Zofran was used by many pregnant women for morning sickness. GlaxoSmithKline, the manufacturer of Zofran, got the drug approved by the FDA for use in cancer patients who required radiation therapy or chemotherapy in 1991. Zofran was not approved for use with pregnant women because medical studies had not been submitted to the FDA to demonstrate the safety of the drug on fetuses.
Lawsuits are being filed on behalf of children with birth defects against GlaxoSmithKline because the company promoted off-label marketing of the drug to pregnant women which is illegal under FDA regulations. When Zofran was promoted for morning sickness in pregnant women there were medical studies that indicated that the drug would cross the human placenta barrier exposing the fetuses to the drug. As sales of Zofran increased in 1992, GlaxoSmithKline began receiving reports of birth defects associated with Zofran but GlaxoSmithKline failed to include warnings in the drug label to prescribing physicians about the danger of birth defects to pregnant women. Further, GlaxoSmithKline, continued its campaign of illegal off-label promotion of Zofran from morning sickness because it was highly profitable. GlaxoSmithKline received at least 32 reports of birth defects by 2000. As of 2014, there were over 200 reports of birth defects associated with Zofran.
In 2012, GlaxoSmithKline paid more than $1 billion to settle civil charges brought by the U.S. Government for its off-label marketing of various drugs including Zofran. In that settlement the U.S. Government claimed that GlaxoSmithKline promoted the sale and use of Zofran for a variety of conditions other than those for which its use was approved as safe and effective by the FDA including hyperemesis and pregnancy related nausea. More specifically, the government claimed that GlaxoSmithKline offered and paid illegal remuneration to health care professionals to induce them to promote and prescribe Zofran.
Children of mothers who took Zofran during pregnancy have been born with birth defects such as cleft palate, heart defects, hearing damage, hernias, webbed toes, and sensitivity to light.
I expect that there will be hundreds of federal lawsuits and class actions that will be coordinated in a nationwide federal multidistrict litigation.
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