Zofran Moves To Boston: How MDL 2657 Will Change Things

Hundreds of families have filed lawsuits against GlaxoSmithKline, claiming the company’s anti-nausea drug Zofran causes birth defects. Gradually, parents in the US have learned that several major studies have linked Zofran to cleft palate and congenital heart defects – and more troubling, that GlaxoSmithKline may have concealed the evidence.

But most of those legal claims, the vast majority actually, were submitted in only one month. So what happened?

How Working Together Will Help The Families Who’ve Filed Zofran Lawsuits

On October 13th, 2015, the Judicial Panel on Multi-District Litigation (JPML) made its long-awaited decision, creating MDL 2657, formally known as IN RE: Zofran (Ondansetron) Products Liability Litigation.

In short, the Zofran litigation has been accelerated. Now “consolidated” as a Multi-District Litigation, all Zofran lawsuits are set to go through pre-trial proceedings together.

Zofran MDL In BostonIn the coming months, the majority of Zofran birth defect lawsuits will make their way to Boston, Massachusetts. One judge, F. Dennis Saylor IV, has been appointed to preside over all of the claims.

What does all that legal jargon mean for families, both those who have already filed lawsuits and ones still considering it? We’ll break down the MDL process in general, and suggest what it could mean for parents and their children, now.

Why Consolidate Zofran Lawsuits Into An MDL?

Almost every observer has noticed that each Zofran lawsuit shares a number of similar, if not identical, allegations against GlaxoSmithKline:

  • the company unlawfully promoted Zofran as a morning sickness treatment – without FDA approval
  • Zofran increases the risk for certain birth defects, including cleft palate and heart defects, as demonstrated by a series of major scientific studies
  • GlaxoSmithKline had an obligation to notify the public of Zofran’s link to birth defects, but failed to do so

None of those allegations have been proven yet, and ultimately they’ll be decided by juries and the court. But in raising them, every Zofran lawsuit has asked the same factual questions.

The JPML, a group of federal judges, recognized that the best way, the most efficient way, to answer those common questions was by going some of the distance together.

These questions will be answered using evidence, both in the form of testimony from medical experts and internal documents held by GlaxoSmithKline. In fact, each Plaintiff is likely to rely on the same evidence in addressing those questions.

To Gather The Right Evidence, The First Time

This is the great strength of Multi-District Litigation, a legal mechanism that transfers similar lawsuits to a central court so they can proceed together. MDL 2657 will allow Plaintiffs, along with their experienced attorneys, to gather this evidence in common.

In a lawsuit, the process of gathering evidence before trial is called “discovery.” To learn more about this important step, visit the American Bar Association.

Evidence gathered for Zofran MDLEvidence can, and will, be gathered in a number of different ways. There are “interrogatories,” in which one side of a dispute will submit a series of written questions for the other side to answer under oath. Witnesses and experts can be “deposed,” asked to provide a statement out of court, which can then be used at trial or just to prepare a line of argument beforehand. “Subpoenas” demand that one side of the dispute produces a specific document or record for analysis.

Now let’s say the Zofran litigation wasn’t consolidated, and hundreds of lawsuits remained scattered in courts across the country. Each Plaintiff would have to depose witnesses, demand documents and submit their own interrogatories individually. But as we’ve already seen, all of the Plaintiffs will likely rely on the same evidence to prove their side of the story. MDL allows us to gather that evidence once, for the benefit of every legal team.

To Allow Plaintiffs Control Over Their Cases

While every Zofran lawsuit shares a core of factual questions, they’re obviously unique. Some involve a diagnosis of cleft palate, and will rely heavily on a study performed in 2012 by researchers at Harvard and Boston University. Others relate to heart defects and will draw instead on several studies conducted in Europe. Beyond these differences, every claim was filed by an individual parent or couple, on behalf of a unique child, who should and will be considered individually.

This is another strength of MDL, as opposed to class action. In a Multi-District Litigation, only pre-trial proceedings like discovery are conducted in common. After those critical steps are complete, it’s up to Plaintiffs to decide how to go forward.

Key decisions, like whether to accept a settlement offer or go to trial, are left for those who will be most affected by those decisions: the families and their children.

In theory, each lawsuit will be sent back to its original court once pre-trial proceedings are over. But many cases consolidated like this actually settle first. In fact, that’s one of the main goals of Multi-District Litigation.

To Promote A Timely Resolution

Court 4Once evidence has been gathered, and both sides of a dispute are prepared for trial, many judges will select a few sample cases from the MDL that go to court before the other ones. These are sometimes called “bellwether trials”; you can think about them as test runs, in which all the evidence and arguments determined beforehand are tried out before a real jury.

Of course, bellwether trials aren’t “test runs” for the specific Plaintiffs involved; they’re the real deal and the jury’s final decision will be binding on them. But those results can be very real for a Defendant, too. Losing a major bellwether trial might make GlaxoSmithKline more likely to offer acceptable settlements, rather than defend every other claim in court.

For guidance, it’s likely that a Plaintiffs’ Steering Committee will be appointed. This group of attorneys will make the most essential decisions, determining a course for the investigation and which legal arguments to pursue in-depth.

How Big Is The Zofran MDL?

At this point, a little under 200 Zofran lawsuits have been filed, but only 70 have been officially consolidated in Boston and assigned to Judge Saylor. Those numbers are certain to change in the near future, as more families learn of the link between Zofran and birth defects.

Fact Check: Zofran MDL

The announcement of the Zofran MDL, and the rapid increase in filings that followed, have created a lot of excitement within the legal community. Maybe it’s the feverish pace, but there are some inaccuracies being published and shared. Here’s where we’ll set them straight.

  1. Zofran lawsuits are being consolidated in the US District Court for Massachusetts, not Pennsylvania. When GlaxoSmithKline first petitioned for consolidation, the company suggested a District Court in Philadelphia as the proper venue. The JPML disagreed, opting instead for Plaintiffs’ suggestion: Boston.
  2. Some sources have reported that the US Food & Drug Administration has spoken out about Zofran’s potential association with birth defects. That’s not true; the FDA has issued two safety warnings about Zofran, but neither have anything to do with birth defects, or the drug’s use during pregnancy for that matter.
  3. Other reports have suggested that every Zofran lawsuit is automatically consolidated in the MDL. That’s false.

Can Families Still File Zofran Lawsuits?


The MDL in no way limits other parents from filing birth defect claims against GlaxoSmithKline. Actually, the consolidation could make filing new claims simpler.

During many MDLs, a “short form complaint” is made, so parents who want to file a lawsuit don’t have to start from scratch. Essentially, the short form complaint lists every allegation being made, and new families can choose to adopt the ones they’ll make.

Will My Lawsuit Be Part Of The Zofran MDL?

Most likely, but not automatically. People will still be filing individual lawsuits, even though consolidation has begun. Additional claims filed now can be transferred to Boston and added to the MDL as “tag-along actions”; that’s a step the JPML makes.

How Can I Learn More?

Give us a call. We offer free consultations, so you can find more information on your legal options at no risk. Our experienced Zofran lawyers are available 24 / 7 if you need anything.

To learn why families choose to pursue justice with the help of the attorneys at Zofran.Monheit.com, click here to find more about our experience and qualifications.