Zofran Lawsuit

close up of a group of white tablets with an out of focus prescription bottle in the background

Up to 80 percent of women suffer from moderate to severe nausea during pregnancy. For years, doctors have prescribed Zofran to treat morning sickness, even though the drug was never FDA-approved for this purpose. The fact that no human trials were performed to establish the safety of Zofran during pregnancy raises issues of liability in cases where children were born with severe birth defects.  

Every year, more than 1 million women in the U.S. are given Zofran for pregnancy-related morning sickness — many during the first trimester when the developing fetus is most vulnerable to harm. Should manufacturer, GlaxoSmithKline, be held responsible for marketing Zofran for “off-label” or unapproved purposes without clearly underscoring the benefit-risk ratio? Hundreds of families across the nation say yes.

Zofran risks during pregnancy not explained

The pharmaceutical giant ultimately paid a $3 billion settlement to the Department of Justice, after investigations revealed GSK was promoting several of its top-selling drugs including Zofran for off-label uses and making false representations about their safety and efficacy.

Based on studies and anecdotal evidence showing a link between Zofran (ondansetron) use in early pregnancy and congenital malformations, women who took the drug for morning sickness and gave birth to a child with birth defects have taken their grievances to court. The first Zofran lawsuit was filed and 2015, and now GSK faces hundreds of claims in courts around the country.

Discuss your eligibility for filing a Zofran birth defects lawsuit with attorney Bart Bernard. Renowned for his staunch advocacy and client-focused representation in complex product liability cases, Bart Bernard holds membership in the Multi-Million Dollar Advocates Forum and the Elite Lawyers of America. When your child has suffered needless injuries because of a manufacturer’s failure to warn, you need qualified legal counsel who can fight for your rights to maximum compensation. Be Smart. Get Bart.™

FDA briefing document underscores risks of drugs in pregnancy

In 2018, the FDA released a briefing document intended to help patients make informed decisions about the use of prescription drugs during pregnancy. According to the advisory panel, “reliable clinical evidence informing safe drug use in pregnancy is generally lacking, but labeling regulation under the Pregnancy and Lactation Labeling Rule requires the inclusion of available data about use of the medication during pregnancy.”

The FDA states that “pregnant women and their healthcare providers rely on information and the prescription product labeling to guide the safe and effective use of these products,” and that a “lack of interpretable human data combined with potential risk misperceptions can impact appropriate risk-benefit decisions about the use of a drug during pregnancy.”

Is Zofran causing birth defects in unborn children? Post-market studies on pregnant women who took ondansetron in their first trimester suggest that neonatal exposure to the drug may increase the risk of:

  • Oral clefts such as cleft lip and cleft palate
  • Neural tube defects
  • Cranial defects
  • Congenital heart malformations including ventricular septal defect and atrial septal defect

Zofran lawsuits consolidated under MDL

By the end of 2015, more than 200 Zofran lawsuits alleging the anti-nausea drug caused birth defects had been filed by plaintiffs throughout the country. Given the growing litigation, GlaxoSmithKline requested the cases be centralized before one judge for more efficient proceedings. The Judicial Panel on Multidistrict Litigation transferred the Zofran actions to the U.S. District Court of Massachusetts, before the honorable Judge F. Dennis Saylor.

The discovery phase of the federal Zofran multidistrict litigation began in 2016. The first bellwether trial, scheduled for January 13 has been postponed until May 4, 2020, allowing the FDA to review Zofran’s pregnancy-related labeling. 

Meanwhile, GSK maintains that plaintiffs’ allegations of ‘failure to warn’ should be preempted by federal law – an argument previously rejected by the Massachusetts federal judge.

Key allegations in Zofran birth defect claims

Lawsuits contend that GlaxoSmithKline did not provide sufficient warnings about the possibility of fetal harm on Zoloft labels.

Claimants also allege that: 

  • The defendant vigorously promoted Zofran as a treatment for morning sickness even though its safety to developing babies was not proven
  • The defendant failed to caution about potential side effects to the unborn fetus
  • The defendant knowingly withheld information regarding the risks of Zofran during pregnancy

Free case review with Bart Bernard Injury Lawyers

If your child was born with birth defects after Zofran exposure in-utero, contact Bart Bernard Injury Lawyers to arrange a free, no-obligation case review.

Our legal team operates on a contingency fee basis, which means we advance all costs to investigate and litigate your claim. Put the experience and resources of a dedicated Zofran lawyer to work for you. Call today to discuss your rights to compensation.

Additional Resources:

  1. Reuters, Judge delays first Zofran birth defect trial for potential FDA action https://www.reuters.com/article/products-liability-zofran/judge-delays-first-zofran-birth-defect-trial-for-potential-fda-action-idUSL2N28021P
  2. FDA, Drug Safety Communication: New information regarding QT prolongation with ondansetron (Zofran) https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-new-information-regarding-qt-prolongation-ondansetron-zofran
  3. FDA, Communicating Information about Risks in Pregnancy in Product Labeling for Patients and Providers to Make Informed Decisions about the Use of Drugs during Pregnancy https://www.fda.gov/media/110905/download
  4. National Birth Defects Prevention Study, Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects https://www.ncbi.nlm.nih.gov/pubmed/22102545