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More than 200 families have filed suit against GlaxoSmithKline, the manufacturer of Zofran, a drug parents say causes major birth defects. Their lawsuits have been consolidated in the US District of Massachusetts, a federal court in Boston, since October of 2015.

The families say that GlaxoSmithKline’s anti-nausea drug caused their children to be born with birth defects. Zofran is often prescribed to pregnant women as an off-label treatment for morning sickness. The drug has not been approved for that use, and several studies suggest that its active ingredient, ondansetron, can significantly increase the risk for congenital heart defects and cleft palate.

In a new proposal, filed with the court on May 5, 2016, Plaintiffs and GlaxoSmithKline outline their tentative agreement on the steps that will soon follow.

Families Prepare Master Complaint

“Master Pleadings” are at the center of this joint proposal. The court has decided to implement a technique common when a large number of lawsuits are filed on a similar legal foundation.

While each lawsuit will remain its own individual legal action, Plaintiffs have been tasked with preparing a “Master Complaint.” This standardized document will list the common allegations of fraud, unlawful marketing and evidence concealment that each lawsuit levels against GlaxoSmithKline.

In actuality, two Master Complaints will be created, one for lawsuits in which GlaxoSmithKline’s brand-name Zofran was prescribed and another for cases involving generic versions of the drug’s active ingredient, ondansetron.

Both Master Complaints will be filed, and served on GlaxoSmithKline, by May 31, 2016, according to the parties’ proposed timeline.

Short Form Complaints

On its own, the Master Complaint is an administrative document. It only becomes “legally operative and binding,” according to the proposal, once Plaintiffs have also filed their “Short Form Complaints.”

In these documents, individual Plaintiffs will be able to choose which of the Master Complaint’s allegations they want to adopt, while providing other relevant personal details that could not be included on the standard Master Complaint. Eventually, there will be a Short Form Complaint for brand-name Zofran cases and another for generic ondansetron cases.

But Plaintiffs and GlaxoSmithKline have yet to agree on what should be included in the Short Form Complaints, and what should be left out. Plaintiffs will submit their proposals for what the Short Form Complaints should look like on the same day they file their Master Complaint, May 31, 2016. Negotiations will likely follow, and agreed-upon Short Form Complaints will be submitted for the court’s review by June 10, 2016.

Once the court has approved these Short Form Complaints, Plaintiffs will have 30 days to file their own version of the documents. New Plaintiffs who file suit directly in the US District Court of Massachusetts will do so by filing a Short Form Complaint.

GlaxoSmithKline Will Respond In Master Answer

In the meantime, GlaxoSmithKline will be busy preparing a “Master Answer” to Plaintiffs’ Master Complaint, responding to each of the allegations listed on the standardized document. The company’s Master Answer will be filed and served on Plaintiffs by June 21, 2016.

But like Plaintiff’s Master Complaint, it will be considered an administrative document until Short Form Complaints have been filed. Once a Short Form Complaint is filed, Glaxo will have 30 days to file a motion to dismiss that individual case. If the company doesn’t, then its Master Answer will be considered its “legally operative and binding” answer to the Short Form Complaint.

Again, this timeline has not yet been approved by the court, but it seems at least that the more than 200 families have come to a tentative agreement on a path forward with the company they are suing.


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