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More than 200 lawsuits have been filed against GlaxoSmithKline, claiming the company’s anti-nausea drug Zofran can cause birth defects. The lawsuits are now consolidated in the US District Court of Massachusetts.

But GlaxoSmithKline is not the only company to produce a version of Zofran’s active ingredient, ondansetron. In fact, the British multinational now controls only around 12% of the global market for the drug, which is approved to treat severe nausea and vomiting, most commonly in cancer patients undergoing chemotherapy or radiation therapy. More than 30 different companies now manufacture generic ondansetron.

Battle Over “Early” Product Identification Continues

This February, GlaxoSmithKline petitioned the Boston court to require “product identification”, in hopes of dividing birth defect cases involving brand name Zofran from those in which a mother was prescribed generic ondansetron. Notably, Glaxo wants product identification now, before initial discovery has begun.

In a new court filing, plaintiffs’ attorneys have raised a vigorous opposition to the company’s proposal, calling it “unwarranted” and “unfairly prejudicial.” Plaintiffs’ memorandum was filed on March 8, 2016. A copy of their response is available on

In court documents, Plaintiffs agree that product identification is common and important in mass tort litigation involving potentially dangerous drugs. But the step, in which plaintiffs confirm whether they took a brand name or generic drug, is only one part of discovery, and “with the rarest of exception,” this disclosure “is obtained initially through the Plaintiff and Defense fact sheet process.”

Plaintiffs and GlaxoSmithKline are currently drafting their “fact sheets,” standardized documents that often take the place of individualized discovery procedures in Multi-District Litigation. With so many Plaintiffs involved, it would be inefficient for GlaxoSmithKline to question each one individually. It would also be inefficient for each Plaintiff to question employees of GlaxoSmithKline individually. Instead of gathering information one-by-one, GlaxoSmithKline will create a master list of the questions it wants to ask each Plaintiff. Attorneys representing families will create their own master list, demanding information relevant to each case from the company.

Glaxo Wants To “Tilt The Playing Field” To Its Advantage, Plaintiffs Argue

A fact sheet, according to Plaintiffs, is the appropriate place to ask about product identification, not beforehand.

For one, it would be very unusual for Judge F. Dennis Saylor IV to grant GlaxoSmithKline’s request, they argue. In advancing its proposal, Plaintiffs write in their memorandum, GlaxoSmithKline has made “a departure from countless MDL product liability litigations.”

At such an early stage, product identification would be “cumbersome,” an “unnecessary hurdle for the families involved in these cases,” especially the method of product identification GlaxoSmithKline has suggested. Plaintiffs note that the company has proposed a “complicated eight-step mandate,” far more complex than the Fact Sheet, created by Plaintiffs themselves, which already includes an “earlier, more comprehensive production of product identification information.” In fact, GlaxoSmithKline’s way of doing things would delay the beginning of initial discovery by “anywhere from 90 days to 180 days,” Plaintiffs claim. Ultimately, that would postpone the production of information, the very information GlaxoSmithKline wants, longer than necessary.

Glaxo’s proposal, the memorandum continues, will also inevitably hinder the wrong Plaintiffs. While some of the women who have filed lawsuits may, indeed, have taken a generic form of Zofran, many others became pregnant prior to 2007, and thus before any generic versions of the drug became available. But GlaxoSmithKline is asking them for product identification, too.

Zofran “Unlike Any Other Pharmaceutical Case Involving Generic” Drugs

Even more importantly, Plaintiffs argue, this litigation is different.

GlaxoSmithKline wants generic ondansetron cases to be dismissed, they write, and in other MDLs that can happen. Courts frequently hold that brand name drug companies can’t be held accountable for injuries caused by generic equivalents. But as the US Justice Department alleged in 2012, Plaintiffs claim that GlaxoSmithKline illegally marketed Zofran for use as a morning sickness treatment, and that this marketing began well before any generic versions became available.

Along those lines, “Plaintiffs will prove (and GSK implicitly has conceded in the largest healthcare fraud settlement in U.S. history) that GSK’s pervasive illegal and fraudulent conduct marketing for an untested, unapproved and virtually experimental use gives rise to its liability for injuries based on the ingestion of generic ondansetron by mothers after 2007″ [emphasis added].

In effect, Glaxo’s allegedly illegal promotion of Zofran created an entirely new, and illegitimate, market for the drug, namely OB / GYNs and pregnant women. When generic drug manufacturers came along, they only exploited this market for ondansetron, a market Plaintiffs claim was intentionally created by GlaxoSmithKline. Under that legal theory, GlaxoSmithKline should be held accountable for the birth defects families believe were caused by ondansetron, whether or not the drug was actually manufactured by the brand name company.

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