Massachusetts federal judge F. Dennis Saylor, IV has issued a new court order in the Zofran birth defects multidistrict litigation (MDL) that now includes more than 200 birth defect complaints.

Each Zofran lawsuit similarly alleges that GSK’s anti-nausea drug causes major birth defects.

Citing multiple research studies, Zofran lawsuit claims say the drug, which is often prescribed off-label to pregnant women to treat morning sickness, increases the risk of heart defects, cleft lip and cleft palate, kidney defects and other congenital abnormalities,

In 2012, the federal government accused GlaxoSmithKline of illegally marketing Zofran for use during pregnancy, despite the fact that Zofran’s effects on fetal development had never been studied.

Many parents who have filed a Zofran lawsuit claim that the company has been aware of Zofran’s birth defect risks for two decades, but failed to warn the public or the medical community.

The Food and Drug Administration (FDA) approved Zofran for patients suffering nausea or vomiting following chemotherapy, radiation, or anesthesia but the parents who have filed birth defect lawsuits claim GSK marketed the drug to doctors as a treatment for morning sickness.

Under Judge’s Saylor’s order, a set of standardized documents—master complaints—will collect the Zofran lawsuit allegations made against GlaxoSmithKline by the affected families.

GSK will prepare a master answer, responding to those allegations. After that, individual plaintiffs will submit a short form complaint, which may adopt allegations listed in the master document.

GlaxoSmithKline will then have the option to file a motion to dismiss each specific case. If the company chooses not to file a motion to dismiss, the court will consider GSK’s master answer an official answer to the short form complaint.

Zofran Lawsuit Filing Timelines

The timeline presented in the court’s order sets May 31, 2016 as the deadline for plaintiffs to file and serve their master complaints, one for Zofran lawsuit claims involving GlaxoSmithKline’s branded Zofran and another for Zofran lawsuit cases involving generic versions of ondansetron. Plaintiffs must serve, but not yet file, their proposed short form complaints.

June 10, 2016 is the deadline for agreement on final short form complaints. If this cannot be agreed to before this date, both parties will submit proposals to the court for consideration. Once a short form complaint is approved, each plaintiff will have 30 days to file completed versions of the document. June 21, 2016 is the deadline for defendants to file and serve their master answer to the plaintiffs’ master complaint.

The master complaints and master answers are not themselves legally binding documents. Only after a short form complaint has been filed, and the plaintiff has endorsed individual allegations, does the short form complaint, along with those portions of the master complaint to which they have consented, become legally operative and binding.

For the defendants, master answers become legally binding only after a motion to dismiss has been decided by the court, or after defendants have decided to forego the filing of a motion to dismiss.

The Zofran lawsuit timeline and procedures set out in Judge Saylor’s order are intended to simplify the pretrial proceedings in the MDL.

If you took Zofran during pregnancy and your child was born with major birth defects, there may be a connection.  A qualified drug injury attorney can help you at no cost to determine if filing a Zofran lawsuit is right for you.

The Zofran Lawsuit MDL is In Re: Zofran (Ondansetron) Products Liability Litigation, MDL No. 2657 in the U.S. District Court for the District of Massachusetts.