In a new court filing (PDF), GlaxoSmithKline (GSK) has requested a “product identification” mandate for the Zofran multidistrict litigation (MDL) in Boston that would require plaintiffs to identify whether they were prescribed the brand name version of the drug or its generic equivalent.
Free Confidential Lawsuit Evaluation: If your family has been affected by Zofran, 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?
February 25, 2016 – The Zofran product identification mandate would “will allow for a meaningful and fair assessment of the viability (or lack thereof) of the cases before time and money are expended on cases and claims that can and should be dismissed at an early stage,” GSK wrote in a separate memorandum.
Courts have traditionally ruled that brand name drug manufacturers cannot be held liable for injuries caused by their generic counterparts. However, a dilemma arises due to the fact that generic manufacturers are unable to update their products’ warning labels with new risks until the brand name manufacturer does so first. This is especially problematic considering the fact that at least 30 different companies make their own version of an active ingredient, as is the case with Zofran.
Sales of generic Zofran have severely cut into GSK’s profits. In 2007, a year after generic equivalents hit the U.S. market, brand name sales dropped by 88%, according to court documents (PDF) submitted in support of the company’s proposed mandate.
Adverse event reports are often submitted to a manufacturer before they reach the U.S. Food & Drug Administration (FDA). Where ondansetron (the active ingredient contained in Zofran) is concerned, those reports are likely split between the 30 different companies that manufacture generic versions of the drug. Therefore, it’s possible that each manufacturer has a different view of the medication’s potential health risks. But only GSK, who no longer controls the market, is legally allowed to warn the public of these risks.
FDA is aware of this dilemma, and has even proposed a fix – to allow generic manufacturers to update their products’ warning labels. But the companies don’t want that, since it would open them up to increased liability.
The other solution is to hold brand name manufacturers liable for failure to warn in their own labeling, even when a plaintiff took the generic. That’s the theory behind “innovator liability,” which contends that since brand name manufacturers control the labeling for generic companies, the former should be held accountable for injuries caused by an active ingredient, no matter who made the drug. Unfortunately, innovator liability is currently recognized in only California, Illinois and Vermont.
GSK acknowledges innovator liability in its recent court filing, saying: “the fact that some Plaintiffs may claim that GSK is liable for injuries allegedly caused by a generic manufacturer’s product does not relieve them of their obligation to identify the product they allegedly ingested.” Defining whether or not a plaintiff took generic ondansetron will “promote efficiency and preserve the resources of the parties and the Court,” the company asserts.
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 investigating potential settlements in all 50 states.
Free Confidential Evaluation: Again, if your child or other loved one was harmed by Zofran side effects, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and our lawyers can help.