Montgomery County, Pennsylvania

HomePennsylvaniaMontgomery County

Email Michael Monheit Michael Monheit on LinkedIn Michael Monheit on Twitter Michael Monheit on Facebook Michael Monheit on Avvo
Michael Monheit
Michael Monheit
Attorney • (215) 840-6573

Key Court-Mandated Deadlines Announced For Zofran Lawsuits


Four new court orders have spurred a flurry of activity among more than 200 families who have filed Zofran lawsuits against GlaxoSmithKline.

Four New Court Orders Set Essential Timeline For Zofran MDL Discovery

As of June 7, 2015, 265 Zofran lawsuits have been consolidated as a Multi-District Litigation (MDL) in the US District Court of Massachusetts. Other lawsuits are currently pending in federal courts outside Massachusetts, but experts believe these cases will soon be transferred to Boston, where the MDL is being guided through pre-trial proceedings by Judge F. Dennis Saylor IV.

Each lawsuit claims GlaxoSmithKline’s anti-nausea drug Zofran causes major birth defects. Citing key epidemiological studies, most of the lawsuits pursue damages in relation to congenital heart defects or cleft palate. Parents say GlaxoSmithKline failed to warn them of Zofran’s potential risks, despite alleged knowledge that doctors had begun prescribing the drug as an “off-label” (or unapproved) morning sickness treatment.

After months of negotiations, the first steps of discovery are set to begin. On May 26, 2016, Judge Saylor issued MDL Orders 10, 11, 12 and 15, mandatory instructions that require immediate action, attorneys close to the litigation say.

Product Identification Deadlines

In MDL Order 10, the Boston court outlines deadlines for the service of Product Identification Fact Sheets. We wrote extensively on the issue of product identification in a previous post. In brief, the court is asking every Plaintiff to specify whether they took GlaxoSmithKline’s branded Zofran product or one of around 30 generic equivalents available on the market.

Product Identification (PID) Fact Sheets must be served on GlaxoSmithKline within 30 days of filing suit directly in the US District Court of Massachusetts or within 30 days of the date a case is transferred to Boston. For Plaintiffs’ whose cases have already been consolidated in Boston, the PID Fact Sheets must be served on GlaxoSmithKline on or before June 27, 2016.

After serving GlaxoSmithKline with their Product Identification Fact Sheets, families have an additional 30 days to produce documents substantiating the assertions made in their PID Fact Sheets. For cases currently consolidated in Boston, these documents must be produced on or before July 25, 2016.

Plaintiff Fact Sheet Deadlines

In MDL Order 11, the court sets a series of crucial deadlines for the completion of Plaintiff Fact Sheets, standardized documents that will serve as an initial fact-gathering exercise. Every family must complete a Fact Sheet, supplying substantial personal and medical information. Along with the Fact Sheet itself, Plaintiffs will be required to sign-off on legal documents authorizing the release of their pertinent medical records.

Both the Plaintiff Fact Sheet and associated Authorizations must be finished and served on GlaxoSmithKline no later than 60 days after a case is filed (or transferred to the US District Court of Massachusetts). For families who have already filed suit in Boston, these documents must be served on or before July 25, 2016.

As with the Product Identification Fact Sheets, additional supporting documents are required for Plaintiff Fact Sheets. These documents must be produced within 30 days of a Plaintiff Fact Sheet’s service. For lawsuits already centralized in Massachusetts, the documents must be produced on or before August 24, 2016.

Defendant Fact Sheet Deadlines

After a Plaintiff Fact Sheet has been served, GlaxoSmithKline will have 45 days to complete its own Defendant Fact Sheet.

The Fact Sheet revolves around GlaxoSmithKline’s contact, or lack of contact, with Plaintiff’s health care providers. You can learn more about what Plaintiffs want to know from GlaxoSmithKline here.

After serving the Defendant Fact Sheet on a Plaintiff, GlaxoSmithKline will have an additional 30 days to produce supporting documents.

MDL Centrality Allows For Online Service Of Fact Sheets

Rather than serving their Fact Sheets in person, Plaintiffs and GlaxoSmithKline will be able to use an online portal run by BrownGreer, a legal data management company based in Richmond, Virginia.

In MDL Order 15, the court has granted its approval to the use of BrownGreer’s online system, MDL Centrality, for the completion and service of both Plaintiff and Defendant Fact Sheets. Families will be able to login to BrownGreer’s system, complete their Fact Sheets online and submit the documents for service with the click of a button.


Leave a Comment

Have an opinion? Please leave a comment using the box below.

For information on acceptable commenting practices, please visit Lifehacker's guide to weblog comments. Comments containing spam or profanity will be filtered or deleted.