Graham ex rel. Graham v. Wyeth Laboratories (760 F. Supp. 1410, 1991)

MEMORANDUM AND ORDER

PATRICK F. KELLY, District Judge.

This case was recently reversed by the Tenth Circuit Court of Appeals and remanded for new trial. Graham v. Wyeth Laboratories, 906 F.2d 1399 (10th Cir.1990). Defendant Wyeth, through its counsel A.J. Knopp, now moves for disqualification of this court pursuant to 28 U.S.C. § 455(a), and to bar this court from participation in the retrial of this case on June 18, 1991.

Defendant’s complaints are: (a) that the court has already made up its mind, has lost its impartiality, and cannot be impartial in the retrial of the action; and (b) that it has exhibited deference to plaintiffs and hostility to defendant Wyeth. Each claim of the defendant addresses several sub-parts, and each will be addressed here, although not necessarily in the order raised by defendant.

As an aside, and by way of preface, the court takes up this motion with both surprise and disappointment. This is not to say that the court is disappointed with the filing of such a motion. That is the right of any litigant. The disappointment is with the lack of context and the hostility, even animosity, which seem to pervade the motion. The thrust of the defendant’s motion and the allegations therein, asserted through counsel Knopp, are entirely out of character and unbecoming to the lawyer known and held in high regard by the court.

It appears now that counsel Knopp has scoured volume after volume of record for any statement or comment made by the court, to obtain support for the present motion. At the same time, that motion fails to place such comments or findings in their true context and background. The court regrets this approach.

While these claims are crafted by the attorney, they are brought in the name of Wyeth. Again, there is nothing unusual about this. There is some irony, however, in the fact that up to this moment, save for an introduction to a young lady from defendant’s claim department, who appeared before the jury to express Wyeth’s corporate interest, I have never met anyone from Wyeth. As I explained to counsel at the time of hearing, it would have been far better for all of us, Wyeth included, if during the trial, the president or some corporate executive had been here. This person would have heard the case and learned first hand what was important. It is certainly in the company’s interest that this should occur. It would have afforded the president an occasion to know his judge and to make his own judgments.

On March 1, 1991, following review of my trial notes and much of approximately 6,000 pages of trial transcript, together with many exhibits, hearing was held and the motion was taken under advisement. In the course of such a hearing, the trial judge is the respondent of sorts. There is no place actually for arguments pro or con between the adversaries, and none were requested here. In sum, this is a searching time and the hearing is taken up, if for no other reason, to ascertain if we can “reason” together. At the time of hearing, the court also traced certain options, the pragmatics of same, as well as certain ramifications should it elect to decline the motion. Those comments are intended to be incorporated here.

At the outset, no trial judge can lightly entertain the gravity of defendant’s claim. I am mindful of my responsibilities and the requisites set forth by the Tenth Circuit Court of Appeals. See United States v. Gipson, 835 F.2d 1323 (10th Cir.1988); United States v. Page, 828 F.2d 1476 (10th Cir.1987); Franks v. Nimmo, 796 F.2d 1230 (10th Cir.1986); Varela v. Jones, 746 F.2d 1413 (10th Cir.1984); United States v. Hines, 696 F.2d 722 (10th Cir.1982); Webbe v. McGhie Land Title Co., 549 F.2d 1358 (10th Cir.1977); and United States v. Ritter, 540 F.2d 459 (10th Cir.1976).

I am also mindful of my own responsibilities and duties, appreciating that if there is no basis for recusal, I should not do so.

The purpose of this opinion is to fully address and review each of the defendant’s claims in context with the trial, and attempt to recite the reasons for the cited comments or actions of the court which have disturbed the defendant’s counsel. The court will proceed here as if any reasonable person, given all of the circumstances, would have no reason to question its impartiality. United States v. Gigax, 605 F.2d 507, 511 (10th Cir.1979).

Some Comments by the Court

Defendant challenges certain comments extended at the time of substantive rulings. First, defendant claims that I have made it absolutely and unequivocally clear that I believe Wyeth’s DTP vaccine is defective and caused Michelle Graham’s injury. Defendant supports its claim by referring to a statement taken from comments extended by the court at the time of hearing on defendant’s motion for judgment notwithstanding the verdict or in the alternative for new trial or remittitur:

Simply said, the plaintiff’s evidence showed that endotoxin, a poison, in excessive quantums can invade the cellular process of the blood vessels. If this occurs in the midbrain, which it is shown can occur, a stroke is likely. You may be sure that following the completion of the plaintiffs’] case, it was my view that the treating physicians of this country ought to know of this situation and, if you will, to this day most of them don’t.

(Transcript of 1/29/88 Hearing on Post-Trial Motions, p. 12.)

Defendant further argues that after hearing only plaintiffs’ evidence, and before hearing defendant’s case, the court had already made up its mind and hence had lost its impartiality on the ultimate trial issues. This is clearly not the case.

Defendant also asserts a lack of impartiality in a later statement to the same effect, during the same hearing, when I said at page 31 of the January 29, 1988 transcript:

Having said this, I’m also prepared to say now that this fully-tried case says loud and clear that the DTP vaccine can indeed cause encephalopathy and death. I would commend that this most comprehensive record be forwarded for the examination and review not only by defendant’s principals but by responsible representatives of FDA and other esteemed authorities. In my view the likes of Drs. Zahalsky and Geier and Gilmartin ought to be invited to their session and to debate, if you will, the merits of their claims and the evidence, but whoever is involved must have at hand this record. The findings in this case in some way ought to be articulated to every physician in this country who momentarily harbors the defendant’s view.

Finally, counsel argues that an additional statement made at the same hearing is even more telling of my state of mind. That statement is as follows:

To this day, Wyeth arrogantly chooses to hide behind its ignorance. Their posture throughout this proceeding has been: “If we haven’t found this for ourselves, how can it be true?” The jury did not accept this argument. The jury found that Wyeth was completely negligent in its lack of aggressiveness and its lack of concern, and I concur.

Therefore, I don’t need any more arguments in any case I think I will ever hear on Wyeth vaccine about plaintiff’s wanting the vaccine to be replaced with a less efficacious variety or wishing to allow whooping cough to proliferate. Such statements by Wyeth, in my view, are completely misleading and totally merit-less.

(Transcript of 1/29/88 Hearing on Post-Trial Motions, p. 17.)

Taken wholly apart from their context, some argument can be made that these comments compromise the impartiality of this court. To lend clarity and context to what I did say, however, a reasonable person would want to hear also all that was said with regard to any of these statements, and to further that end the full context of those statements will be presented.

The court’s ruling on the defendant’s motion for a directed verdict, when plaintiff rested, is a good place to start. Defendant’s counsel will note that none of the referenced remarks were made at that point in the trial. I prefaced those rulings as follows:

THE COURT: Let me commence any comment here by recalling what I said when this case opened, somewhere in banter, limine conferences or selection of the jury conferences or what, we’re undertaking here what I clearly appreciate to be a rather important and provocative medical question, biologic question. One dearly of interest to the public safety. You’re probably correct, Mr. Knopp, that the entire scientific community is watching this ease. If the quantums of a daily copy tell me anything that I know is going off. From the trial court’s standpoint it’s a pleasure to administer the case in that two most able counsel have squared off here. I don’t know how the issues that are of interest here could be better presented than through Mr. War-shafsky or better defended at the hands of Mr. Knopp. You both are most knowledgeable with regard to the sensitive important scientific issues.

(Trial Transcript, p. 2350.)

Defendant’s counsel will also recall that at that time I took under advisement the defendant’s motion, which is hardly the kind of ruling one would expect from a judge who is already predisposed as to the outcome of the case.

Next, because this hearing adequately traces the evidence to that point, I here recite all of my rulings on defendant’s motion for directed verdict at the close of all the evidence. In other words, this case was now headed for the jury’s decision. I have deleted the portion of my findings which removed the plaintiffs’ claim for punitive damages. Defendant has not objected to this ruling or suggested that such a ruling would somehow denote bias.

“THE COURT: Well. All right, let me say again that this case truly has been fully tried, and if you will, probably more fully tried than any DTP vaccine of date. I’m comfortable in saying I’m sure that includes the White [v. Wyeth Laboratories, Inc., 40 Ohio St.3d 390, 533 N.E.2d 748 (1988)] case, and if in time, Mr. Knopp, you see our friend Judge Marcus, please say to him that I’m certain that he would truly have enjoyed the trial of this case, first as a trial lawyer, knowing something about the contribution he has made in the successful trial of provocative cases of this sort; and certainly as a trial judge. You’d have him understand that I am ever certain he would have enjoyed it, probably more from the vantage point of an appellate level; or the Toner [v. Lederle Laboratories, 779 F.2d 1429 (9th Cir.1986)] case which is of interest here. We used it in the opinion, and since this case commenced have had the benefit of the 9th Circuit’s decision. If there’s anything left to either compound or to further cumulate this case, perhaps it would come from the likes of some others; perhaps authorities of the Bureau of Bio-logies; consultants to FDA, such as Doctors Pittman or Manclark or their successors. Perhaps, if from the Plaintiff, Dr. Fibin or Stuman or Yolpe. Even perhaps Dr. Baraff as it appears at least to me he is not necessarily in concurrence with conclusions drawn from the Body-Baraff-Cherry

drawn from the Body-Baraff-Cherry studies as are professed by the Defendant; or perhaps the writers of Nelson. As an aside, years ago a prominent neurologist commended that text to me for my own library, and I drew upon it from time to time coming to grips with a given neurologic problem. To this date I don’t recall visiting any family practitioner’s office or pediatric’s office or internist’s office or any neurologist’s office where that text is not on his back bar. As for the Defendants, perhaps we could have heard from Dr. Cherry or maybe even Dr. Mortimer, and I’m sure there’s others, all of whom could only serve to cumulate the record here. I must say as an aside that both counsel have probably bootlegged more authoritative material and opinions into evidence than was actually offered. We’ve heard from Mayo’s and John[s] Hopkins and many others. Even so, notwithstanding who else could be called to compound or corroborate the respective views, it’s my certain opinion that as of this moment nothing would be changed as to the adversaries^] resolution of these most provocative important issues, the thrust of which.says: Does the DTP vaccine cause or contribute to encephalopathy, a permanent brain injury; and if so, why; and if known, what can be or should be done about it?

“I suppose, again as an aside, the very posture of these issues as of this moment is a tribute to the state of preparation and readiness at the hands of respective lead counsel. I do not recall a case that’s been so thoroughly discovered and so thoroughly researched, so well organized and so well articulated. You have both truly gone to the mat. You’ve both exhausted the subject, every aspect, every nuance, every morsel. There’s just nothing left.

“So now with the benefit of your brief from Defendant and some reflection, it’s time for substantive decision as it pertains to these motions. In doing so I’ll give credence to the Plaintiff’s claims, as I must, and mindful of my responsibilities as most recently set forth in Celotex and Anderson, and I am prepared to fully rule as to each. I must say that I have also done my homework. I welcomed this weekend for review and for reflection. It was, again, an occasion to review my own notes and organize my thoughts and prepare the comments that will follow. I would say as well, I reviewed the Plaintiff's trial brief. When first presented it said to me that I am in for the trial of a very complex complicated kind of case and terminology and relevance and significance with some mystery. But having reviewed it again quietly, it puts in place this entire case, at least insofar as the Plaintiff’s case is concerned.

“I think it’s best to first recall that when Plaintiff rested I took Defendant’s motions under advisement knowing that the Plaintiff’s evidence arguably articulates a prima facie case as to all issues. Notwithstanding how simple and direct the issues appear, and notwithstanding the persuasive [ejffect of Plaintiff’s witnesses and the evidence as it may appear, I simply asked: Are there not uncontroverted and scientific answers for each, the thrust of which would wipe away those claims? I think you can recall that my concern from the outset was that I’m just not interested nor want the responsibilities for the litigation of a provocative scientific issue, the findings of which would belie scientific truth. I mentioned to you then that I had addressed that subject in a case of Johnson [Johnston] vs. United States [597 F.Supp. 374 (D.Kan.1984) ] where I had attempted to point out the importance of foundation for scientific evidence. I reminded counsel of my own concern, which is to say that a witness may be qualified, and many say that they are, but the issue I have is: Does that witness know what he’s talking about as pertains to the physical evidence pertinent to the case at hand? Has he considered it, and as a consequence, does he rule it in or rule it out? If Rule 702 has significance, the witness’s knowledge will assist the fact finder, yet he must be conversant with the facts at hand and not necessarily conversant in the field per se. Thus you will recall I encouraged voir dire prodding from both sides and from which some discretionary judgments could be reached as to the presentation of the opinions. Credibility of an expert, of course, is for the jury; but unfounded opinions ought to be ruled out at the outset, and for my part, that decision is mine. Thus, I urged both counsel to dig deep, prod and to explore fully if you can. As to the Defendant, it was urged that it place on the table some or any uncontroverted scientific basis which would preclude the right of any lay jury the right to intrude; and that test was to be applied to each expert in this case.

“Now, given all the evidence, the Plaintiffs case says that the Wyeth whole cell vaccine causes or contributes to encephalopathy. It says that endotoxins, perhaps in excessive and unpredictable quantums, given a circumstance, can disrupt the vascular tissue, penetrate the brain barrier, and damage the brain as its consequence. Dr. Zahalsky and Dr. Geier support this. Dr. Gilmartin, a neurologic pediatric, concurs. Given a host of material, research findings, coupled even with Defendant’s inneroffice papers and their findings, opinions of others, and a host of them, Dr. Zahalsky and Geier and Gilmartin are not alone. But is it so? The Defendant claims it cannot happen, and thus we hear from Dr. Bogash, Tint, Bierly, Irwin, Levner, Deitch, Bernstein and perhaps others. From it collectively we learn all there is to hear as to the history and the development of their whole cell Pertussis vaccine. We understand much as to its process. We become conversant with such terms as agglutinogens, opacity, agglutinations, detoxification, potency and toxicity. We understand the latter term also deals with levels of endotoxin. And endotoxins, we understand, a pyrogen or a poison, which is agreed to speak for fever and hypotension, even convulsive seizures. By the testimony of the Wyeth people such findings are accepted out of hand, though only thought to be temporal in nature.

“No one can question but what this company is processing a complex organism and the resultant vaccine is of considerable benefit to the public safety. Its use has nearly eradicated the whooping cough, a dread disease, and, of course, in the public’s interest, this company is highly federally regulated and monitored. There is no showing here that this company has been out of compliance with any of the FDA requisites.

“The Defendant seems to recognize the benefit of some form of accellular vaccine, the thrust of which would likely reduce the presence of endotoxin, and as its consequence, reduce the incidence of adverse responses. According to the Defendant, these problems have been, and their problems have been, that they somehow could not find the appropriate strains or the media or the mix to alter or to attain such a breakthrough. All the while, however, given compliance with that with which they are required, and given the state of the science, they profess that they can safely rely upon the benefit of prominent epidemi-ologic findings, the thrust of which does not support the Plaintiff’s claim. Indeed it is upon the strength of this evidence, and not upon any scientific breakthrough or laboratory or clinical findings, or as I see it, as a consequence of any research of its own, that the Defendant says with confidence: ‘There is no relationship between our vaccine and encephalopathy.’ Each witness that I’ve referred has ventured this, and some have volunteered it. Dr. Pollock was first called, and for reasons stated and not referred here, he did not survive. Dr. Ross was called, and given defense counsel’s persuasive plea to draw upon Dr. Cherry’s abstract as if gospel, and Dr. Hooker’s findings that all vaccines are the same, he survived. Now, I’m not the fact finder, but recalling cross-examination of that witness, Dr. Ross’ findings just aren’t all that conclusive and uncontrovert-ed. And, of course, we heard from Dr. Hewlett. It was on the strength of his appearance here that I was somehow to ignore certain testimony, even strike Dr. Zahalsky’s findings, as considerable weight was to be affixed to his testimony. To say his testimony is uncontroverted or gospel insofar as the state of the science is concerned is nonsense. He is just another voice, if you will, not all that authoritative as compared with others. Simply another person willing to state and explain his views. To be sure, through the likes of these witnesses’] testimony, in direct, whoever called, and sharp cross-examination, the issues were shaped, narrowed, [finely] honed. They are not, however, resolved in some uncontroverted way.

“Conversely, this provocative issue is clearly placed on a collision course awaiting timely resolution, and this jury and the impartial intelligent body which has listened most patiently and attentively here, the labor and the [quest] for truth will appropriately decide the issue, and for all to hear. In time I’m convinced whomever wins, should there be an appeal, the decision in this case will be a most important one, a far reaching one as to its consequences, and will exceed the weight of anything assigned to that of White or Toner or others.

“This jury will first address the following question: Is there a causal connection between the Wyeth DTP vaccine and encephalopathy? As an aside, I might add that given the extent to which this case has been tried, and while such a decision will wait another day, I’m presently convinced that the jury’s findings here, whatever, yes or no, resolves that issue as to any other Wyeth vaccine case, at least pending here. This court is just not going to permit some other jury to reinvent the wheel, but again will save that question for another day.

“Now, since the substantial issue as defined is for the jury, it follows that the resultant issues which flow from an affirmative response are also in order. That is to say, are also for the jury. These include the Plaintiff’s claims of negligence and/or strict liability. Here, again giving credence to the Plaintiff, first as pertains to its negligence claims, the Plaintiff states in part that the Defendant company which produces the vaccine for the public safety has a high standard of care. This standard includes the requisite to research and test the ultimate safety of its product. Plaintiff says that it’s not enough to stand behind minimal FDA standards and rely upon what others may say and somehow contend that serious risk in the use of its product has.not been shown. The Plaintiff’s case says that for this company over the years to say it has not been aware of the prospect, if not the likelihood, that its whole cell vaccine does not somehow cause or contribute to encephalopathy is also nonsense. Their case suggests that this company has a certain duty to explore the prospect; and if affirmative, why; and when ascertained, to do something about it, and to do far more than to present the product in its present state, however effective it may be.

“There is evidence to support the Plaintiff’s claim. Moreover, the Plaintiff’s evidence supports the argument that through the years this company has not expended .10$ of its own assets in such a quest. Now, whether such a failure is found and then found to be causative is for the jury.

“Next the Plaintiff’s evidence suggests more than a few innovative timely procedures, the thrust of which even in its present form, can reduce the likelihood of serious adverse consequences. Lots, like patients, differ. There are hot lots. Lot 67701 is such a hot lot. It is from this lot that the Plaintiff’s vaccine was drawn. It has been known for years the mouse toxicity test doesn’t measure the levels of endo-toxin. It’s also been known by the Defendant that the toxic effect of its own vaccine is due to the high level of its endotoxin. And notwithstanding all that I heard, memo 11 and 12 of Dr. Bernstein says that. The Defendant's annual reports, exhibit 59, offered early on by the Plaintiff, even seem to suggest Defendant’s concern as to whether encephalopathies are obscured.

“We heard about the LAL test known by Defendant since at least 1975, if not before. We hear evidence of skin tests for hypersensitivity. Those found in India. We hear suggestions of the taking of electroencephalographic readings before and after inoculation of children. That makes sense. And it seems to me deserving of review. And we hear of the suggestion of autopsies, certainly on some controlled basis, of the brains of mice to ascertain if indeed endotoxin will indeed disrupt the tissue of some mice; or perhaps with consent of the parents of some deceased children, autopsies of those children who have died following the injection. Now, all of this is disclaimed, particularly through Dr. Bernstein, as wholly unreliable. Nor are such tests by autopsy of mice realistic. He points out that the vaccine that would be pumped into the mice compares to that found in a bottle of it, as Dr. Hewl[e]tt demonstrated. Now, I’m not the fact finder, but even so, if the presence of endotox-in in whatever quantum, gives rise to disruption of the vascular tissue within the mid brain, and gives rise, then, to stroke, wouldn’t that be of interest to Wyeth and certainly to FDA? I recall the diethylstil-bestrol case tried here wherein the issue is the relationship, if any, between it and carcinogenic effects. And, of course, it is. Point zero six parts per billion of diethyl-stilbestrol found in the mouse was thought to be the minimal level. And that level was thought to induce carcinogenic effects in the mouse. I recall the livestock company’s arguments, but that .06 per billion, which is the nanograms, is akin to a person consuming a hundred plus pounds of beef per day. And to which the FDA would say, even so, it is of significance because die-thylstilbestrol is shown to cause cancer.

“As I listened to Dr. Bernstein I had to wonder if the tests that have been proposed here wouldn’t be of significance. I’m sure it is that the Defendant has not considered it, and I wonder if FDA is even aware of such findings.

“I also recall Dr. Bernstein’s plea that somehow with all of its facilities and its expertise, and he a microbiologist, could not timely autopsy the brains of a mouse. Again, I’m not the fact finder, as I listened to this gentleman my mind ventured to those happy days about the 9th grade in biology class when the big moment for us was to dissect a poor frog with a razor blade and a tweezer in hand. The task was to remove his or her vital organs and to identify each, including the brain. Presently, some must call that a gross autopsy. Of interest was to smear a portion of the brain upon a slide and study the cellular formations through microscope. Now, while I’m not that certain how our process compares to a dissecting of a mouse, and I’ve only participated in the skinning and dressing of rabbits, squirrels and many birds; for the life of me it never occurred that what we were doing in the 9th grade was an accomplishment of some [feat] unbeknownst to Wyeth. And for my part, Dr. Bernstein’s plea was also nonsense, but that, too, is for the jury who may have been entirely sympathetic and see it differently.

“Next, notwithstanding explanations tendered by Defendant’s witnesses, the Plaintiff claims that long before the Plaintiff’s injury this Defendant company was in a position to develop the safer vaccine. Here the answer seems to be with an acellular vaccine, the thrust of which retains the product’s potency and safety. Momentarily, we learned that the world will await the advent of the Japanese breakthrough in three or so more years. I recall Dr. Bo-gash: ‘You know these Japanese, once they set their mind to it,’ he said. But what of Defendant’s efforts and their wherewithal? What of project 77-A, Exhibit 49, abandoned. The promise of the Tint patent, or Dr. Long’s research, notwithstanding its promise, abandoned; or of the success of the Lilly Tri-Solgen vaccine. By the Defendant’s own admission, a better and safer and more prestigious product. Reports of adverse effects are reduced 90 plus percent. A vaccine sought out by physicians two to one over the Defendant’s product. In 1974 this company, the Defendant, owned Lilly’s patent rights, the rights of process, which is to say, how to make it; and the license to immediately go on the market as Tri-Solgen, a product of Wyeth Lab.

“To this the defendant says: ‘But we somehow just couldn’t make it. Just couldn’t replicate it. The strains are different. The media is not the same. Given our process, FDA won’t license it,’ and, of course, given the circumstances they shouldn’t, nor did they. This jury, however, also knows that production of the Lilly product is four times the cost of production of the Wyeth vaccine, the difference of about twenty cents to eighty cents to produce. Now at that time, 1974 or thereabouts, they owned both vaccines. As I read Dr. Bogash — that is for the jury — he seemed to say: It just doesn’t make good business sense to pursue Lilly. After all, the whole cell vaccine is in compliance. It makes good sense to leave it where it lies, a dead product, and proceed with its own, surely then in greater quantums as there is no place for the physician to go. The sale increase in this evidence is that from 1976 to 1980, Wyeth was on the rise. If such an analysis is thought unfair, I simply say tell that to the jury as they have heard it all. For my part I remain at a loss to follow the defense on this score.

“Next the defendant warnings to the physician and as contained within the insert is claimed to be inadequate. The thrust of this argument is that given the significance of the presence of endotoxin, its quantum, and the fact that each may vary, the hypersensitivity of some patients ought to be of interest, the causative effect that may, if not probably, result of its consequence, all of this would be of interest to any physician to be so apprized [sic], particularly if he or she has a choice of the product, which in the 70’s they did, and for the purpose of enhancing the physician’s own alert and information, particularly as to the histories of each child and his follow-up, should any complications arise.

“Now, that is my analysis of the plaintiffs’ claim on the inadequacy of warning. To this the defendants say that their warnings state incidence between the product’s use and all forms of serious reactions, and that they have been reported, however rare; that the defendant’s warning is within FDA guidelines and is so approved. It claims immunity as its consequence. This is claimed as if there is a relationship between an association with the use of the product and the causative effect from its use. As Dr. Bierly noted, an association is when two events occur temporally and/or are next to each other. But what he doesn’t say is that there’s no way in God’s world that one can be injured from an association, and everyone in this room knows it and I trust by now that will include the jury tomorrow at 1:00 o’clock. Indeed, if the first question is responded in the affirmative, it will be because the plaintiff’s evidence is [accepted] and the presence of endotoxins, its quantums, its unpredictable quantums, does play a role in permanent injury to children. In such an event of that finding, they can surely find that the present form of the defendant’s warnings are inadequate.

“Now, having extended the foregoing comment and findings, it follows as well that if the causative relationship is answered in the affirmative, the claims on strict liability also are for the jury. It’s clear the claims that defendant’s product was unreasonably dangerous flow in several ways. Plaintiff’s evidence with regards to the presence and significance of endotoxins and its unpredictable quantums has been reviewed, as have the plaintiff’s evidence as pertains to the vaccine and the causative effect, including children who may be predisposed or vulnerable and wherein the vaccine may result in cerebral injury. The defendant’s alleged failure or unwillingness to toxiod its vaccine relate to design defect. Additionally, the defendant’s warnings in their present state, if believed, pertain to design defect, and these issues are for the jury.

“Now having said this, I have not overlooked the requisites set forth in Johnson versus American [Cyanamid], 239 Kansas [279, 718 P.2d 1318 (1986) ]. I need to address certain issues, as a matter of law. To ascertain if, given all of the facts, the defendant’s whole cell vaccine is unavoidably unsafe as contemplated in Restatement 402, Comment K. As indicated, and partially for this reason, I have paid particular and careful attention to all of the evidence adduced in this case. To be sure, the Wyeth vaccine is highly beneficial. No one here suggests that the same shouldn’t be available to children, and as it is and as it has been underway, the plaintiffs only say: But subject to conditions far more realistic than in its present form or in the form of 1980. As to the risk, however rare, at least as of that time, 1980, the risk is inherent and will probably be so as a part of any pertussis vaccine within the content of defendant’s whole cell vaccine in its present form. The question begs, however, following [Kearl] Pearl versus Lederle, 172 California Appeals [3d 812, 218 Cal.Rptr. 453 (1985)] which is followed and addressed by the Kansas Supreme Court: One: Has the defendant already minimized the risk to the extent known? Here, given the evidence, much of which I reviewed, it is to say that in the absence of its own research or on any other, so far as I see, on the issue of whether the presence of endo-toxin per se, its quantum, its unpredictable quantum causes or contributes to brain injury is unsettled, and as long as this defendant is content to disregard its own findings and limited studies commenced in such as the 77A study or the prospects noted by Dr. Long, I’m certainly not in a position to say, as a matter of law, that in March of ’80 this product was unavoidably unsafe.

“Next, Pearl \Kearl~\ suggests a decision of whether an alternative produce was unavoidable. I have already noted that by 1974 the Lilly Tri-Solgen product was on the market, and by my standard, including those of the defendant, was clearly thought to be safer, equally effective vaccine, and in 1974 was in the defendant’s hands. For its own reasons, the product was taken off the market, at least not available by the defendant. If you would say by contrast in time when the Japanese product comes on the market and given honest, objective and forthright regard, such a product will probably be deserving of Comment K findings, but for my part and for reasons noted, I will make no such finding as pertaining to the Wyeth whole cell vaccine on the market in March of 1980.

“Third requisite is[,] are the warnings adequate, and I have commented sufficiently on that and I could not say, as a matter of law, that they are.

“There is an additional reason: While I cannot say that the defendant’s product is unavoidably unsafe, as a matter of law, and it’s one not contemplated in Johnson nor included in the Pearl \Kearl ] decision, it is simply this: To this moment, for whatever reason, however sound it may appear to Wyeth and it may be, they deny even the likelihood of a causal relationship, even the possibility, however remote, between the use of its product and serious permanent injury or death. ‘It just can’t happen,’ so says the defendant. Given this posture, indeed even if true, there just is no way its product can hurt anyone, and as long as this defendant and in my view any company persists with its position, this Court, and again in my view, no Court should be persuaded that such a product can also be unavoidably unsafe. Perhaps in time, in the event of an appeal to the Tenth Circuit, that Court can certify the unavoidably unsafe issue to the Kansas Supreme Court wherein again it could review the Johnson decision. But, simply said, Comment K doctrine is not found as a matter of law, nor is it an available affirmative defense in this case.

“Now while probably not all inclusive with regard to my findings, they do complete then as to the substantive issues that have been raised here, if not all of them. While not raised in your motion for directed verdict, there are others, however, that I will address now as they deserve mention. They deserve explanation as I would clarify my rulings.

“First of these are that I will address the sufficiency of the plaintiffs’ claim as to the nature and the extent of her injuries, and in concert with certain defenses raised. In turn, I will want to complete then the record with regard to substantive rulings recently made.

“In sum the plaintiffs’ claim is that the child was normal from birth in all respects, save for a fixed right gaze through March 17, 1980. Following her innoculation [sic] at about age three months, she underwent fever to a hundred and six degrees and suffered what’s been described now as infantile seizures, inconsolable crying and leg puffiness and redness. When finally in the hands of Dr. Gilmartin, given work off at Wesley and by his own staff, given his own examination, encephalopathy, being permanent brain damage with retardation, was found and diagnosed. The child suffering many disabling features and syndromes, including left hemiplagia, Dr. Gilmartin needed no CAT scan to appreciate that massive and catastrophic injury had occurred within the mid brain, nor is his diagnosis in dispute. Given his understanding of the effects from DPT vaccine as previously reviewed, he attributes this event to the innoculation [sic] — that is, the vaccine.

“Now I review this for several reasons: If you will, as to the substantive issue which I have discussed at first, the defense appears to proceed on two levels: First, aggressive, intelligent, substantive one and which matches the plaintiffs’ case as if blow by blow, from a trial Court’s view, a joy to officiate, a fair fight and the makings of what I see to be a great trial. But there’s another side to the defense, and particularly as might pertain to the second issue I have just addressed, in my view a darker side akin to a wrecking crew or a hatchet man: Admit nothing, deny everything, create havoc, raise doubt, perhaps provoke trial error, all the while play the martyr, make a full record, proffer, proffer, proffer as if this case is being tried to the Circuit panel and a jury trial is only some hurdle it must first pass. If you will, the rests [sic] of this is the prejudicial effect it probably has upon this jury. That’s not my problem, but it is a disappointment and deserving of mention.

“I saw it coming first as counsel attacked the mother’s testimony at every juncture. It was clearly an attempt to prejudice her testimony, cast doubt as to its propriety, even though much of what was raised is not shown to be relevant, and from what I can garner from the evidence, the defendant had to have known that from the outset. The defendant’s counsel has addressed every waking moment of the mother and her child since inception, preterm, post-term. They seized upon spotting in pregnancy, her nutrition, the cord size, the jaundice[d] skin, you say. What do you mean? Your panic that you sought a healer and acpuncture [sic] and chiropractic care. If anyone was prejudiced by reason of what I perceive to have been the most demeaning, if not disgusting, form of cross-examination, it had to have been at the hands of defendant’s own counsel, whose principals unfortunately were not here to see or to have listened, and being of a decent sort — I’m sure they are — would surely have put a stop to such conduct. And I say to you, Ms. Roth, I know you’re all sensitive to this record and that eleven copies of this daily copy are going forward. I would be pleased if you would hand to your president a copy of what I have just said, but you can also have him understand that those problems are the defendant’s problems and not of my making.

“The evidence clearly shows that the plaintiffs seem to have withstood it all, and her stories, her history, perhaps bazaar [sic] to the defense counsel, was and is believable to her treating experienced physician who found it not unusual to a frightened mother under the circumstances. Given the whole picture, Dr. Gilmartin waded through and made his own professional judgments and determined what was important and what was not. What was importance [sic] to him, a history of physical and neurologic normalcy, save for the eye gaze, which was Cogen’s apraxia, not brain connected, and which was normal otherwise down through the date of her innocu-lation [sic]. But from that moment forward, at least within days, catastrophic result occurred.

“That’s the plaintiffs’ case, and to this defendant has also claimed the whole event precedes the shot. This child suffers unexplained stroke, probably within the second month or earlier. It’s claimed some satisfaction for having ordered the CAT scan and now read its significant findings as to the CAT scan itself, which was again helpful to confirm the diagnosis of Dr. Gilmar-tin and the existence of the stroke, but doesn’t change a thing. For what it’s worth, as I listened to the defendants boasting for callpng] up the CAT scan, and, as an aside, I wonder if in addition to EEG findings following seizure activity, as proposed by plaintiff’s witness, if routine CAT scans of those children reported as ence-phalopathies wouldn’t be of interest if in time a host of cases are shown to be encephalopathy by reason of stroke. It is just a little thing. Seems to me, as well, if Wyeth can’t do autopsies, maybe they could CAT scan the mice.

“The defendant first called a radiologist to confirm the stroke and to find the pathology, which was admissible. He’s then called upon to extend his expertise, as if a neurologist, to discuss relevant signs and symptoms and to consider the history and to advise the jury as to the timeliness of the stroke, convinced that by any standard that physician’s expertise must be limited and not inclusive of that which I would require. When plaintiffs’ counsel finally objected, I struck that testimony as to the latter.

“Next Dr. Guggenheim was called. Somewhat akin to Dr. Hewlett’s role, the jury awaits her as her testimony on this score, that is, the timing is of significance, at least so says the defendant. As of that time, my attention turned to what ought to be required if any person, however qualified, is to assign a time frame for the stroke, certainly if it differs from that of Dr. Gilmartin. Whether it is she or Dr. Gilmartin, there are certain physical thumbprints that need to be considered and a requisite level of expertise to reach any opinion. The criteria that I had at hand and prepared in advance of the testimony, includes the following: That she would assume the stroke as reflected in the CAT scan; that she would assume encephalopathy as its consequence, i.e., massive brain damage and which by its nature gives rise to certain syndromes unmistakable in the hands of specialists. We heard as these injuries manifest themselves, the layman’s reminder of the cut wires and how proper that is as one understands the effect of brain injury. Those syndromes include the left hemiplagia, and which, in turn, means absent head thrust. I should think any competent specialist would consider the Wesley tests taken at the direction of Dr. Gilmartin and found about Exhibit 86 or Number 86 of those records. I doubt if they are in dispute, and they appear to be objective and I should think relevant and which, by example, include findings of nys-tagmus not found by Dr. Cibis.

“Of course, the witness’s appreciation as to the significance of the DTP vaccine itself, if any, together with the witness’s appreciation as to the significance of any endotoxin and its quantum is in order. Who knows? Should an objective expert witness appear and had not been apprized [sic] of the presence or the significance of the shot, and first hears of it from the stand, he or she, like so many others who have appeared in this case, directly or indirectly, including Mayo and Johns Hopkins, may well assign significance. Certainly if it is of no importance, the witness ought to be able to say so and why. In every way, the witness’s understanding and grasp of the subject, in my view, is of import and would have been required.

“Next the witness needs a fair history of the child, delivery, pre-delivery, post-delivery. If there is anything untoward, by all means she can raise it. That history, however, will include the fact that when Dr. Hertenstein examined the child by way of full pediatric examination, the child was normal, save for the gaze. What is clear in this case that this gentleman is board eligible for pediatric certification. He only writes down abnormal findings. He did write the fixed right gaze. He did do a complete physical examination, save for the eye, the balance was normal. His complete examination means that he looks at everything, including abdominal sounds, joint mobility, muscle strength, reflexes. He states he examines a lot of complicated reflexes. His examination shows no abnormality, other than the eye. He would have noted anything else.

“The tendered witness would further understand that the diagnosis of the eye was that of Cogen’s apraxia and no other, and to note that during the course of that examination, according to Dr. Cibis, the child manifests head thrust.

“Now, given the foregoing, which were at least my requisites and awaited the witness’s qualifications, I saw that the defendant was faced with a problem, and I was surprised, and perhaps I should not have been, particularly as to Dr. Guggenheim. I was surprised with both sides in this, the history that I have defined and would require, was not addressed and the witness’s experience with DTP and endotoxin was deleted in its entirety. Here my first surprise came when plaintiffs’ counsel has no objection to the requested opinion as to timeliness. I only mention this because, again, and as I stated later in this case, if the plaintiff had objected, the witness’s testimony would probably cease and would have ceased consistent with the rule that I have outlined in this case and mentioned at the outset of these findings.

“There’s some irony to this in that plaintiffs’ counsel raised the issues that I have mentioned in his cross and at which time the [defendant] complained. This is the same counsel who insisted that before Dr. Gilmartin could ever testify, his opinion as to causation and correctly argued that he must establish his experience and training in the field with regard to DTP vaccines and endotoxins and their effect. I can recall a heated conference at the bench joined by both defense counsel to remind me of this importance. As I then recall, and because I agreed, the defense counsel proceeded with a thorough and exhaustive voir dire examination which extended for a day and a half, and at which time, insofar as Dr. Gilmartin’s credentials are concerned, they grew every [sic] strong. But, as I said, the absence of even a mention of them by Guggenheim presents no problem to the defense counsel and clearly no problem to Dr. Guggenheim. The weight of her testimony is for the jury.

“But this leaves us with a last witness. The reason I have mentioned some of this is to put in place some of my rulings. The last witness being Dr. Bodensteiner. When this gentleman arrives, I have at hand his report; it was submitted to me in conference with regard to the substance of what it is he was going to say and whether it is cumulative. Understand then that he was a pediatric neurologist and that he too will address the time factors surrounding the stroke. As mentioned, we took up discussion with regard to the cumulative effect or the breadth of his testimony. Given defense counsel’s representation, I reserved, and correctly so, any comment or any finding, given my comment as to having required some appreciation for the significance of endotoxin as I would have required from Dr. Guggenheim. From what I now know, this witness gets ready. I had presupposed he was already qualified. I put in place my own criteria that I prepared for Dr. Guggeneheim, and which I reviewed, and awaited the witness’s testimony.

“Here the doctor is a pediatric neurologist. In very short order, defense counsel moves to the witness’s opinion as to the adequacy of the warning. This struck me as a departure from what he was endorsed to testify. Plaintiffs’ counsel objected, but also sought an occasion to voir dire that witness and I agreed, but always presupposing that the witness would pass muster, and when we reached that level, we then addressed the cumulative effect of his testimony or its breadth. It appears that in a case tried, at least discovered within the year, the Percival case, his testimony was taken in May of 1987 and at which time that witness testified for some other drug company in some other DTP related claim. He was not called for purposes necessarily similar here in that his interest was with the state of the child’s condition and not the significance of the shot or its timeliness. At Page 56 of the transcript of that testimony, the witness has stated unequivi-cally [sic] that it is his opinion DTP vaccine causes death and DTP vaccine causes brain damage. I appreciate that such testimony is entirely inconsistent with what he ostensibly is tendered here and I appreciate further that such might run to credibility. In other words, if he has changed his mind somehow, or perhaps in his own mind he can testify one way in one Court or one way in another, that is for him. Even so, in twenty-nine years of rather active practice and some seven and a half years here, I have never seen a witness so totally devastated and so totally impeached by his answers to those questions, two questions that put him down and out. If you will, given fortitude, most lawyers would simply want to assist the poor man to his feet and led [sic] him out the door, then return and express regrets to the Court and to the jury. But not so here. I’m as convinced as I’m sitting here that Dr. Bodensteiner never dreamed plaintiffs’ counsel was so prepared and so ready with those questions, and I’m also convinced that if it were not for such preparation, this Court, nor the jury, would have never known of his entirely inconsistent position months, short months ago. And I should hope that defendant’s counsel was also so surprised and would not dare foist such arrogance upon this jury, but, again, such is probably for the jury, and for my part at that point his credibility was zero. But then we learn — I learn in the course of the witness’s discovery deposition of this case taken in July of 1987 he’s asked with some precision at Page 40 about his understanding of endo-toxin and the defendant’s DTP vaccine. His understanding is zero. He’s done no research nor claims expertise. I would surmise that he safely ventured that because he was not to understand that he need address this in this case. He also ventured at Page 40 of that discovery that the vaccine could cause cerebral infarct.

“Now, if this witness is here in this case to address the relevant evidence for his opinion, and whether it’s within or without the content of his report, he surely must have been told that he now has to become an expert and have expertise with regard to the vaccine and endotoxin, and here he comes. He first appears here and sits in the back of the room to listen to Dr. Hewlett, and he reads a lot, and apparently he reads fast. He’s enamored with Dr. Ross and, guess what, and to the surprise of everyone, including the plaintiffs’ counsel, who has every reason to rely upon the findings of his discovery, Dr. Bodensteiner is now an expert, and he has, in his judgment, all of the expertise that is required and he’s ready to go. It’s no wonder, therefore, that the defendant’s counsel could comfortably start the tendering of opinions with the warning issue. I sustained the objection to any testimony of this witness that requires expertise in this field of endotoxin and that of the defendant’s DTP vaccine. The significance of that ruling is not only because it’s cumulative and a complete departure from that which is tendered, which it is, as to both, but because given revelation here, under no circumstances will I accept the testimony of such a witness, a witness and a person who on at least the previous weeks previously, if his position had held true, possessed no expertise but who somehow nearly overnight becomes all proficient. No such witness will testify in this Court in this case or any case and no adversary need to be so confronted and so surprised. At best the doctor is now conversant with he subject, but clearly there is no way it can be said that he has demonstrated that he knows what he’s talking about in this case. Given what discretion that is mine, this witness, nor the likes of him — and I hope I don’t meet him again — will testify in this or any case involving similar issues. I appreciate the defense counsel has protected its record and proffered all it should with regard to the doctor’s testimony — I guess it went on for several hours — but should this case reach the Circuit panel, I should hope one would at least recite what I have just said and found: There’s no way this witness can now be qualified to testify in this case. And, moreover, should defense counsel also claim that the force of my rulings have somehow prejudiced the defendant, I think it ought to be known and stated here, and the reason I mention it, that if defendant Wyeth was prejudiced, it has come solely at the hands of its own counsel. In the course of thirty minutes or so, questions were put to that witness in a machine gun fashion, perhaps well thought out and in some organized fashion, and at which time each was objected to and each sustained. Counsel, at its insistance [sic] to somehow preserve its record, perhaps provoke error for me, persisted and persisted, and throughout it all, from my vantage point I can tell you this jury watched in aghast as if astonished, as if embarrassed for me by such arrogance. This jury by this time, however, should not have been surprised, notwithstanding my early explanation to them as to mention of my ruling when I told them what “overruling” means and “sustained” means, and, of course, that these good lawyers would adhere. This counsel could care less as this case will somehow be tried and his record made any way he pleases, and if counsel today is somewhat pleased for having made his point, fine, but he can tell that to the jury as I don’t believe at this time they are all that pleased, and I certainly await his final argument.”

(Trial Transcript, pp. 5513-5544 (bold emphasis added).)

Lastly, following receipt of the defendant’s massive brief on its motion for new trial or alternatively for judgment notwithstanding the verdict or remittitur as to damages (Dkt. No. 162), I reviewed my trial notes and much of the available record before addressing defendant’s motion. Again, I recite my findings as follows:

“THE COURT: Counsel, I scheduled hearing today for several reasons, but the first of which is to take up defendant Wyeth Laboratories’ motion for judgment notwithstanding the jury’s verdict, or, alternatively, for new trial, or for remittitur.

“As to the first, which is the motion for judgment notwithstanding the verdict, if I were to summarize the substance of it, it [is] to say that Wyeth claims that the plaintiff has failed to produce evidence upon which the jury could reasonably conclude that her injuries were caused or contributed to buy [sic] the DTP vaccine of the defendants, or that there was insufficient evidence upon which the jury could reasonably have found for the plaintiff on any design defect claim, or that the evidence is insufficient to support a reasonable determination by the jury that the whole cell vaccine was defectively designed, or that there simply is no evidence from which the jury could reasonably have concluded that the Wyeth package insert was inadequate or causative, or that the evidence is insufficient to support that Wyeth failed to test or otherwise was shown to be negligent, taking into account industry standards, or that it acted unreasonably. A part of Part 2 of the new trial found at Page 39 of this rather massive brief also suggests that a new trial should be granted because the findings are against the weight of the evidence.

“I think I have reasonably capsuled the defendant’s claim on this score, which, for the most part, is the first thirty-eight pages of the motion and perhaps Pages 39 through 45 as well. I will say out of hand I will delete any consideration of the motion as it would pertain to warranty instructions or its application here in that as all of you know, those claims were deleted from this case.

“I will say next that I have reviewed these briefs, plaintiff’s reply and the defendant’s response to it, and have reviewed as well a wealth of trial material, my own notes, which were rather extensive, and much [of] a part of the transcript of this case, if not all of it.

“So, having said that, I will hear from the defendants.

“MR. KNOPP: Your Honor, on behalf of the defendant Wyeth, actually I don’t think that I will burden the Court with anything more. I think we have covered those points that we felt should be brought to the Court’s attention in the brief.

“THE COURT: That is your privilege, I guess, Mr. Knopp.

“MR. KNOPP: Very happy to respond to any questions the Court may have, Your Honor.

“THE COURT: No, I think I have it reasonably in mind as I capsuled the case a moment ago and as I have attempted to analyze and review the evidence that was before me, either as to the causative question or whether the DTP vaccine did, in fact, cause the injury to this plaintiff or whether the stroke preceded the shot. I think I have a ready grasp of it. Simply here to hear you if you had anything else you wanted to say.

“MR. KNOPP: I do not, Your Honor.

“THE COURT: All right. I take it then that includes any arguments of newly discovered evidence, which is the second part of the motion that is found at Page 45, or as to some claim for remittitur?

“MR. KNOPP: May I have just a moment, Your Honor?

“THE COURT: Sure.

“MR. KNOPP: Your Honor, this is something that I have — do we have extra copies? Your Honor, perhaps I could, while we are searching for a copy for Mr. War-shafsky, and for the Court — an article appeared in Clinical Pediatrics, one of the outstanding journals involving pediatrics, it’s a case report, some literature review and congenital oecular motor apraxia that appeared for the first time in January of ’88. I have never been in this position before, Your Honor, where I have been of the opinion that an article appearing in a medical journal may support a motion for a new trial on the basis of newly discovered evidence, but I think because the thrust of this article deals with the fact that the condition that was found by Dr. Cibis prior to the administration of the vaccine is, according to this article and the studies done by the authors, something that accompanies serious central nervous system problems and not a transient thing such as the body of literature had led most physicians to believe before.

“THE COURT: Shown to be the evidence in this case and is the evidence in this case?

“MR. KNOPP: In any event, I would like to add this article to our motion in support of our motion for new trial based upon newly discovered evidence and offer this in addition to that which—

“THE COURT: You’re welcome to offer it. I’m going to overrule its admissibility insofar as its application here for a motion for new trial. I haven’t read it, of course, but I’m certain it is just not that compelling that somehow the trial court should set aside this entire jury trial in the face of all that this jury heard to receive new findings in connection with Cogen’s apraxia.

“MR. KNOPP: May I simply proffer it then or whatever the procedure might?

“THE COURT: Fine. Anything else?

“MR. KNOPP: No, Your Honor.

“THE COURT: All right. Well, given that situation, let me proceed in this manner then. I think as pertains to any of the motions, all of them are overruled. But in doing so, I believe it’s appropriate that I set out my reasons, and particularly as I would address the motions, argued or not. In doing so, I think first it’s best that [I] recite the state of affairs which brings us here.

“Michelle Graham, who is a child now of abou