Zofran MDL 2657 In Boston

Boston 2Hundreds of families have joined the Zofran litigation, filing birth defect lawsuits in federal courts across the nation. While the details presented in each complaint differ widely, the lawsuits share a core of similar allegations against GlaxoSmithKline.

Because all the claims raise identical “questions of fact,” the Judicial Panel on Multi-District Litigation (JPML) decided to send them to Boston, specifically the US District Court for the District of Massachusetts. Judge F. Dennis Saylor IV has been selected to preside over consolidated pretrial proceedings in what has been officially titled:

MDL 2657

                 IN RE: Zofran (Ondansetron) Products Liability Litigation

How The Zofran MDL Will Change Things For Parents & Children

That’s a lot of legal jargon, and we don’t want to leave any families in the dark. So what does the Zofran MDL mean for parents who have already filed birth defects lawsuits? Will it change things for families who are still considering bringing their own claims? We’ll answer all those questions, and walk through the MDL process in detail, now.

First, let’s talk about what the JPML does.

How The JPML Works

The JPML is a panel of federal judges. They decide whether lawsuits filed in different courts are similar enough to go through certain steps of the legal process together. If they decide that several lawsuits share “questions of fact,” they can send them to a single court for coordinated pretrial proceedings.

That’s exactly what has happened. The panel reviewed a number of Zofran lawsuits, decided they shared common “questions of fact” and sent them all to one federal court in Boston. You can read the JPML’s reasoning behind the decision in their transfer order:

Zofran MDL 2657 Transfer Order

Q. Why Has The Zofran Litigation Become An MDL?

Beyond claiming that prenatal exposure to Zofran caused their sons and daughters to be born with birth defects, parents say the drug’s manufacturer:

  • unlawfully promoted Zofran for “off-label” use during pregnancy
  • hid evidence that Zofran can increase the risk for congenital defects
  • failed to warn the public of Zofran’s alleged risks

These are questions of fact. So is whether or not Zofran causes birth defects after a pregnant woman takes it. Very simply, each family says that certain things happened; they’re making claims about the course of events, allegations that GlaxoSmithKline is likely to deny. In any event, something did happen; either Plaintiffs or GlaxoSmithKline are correct in their account of what actually went on.

A. So Evidence Can Be Gathered All At Once

Thus we’ll have to turn to facts and evidence to figure out what did and did not happen. Gathering these facts, and developing lines of evidence (usually through the testimony of experts and witnesses), is one of the most important steps in pursuing a lawsuit. All the information that will be used is gathered during “discovery,” a formal process that takes place before trial.

Since the allegations shared by all the lawsuits will either be substantiated or falsified by the same evidence, it makes sense for this evidence to be gathered all at once, rather than multiple times by numerous attorneys working separately in different states. Discovery is also the time in which Plaintiffs will be able to find out what evidence GlaxoSmithKline intends to present at trial, and vice versa.

Here are a few of the ways that evidence can be gathered during discovery:

Gathering Evidence

  • Depositions – written statements made under oath by someone related to the case. Depositions can be used in court, or to prepare a case before trial. Deposing a witness allows you to know beforehand what they’re going to say at trial.

One party can depose the other party’s witnesses. So deposition can also be used as a strategy to “trip” witnesses up; if their pretrial deposition doesn’t match their testimony in court, an attorney can attempt to undermine their credibility.

  • Interrogatories – written questions submitted for the opposing side to answer under oath.
  • Subpoenas – a written order issued by the court that compels one party to testify or produce documents for the other party’s inspection.

To learn more about obtaining evidence during discovery, visit the American Bar Association.

Obviously, if every Plaintiff wants to depose the same person, it’s more logical to hold a single deposition for all of the Plaintiffs, rather than deposing that person multiple times. The same logic holds for obtaining documents and expert medical testimony as well.

A. To Prevent Conflicting Rulings

Another thing that happens before a trial starts is the filing of “motions.”

Motions are written documents that ask the court to do something, like exclude evidence. One of the most common motions is a “motion to dismiss,” which asks the court to dismiss the lawsuit because it doesn’t have a sound legal basis. Some lawsuits are dismissed for legal reasons even when all their factual allegations are true.

But obviously, these are question for the judge to answer, in this case the Honorable F. Dennis Saylor IV. Imagine what could happen if the claims weren’t consolidated. GlaxoSmithKline would have to file a motion to dismiss with multiple judges. What if some of them agreed with Glaxo’s arguments, but others disagreed?

Consolidating Zofran lawsuits under a single judge eliminates that problem.

Update January 26, 2016 – Saylor Denies GlaxoSmithKline’s Motion To Dismiss Zofran Lawsuits

In a major early move, GlaxoSmithKline filed a motion to dismiss every Zofran lawsuit, arguing their failure-to-warn claims, based on state law, are preempted by federal law. The company’s motion, filed back on December 11, 2015, noted a citizen’s petition to alter Zofran’s warning label that was rejected by an FDA reviewer. For GlaxoSmithKline, the rejection stands as “clear evidence” that the FDA won’t entertain plaintiffs call for a labeling change, and effectively invalidates the legal basis for their lawsuits.

Two months have passed since the company’s initial motion, and families finally have their answer. Saylor isn’t dismissing the lawsuits yet, although GlaxoSmithKline retains the right to bring up its federal preemption argument at a later stage.

Update February 25, 2016 – Discovery Begins, With Creation Of Fact Sheets

Discovery is currently underway, albeit in its earliest stages. Records filed in the US District Court of Massachusetts show that GlaxoSmithKline, along with the attorneys representing families, are now developing “fact sheets.” These are standardized forms that allow the court and both parties to gather basic information about specific lawsuits in a more efficient way.

How Fact Sheets Work In Multi-District Litigation

In many MDLs, fact sheets replace interrogatories. Instead of GlaxoSmithKline submitting a list of pertinent questions to each plaintiff individually, plaintiffs will simply fill out the standardized fact sheet, providing the company with all of the preliminary information it needs. But that means the specific questions asked in the fact sheet will likely be a matter of negotiation. GlaxoSmithKline will request certain facts, plaintiffs’ counsel will suggest other questions be included and ultimately the fact sheets will reach their final form.

In the plaintiff fact sheet, plaintiffs will probably be asked to provide basic information on their medical history, their experiences with Zofran and details on the birth defects they believe were caused by the drug. Some of this information will likely be very specific. For example, the chances are good that plaintiffs will be asked to identify the physician who initially prescribed them Zofran.

You can take a look at a plaintiffs fact sheet used in the Accutane litigation here.

The defendant fact sheet will act something like a response to the information provided in the plaintiff fact sheet. If plaintiffs are asked to identify their doctor, it’s probable that GlaxoSmithKline will be asked questions like:

  • did one of your sales representatives ever approach that specific doctor with information about Zofran?
  • did a sales representative ever supply that doctor with samples of Zofran?
  • has that doctor ever been tied to Zofran in an official capacity, as a paid speaker for GlaxoSmithKline?
  • do you track how much Zofran that physician prescribes?

With these initial answers in hand, plaintiffs will be able to start building their cases. So will GlaxoSmithKline, who will be able to use this basic information to develop a set of specific questions to ask of each individual plaintiff.

Keeping Information Private

Confidentiality will be a major concern here. In civil lawsuits, the court gains “subpoena power.” That means plaintiffs and defendants can demand information from one another, and the court can hold them legally accountable for not providing it. In principle, each party has a right to any and all information, as long as they can figure out how to ask for it. In other words, you can’t demand information that you don’t know exists. But in practice, discovery is a little trickier, especially when major corporations like GlaxoSmithKline are involved.

In the past, any demand for discovery was filed with the court, and the court would then pass the demand on to the relevant party. Responses to the demand, including the information requested, would be filed with the court, too. But that placed every demand, and every response, in the public record, since court records are theoretically open for public inspection. Information, even classified information like trade secrets, had a way of leaking out.

Confidential File Folder

Most courts don’t work like that anymore. Demands for discovery now usually bypass the court, going directly from plaintiffs to defendants and vice versa. Thus sensitive information stays out of the public record – until it doesn’t. Parties can still share it with the public if they choose, unless both parties agree to keep certain information confidential or the court orders them to. It appears that GlaxoSmithKline has requested such a court order, since the District Court of Massachusetts mentioned reviewing “the status of […] a protective order of confidentiality” during a status conference held on February 23, 2016.

Q. What Happens After Pretrial Proceedings?

Theoretically, every lawsuit will be sent back to its original court. There, Plaintiffs will be able to decide for themselves whether or not they want to proceed to trial. In practice, many cases in MDLs settle before that.

Bellwether Trials

As pretrial proceedings are winding down, the court can decide to select one or more cases as “bellwether trials.” These claims proceed to trial first. It’s a way of airing out evidence, witness and expert testimony and arguments before an actual jury.

Juries decide on questions of fact. If bellwether trials happen in MDL 2657, a selected Plaintiff and GlaxoSmithKline will be able to present their two sides of the dispute, and find out how a jury reacts to their competing narratives. Ultimately, the jury will decide on what actually happened.

But that one decision won’t be binding for any of the other lawsuits. Instead, bellwether trials serve an “informational” purpose. After learning how one jury received the evidence presented, GlaxoSmithKline might decide that offering settlement agreements is a better idea than seeing every claim to trial.

Q. Who Will Lead The Zofran MDL?

Judge Saylor has appointed 3 trial attorneys to serve as Co-Lead Counsel, including Elizabeth Graham, Esquire, who works as part of the alliance of distinguished attorneys here at ZofranLegal.com. As Co-Lead Counsel, Beth will help guide the development of legal strategies and the collection of evidence.

Along with Co-Lead Counsel, Saylor appointed 2 attorneys to serve as Liaison Counsel, both of whom count among the members of ZofranLegal.com’s alliance of lawyers. Robert Jenner, Esquire and Kim Dougherty, Esquire will handle administrative issues for the MDL.

Q. Can Other Families Still File Zofran & Birth Defects Lawsuits?


In fact, the process of filing a new complaint may get easier. In many MDLs, a “short form” complaint is created. Basically, this document lists all of the possible causes of action, and other families can simply check off the ones they’d like to adopt.

Q. How Did We Get Here?

Usually, several Plaintiffs ask to have their claims consolidated. But in an uncommon move, GlaxoSmithKline petitioned the Judicial Panel on Multi-District Litigation to consolidate a number of the lawsuits. Plaintiffs agreed with the general idea, but disputed a few of Glaxo’s specific suggestions. After a lengthy debate over where the claims should be sent, the JPML sided with Plaintiffs and sent their claims to Boston.

As of February 16, 2016, the Judicial Panel on Multi-District Litigation lists 223 pending lawsuits in the Zofran MDL. Every other claim can be added as a “tag-along action”; that’s likely, but not inevitable.

When the JPML learns of a new claim similar to those already consolidated, it can issue a “conditional transfer order,” essentially adding the lawsuit to the MDL. The Plaintiff’s lawyer then has 15 days if they want to dispute the transfer.

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