Lawsuits against GlaxoSmithKline are gaining steam because the company 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 potential 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 with 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 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 for 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 to 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 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 to pregnant women on the up-and-up.What the Studies Show
The medical evidence is evolving. What we have known over 20 years is that we do not know if the 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 whether it was safe for their unborn child.
Medical journals and studies have consistently showed 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 a period of 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.
There are doctor who 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.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 actually capable of causing the plaintiff’s injuries, while specific causation requires that the plaintiff’s injuries were actually 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? In answering the question, we have to concede that we have no idea. This is pretty new litigation and drug injury cases can break a lot of different ways.
But we can talk historically about how these types of case proceed. Many cases are going to be filed and the likelihood is that this becomes a MDL class action. Usually, when the cases get consolidated in a class action, few cases get very far in the litigation process. Instead, a few cases might get tried and then the plaintiffs’ lawyers and the drug company gets a better sense of the settlement value of these cases. That is the history of most mass torts like this. They take a lot of time but the vast majority of cases are never fully developed and most of the cases are included in a global settlement of claims.Do You Need a Lawyer to Help You and Your Child
Our law firm is reviewing claims that may potentially become Zofran birth injury lawsuits. If you think you and your child might have a claim, call 800-553-8082 or get a free online consultation.