Zofran Birth Defects Lawsuit Claims Allege The Use Of The Anti-Nausea Drug During Early Pregnancy Can Cause Serious Birth Defects, Including Cleft Palate, Cleft Lip And Musculoskeletal Defects.
Southern Med Law, who is currently representing women in product liability lawsuits has learned that two Louisiana mothers have jointly filed a Zofran birth defects lawsuit alleging one woman’s child was born with several congenital heart defects, including perimembranous ventricular septal defect (VSD), which required surgery to correct, atrial septal defect (also known as “hole in the heart”), and intermittent tachypnea, which is reflective of congestive heart failure. The second plaintiff took Zofran around February 2005 and her child was born August 9, 2005 and diagnosed soon after birth with accelerated ventricular arrhythmia, a serious heart defect which nearly caused the baby to die shortly after birth. The Zofran lawsuit purports that Zofran’s manufacturer, GlaxoSmithKline, knew about the congenital heart defect risks and not only concealed the information to physicians and their patients but illegally promoted Zofran as a treatment for morning sickness in pregnant women. (Case No. 6:15-cv-01815, U.S. District Court, Western District of Louisiana)
Zofran (ondansetron) is approved by the U.S. Food and Drug Administration to treat severe nausea and vomiting induced by surgery, chemotherapy, and radiography. The law firm notes that the FDA has not approved Zofran to treat morning sickness in pregnant women and the drug’s prescribing information states that there are “no adequate and well-controlled studies” conducted regarding pregnant women and Zofran use.
[accessdata.fda.gov/drugsatfda_docs/label/2011/020103s030,020605s014,020781s014lbl.pdf, September 2011]
Southern Med Law is currently evaluating potential Zofran birth defect lawsuits on behalf of families who believe their child was born with a birth defect due to this medication. To learn more about the litigation involving Zofran and birth defects, please contact the Firm as soon as possible to learn more about your legal rights. You can arrange for a free, no obligation Zofran lawsuit review by calling Southern Med Law today, at 205-547-5525.
Court records indicate that Zofran complaints are being filed on behalf of mothers and their children who were born with serious birth defects such as cleft lip, cleft palate, heart murmur, heart defects, atrial septal defect (hole in the heart), musculoskeletal defects and other abnormalities. According to court documents, one of the first Zofran complaints filed was on behalf of a Massachusetts mother whose child was born with birth defects including atrial septal defect, right ventricular hypertension, facial dysmorphia, low set ears, hearing loss, and webbed toes. The Zofran lawsuit further claims GlaxoSmithKline promoted Zofran to pregnant women without receiving FDA approval and without conducting clinical trials in pregnant women. (1:15-cv-10429, U.S. District Court, District of Massachusetts)
The courts further indicate, that in an earlier lawsuit, GlaxoSmithKline agreed to pay $3 billion to settle criminal and civil claims brought by the U.S. Department of Justice (DOJ) which charged the company for illegally promoting Zofran as a treatment for morning sickness and for paying kickbacks to doctors to influence them to prescribe Zofran to their pregnant patients. GlaxoSmithKline also pleaded guilty to promoting the off-label use of its drugs, Paxil and Wellbutrin and concealing safety data of its diabetes drug, Avandia. In announcing the settlement agreement in July 2012, the DOJ said this was the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company.
[justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report, July 2, 2012]
About Southern Med Law
Southern Med Law is a patient and consumer advocacy organization providing legal representation to the victims of negligent personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products. Led by Dr. François Blaudeau, an attorney and a practicing obstetrician/ gynecologist, the legal staff at Southern Med Law possesses a deep understanding of the complex medical and legal questions at issue in all manner of product liability and personal injury claims. They’re not afraid to take on the nation’s largest corporations in their pursuit of justice, and are committed to ensuring that all victims have access to the type of aggressive legal advocacy that assures success.
Southern Med Law
Southern Institute for Medical and Legal Affairs
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