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The Number of Zofran Cases Continues to Climb


Plaintiffs from across the U.S. continue to file legal actions against the pharmaceutical giant GlaxoSmithKline (GSK), the manufacturer of the prescription drug Zofran. Zofran cases now number over 220, the majority of which have been filed by parents of children who were born with various birth defects thought to be caused by their exposure to the drug. Zofran has been prescribed for the off-label purpose of treating morning sickness since the mid-1990s.

A child with cleft lip
An increased incidence of birth defects has led to many Zofran cases.

Zofran, Zuplenz, and the generic form ondansetron, were approved by the U.S. Food and Drug Administration (FDA) to prevent nausea and vomiting resulting from radiation and chemotherapy in cancer treatment. These drugs have not been sufficiently tested or cleared for use during pregnancy, yet GSK has aggressively marketed Zofran to OB-GYN doctors as a safe treatment for morning sickness.

Clinical studies have added to mounting evidence that ondansetron is unsafe during gestation and that GSK was negligent in marketing the drug for this off-label use.

It has been estimated that one million pregnant women a year take Zofran to prevent nausea, which affects about 80 percent of pregnancies. Reports of adverse outcomes began as early as 1992, including cases of congenital heart defects, craniofacial abnormalities, and other birth defects. Clinical studies have added to mounting evidence that ondansetron is unsafe during gestation and that GSK was negligent in marketing the drug for this off-label use.  

Families who have been affected by the medication are filing claims in the Zofran lawsuit. Even if your child suffered a congenital birth defect years ago, you may be entitled to legal compensation. An experienced defective drug attorney can evaluate your case and explain your litigation options. Please contact our legal team today to schedule a free consultation.

The Zofran Lawsuit

Before the first plaintiff filed suit against GSK in early 2015, the Philadelphia-based company settled a significant criminal and civil case with the U.S. government. In 2012, GSK’s fines and restitution amounted to more than $3 billion, one of the largest settlements from a major drug company. Among allegations of fraud related to several drugs manufactured by the company, GSK was fined for promoting Zofran for purposes not approved by the FDA, and for making unsubstantiated claims about the safety of the drug during pregnancy. There were also accusations of payments made to induce healthcare professionals to promote and prescribe Zofran.   

In February 2015, a Massachusetts mother filed a lawsuit after she was prescribed Zofran and her baby was born with several congenital defects. Her daughter suffered from heart defects, facial dysmorphia, low set ears, hearing loss, webbed toes, sensitivity to light and an inguinal hernia. These abnormalities required more than 10 surgeries in 12 years to treat the various conditions.

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Many similar lawsuits followed, filed by plaintiffs from all over the country. The most common complications cited were cardiac septal defects and cleft lip/cleft palate defects. On October 14, 2015, 12 pending cases from Louisiana, Ohio, New Jersey, Montana, Massachusetts, Arkansas, Alabama and Texas were consolidated into multidistrict litigation (MDL). The case is now under the jurisdiction of Judge F. Dennis Saylor in the District of Massachusetts.

As stated by the federal judges who transferred the cases to MDL, “Centralization will eliminate duplicative discovery, prevent inconsistent pretrial rulings, and conserve the resources of the parties, their counsel, and the judiciary.” Despite this consolidation, the MDL plaintiffs will be treated individually for verdicts and compensation awards. This contrasts with class action lawsuits, in which a small number of plaintiffs represent a larger group, and all parties share in a single case outcome.  

As of late February 2016, there were 223 cases transferred into the MDL, including 12 new cases filed since mid-January. There is also a pending class action lawsuit against GSK in Canada.

Plaintiffs are alleging that GSK was aware of the potential danger that Zofran could pose to a developing fetus and failed to warn physicians and patients about the risks. Allegations include failure to warn, failure to evaluate data and safety information, and advertising the drug as a safe treatment for pregnant women when it was not FDA approved for pregnancy.

Recent Claims in the Zofran Lawsuit

Claims filed in the Zofran lawsuit against GSK in 2016 include:

  • On February 23, the parents of a boy diagnosed with congenital heart defects filed suit in Louisiana. The mother was prescribed Zofran during the first trimester of her pregnancy to treat morning sickness. The baby, born in 2012, required surgery immediately after birth and extensive follow-up treatment.
  • Florida parents filed a lawsuit on February 2, on behalf of their 11-year-old daughter. She was born with a ventricular septal heart defect after her mother was prescribed Zofran during gestation. The child needed surgery to treat the condition, and may require additional procedures in the future.
  • An Oregon woman’s January 14 lawsuit alleges that her baby boy’s cleft palate and laryngeal cleft were caused by in vitro exposure to Zofran. These types of craniofacial defects require surgery to correct, and may cause feeding difficulties that lead to poor weight gain.

Other representative Zofran cases filed in 2015 include:

  • On October 30, 2015, Alabama parents filed a claim on behalf of their son, born in 2013 with a severe congenital atrial septal defect. His condition may require surgery and he is said to be at an elevated risk for injury, infection, and potentially fatal complications.
  • An Illinois case was filed on July 21, 2015, connecting Zofran use during pregnancy to a baby boy’s heart defect. This complication, Tetralogy of Fallot, is considered permanent and life-threatening, requiring ongoing restriction of the boy’s activities.
  • New Jersey parents filed a claim against GSK on June 26, 2015, after their infant was born with clubfoot in 2011. His mother took Zofran throughout her pregnancy. The boy has endured surgery, plaster casts, and other invasive treatments, and the effects of his disability are expected to last a lifetime.

Corroborating Evidence

Documentation shows that GSK conducted animal studies in the 1980s that should have alerted the company of potential concerns. The data indicated that the active ingredients in Zofran had crossed the placental barrier to reach the developing fetus, and showed evidence of toxicity, malformations, and intrauterine deaths.

Pharmaceutical companies are not legally allowed to market drugs for unapproved purposes and without proper clinical testing.

GSK has not conducted any clinical studies on pregnant women using Zofran, but outside researchers have connected the drug to incidences of birth defects. A 2013 Denmark Study connected use of ondansetron by pregnant mothers with a twofold increased risk of cardiac malformations and a 30 percent increased risk of major congenital malformations.

In 2011, researchers in the U.S. published a study of 9,000 pregnancies involving ondansetron, concluding that exposure to the drug led to a higher incidence of cleft palate.

The FDA recalled high-dose Zofran prescriptions for cancer patients in 2012, citing risks of heart complications in patients. A 2006 Hong Kong clinical study confirmed that the drug could pose this same risk to developing fetuses, as researchers found that Zofran can cross the placental barrier in humans. A 2014 study also reported this finding, and noted “rapid transplacental transfer,” with the drug remaining detectable in the fetus longer than in the mother.

Physicians can legally prescribe medication for off-label purposes, and routinely do so when they feel the drug can help their patients. However, pharmaceutical companies are not legally allowed to market drugs for unapproved purposes and without proper clinical testing.

If Your Child Was Affected by Zofran

If you took Zofran during your pregnancy and your child was born with a congenital birth defect, a qualified pharmaceutical liability attorney can help. You may be entitled to significant compensation for losses and expenses related to the use of this dangerous drug. Please contact our legal team to arrange a complimentary case evaluation and explore your legal rights.

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