For more information or confidential assistance
se habla español

Zofran Birth Defect Lawsuit Accuses GSK of Misrepresentation

ultrasound on pregnant woman

An Alabama mother has filed a Zofran lawsuit against GlaxoSmithKline on behalf of her daughter. She claims the pharmaceutical giant engaged in false and misleading marketing of the drug, which caused her and her physician to believe it was safe for use by a pregnant woman.

The mother was prescribed Zofran to quell symptoms of morning sickness during the first trimester of her pregnancy. She took the drug as directed from approximately July 2011 to August 2011. Six months later, in February 2012, her daughter was born with multiple, congenital abnormalities including severe, pulmonary valve stenosis, patent ductus arteriosus and flattening of the interventricular septum.

The child was exposed to Zofran in utero when each of these tissues was forming and susceptible to injury from exposure, states the claim. According to her physician’s records, there is no genetic cause for the little girl’s condition. She has no family history of any birth defects that she suffers from.

Zofran received FDA approval as an injectable drug on January 4, 1991. It subsequently received FDA approval as an oral solution and in tablet form on January 24, 1997 and December 31, 1992, respectively. The drug is approved to prevent nausea and vomiting experienced by patients undergoing cancer chemotherapy, radiation therapy and surgery.

Zofran lawsuit alleges birth defects caused by drug

The mother claims her daughter would not have suffered these teratogenic injuries and related damages if she had not taken Zofran while pregnant. The claim notes that at the time, her physician did not know the harmful side effects of Zofran or its generic equivalent, ondansetron, when ingested during pregnancy.

“Although the FDA has never approved Zofran to treat nausea outside of the limited contexts of cancer treatment and post-operative related nausea, GSK nevertheless engaged in off-label marketing and promotion of Zofran for treatment of morning sickness during pregnancy,” states the claim.

The mother is suing GSK on five counts, including:

  • Fraudulent Misrepresentation
  • Negligence
  • Negligent Misrepresentation
  • Negligence Per Se
  • Fraudulent Concealment

Plaintiff accuses GSK of concealing pregnancy risks

The plaintiffs allege GSK has been receiving complaints on birth defects related to the use of Zofran by pregnant women since the mid-1990’s.

“Upon information and belief, the most commonly reported birth defects arising from Zofran use during pregnancy and reported to GSK were congenital heart defects, though multiple other defects such as orofacial defects, intrauterine death, stillbirth and severe malformations in newborns were frequently reported,” alleges the claim.

The plaintiff accuses GSK of not disclosing information from the 2006 study “Placental Transfer of Ondansetron During Early Human Pregnancy,” by Shing-Shun N. Siu, Matthew T.V. Chan and Tze-Kin Lau, to physicians or altering it’s off-label marketing strategy after finding that ondansetron was able to pass through the human placental barrier in the first trimester in a concentration of fetal tissue in all samples studied.

  1. U.S. District Court for the Northern District of Alabama — Northeastern Division, Tara Hogan vs. GlaxoSmithKline
  2., Generic Zofran Availability
  3. U.S. Food and Drug Administration, Ondansetron (marketed as Zofran) Information