Friday, November 6, 2015 - The Zofran multidistrict litigation will hold its first status conference on November 17. The litigation received class certification from the JPML less than a month ago from the JPML for 12 lawsuits and has already grown to more than 100 cases total in the MDL. The plaintiffs claim that this negligent action led to serious birth defects being discovered in their children. The MDL consolidated many of the lawsuits against GSK into one large federal litigation that will be heard before a single federal judge.
The transfer of the Zofran birth defect lawsuits was originally comprised of 12 cases filed before the JPML, as well as a note of 42 additional cases that are likely to be added in as tag-along actions. The lawsuits will be heard before U.S. District Judge Dennis F. Saylor, IV, who was already presiding over four Zofran actions at the time of the transfer. One of the four before Judge Saylor was also the first action filed in the lawsuits included in the MDL.
The Zofran lawsuits focus on allegations against GSK that claim the pharmaceutical company marketed its strong anti-nausea drug Zofran off-label to be prescribed for morning sickness in pregnant mothers. The plaintiffs have brought evidence that demonstrates a number of studies have shown a strong connection between Zofran an increased risk in the development of birth defects in children. The plaintiffs have claimed that not only should GSK have been aware of the Zofran research being done in connection with birth defects, but that the company may have been aware of the work being done into the serious side effects and chose to protect the marketability of its popular drug.
Zofran is a strong anti-nausea medication made by GSK that was initially intended to be used for surgery and chemotherapy patients suffering from post-operative and post-treatment nausea. Plaintiffs claim that GSK saw an opportunity to market the drug to mothers having difficult pregnancies, but did not go through the FDA and did so off-label. This allowed GSK to avoid testing usually performed by the FDA to avoid side effects such as birth defects from occurring with prescribed medicines.
GSK has had a history of marketing drugs off-label to patients, and settled with the Department of Justice in 2012 for $3 billion that brought to an end a number of charges against the company including many off-label marketing claims. More than two decades of studies have been produced by medical journals, universities and newspaper that have found the increased risk of birth defects relate to Zofran can jump up to 30 percent when the drug is prescribed in the first trimester. The birth defects range from heart deformities, kidney failure, cleft lip, and a number of other serious problems allegedly caused by a fetus‘ exposure to Zofran in the womb.
The multidistrict litigation will combine the lawsuits included in the motion to transfer before a single federal judge, and likely include more as the news of the certification and the Zofran birth defect information spreads throughout the country. Lawyers for the plaintiffs will coordinate with the District of Massachusetts federal court for pretrial proceedings in the coming weeks.
The status conference on November 17 will take place at 9:30 a.m. The status conference will likely go over the initial procedures meant to take place in the litigation and look at the scheduling as the MDL heads into its pretrial phase. Another status conference will be head in December.