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The U.S. Food and Drug Administration approved Zofran to help cancer patients with nausea after treatments or after surgery. It helped people who vomited as a side effect from chemotherapy or who grew sick after taking post-op meds to help with pain or other complications.
But drugmaker GlaxoSmithKline soon found other patients to take the drug – pregnant women suffering from morning sickness. There was just one problem. The FDA never approved Zofran for use by pregnant women.
In 2006, Zofran lost its patent and doctors began prescribing generic versions of ondansetron, manufactured by Novartis and subsidiary Sandoz, to patients. Looking to capitalize on a void in the market, a company developed a similar drug called Zuplenz that dissolves in the mouth without water in 2010.
In 2012, Glaxo plead guilty to federal charges of fraud and illegal promotion of several drugs, including Zofran, and paid $3 billion as part of the legal settlement. Three years later, Galena Biopharma acquired licensing rights for Zuplenz and launched it in the U.S. Novartis also acquired the rights to market Zofran from GSK in 2015.
Now, Glaxo is going back to court to defend more specific allegations about Zofran (ondansetron), and Novartis, Sandoz and Galena could face litigation too.
Glaxo had a duty to ensure its drug was safe before offering it to the public and failed to determine safety risks before selling it.
Glaxo failed to warn the public about dangerous side effects.
Glaxo advertised the drug as a safe treatment for morning sickness and hyperemesis gravidarum even if it was not approved for this use.
Glaxo misrepresented that animal studies showed the drug was safe, when in actuality the results showed abnormal bone growth and signs of toxicity.
Glaxo failed to properly evaluate all data and safety information on Zofran for use in pregnant women.
Glaxo produced a defective drug.
Glaxo falsely and fraudulently claimed Zofran was safe for pregnant women.
No version of Zofran, including Zuplenz and generic ondansetron, is approved for use in pregnant women. Lawsuits accuse GlaxoSmithKline of marketing Zofran to expectant mothers as well as paying doctors to prescribe it. The drug brought in millions of dollars for Glaxo, and roughly 1 million women take the medication or its generic counterpart each year.
About 80 percent of women suffer from some form of nausea or vomiting during pregnancy (NVP), commonly referred to as morning sickness. The most severe form of NVP is called hyperemesis gravidarum and can cause malnutrition and endanger the mother and unborn baby.
Several women turned to Zofran or another version of the drug to keep them and their babies safe from complications. Instead their babies suffered from severe birth defects that render them forever dependent on their parents for care.
Tomisha LeClair of Massachusetts filed one of the first birth defect lawsuits in February 2015. Like many other expectant mothers, LeClair took Zofran to treat severe nausea and vomiting that was interfering with going to work and performing other daily tasks. She never suspected anything was wrong because she was told it was safe.Unfortunately, her daughter – identified as A.S. in court documents – was born with several congenital defects, including: several heart defects, facial dysmorphia, low set ears, hearing loss, webbed toes, sensitivity to light and an inguinal hernia. A.S. had 10 surgeries in 12 years to try and correct several abnormalities.
LeClair's lawsuit claims if she had known the risks, she would never have taken Zofran and says Glaxo concealed the truth about the drug. She is claiming compensatory as well as punitive damages and hopes to warn other mothers-to-be about the dangers of the medication.
In July 2015 Angela and Brian Kutzer filed a claim that Glaxo paid doctors to promote and prescribe Zofran and made “false representations about the safety and efficacy” of the drug.
The couple’s son was born with multiple defects, including a missing kidney and incomplete sexual organs. Because of Zofran he may never be able to have children or “any normal male sexual function at all,” according to the suit.