In a new court filing, GlaxoSmithKline has asked the US District Court of Massachusetts to mandate “product identification,” which would require plaintiffs to identify whether they were prescribed the company’s brand name Zofran product or a generic equivalent manufactured by some other company. In a separate Memorandum, the company’s attorneys wrote that product identification at this stage “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.”
Generics Hurt Glaxo, But Brand Name Companies Control Warning Labels
Courts have ruled in the past that brand name drug companies cannot be held accountable for injuries caused by generic medications. That may sound reasonable, until you realize that generic manufacturers are legally barred from updating their warning labels with new risks until the brand name company does so first. That’s a problem, especially when you have at least 30 companies manufacturing their own version of an active ingredient, as we do in the case of Zofran.
Generic sales hurt GlaxoSmithKline considerably. In 2007, one year after generic equivalents of Zofran became available, the company’s branded sales dropped by 88% in the US, according to court documents submitted in support of GlaxoSmithKline’s Motion.
Adverse event reports are often submitted to a manufacturer before they reach the FDA. Where ondansetron, Zofran’s active ingredient, is concerned, adverse event reports are likely split between those 30 different companies. It’s quite possible then that each of those companies has gained a different picture of the drug’s potential risks. But only GlaxoSmithKline, a company that no longer controls the market, is allowed to act on their own picture and warn the public of a developing safety problem. The other companies can’t, even if they’ve received substantial evidence that ondansetron can cause serious harm.
The FDA is well-aware of this problem, and has even floated a potential fix: allow generic drug manufacturers to change their warning labels. But the companies in question don’t want that, since it would only open them to further liability.
The other solution is to hold brand name drug manufacturers accountable for glaring omissions in their labeling, even when a patient took the generic equivalent. That’s the logic behind a legal theory called “innovator liability.” Since brand name manufacturers control the labeling for generic manufacturers, the former should be held accountable for injuries caused by an active ingredient, no matter who manufactured the drug. Unfortunately, “innovator liability” is currently recognized in only three states: California, Illinois and Vermont, according to ZofranLegal.com.
GlaxoSmithKline recognizes this theory, albeit obliquely, in its recent court filing, writing: “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.” Identifying whether or not a particular Plaintiff took generic ondansetron, a product not manufactured by GlaxoSmithKline, will “promote efficiency and preserve the resources of the parties and the Court,” the company’s counsel opines.
In the company’s eyes, product identification will root out “legally nonviable cases and claims,” lawsuits that can be dismissed quickly. Judge F. Dennis Saylor IV has not yet granted GlaxoSmithKline’s motion, although the issue was scheduled to be discussed during a status conference on September 23, 2016.