Opinion ID: 1154282
Heading Depth: 1
Heading Rank: 2

Heading: Partial Oral Argument of Mr. Koontz for Lederle Laboratories

Text: JUSTICE HUNTLEY: Now, Mr. Koontz, for the reasons you and Justice Bakes have just discussed, I have to admit that as I read through the briefs my first inclination was that perhaps it would be desirable to engraft comment k on the negligence law, because we do need these ethical drugs. But when I try to take it a step further and see what we're doing if we do it, and neither of you have gotten to it in the briefing, what is  what are you ultimately doing? Are you asking for us now  if we buy your program here, will we now in the future instruct the jury that a manufacturer may manufacture an unavoidably unsafe drug in a negligent and careless manner? MR. KOONTZ: No. JUSTICE HUNTLEY: What are  what do we have when we put comment k together with negligence? What will we tell the jury? MR. KOONTZ: Well let  let me tell you, because, obviously, Justice Huntley I've  you know, thought about that long and hard. And you'll hear from the Pharmaceutical Manufacturers Association. And we  we talked about this in the 9th circuit. As a matter of fact the judge who had that case asked me almost that very  very same question. And I think with comment k this Court has the opportunity to engraft on comment k a rather limited exception. And that limited exception is this; that if medical science has only one product, i.e. the DPT vaccine, which is this case, there's no other licensed drug on the market. That given that set of circumstances, the Court as a matter of law must defer to the FDA, they must defer to the National Institute of Health, they must defer to the CDC and they must defer to the Bureau of Biologics in terms of study committees which are the people who make the policy for the United States. JUSTICE HUNTLEY: Okay now. Okay, go ahead. MR. KOONTZ: Let me just  I've only got ... JUSTICE HUNTLEY: Go ahead, finish. I've got to follow up ... MR. KOONTZ: ... I'm saying that there is  that you can engraft on comment k a rather limited exception with the one vaccine. Now I'm excluding from that (inaudible) out the Johnson case, because Johnson there are two (inaudible). And I'm saying here in this case with the DPT vaccine, if you want to do that. I prefer the pharmaceutical manufacturers position that if you  if you find a social mandate to give a drug that  and I'm not talking about cosmetic drugs or anything like that. I'm talking about cancer drugs, DPT vaccine, Reubella, those kinds of things. That if the FDA approves those drugs you should limit it to warning and you should limit it to efficacy of manufacture, that it was made appropriately. JUSTICE HUNTLEY: Okay now. You've focused me very well, and that's why  and getting me right to the problem I'm having. You framed that that the narrow rule would be that if there is only one product then we defer to the F  we tell the jury we defer to the FDA. MR. KOONTZ: I'm simply saying, Justice Huntley, if you want to do that. JUSTICE HUNTLEY: Okay. Okay now, I'm going to take ... MR. KOONTZ: If you want to really narrow the issue you can do it  you can do it that way. JUSTICE HUNTLEY: I want to take you just one  one step at a time. Now, let's try that one. Now if we adopted that rule, you then would not foreclose a plaintiff from bringing a case saying there is a way to make another product and you're negligent in not doing it. MR. KOONTZ: The answer to that is, Justice Huntley, that you give me the proposition in a products liability case and I'll find you an expert to testify to that fact. They're all trial lawyers and you'd  that's a fact of life in our business. I'll give you somebody who will say, you could have made a better product. Now I think comment k is saying, no, you can't  you can't do that because where does it put the manufacturer? Because I'll tell you the next case. The next case is when you let a jury in Idaho reallocate American Cyanamid resources in R & D. They're big in the chemotherapy area. They're big in the (inaudible) cancer research area. Is our next case a cancer victim who says, well you developed a cure in  in, you know, in 1989, but you should have done it in '86 because ...