulsive.
At that point, I’m sure the marketers at GlaxoSmithKline should not have been surprised if they learned Zofran cured the common cold.
Zofran Was Never Approved for Pregnant Women
But Zofran had never been approved by the FDA for the treatment of nausea and vomiting in pregnant women. But it was prescribed for women — again, including one of our lawyers — for morning sickness. For most women, morning sickness is the worst in the first trimester of pregnancy. Regrettably, taking Zofran during pregnancy, especially during the first trimester, has been linked to various birth defects.
In 2013, a New England Journal of Medicine study suggested a causal relationship between Zofran use during pregnancy and congenital malformations. These malformations were often cardiac and craniofacial defects.
Lawsuits being filed around the country now allege that GlaxoSmithKline was actively promoting the benefits of Zofran to pregnant women. These lawsuits alleged that after the FDA approved Zofran, Glaxo had evidence that Zofran presented an unreasonable risk of harm to babies exposed to Zofran prenatally. Instead of warning doctors and mothers-to-be, Glaxo instead pushed a marketing scheme to promote Zofran to OBs and other doctors as a treatment for morning sickness.
It should be noted again — because it bears repeating — that the federal government similar charges and that a $3 billion settlement came out of it.
Women Should Have Known All of the Risks
These lawsuits also make a critical point that will be central to this litigation: Glaxo knew or should have known that the side effects of Zofran could include birth defects in children and that a warning should have been placed on the drug to make clear that this drug could cause birth defects in children. There is a drug, Diclegis, that is FDA-approved to treat stomach problems during pregnancy. No one is saying Zoloft should be recalled. But women cannot choose unless all of the risks are explained to them.
Is it that Glaxo knew or should have known? The litigation process should flush this out. Again, the antennae are especially high in these cases in light of the allegations that GSK buried safety data.
Certainly, everyone knew that there are drugs that have the capacity under certain exposure conditions to trigger abnormal development in an embryo or fetus. With clinical trial testing and so many years of seeing the product on the market and its real impact on people, it is hard to believe that GlaxoSmithKline and the FDA would not know the risks of this drug on a pregnant woman. It is going to be important to figure out not only what Glaxo knew but what it willfully or negligently did not know.
History of Zofran Claims
Lawsuits against GlaxoSmithKline are gaining steam because the company’s blockbuster drug Zofran has been consistently linked to birth defects in pregnant women. The allegations against the company are fairly straightforward: Glaxo failed to warn women about the potentially harmful effects of the drug, and as a result, doctors began prescribing the drug for uses other than its intended one. This practice is called using a drug “off-label,” and here Glaxo’s insistence on pushing the drug led to some serious side effects.
In 1991, Zofran was first approved by FDA in 1991 with an incredibly important use: the prevention of nausea or vomiting who are taking chemotherapy or receiving radiation. It is also approved to help some patients who have these symptoms after surgery.
The knock on some drugs is that it is just really not worth the risk because the drug is just not that effective. Zofran beats the rap on this allegation. It works tremendously well in proving life-changing relief for these cancer patients.
GlaxoSmithKline made a fortune off Zofran as it well should. But the problem is that for drug companies, a fortune is not enough. They want a fortune to the 10th power. And greed takes over. If this sounds like anti-big company propaganda coming from a plaintiffs’ lawyer, consider this: GlaxoSmithKline paid a whopping $3 billion to settle an allegation brought by the federal government that the company committed fraud, misreported safety data, and promoted Zofran off-label.
Ultimately, that is just what happened here. Zofran is not approved by the FDA for preventing morning sickness in pregnant women. Why? Because there is no data was ever presented that this is a safe drug for women carrying a vulnerable fetus. But plaintiffs’ lawyers allege that Glaxo knew and even promoted the use of Zofran in pregnant women. They also claim that 15 years ago, Glaxo already had 32 reports of birth injuries in children with moms who were taking Zofran. This is a big number because there was no buzz in the media about the possible connection between birth injuries and Zofran. So you can bet a multiplier of that number had birth defects while their mothers were taking Zofran and no one thought the connection was significant enough to report.
What was the result of this greed? Most of the lawsuits against Glaxo allege that the drug resulted in children being born with cleft palettes, cleft lips, or heart defects. Zofran, which is used to treat nausea in cancer and surgery patients, was pushed on pregnant women for the treatment of morning sickness. There is no evidence of which our lawyers are aware that GlaxoSmithKline conducted any clinical trials to see if the drug was harmful to an unborn child. Glaxo certainly never sought FDA approval to push Zofran’s effect on pregnant women on the up-and-up.
What the Studies Show
The medical evidence is evolving. What we have known for over 20 years is that we do not know if Zofran is safe for pregnant women. Even the medical literature was pointing out the problem. In 2004, there was an article in the International Journal of Obstetrics and Gynaecology expressing concern that women were taking this drug without any evidence at all of whether it was safe for their unborn child.
Medical journals and studies have consistently shown a significant increase in the chance of malformations in unborn children. A 2013 study in the American Journal of Obstetrics and Gynecology found that taking Zofran increased the chance of malformations in unborn children by a whopping 30%. Although studies on the drug have produced conflicting results, this 2013 study had a sample size of 900,000 women, which is more significant than past studies, which have suggested that the concerns over Zofran are unwarranted.
One of those studies, which was mentioned in the New England Journal of Medicine, had a sample size of only 2,000 women, who were only taking the drug for ten weeks, skewing the data in favor of Glaxo. But scientists from the International Society of Pharmacoepidemiology soon refuted these stats with a thirteen-year study confirming the 30% figure from the American Journal of Obstetrics study. Notwithstanding the conflicting data, the FDA has publicly warned pregnant mothers that Zofran might be dangerous for their unborn children.
Some doctors still maintain that the evidence is unclear as to whether Zofran causes birth defects. But the prediction here is this opinion here is going to become extinct sooner rather than later.
2023 Update: Listen, we may have been wrong about this. It is important to fess up when we are wrong. Later studies failed to confirm the connection between birth injuries and Zofran.
How the Studies Can Affect a Zofran Case
One of the challenges of every medical malpractice or bad drug case is showing “causation.” This is an element that must be proven in every tort case, however, it is often more difficult to do when a lot of evidence in a case is expert testimony regarding medical studies. At its core, causation is merely a way of saying that the defendant’s actions/inactions caused the plaintiff’s injuries.
In a bad drug case, a plaintiff must show both general and specific causation. General causation means that a drug is capable of causing the plaintiff’s injuries, while specific causation requires that the plaintiff’s injuries were caused by that specific drug. The burden of proof in these cases is essentially a “more likely than not” standard, so the hurdle is not as high. Still, proving a case with these conflicting studies in your back pocket can be a tough road to travel.
Given that Zofran causes genetic abnormalities, proving causation in these cases is almost like a process of elimination. You would need to show that the birth defects caused by Zofran were not caused by other sources. This could require genetic mapping, molecular chemists, and a cavalry of other experts. Sure, the experts can allude to the studies and mention those as evidence (provided that they are reliable). But there are conflicting studies in these cases, meaning the defense is going to push one study while the plaintiff is going to push another.
What Will Happen to Your Zofran Case?
What will happen to your case if you and your child or grandchild have a viable claim for injuries? Again, barring the unlikely event that the Supreme Court overturns the 1st Circuit Court of Appeals, this litigation is over.