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Between February 2nd and 5th, 9 more lawsuits claiming GlaxoSmithKline’s anti-nausea drug Zofran causes birth defects joined the Multi-District Litigation now consolidated in the US District Court of Massachusetts. But only 1 of these lawsuits was originally brought in a different court. The other 8 were filed for the first time last week, directly in the US District Court of Massachusetts. This may well mark a turning point in a litigation that today includes at least 224 Zofran birth defect lawsuits, according to the Boston court’s docket.

Parents Now Filing Directly In The US District Court Of Massachusetts

Like most of the Zofran lawsuits pending in Massachusetts, case number 1:16-cv-10156-FDS was transferred there from another court. The suit, in which a mother from Tennessee claims Zofran caused her daughter’s heart defects, was initially filed in a Kentucky state court on January 19, 2016. More than 200 other lawsuits have taken a similar journey, as the litigation has been centralized for pre-trial proceedings.

But now that Judge F. Dennis Saylor IV has announed that forthcoming lawsuits may be filed directly in the Boston MDL, entirely new claims are also joining the fray. Among them is case number 1:16-cv-10153-FDS, filed by a mother from Virginia Beach, Virginia.

Virginia Mother Says Zofran Caused Life-Threatening Heart Defects

In her lawsuit, Plaintiff claims she was prescribed Zofran in April of 2013, little more than 13 weeks into the first trimester of pregnancy. The drug, she notes, is frequently prescribed as a morning sickness treatment – but was never approved for such use. Despite this lack of approval, GlaxoSmithKline actively promoted Zofran for use during pregnancy, the mother says, using misleading claims about the drug’s safety to deceive physicians into prescribing it to pregnant women.

In August 2013, Plaintiff underwent an ultrasound exam, according to her lawsuit. Her unborn daughter, who would be named C.S. after birth, was soon diagnosed with Tetralogy of Fallot, a rare cluster of debilitating heart defects. The child was born in November, and only 3 months later, underwent an open heart surgery. Without treatment, Tetralogy of Fallot is almost invariably life-threatening.

Distraught, the mother sought an explanation for her daughter’s abnormalities, but writes: “to the fullest extent that medical technology can determine, there is no genetic cause for C.S.’s condition.” “Rigorous” genetic testing has been unable to explain why the child was born with heart defects, a fact that, to her mother’s mind, suggests an environmental cause. It is only now, nearly 3 years after her daughter’s birth, that Plaintiff has become aware of the multiple major studies linking Zofran to an increased risk for heart defects. She says that she would never have taken the drug, if she had been made aware of its potential association to fetal harm.


  1. Gravatar for Danielle

    Do you have any updates on the Zofran cases?

    Thanks so much for your blog, this is how I keep up with what is going on.

    1. Gravatar for Michael Monheit
      Michael Monheit

      The Zofran MDL litigation is proceeding in front of Judge Dennis Saylor in Boston. The Court holds monthly status conferences. The next big step will be corporate structure depositions and continuing discovery, including document production by GSK.

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