Court Opinion

ID: 9539075
Source: CourtListenerOpinion
Date Created: 2023-08-07 07:46:21.316832+00
Date Added: 2024-06-11T14:58:26.206111
License: Public Domain

SHEPARD, Chief Justice,
specially concurring in part:
I view the holding of the majority to be that comment k applies to negligence claims as well as claims based in strict liability. I draw that conclusion from the language of the majority:
*351[W]e conclude that the principles of comment k do not literally apply to negligence claims. More specifically, comment k does not shield sellers of products from negligence claims. On the other hand, in a general sense, the principles of comment k relate to the negligence concepts as expressed in Restatement §§ 291-93. (emphasis added)
As to the remainder of the opinion, I concur in the special concurrence of BAKES, J.
APPENDIX A
Partial Oral Argument of Mr. Koontz for Lederle Laboratories
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 Biologies 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.
*352JUSTICE 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 ...
JUSTICE HUNTLEY: Okay.
MR. KOONTZ: ... you didn’t allocate your resources right.
JUSTICE HUNTLEY: The short answer then is — is you’re saying then that the rule of law would go one step further and it would say that there is no way to — in the circumstance we just described, that a party can bring an action on the basis of negligence in that a different or better product could have been made.
MR. KOONTZ: That’s right.
JUSTICE HUNTLEY: So you would foreclose that type of action.
MR. KOONTZ: That’s what comment k says.
JUSTICE HUNTLEY: Okay.
MR. KOONTZ: And that’s what Dean Prosser discusses in great detail when that — and you have to understand that comment k is a national public health policy.
JUSTICE HUNTLEY: I understand that
MR. KOONTZ: We’re not talking about negligence or some — you know, a bunch of lawyers sitting around a table talking about strict liability and negligence. We’re talking about a national public health policy.
JUSTICE HUNTLEY: Okay. I understand. I’m trying to have a conversation with you here so I can understand this. Now aren’t we, if we applied comment k to this case and gave it the answer and the gloss that you’ve just discussed with me, don’t we run into a little bit of a problem that, by definition the jury in having found for the plaintiff on negligence in this case has to have found that there was a better way to build this mouse trap?
MR. KOONTZ: Well, I’ve got a couple of responses to that. First of all, this case was — I’m not sure of the year. Maybe Ken can — Ken can correct me. The vaccine was given in 1979, and we all live in a real world. It’s 1986 and we don’t see Tri-solgen on the market today, and we don’t see it in any country in the world. And what I’m saying is, Justice Huntley, that you cannot — and it’s what the Johnson court said in determining that case on the Sabin vaccine____
JUSTICE HUNTLEY: Well then you’re saying the jury was wrong in what it found.
MR. KOONTZ: Well, it isn’t that the jury’s wrong.
JUSTICE HUNTLEY: Well, they’re either right or wrong.
MR. KOONTZ: I’m not arguing that — you know, that the jury is wrong, because— you know, I’ve tried lawsuits all my life, and you never say — you know, quote “juries are wrong.” What I’m saying is, you don’t submit that action to them. You can’t have juries deciding what the — what the United States Public Health Service should do. I mean, you get into this interesting anomaly and I’d like you to consider it. If the 9th circuit — if—if you rule against us and say comment k doesn’t apply, the instruc*353tions were okay, the verdict ought to stand as it is, where does that leave American Cyanamid? Where does it leave people who make vaccines, not just Cyanamid? What are we saying, in the 9th circuit we can’t sell it, but we can sell it in the 10th circuit? You know, I think sometime you have to say that the feds have to control this type of vaccine, that you have to have professionals back there that say, we deem it — and you’re talking about the American Pediatrics Society, the American Medical Association, the NRH, the CDC, everybody says, give this vaccine. What are we suppose to say now? You can’t give it in Idaho?
JUSTICE HUNTLEY: Well, Mr. Koontz, you are in effect, I think on the bottom line here, virtually asking us to take this out of the jury system and defer to the FDA. Now ...
MR. KOONTZ: No. No, I’m not asking
JUSTICE HUNTLEY: You’re not ...
MR. KOONTZ: No, and I think — and that’s why I asked you to defer to the ... PMA amicus brief, to say — this is how — this is the history of comment k that started, you know, way back when. They’re not talking necessarily about FDA approval. What they’re saying is, if medical science can’t develop anything any better, we’re not going to let a lay jury sit here with some expert who comes from Kuna, Idaho, saying, Hey I can build a better mouse trap and they should have built it. That’s what we’re saying. It’s a warning issue, and it’s an improper manufacture issue.
JUSTICE HUNTLEY: Well, I’m genuinely trying to have this discussion with you to get the concepts clear in my mind as to what you’re proposing and what the consequence of it is. I have to say that it seems to me where you’ve taken us is to the point of saying that in the case where there is at a present moment in history only one product on the market and it’s unavoidably unsafe, we cannot have a jury question and should not submit to the jury the question of whether it was negligent to have produced that drug even if a plaintiff can establish that there was a way to manufacture a better and safer drug.
MR. KOONTZ: I think that’s — that’s accurate given the limitations of comment k, that it was manufactured in accordance with FDA, NIH, CDC or whatever standard you want to talk about. But it was not a defectively manufactured product in the sense that it wasn’t what it was suppose to be when it was manufactured, and that there was proper warning given. Because every case, and this is interesting, every case. Mr. Pederson criticizes me because all I cited was warning cases; I look at his brief, all he cites are warning cases, because from Davis on, that’s all you’re talking about, are warning cases. You know, were the warnings proper to the learned intermediary. He’s got to ultimately make the decision. Because I think you have to think, Justice Huntley, not in a sense just of this vaccine, but think about the new drugs that are coming out for — you know, for heart patients, the artificial heart. Are we now going to have a year from now somebody saying Debachy didn’t do it right____
JUSTICE HUNTLEY: Well, there — there’s a problem that we’ve all had experience with. The testing on these new drugs is usually done by the proponents who wish to market them or their independent labs. And we know of case after case in history where the data they have submitted to the FDA was incorrect.
MR. KOONTZ: Oh, Judge — I mean, Justice Huntley, that’s a separate exception in comment k, the fraud exception. I mean, if American Cyanamid produces a drug— if the DPT vaccine, if they had erroneous information, the FDA, I don’t have any problem in saying that’s a jury issue, back there. If they submitted erroneous information, the FDA stick ’em. I don’t have any problem with that at all. I mean, those are questions where there was fraud involved, and I’m sure if fraud is not too strong a term, but I'll ... accept what you said.
*354JUSTICE HUNTLEY: I didn’t say fraud.
I said inadequate testing ...
MR. KOONTZ: Well you and I are talking about the same thing. You’re talking about hoodwinking the government in terms of what happens with a drug that you want to license. Now, that’s not the DPT vaccine, its’ been licensed since 1944 or 45. Nobody has ever suggested, and it as not — Mr. Patterson will agree, in this case, nobody’s ever suggested in this case that American (inaudible) would ever produce any evidence to the FDA or the NIH or the CDC, or anybody else, but Bureau of Biologies that was inaccurate information. And I would agree with you that inaccurate information which you’re getting into some of the— the recent cases of (inaudible) basically fraud with the government where the drug company lied to them. And I don’t have any problem with — that’s an exception to 402(a)(k) which is in there. It says we — we accept the fraud rule. That’s — that has no part of this case, and I don’t want you to get confused on that — that area.
APPENDIX B
Oral Argument of Malcolm E. Wheeler for Pharmaceutical Manufacturers Association
MR. WHEELER: May it please the Court. Your Honors, I’m here on behalf of the Pharmaceutical Manufacturers Association and as such I don’t propose to get into the specific facts of this case and I think it probably will even help the Court’s analysis, and certainly my own, if we don’t get into a discussion or any bickering between me and the plaintiff’s counsel over whether we are, in fact, trying to engraft comment k onto negligence. Because what I view as being the question that’s before this Court today is, in fact, much more easily framed than to talk about comment k. It’s a policy question. And the question is, does this Court, as the highest court in the state of Idaho, and the court that is ultimately responsible for articulating the common law of this jurisdiction, want to articulate a common law that allows a plaintiff to sue a pharmaceutical manufacturer when that plaintiff has, (1) voluntarily chosen to use a particular vaccine or a drug, as the case may be, having been fully warned of what the possible risks, what the possible consequences and side effects of that drug might be ...
JUSTICE SHEPARD: Warned by who?
MR. WHEELER: ... or in this case a vaccine. A learned intermediary, namely a doctor. And that’s a persevering point, Your Honor. And, (3) where the plaintiff does not contend in any way, shape or form that the warnings were inadequate, that the product was improperly manufactured, that it failed to do what it was held out to do, or that it did something ... (END OF TAPE) ... common law policy to allow a plaintiff to sue on the ground that this manufacturer, having developed a drug or a vaccine in this case, that prevents illness and disease and suffering. Having done that, now it thereby incurs an obligation to do more research and develop an alternative arguably safer or more efficacious product. That is really the issue. And I want to go directly, if I may, to Justice Huntley’s question, because I will take that one head on. And Your Honor, the answer is, I think that what this Court ought to do, as a matter of common law policy, is to rule that a plaintiff ought not to be allowed, in fact, to bring an action in negligence or in strict liability in which the contention is that a product, a pharmaceutical product that is a prescription medicine that has in fact been certified or licensed by the FDA, cannot bring an action that says that manufacturer has an obligation to make a different product. The plaintiff can bring the following actions — can bring an action in which the plaintiff argues that the product was improperly made. That is to say, it was impure, there was something about the process by which it was made so that the person in fact incur an illness, a disease, or some harm that wasn’t anticipated. That’s a legitimate claim. Number two, a plaintiff ought to be able to sue on the ground that the manufacturer did not *355sufficiently test so as to be able to discover what side effects this drug might have. Number three, the plaintiff ought to be able to sue on the ground that the manufacturer had knowledge. They should have generated warnings of a different type than the warnings that were given. And finally, the plaintiff ought to be able to sue on the following ground, and I’m quoting directly from McDaniel v. McNeil Laboratories, which is a case cited by both sides. On page 828 of the McDaniel case, the Nebraska Supreme Court said, “The FDA’s determination is persuasive and controlling in the absence of evidence that the determination was based upon inaccurate, incomplete, misleading or fraudulent information. And that goes directly to the question that you asked, Justice Huntley, which is, “If the information is incomplete because the manufacturer did inadequate testing, or its incomplete because the manufacturer withheld it, whether intentionally, or negligently or recklessly,” a suit would be proper. But what we cannot have, what makes no sense, as a matter of public policy, is to have a rule of law that says that someone who does a good deed, a manufacturer who develops a lifesaving, or illness preventing, or a disease preventing product, that by having done that and having put that product on the market and made it available to the public to prevent disease or cure illness, thereby incurs an obligation to use its earnings to generate a better product. That kind of a rule just doesn’t make any sense and you can see what the ramifications of a rule like that have to be. What the ramifications have to be are (1) you will get some manufacturers — or forget manufacturers, you will get some scientists, some independent researchers, who having developed a new product will say to themselves, do I dare put this product on the market today? Do I dare apply for a license from the FDA? Because, even if it get the FDA license, some plaintiff can come down and say, “Well wait a minute. You should not have put that product out so fast, even though everybody agrees that its social utility outweighs its risks, because if you just waited a little longer and spent a little more money, you might have developed even a better product.” So you’ll have people who are going to refrain from putting a product on the market at a time when it could help people; (2) And this is not a threat, and it’s not blackmail as plaintiff’s counsel would have it. If you look at the examples that we’ve cited in our brief of the DPT vaccine history, of the polio vaccine history, of the measles and mumps vaccine history, you will see that it is empirically the case that when this kind of liability follows that what the manufacturers are forced to do — they have no choice, is withdraw from the market. Now that’s not blackmail, that’s empirical fact. So, what I ask the Court to do is to focus both in the conceptual underpinnings of what the plaintiff’s claim is an on the empirical evidence. And what I would like to do now is to go through and explain, not so much in terms of comment k, or why comment k should apply to negligence claims. I’d like to just go through and explain what the policy reasons are that, in fact, make the pharmaceutical industry, that is, prescription drugs as opposed to patent-type drugs. What makes them unique? Why do we need to treat them differently than we treat automobiles and why do we need to treat them differently than we treat drill presses and punch presses? Let me begin again by reference to Justice Huntley’s question. “Is the result of this that manufacturers are going to be able to market negligently made products?” The answer to that is clearly, no. What it is is its a rule that says who should determine whether the manufacturer engaged in negligent conduct? Should that determination of negligence vel non be made by jury after jury, after jury, some in Idaho, some in Washington, some in California, some in Missouri, or, should it be made by the expert agency, in this case the FDA, that has the massive scientific knowledge and the expertise to be able to make that reasonable determination. Let me— let me in fact be very specific with an example. Someone mentioned the Pinto. The Pinto, of course, received a lot of adverse notoriety. But what very few people realize is that after the very famous Pinto *356case, which was the Grimshaw case, that Indiana criminal case occurred and the jury found for not guilty on the charge. Seven months later, Ford Motor Company tried another Pinto case in San Antonio, Texas, and the jury found there was no defect and no negligence. Now, was Ford negligent? Was the Pinto defective? You have a San Antonio jury that says no. You have a California jury that says yes. You have an Indiana jury that says no criminal liability. Well, I don’t know what the answer is on the Pinto, but what I do know is that the answer with respect to a pharmaceutical prescription drug is one that has to be determined once and for all. You can’t have a situation where you put out a lifesaving, illness preventing, disease curing product and then subject the manufacturer of that product, when the agency has said that the — that the benefits outweigh the risks, you can’t subject that manufacturer over and over and over again to potential liability.
JUSTICE HUNTLEY: Counsel, I’m sure you’re aware of the limitations of staff and the funding that the FDA has, like almost any other agency has. This suggestion that we should defer, take it away from the jury — well, for example to be — to give a gross example, thalidomide was approved by the same agent — the FDA-type agencies of both Germany and England. Isn’t it a pretty astonishing thing you’re asking us to take all this away from the jury system?
MR. WHEELER: I don’t think — I think it’s unusual, Your Honor. I don’t think its astonishing. It’s — there’s no question. No one’s going to stand up. I think even the FDA itself, and try to represent to this Court or any other forum that they’re perfect, and that they’re not going to make mistakes, thalidomide it’s my recollection and also in the MER cases was that there was in fact the finding that information was withheld, that the information was incomplete. And I don’t mean fraudulently, I mean either negligently or — or in some form. That would answer those questions. But I’m prepared to go beyond that, Your Honor. There are going to be cases, over the years, I don’t know how many it will be. Maybe it will be one, maybe it will be five, some percentage of the time the FDA will make mistakes. But the fact is that juries make mistakes. Again, which jury was right in the Pinto case? Was the San Antonio jury right? Was the California jury right? Was Ford negligent or was it not? We don’t really know. There’s no— that’s a — an imponderable, unanswerable question because you have two findings and you simply can’t say what the answer is. It’s going to be the case that some people within the FDA as to a particular application will say, we shouldn’t approve that. And other people within the FDA undoubtedly, on some cases, are going to say, yes we should approve that. And there will be a difference of opinion. But at least in those instances the people making the judgment will have the benefit of years of experience and of all the data that they’re able to compel the manufacturers to produce. The jury doesn’t have that. As the Court knows, in a typical negligence trial there are all the artificial constraints of hearsay, the limitations on who can testify and what they can say, and you get a very, very different kind of analysis. But the bottom line question that the FDA people are asking is the same bottom-line question, which is, does the benefit of this product outweigh the risk of this product? But they’re in a much better position to make that determination. Let me make — let me give you a couple of other examples of why. In the typical negligence case, automobile, punch press, drill press, ladder, anything of that nature, what the jury is asked to do is to go through the typical Judge Learned Hand formula from U.S. v. Carroll Towing Co. where they simply asked the question in gross, what are the risks of this product? What are the benefits of this product compared to some alternative design, and does the marginal risk outweigh the marginal utility. That’s — it’s in gross. It’s a fairly easy question, although its in abstract terms, for a jury to answer. That’s not the way it’s done in the drug area. Why is that? Because in the *357drug area, the question is going to be, you have some benefits accruing to group A. In the case of a vaccine, all of the people who are prevented from catching this disease, 50,000, 40,000 whatever the number might be, they get the benefit of having had Tri-immunol on the market. Some smaller number of people are going to suffer and suffer terribly as a result. Juries are going to have to ask the question, group A v. group B. Efficacy with respect to group A v. harm in group B. That’s a very difficult question. It’s essentially a moral question. It’s a legislative question. It’s the kind of a question that juries ought not to be asked to answer. They’re ill-equipped to do it, and it’s really an unfair question for juries. But it is a fair question for the legislatures and regulatory bodies that are created by legislatures to be required to answer. I see I’m out of time. I have many other points, but I thank you for your attention.