It’s not uncommon for a medication to be prescribed off-label. But doing so with some, like a drug that has been suggested to cause cleft lips and palates, as well as other birth defects that could eventually result in numerous Zofran lawsuit filings, may result in problems that are serious and potentially life-changing.
The medication, Zofran, which is also referred to as ondansetron, is specifically approved in the U.S. and Canada to treat nausea and vomiting in chemotherapy and surgery patients. It has not been cleared for these uses in expectant mothers who may be suffering from morning sickness, despite its fast-increasing popularity for this demographic.
In recent years, numerous researchers have explored the ramifications of Zofran, which is manufactured by GlaxoSmithKline. Studies involving the medication have uncovered the following problems in some children whose mothers used the drug while they were pregnant:
- Birth defects
- Heart murmur
- Kidney defects
- Heart defects
- Atrial septal defect (“hole in the heart”)
- Cleft palate
- Cleft lip
- Fetal growth restriction (poor growth in the womb)
- Life-threatening pregnancy complications
The U.S. Food and Drug Administration (FDA) specifies on its Zofran prescribing information that it should not be used to treat pregnant women, even though reproduction studies have been performed in pregnant rats and rabbits at I.V. doses up to 4 mg/kg per day. Officials stress that no evidence in these trials has confirmed a risk of impaired fertility or harm to the fetus, but that no adequate or well-controlled studies in pregnant women have been conducted, either. As such, Zofran has been classified as a “Pregnancy Category B” medication.
Updates on Federal Zofran Litigation
- September 2016: The federal Zofran litigation’s next Status Conference is scheduled to be convened on Friday, September 9th. A Joint Agenda proposed by the parties indicates that a number of matters will be discussed, including updates on filings, ESI protocol, and document production and discovery. Read More
- July 2016: The federal Zofran litigation was scheduled to convene a Status Conference on July 21st. According to the meeting’s agenda, the Court will also hear arguments on GlaxoSmithKline’s motions for sequenced discovery and a protective order concerning certain plaintiffs’ deposition notices. Read More
- June 2016: Proposed Master and Short Form Complaints have been submitted to the Court overseeing federal Zofran birth defects lawsuits. One set of complaints is to be used by plaintiffs who file cases involving the name brand drug, and another for those involving generic versions of ondansetron. The Master Complaints will detail all of the allegations common to the lawsuits pending in the litigation. The Short Form Complaints will allow plaintiffs to provide details specific to their individual Zofran lawsuit. Read More
- June 2016: A Michigan couple has joined the federal Zofran litigation, after one of their children died as a result of heart defects allegedly related to the mother’s use of the medication. The complaint also claims that the couple’s surviving twin continues to suffer from multiple heart birth defects that were the result of pre-natal Zofran exposure. Read More
- May 2016: At least 151 Alabama families have filed federal Zofran lawsuits against GlaxoSmithKline for birth defects they claim were caused by generic brands of ondansetron. However, others in the state are now barred from pursuing similar lawsuits, thanks to a law enacted by the Alabama legislature last year that bars cases filed under a legal concept known as “innovator liability.” Read More
- May 2016: The status of more than 200 federally-filed Zofran birth defects lawsuits was discussed during a Status Conference on May 19th in the U.S. District Court, District of Massachusetts. That same day, the Court issued a Protective Order that sets forth procedures for the handling of confidential materials produced in the course of discovery, as well as an Order governing the sequence and effects of Master Pleadings. Read More
- April 2016: The federal Zofran litigation is scheduled to convene a Status Conference on April 14th. Among other things, the Court will address a request by GlaxoSmithKline that plaintiffs be required to identify whether they were prescribed the name-brand medication or a generic version of Zofran. Read More
- March 2016: The federal multidistrict litigation will hold its monthly Status Conference on March 17th at 1:30 p.m., EST. Read More
- February 2016: The federal Zofran litigation will convene a Status Conference on February 23rd at 1:30 p.m., EST. Court documents indicate that just over 220 birth defects cases are pending in the proceeding. Read More
- January 2016: The federal judge overseeing the Zofran multidistrict litigation has refused Glaxo’s Motion to Dismiss all birth defects lawsuits pending in the proceeding, finding that doing so would be premature. Glaxo had argued that the plaintiffs’ claims were preempted by federal law. The company’s motion was denied without prejudice, and may be refiled at a point sometime in the future: Read More
- December 2015: The first Status Conference is convened in the federal Zofran litigation on December 16th. A series of orders are subsequently issued that, among other things, establish a Plaintiffs Steering Committe and will allow for the filing of cases directly in the District of Massachusetts. Read More
- October 2015: The U.S. Judicial Panel on Multidistrict Litigation (JPML) has consolidated all federally-filed Zofran lawsuits in the U.S. District Court, District of Massachusetts. Read More
- September 2015: The JPML will consider a motion to consolidated all federally-filed Zofran birth defect claims in a single federal court at its October 1st Hearing Session. Read More
Zofran Research Relays Conflicting Results
Over the past few years, a wealth of Zofran research has been conducted, but its risk for side effects has not been clearly ascertained.
The latest findings were released in a June 25, 2014 report from the Toronto Star.com. Among other things, researchers for the publication found that some 20 Canadian women experienced serious side effects—one reported an infant death and others reported cases of newborns with kidney malformations and heart defects—after taking Zofran. The Star analysis similarly looked at records from 2012 in the FDA’s adverse event report database.
Before that, a study released in August 2013 by Denmark researchers found an increased risk of birth defects in children born to Zofran-using mothers. Findings were presented at the International Society of Pharmacoepidemiology in Montreal and involved data from women who were pregnant between 1997 and 2010. 897,018 pregnancies were factored into the study, which detected a 2-fold increase in cardiac malformations, equating to a total malformation risk of 30 percent.
Less than a year earlier, data that was similarly obtained from the Danish Birth Registry relayed conflicting results. Women exposed to ondansetron during pregnancies that occurred between 2004 and 2011 were found to not have been at risk for birthing children with defects. The mean age of exposure was 10 weeks, meaning that half the women tested took the medication after birth defects could no longer have been produced. It was discussed during the time of this study’s release in a February 2013 issue of the new England Journal of Medicine whether this created a bias.
Zofran Class Action vs. Individual Lawsuits
As the birth control defects alleged in potential Zofran-related claims may vary in type and severity, women and children who may have been harmed by the medication may be wise to file an individual lawsuit. Filing a Zofran class action case may not earn you the compensation you and your family deserve, as rewards in these types are distributed among a large number of plaintiffs.
Last Modified: September 8, 2016