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Plaintiffs Fight GSK Over Zofran ‘Product Identification’

The manufacturer of Zofran, GlaxoSmithKline, has petitioned a court in Boston to furnish “product identification” before initial discovery in the Zofran MDL in hopes of keeping cases with the brand name, Zofran, separated from those naming its equivalent generic version.

GlaxoSmithKline (GSK) has petitioned a Boston court to require “product identification” before initial discovery in the Zofran multidistrict litigation (MDL) in hopes of separating birth defect cases involving brand name Zofran from those naming its generic equivalent, ondansetron.

Free Confidential Lawsuit Evaluation: If your child or other loved one was born with a birth defect after the mother took Zofran during pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.

What’s the Problem?

April 19, 2016 – More than 200 Zofran birth defect lawsuits filed against GSK have been consolidated in the U.S. District Court of Massachusetts before Judge Dennis F. Saylor, IV. However, GSK is not the only company to produce a generic version of the drug’s active ingredient, ondansetron. In fact, GSK currently only controls about 12% of the global market for the drug, and there are over 30 other companies that manufacture generic ondansetron.

Plaintiffs in the MDL have vigorously opposed GSK’s petition for product identification, calling the move “unwarranted” and “unfairly prejudicial.” They agree that product identification is important in mass tort litigation involving allegedly defective medications. But this process, in which plaintiffs state whether they used a brand name or generic, is only one component of discovery, and “with the rarest of exception,” this step “is obtained initially through the Plaintiff and Defense fact sheet process.”

The opposing parties are currently drafting their “fact sheets,” documents that often take the place of individualized discovery in MDLs. With the large number of plaintiffs involved, it would be inefficient and extremely time consuming for GSK to question each one individually. It would also be inefficient for each plaintiff to question GSK employees one by one. Instead of obtaining data in this fashion, the company will compile a master list of questions it wants to ask each plaintiff. Attorneys representing families will create their own list, requesting info relevant to each case from the drugmaker.

Plaintiffs believe the fact sheet is the appropriate place to ask about product identification, and that it would be extremely unusual for Judge Saylor to grant GSK’s request, calling it “a departure from countless MDL product liability litigations.”

At this preliminary stage, product identification would be “cumbersome,” an “unnecessary hurdle for the families involved in these cases,” according to the plaintiffs. They claim GSK has proposed a “complicated eight-step mandate,” far more complex than the traditional fact sheet, and that the company’s method would delay initial discovery by “anywhere from 90 days to 180 days.”

GSK’s proposal will also hinder the wrong plaintiffs, according to a memorandum filed last month. While some of the women who filed lawsuits may have taken generic ondansetron, many others became pregnant prior to 2007, before any generic versions of Zofran hit the market. However, GSK is asking them for product identification as well.

Additionally, plaintiffs argue that the Zofran MDL is unlike any other pharmaceutical case involving generic drugs. GSK wants generic ondansetron cases to be thrown out, and in other multidistrict litigations this can happen. Courts often rule that brand name drug manufacturers can’t be held accountable for injuries allegedly caused by their generic equivalents. However, as the U.S. Justice Department claimed in 2012, GSK illegally marketed Zofran “off-label” as a treatment for morning sickness, and that this began prior to any generic versions becoming available.

Do I Have a Zofran Lawsuit?

The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Zofran lawsuits. We are handling individual litigation nationwide and currently accepting investigating potential settlements in all 50 states.

Free Confidential Case Evaluation: Again, if your child was harmed by Zofran side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.

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