London-based GlaxoSmithKline (GSK) introduced Zofran (ondansetron) in the early 1990s to treat nausea and vomiting brought on by chemotherapy, radiation therapy, and surgery.
Zofran received U.S. FDA approval in January 1991 and quickly grew in popularity. In 2006, the last year of GSK’s patent, Zofran was among the top twenty bestselling drugs in America, with sales surpassing $1.3 billion from January to September. (Generic versions of the drug were approved in December 2006.)
But part of the reason Zofran use is so widespread is because doctors often prescribe it for pregnant women suffering from morning sickness. Zofran was never approved for this use, making this an “off-label” use of the drug.
Unfortunately, studies have shown that expecting mothers who take Zofran are at a higher risk for delivering children with birth defects such as heart defects, craniofacial defects like cleft palates, and kidney malformations.
As a result, hundreds of women have sued GSK for damages, while the Justice Department has brought serious charges against the drug maker for unlawful promotion of Zofran and other drugs. In 2012, GSK plead guilty to these charges and agreed to pay $3 billion in a settlement.
About Zofran and Its Marketing
Zofran is similar to Aloxi (palonosetron), Anzemet (dolasetron), and Kytril (granisetron). It works by preventing the chemical actions in the body that cause nausea and vomiting. Originally created to treat patients of chemotherapy and radiation therapy, and those who had undergone surgery, it was later prescribed (off-label) to pregnant women for morning sickness.
While it’s not illegal for doctors to prescribe drugs for off-label uses, it is illegal for drug makers to promote their products for these uses. Which, among other issues, is where GSK has run into trouble.
In 1999, the FDA warned GSK (then GlaxoWellcome) about promoting Zofran “in a manner that is false or misleading because it lacks fair balance.” The FDA said the drug maker “should immediately cease distribution of this and other similar promotional materials for Zofran.”
GSK didn’t listen, and it wound up costing them billions.
In 2012, the Justice Department charged GSK with unlawful promotion of Zofran and other drugs, as well as false price reporting practices, failing to report safety data, and paying kickbacks to doctors to sway them to promote Zofran. GSK plead guilty and agreed to pay $3 billion to settle the matter.
This was not the first time that GSK had to pay for its criminal misconduct.
GSK’s History of Manipulation and False Claims
GlaxoSmithKline has a long history of unethical business practices, including bribery, tax evasion, and other corruption.
In 2006, the American branch of GSK paid the IRS $3.1 billion to resolve the largest tax dispute in the agency’s history.
In 2010, the company paid $600 million in civil penalties—and $150 million in criminal penalties—for violating the False Claims Act. From 2001 to 2005, GSK’s Puerto Rican subsidiary (SB Pharmco Puerto Rico) manufactured several “adulterated” drugs, including Kytril, Bactroban, Paxil CR, and Avandamet. This means the drugs were not produced or packaged “in conformity with current good manufacturing practice” (per the Justice Department) to assure that drugs met safety standards.
In 2013, the Chinese government announced that GSK had given billions to doctors and hospitals to persuade them to prescribe GSK drugs. Four GSK executives were arrested; one, Mark Reilly, was sentenced to three years in prison. (He was later deported from China.) Chinese courts leveled a $490 million fine against GSK for bribing doctors with money and sexual favors.
In 2014, the UK’s Serious Fraud Office (SFO) launched a criminal investigation into GSK’s business practices. That same year, the Justice Department followed suit, exploring possible violations of the Foreign Corrupt Practices Act.
Earlier this year, the UK’s Competition and Markets Authority fined GSK £37 million for paying rival companies massive sums of money to keep generic versions of GSK drug Paroxetine off the market.
Given all of the above, it sadly seems right in line with GSK’s modus operandi to continue promoting and selling a drug that could cause serious birth defects.
Research Links Zofran to Birth Defects
Several recent studies suggest a link between Zofran and an increased risk of birth defects.
In January 2012, researchers found that mothers who took Zofran (or the generic ondansetron) for morning sickness were at a higher risk of delivering children with craniofacial defects. Specifically, the study found that children exposed to ondansetron during the first trimester of pregnancy were twice as likely to develop cleft palates. Doctors said that further investigation into these findings was warranted.
The following year, scientists studied medical reports of more than 600,000 children exposed to Zofran during pregnancy, but found no increased risk of birth defects. However, a group of Swedish researchers reviewing the same medical reports found contradictory results. The Swedish scientists found that women who took Zofran during the first trimester of pregnancy were, in fact, at an increased risk for delivering children with major congenital heart defects, including septal heart defects (holes in the heart).
Most recently, a Toronto Star investigation found similar risks when reviewing medical records for Canadian women who submitted reports to the U.S. FDA’s Adverse Events Report Database. The Star found 20 cases where Canadian women were treated for morning sickness with Zofran and delivered children with various birth defects, such as heart defects and kidney malformations. In addition, the investigation found reports of two infant deaths after exposure to Zofran.
Research has also shown that, when taken by pregnant mothers, Zofran can pass on to the developing fetus. One study concluded that “a significant amount of ondansetron” was detected in neonates, and that the drug had a longer half-life in neonates than their mothers.
Besides heart defects and craniofacial defects, Zofran may also cause kidney malformations.
Canadian Labels Warn Against Use by Pregnant Women
Incredibly, since April 2015, Canadian Zofran labels have acknowledged that “the safety of ondansetron for use in human pregnancy has not been established,” and that “use in pregnancy is not recommended.”
Conversely, the U.S. label still reads:
Pregnancy Category B. Reproduction studies have been performed in pregnant rats and rabbits at I.V. doses up to 4 mg/kg per day and have revealed no evidence of impaired fertility or harm to the fetus due to ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
It’s unfathomable why GSK would include an adequate label on its Canadian Zofran but not the American one. Regardless, the drug maker itself has acknowledged (in Canada, at least) the risks inherent in taking Zofran while pregnant, which makes them particularly vulnerable to litigation.
Zofran Defects Spawn Lawsuits
Hundreds of women have taken legal action against GSK, alleging that Zofran caused their children to develop congenital defects.
The lawsuits also allege that GSK promoted Zofran off-label for morning sickness despite never establishing the safety of the drug for this use in a single clinical study. Plaintiffs allege that, lacking sufficient data, they had no way of knowing whether Zofran was a safe and effective treatment for morning sickness. Many say that, had they known of birth defect risks, they never would have taken the drug.
Women from all corners of the United States have filed Zofran birth defect lawsuits. To help with pretrial evidence gathering and other procedures common to these suits, all Zofran cases have been centralized in a Massachusetts District Court as part of a multidistrict litigation (MDL, or mass tort). A mass tort allows each plaintiff to maintain their own lawyer and their own lawsuit.
As of today, the Zofran MDL contains more than 230 claims—a number that is expected to grow as more mothers learn of Zofran’s side effects and seek justice.
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If you took Zofran while pregnant and your child has since suffered birth defects, contact us today. You may be eligible for compensation.