Ondansetron`s Zofran drug continues to be the subject of class action lawsuits across the country. In 2011, the CDC reported that the anti-nausea drug doubled the risk of birth defects in children whose mothers took Zofran during pregnancy. Despite these findings, the drug was marketed as a “morning sickness” pill. Shortly thereafter, the drug`s manufacturer, GlaxoSmithKline, reached a $3 billion settlement with the DOJ for illegal advertising of several drugs, including Zofran. Now, the manufacturers of this product are fighting a bunch of class action lawsuits. These are followed by families harmed by the suspected side effects of the drug. As parents across the country become aware of the possibility that Zofran disrupts fetal development during pregnancy and causes birth defects in babies, a growing number of Zofran birth defects lawsuits are being filed against GlaxoSmithKline. All product liability lawsuits include similar claims that GSK failed to adequately warn consumers and healthcare professionals of Zofran`s potential to cause serious birth defects in babies when used off-label to treat morning sickness in pregnant women. In August 2012, the U.S. Department of Justice filed a lawsuit against GSK for allegedly marketing Zofran as an off-label treatment for pregnant women, which is illegal, and the drugmaker was ordered to pay $3 billion to settle claims. The illegal marketing of Zofran has caused irreparable harm to thousands of mothers and their babies.
Zofran`s makers have already made a multibillion-dollar payment to settle the largest healthcare fraud lawsuit in U.S. history, involving inappropriate marketing practices for a number of their best-selling drugs, including Zofran. In exchange for the $1 billion payment, GlaxoSmithKline avoided prosecution for its illegal marketing activities. Mothers and families across the country are taking action and looking for lawyers to ensure this never happens to another child. It wasn`t until 2015 that hundreds of families across the country filed lawsuits, citing the claims listed above. A Zofran lawyer from our firm can and will defend you – find out how we can help you here. Please note: Due to the limitation period, the time you have to file a Zofran claim is limited. Call us immediately at 888-215-7834, email us at intake@bannerlegal.com or fill out the form on this page now.
Personal injury lawyers could benefit from the referral fees associated with such widespread litigation. As this series of cases evolves, it will be interesting to see what other defendants, if any, will be involved in the multidistrict litigation in Massachusetts. Party buy-in could be a more complex legal issue for individual lawsuits filed across the country. “Searcy Denney`s lawyers and staff are some of the most compassionate and caring people I have met in the legal field. They work tirelessly for their clients to ensure the best possible outcome. I highly recommend them to anyone looking for excellent legal representation. Written by: Lauren Schumacher The U.S. Department of Justice (DOJ) filed criminal and civil lawsuits against GSK in 2012, prompting the company to plead guilty to fraud and illegal advertising of several drugs, including Zofran. The drugmaker paid $3 billion as part of the legal settlement — the largest health care fraud settlement in U.S.
history. The lawsuit alleged that GSK not only promoted anti-nausea drugs for pregnant women without FDA approval (often referred to as “off-label promotion”), but also paid bribes to doctors and health care providers. In 1991, Zofran was first approved by the FDA, with an incredibly important application: preventing nausea or vomiting taken with chemotherapy or radiation. It is also approved to help some patients who experience these symptoms after surgery. In 2012, GSK agreed to pay $3 billion to settle claims by the U.S. Department of Justice that it had marketed several off-label drugs that were not approved by the FDA, including Zofran. In California, a mother filed a lawsuit against GSK after taking Zofran during pregnancy, and her baby was born with a heart rhythm disorder known as supraventricular tachycardia (VT). This condition causes rapid breathing, shallow breathing, and shortness of breath.
Ondansetron was patented in 1984 and approved for medical use in 1990. [13] It is on the World Health Organization`s list of essential medicines. [14] It is available as a generic drug. [9] In 2020, it was the 83rd edition of the city. The most commonly prescribed drug in the United States with over 8 million prescriptions. [15] [16] The significant consolidation of lawsuits resulting from the use of multi-district litigation and class actions reduces litigation costs. For example, discovery costs and expert witnesses could be pooled by many complainants who are also affected by Zofran. However, some companies choose to sue individually. They hope to get more reasonable settlements and claims for damages for their clients. Lawsuits filed across the country now claim that GlaxoSmithKline actively promoted Zofran`s benefits among pregnant women. These lawsuits alleged that after Zofran was approved by the FDA, Glaxo had evidence that Zofran posed an unreasonable risk to babies exposed to Zofran before birth.
Instead of warning doctors and pregnant women, Glaxo instead pushed a marketing program to promote Zofran to obstetricians and other doctors to treat morning sickness. Hundreds of parents have filed lawsuits against Zofran`s makers, claiming their babies suffered from birth defects because they were exposed to Zofran while their mothers were pregnant. Several thousand other children have likely been injured by Zofran, but no individual action has yet been filed in the National Multi-District Consolidated Court (MDL) pending in federal court. Ondansetron is in pregnancy category B in the United States. [7] [3] It is not known whether ondansetron is excreted in breast milk. [7] [3] One of these studies, mentioned in the New England Journal of Medicine, had a sample of only 2,000 women who only took the drug for a ten-week period, skewing the data in favor of Glaxo. But scientists at the International Society of Pharmacoepidemiology quickly refuted these statistics with a thirteen-year study that confirmed the 30% figure of the American Journal of Obstetrics study. Despite conflicting data, the FDA has publicly warned pregnant women that Zofran could be dangerous to their unborn children. There seems to be a small risk of harm to the baby during pregnancy, although there may be an increase in heart problems in babies. [19] [20] In a case of bad drugs, an applicant must prove both a general cause and a specific cause. General causality means that a drug is actually capable of causing the applicant`s injuries, while specific causality requires that the applicant`s injuries were actually caused by that specific drug. The burden of proof in these cases is essentially a “more likely than not” standard, so the barrier is not as high.