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As of December 1, 2015, between 150 and 160 Zofran lawsuits have been transferred to the US District Court of Massachusetts. Consolidated before the Honorable F. Dennis Saylor IV in Boston, the claims accuse drug giant GlaxoSmithKline of hiding evidence that its anti-nausea medication Zofran causes birth defects.

Does Zofran MDL Spell End For New Lawsuits?


With the Zofran litigation speeding up, many families have expressed concern that their own voices won’t be heard. “Consolidation” is a legal process in which lawsuits that make similar allegations are transferred to a central location for coordinated proceedings, and it often sounds like the end for people who haven’t yet brought their own claims.

But new lawsuits can still be filed, says Michael Monheit, Esq., lead attorney at Pennyslvania’s Monheit Law. Monheit has helped many families pursue justice for their children and continues to offer free consultations. In his experience, the creation of a Multi-District Litigation, or MDL, has no effect on the rights of other potential plaintiffs. In fact, MDL often makes it easier for injured parties to seek compensation.

Off-Label Drug Finds Home As Morning Sickness Treatment, But Link To Birth Defects Causes Alarm

“A range of extremely large studies have linked Zofran to congenital heart defects and cleft palate,” Monheit told us, “but GlaxoSmithKline still hasn’t responded to the results. The warning label doesn’t contain any mention of birth defects, even about a potential risk.”

Soon after its approval, Zofran became a popular choice among obstetricians and gynecologists wishing to control their patients’ morning sickness. But the drug was never approved for use during pregnancy, and its effect on unborn children went unstudied until a team from Harvard found an association between its active ingredient ondansetron and cleft palate birth defects in 2012.

Three huge European reviews came next, with two finding explicit links between Zofran and “hole in the heart” defects among millions of Danish and Swedish birth records.

Reports Of Corporate Fraud Raise Questions

Recent evidence has cast doubt on GlaxoSmithKline’s marketing of Zofran, along with the corporation’s handling of birth defect reports.

“First, the US Department of Justice accused Glaxo of promoting Zofran as a morning sickness treatment,” Monheit says. “That would be illegal under federal law, and while the company never admitted wrongdoing, it’s interesting to note that it still settled the government’s case for $3 billion.”

In their lawsuits, plaintiffs who gave birth to children with birth defects have made even more troubling allegations. They say Glaxo has been concealing evidence that Zofran presents an “unreasonable risk of harm” to unborn babies – for over 20 years.

No word has yet reached the public on when, or how, the “Multi-District Litigation” will proceed, although unconfirmed reports have surfaced that a Plaintiffs’ Steering Committee (PLC) will be appointed shortly. In complex forms of litigation, a team of trial attorneys is normally appointed to a PLC and charged with protecting the interests of numerous plaintiffs.

Update December 3, 2015: The US District Court for Massachusetts has now issued five “orders” as the Zofran MDL gears up to begin pre-trial proceedings. Find out what the court’s telling attorneys and plaintiffs in our new article.

Michael Monheit is working in tandem with a number of other distinguished attorneys to pursue GlaxoSmithKline in court. For more information on what it takes to file a Zofran lawsuit, call 1-877-621-4809. Monheit provides case evaluations at no charge and no obligation.


  1. Gravatar for Bob Jones

    No mention of the 600,000 patient study in a real medical journal, NEJM, that shows no association between Zofran and birth-defects?

    1. Gravatar for Michael Monheit

      Bob, If that really is your name... New England Journal Of Medicine Study 2013 (also Known As The Pasternak Study) was, over 600,000 pregnancies were analyzed from 2004 to 2011 in Denmark. The study classified pregnancies as being exposed to Zofran if the drug was taken in the first 12 weeks of pregnancy. There is a fundamental flaw with how patients were selected. Upon drilling down into the data, it becomes clear that half of the exposed pregnancies reviewed involved Zofran being prescribed at week 10, which is after formation of the cleft and heart chambers occur in the fetus, placing in question the validity of the study. Supplemental materials to the study suggests that Zofran taken during the first trimester of pregnancy may result in an increased risk of:

      Septal defect by 22%

      Ventrical septal defect by 41%

      Atrioventrical septal defect by 400%

      Read more:

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