Zofran lawsuits have been filed against drug maker GlaxoSmithKline over off-label marketing and the potential for serious complications like birth defects. More lawsuits in the future are possible and GlaxoSmithKline may be forced to pay settlement fees to the patients and their children who were harmed by Zofran and similar drugs.
As a drug designed to treat nausea and vomiting, Zofran, generic name ondansetron, is important to certain patients, particularly those suffering the side effects of cancer treatments. However, GlaxoSmithKline made the mistake of promoting the use of this drug in women with morning sickness, although that use has never been approved. The result has been that some children were born with birth defects and the drug company is being blamed in lawsuits.
Ondansetron, Zofran, and Zuplenz
Ondansetron is the generic name for the brand name drugs Zofran and Zuplenz, both made by drug company GlaxoSmithKline. Zofran is a tablet while Zuplenz is a dissolvable strip that can be used simply by placing it on the tongue. Ondansetron is an antiemetic, which means that it treats nausea and vomiting.
The U.S. Food and Drug Administration (FDA) approved ondansetron in 1991 to be used in patients whose nausea and vomiting are caused by specific medical conditions or treatments. For instance, Zofran is most commonly used in patients undergoing chemotherapy or radiation treatment for cancer, which tend to cause nausea and vomiting. Ondansetron is not approved for nausea and vomiting caused by any illness or condition.
Although Zofran and Zuplenz are only indicated for certain uses, doctors are allowed to prescribe these drugs off-label using their own discretion. Some of the more common off-label uses include cyclic vomiting syndrome, gastroenteritis, and a severe form of morning sickness called hyperemesis gravidarum. Some doctors may even prescribe ondansetron for women experiencing normal to moderate morning sickness.
Off-Label Marketing and Lawsuit
While doctors can use their own judgement to prescribe drugs off-label, drug makers cannot market their products for off-label uses. To do so is illegal because it promotes drugs for uses that may present risks and complications. Such has been the case with Zofran and GlaxoSmithKline, which was found guilty of off-label marketing, kickbacks, and more.
The U.S. Department of Justice started a lawsuit against GlaxoSmithKline over off-label marketing and fraud, which was resolved in favor of the government in 2012. The suit involved a number of drugs, including Zofran. GlaxoSmithKline was found guilty of civil infractions related to Zofran. This included off-label marketing and using kickbacks to doctors to promote Zofran for uses other than treating cancer patients. Specifically, the company was found to be guilty of promoting Zofran for morning sickness. With all charges considered, GlaxoSmithKline ended up paying $3 billion in civil and criminal fines.
Birth Defects and Lawsuits
That GlaxoSmithKline was found to have promoted Zofran off-label for morning sickness was especially important because the drug was also found to be connected to birth defects. Research has been limited, but reports of women using ondansetron while pregnant and then having children born with birth defects are numerous. The FDA’s adverse events reporting system has been a major source of these troubling examples of children with birth defects.
In one of the few studies conducted into the possibility of birth defects associated with ondansetron, Danish researchers looked at almost one million women and their children. They found a doubled risk of birth defects related to the heart in the children born to women who had used ondansetron to treat morning sickness. Other defects seen in children of these women include cleft palate and cleft lip, club foot, skull deformities, and kidney defects.
Although GlaxoSmithKline has already had to pay the federal government over it is marketing practices in off-label promotion of Zofran, individuals who actually experienced the devastating results of birth defects are also filing lawsuits. In one of these cases a mother is suing the company because she used ondansetron to treat morning sickness and her child was born with several defects. These include heart defects, facial defects, hearing loss, a hernia, and webbed toes. She is seeking compensation for herself and her child, but also punitive damages against GlaxoSmithKline.
Another risk associated with using Zofran or Zuplenz is the possibility of altered electrical activity in the heart, which can cause an irregular heartbeat, and ultimately death. As with birth defects, adverse events reports have been a major source of information regarding this possible complication. Based on these the FDA issued a warning in 2011, several decades after the drug had already been in use.
After further investigation the FDA decided to recall one form of ondansetron. The heart problems were most strongly associated with the 32-milligram intravenous dose of the drug. All of these were recalled to prevent death by heart failure in patients. Some of the people affected by this complication believe that GlaxoSmithKline should have known of the risk and should have warned patients about it sooner.
Potential for More Lawsuits
GlaxoSmithKline no longer owns the rights to Zofran and Zuplenz. The latter was sold to Galena Biopharma and the former to Novartis, both in 2015. That doesn’t mean that GlaxoSmithKline won’t still have to answer for the mistakes it made when marketing and selling these medications. Many more lawsuits may be filed by patients who suffered heart failure or gave birth to children with birth defects.
Plaintiffs in cases against the makers of ondansetron claim that they should have tested the drug better, warned the public more effectively of the risks, not marketed the drug for off-label uses, and that they produced a defective products. There have also been claims that GlaxoSmithKline misrepresented studies making the drug seem safer than it really is.
If you think you have a case against ondansetron, you may need a lawyer to help you decide what to do and what steps to take next. A lawyer can guide you and help you figure out if your case is strong enough to ask for and get compensation from the drug companies.