This past month, the U.S. Judicial Panel on Multidistrict Litigation (“MDL”) consolidated lawsuits filed by families claiming that the anti-nausea drug Zofran (Ondansetron) caused birth defects in their children, including but not limited to, cleft lip, cleft palate, club foot, and heart defects.
According to the complaints, GlaxoSmithKline (“GSK”), Zofran’s manufacturer, concealed a known risk of harm related to Zofran which, on-label, is used to treat nausea and vomiting resulting from chemotherapy. However, doctors have long prescribed the drug off-label for severe morning sickness or hyperemesis gravidarum. Whether GSK will litigate or settle the product liability lawsuits, now consolidated as MDL 2657, is unknown.
In 2012, GSK pleaded guilty and agreed to pay $3 billion for unlawful promotion of several drugs, including Zofran. As part of the settlement agreement, GSK conceded that it knowingly promoted the sale and use of Zofran for conditions other than those for which its use was approved as safe and effective by the FDA, including hyperemesis or pregnancy-related nausea. Since then, several studies have raised concerns about the risk of Zofran causing congenital malformation (birth defects), resulting in a growing number of families pursuing a Zofran lawsuit against GSK.
If you took Zofran during pregnancy and your child was born with a cleft lip, cleft palate, club foot, heart defect, or other serious birth defects, contact our legal team to determine whether you should file a Zofran birth defect lawsuit. Bottar Leone, PLLC, has decades of experience investigating and pursuing claims for injured patients, workers, motorists and consumers. To learn more about your rights, please feel free to contact the Firm by telephone, email, or by submitting an online contact form.