Zofran lawsuits are mass tort claims against the pharmaceutical company GlaxoSmithKline for birth defects caused by its nausea pill, Zofran. Zofran was routinely prescribed for expectant mothers who suffered from morning sickness, even though the drug was not approved for use during pregnancy. It has since been linked to sharp increases in the risk for cleft palette and congenital heart defects. The lawsuits claim that GlaxoSmithKline failed to warn doctors and patients of the risks, and seek compensation for:
- Medical expenses,
- Lost wages for the mother,
- Reduced earning capacity, and
- Pain and suffering.
- 1. What is Zofran?
- 2. Side effects of Zofran
- 3. Lawsuits over birth defects caused by Zofran
- 4. Compensation for victims of Zofran
- 5. What to do if you think you have been hurt by Zofran
1. What is Zofran?
Zofran is the brand name of the drug ondansetron. It is a powerful anti-nausea drug that has been approved by the U.S. Food and Drug Administration (FDA) to prevent vomiting and nausea caused by cancer treatments like chemotherapy. It can be taken orally in a pill form, or through intravenous injection.
Importantly, Zofran’s approval by the FDA has never included use by pregnant women.1 Nevertheless, Zofran has been prescribed by doctors to pregnant women to treat nausea associated with morning sickness. This “off-label” use is legal for doctors to do, but is illegal for pharmaceutical companies to promote.
Even though promoting Zofran as a treatment for morning sickness violated the Food, Drug and Cosmetic Act, GlaxoSmithKline did it, anyway. After a whistleblower lawsuit brought attention to GlaxoSmithKline’s illegal promotion of Zofran, the U.S. Department of Justice took up the case. GlaxoSmithKline ended up pleaded guilty to claims of healthcare fraud and paid $3 billion in fines in 2012.2
2. Side effects of Zofran
Zofran has several side effects. The most common and least severe include:
- Blurred vision,
- Drowsiness and fatigue,
- Skin rash,
- Diarrhea, and
However, Zofran also has several serious side effects:
- Irregular heartbeat, and
- An increased risk of birth defects when taken by pregnant women.
2.1 Zofran increases the risk of birth defects
Several medical studies have found that Zofran can drastically increase the risk of serious birth defects when the drug is taken by a pregnant woman, including:
- Cleft palette, and
- Congenital heart defects.
A cleft palette happens when the tissues that form the roof of a newborn’s mouth fail to come together. As a result, there is a hole in the roof of the newborn’s mouth, which opens into the baby’s nose. The condition can lead to feeding, speech, and hearing problems, as well as frequent ear infections. It often requires surgery to correct.
In one study, medical researchers found that babies born to mothers who took Zofran to treat morning sickness were 237% more likely to have a cleft palette.3
Congenital heart defects are another type of birth injury that has been associated with Zofran. There are a variety of forms of these defects, some of which are often fatal to newborns within weeks, while others are minor enough that they escape detection for years. Examples of congenital heart defects include:
- Atrial or ventricle septal defects, or abnormalities in the walls that separate the heart’s main chambers,
- Single ventricle defects, which leaves one of the heart’s pumping chambers undeveloped,
- Anomalous pulmonary venous connection, where the four veins that bring blood from the lungs to the heart are not correctly connected, and
- Pulmonary valve stenosis, where the valve that pumps blood from the heart to the lungs is too narrow.
Zofran has been linked to exceptionally higher risks for septal defects. Two studies found that babies born to women who took Zofran were 60% more likely to develop any type of congenital heart defect.4 Septal defects, however, were especially common in newborns whose mothers took Zofran during pregnancy. Newborns were:
- 2.1 times more likely to have an atrial septal defect,
- 2.3 times more likely to have a ventricular septal defect, and
- 4.8 times more likely to have an atrioventricular septal defect, or a literal hole in the inside of the heart.5
3. Lawsuits over birth defects caused by Zofran
Hundreds of lawsuits have been filed against GlaxoSmithKline for birth defects caused by Zofran. These lawsuits claim that GlaxoSmithKline breached its legal duty to warn doctors and patients about the dangers of the drug, and actively promoted its off-label use for pregnant women who were at the most risk of its side effects.
Drug companies have a legal obligation to warn doctors and patients about the serious side effects of their drugs. Both doctors and patients rely on these disclosures to make informed health decisions and avoid serious health complications. However, drug companies often try to avoid disclosing the dangers of their drugs because it makes them seem unsafe and could threaten sales.
The lawsuits against GlaxoSmithKline claim that the pharmaceutical company knew about the dangers that Zofran posed to pregnant women and unborn babies, but failed to warn anyone about the risks. The lawsuits claim that GlaxoSmithKline marketed Zofran to pregnant women by urging doctors to prescribe it to them, even though there were no scientific studies that showed it was safe.
Because so many people across the U.S. have been hurt by Zofran, and because they were all hurt by a single course of conduct – GlaxoSmithKline’s failure to warn about the dangers of the drug – Zofran birth defects are a classic example of a mass tort. Like many mass torts, courts have consolidated the hundreds of cases involving Zofron’s birth defects into one federal district court through the process of multidistrict litigation (MDL). Multidistrict litigation streamlines the process by allowing the lawsuits to collectively go through pretrial procedures like the discovery of evidence, preliminary motions, and depositions.
The MDL involving birth defects associated with Zofran is being heard by the District Court of Massachusetts.6 As of April 15, 2019, there were 460 lawsuits consolidated in that MDL.7
Lawsuits seeking to hold GlaxoSmithKline accountable for birth injuries caused by generic versions of Zofran have been getting dismissed from the MDL.8 However, cases filed by victims who suffered from Zofran, itself, have survived the summary judgment stage.9
Bellwether trials are currently being scheduled for a select group of cases in the MDL.
4. Compensation for victims of Zofran
Victims who have suffered from Zofran have been seeking compensatory damages as well as punitive damages in their lawsuits against GlaxoSmithKline.
Compensatory damages aim to compensate victims for all of the losses and setbacks they have endured because of Zofran. These include:
- Medical expenses incurred to treat and correct the birth defect, including the costs of corrective surgeries and speech therapy for children born with a cleft palette,
- Anticipated future medical expenses, including the ongoing care that children born with congenital heart defects need,
- A child’s diminished capacity for professional success, due to their medical condition,
- Wages that a parent has lost while caring for their child’s condition,
- Physical pain, and
- Mental suffering and loss of life’s enjoyments.
Additionally, Zofran lawsuits have pursued punitive damages, as well. Punitive damages are meant to punish the defendant – in this case, GlaxoSmithKline – for egregious conduct that needlessly put victims in harm’s way.
5. What to do if you think you have been hurt by Zofran
If you or your child was born with a congenital heart defect or cleft palette, and you or your mother was taking Zoloft while she was pregnant, you may be entitled to compensation for your medical condition.
Because birth defects involve newborn children, most states “toll,” or delay, their statutes of limitations until the child turns 18 years old. This allows the child to pursue their legal rights to compensation, even if their parents refused to do so.
- See FDA Approval Letter (January 27, 1999) (approving the use of Zofran in pill form).
- Department of Justice, “GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data,” (July 2, 2012).
- Anderka M, Mitchell AA, Louik C, Werler MM, Hernández-Diaz S, Rasmussen SA, “Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects,” Birth Defects Research 94(1):22-30 (January 2012).
- Pasternak B, Svanström H, Hviid A, “Ondansetron in Pregnancy and Risk of Adverse Fetal Outcomes,” New England Journal of Medicine 368:814-23 (January 28, 2013); Danielsson B, Wikner BN, Källén B, “Use of ondansetron during pregnancy and congenital malformations in the infant,” Reproductive Toxicology 50:134-7 (December 2014).
- In re: Zofran (Ondansetron) Products Liability Litigation, MDL No. 2657.
- MDL Statistics Report – Distribution of Pending MDL Dockets by District (April 15, 2019).
- In re: Zofran (Ondansetron) Products Liability Litigation, MDL No. 2657 (D. Mass. 2018) (order on defendant’s motion for judgment on the pleadings).
- In re: Zofran (Ondansetron) Products Liability Litigation, (order on defendant’s motion for summary judgment based on federal preemption).