GlaxoSmithKline (GSK) will not be allowed to sidestep its accountability for failing to warn pregnant women and their doctors about the dangers of Zofran when used to treat morning sickness, according to the Jere Beasley Report. U.S. District Judge F. Dennis Saylor IV will allow claims about the drug’s labeling to move forward in the multidistrict litigation (MDL). He determined that plaintiffs adequately pleaded their claims that information about Zofran’s teratogenic effects that has been included in its prescribing information since 1993 misrepresented its safety during pregnancy.
Drug Watch explained that the MDL was created in November 2015 in the U.S. District for the District of Massachusetts. It was in response the growing number of lawsuits filed by women who took Zofran while pregnant then discovered the link between in utero exposure to the drug and devastating birth defects such as congenital heart problems and cleft palate. The U.S. Judicial Panel on Multidistrict Litigation reports that 385 fraud-based claims involving prenatal use of Zofran are part of the MDL.
Previously, Beasley Allen reported that GSK’s alleged deceptive marketing practices regarding Zofran significantly expanded its market. Consumers say such practices began in 2002 when Zofran sales netted the GSK more than $1 billion. The scheme allegedly continued for two years, despite the lack of studies to determine the drug’s safety for pregnant women and developing fetuses.
According to the Jere Beasley Report, the Food and Drug Administration (FDA) approved Zofran, which contains ondansetron, in 1991 to treat nausea and vomiting in chemotherapy patients. While the agency forbids pharmaceutical companies from promoting their medications for off-label uses, doctors are free to prescribe drugs for uses outside of the labeled indications.
To date, the FDA has received more than 500 reports linking in utero use of Zofran to birth defects. 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 following a federal governmental investigation.
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Lawyers in our firm’s Mass Torts Section continue to investigate cases involving children born with a heart defect or cleft palate after in utero exposure to Zofran. If you would like more information about this litigation, or if you or someone you know has had a family member who suffered from a congenital heart defect or cleft palate as a result of prenatal Zofran exposure, contact Roger Smith or Liz Eiland, lawyers in our firm’s Mass Torts Section, at 800-898-2034 or by email at Roger.Smith@beasleyallen.com or Liz.Eiland@beasleyallen.com.
Jere Beasley Report (May 2017) – Judge Keeps Fraud Claims Against GSK Alive In Zofran MDL, page 15.
U.S. Judicial Panel on Multidistrict Litigation
Jere Beasley Report (March 2016) – An Update On The Zofran MDL Litigation, page 18.