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Michael Monheit
Michael Monheit
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Massachusetts Judge Finalizes Upcoming Zofran Lawsuit Timeline


After a successful status conference on May 17, 2016, Judge F. Dennis Saylor, IV has issued a new court order in the Zofran MDL, a consolidated litigation that now includes over 200 birth defect lawsuits.

Master Pleadings – MDL Order No. 14

In MDL Order No. 14, Saylor concluded a minor dispute over the sequence and effect of “master pleadings.”

A set of standardized documents (“master complaints”) will gather in one place each of the allegations leveled against GlaxoSmithKline by more than 200 families. The company itself will prepare a “master answer,” responding to the allegations set forth in Plaintiffs’ master complaint. After that, each individual Plaintiff will submit a “short form complaint,” adopting or choosing not to adopt allegations listed on the master document. GlaxoSmithKline will then have the option to file a motion to dismiss that specific case. If the company chooses not to file a motion to dismiss, the court will consider its master answer an official answer to the short form complaint.

Here is the finalized timeline, as presented in the Boston court’s 14th order:

May 31, 2016

  • Plaintiffs file and serve on applicable Defendants their Master Complaints, one for cases involving GlaxoSmithKline’s branded Zofran product and another for cases involving generic versions of ondansetron.
  • Plaintiffs serve, but don’t yet file, their proposed Short Form Complaints, both for branded and generic cases.

After Plaintiffs have served on GlaxoSmithKline their proposal for a Short Form Complaint, both parties will negotiate over the document’s contents.

June 10, 2016

  • Unless they can agree on a final Short Form Complaint before this date, both parties will submit their own proposals to the court for consideration.

Once the court has approved a Short Form Complaint, each Plaintiff will have 30 days to file their own completed version of the document. Lawsuits filed previously in other federal courts will have 30 days from the date of being transferred to the US District Court of Massachusetts to file a Short Form Complaint. New Plaintiffs who file directly in the Boston court will do so by filing a Short Form Complaint.

June 21, 2016

  • Defendants file and serve their Master Answer to Plaintiffs’ Master Complaint.

Once a Plaintiff’s completed Short Form Complaint has been received, Defendants will have 30 days to file a motion to dismiss the case. Before filing the motion, Defendants are required to meet with Plaintiff’s counsel for a conference. Plaintiffs themselves have 30 days to file an opposition to the motion to dismiss.

If a Defendant doesn’t file a motion to dismiss, its previously-filed Master Answer will be deemed an answer to the Short Form Complaint.

What’s The Point?

Saylor’s order also outlines the “effect,” the legal weight, of these master complaints, short form complaints and master answers.

On their own, neither master complaints nor master answers are legally binding documents. It’s only after a short form complaint has been filed, and individual allegations have been endorsed by a particular Plaintiff, that their short form complaint, along with those portions of the master complaint to which they have consented, become legally operative and binding.

For Defendants, master answers only become legally binding after a motion to dismiss has been decided on by the court, or after they’ve chosen to forego the filing of a motion to dismiss.

In a wave of federal lawsuits, parents from across the country say GlaxoSmithKline’s potent anti-nausea drug Zofran causes major birth defects. Citing multiple recent medical studies, families claim the drug, which is often prescribed as an off-label treatment for morning sickness, increases the risk of congenital heart defects, cleft palate and a litany of other congenital abnormalities.

Now caring for children who face serious medical needs, the parents were shocked to learn that in 2012, GlaxoSmithKline was accused by the US Federal Government of illegally marketing Zofran for use during pregnancy, despite having never studied the drug’s effects on fetal development. Moreover, they claim that the company has been aware of Zofran’s potential birth defect risks for two decades, but failed to warn the public or health community.

Today, their numerous lawsuits have been centralized in the US District Court of Massachusetts, where the families will continue through pre-trial proceedings together. For more information, contact the experienced attorneys at Monheit Law today for a free consultation.

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