You may be able to sue GlaxoSmithKline LLC, the maker of Zofran, on behalf of your child. Hundreds of parents have already filed lawsuits, and you and your child can join them in taking legal action to get compensation and hold GlaxoSmithKline accountable. Contact our law firm for a free case review. Attorneys Fred Pritzker and David Szerlag are our lead lawyers for these cases.

Zofran (Ondansetron) is a medication used to treat nausea and vomiting in patients receiving chemotherapy. However, off-label use is for treatment of morning sickness. Medical studies have associated Zofran with an increased risk of certain birth defects, including:

  • Cleft palate (a “doubling of odds,” according to one study (1));
  • Cardiovascular defects, “notably a cardiac septum defect were increased and statistically significant” (2)

Zofran Labeling Mentions Pregnancy Even Though it is Not an FDA-Approved Use

Attorney David Szerlag
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In 1999, the FDA approved the use of Zofran for “the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy” (3). The drug label and approved usage have changed over the years, but use for morning sickness has never been an FDA approved use as listed under the “Indication and Usage” section of the product label.

In 2000, the following language was added to the labeling, and it has remained, unchanged, since then:

Pregnancy Category B: Reproduction studies have been performed in pregnant rats and rabbits at daily or all doses up to 15 and 30 mg/kg/day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed” (4).

A majority of pregnant women have some morning sickness in the first 3 months of pregnancy, called the first trimester. It is during this time that unborn babies are most at risk for developing birth defects from certain medications (5). In the first 4 weeks, the baby’s heart begins to form (6) and, by the end of 8 weeks, the mouth is developing tooth buds (7).

Our hope is that these lawsuits will help get some answers for the many parents whose children were born with cleft palate or cardiovascular defects after use of Zofran for morning sickness.

Lawsuits in MDL, not a Class Action

Pretrial procedures for Zofran lawsuits have been consolidated in multi-district litigation (MDL), which is somewhat like a class action, but each claimant (the person suing) has an individual lawsuit seeking money damages specific to that person’s injuries. This is important because every child allegedly injured by this product is unique and has unique injuries. These children should not be lumped together in a class action.

Multidistrict Litigation is litigation comprised of multiple civil cases involving one or more common questions of fact which have been transferred from different federal districts by the Judicial Panel on Multidistrict Litigation to a single federal district for coordinated or consolidated pretrial proceedings under 28 U.S.C. Section 1407.

The Zofran MDL is in the United States District Court for the District of Massachusetts and the presiding judge is the Honorable Dennis F. Saylor IV (In re: Zofran (Ondansetron) Products Liability Litigation, MDL No. 2657).

Baby Injured Lawsuit

  1. Anderka, Marlene, et al. “Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects.” Birth Defects Research Part A: Clinical and Molecular Teratology 94.1 (2012): 22-30. Accessed at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3299087/.
  2. Danielsson, Bengt, Birgitta Norstedt Wikner, and Bengt Källén. “Use of ondansetron during pregnancy and congenital malformations in the infant.” Reproductive Toxicology 50 (2014): 134-137. Accessed at http://www.sciencedirect.com/science/article/pii/S0890623814002810.
  3. FDA Approval Letter 1999. Accessed at http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20103S15_Zofran_appltr.pdf.
  4. Zofran Prescribing Information 2000. Accessed at http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20781S2LBL.PDF.
  5. http://www.cdc.gov/reproductivehealth/maternalinfanthealth/pregcomplications.htm
  6. http://www.womenshealth.gov/pregnancy/you-are-pregnant/stages-of-pregnancy.html#first
  7. http://www.hopkinsmedicine.org/healthlibrary/conditions/pregnancy_and_childbirth/first_trimester_85,P01218/