Zofran, created by Glaxo Wellcome (forerunner of Glaxo-Kline-Smith), began its life as a compassionate response to a societal need. It was originally devised as an antiemetic to help suffering cancer patients. Although not FDA approved, Glaxo Wellcome claimed that Zofran was also for patients who suffered from nausea due to pregnancy and morning sickness.
The drugmaker's decision to financially encourage doctors to prescribe Zofran in unapproved ways has led to a mass tort litigation.
What is Zofran?
The active ingredient in Zofran is a chemical called ondansetron. Ondansetron is in a class of drugs known as "5-HT3 receptor antagonists" that block the effects of serotonin in the body. Serotonin occurs naturally in the body and may cause nausea and vomiting.
Glaxo-Smith-Kline (GSK) developed the active ingredient in Zofran in the UK in the 1980s (under its former iteration Glasco Wellcome). After the pharmaceutical giant received the Food and Drug Administration’s (FDA) approval of ondansetron in 1991, it introduced the approved drug to the U.S. marketplace under the brand-name Zofran. When Zofran's patent expired, the drug was then sold under the generic name ondansetron.
At first, GSK marketed Zofran to surgeons who prescribed the medicine to relieve vomiting and nausea following surgery. GSK also marketed the drug to oncology physicians who prescribed it to alleviate nausea and vomiting stemming from chemotherapy and radiation treatments for cancer patients.
By 2012, however, GSK had started marketing Zofran to obstetricians and gynecologists as the drug of choice to alleviate morning sickness in pregnant women, even though the FDA did not approve the drug for that use. GSK never applied to the FDA for approval that the drug could be used to alleviate morning sickness.
The following is a timeline showing the history behind the Zofran product liability cases:
January 4, 1991: The U.S. Food and Drug Administration (FDA) approved Zofran for use in combating nausea and vomiting caused by chemotherapy.
January 4, 1993: FDA approved Zofran in pill form.
June 25, 1995: GSK submitted a new FDA application for a higher dosage of Zofran.
June 24, 1997: FDA approved the new Zofran application.
March 9, 1999: FDA issued a warning to Glaxo Wellcome (forerunner to GSK) stating that the company had not disclosed adverse side effects of Zofran.
January 17, 2000: Glaxo Wellcome and SmithKline Beecham agreed to merge in an approximately $76 billion stock-swap deal to form GlaxoSmithKline (GSK).
December 27, 2006: FDA approved a generic form of Zofran.
September 15, 2011: FDA issued a Drug Safety Communication warning that Zofran may affect the heart's electrical system and cause abnormal heart rhythms.
January 2012: GSK study showed Zofran could cause fatal heart rhythms. Center for Disease Control's National Center on Disease Control and Birth Defects issued a report on Zofran indicating that the drug taken in the first trimester doubled the chance of cleft palate birth defect.
July 2, 2012: GSK pleaded guilty to illegally marketing and selling Zofran for uses not approved by FDA, namely as medicine for morning sickness in pregnant women. The settlement with the Department of Justice was $3 billion. GSK paid $1 billion in criminal penalties and $2 billion in civil penalties.
August 2013: A study showed congenital heart defects in children whose mothers took Zofran for morning sickness in the first trimester.
July 2014: Researchers show Zofran crosses the placenta.
February 12, 2015: The first Zofran lawsuit was filed by a Minnesota woman alleging heart defects in two children.
February 16, 2015: Second Zofran lawsuit was filed alleging birth defects.
March 23, 2015: GSK sold the rights to Zofran and its oncology medications to Novartis, and Novartis assumed responsibility for Zofran's U.S. labeling, warnings and precautions.
October 13, 2015: The Judicial Panel on Multidistrict Litigation agreed to consolidate In Re: Zofran Products Liability Litigation (MDL 2657) for discovery purposes. All federal cases were transferred to the United States District Court in Massachusetts under U.S. District Judge F. Dennis Saylor. At the time of the consolidation, there were 60 pending cases.
June 2016: The U.S. District Court in Massachusetts added Novartis as a defendant in the MDL 2657 cases. Novartis learned of GSK's deceptive promotion of Zofran as a safe treatment for morning sickness when it acquired Zofran from GSK. GSK continues to manufacture Zofran for Novartis after the sale.
October 2019: GSK lost its motion to end birth defects cases under the MDL 2657 when the presiding federal judge ruled there was enough evidence to continue to pursue 53 such cases.
January 2020: GSK told the court it wanted to go on paper record only, not a full trial, in the first MDL 2657 bellwether birth defects case because the plaintiff could not prove she would not have taken Zofran even if there was a warning on the label.
Are You Taking on Zofran Cases?
MDL 2657 remains ongoing in the United States District Court for Massachusetts under Judge Saylor. More than 200 Zofran cases have been filed so far, though not at all cases have been consolidated under Judge Saylor.
If your firm is interested in finding clients to join MDL 2657, you must access quality leads and field intake on a massive scale. Outsourcing to a legal call center is the most efficient way to capture as many qualified cases as possible. Superior legal call centers feature customizable intake procedures that respond to, qualify and convert legal leads so you can make the most of your campaign.