A Utah couple has filed a product liability lawsuit against GlaxoSmithKline (GSK) alleging that its anti-nausea medication Zofran (generic: ondansetron) caused their daughter to be born with a cleft lip and cleft palate.
Free Confidential Lawsuit Evaluation: If your child or other loved one was injured by Zofran side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
What’s the Problem?
March 16, 2016 – According to the complaint, the mother was prescribed Zofran during early pregnancy in 1995, which she took through January 1996. Her daughter, referred to in court documents as ‘E.M.’, was born on February 24, 1996, and immediately diagnosed with a “wide right unilateral complete cleft lip and palate,” a large split in her upper lip that extended all the way through the roof of her mouth. As a result of these problems, she was forced to undergo a number of unspecified corrective surgeries, according to the lawsuit.
Now 20 years old, E.M. “exhibits physical malformations resulting from the clefts and subsequent surgeries,” according to her parents. She “is unable to participate fully in life,” they say, “and has “required […] speech, occupational and physical therapy.”
Studies Link Zofran During Pregnancy to Cleft Palate
The new lawsuit cites a 2012 study that found a link between Zofran use during the first semester and an increased risk for cleft palate. Researchers at Harvard and Boston University looked at interviews and birth records to identify babies who had been exposed to Zofran in the womb. Comparing these children to those whose mothers had not used Zofran for morning sickness, the authors determined that exposed babies were more than twice as likely to be born with a cleft palate.
Did GSK Warn About Birth Defect Risk?
GSK never publicized the study’s findings, according to the lawsuit, nor has the drugmaker warned the public of research indicating a link between Zofran and birth defects. Instead, GSK has “marketed and sold Zofran without adequate warning to healthcare providers and consumers that Zofran was causally associated with increased risks of birth defects,” according to the lawsuit.
The complaint was filed Feb. 19 in the U.S. District Court for the District of Utah, Central Division, under case number 2:16-cv-00131-EJF. On March 2, the U.S. Judicial Panel on Multidistrict Litigation issued a Conditional Transfer Order (PDF) to move the case to the multidistrict litigation (MDL) currently underway in Boston.
Do I Have a Zofran Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Zofran lawsuits. We are handling individual litigation nationwide and currently accepting new birth defect cases in all 50 states.
Free Confidential Case Evaluation: Again, if your child was harmed by Zofran side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.