Southern Med Law Is Investigating Zofran Birth Defect Lawsuits That Allege Using The Anti-Nausea Drug During Early Pregnancy Can Cause Serious Birth Defects.
Another claim was added to Zofran birth defect lawsuits filed in federal courts across the country as attorneys await a decision on whether lawsuits against the anti-nausea manufacturer should be consolidated in the U.S. District Court, Eastern District of Pennsylvania. Zofran bleeding lawsuits have been filed against GlaxoSmithKline by women who took Zofran to treat morning sickness during early pregnancy and purport their babies suffered birth defects such as cleft lip, cleft palate and heart defects after being exposed to the drug.
The latest Zofran lawsuit was filed by a California couple against GlaxoSmithKline, the maker of Zofran, who claims their daughter was born in 2007 with severe congenital heart malformations allegedly as a result of the mother being prescribed Zofran during pregnancy. The child had to undergo numerous examinations as well as a surgery when she was four, according to the lawsuit. The Zofran complaint accuses GlaxoSmithKline of failing to disclose the risk of using the anti-nausea medication during pregnancy. (Case No. 3:15-cv-04474, U.S. District Court, Northern District of California)
“Because of the growing number of Zofran complaints, GlaxoSmithKline asked the U.S. Judicial Panel on Multidistrict Litigation to consolidate Zofran bleeding lawsuits filed nationwide,” explains Dr. François Blaudeau, the founder of Southern Med Law, which is currently evaluating potential Zofran lawsuits on behalf of families who believe their child was born with a birth defect due to this medication.
Zofran (ondansetron) is approved by the U.S. Food and Drug Administration (FDA) to treat nausea and vomiting in cancer patients undergoing chemotherapy and radiation, and for patients who had surgery. According to an article published in December 2014 in the American Journal of Obstetrics and Gynecology, the use of ondansetron to treat nausea and vomiting in pregnancy has increased from 50,000 monthly prescriptions in 2008 to 110,000 at the end of 2013, despite unresolved issues regarding fetal safety and the FDA’s warning about serious cardiovascular side effects from Zofran, including fatal heart rhythms.
[fda.gov/Drugs/DrugSafety/ucm271913.htm, September 15, 2011]
[sciencedirect.com/science/article/pii/S0002937814008539, December 2014]
Although Zofran’s prescribing information says there are “no adequate and well-controlled studies” conducted regarding pregnant women and Zofran use, several studies have suggested that Zofran use during pregnancy may cause birth defects in newborns, particularly if they are exposed to the medication in the first trimester. In January 2012, a study conducted by the Center for Birth Defects Research and Prevention found newborns were twice as likely to be at risk for the cleft palate birth defect due to their mothers using Zofran in the first trimester of pregnancy. Additionally, a study published in December 2014 in the journal Reproductive Toxicology found a 62 percent increased risk in cardiovascular defects, notably a cardiac septum.
[ncbi.nlm.nih.gov/pubmed/22102545, January 2012}
[ncbi.nlm.nih.gov/pubmed/25450422, December 2014]
GlaxoSmithKline was charged by the U.S. Department of Justice (DOJ) with criminal and civil counts of improperly promoting Zofran and other of its prescription drugs for uses not approved by the FDA. The company was accused of marketing Zofran to doctors and their patients as a treatment for morning sickness in pregnant women. GlaxoSmithKline agreed to pay $3 billion to resolve the DOJ’s civil and criminal claims.
[justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report,DOJ, June 2012]
Court documents indicate that at least 33 Zofran birth defect lawsuits are filed against GlaxoSmithKline alleging that Zofran use by women during the early stages of pregnancy resulted in their children being born with birth defects, such as cleft lip, cleft palate, heart murmur, heart defects, atrial septal defect (hole in the heart), musculoskeletal defects and other abnormalities.
Southern Med Law and Dr. François Blaudeau possess a unique understanding of the medical and legal questions at issue in Zofran lawsuit claims. It is this in-depth knowledge that is tantamount to a successful legal representation that protects the rights of the injured. The staff at Southern Med Law is not only trained in successfully handling your legal needs but also understand the pain and suffering and treatment from a medical point of view, and is committed to protecting the rights of all individuals. For more information on filing a Zofran birth-defects lawsuit contact Dr. Blaudeau by calling 1-(205) 547-5525 or visit www.southernmedlaw.com for more information and to fill out an online contact form.
Southern Med Law
François M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203
Phone: (205) 547-5525
Fax: (205) 547-5526
Medical Negligence/MedicalDevice/Pharma/Qui Tam