Zofran lawsuits claim the manufacturer failed to warn patients of the possibility of birth defects associated with the anti-nausea drug. More than 670 Zofran lawsuits have been filed by mothers whose babies suffered birth defects like cleft palates, kidney malformations, skull deformities and heart defects.
Why Parents Are Filing Zofran Lawsuits
In 1991, GlaxoSmithKile's anti-nausea drug Zofran (ondansetron) received approval from the U.S. Food and Drug Administration (FDA) to manage nausea and vomiting side effects of cancer treatments like chemotherapy, radiation and surgery. Given the effectiveness of the drug at treating those side effects, some doctors also began prescribing Zofran to pregnant women as an off-label treatment for morning sickness.
Some women who took Zofran while pregnant later delivered babies with various birth defects. Believing that Zofran caused their babies' birth defects, several hundred women filed lawsuits against GSK, claiming that the company knew about the potentially dangerous side effects of the drug but failed to warn doctors and patients about them. Some of these lawsuits may end up being medical malpractice cases rather than product liability, depending on if and where courts assign responsibility for these serious adverse events.
Does Zofran Cause Birth Defects?
Early Zofran lawsuits relied on evidence from a handful of studies showing a slightly increased risk of certain birth defects. For example, one study that reviewed Swedish birth records found a low increased risk of heart-related defects. Another study using data from the National Birth Defects Prevention Study (NBDPS) suggested an increase in the risk of cleft palate in children whose mothers took Zofran while pregnant.
However, in recent years a number of other studies have shown no link between ondansetron and birth defects in women who take the drug during their first trimester (when morning sickness is typically at its worst). GSK has even accused plaintiffs' lawyers of funding studies that found a link between Zofran and birth defects.
While studies may show no or little risk of birth defects due to Zofran, some researchers nonetheless add statements to their findings indicating that the safety of the drug for pregnant women and developing fetuses is still unclear.
Zofran Off-Label Marketing
Although it was not approved for use during pregnancy, Zofran quickly became the top-selling morning sickness drug in the United States in the 1990s. Concerned that GlaxoSmithKline was marketing the drug in a false or misleading manner, the FDA issued a warning letter in March 1999, ordering the company to cease distribution of its promotional materials because they failed to note risks associated with Zofran.
In 2003, two former employees of GlaxoSmithKline claimed the company promoted the off-label use of Zofran for morning sickness. The Justice Department took the drugmaker to court in 2011, and GlaxoSmithKline agreed to pay the government $3 billion to settle the agency's claims related to Zofran and other drugs. As of March 2019, this is still the largest settlement for alleged drug marketing violations in U.S. history.
Based on the birth defect claims, GlaxoSmithKline is now a defendant in more than 670 Zofran lawsuits in federal courts. (Novartis, another drug manufacturer, is also named in lawsuits filed after March 23, 2015, due to its purchase of GSK's oncology division.)
The first Zofran lawsuit was filed in February 2015 by a Minnesota mother on behalf of her two daughters born with congenital heart defects. More families quickly followed suit, with actions piling up in federal courts in New Jersey, Texas, Alabama, Ohio, Montana, Louisiana, Arkansas, and Massachusetts. A couple of lawsuits have also been filed in state courts, but most are being handled by federal jurisdictions.
Zofran Multidistrict Litigation (MDL 2657)
In October 2015, twelve lawsuits related to Zofran were transferred to the U.S. District Court for the District of Massachusetts as a multidistrict litigation filed under MDL 2657, In re: Zofran (Ondansetron) Products Liability Litigation. Since then, the MDL has grown to encompass more than 700 lawsuits, about 445 of which were still active as of May 2020. Proceedings for Zofran lawsuits being overseen by Judge F. Dennis Saylor.
A common complaint among plaintiffs in the Zofran MDL is that GlaxoSmithKline (and later Novartis) failed to warn patients, medical providers and the general public of the potential dangers of prenatal exposure to the drug. Furthermore, since the FDA has never approved Zofran to treat morning sickness, plaintiffs argue that the companies violated federal laws and regulations related to drug marketing.
GlaxoSmithKline tried to have all of the MDL cases dismissed through summary judgment, claiming that federal regulations preempted claims of the plaintiffs. However, in February 2019, Judge Saylor denied GSK's motion, allowing the lawsuits to move forward. In its annual report, GSK said it would continue to vigorously defend itself against these lawsuits and move forward with attempts to dismiss cases on an individual basis.
- Legal obligation to ensure Zofran was safe before releasing and promoting it
- Failure to warn the public and medical communities about the risk of Zofran side effects
- Marketing Zofran as safe for off-label treatments, such as morning sickness and hyperemesis gravidarum
- Misrepresenting animal studies claiming Zofran was safe
- Failure to analyze all data and safety information about Zofran use by pregnant women
- Falsely and fraudulently claiming Zofran was safe for pregnant women
- Manufacturing a defective drug
Zofran Settlements and Verdicts
As of mid 2019, no settlements or verdicts have been reached for Zofran lawsuits tied to birth defects. Most cases are still going through the pretrial motion and discovery phase as part of MDL 2657.
GlaxoSmithKline insists that it will continue to fight claims that Zofran causes birth defects. Whether they remain adamant depends largely on how early cases go. If juries award damages to mothers whose children were born with defects, then it could be in GSK's best interest to offer a settlement to the rest of the plaintiffs.
Zofran Lawsuit FAQs
Can I File a Zofran Lawsuit?
You could have a viable case if your child was born with birth defects after you (or your spouse) took Zofran while pregnant. Note that not all birth defects may be linked with Zofran. Some of the defects named in lawsuits that have already been filed include:
- Congenital heart defects
- Cleft palates and cleft lips
- Kidney malformations
- Skull deformities
The best way to know whether you are eligible to file a Zofran lawsuit is to get a free case review right away.
What Compensation Can I Receive from a Zofran Lawsuit?
Damages for each Zofran case will be determined based on the specific situation. Some of the things that a settlement or verdict will take into account are:
- The type of birth defect and its impact on the infant's expected quality of life
- The costs of treatment for the birth defect, including necessary prescriptions
- The expected costs of ongoing care related to the birth defect
Compensation in birth defect and birth injury cases is intended to help the child throughout their entire life, and the final amount could be quite considerable. It is not uncommon for such compensation to be placed in a trust fund or to be paid out over several years in a structured settlement.
In addition to the above, punitive damages could be awarded by juries as a way to punish GSK for failing to warn about dangerous side effects.
How Much Does a Zofran Attorney Cost?
Initially, you will not need to pay anything, since most prescription drug lawsuits are filed on contingency. This allows people filing to avoid any upfront costs. In a contingency agreement, you will only be required to pay legal fees if your claim is successful and you win compensation through a settlement or verdict.