Zofran Lawsuits Quick Facts
To treat nausea and vomiting associated with a variety of conditions
How Many Lawsuits
Major Side Effects
Federal: District of Massachusetts
Zofran lawsuits claim the manufacturer failed to warn patients of the possibility of birth defects associated with the anti-nausea drug. More than 600 Zofran lawsuits have been filed by mothers whose babies suffered birth defects like cleft palates, kidney malformations, skull deformities and heart defects.
When the only FDA-approved medication used to treat morning sickness (Bendectin) was withdrawn from the market in 1983, pregnant women needed a new solution. Fast-forward eight years to 1991, and GlaxoSmithKline’s anti-nausea drug Zofran received approval to help cancer patients with nausea and vomiting related to chemotherapy, radiation and surgery. Doctors took notice of the effects and began prescribing Zofran for their suffering pregnant patients as an off-label treatment for morning sickness.
Zofran Birth Defects
Cleft palate, kidney malformation, and heart defect are words a new parent never wants to hear in reference to their newborn baby. But that’s exactly what mothers are claiming resulted from using Zofran during pregnancy. Since morning sickness can put a mother and her unborn baby at risk of malnutrition, many women are prescribed Zofran to prevent nausea and vomiting, and to keep their babies safe. Unfortunately, the drug may have had the opposite effect.
Many mothers allege their babies suffered severe birth defects, including:
- Congenital heart defects
- Cleft palates and cleft lips
- Kidney malformations
- Skull deformities
All of these birth defects will require a lifetime of care for the children born with them. Health care costs will be much higher than they would have been without the defects, and parents may need to hire nurses and others to help provide specialized care.
Why People Are Filing Zofran Lawsuits
Although it was never 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 the 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. To this day, this is the largest settlement for alleged health care fraud in U.S. history.
Private Zofran Lawsuits
Based on the birth defect claims, GlaxoSmithKline is now the subject of more than 465 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.
Affected families have sued GlaxoSmithKline over allegations that it marketed the drug to pregnant women without FDA approval, paid doctors to prescribe it, and failed to provide warnings about the risks.
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 as a way to improve the efficiency of the proceedings. While the cases remain individual complaints, many have similar claims and evidence, which can be handled much faster as a “master complaint” than going through the court system separately. The docket, formally known as In re: Zofran (Ondansetron) Products Liability Litigation, is 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 to prenatal exposure to drug. Furthermore, since the FDA has never approved Zofran to treat morning sickness, the companies violated federal laws and regulations related to drug marketing.
Court documents show that as early as 1992, GlaxoSmithKline knew that Zofran was linked with an increased risk of harm to unborn babies as it passes through the human placenta during pregnancy. Despite this knowledge, the company continued promoting the drug to doctors and pregnant women for morning sickness.
- 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 a safe treatment 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
As of December 2018, more than 630 Zofran lawsuits have been transferred to the United States District Court for the District of Massachusetts as part of MDL 2657. GlaxoSmithKline has offered no settlements in pending cases.