Many Question Why So Many Zofran Lawsuits Have Been Filed
By Laurence Banville
The AllegationsIn each lawsuit filed, the plaintiffs are the parent or parents of a child who was born with a birth defect. Birth defects that have been listed in the complaints include atrial septal defect, ventricular septal defect, transposition of the greater vessels, tetralogy of fallot, clubfoot, respiratory distress syndrome, kidney defects, cleft lip, and cleft palate. Plaintiffs have claimed that these birth defects have resulted in the need for their child to undergo extensive medical testing and surgical procedures.
All of the plaintiffs are alleging that these birth defects occurred because the mother was prescribed and took the drug Zofran during her pregnancy. They also allege several other things:
- that there were results from animal studies performed by GSK which showed a potential link between Zofran and birth defects,
- that GSK failed to disclose this information to the public or medical community,
- and that GSK unlawfully promoted the drug “off-label”.
GlaxoSmithKline and ZofranGSK was given approval by the U.S. Food and Drug Administration for Zofran in 1991. However, the FDA only approved the use of the drug for specific patients - those who are nauseous and vomiting after chemotherapy, radiation, and anesthesia. They did not in any way indicate that the drug was safe for pregnant women and their unborn children. The reason why they didn’t approve the drug as a treatment for morning sickness was that neither GSK or the FDA had performed human clinical trials involving expectant mothers.
Despite this fact, GSK promoted the drug as a “safe” and “effective” treatment for morning sickness, a condition commonly experienced by women during the first trimester of their pregnancy. Thousands of women across the country took the drug after their doctors recommended it.
In 2012, the U.S. Department of Justice filed a complaint against GSK, alleging that they had unlawfully promoted several drugs, including Zofran, “off-label”. Although the company never actually admitted to any wrongdoing, they did agree to settle for $3 billion dollars.
The Ongoing LitigationIn October of 2015, the Judicial Panel on Multidistrict Litigation consolidated Zofran lawsuits into MDL 2657. This order transferred the lawsuits to the U.S. District Court for the District of Massachusetts under the Honorable Judge F. Dennis Saylor.
The consolidation was welcomed by both plaintiffs and the defendant, as it will hopefully save everyone involved time and money.