Dangerous drugs news: GlaxoSmithKline, manufacturer of the pharmaceutical Zofran, filed a motion on July 6, 2015 seeking consolidation of all Zofran lawsuits. GSK has requested that the lawsuits be consolidated in the United States District Court for the Eastern District of Pennsylvania. Zofran plaintiffs agree that consolidation of the lawsuits is desirable, however, they oppose consolidation in the Pennsylvania court. Of 33 Zofran lawsuits currently pending, only one is venued in the Pennsylvania district court. Plaintiffs have suggested either the District of Massachusetts or the Northern District of Alabama as suitable courts for a Zofran multi-district litigation (“MDL”).
Zofran is an anti-nausea drug approved by the FDA in 1991 for use during chemotherapy and surgery. Although Zofran has not been approved for treatment of “morning sickness” during pregnancy, it has been widely used “off label” for that purpose. Despite the lack of FDA approval, GSK promoted the drug to doctors and patients as a safe treatment for severe morning sickness. In 2012, GSK agreed to pay $3 billion in fines after pleading guilty to criminal charges including illegal promotion of the drug for non-approved use.
Plaintiffs allege that GSk misled pregnant users into believing that the drug was safe for use during pregnancy and that it failed to adequately warn expectant mothers of the risks of birth defects. Over 200 incidents of birth defects linked to prenatal use of Zofran have been reported.
Several studies have linked Zofran to a greatly increased risk of certain birth defects, including serious heart defects, cleft lip and cleft palate. A Danish study suggested that infants born to women who used Zofran in the first trimester of pregnancy had double the risk of developing atrial septal or ventricular septal heart defects and a 2.4 fold increase in the risk of developing a cleft palate.
The Ohio Pharmaceutical Injury Attorneys at Clark Perdue & List represent individuals who have been harmed by dangerous drugs. If you were prescribed Zofran during the first trimester of pregnancy and your baby was born with a heart defect, cleft lip or cleft palate, you may have a claim. Contact the Zofran birth defect attorneys at Clark, Perdue & List.