Zofran is an anti-nausea drug. It works to prevent nausea and vomiting by blocking the effects of serotonin, a chemical in the body that triggers nausea and vomiting. The drug was designed to help cancer patients dealing with the side effects of chemotherapy but it was also approved by the FDA for those suffering nausea due to radiation therapy, anesthesia and surgery. Nevertheless, GlaxoSmithKline (GSK) eventually pushed to market and sell Zofran to pregnant women. Women who are pregnant are often plagued by morning sickness, and some can suffer from extreme nausea. The problem is, the FDA never approved the use of Zofran for pregnant women; it’s an “unapproved” use of the drug. Unfortunately, “off-label drug use” is very common. I wrote about off-label drug use and its potential dangers here.

By 2013, 110,000 monthly prescriptions of Zofran were issued to pregnant women. If this were an approved use, we could rest easier, as an approved use means the drug has been thoroughly tested and evaluated, with the determination backed up by “strong scientific data.” For unapproved uses there is none of that. If a drug is approved for any use, a doctor can then use his best judgment to prescribe the drug for any other purpose.

more Does Zofran Cause Birth Defects?

In 2014 a study of Zofran was published by the American Journal of Obstetrics & Gynecology (AJOG). Among other findings, the study noted a two-fold increased risk of heart defects in infants whose mothers used Zofran during their pregnancies, which led to a 30% increased risk of major congenital malformations. Other birth defects potentially caused by the pregnant mother’s use of Zofran include cleft palate and cleft lip, skull deformities, and club foot. The AJOG study also noted that other anti-nausea drugs (doxylamine and pyridoxine) were approved for use in pregnant women, which means they were thoroughly tested for use by pregnant women. So why should pregnant women use Zofran, the study asked.

In 2016 a study published in Reproductive Toxicology indicated that researchers did not see a connection between use of the drug Zofran during pregnancy and birth defects. The study appeared to focus on “extreme morning sickness,” and concluded that extreme morning sickness could be worse for the health of the baby than being exposed to Zofran.

Studies on the connection between Zofran and birth defects are continuing.

Zofran Multidistrict Litigation (MDL 2657)

Still, many children born to mothers who used Zofran during pregnancy have been born with serious birth defects. Hundreds of these families have filed lawsuits against GSK. So far more than 400 lawsuits have been filed. A multidistrict litigation (MDL) court was established in 2015 in federal court in Massachusetts (In Re: Zofran (Ondansetron) Products Liability Litigation, Case No. 1:15-md-2657). Because thousands of women have been prescribed Zofran during their pregnancies, this number will likely increase dramatically over the next few years.

MDL Judge Allows Fraud Claims to Stay in Lawsuits

In April 2017, the judge presiding over the Zofran MDL denied GSK’s motion to dismiss all fraud claims from the litigation. Now fraud is a special kind of claim against a defendant, and it requires careful and detailed allegations in the lawsuit in order to survive a motion to dismiss. In a simple negligence action, for example, a plaintiff can simply lay out basic facts to support negligence (“the driver was negligent when he was speeding along the highway, and the driver’s speed caused the car crash”). But fraud is a different animal: it essentially alleges that the defendant was intentionally deceptive, misleading, or untruthful. Fraud claims are big, and if a plaintiff proves fraud in court, the defendant can be exposed to additional damages, including punitive damages, which can explode a trial verdict.

Because fraud claims can be very expensive and burdensome on defendants, the Rules of Civil Procedure require that plaintiffs “state with particularity the circumstances constituting fraud . . . .” In the Zofran MDL, GSK argued to the Court that the plaintiffs had failed to meet this pleading burden, and therefore that the fraud claims should be dismissed.

Judge Dennis Saylor disagreed, at least with regard to allegations of GSK’s misrepresentations in its Zofran labeling. He ruled in April that plaintiffs had satisfied Rule 9(b) of the Federal Rules of Civil Procedure.

The master complaints, according to Judge Saylor, “allege generally that plaintiffs and their physicians relied on the misrepresentation in the label in prescribing and ingesting Zofran and/or ondansetron. [citations omitted] In this context, at least, that is sufficient. Pharmaceutical product labeling is highly regulated, and its very purpose is to advise prescribing physicians, who may reasonably rely on the representations in such labeling.” Memorandum and Order, pp. 14-15.

So What Does All this Mean?

The fraud claims in the Zofran MDL can move forward against GlaxoSmithKline. This is a big court victory for the 400+ plaintiffs in the litigation. But there is still work to do. If the plaintiffs can win their fraud claims at trial, they stand to recover punitive damages, and these damages are extra damages meant to punish a “bad actor.” Punitive damages are intended to send a signal to a defendant found to have intentionally or recklessly harmed someone else, and these damages are intended to be large enough to change behavior. In a recent Depuy Pinnacle hip trial in Texas, a jury awarded one billion dollars in punitive damages to plaintiffs harmed by the bad actions of Depuy, Inc. A billion dollars can certainly change behavior, even in a huge company like Depuy or GSK.

Despite the plaintiffs’ recent win regarding the fraud claims in the Zofran MDL, GSK will still vigorously defend itself. At this point, GSK refuses to admit Zofran is unsafe. However, more lawsuits will be filed, bellwethers cases will soon be tried, and we will get a better sense of the strength of these cases in the coming months.

If you took Zofran during your pregnancy and your child was born with a birth defect, contact me or another product liability attorney to discuss your potential case against GlaxoSmithKline.

Pregnancy brings with it many physical challenges, including nausea and vomiting which impact about 80% of pregnant women. It can range from being a minor issue to a potentially serious health risk, depending on the severity of the nausea and health of the mother. The drug Zofran is designed to limit nausea but it was not approved for use by pregnant women and it may cause birth defects. Although medical causation is not settled on the issue, many women who took Zofran during pregnancy gave birth to children with birth defects. Because of that potential link hundreds of lawsuits have been brought against the maker of Zofran, seeking compensation for the harm possibly done by the drug.

Intended Uses

Zofran (or ondansetron hydrochloride) helps prevent nausea and vomiting by blocking the effects of serotonin, a chemical in the body that can trigger nausea and vomiting. It was originally designed to help cancer patients dealing with the side effects of chemotherapy but is also approved by the Food and Drug Administration (FDA) for those suffering nausea due to radiation therapy, anesthesia and surgery.

more Recent Medical Study

There are conflicting studies of the possible harmful side effects of Zofran but one 2014 article on the use of Zofran by pregnant women in the American Journal of Obstetrics & Gynecology made a strong recommendation against using the drug. Gideon Koren, MD, of the Motherisk Program at the Hospital for Sick Children and the University of Toronto wrote:

• The use of Zofran in the U.S. for nausea and vomiting during pregnancy increased from about 50,000 monthly prescriptions in 2008 to 110,000 at the end of 2013, despite unresolved issues concerning fetal safety and FDA warnings about serious negative heart effects.
• A Danish study presented in August of 2013 showed the results of a study using the Danish birth registry covering 1997 to 2010 and 897,018 pregnancies. This study found a two-fold increased risk of heart defects in infants when their mothers used Zofran during their pregnancies, leading to an overall 30% increased risk of major congenital malformations.
• The FDA approved the use of a combination of doxylamine and pyridoxine in April 2013 specifically for nausea and vomiting during pregnancy. Since this safe and effective drug is available, there is no reason for women to be exposed to Zofran due to safety concerns for the mother and child.

Lawsuits Mounting

More than 200 lawsuits have been filed by plaintiffs claiming that their children were harmed by Zofran during pregnancy and that the manufacturer, GlaxoSmithKline (GSK), is to blame. These legal claims have been consolidated in federal court in Massachusetts. Plaintiffs claim the drug caused heart defects, cleft palates and other birth defects.

This isn’t the only issue involving Zofran that’s gotten GSK in trouble. The company agreed to plead guilty and to pay $3 billion to resolve criminal and civil liability due to their unlawful promotion of certain prescription drugs (including Zofran), its failure to report certain safety data and its civil liability for alleged false price reporting practices in 2012.

Part of the allegations was that GSK promoted some forms of Zofran for the treatment of morning sickness in pregnant women which is a use not approved by the FDA. GSK agreed to settle claims that it paid kickbacks to health care professionals to encourage them to promote and prescribe Zofran and other drugs. This resulted in $1.043 billion in false claims payments to the federal and state governments. The settlement money went to the federal government, several states, the District of Columbia and to plaintiffs involved in GSK whistleblower lawsuits.

GSK has shown it wasn’t afraid to bend the law when it comes to generating sales of Zofran. The drug may also be the cause of serious health problems for possibly thousands of children, leaving parents to care for them and pay a lifetime of medical bills.

If you believe your child has been harmed by Zofran and would like to learn more, the drug’s possible side effects and the growing litigation, feel free to call me so we can talk about your case, how the law may apply and your best options for obtaining compensation.