Zofran Birth Defects Litigation Moves Forward

In the federal multidistrict litigation (MDL) presently underway in the U.S. District Court, District of Massachusetts, more than 260 Zofran birth defect lawsuits continue to move forward. The parties involved have jointly submitted proposed Master Long Form and Short Form Complaints. On May 31, the Master Long Form Complaints were put forward: one to be used by plaintiffs who file cases involving the name brand Zofran; another for those involving generic forms of ondansetron. Novartis, a Swiss pharmaceutical company purchased the right to sell Zofran in American markets in March 2015, and is also involved in the suits.

On June 20, the proposed Short Form Complaints were submitted by plaintiffs. The Short Form Complaint will allow plaintiffs to provide details specific to their individual Zofran lawsuit. The use of Master Long and Short Form complaints is standard procedure in an MDL and will streamline the process for filing a claim in this case, according to Business News.

Zofran has been approved for use in post-operative surgery patients, or patients undergoing certain cancer treatments, as an anti-nausea medication. The Zofran lawsuits pending in the District of Massachusetts claim GlaxoSmithKline concealed hundreds of birth defects reports concerning babies who were exposed to the drug in-utero. Allegedly, Glaxo had knowledge of animal studies as early as 1980 that the active ingredient in Zofran could cross the placental barrier in mammals. The placental transfer of Zofran in humans was confirmed in a study involving 41 pregnancies, according to the lawsuits, reports Business News.

Zofran was never approved for the treatment of pregnancy-related nausea and vomiting. Yet, 1 million expectant women are prescribed Zofran, or its generic equivalents, every year for this purpose, according to an analysis published recently in the American Journal of Obstetrics and Gynecology.

In 2012, GlaxoSmithKline agreed to pay $3 billion to resolve illegal marketing charges with the U.S. Department of Justice that included a number of its medications. Among other issues, the company had been accused of illegally promoting Zofran as an off-label treatment for pregnant women suffering from pregnancy-related nausea and vomiting.

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