Judge Approves Short-Form Complaint in Zofran Products Liability Litigation

Zofran cleft palate birth defect
Zofran cleft palate birth defect

US District Judge F. Dennis Saylor IV on July 8, 2016 approved the new Short-Form Complaint and Jury Demand submitted by the parties in Zofran (Ondansetron) Products Liability Litigation.

Specifically the court approved:

  1. Master Short-Form Complaint and Jury Demand—Brand Zofran Use, Docket No. 274, Exhibit A, filed June 20, 2016
  2. Master Short-Form Complaint and Jury Demand—Generic Ondansetron Use, Docket No. 274, Exhibit B, filed June 20, 2016.

This Order will trigger certain requirements under MDL Order No. 14, including the requirement that each current plaintiff file a Short-Form Complaint within 30 days of this Order.

The Zofran litigation is consolidated in MDL No. 2657 in US District Court in Boston, Massachusetts. According to Zofran complaints filed:

GSK knew about birth defects

Defendant GlaxoSmithKline LLC d/b/a GlaxoSmithKline GSK knew as early as 1992 that Zofran passed through the placenta and into a developing fetus and presented “unreasonable risk of harm” to developing babies.

GSK marketed Zofran “off-label” for treatment of nausea and vomiting associated with pregnancy. The company represented that Zofran was a safe and effective treatment for the nausea and vomiting associated with pregnancy. However, the drug had not been studied for its adverse affects upon pregnant mothers, or the possible teratogenic effects upon their fetuses at any time between 1991 and 2011.

Between April 2009 and December 2013, GSK reported that it made paid doctors and healthcare institutions more than $437.9 million dollars in the United States for speaking fees, consulting fees, research, travel fees and meals.

In 2013, GSK made $12.8 billion in sales in the United States, making it the fifth most lucrative pharmaceutical company doing business in the United States according to IMS Health.

For more, read our article 260 Zofran Cases Filed Against GlaxoSmithKline


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