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Michael Monheit
Michael Monheit
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With Discovery On Horizon, Zofran Lawsuits Await Court’s Fact Sheet Opinion


Two months of negotiation have been relatively fruitful, GlaxoSmithKline’s legal counsel writes in a new memorandum to the US District Court of Massachusetts. Filed on April 8, 2016, the memo presents the company’s position on the fact sheets, standardized fact-gathering documents, that will soon be issued to each of the more than 200 families who have filed their own Zofran birth defect lawsuits.

As we wrote in a recent article, fact sheets are often used in mass torts to facilitate discovery, the process whereby parties in a dispute are required to disclose relevant information. Rather than deposing each family, along with their doctors, individually, GlaxoSmithKline will simply have each plaintiff complete a fact sheet, thus gathering basic information quickly and efficiently. In turn, the company will be required to complete its own “Defendant fact sheet,” elaborating on specific lines of inquiry relevant to the families, for each Plaintiff fact sheet it receives.

But while fact sheets are standardized documents, and each family will be asked the same set of basic questions, there’s no standard fact sheet. The questions asked are determined through lengthy negotiations. Fortunately, as Glaxo’s attorneys write in their April 8 memo, “the parties have been able to reach a consensus on the vast majority of the topics” addressed in both Plaintiff and Defendant fact sheets. But several issues remain “disputed,” the company continues, and, where negotiation has proven ineffective, the court will ultimately decide which questions are appropriate and which should not appear on the fact sheets.

Product Identification Remains A Point Of Disagreement

Product identification, a matter we covered here, continues to be a sticking point. Both parties believe that each family should be required to state whether they were prescribed and took the company’s brand name Zofran product or a generic equivalent of its active ingredient ondansetron. But on how this information should be disclosed, the parties are at loggerheads.

While Plaintiffs consider the question of product identification appropriate for their fact sheet, GlaxoSmithKline believes an entirely separate document should be created, one that would be issued prior to the completion of any fact sheets. In their own memorandum on the matter, also filed April 8, Plaintiffs question the use of a separate “product identification” form, saying it will only delay the use of fact sheets. Rather than being more efficient, they argue, Glaxo’s proposal will in fact hamper progress in the Multi-District Litigation.

Doubts Raised Over Glaxo’s Goal, Dismissal Of Generic Lawsuits

Perhaps more troubling, the families contend, is what GlaxoSmithKline hopes to do once the product identification information has been submitted. After figuring out which parents took Zofran, and which took a generic drug, the company intends to file a motion to dismiss the lawsuits involving generics, Plaintiffs write.

The families have questioned this tactic before. In a memorandum filed on March 8, the families asked why, if some of the lawsuits should not be allowed to proceed because GlaxoSmithKline didn’t actually manufacture the drug ingested, the company didn’t raise that issue in its previous attempt to dismiss the actions, an attempt that the court rejected.

In their more recent memo, however, we see a more pragmatic argument against the use of an independent product identification form. The fact sheets, Plaintiffs write, will provide more than enough information, and will do so earlier than GlaxoSmithKline’s proposal. Once the fact sheets are complete, both parties and the Court will be able to “identify trends and classes of cases that may need to be put on separate tracks for discovery purposes.”

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