Southern Med Law Is Investigating Zofran Birth Defect Lawsuits Alleging The Anti-Nuasea Medication Prescribed During Early Pregnancy May Result In Babies Born With Congenital Birth Defects Such As Cleft Palate, Cleft Lip, And Heart Defects
A federal judicial panel centralized all Zofran birth defects lawsuits filed in federal courts nationwide against GlaxoSmithKline, which manufactures Zofran. The Zofran lawsuits have been awaiting litigation in courts around the country and contend the anti-nausea medication may cause newborns to suffer from birth defects such as cleft lip, cleft palate and heart defects. There are currently over 50 Zofran complaints filed across the country.
The U.S. Judicial Panel on Multidistrict Litigation (JPML) transferred 12 Zofran birth defect lawsuits to the U.S. District Court, District of Massachusetts and assigned U.S. District Judge F. Dennis Saylor, IV to manage the multidistrict litigation. The federal judicial panel noted that 42 additional Zofran claims have been filed since GlaxoSmithKline submitted its petition for consolidation in July. The panel said these claims may potentially be transferred into the Zofran MDL. In its transfer order, the JPML stated that consolidation of the Zofran claims is warranted because the lawsuits share common factual questions arising from allegations that Zofran causes birth defects in babies whose mothers use the drug to treat morning sickness. Coordinating the claims in one central court will eliminate duplicative discovery and prevent inconsistent pretrial rulings, according to the JPML’s transfer order. (In Re: Zofran (Ondansetron) Products Liability Litigation – MDL No. 2657)
“The panel also said that centralization will conserve resources for the parties involved as well as for the court. The Zofran complaints can now move forward in coordinated proceedings,” says 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 an anti-nausea drug approved by the U.S. Food and Drug Administration (FDA) to treat nausea and vomiting related to chemotherapy, radiation, and surgery. Zofran, however, has been prescribed for treating morning sickness in expectant mothers although Zofran’s prescribing information says there have been “no adequate and well-controlled studies” conducted regarding pregnant women and Zofran use. However, there have been studies indicating that Zofran has the potential to cause birth defects in newborns whose mothers used the drug during early pregnancy. A study conducted by the Center for Birth Defects Research and published in January 2012 found that babies were twice as likely to be at risk for the cleft palate birth defect because of their mothers Zofran use during the first trimester of pregnancy.
[ncbi.nlm.nih.gov/pubmed/22102545, January 2012]
Court documents indicate GlaxoSmithKline agreed to pay $3 billion to resolve civil and criminal claims filed by the U.S. Department of Justice (DOJ) for illegally promoting Zofran to doctors and their patients as a treatment for morning sickness. The pharmaceutical company was cited for improperly marketing other prescription drugs for uses that were not approved by the FDA.
In its transfer order, the JPML said that Judge Saylor is presiding over the first Zofran lawsuit filed in a federal court, which is one of the reasons the judicial panel transferred the Zofran cases to the district court in Boston.
According to the complaint, a Massachusetts mother was prescribed Zofran when she was pregnant and her baby was born in 2000 with atrial septal defect (a hole in the heart) and other congenital defects and was also diagnosed with facial dysmorphia, low set ears, hearing loss, and webbed toes. The mother said in the complaint that the child has undergone 10 surgeries in 12 years to correct the numerous congenital abnormalities. (1:15-cv-10429, U.S. District Court, District of Massachusetts)
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