Tuesday, November 2, 2010
Video on preemption issues in generic drug cases and question about inadequate warnings
Here is a short video, courtesy of the Washington Legal Foundation, on some intereting issues related to preemption and generic drug manufacturers. The whole topic is very interesting, but I want to hightlight one related issue. Note how the speaker argues in favor of preemption by arguing that generic manufacturers are obligated by law to provide the exact same warning that brand name manufacturers provide and that generic manufacturers are not allowed to change or update the warning unless the brand name manufacturers do so first. Brand name manufacturers, on the other hand, are permitted to update the warnings when newer information becomes available to them that suggests the warning should be improved or strengthened. But generic manufacturers can't do this; they can't change the warnings unilateraly. Here is what I find intersting about that argument: there has been a lot of discussion (see here) about whether a brand name manufacturer should be held liable for injuries suffered by the user of a generic equivalent. I understand that sounds unfair, and I think it would be unfair if the drugs are not really "equivalent" (for more on that issue go here). But what if the claim is for lack of adequate warnings? If the warnings in the generic drug are essentially controlled by the brand name manufacturer and they are inadequate, can't you say that the brand name manufacturer contributed to the injury and should be partly responsible? I don't see why not. For my previous posts on this topic go here, here, here, here, here and here.