A reader wrote in with this question: “I have 3 children with significant health issues from taking Zofran when I was pregnant. They’re now 18 and I have 17-year-old twins. Do I still have time to file a mass tort case against Zofran’s manufacturer? Or do I need to file a Zofran lawsuit against the hospital that prescribed me the drug instead?”
Reader, first, we acknowledge how difficult it must be to raise 3 children with significant health issues. Parenting can be challenging even with the healthiest of children, and we know that having children with health issues presents an additional, very difficult, set of circumstances to handle.
Unfortunately, we have bad news. Thanks to a January 2023 ruling siding with Zofran’s manufacturer, you likely cannot file a case for your children’s injuries. That ruling in that case, In re Zofran (Ondansetron) Products Liability Litigation, — F.4th —, 2023 WL 128570 (1st Cir. Jan. 9, 2023), basically said that because plaintiffs did not produce “new” evidence, the courts dismissed all remaining Zofran lawsuit claims.
This sets a legal precedent that could be impossible to overcome. Why? Because the only way favor might swing back to the plaintiffs is if the Supreme Court took up the case. We should add that that outcome is extremely unlikely since this case is a year old now.
What is Zofran?
Zofran is a brand name of the drug Ondansetron, which doctors prescribe to radiation and chemotherapy patients for nausea. An off-label Zofran use (“off-label” is when doctors prescribe medication for situations not explicitly approved by the FDA) is to treat nausea during pregnancy.
Studies show that taking Zofran during pregnancy does not lead to an increased risk of fetal death. However, hundreds of parents sued the drug’s manufacturer, GlaxoSmithKline, saying the drug caused birth defects. Studies by Harvard researchers determined a slight risk from using Zofran during pregnancy. Their report states that there is no increased risk of cardiac malformations and a very small increased risk of oral clefts.
Of course, “slight risk” and “small increased risk” means that some babies had adverse reactions from their mother’s consumption of Zofran while pregnant. Zofran lawsuit plaintiffs usually focus on two main elements in their claims:
- The fact that the FDA did not approve Zofran for use during pregnancy.
- GlaxoSmithKline did not warn them of potential risks when doctors prescribed the medication during pregnancy.
These examples are only a tiny representation of all studies regarding Zofran’s safety; to list them all here is impossible. Like any other contentious matter, studies to support both the plaintiff and the defendant in any Zofran lawsuit do exist.
What Recent Change Makes Filing a Zofran Lawsuit Now a Bad Idea?
The important change in January 2023 is that a ruling (referenced above) came down siding with GlaxoSmithKline, which set a precedent that might prevent people from winning suits going forward.
This reader also asked if she should file suit against the hospital that prescribed Zofran rather than the drug’s manufacturer. That type of case would be a medical malpractice case, which falls under the umbrella of personal injury law.
Can I Sue for Medical Malpractice if Zofran Harms Me?
All valid medical malpractice claims share three things:
- Your doctor or facility did not provide what’s called an adequate standard of care.
- That act of negligence or omission injured you or caused substantial harm.
- You can prove that the injury resulting from those negligent actions resulted in significant damages for which you deserve payment.
To say that a doctor or hospital did not offer the proper standard of care is the same as saying they didn’t treat you the same as they’d treat others in the exact same situation. Since doctors prescribed countless pregnant women Zofran, that would likely be difficult to prove.
Saying that a doctor or hospital caused your injury means that injury wouldn’t exist without their direct actions (or lack thereof). One element you might prove is true, however. If the doctor hadn’t prescribed Zofran, your children may not have the medical issues they suffer from today. But you would also have to show that Zofran directly caused your children’s medical issues, not anything else.
Finally, to prove that you suffered significant damages as a result of their action or inaction means that you must show that those injuries or damages resulted in lost wages, significant medical costs, pain and suffering, and other expenses you can recover from a Zofran lawsuit.
Lisa Allen is a writer and editor who lives in suburban Kansas City. She holds MFAs in Creative Nonfiction and Poetry, both from the Solstice Low-Residency Program in Creative Writing at Pine Manor College. Prior to becoming a writer, Lisa worked as a paralegal, where she specialized in real estate in and around Chicago.