US District Judge F. Dennis Saylor IV on July 15, 2016 had to remind attorneys about the rules governing the attendance and participation by telephone in any court proceedings in In Re: Zofran (Ondansetron) Products Liability Litigation, MDL 2657,
“Because of the high volume of telephone attendance, counsel attending by telephone should endeavor to minimize background noise and other interference during the call. Counsel should normally mute their telephones, so that they can hear the proceeding but other participants will not hear any unwanted noise or interference. Counsel should also avoid placing the Court on hold, which may have the unfortunate effect of playing “hold” music to all participants and throughout the courtroom. The cooperation of all counsel in observing these requirements is greatly appreciated,” he wrote
Judge Saylor is hearing 260 Zofran Cases Filed Against GlaxoSmithKline in federal court in Massachusetts.
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.