Zofran Birth Defect Lawsuits Increase Alleging The Anti-Nausea Drug Causes Babies To Be Born With Cleft Lip, Cleft Palate, and Atrial Septal Defect (Hole In The Heart)
As Southern Med Law attorneys continue to investigate Zofran birth defect lawsuits alleging the drug causes newborns to suffer cleft lip, cleft palate, heart murmur and other birth defects, the number of Zofran complaints being filed against Zofran’s maker, GlaxoSmithKline, continue to increase. The Zofran lawsuits contend the pharmaceutical giant illegally promoted its anti-nausea drug to expectant mothers as a treatment for morning sickness. However, Zofran allegedly places newborns at risk for birth defects such as cleft palate, cleft lip, heart defects, musculoskeletal defects and other abnormalities.
The Zofran birth defect complaints consolidated in the U.S. District Court, District of Massachusetts rose from 211, as of January 15, to 223 as of February 16. The number of Zofran birth defect complaint filings have been rising significantly since October when a federal judicial panel centralized only 12 lawsuits in the Massachusetts court. The U.S. Judicial Panel on Multidistrict Litigation (JPML) took the Zofran complaints that were filed in federal courts nationwide and consolidated the claims for coordinated pretrial proceedings. The JPML said centralizing the Zofran lawsuits was warranted because the lawsuits shared common factual questions arising from allegations that Zofran causes birth defects in babies whose mothers use the drug to treat morning sickness. (In Re: Zofran (Ondansetron) Products Liability Litigation – MDL No. 2657)
Zofran is approved by the U.S. Food and Drug Administration (FDA) to treat nausea and vomiting in patients undergoing chemotherapy, radiation, and surgery. The Zofran birth defects complaints maintain that the antiemetic drug was not approved by the FDA for use in pregnant women who experience morning sickness, which includes nausea and vomiting. According to Zofran’s prescribing information, “no adequate and well-controlled studies” have been conducting regarding Zofran use in pregnant women. The Zofran birth defect complaints point to studies that show Zofran causes babies to be born with serious birth defects. For instance, a study published in the medical journal, Birth Defects Research Part A Clinical and Molecular Teratology published in November 2011, found that women who were prescribed Zofran during the first trimester of pregnancy had a twofold increased risk for having a baby born with a cleft palate and cleft lip.
[ncbi.nlm.nih.gov/pubmed/22102545, November 2011]
The Zofran birth defect complaints also accuse GlaxoSmithKline of failing to warn doctors and their patients about Zofran’s birth defect risks. The pharmaceutical company, however, asked to have the Zofran lawsuits pending in the Massachusetts federal court dismissed based on consumers request to change Zofran’s label to warn about the birth defect risks. The company claimed the FDA’s rejection of a citizen petition seeking a new pregnancy category for Zofran was a clear indication that the FDA would not have allowed label changes regarding the drug’s potential association with birth defects. In January, the court denied the company’s motion finding that it was premature and dismissed it without prejudice. (In Re Zofran Products Liability Litigation – MDL 2657)
Southern Med Law is currently evaluating potential Zofran 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. 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 Defect Lawsuit: Southern Med Law is an experienced law firm providing legal representation individuals across the country who have been 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
François M. Blaudeau, MD JD FACHE FCLM Esquire
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