Judge In Zofran Birth Defects Lawsuits Rules Against Dismissal Of Anti-Nausea Drug Complaints
Southern Med Law commends a recent court ruling that will allow hundreds of Zofran birth defects lawsuits to move forward in a federal multidistrict litigation now underway in the U.S. District Court, District of Massachusetts. GlaxoSmithKline, the manufacturer of Zofran, had sought dismissal of every case in the proceeding by asserting that plaintiffs’ state failure-to-warn claims were pre-empted by federal law. Among other things, the drug maker asserted that the U.S. Food & Drug Administration’s (FDA) rejection of a citizen petition seeking a new pregnancy category for Zofran was a clear indication that the agency would not have allowed label changes pertaining to the drug’s potential association with birth defects. However, in a decision rendered on January 22nd, the Court found that Glaxo’s motion was premature and dismissed it without prejudice. (In Re Zofran Products Liability Litigation – MDL 2657)
“Numerous families have contacted our attorneys to discuss filing Zofran lawsuits on behalf of their own children. We are pleased that Glaxo’s motion was denied, especially at such an early stage in the litigation. These families deserve a chance to make their case,” says Dr. François Blaudeau, the founder of Southern Med Law. As both an attorney and a practicing obstetrician/gynecologist, Dr. Blaudeau possesses unique insight into the various legal and medical issues at the center of Zofran birth defects cases such as those pending in Massachusetts.
Zofran (ondansetron) has only been approved to treat nausea and vomiting related to surgery, chemotherapy and radiation therapy. However, Zofran lawsuit plaintiffs claim that Glaxo has a history of aggressively marketing the drug as an appropriate remedy for morning sickness, even though its impact on a developing pregnancy is not well studied. They also allege that the company has concealed certain studies linking Zofran to the development of serious birth defects, as well as reports of children born with congenital abnormalities that allegedly resulted from their mother’s use of the anti-nausea drug during the first trimester of pregnancy.
In 2012, GlaxoSmithKline entered into a $3 billion settlement with the U.S. Department of Justice (DOJ) to resolve criminal and civil charges involving Zofran and a number of other medications it marketed. Among other things, the federal government had accused Glaxo of illegally promoting Zofran as a morning sickness remedy and of paying doctors kickbacks for prescribing the medication to pregnant women.
[justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report, DOJ, August 2012]
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
2224 1st Avenue North
Birmingham, Alabama 35203
Medical Negligence/MedicalDevice/Pharma/Qui Tam