The federal multidistrict court, where 260 Zofran birth defect lawsuits are filed, has issued two Pretrial Orders in MDL 2657: Zofran (Ondansetron) Products Liability Litigation
- The first is a Protective Order that sets forth procedures for the handling of confidential materials produced in the course of discovery.
- The second Pretrial Order governs the sequence and effects of Master Pleadings, and stipulates that Plaintiffs file and serve Master Complaints on applicable Defendants by May 31, 2016, according to Sandy A. Liebhard, a partner at Bernstein Liebhard LLP.
One Master Complaint will cover GlaxoSmithKline’s branded Zofran products, while a second will cover cases involving generic versions of ondansetron. Plaintiffs are also to file, but not serve, Short Form Complaints for branded and generic cases by May 31st, after which the parties will have an opportunity to negotiate the contents of those documents. If they are unable to reach agreement by June 10, 2016, the parties are each to submit their own proposals to the Court for consideration.
Plaintiffs accuse GlaxoSmithKline of concealing information tying Zofran to birth defects. They assert:
- That since 1992, the company has received hundreds of reports of children who were born with serious abnormalities following pre-natal exposure to the drug.
- That as early as 2006, studies have suggested that Zofran crosses the placental barrier in significant amounts when taken by pregnant women, which may potentially harm a developing fetus.
- That Zofran has never been approved to treat pregnancy-related nausea and vomiting, and accuse Glaxo of improperly marketing the medication for this purpose.
In 2012, the drug maker agreed to pay $3 billion to resolve illegal marketing charges with the U.S. Department of Justice that involved a number of its medications. Among other things, the company had been accused of illegally promoting Zofran as an off-label treatment for morning sickness.
Fraudulent marketing campaign
In Flynn v. GlaxoSmithKline, the plaintiffs charge that because of GSK’s fraudulent marketing campaign, Zofran was placed into the hands of unsuspecting pregnant women throughout the US. These women ingested the drug because they innocently believed that Zofran was an appropriate drug for use in their circumstance. When they ingested the drug, these pregnant women had no way of knowing that Zofran had never been studied in pregnant women, much less shown to be a safe and effective treatment for pregnancy-related nausea
In contrast, GSK knew that Zofran was unsafe for ingestion by expectant mothers. In the 1980s, GSK conducted animal studies which revealed evidence of toxicity, intrauterine deaths and malformities in offspring, and further showed that Zofran’s active ingredient transferred through the placental barrier of pregnant mammals to fetuses. A later study conducted in humans confirmed that ingested Zofran readily crossed the human placenta and exposed fetuses in substantial concentrations. GSK did not disclose this information to pregnant women or their physicians.
Plaintiff B.F. was born in 2004 with a congenital heart defect after her mother, Ms. Flynn, was prescribed and began taking Zofran beginning early in her first trimester of pregnancy to alleviate the symptoms of morning sickness. B.F.’s condition at birth and in her early years of life prevented her from thriving physically and developmentally. As a result of her condition, B.T.’ s growth metrics were below the fifth percentile compared with other children her age. Ultimately, in 2011, she was forced to undergo surgery to repair the hole in her heart. Until recently, Ms. Flynn did not suspect Zofran as the cause of B.T.’s condition, having never been informed until recently that the safety of Zofran treatment in pregnant women has not been established and that Zofran was never FDA-approved to treat morning sickness.
Plaintiff T.F. was born in 2006 with a with a congenital heart defect after her mother, Ms. Flynn, was again prescribed Zofran to treat morning sickness in her first trimester of pregnancy with T.F. As a result of T.F.’s condition at birth, she was unable to breathe adequately and required 24-hour monitoring with an electronic alarm that would alert her parents and caregivers that her oxygen levels were dangerously low. T.F.’s condition also stifled her growth and development, causing her growth metrics to fall short of the fifth percentile compared with other children her age.
The Plaintiffs are Cheri Flynn, Individually and as Parent and Guardian of B.F. and T.F., Minors.