Zofran Birth Defect Lawsuit Claims Allege That The Anti-Nausea Medication Used To Treat Morning Sickness During Pregnancy Causes Cleft Palate, Heart Defects And Other Congenital Birth Defects.
The rising number of Zofran birth defects lawsuit claims alleging heart defects, musculoskeletal defects and other birth defects, has prompted Zofran’s manufacturer, GlaxoSmithKline to ask a federal judicial panel to consolidate all federally filed Zofran side-effects lawsuits. In its motion filed on July 6, GlaxoSmithKline petitioned the U.S. Judicial Panel on Multidistrict Litigation (JPML) to transfer 12 pending Zofran product liability lawsuits to the U.S. District Court, Eastern District of Pennsylvania for coordinated pretrial proceedings. According to the motion, GlaxoSmithKline asked for current and subsequent Zofran birth defects lawsuit claims to be consolidated in a federal multidistrict litigation (MDL) in Pennsylvania because the company has its U.S pharmaceutical operations and office there and the district court is already handling similar birth defects MDLs involving Zoloft and Effexor. The company explained that the Zofran birth defects lawsuit claims have common questions of fact and allegations that the mothers’ use of Zofran during 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. (In Re: Zofran Products Liability Litigation MDL No. 83)
“We expect this litigation to grow because we continue to hear claims of babies suffering birth defects due to their mothers being prescribed Zofran in their first trimester of pregnancy to treat morning sickness,” says Dr. François Blaudeau, a founder of Southern Med Law, which is representing women nationwide in product liability lawsuits. The firm continues to offer legal evaluations to families who have experienced Zofran birth defects. You can speak with Dr. Baudeau or one of the firms attorneys by calling 205-547-5525 or you can visit www.southernmedlaw.com for more information on this and Mirena pregnancy lawsuits.
Zofran (ondansetron) is approved by the U.S. Food and Drug Administration (FDA) to treat nausea and vomiting induced by chemotherapy, radiation therapy and surgery. Zofran is a 5-HT3 receptor antagonist that works by blocking serotonin in the brain that triggers vomiting and nausea.
The Zofran birth defects lawsuit claims allege that GlaxoSmithKline has been aware that Zofran was not safe for pregnant women after the company conducted animal studies in the 1980s that showed Zofran’s active ingredient transfers through the placenta barrier of pregnant animals to their fetuses. According to the Zofran claims, GlaxoSmithKline was also aware of a study showing Zofran readily crossed the human placenta barrier and exposes fetuses to substantial concentrations of the drug.
Additionally, the Zofran birth defects lawsuit claims cite a study published in August 2013 from Denmark that found a two-fold increase in congenital heart defects as a result of women using Zofran during the first trimester of pregnancy. The Zofran complaints accuse GlaxoSmithKline of failing to disclosing the risks of using Zofran to pregnant women or their physicians. (In Re: Zofran Products Liability Litigation MDL No. 83)
Southern Med Law also points out that the FDA has not approved Zofran for treating morning sickness and GlaxoSmithKline was accused by the U.S. Department of Justice (DOJ) of improperly promoting Zofran to doctors and pregnant women without disclosing the risks associated with the drug during pregnancy. According to Zofran’s prescribing information, there are “no adequate and well-controlled studies” conducted regarding pregnant women and Zofran use. The DOJ leveled civil and criminal charges against GlaxoSmithKline over the off-label use of Zofran and other prescription drugs, and over offering kickbacks to health care professionals who promoted and prescribed Zofran. GlaxoSmithKline agreed to pay $3 billion to resolve the DOJ’s civil and criminal claims.
[accessdata.fda.gov/drugsatfda_docs/label/2011/020103s030,020605s014,020781s014lbl.pdf, September 2011]
[justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report,DOJ, June 2012]
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 Zofran birth defects lawsuits, 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.
About Southern Med Law and Filing A Zofran Birth-Defects Lawsuits
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