Zofran and Zuplenz help cancer patients and those who have recently undergone surgery avoid nausea and vomiting. The drug can also minimize nausea for pregnant women — but its usage comes accompanied by a significantly increased risk of birth defects. Many families have taken Zofran manufacturer GlaxoSmithKline to court, alleging that the drugmaker marketed the medication to expectant mothers without Food and Drug Administration (FDA) approval. Additionally, many plaintiffs have claimed that Glaxo misrepresented animal studies to prove the alleged safety of the drug.
Unapproved Use of Zofran for Pregnant Women
Zofran (ondansetron) was originally designed to control chemotherapy-induced and postoperative nausea and vomiting. Approved by the FDA in 1991, the drug proved very effective when used for its original purpose.
In an ideal world, drug manufacturer GlaxoSmithKline would have continued to market Zofran exclusively for the aforementioned approved purposes. Instead, Glaxo decided to market Zofran to pregnant women, many of whom were desperate to keep morning sickness and other instances of nausea to a minimum. The drug did successfully reduce nausea for many expectant mothers, but it also left their children susceptible to a variety of serious birth defects. The FDA never approved Zofran for use by pregnant women, and yet, many were prescribed this exceedingly dangerous drug, which passes through the placenta.
Zofran was by no means the only antiemetic agent marketed to pregnant women. After the drug lost its patent in 2006, a generic version of ondansetron manufactured by Novartis and Sandoz was prescribed to numerous patients. A few years later, many others were put at risk when a dissolving drug known as Zuplenz was released.
Glaxo recently pleaded guilty to three charges of fraud in a $3 billion settlement involving antidepressant medications Wellbutrin and Paxil, and now, hundred of lawsuits related to Zofran further threaten the already disgraced drug manufacturer. Galena Biopharma could also face legal action as the cancer immunotherapy company recently acquired marketing rights for Zuplenz.
Why are Patients filing Zofran Lawsuits?
Extensive evidence indicates that, as early as 1992, Glaxo was aware of the increased risk of birth defects among expectant mothers prescribed Zofran. The manufacturer continued to market Zofran to pregnant women long after the risks were made clear. In fact, the medication was marketed as a “wonder drug,” despite the fact that not a single study had indicated that it was safe for pregnant women to use. Furthermore, expectant mothers were purposefully excluded from Glaxo’s clinical trials when the company initially sought approval from the FDA.
Not only did Glaxo market Zofran to an at-risk population, but it is also believed to have improperly evaluated safety data — and even misrepresented animal studies in hopes of convincing potential users of the drug’s safety. Despite receiving dozens of reports of birth defects related to Zofran consumption, Glaxo neglected to disclose health concerns to pregnant women or their doctors.
After pleading guilty to criminal charges, Glaxo reached a civil settlement with the United States, in which it admitted to marketing Zofran for multiple conditions — including morning sickness — for which it had never been approved. The company also confessed to paying health care professionals to market and prescribe Zofran.
Those who file Zofran lawsuits aim to hold GlaxoSmithKline accountable via punitive damages. Additionally, many patients seek compensatory damages for the physical suffering endured by their children, along with the emotional distress related to caring for children with birth defects. The medical bills associated with these birth defects have been substantial for many victims, who face a lifetime of rehabilitative care.
Types of Birth Defects Suffered by Zofran and Zuplenz Users
The vast majority of expectant mothers experience morning sickness during the early stages of pregnancy. Many suffer hyperemesis gravidarum, a form of nausea that can endanger both the mother and child by causing malnutrition. Sadly, while Zofran and Zuplenz have helped numerous women minimize morning sickness and hyperemesis gravidarum, use of the drug has also led to a variety of severe birth defects, including the following:
- Septal Defects and other heart defects
- Cleft Palate
- Cleft Lip
- Club Foot
- Kidney defects
Examples of Zofran and Zuplenz Birth Defect Lawsuits
According to a Centers for Disease Control (CDC) study, Zofran doubles the risk of birth defects. Aware of this increased risk far too late, many mothers who took the medication while pregnant have since sought to hold GlaxoSmithKline and other drug companies accountable. Numerous pending cases were consolidated to a multidistrict litigation court in late 2015.
LeClair v. GlaxoSmithKline
Massachusetts resident Tomisha LeClair was one of the first Zofran victims to file a birth defect lawsuit. She initially took Zofran in hopes of reducing severe nausea that compromised her work schedule while she was pregnant. She was told that the drug safe, so she never suspected that it would cause her daughter to suffer numerous congenital defects. Sadly, her daughter was born with facial dysmorphia, webbed toes, hearing loss, an inguinal hernia, and multiple heart defects. Had she known that her daughter could suffer so many birth defects, LeClair would have never taken Zofran while pregnant.
Easterly et al. v. GlaxoSmithKline
In a lawsuit initially filed in Kentucky, a family claimed that Zofran led to the premature birth of their child, who was promptly diagnosed with several heart defects. These included the exceedingly rare hypoplastic right heart syndrome, which is marked by an almost entirely unformed right side of the heart. The baby died just eight days after his birth. This occurred over three years ago, and the parents have suffered severe emotional distress ever since.
Trish Belanger and Bryce Belanger v. GlaxoSmithKline
In March 2016, Trish and Bryce Belanger filed a complaint with the U.S. District Court for the Eastern District of Louisiana. This complaint has since been transferred to the multidistrict litigation court in Boston. The Belangers allege that both of their daughters suffer heart defects, which were caused by exposure to Zofran while Trish Belanger was pregnant.
GlaxoSmithKline’s Fraud Settlement
In 2012, the U.S. Department of Justice filed civil and criminal claims against GlaxoSmithKline. With an agreed-upon $3 billion payment, this was the largest health care fraud settlement in United States history. The first billion was used to cover fines for the three counts of criminal behavior for which the company pleaded guilty. The rest of the payment was used to settle state and federal civil liabilities for fraud. Although this lawsuit involved Paxil, Wellbutrin, and Avandia, it is indicative of a corporate culture of obfuscation at Glaxo.
Glaxo and other drug manufacturers have put millions of women and their children at risk by neglecting to inform them of the increased likelihood of birth defects among those who take Zofran and Zuplenz. If you believe your child’s birth defect can be attributed to in utero exposure to Zofran or Zuplenz, you may be eligible for remuneration. The right attorney can help you secure the compensation you deserve, while also holding GlaxoSmithKline and other drug manufacturers accountable. By exercising your legal rights, you can get the word out and prevent other families from experiencing the devastation of birth defects.