Zofran Litigation Update

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Zofran Litigation Update
08.29.2016 News

More than 300 families are fighting pharmaceutical giant GlaxoSmithKline (GSK) over birth defects caused by the anti-nausea medication Zofran. With federal cases consolidated into a multidistrict litigation in Massachusetts, the litigation is making progress and moving closer to its first trial date.

This past May, plaintiffs filed a Master Long Form Complaint summarizing their shared allegations against GSK. Shortly thereafter, plaintiffs individually filed short-term complaints outlining their specific circumstances. 

In July, GSK proposed a sequenced discovery plan for the litigation, which detailed the order in which the discovery could take place. The company believes discovery should focus on two questions first: (1) whether Zofran causes the specific birth defects alleged by plaintiffs and (2) whether GSK withheld relevant safety information from the FDA.

The plaintiffs immediately refused to agree to this discovery plan because it failed to address the company’s liability in illegally marketing Zofran. Plaintiffs want GSK to demonstrate how a medication never approved for use in pregnant women became the most popular morning sickness treatment. 

In 2012, GSK paid $3 billion to the U.S. Department of Justice to settle criminal and civil allegations of fraud and illegal marketing of several drugs, including Zofran. The DOJ alleged GSK illegally promoted Zofran to pregnant women for the treatment of morning sickness even though the medication was never tested on or approved for use in pregnant women. The company’s sequenced discovery plan attempts to circumvent charges of illegal marketing, but plaintiffs aren’t going to let that happen. The sides have yet to agree on a discovery plan.

Zofran Birth Defects

In 2013, a study found that babies exposed to Zofran in utero were between two and four times more likely to develop birth defects, including congenital heart defects, cleft lip, cleft palate, club foot, and skull deformities, among others. Zofran was approved to treat nausea and vomiting in cancer patients and patients who have undergone surgery. Pregnant women were specifically excluded from the clinical trials that led to Zofran’s approval.

Zofran Birth Defects Lawyers

If you or someone you know took Zofran during pregnancy for nausea and your child was born with birth defects you may be entitled to compensation. Taking on pharmaceutical companies is an intimidating prospect, but the attorneys of Blizzard Law PLLC have experience holding drug manufacturers responsible. Contact us today for a free consultation to discuss your case.