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Zofran Birth Defect Lawsuits

In June 2015, the first claims were filed against GlaxoSmithKline (GSK), the makers of the anti-nausea pharmaceutical Zofran. Approved by the Federal Drug Administration to treat only chemotherapy, radiation, and post-surgical patients, GSK chose to market Zofran to physicians and expectant mothers as an antidote to morning sickness. For over a decade, millions of pregnant women across the United States were prescribed Zofran, usually during the first trimester when nausea and vomiting are most common.

Recent research has revealed that the drug may cause cardiovascular complications in the mother and heart defects in the fetus. The infant’s risk for atrial or ventricular septal defects (holes in the heart) has been found to potentially increase by 50% with Zofran use. Congenital malformations, including cleft lip and cleft palate, have also been linked to Zofran.

Failure to Warn

Current liability claims are based on the failure to investigate short and long term side effects and risks for pregnancy use. Placement as FDA’s “Pregnancy Category B” classifies Zofran among pharmaceuticals with insufficient research regarding harm to fetal development. Claims also include federally unapproved and negligent marketing, legally considered “failure to warn.”

Introduced in 1991, Zofran (ondansetron) is included in the class of drugs that functions to block serotonin, a neurotransmitter that balances mood. Separate studies over the past nine years have raised questions about the safety of Zofran regarding pregnancy use:

  • A 2006 Hong Kong study uncovered Zofran’s ability to cross the placenta barrier between a pregnant woman and her fetus.
  • In 2011, Boston researchers for the National Birth Defects Prevention Study were examining the potential for morning sickness to cause birth defects. Instead, they discovered that women prescribed Zofran had twice the risk of delivering an infant with cleft palate abnormalities.
  • In 2013, researchers examined long-term data from 900,000 pregnancies. This study revealed that twice the risk of heart defects and a 30% higher risk of malformations were associated with infants exposed to Zofran.
  • That same year, Dr. Gideon Koren publicized his concern about Zofran’s risks to Pediactric News. The director of Canada’s Motherrisk Program, Dr. Koren reiterated potential cardiovascular dangers regarding the combination of electrolyte imbalances and intake of Zofran.
Zofran has also been linked to dangerous changes in the heart’s electrical activity. As these changes may cause an abnormal or life-threatening heart rhythm, the FDA requested additional information from GSK in 2011. Zofran warning labels were subsequently updated to endorse ECG observation for all patients with potential congestive heart failure, electrolyte abnormalities, brady-arrhythmias, or specific medication.GlaxoSmithKline's "Healthcare Fraud" - Zofran, Paxil, Wellbutrin, and Avandia

This is not GlaxoSmithKline’s first involvement with questionable marketing ethics. In 2012 they suffered a $3 billion fine by the US Justice Department after misbranding two highly publicized pharmaceuticals, Paxil and Wellbutrin. The fine included a third offense involving misrepresentation of safety data for the diabetes drug Avandia between 2001 and 2007. This has been considered the “largest healthcare fraud settlement in US history.”

At Altman & Altman, LLP, our legal team understands the burden placed on families dealing with a child’s unexpected and frightening medical disabilities. One Zofran plaintiff in Alabama watched her child undergo surgery for a permanent pacemaker at the age of four. A Louisiana plaintiff’s child underwent two consecutive surgeries for heart defects. Such circumstances can not only prove financially devastating, but they can also take a toll on the health of each spouse as they struggle to balance home health care, extended absences from work, and parenting of the affected child’s siblings.

If you were prescribed Zofran for morning sickness during your pregnancy and suspect your child has suffered heart problems, congenital malformation, or any other medical condition because of it, you may have a product liability claim. The first step towards compensation is to contact an experienced accident and injury attorney. At Altman & Altman LLP, our legal team is committed to helping our clients obtain the compensation they deserve. Should your claim advance to trial, our MA drug injury lawyers are dedicated to investigating every detail of your case to obtain the best possible outcome. We understand that financial recovery is vital to regaining control over your life and providing your child with the care he or she needs.

Contact Altman & Altman, LLP If You've Been Injured By Zofran or Any Other Drug

With offices in Boston, Cambridge, and Salem, we believe in full-time availability for our clients. Pursuing a drug product liability lawsuit against a large pharmaceutical corporation may seem overwhelming. We will use our extensive knowledge and experience in this area to advocate for your rights. Our legal team will keep you informed, educated, and empowered with every decision. Contact us for a free initial consultation.

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