Long time readers of this blog will remember the debate over the so called "innovator liability" about which I have posted in the past. You can find some of those posts by going to the "warnings" label and scrolling down.
In an nutshell, the debate is this: Current FDA regulations require manufacturers of generic prescription drugs to use exactly the same warnings that the name brand manufacturers use. By "name brand manufacturers" I mean the manufacturers of the original drugs of which the generics are now an option. The manufacturers of generics are not allowed to deviate from those warnings even if they think that they should provide better warnings that could make the product safer. And, the language of the warnings are largely determined by the name brand manufacturers themselves, not by the FDA.
Because of this, manufacturers of generics can say that it is not their fault that the warning is inadequate since their hands are tied when it comes to deciding what the warning should say. For that reason, at some point plaintiffs' lawyers started to file claims against the name brand manufacturers arguing that since the problem was that the warning was inadequate, it is the party that decided what the warning should be who should be liable, even if that defendant was not the person who manufactured the drug used by the plaintiff. This theory of liability is what is not often referred to as "innovator liability."
To me, it makes perfect sense because the claim is not based on a manufacturing problem, but on the lack of, or adequacy of, a warning. But, not surprisingly, brand name manufacturers and their lawyers have reacted negatively to the possibility of liability.
Some courts have adopted innovator liability as a possible way to support a claim; others have rejected it, and just a few days ago I heard of a recent decision by a state court in Idaho rejecting it. The case is called Sterling v. Novartis and you can read the opinion here.
It is interesting that the court starts its discussion of the issue by pointing out what it refers to as the “crucial fact” that “Novartis did not manufacture the drug that caused the injuries.”
Obviously, sated that way it sound like imposing liability on the defendant would be contrary to basic principles of tort law. After all, as the court also points out the common law generally does not impose liability on a company for injuries caused by other companies.
But here is the thing. That "crucial fact" is also irrelevant.
That fact would be crucial if the claim was for an injury related to the manufacturing or design of the product because in a case like that the plaintiff would be trying to impose liability on the defendant for the conduct of the generics manufacturer.
This claim is based on an inadequate warning and the brand name manufacturer is the one whose conduct is related to the warning. Thus, the possible liability is not for the conduct of another but for the conduct of the defendant.
The question is whether the duty owed by the defendant to its customers should extend to the customers of the generics manufacturers. Applying the most commonly adopted analysis for this question, we would say the duty should extend to those whose injuries are a foreseeable consequence of the risk created. If the risk was created by the defendant given its role in determining the content of the warning, then it makes sense to extend the duty and to recognize the possibility of liability for the resulting injuries.
Here is a comment from the perspective of the defendant which argues against my view.
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