Zofran was approved by the Food and Drug Administration in 1991 to treat those patients suffering from nausea as a result of chemotherapy or radiation treatment and following surgery. Between 2002 and 2004, GlaxoSmithKline (GSK) promoted Zofran for nausea and vomiting during pregnancy (commonly known as morning sickness), despite the fact that no clinical trials have ever proven Zofran to be safe and effective for that purpose. Relying on GSK’s promotions and trusting that Zofran was safe for the treatment of morning sickness in pregnant women, doctors began to prescribe Zofran off-label. GSK made more than $1 billion in Zofran sales in 2002 alone.
While doctors have discretion to prescribe medications to treat conditions for which they are not approved, FDA regulations forbid pharmaceutical companies from promoting their medications for off-label uses. GSK’s promotion practices eventually led to a federal governmental investigation. In July 2012, GSK agreed to plead guilty and pay $3 billion to resolve criminal and civil liabilities stemming from its illegal promotion of Zofran and other drugs.
Now available as an inexpensive generic, Zofran continues to be prescribed routinely for pregnant women suffering from morning sickness. Recent epidemiological studies investigating the association between in utero exposure to Zofran and the risk of birth defects have raised concerns about this practice. Two studies have shown a doubling of the risk of certain congenital heart defects in babies whose mothers took Zofran early in pregnancy. A third study showed a doubling of the risk of cleft palate for babies whose mothers took Zofran.
To date, more than 200 lawsuits have been filed against GSK, alleging that in utero exposure to its anti-nausea drug Zofran caused children to be born with birth defects. In October 2015, the Judicial Panel on Multidistrict Litigation decided to consolidate in one court all of the Zofran cases filed in federal courts across the country and assigned the consolidated litigation to U.S. District Judge F. Dennis Saylor, IV, in the District of Massachusetts.
If you would like more information about this litigation, or if you or someone you know has suffered from a congenital heart defect or cleft palate as a result of prenatal Zofran exposure, contact Liz Eiland or Roger Smith, lawyers in our firm’s Mass Torts Section, at 800-898-2034 or by email at Liz.Eiland@beasleyallen.com or Roger.Smith@beasleyallen.com.
Sources: www.qsk.coom and www.justice.gov
