# Appendix — Wyeth-Ayerst Laboratories Division of American Home Products Corp. v. Graham > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385020_2841%3A2 ## Record - **Collection:** Supreme Court brief - **Document type:** Appendix - **Published:** January 1, 1990 - **Citation:** 498 U.S. 981 ## Text IN THE SUPREME COURT OF THE UNITED STATES OCTOBER TERM, 1990 WYETH-AYERST LABORATORIES DIVISION OF AMERICAN HOME PRODUCTS CORPORATION, Petitioner, VU. MICHELLE GRAHAM, an Infant under the age of 18 who sues by her Parents, Guardians and Next Friends, CHARLES GRAHAM AND TAMMY GRAHAM. Respondent. APPENDIX TO THE PETITION FOR A WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE TENTH CIRCUIT Albert J. Knopp Michael T. Scott Wayne C. Dabb. Jr. Counsel of Record Mary M. Bittence (LED SMITH SHAW & MCCLAY BAKER & HOSTETLER 2500 ne Liberty Place 3200 National City Center Philadelphia, PA 19103 Cleveland, OH 44114 (215) 851-8100 (YQ1 J1()9 210) ee Hedy M. Powell Legal Division WYETH-AYERST LABORATORIES Post Office Box 8299 Philadelphia, PA 19101 (215) 971-2660 Counsel for Petitioner PACKARD PRESS / LEGAL DIVISION, 1617 JFK BOULEVARD, PHILA, PA. 19103 (215) 563-9000 "4-1" TABLE OF CONTENTS Fage APPENDIX A (court of appeals decision dated June i SCA rhhn ccna ANeUEKDAS Owed 62's 60-000 la APPENDIX B (district court decision on summary judgment dated July 22, 1987) .............. 43a APPENDIX C (district court verdict dated October PL och Cekk ss Maeda ayn WOeeeeN esuns oes 78a APPENDIX D (Brief for the United States as Amicus Curiae in the court of appeals dated PS ES O85 6 es vetensseesdeeeuv esos 80a APPENDIX E (Fifth Circuit opinion in Hurley v. Lederle Laboratories, as amended, dated Janu- CE PE TUNGEAL s ANA DREEN SG kus cre deoes 105a APPENDIX F (statutes and regulations) MPP PET TERE rT TTT TT TC TEE EET Ter 119a ED cs cd céveseenekteeenetneeckdens 168a APPENDIX G (Program for Sixth International Symposium on Pertussis, September 26-28, REG aa kb nd 0 6 bb6 pebas bSeneneredecea eee 238a Tenth Circuit. JUNE 25, 1990 ROBERT L. HOECKER Clerk PUBLISH UNITED STATES COURT OF APPEALS FOR THE TENTH CIRCUIT [LI \ s,RAHAM, er the age of eighteen APP] [ED STATES DISTRICT >TRICT OF KANSAS, 5-148] oo 2a James M. Clark and Fred M. Winner, of Baker & Hostetler of Denver, Colorado, Attorneys for Appellant. Alvin D. Herrington and Debra J. Arnett, of McDonald, Tinker, Skaer, Quinn & Herrington, P.A., of Wichita, Kansas, Attorneys for Appellant. Hedy M. Powell (Of Counsel), Legal Department of Wyeth Laboratories of Radnor, Pennsylvania, Attorney for Appellant. Marlys A. Marshall, Andrew W. Hutton of Michaud & Hutton of Wichita, Kansas, Attorneys for Apr Yer int en | | he manufacture of vaccines preempted by federal ition? (3) Does Kansas allow for tort awards based n strict liability or the negligent manufacture of an herently unsafe” vaccine? (4) Were a number of yeth’s experts improperly excluded from testifying at > trial? (5S) What is the correct procedure for th 3a entitled to post-judgment relief when one of Graham’s experts recanted much of his testimony in subsequent court proceedings? Other less significant allegations of Rather, it must view the evideiice most favorably to the party against whom the motion is made and give that party the benefit of all reason- able inferences from the evidence. On appeal, we employ the same standard of review as coes the trial court. Brown v. McGraw, 736 F.2d 609, 612-13, (10th Cir. 1984). On the other hand, we test the various individual evidentiary rulings made by the district court and the denial of Wyeth’s Fed.R.Civ. Pro. 60(b) motions, for an “abuse of discretion”; see In re International Coating 1. One additional issue raised was whether one of Graham’s | should be disqualified based on a conflict of interest. That —_ ’ tft ¢ } ith rt the 4a Applicators, 647 F.2d 121, 124 (10th Cir. 1981). On issues related to interpreting federal law the standard of our review is plenary, and on interpreting Kansas law we give some deference to the district court’s interpretation, but review is ultimately de novo. See Wilson v. Al McCord Inc., 858 F.2d 1469, 1473 (10th Cir. 1988) (“The issue for our consideration is the trial judges legal interpretation of state law to which we give some defer- ence but ultimately review de novo.”) We will affirm the denial of judgment NOV, reverse the denial of the motion tor 4 new trial, and remand to the district court for a new tria! on all issues. Addition- ally, we will reverse the district court’s denial of Wyeth’s Fed.R.Civ. Pro. 60(b) motion for post-judgment relief. Inasmuch as we are ordering a new trial on all issues, we assume that the subject matter of Wyeth’s 60(b) motion will find expression during that proceeding. I. A. This appeal originated from a $15,000,000 jury verdict in favor of Michelle Graham (“Graham”) and against Wyeth for the defective manufacture of Wyeth’s DTP vaccine. Wyeth manufactured a DTP vaccine which is used to immunize children against the diseases of diphtheria, tetanus (lockjaw) and pertussis (whooping cough). The vaccine is administered to in- fants at two, four, six and eighteen months. A booster injection is administered prior to the child’s entrance into school. The DTP vaccine is comprised of three component parts, diphtheria toxoids, tetanus toxoids, and a per- tussis whole cell vaccine. It is the pertussis component f the vaccine that is the subject of this litigation and ch allegedly caused the severe reaction suffered by ‘ham. While Graham contends that the pertussis mponent of this vaccine could have been safer, and Sa that in fact safer versions of the vaccine are available, she does not argue that a pertussis vaccine is generally unnecessary or that it has not saved thousands of lives.? The DTP vaccine containing the “whole cell” per- tussis vaccine was licensed by the FDA in 1949. Due to the widespread use of the vaccine in this country, pertussis has virtually been eradicated. However, be- cause of the persistent nature of the pertussis bacte- rium, there is a continuing and substantial risk of epidemics if the use of the vaccine was to be discontin- ued or was to decline significantly, and in fact epidemics have occurred in countries that have eliminated the pertussis vaccine from their list of mandatory vaccines. The nature of the DTP vaccine and its component parts was recently described by the Ninth Circuit as follows: By introducing an antigenic factor into the body, vaccines stimulate the production of antibodies that protect against disease. Some infectious organisms, such as those causing diphtheria and tetanus, ex- crete soluble toxine insolable [sic] by medical re- search. The toxin is inactivated with formaldehyde and transformed into a toxoid. The toxoid is then used in a vaccine, as it can immunize against 2. In the early 1900's, pertussis was a leading cause of death in children in this country. In 1934, when this country suffered its worst pertussis epidemic, there were 265,000 reported cases of pertussis that year, and 7500 related deaths. By the early 1940's, pertussis was responsible for two and one-half times the number of deaths as all of the following diseases combined: measles, mumps, rubella, diphtheria, polio, meningitis, chicken pox, and scarlet fever. See Minman and Koplan, Pertussis and Pertussis Vaccine: Re-Analysis of Benefits, Risks and Costs, 251 Journal of the American Medical Association (JAMA) 3109 (June 15, 1984). 3. For an extensive comparison of the various countries’ prac- tices, and the epidemiological results, see Loveday v. Renton, (Queens Bench, England) March 31, 1988 (available on Lexis, No. 1982 L 1812). 6a disease by stimulating the production of antibodies in the recipient, even though it has lost its own poisonous qualities. This is not the case, however, with [the per- tussis component]. [The pertussis vaccine] is a so-called whole cell vaccine because it contains whole killed pertussis organisms. The whole organ- ism is used because the pertussis organism contains fifteen or sixteen different antigens, and medical science has yet to isolate the one that stimulates protection against the disease. Toner v. Lederle Laboratories, 779 F.2d 1429, 1430 (Sth Cir. 1986). Because the whole cell vaccine retains the poison- ous qualities, it is meurotoxic and can cause adverse reactions which may be mild or severe. Mild reactions may include swelling, fever, irritability, and crying spells. Severe reactions can perhaps _ include encephalopathy,‘ paralysis and death. In recognition of the dangerous propensities of the whole cell vaccine, efforts have been made to develop a fractionated cell pertussis vaccine without any of the harmful toxoids. During the 1950's, the Eli Lilly Company developed a “split cell” vaccine called Tri-Solgen. Early studies indi- cated a fractionated vaccine was less toxic than the whole cell and it was approved by the FDA in 1967. At that time, Lilly occupied a substantial share of the DTP market. In 1975, Lilly withdrew from the vaccine busi- ness and sold its Tri-Solgen vaccine to Wyeth. According to Graham, in ar effort to save on cost, Wyeth substi- tuted its own “ingredients” (or “strains”) into the Lilly “recipe” for the split cell vaccine. Wyeth then attempted to license this vaccine, but no licens< was granted by the FDA. Wyeth has made no further attempts to license a 4. “Any disease of the brain”, Stedman’s Medical dictionary, Sth ed. (1982). 7a fractionated cell vaccine and no such vaccine is licensed in this country> today. Moreover, pharmaceutical com- panies are prohibited from marketing a product absent a license — to do so would constitute a criminal offense; (21 U.S.C. §$§ 331(d), 333(a), 355(a)). B. This lawsuit had its origins in the tragic history of the plaintiff, Michelle Graham, a child who has suffered, and is suffering from brain damage, and who requires continuous treatment and care. Michelle Graham (by her parents) alleged that she sustained severe and irreversible brain damage after being vaccinated against diphtheria, pertussis and tetanus with a defective vac- cine produced by Wyeth. On March 17, 1980, Michelle Graham, who was only a few months old, was administered Wyeth’s DTP vaccine by a nurse at a county office of the Missouri Department of Health. Shortly thereafter Graham was diagnosed as having suffered from a severe and irrevers- ible neurological condition known as encephalopathy which caused retardation and prevents Graham from ever leading a normal life. Graham sued Wyeth alleging that its DTP vaccine caused the brain damage, and that this type of injury could have been avoided if only Wyeth had used more care in controlling the level of toxoid in its vaccine. Wyeth denied that its DTP vaccine did in fact cause Graham’s brain damage, or that the DTP vaccine even could, in fact, cause this particular type of damage. Wyeth additionally maintained that, as a matter of law, it could not be liable even if the vaccine did cause Graham’s injury because, vaccines, under applicable 5. Japanese companies have developed and are currently using a pertussis toxoid (i.e., acellular) vaccine. This vaccine is purported to be as efficacious as the whole cell vaccine, but far less reactive. There appear to be some problems with the acelluiar vaccine as well, see Loveday, supra note 2, at 43-47. 8a Kansas® law, are to be treated as inherently dangerous products and thus the vaccine manufacturers are deemed immune from liability.” The district court determined according to Kansas law® that Graham could proceed on its negligence the- ories. In the district court’s summary judgment opinion, however, it held for Wyeth, and against Graham, on the strict liability “warning” issue. On Graham’s “design defect” strict liability claim, the court determined that there was an issue of material fact as to whether the vaccine was “unavoidably unsafe” within the meaning of Restatement of Torts $402A comment (k) thereby precluding summary judgment for Wyeth on its com- ment (k) defense. The court therefore perr:itted Gra- ham to seek to establish that Wyeth’s vaccine was “avoidably unsafe”; see infra p. 13-16. After more than seven weeks of trial during which numerous experts testified as to causality, and others were excluded from testifying, the jury returned a verdict in favor of Graham for $15,000,000 in compen- satory damages. Motions for judgment notwithstanding the verdict and for a new trial based on evidentiary errors were made by Wyeth and denied by the district court. Wyeth appealed. Thereafter, Wyeth, claiming to have discovered new evidence after its notice of appeal was filed, brought two Fed. R.Civ.Pro 60(b) motions in the 6. Both parties stipulated that Kansas law applied to this case, which was brought pursuant to our diversity jurisdiction, 28 USC §1332; Graham v. Wyeth Laboratories, 666 F.Supp. 1483, 1485 (D. Kan. 1987). 7. As a general matter, Kansas subscribes to the principles of strict (products) liability for manufactured goods; see Brooks v. Dietz, 218 Kan. 698, 699-703, 545 P.2d 1104 (1976) and Note. Strict Liability in Tort Adopted in Kansas, 25 Kan.L.Rev. 462 (1977). This court in Symons v. Mueller Co., 493 F.2d 972 (10th Cir. 1974) forecast that Kansas would adopt such a rule. 8. See Graham v. Wyeth Laboratories, 666 F.Supp. 1483, 1484-85 (D. Kansas 1987) for the district court’s analysis of all the pre-trial issues. 9a district court for relief from the judgment and for a new trial. Those motions were denied by the district court, _and an appeal from those denia!s was taken as well. Il. We turn first to Wyeth’s contention that the district court erred in denying Wyeth’s action for judgment N.O.V. As we have observed, the appropriate standard to be satisfied for a judgment notwithstanding the verdict where proofs are at issue is “whether there is evidence upon which the jury could properly find a verdict for” the non-moving party, Brown v. McGraw, 736 F.2d 609, 612-13, (10th Cir. 1984) — in this case, Graham. Wyeth contended that no evidence which would prove a causal relationship between the DTP vaccine and Graham’s injury was adduced. Wyeth focused on Graham’s hypothesis that the whole call DTP vaccine contains two components (endotoxin and pertussis toxin) which can cause retardation, and argued that no such proofs appear of record. Because of the critical significance of a causal connection between the DTP vaccine and Graham’s injury — a connection bitterly disputed by the parties — we requested additional briefing on this issue. We were thereupon directed to Graham’s evidence that at birth, Graham was normal (Tr. 1416-1422); that she experi- enced no health problems prior to her vaccination (Tr. 2028-2034); that Dr. Gilmartin, a pediatric neurologist, testified that Graham’s retardation was caused by the DTP vaccine (Tr. 1570, 1573)); that Dr. Gilmartin did not believe her injury was due to a stroke occurring prior to her vaccination (Tr. 1587-1588, 1619); that endotoxin can injure blood vessels from the inside out (Dr. Za- halsky) (Tr. 302-307, 313-320); and that endotoxins can cause stroke (Dr. Guggenheim) (Tr. 3801-3803, 3870- 3877). 10a Wyeth, which claimed among other theories, that Graham had suffered a stroke prior to her vaccination and that it was the pre-vaccination stroke which resulted in her disability, took issue with each of Graham’s experts and with the evidence of causation. However, in ruling on a motion for judgment N.O.V., the district court and this court, are precluded from weighing the evidence, passing on the credibility of witnesses, or substituting a court’s judgment for that of the jury. Yazze v. Sullivent, 561 F.2d 183, 188 (10th Cir. 1977). Thus, the fact that Wyeth alleged that the evidence of causation was misconceived and that examined prop- erly, the evidence would result in a finding of no causal connection between the DTP vaccine and Graharn’s injury, is of no relevance. Viewing, as we must, the evidence most favorably to the party against whom the motion was made — here, Graham — and giving Gra- ham the benefit of all reasonable inferences, we are satisfied that the district court did not err in denying Wyeth’s motion for judgment N.O.V. addressed to cau- sation. Wyeth also moved for judgment N.O.V., relying essentially, among other grounds, on various theories of law and the failure of Graham’s evidence to meet her requisite burden of proof. Wyeth claimed that Graham’s design defect theory was barred as a matter of law, and was unsupported by the evidence; that Graham’s claims of inadequate warning based upon negligence were legally insufficient and not supported by evidence; and that Graham’s claims were preempted by federal law. Although our review of motions for judgment NOV relating to evidentiary errors is to determine whether there is any evidence on the record, our review of a district court’s legal conclusions is plenary. We are in agreement with the district court’s legal analysis of rete lla Wyeth’s preemption claim,® and its determination that Wyeth’s defense of adequate warning was a jury func- tion. See Graham v. Wyeth Laboratories, 666 F. Supp. 1483, 1488 (pre-emption), 1494 (application of Kansas law), 1498 (adequacy of warning), (D. Kan. 1987). We recognize, of course, that the district court opinion was written in response to Wyeth’s motion for summary judgment. However, the same legal principles and arguments with which the district court treated, albeit in a summary judgment context, have now been advanced by Wyeth on appeal as grounds for reversing the district court’s ruling which denied Wyeth’s motion for judgment N.O.V. Because our reading of the record and our analysis of the relevant authorities cited by the parties and the district court are in accord with the conclusions reached by the district court in its summary judgment opinion and with its denial of Wyeth’s mo- tions, we do not deem it necessary to discuss these issues (other than Wyeth’s §402A comment (k) defense to Graham’s “design defect” claim) in any greater detail than the district court discussed them in its opinion. And, to the extent that Wyeth put in issue the proofs adduced with respect to each legal ground advanced, our independent review of the record satisfies us that judgment NOV in favor of Wyeth should not have issued. 9. We note that since the district court correctly analyzed the pre-emption issue, two State Supreme Courts and two Federal Courts of Appeal have addressed this issue as well. Each has determined that pre-emption does not apply. See Abbot v. American Cyanamid, 844 F.2d 1108 (4th Cir. 1988); Hurley v. Lederle, 863 F.2d 1173 (Sth Cir. 1988); White v. Wyeth Laboratories, Inc. , 533 N.E.2d 748 (Ohio 1988) and Shackil v. Lederle Laboratories, 561 A.2d 511 (N.J. 1989). We agree with their rulings that federal pre-emption does not prevent state tort law awards arising from improperly manufactured drugs or vaccines, even in situations where the drugs or vaccines have met the FDA’s minimum stan- dards for licensing. 12a With respect to Wyeth’s §402A Comment (k) de- fense the Kansas Supreme Court has recently addressed this issue in Johnson v. American Cyanamid, 718 F.2d 1318 (Kan. 1986) and, as this court’s jurisdiction is based on diversity, the pronouncements of that tribunal bind us on this issue. Under the guidance of Johnson we are satisfied, as was the district court, that Kansas has accepted comment (k) as the law. The rationale under- lying comment (k) is that since the manufacturer is using the best technology available to it in order to produce a product that under current technology is “inherently dangerous” (i.e. “unavoidably unsafe”) we should not hold the manufacturer strictly liable for any injury that may result. The over-arching goal of strict liability is to force manufacturers to lessen, if not elim- inate, the danger of their products. The comment (k) exemption is granted in the case of “inherently dange- rous” products since it is assumed that the products cannot be improved: thus no liability should attach. Wyeth claimed that because its DTP vaccine was “unavoidably unsafe”, it could not be held liable on a strict liability “design defect” theory. In its opinion denying summary judgment to Wyeth on this claim, the district court determined that a material dispute of fact existed as to whether the DTP vaccine produced by Wyeth was “unavoidably unsafe”. The district court referred to an affidavit by Dr. Zahalsky, one of Graham’s experts, which asserted that Wyeth had the capability to produce a safer vaccine. Hence the question was pre- sented as to whether the “unsafety” of the vaccine produced by Wyeth was “unavoidable.” The district court read Johnson to require a deter- mination at the outset as to whether the vaccine was “unavoidably unsafe”. The district court found that a material dispute of fact precluded that determination at the summary judgment stage. Applying Johnson to such ~ Bete mo ane 13a a circumstance,!° the district court then permitted Gra- ham to proceed on a “design defect” theory, both as to negligence and strict liability, stating: 10. Johnson v. American Cyanamid, 718 F.2d 1318, 1323 (1986) states unequivocally that “The trial judge should have heard the evidence on the [unavoidably unsafe product] issue outside the presence of the jury and made the determination thereon.” Despite this statement the Kansas Supreme Court in Johnson did not remand the §402A comment (k) issue for a factual deter- mination. Instead the court determined as a matter of law that the vaccine in question was an “unavoidably unsafe” product and thus subject to a 402A comment (k) defense. As we indicate in text, the district court, finding a material dispute of fact with respect to the issue of unavoidable “unsafety”, delayed ruling on this issue until mid-trial, when the court struck Wyeth’s §402A comment (k) defense. We cannot say that the district court abused its discretion in declining to hold a “mini-trial” prior to trial limited to the issue of “unavoidable unsafety.” See Moe v. Avione Marcel Dassault-Brequet Aviation, 727 F.2d 917, 935 (10th Cir. 1987) (Although arising in a different context, this Court, among other things, stated: mini-trials can result in “undue delay, waste of time, and needless presentation of cumulative evidence”). Wyeth argued below and reasserts here that the comment (k) defense, if successful, also precluded a design defect negligence action. We disagree. Exempting manufacturers from strict liability clearly differs from exempting them from negligence liability. In Johnson, 718 P.2d at 1319, the Kansas Supreme Court made clear in its first syllabus that a plaintiff may proceed on a theory of negligent design defect where she is prohibited by comment (k) from proceeding on a strict liability design defect theory. This is as weil the position taken by the California Supreme Court in its most recent discussion of this issue. In Brown v. Superior Court, 751 P.2d 470, 482, n.12 (Cal. 1988) the Court stated: Our conclusion [that drug manufacturers are not strictly liable for the damage their product causes] does not mean, of course, that drug manufacturers are free of all liability for defective drugs. They are subject to liability for manufacturing defects, as well as under general principles of negligence and for failure to warn of known, or reasonable knowable side effects. (Emphasis added.) 14a [C]jomment k’s application does not shield the seller of a product from negligence claims. Such a result fits within the policy of comment (k) — z.e., by denying plaintiffs recovery based on finding the manufacturer strictly liable if the drug is dangerous, and requiring the plaintiff to prove negligence, the policy of encouraging the production and marketing of safe, useful products is furthered. Of course, the inquiry into whether a manufac- turer acted negligently is, in a-general sense, similar to the comment k inquiry of whether a drug is unavoidably unsafe. Thus, in a case such as this where both theories (strict liability and negligence) are asserted, the evidence from which the court must determine if the product is unavoidably unsafe need not be heard outside the presence of the jury as it will be the same evidence from which the jury will determine negligence. 666 F.Supp at 1498 (citations omitted). At a subsequent hearing during trial, the district court struck Wyeth’s §402A comment (k) defense, as the district court found that it was not an available defense to Wyeth in light of the proofs developed at trial. Wyeth contends we should construe Johnson to hold that the comment (k) defense precludes a strict liability design defect claim as a matter of law in all cases involving licensed prescription vaccines. Other state Supreme Courts are divided on how to address comment (k) defenses. Compare Brown v. Superior Court, 751 P.2d 470, 481-83 (Cal. 1988) with Toner v. Lederle Laboratories, 732 P.2d 297, 3050309 (Idaho 1987). We view the Johnson opinion as unclear on this issue. Given the range of views of other state courts, see generally, Note. A Prescription for Applying Strict Liability: Not all Drugs Deserve Comment K Immunization, 21 Ariz. St. L. J. 809, 819-20 (1989), we are not inclined to disturb the district court’s interpretation of Kansas law. 15a 92 Oh acon In view of these rulings, and particularly its sum- mary judgment determination, we construe the jury’s response to the “design defect” interrogatory as well as to the negligence charge’! as having its roots in the same evidence: that is, that Wyeth’s vaccine would have been safer if the level of endotoxin had been reduced — a subject to which we refer in section V, infra.12 Thus, the jury’s affirmative answer to interrogatory 4 (“design defect”) must be read as a jury finding that Wyeth’s vaccine was “avoidably,” and not “unavoidably,” unsafe ' and that a reuuction of endotoxin levels was technolog- ically feasible. We have also considered the other errors asserted by Wyeth, in connection with the district court’s charge. Because we are ordering a new trial, we do not find it : necessary to discuss or rule on the errors which Wyeth claims, over its objections, were committed by the district court judge. This is particularly so, because it is unlikely that the same errors will occur again on retrial, and we are confident that Wyeth will have an opportu- nity to address itself to any such new instructions that will be given at a new trial. ee ee Ill. Wyeth raises numerous issues as grounds for the ; granting of a new trial, and we find many of them persuasive. In particular we conclude that numerous evidentiary errors occurred at trial and were of such a degree as to mandate a new trial. ane ~ OR oer 3. In March of 1980, was defendant Wyeth negligent in connection with testing, desi and/or warning in regard to its DTP whole cell vaccine, ch was the legal cause of plaintiffs injuries? : The jury answered “Yes.” 12. In that action we refer to Wyeth’s newly discovered evi- dence of miscalculation made by Graham’s experts as to endotoxin levels. a ) 11. Special verdict form question 3 asked: 16a A. In our view, one of the most serious evidentiary errors committed at the trial was the exclusion of critical portions of Dr. Cibis’ testimony. Dr. Cibis, a pediatric ophthalmologist who had treated Graham, was prepared to testify, and did so testify at deposition,!3 that Graham had suffered a stroke before her vaccination and that accordingly the DTP vaccine was not the cause of her disability. The essence of Dr. Cibis’s testimony was that, in light of the CT scan which had been made available to him after his initial diagnosis of Graham, he would now attribute to an eye problem (Cogan’s Apraxia), a clear manifestation of stroke. (Tr. 3974-81, 4002-4006). He originally, and without the benefit of a CT scan, diag- nosed Graham’s eye problem as minor. The thrust of his testimony would thus support Wyeth’s contention that Graham had already suffered her stroke before she had been vaccinated, since Dr. Cibis’ examination occurred before the DTP vaccine had been administered. The district court prevented Dr. Cibis from so testi- fying, ruling that for any expert who testified as to causation the expert had to be knowledgeable about the workings, nature and medical literature concerning en- dotoxins. (Tr. 3924-26) This was error. Dr. Cibis would have testified that the vaccine did not cause Graham’s injury. The lack of knowledge by Dr. Cibis as to the workings or nature of DTP, his lack of expertise as to endotoxin, or his unfamiliarity with the course of this particular litigation, was not reievant to that testimony. To promulgate a rule that one must be an expert in DTP or endotoxin in order to testify as to that particular substances’ effect may be perfectly rea- sonable; but to use such a criterion to exclude experts from testifying that the vaccine was not the cause of injury (because Graham had already suffered the stroke 13. The deposition of Dr. Cibis took place the morning he testified. The district court judge attended parts of the deposition. 17a at the time of the original examination) had to remove from the jury significant evidence that Wyeth’s vaccine was not responsible for Graham’s condition.!4 As a general rule, to warrant or permit the use of expert testimony, two { conditions must be met; first, the subject matter must be closely related to a particular profession, business or science and not within the common knowledge of the average layman; second, the wit- ness must have such skill, experience or knowledge in that particular field as to make it appear that his opinion would rest on substantial foundation and would tend to aid the trier of fact in his search for truth. Bridger v. Union Railway Co., 355 F.2d 382, 387 (6th Cir. 1966); see Bratt v. Western Airlines, 155 F.2d 850 (10th Cir. 1946). There is little doubt that in this case scientific (medical) evidence was needed to resolve a number of critical disputes. Furthermore, few would contend that these medical disputes were within the knowledge of the average layman absent expert testi- mony. Thus the evidentiary issue presented to the district court concerned Dr. Cibis’ qualifications as an expert to give testimony as to whether Graham suffered 14. An illustration by analogy points out the district court’s error. If Dick sues Dentist Jane for dental malpractice, and Jane’s defense is that her dental technique could not have caused the injury, expert dental testimony would be needed to determine if in fact, Jane’s technique could have caused the injury. Furthermore, in such a context it would be an abuse of discretion for the court to not limit those who can testify on this issue to “experts” qualified to issue an opinion on dental technique. If Jane’s defense, however, was that Dick had suffered the injury of which he complains when he was struck in the mouth during a fight, the experts who could testify as to correctness of that possibility need not have the same qualifications as those needed for Jane’s “technique” defense — in fact it would be an abuse of discretion to require the same standard. 1 s 4 - 18a a stroke prior to her receiving DTP vaccine.'5 Dr. Cibis was a pediatric ophthalmologist who had received training in neurology as it relates to the eye. He was additionally one of Graham’s original treating phy- sicians. Dr. Cibis, upon the recommendation of Dr. Hertenstein, Graham’s pediatrician, examined Graham on February 27, 1980 (when Graham was 11 weeks old and three weeks before her DTP vaccine) for an eye problem which he diagnosed as Cogan Apraxia (congen- ital motor apraxia). (Tr.1153-54). The district court’s approach to the admissibility of expert witness’ testimony in this case was evidently fashioned by what it believed to be the central issue in the case: could endotoxins cause this type of damage? It ruled that no expert could testify who was not familiar with toxins. The district court stated the rule as follows: I don’t know how anyone can fairly assess the significance of the time of that stroke in this case without addressing an awareness of the endotoxin, rule it in or rule it out. (Tr. 2925). 15. The Federal Rules of Evidence as they concern expert testimony are found in Rules 702 and 703 respectively. They read: Rule 702. Testimony by Experts If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to deter- mine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise. Rule 703. Bases of Opinion Testimony by Experts The Facts or data in the particular case upon which an expert bases an opinion or inference may be those perceived by or made known to the expert at or before the hearing. If of a type reasonably relied upon by experts in the particular field in forming opinions or inferences upon the subject, the facts or data need not be admissible in evidence. ee es - oA OR tat BONE me 19a The minute the [expert] says: “I have no where- withall in the field of neurology, I have no appreci- ation of endotoxin or their significance or effects, if any” the witness isn’t going to testify. (Tr. 4585). This approach forced Wyeth to limit the experts it called, to those who testified to alternative theories of injury to Graham. Thus, the district court compelled Wyeth to forgo critical testimony of a treating physician that Graham had suffered a stroke prior to her vaccina- tion — testimony that if believed by the jury would have resulted in a verdict that Wyeth was not liable. It deprived Wyeth cf a primary defense that it was not liable, due to an intervening cause (i.e., that a pre- vaccination stroke caused Graham’s injury) and instead left Wyeth with only an alternative theory that the DTP vaccine could not, rather than did not, cause a stroke. While under the Federal Rules of Evidence a district court has substantial discretion in deciding which ex- perts can and cannot testify, the district court may not employ that discretion to restrict viable and relevant theories offered by a party. In this instance the district court, by excluding Dr. Cibis’ testimony, deprived Wyeth of crucial testimony, which if available to the jury, may well have swayed the jury in its determination. We cannot regard the exclusion of such evidence as harmless because it affected the substantial rights’* of 16. Fed.R.Civ. Proc. Rule 61 states: Rule 61. Harmless error No error in either the admission or the exclusion of evidence ...is ground for granting a new trial ... unless refusal to take such action appears to the court inconsistent with substantial justice. The court at every stage of the proceeding must disregard any error or defect in the proceed- ing which does not affect the substantial rights of the parties. See,e.g., Lusby v. T.G. & Y. Stores, Inc., 796 F.2d 1307 (10th Cir. 1986) (harmless error doctrine); Prebble v. Brodrick, 535 F.2d 605 (10th Cir. 1976) (same). 20a the defendant Wyeth, particularly when other expert testimony bearing on the same defense was also ex- cluded. B. Dr. Breckbill, another physician called by Wyeth, was a specialist in pediatric radiology. Dr. Breckbill’s credentials as a pediatric radiologist were detailed dur- ing his examination, and are extensive. On May 12, 1987, Graham underwent a CT head scan under the direction of Dr. BreckbiJl. He determined that she suf- fered a stroke. A large part of his testimony at trial dealt with the manner in which head scans are conducted. He testified that it was not uncommon for family practitio- ners or pediatricians to fail to diagnose brain lesions in infants, because of their young age, and the difficulty that physicians have in distinguishing normal from abnormal gross reflexes in infants. (Tr.3573-74). During his testimony he acknowledged that he knew Graham had received a DTP vaccine on March 17, 1980 (Tr. 3580). After having reviewed the medical records and after acquainting himself with the testi- mony of other experts who testified as to the cause of Graham’s disability, Dr. Breckbill stated: My opinion would be that the child had suffered a stroke when seen by Dr. Hertenstein, [she] had the stroke previous to the time that child was seen by him. (Tr. 3895). We note parenthetically that Dr. Hertenstein examined Graham on February 2, 1980, more than six weeks before her DTP vaccination. Dr. Breckbill explained the basis tor his opinion that the stroke occurred sometime before February 2, 1980 by referring to the CT scan and the changes in both Graham’s skull and brain. No objection was raised either as to Breckbill’s qualifications or to his testimony at that 2ia time. An extensive cross-examination occurred. On re- direct examination, Wyeth inquired as to whether it was still Dr. Breckbill’s opinion that Graham’s stroke oc- curred before February 20, 1980 (the date of Dr. Cibis’s examination). That question elicited an objection from Graham’s counsel: (Tr. The following colloquy took place: MR. WARSHAFSKY [Graham’s attorney]: I object on the grounds that with the totality of the exami- nation and now with what the Doctor had to exam- ine and his background, I don’t think the Doctor is qualified to give the opinion. THE COURT: Sustained. MR. WARSHAFSKY: And I move that his opinions given during direct testimony on the same subject be stricken. MR. HERRINGTON: [Wyeth’s attorney]: Your Honor, there was no objection made during the direct examination. 3693). * * » . MR. HERRINGTON: I’m not sure I’m clear. What is the Court ruling with regard to moving to strike his opinion with regard, on direct testimony that he gave? THE COURT: Sustained. MR. HERRINGTON: Where no objection was raised at the time. THE COURT: Well, you’ve reraised it and you restated it. Now its raised, and now I rule on it. MR. HERRINGTON: Id like to make a proffer, your Honor, outside the hearing of the jury. 22a (Tr. 3697) Wyeth’s counsel proffered the testimony of Dr. Breckbill as follows: MR. HERRINGTON: Based upon the information in the medical records that I asked you to review and that you have reviewed and the portions of Dr. Hertenstein’s deposition that you were furnished and your reliance upon the head charts and their significance ... do you still hold the same opinion you expressed yesterday that the stroke of Michelle Graham occurred before February 20, 1980 when the right fixed gaze was found by Dr. Hertenstein!’ [sic]? Do you still have the same opinion? DR. BRECKBILL: Yes. (Tr. 3719). Thus, the testimony of Dr. Breckbill, which focused on events occurring before the DTP vaccination of Graham, was removed from the jury’s consideration. We do not focus on the fact that no objection was initially raised by Graham because we are satisfied that Dr. Breckbill’s testimony should not have been stricken. His testimony not only bolstered Dr. Cibis’ testimony but was directed to the very essence of Wyeth’s defense, and was both highly relevant and material to that defense. C. In line with its earlier approach that no expert’s testimony could be considered unless the doctor or expert had an appreciation of endotoxins or its effect, the district court also sustained Graham’s objection to the testimony of Dr. Deitch. Wyeth made an offer of proof outside the presence of the jury as to Dr. Deitch’s testimony. Dr. Deitch, a Board 17. Although the substance of Dr. Breckbill’s testimony is unchanged, in fact it was Dr. Hertenstein who examined Graham on February 2, 1980 and Dr. Cibis who examined her on February 20, 1980. OP Dt Tat Bm ». dnatenmemnes eat nd te et er ne ee ee ee 23a certified pediatrician, reviewed Graham’s medical his- tory and had noted the fixed right gaze which had earlier been observed by Drs. Hertenstein and Cibis. The significance of this was, in Dr. Deitch’s view, that “one of the things to be ruled out at that time [of Dr. Hertenstein’s examination] was a stroke sometime prior to that [the time of Graham’s DTP vaccination].” (Tr. 4353). Dr. Deitch would also have testified that even a thorough pediatric examination of a child between two and three months of age [Graham was 7 weeks old at the time of Dr. Hertenstrein’s examination and 11 weeks old at the time of Dr. Cibis’] would not necessarily reveal a stroke that had occurred because a loss of functions, slurring of speech, and distortions of the face, which manifest themselves when adults have strokes, do not show up in children at that young age. The relevant and particular question that was ex- cluded from jury consideration was: “Would the result of that stroke be apparent to a competent pediatrician performing such an examination at that time?” (Tr. 4161). Dr. Deitch’s answer to that question would have been: “No.” Thus, the affect of the district court’s ruling was to prevent the jury’s consideration of Dr. Deitch’s confirmation that Dr. Hertenstein might not have ini- tially recognized the manifestations of a stroke even though Graham might have suffered a stroke at a time prior to her vaccination. D. In sum, the result of the district court’s rulings which prevented any evidence of a pre-vaccination stroke from reaching the jury, effectively vitiated a relevant theory which Wyeth was entitled to establish. As we have noted above, Wyeth’s experts would have testified that Graham was originally diagnosed by her treating physician (Dr. Hertenstein) as having an eye 24a problem which he, as a pediatrician, could not diagnose. Dr. Hertenstein referred Graham to Dr. Cibis, a pediatric ophthalmologist, who examined Graham three weeks before her DTP vaccination. At that time, Dr. Cibis identified Graham’s eye problem as relatively minor. Approximately one month later, Graham was vaccinated by Wyeth’s DTP vaccine, and after that event, she was diagnosed as suffering from brain damage, which was caused by a stroke. Graham thereafter had a CT scan taken by Dr. Breckbill. When the results of this CT scan were dis- closed to Dr. Cibis, he indicated that, given what he now perceived from the CT scan, he would now have diag- nosed Graham as having suffered a stroke prior to his original examination. Supporting Dr. Cibis’ diagnoses was Dr. Breckbill, a pediatric radiologist and a pediatric neuro-radiologist, who was prepared to testify that Graham had suffered a stroke before she had been vaccinated. Dr. Deitch, a Board certified pediatrician, was prepared to testify that it would not be uncommon for a pediatrician to fail to recognize signs of a stroke in an infant, thus giving additional credence to Wyeth’s theory of pre-vaccination injury.'® While we obviously cannot, and do not, find that Graham’s DTP vaccination occurred after she had suf- fered a stroke (fact finding here was a function for the jury), it is clear that causation evidence of this import could not be withheld from jury consideration. Thus, whether the district court’s rulings excluding Dr. Cibis’ stimony is considered alone, or is considered in coui- junction with the exclusion of the testimony of Drs. Breckbill, and Deitch, we are satisfied that the district 18. We do not elaborate on the district court’s ruling restricting Dr. Pollack’s examination, as Dr. Pollack’s testimony was not focused specifically on the issue of pre-vaccination injury. In light of our disposition of this appeal, we express no opinion on the admissibility of Dr. Pollack’s testimony. 25a court prevented the jury from hearing the opinion of these experts on the cause of Graham’s injury. More- over, as we have eerlier observed, an error of this magnitude inevitably had to prejudice Wyeth’s defense, and cannot be deemed harmless. IV. Wyeth also argues that the district court abused its discretion when it admitted an American Medical Asso- ciation Ad Hoc Panel Report, “Pertussis Vaccine Injury,” 245 JAMA 21:3083 (December 6, 1985) (PX376) into evidence, when it redacted the Report, and when it, contrary to the provision of Fed. R. Evid. 803(18), not only permitted the report to be read to the jury in its redacted form but then permitted the jury to receive the document as an exhibit. Wyeth charges that this docu- ment was so fatal to Wyeth’s case that Wyeth was obliged to move for a mistrial.!9 The Report’s first sentence stated its objective: In an effort to ensure an adequate and uninter- rupted supply of vaccine for mandated pediatric immunization and to encourage the continued timely administration of these vaccines, the Ameri- can Medical Association formed a commission to explore the need for a compensation system for vaccine-injured patients. The remainder of that paragraph and a portion of the succeeding paragraph addressed itself to the issue of establishing a federal vaccine compensation program as an exclusive remedy for any individual injured by a mandated vaccine and noted that there was only one remaining supplier of DTP — a supplier who might be unable to obtain insurance renewal. 19. The district court cheracterized the AMA Report as “the smoking gun we have been looking for . . .” (Tr. 1627) and denied Wyeth’s motion. 26a Other portions of the exhibit, while acknowledging that the Report did not have as its purpose stringent proof of causation of injury by the vaccine, did refer to injuries “reputed” to be vaccine-related and reported by television and radio news programs, newspapers or parents groups but whose relationship to DTP vaccine was not necessarily supported by medical evidence. It went on to state that it was the impression of the AMA panel that about 10% of patients exhibiting seizures may have residual brain damage after one year. Other prob- abilities of related injuries were discussed in the Report, although the panel noted that there was “no evidence that killed vaccine (such as [Wyeth’s] pertussis vaccine) can cause any prolonged insidious or delayed deleterious effects (in contrast to live attenuated organism vacci- ne).” While the Report did not address the issue of whether DTP could cause retardation — but rather addressed itself to a proposed legislative solution to compensate vaccine victims — some of its content could be read as relating to the issues in this case. We reproduce in full in the margin, the one and one-half paragraphs of text redacted by the district court.?° 20. The redacted material read as follows: In an effort to ensure an adec .ate and uninterrupted supply of vaccine for mandated pediatric immunization and to encourage the continued timely administration of these vac- cines, the American Medical Association formed a commission to explore the need for a compensation system for vaccine- injured patients. From these deliberations recommendations for federal legislation were made and approved by the Associa- tion’s House of Delegates in June 1984. Draft federal legislation was prepared calling for the establishment of a federal vaccine compensation program as an exclusive remedy for those seri- ously injured by mandated vaccines. There was considerable urgency since the number of national suppliers for one of these vaccines (diphthcria-tetanus-pertussis, or DTP) decreased from three to one. There also was a reasonable possibility that the sole remaining supplier would be unable to obtain insur- ance renewal. The concern with DTR vaccine resides with its pertussis SF eee — er Ne ede OR eS eee ee ene nn ai . 27a Wyeth objected to the admission of the Report in its entirety, claiming that the Report was neither a scien- tific nor a clinical study nor a learned treatise. It also objected to the court’s sua sponte redaction of the introductory portion of the Report which, as noted, dealt with a proposed compensatory and insurance scheme. In addition, Wyeth contended that when the district court permitted the jury to have the redacted document in its possession during deliberations as a written ex- hibit, the district court had acted contrary to the express provision of Fed. R. Evid. 803(18) which provides that if a learned treatise is admitted “the statements may be read into evidence but may not be received as exhibits.” A. Wyeth claimed among other things that the Report did not qualify as a learned treatise because Graham’s expert had not established that it was a reliable authority within the meaning of Fed. R. Evid. 803(18).21 Wyeth cell components, which occasionally induce severe neurologi- cal injury. In order to prepare an appropriate information base on potential pertussis vaccine injuries in the context of Con- gressional consideration of vaccine injury compensation legis- lation, ... American Medical Association Ad Hoc Panel Report, “Pertussis Vaccine Injury,” 254 JAMA 3083 (December 6, 1985). 21. Fed. Rule of Evid. 803(18) reads: The following are not excluded by the hearsay rule, even though the declarant is available as a witness: 7 * ” (18) Learned treatises. To the extent called to the atten- tion of an expert witness upon cross-examination or relied upon by the expert witness in direct examination, statements con- tained in published treatises, periodicals, or pamphlets on a subject of history, medicine, or other science or art, established as a reliable authority by the testimony or admission of the witness or by other expert testimony or by judicial notice. If admitted, the statements may be read into evidence but may not be received as exhibits. 28a also claimed that in order to be admitted into evidence, the Report would have to be demonstrated to be relevant to the facts of the case at issue. Dr. Gilmartin, who testified on behalf of Graham, testified only that the panel was a prestigious panel, and that the Journal of the American Medical Association, in which the Report appeared, was an authoritative publi- cation. Significantly, Dr. Gilmartin did not testify that the Report itself was a reliable authority or that it constituted a learned treatise. Moreover, because the Report did not dea! with the causal relationship between DTP and stroke, Wyeth asserted that a specific issue in this case which focused on causation was not addressed and therefore the Report was irrelevant. Our reading of the record does not disclose Wyeth’s specific objection to the introduction of this Report on the ground that the foundation for its introduction was inadequate. Rather, Wyeth objected strenuously to the Report on the grounds that its purpose was not to establish causation, but was rather tangential in the sense that it advocated a legislative compensatory scheme. Indeed, Wyeth’s strongest objection was to the sua sponte redaction of a portion of the Report which deprived the jury of knowledge that the Report did no more than propose a plan to compensate any DTP victims. In the absence of a specific objection to the manner in which Graham laid the foundatio’. for the Report’s introduction, we cannot say that the district court judge would have abused his discretion had he permitted the entire Report in evidence, leaving it to Wyeth to cross-examine Dr. Gilmartin on the purpose of the Report. By doing so, Wyeth could have clarified the relevance and import of the Report itself. B. Whether or not the full Report was admissible in evidence within the ambit of Fed. R. Evid. 803(18), the ~ 7 | f eiitniia ae 29a district court’s subsequent action in sua sponte redact- ing a significant portion of the Report stands on a different footing. After Wyeth had objected to the rele- vancy of the Report because the panel had not estab- lished a causal relationship between DTP vaccine and encephalopathy, the district court on its own motion redacted the first paragraph and a substantial portion of the second paragraph of the Report. The sentences redacted, as we have noted earlier, contained a state- ment as to the purpose of the Report (compensation) and a reference to the possibility that insurance might be unavailable. The district court recognized that the issue of compensation as presented in the Report was irrelevant to the issues of this case, but by redacting all reference to compensation the court unwittingly dis- torted the thrust of the Report. Not only was the purpose and theme of the article withdrawn from the jury’s consideration, but the district court explicitly ordered that Wyeth could not cross-examine any witness on the material which appeared in the redacted paragraphs. The district court answered Wyeth’s observation that the subject of the Report’s purpose would have to be addressed in cross-examination, by stating: THE COURT: Let me see if I can make it clear then. You’re entitled to get into it [the Report], but you’re admonished not to get into anything men- tioned in the first paragraph.?2 (Tr. 1629). * * * 22. We cannot reconcile the district court’s order redacting only the first paragraph with the actual redaction of the exhibit which included an additional portion of the second paragraph. No explanation appears as to why more than the first paragraph was redacted. Inasmuch as we hold that the district court improperly redacted any part of the report once it had decided to admit the entire report into evidence, the additional redaction only added to the error. : 30a THE COURT: You can take out the first para- graph which gives rise to the reason it [the Report] was formulated, ostensibly, because they were about “the formation of some kind of compensation pro- gram. After the first paragraph, there isn’t a thing in this paper you can’t go into. (Tr. 1667). . THE COURT: Very well. I only say, seem [sic] to me we could cut out the first paragraph. I’ve already told the jury the first paragraph’s irrelevant. It’s no longer of concern to them. Take it out. All of you can use the exhibit. .. . (Tr. 1667). Through its redaction, the district court admitted evidence into the case which could only mislead the jury. By prohibiting cross-examination about the true purpose of the Report the district court compounded its error. Moreover, although Dr. Gilmartin testified to some statements in the redacted Report having to do with the panel’s recitation of probability of vaccine causation, (Tr. 1631) the entire redacted Report was given to the jury for their study during deliberations. What the last pro- vision in Fed. R. Evid. 803(18) seeks to preclude by prohibiting the receipt of the written exhibit into evi- dence is described in Weinstein’s Evidence as: To insure that the jurors will not be unduly im- pressed by the treatise, and that they will not use the text as a starting point for conclusions untested by expert testimony, the last paragraph of Rule 803(18) bars the admission of treatises as exhibits so that they cannot be taken into the juryroom. J. Weinstein & M. Berger, 4 Weinstein’s Evidence 7803(18)[02]. Thus, as Wyeth contends in its brief on appeal — a contention with which we agree: 3la . The redacted portion of the report was critical. It explained the background and limited purpose of the report, namely to provide an information base on potential pertussis vaccine injuries for Congres- : sional consideration of vaccine injury compensation legislation. The redaction of such material made the re- dacted report prejudicially [sic] misleading. By ex- cluding such information, PX376 was made to look like an AMA report on causation, when it was not. In fact, the reported stated that “[w]ithin the purpose of this report,” which purpose was redacted, “stringent | proof of causation by the vaccine was not required.” i Nonetheless, the trial court described the report as a ; “smoking gun” on the issue of causation, and, indeed, in its redacted form it was a deadly weapon. 5 The judge then admonished the parties not to mention anything contained in the redacted portion of PX376. ; Wyeth was severely prejudiced because of its inability to counter the portions of PX376 read into evidence by Dr. Gilmartin (plaintiffs medical ex- : pert) over Wyeth’s objection, which appeared to | establish that the AMA had concluded that DT? causes encephalopathy, when there is no scientific evidence establishing such causation. (Wyeth br. at 88-1339, p. 51) (Internal citations omit- ted). We are satisfied that the district court abused its discretion in redacting the portions of the Report which explained the Report’s purpose and background and in prohibiting Wyeth from addressing those issues on cross-examination or through its own witnesses. We are also satisfied that it was improper to submit the Report in its redacted version to the jury in contravention of Fed. R. Evid. 803(18). We need not decide if this abuse 32a of discretion on the part of the district court, even though it may have been well intentioned, would by itself require a reversal of the judgment in favor of Graham. We are convinced however, that when we consider both the exclusion of the testimony of Wyeth’s experts (Drs. Cibis, Breckbill, and Deitch) which the district court ordered, together with the unfortunate redaction of the Report and its submission to the jury as an exhibit, the judgment in favor of Graham cannot stand. V. Wyeth has also asserted additional alleged errors which do not require extensive discussion in light of our disposition of this appeal. All of the other errors asserted are matters which were peculiar to the trial whose judgment we are reversing, and hence may not occur, or may not be the subject of error, at the new trial which we have directed the district court to hold. Indeed, Wyeth’s appeal from the district court’s denial of its Fed. R. Civ. Pr. 60(b) motions fall within the same category. In normal course we would not discuss in this appeal the denial of Wyeth’s post-trial motions, as it is apparent that at the retrial the very information which Wyeth claims to have newly discovered will, if it desires, become part of its defense. Nevertheless, because the evidence which was the subject of Wyeth’s 60(b) motions goes to the heart of the testimony of Graham’s experts and would in our opinion require a new trial, even had we not decided that the evidentiary errors on direct appeal required reversal, we will explain our conclusion that a new trial was required on the grounds of newly discovered evidence. A. A final error was committed by the district court in its denials of post-trial relief to Wyeth under F.R.Civ.P. 33a 60(b) when Wyeth sought a new trial on the grounds of newly discovered evidence. The grant of denial of a Rule 60(b) motion is reviewed for abuse of discretion; Jn re International Coating Applicators, 647 F.2d 121, 124 (10th Cir. 1981).23 B. At the conclusion of trial the jury awarded Graham $15,000,000 in compensatory damages. Through later depositions taken in other DTP cases unrelated to the instant proceeding, Wyeth discovered that two of the key 23. It is unclear if jurisdictionally a district court can ever grant a rule 60(b) motion after a notice of appeal has been filed. The procedure approved by us in this case is for the district court to indicate that it would grant the 60(b) motion if it had jurisdiction, and for the our court to then remand the case to the district court for that court to decide the motion; see Blinder, Robinson & Co. v. SEC., 748 F.2d 1415, 1420 (10th Cir. 1984) (“In ordinary civil cases the rule is that after an appeal has been taken the district court retains jurisdiction to consider and deny a rule 60(b) motion and, if it indicates that it will grant the motion, the movant may then ask the court of appeals to remand the case so that the district court may act.”) quoting Aune v. Reynders, 344 F.2d 835, 841 (10th Cir. 1965); see also United States v. 397.51 Acres of Land, 692 F.2d 688, (10th Cir., 1982). As we reconstruct the sequence of events from the docket sheets, the jury verdict in favor of Graham was entered on October 15, 1987. Timely motions were made by Wyeth for judgment NOV or for a new trial. These were denied on February 2, 1988 followed by a timely notice of appeal, the time for which had been tolled by Wyeth’s post trial motions. Thereafter, on April 15, 1988, Wyeth moved for relief from the Graham judgment pursuant to Fed. R. Civ. Pro. 60(b). On July 19, 1988, the district court denied Wyeth’s 60(b) motion which was followed by Wyeth’s motion for reconsid- eration — a motion that was also denied by the district court. Wyeth then appealed on April 17, 1988 from the denial of its original 60(b) motion. On October 13, 1988, Wyeth moved again for relief of judg- ment under Fed. R. Civ. Pro. 60(b). That motion was also denied on February 16, 1989. A timely appeal was taken from that denial as well. 34a expert witnesses who had testified on Graham’s behalf, had erred in their testimony as to the toxicity of Wyeth’s vaccine. These two witnesses, Dr. Geier and Dr. Za- halsky, both misstated in their testimony to the Gra- ham jury, the results of Dr. Geier’s experimentation respecting the levels of endotoxin in Wyeth’s DTP vaccine. This evidence was addressed to Wyeth’s alter- native defense: that DTP vaccine could not have caused Graham’s stroke. Both of Wyeth’s 60(b) motions con- cerned this testimony. At trial, in the present case, Dr. Geier had testified extensively as to the critical relationship between the toxicity of any pertussis vaccine and the level of endo- toxin. The thrust of his testimony was that the higher the level of endotoxin, the greater the danger that any given vaccination would lead to adverse reactions, in- cluding those allegedly suffered by Graham. Dr. Geier stated that the “[mlJore the endotoxin, the more severe [the] reaction” (Tr. 892). Specifically, Dr. Geier stated that the endotoxin content of Wyeth’s vaccination was 240 micrograms per milliliter (Tr. 1028) — a level four times higher than that of the next most toxic pertussis vaccine made by other pharmaceutical companies and 2400 times higher than the least toxic of the other pertussis vaccines. (Tr. 1028-31). In fact, it later appears that Dr. Geier had erred in his computation of the toxicity <= the Wyeth’s DTP vaccine. Instead of Wyeth’s vaccine having an endotoxin level of 240 micrograms per milliliter, it actually had only a level of 20 micrograms per milliliter. Thus, when Dr. Geier was deposed in a later case entitled Talley v. Wyeth Laboratories, (case no. 87-349-C, E. D. Okla., Feb. 24, 1988), he testified: 24. We assume that any error that occurred in Drs. Geier’s and Zahalsky’s testimony was due to unintentional mathematical cal- culations. ”_ ee EF ge ee . | ' | 35a Q: Your initial estimate of this Lederle [DTP ‘vac- cine] made by Wyeth was that it had 240 micro- grams per milliliter, and then on subsequent reflec- tion and further testing, you found that it had tenfold less than that; is that correct? A: That’s right, that one looks like an error of — what we call an order of magnitude error, that is when I did the calculation, I must have missed a zero Q: And a tenfold difference can be pretty significant in terms of your opinion, can’t it? A: Sure. (Tr. 468). Dr. Geier, in a number of other depositions, had given substantially identical testimony to the effect that Wyeth’s vaccine is not as toxic as he originally thought it was.25 This testimony substantially undermined the weight of the evidence to which he testified in Graham’s case. Almost by definition, any error in Dr. Geier’s testi- mony had to affect the testimony and conclusions of Dr. Zahalsky, who when he testified, relied on Dr. Geier’s calculations. Thus Dr. zahalsky testified at trial that: And the reason I chose to identify this [a high endotoxin value] as probably the more likely value, the higher value, is because I had discussed with Dr. Geier what his analysis revealed. . . . I chose to take this value here [the higher endotoxin number] because he [Dr. Geier] had actually assayed [Wyeth’s vaccine] which had 240 mi- crograms per mil[liliter]. 25. In the cases of McLean v. Wyeth, 86-4077 (W.D. Ark. 1988), Cavallo v. Wyeth, Circuit Court, Milwaukee County, Mil- waukee, Wis. 716-507, and Cooper v. Wyeth, 86-1177C (E.D. Miss. 1987), Dr. Geier acknowledged the error of his testimony in the Graham case. These depositions can be found in Wyeth’s Adden- dum of Exhibits, Volume I, 89-3066. 36a (Tr. 639). Dr. Zahalsky also identified himself as a “collaborator” with Dr. Geier on those experiments (Tr. 498) and at the Graham trial, Dr. Zahalsky substantiated the validity of his results by identifying them with the results of Dr. Geier’s experiments. Thus, any error in Dr. Geier’s experiments had to affect the testimony of any other expert who relied on Dr. Geier’s results. C. After discovering that Dr. Geier’s testimony in Gra- ham had an erroneous basis, Wyeth filed its F.R.Civ.Pro. 60(b) motions in the district court, seeking post-trial relief from Graham’s judgment based upon these errors in the testimony. Federal Rule of Civil Procedure 60(b) provides for relief from judgments or orders. Subsection (b) specifies that such relief may be available where among other things: (2) Newly discovered evidence which by due diligence could not have been discovered in time to move for a new trial under rule 59(b); or * * * (6) Any other reason justifying relief from the operation of the judgment. The district court denied Wyeth’s motions for post- judgment relief. We cannot agree with the district court’s resolution of Wyeth’s motions grounded on newly discovered evidence. Thus, we hold that the district court abused its discretion in refusing to grant Wyeth’s rule 60(b) motions, to the extent that Wyeth predicated its motions on alleged newly discovered evi- dence. O° CRE NA het 37a D. For newly discovered evidence to provide a basis for a new trial under Fed. R. Civ. Pro. 60 (b)(2), Wyeth was required to satisfy five conditions: Wyeth had to demonstrate that: (1) the evidence was newly discovered since the trial; (2) Wyeth was diligent in discovering the new evidence; (3) the newly discovered evidence could not be merely cumulative or impeaching; (4) the newly discovered evidence had to be material; and (5) that a new trial, with the newly discovered evidence would probably produce a different result. See Ag Pro. Inc. v. Sakraida, 512 F.2d 141, 143 (Sth Cir. 1975), rev'd on other grounds, 425 U.S. 273 (1976). In its July 19, 1988 disposition of Wyeth’s 60(b) motion, the district court concluded that Wyeth had not met three of the five requirements for relief under 60(b). The district court found that Wyeth had not exercised diligence in obtaining the new evidence; that the evi- dence did not meet the test of materiality and that even with this new evidence, a new trial would probably not produce a different result. In so holding, the district court did not dispute that the evidence was newly discovered, i.e., that Dr. Geier’s miscalculations did not come to light until after the Graham trial had concluded.?6 Nor did it find that this 26. See Rosebud Sioux Tribe v. A. & P. Steel, Inc. 773 F.2d 509 (8th Cir.), cert. denied, 469 U.S. 1072 (1982) (a witness’ perjury in his deposition and at trial, [like Dr. Geier’s miscalculation of the 38a new evidence of Dr Geier’s was cumulative or could be characterized as impeaching. We agree that these two prongs of the five-prong test have been satisfied. Indeed, as we discuss below, we are persuaded that all five requirements of 60(b) were met by Wyeth. We reject Graham’s and the district court’s asser- tions that Wyeth’s decision not to duplicate all of Dr. Geier’s experiments was a form of “lack of diligence.” Rule 60(b) does not set that high a standard. If such a standard was mandated, there would be few cases where a 60(b)(2) motion could be granted, inasmuch as the movant would have to demonstrate that it could not have independently confirmed the erroneous calculation of the results.27 As Wyeth contends, “The change in Dr. Geier’s endotoxin figure was produced by a change in the value of the Reference Standard used to calculate the endotoxin content of the Wyeth DTP vaccine (Geie1 Deposition in Talley v. Wyeth, L86-4077 W.D. Ark. 1988, pp. 458, 463). Since the change in the Reference Standard was not made until after Dr. Geier testified at trial, Wyeth could only have discovered the evidence after trial.” (Wyeth br. at 88-2302, p. 15). So too, we reject Graham’s assertion (Appellee’s br. at 88-2302, p. 20 n.4) that because Dr. Geier already knew about the potential mistakes in his research at the time of his testimony in Graham’s trial, it was Wyeth’s lack of “diligence” that caused Wyeth to fail to discover that fact by asking Dr. Geier if he was mistaken! We must assume that Dr. Geier was unaware of the errors in his testimony at the time he testified. Moreover, the miscalculations made by Dr. Geier changed the entire complexion of the case. Had the Graham jury been NOTES (Continued) toxicity level of DTP] constituted newly discovered evidence. 27. The intent of the diligence requirement is to insure that litigants do not “hold back” evidence so as to be granted a new trial if the first trial is lost. ee ee ee ee ee a ee ey 39a alerted to the correct calculations of toxicity, it may well have taken a different view of the case. The third prong of the test (that the evidence must not be merely cumulative or impeaching) appears to us, (as it must have appeared to the district court) to have been satisfied because of the gravity of Dr. Geier’s error in miscalculating the toxicity of Wyeth’s vaccine. We cannot help but observe that this error was testified to by Graham’s most significant expert — Dr. Geier — who tes- tified in support of her claim. The fourth prong of the test (that the evidence must be material) was satisfied because Dr. Geier’s testimony focused on one of the most significant aspects of Gra- ham’s claim—the allegedly high endotoxin level of Wyeth’s pertussis vaccine. Dr. Geier, as noted was Graham’s key witness on this issue. Without evidence being adduced as to high endotoxin levels, the case might not have even reached the jury. Additionally, a proper calculation of the endotoxin level by Graham’s experts might have lead the district court, in either its summary judgment opinion or in its consideration of the motion to strike Wyeth’s §402A comment (k) defense to “design defect” strict liability, to rule that Wyeth’s vaccine was “unavoidably unsafe” and thus exempt from liability under §402A comment (k) from alt but 28. We are also persuaded that Dr. Zahalsky’s testimony was gravely undercut by Dr. Geier’s failure to analyze his data. Dr. Zahalsky himself has significantly recanted much of his testimony in Graham’s case in other testimony given in other cases. Thus for example he seems to have lowered his estimate of the endotoxin level in Wyeth’s vaccine from 353 micrograms per milliliter (Tr. 638-639), the amount he testified to in Graham’s case to somewhere between 7.5 - 75 micrograms in other cases (Overlay v. Warner Lambert (IP83-1780-C) (S.D. Ind. 1986), and Knudsen v. Con- naught Laboratories (85-703-CIV-J-16) (M.D. Fla. 1987). A twelve fold decrease in Dr. Geier’s measurements would lead to a decrease in Dr. Zahalsky’s measurements from 353 to 30 micrograms per milliliter. These depositions can be found in Wyeth’s Addendum of Exhibits, I, 89-3066. 40a negligence claims. We hold that the district court’s perception of this testimony as not being material was an improper exercise of the district court’s discretion. Con- trary to the district court’s view, we cannot regard the evidence in question as less than material. Finally we are left with the fifth prong of the Rule 60(b) calculus — whether the new evidence would have probably lead to a different result at trial. This prong of the test is logically the one that requires the most deference to the district court — that court which heard all of the evidence, which was present at trial to examine the demeanor and credibility of all of the witnesses, and which had its finger most closely on the pulse of the trial. As we stated in Kodekey Electronics, Inc. v. Mecha- nex, 486 F.2d 449, 458 (10th Cir. 1973): Such a determination [would the new evidence have lead to a new trial?] is not particularly favored by the courts, and rests largely and almost wholly within the sound judicial discretion of the trial court. Whether the newly discovered evidence would be likely to change the result of the district court’s decision is one peculiarly within the deter- mination of but one man — the trial judge. However, we have observed that where the subject of a district court ruling involved experimental evidence which should not have been allowed and which misled the jury, this court has reversed the district court notwithstanding the general deference which is nor- mally accorded to a trial judge on these matters. See Jackson v. Fletcher, 647 F.2d 1020, 1027 (10th Cir. 1981). We recognize that Jackson was decided on direct appeal and not on appeal from a post-trial 60(b) motion, as is the case here. Nevertheless and even though not directly on point in this appeal, we are enlightened by and subscribe to Judge Doyle’s statement in Jackson that, “in many instances, a slight change in the condi- tions under which the experiment is made will so distort ai er ao Peete Se Ot 4la the result as to wholly destroy its value as evidence, and make it harmful, rather than helpful.” (Emphasis added.) (quoting Navajo Freight Lines v. Mahaffy, 174 F.2d 305, 310 (10th Cir. 1949).) This pracept is even “more relevant in a case such as Graham’s where the jury is less able to resolve technical and scientific facts by relying on its own common sense and experience. The district court found no impropriety or unfair- ness in testimony of Drs. Geier and Zahalsky even when the deficiencies in their testimony were brought to his attention by Wyeth’s 60(b) motions. We are hard pressed to understand that conclusion in light of the context in which their evidence was presented at trial. Elementary reasoning and our complete review of the trial record reveals that an accurate presentation of the endotoxin level in Wyeth’s vaccine could not help but dilute the total impact of Graham’s case. Moreover, Rule 60(b) is intended “to prevent the judgment from becom- ing a vehicle of injustice,” see United States v. Walus, 616 F.2d 283, (7th Cir. 1980), and the Rule is to be construed liberally to do substantial justice. It is true, we cannot say with certainty that at a new trial Graham may not again prevail, however with the significant modification in Dr. Geier’s testimony which Wyeth has now discovered, it is probable that a different result in the verdict would occur. We are not required in this context to deal with “certainties” but only “probabi- lities.” The test is whether the new evidence introduced would probably produce a new verdict. We are satisfied, after having examined in detail the argument of both Graham and Wyeth in light of the entire record, that in this case, that probability exists. Having concluded that the five requirements for relief from a judgment on the grounds of newly discov- ered evidence were satisfied by Wyeth when it discov- ered Dr. Geier’s miscalculations as to the toxicity of Wyeth’s vaccine, we hold that the district court should have exercised its discretion by vacating the Graham 42a judgment and by granting Wyeth a new trial.29 Because it did not do so, we will reverse the orders of the district court denying Wyeth’s post-trial relief. In doing so, we recognize that this holding with respect to Wyeth’s 60(b) claims, accords with our holding with respect to trial errors, in that the dispositions of both appeals require a new trial. We assume that the miscalculations now disclosed in Dr. Geier’s testimony will be corrected or addressed at a new trial if the same issues are presented. VI. We have held that trial errors and the discovery of new evidence by Wyeth compel a new trial to be held. We will, therefore, reverse the judgment in favor of Graham and remand to the district court for proceedings consistent with the foregoing opinion. 29. Having determined that Wyeth has satisfied the require- ments of Rule 60(b)(2), we do not find it necessary to address Wyeth’s claim for relief from judgment under Rule 60(b)(6). ee i ee 43a APPENDIX B Michelle GRAHAM, an Infant Under the Age of Eighteen, Who Sues by Her Parents, Guardians and Next Friends, Charles GRAHAM end Tammy Graham; and Charles Graham and Tammy Graham, Individually, Plaintiff, Vv. WYETH LABORATORIES, A DIVISION OF AMERICAN HOME PRODUCTS CORPORATION, a Pennsylvania Corporation, Defendant. No. 85-1481-K. United States District Court, D. Kansas. July 21, 1987. Order Nunc Pro Tunc July 22, 1987. Andrew Hutton, Michaud, Hutton & Michaud, Wichita, Kan., for plaintiff. Albert J. Knopp, Baker & Hostetler, Cleveland, Ohio, Alvin D. Herrington, Wichita, Kan., Hedy M. Powell, Philadelphia, Pa., for defendant. MEMORANDUM AND ORDER PATRICK F. KELLY, District Judge. This case is before the court on defendant’s motion for summary judgment. Plaintiffs Charles and Tammy Graham claim their infant daughter, Michelle Graham, sustained severe and irreversible brain damage after being vaccinated against diptheria, pertussis (whooping cough) and tetanus. The DPT vaccine she received was manufactured and distributed by defendant Wyeth Lab- oratories (“Wyeth”). The plaintiffs, parents and daughter, brought this diversity action asserting claims of strict liability and 44a negligence for design defect and failure to warn, breach of the implied warranties of merchantability and fitness for a particular purpose, and intentional misrepresenta- tion. Plaintiffs also seek punitive damages, claiming the defendant willfully, wantonly and recklessly failed to adequately warn of the possible‘severe reactions to the DPT vaccine and willfully failed to rectify the product’s design. Defendant has moved for summary judgment, con- tending that federal law preempts plaintiffs’ claims in their entirety. Alternatively, defendant contends that under Kansas laws as set forth in Johnson v. American Cyanamid, 239 Kan. 279, 718 P.2d 1318 (1986), this court must find as a matter of law that DPT vaccine is an “unavoidably unsafe” prescription drug which contains an adequate warning, and enter judgment in defen- dant’s behalf. After considering all well-pleaded facts in plaintiffs’ favor, the court is convinced that defendant is not entitled to summary judgment and this case must proceed to trial. As will be explained herein, the court finds Congress did not intend to preempt state tort claims asserted by a victim of an adverse reaction to an FDA-approved drug. Further, the court finds that John- son is distinguishable from the case at bar and does not require the entry of judgment in defendant’s behalf. FACTS Defendant Wyeth manufactures the DPT vaccine which is used to immunize children against the diseases of diptheria, pertussis (whooping cough) and tetanus (lockjaw). The vaccine is administered to infants at two, four, six and eighteen months. A booster is administered prior to the child’s entrance into school. The DPT vaccine is comprised of three component parts which will be more thoroughly described herein. Those components are diptheria toxoids, tetanus tox- Le a INN ee Rts fn! Fu shelled aia Se RE MO 0! ta Oe aid 45a oids, and a pertussis whole cell vaccine. It is the per- tussis component which causes severe reactions such as suffered by Michelle Graham. While plaintiffs contend the pertussis component of the vaccine could have been safer, they do not argue that a pertussis vaccine is unnecessary or that it has not saved millions of lives. In the early 1900s, pertussis was a leading cause of death in children in this country. In 1934, when this country suffered its worst per- tussis epidemic, there were 265,000 reported cases of pertussis per year, and 7500 related deaths. Hinman and Koplan, Pertussis and Pertussis Vac- cine: Re Analysis of Benefits, Risks and Costs, Journal of the American Medical Association (June 15, 1984). By the early 1949s, pertussis was respon- sible for two and one-half times the number of deaths as all of the following diseases combined: measles, mumps, rubella, diptheria, polio, meningi- tis, chicken pox, and scarlet fever. Id. Hurley v. Lederle Lab., Div. of American Cyanamid, 651 F.Supp. 993, 995 (E.D.Tex. 1986). The DPT vaccine containing the “whole cell” pertussis vaccine was li- censed by the FDA in 1949. Due to the widespread use of the vaccine in this country, pertussis has virtually been eradicated. However, because of the persistent nature of the pertussis bacteria, there is a continuing and substantial risk of epidemics if the use of the vaccine were to decline significantly. Hurley, 651 F.Supp. at 995. The nature of the DPT vaccine and its component parts was recently capsu!ed by the Ninth Circuit, and is instructive herein: By introducing an antigenic factor into the body, vaccines stimulate the production of antibodies that protect against disease. Some infectious organisms, such as those causing diptheria and tetanus, excrete 46a soluble toxins insoluble by medical research. The toxin is inactivated with formaldehyde and trans- formed into a toxoid. The toxoid is then used in a vaccine, as it can immunize against disease by stimulating the production of antibodies in the re- cipient, even though it has lost its own poisonous qualities. This is not the case, however, with [the Per- tussis component]. The [Pertussis] vaccine is a so-called whole ceil vaccine because it contains whole killed pertussis organisms. The whole organ- ism is used because the pertussis organism contains fifteen or sixteen different antigens, and medical science has yet to isolate the one that stimulates protection against the disease. See Tinnerholm v. Parke, Davis & Co., 411 F.2d 48, 50 (2d Cir. 1969). Toner for Toner v. Lederle Laboratories, 779 F.2d 1429, 1430 (9th Cir. 1986). Because the whole cell vaccine retains its poisonous qualities, it is “neurotoxic” and can cause adverse reactions which may be mild (local), or severe. Mild reactions may include swelling, fever, irri- tability, and crying spells. Severe reactions include en- cephalopathy, paralysis and death. The expected rate of such reactions is controverted by the parties. Defendant claims about one out of every 7,000 children will suffer high fever or convulsions while one of every 100,000 children will suffer brain damage; plaintiffs claim these figures are inaccurate as to the Wyeth vaccine because they are based on faulty data. Plaintiffs further contend that Wyeth is aware that the incidence of s~vere reac- tions is actually much higher. In recognition of the dangerous propensities of the whole cell vaccine, efforts have been made to develop a fractionated cell pertussis. vaccine. During the 1950s, the Eli Lilly Company developed a “split cell” vaccine called Tri-Solgen. Early studies indicated this vaccine was less toxic than the whole cell and it was approved by Dat te ait Ol tw Claw ote, x 47a the FDA in 1967. At that time, Lilly occupied a substan- tial share of the DPT market. In 1975, Lilly withdrew from the vaccine business and sold its Tri-Solgen vac- cine to Wyeth. According to plaintiffs, in an effort to save on cost, Wyeth substituted its own “ingredients” (or “strains”) into the Lilly “recipe” for the split cell vaccine. Wyeth then attempted to license this vaccine, but no license was granted by the FDA. Wyeth has made no further attempts to license a fractionated cell vaccine. Moreover, no such vaccine is licensed in this country today.' Of course, a pharmaceutical company is prohib- ited from marketing a product absent a license — to do so would constitute a criminal offense.2 21 U.S.C. §$§331(d), 333(a), 355(a); see also Toner v. Lederle, 779 F.2d at 1431; but see 21 CFR 620.1 (allowing for manufacture of “either killed whole Bordetella pertussis bacteria or a fraction of Bordetella pertussis bacteria.” [emphasis added]}). On March 17, 1980, plaintiff Michelle Graham, who was only a few months old, was administered defen- dant’s DPT vaccine by a nurse at a county office of the Missouri Department of Health. Shortly thereafter Mi- chelle developed a severe and irreversible neurological condition known as encephalopathy. For the purposes of 1. Japan has developed and is currently using a pertussis toxoid (i.e., acellular) vaccine. Japan’s vaccine is purported to be as efficacious as the whole cell vaccine, but far less reactive. Lederle Laboratories is currently attempting to negotiate for, or duplicate, the Japanese vaccine. See Toner, 779 F.2d at 1431. 2. “[T]he fact that a fractionated cell vaccine is not now licensed does not mean it is disapproved—it merely means either that no manufacturer has sought and obtained approval or that, in the instance of the 1972 refusal [of Wyeth’s split-cell vaccine] by a review panel of the Bureau of Biologics, the application therein failed to make an adequate showing of safety or efficacy which is not to say that another manufacturer could not have made a successful application.” Toner v. Lederle Laboratories, 112 Idaho 328, 732 P.2d 297, 313 (1987) (Huntley, J., concurring). 48a this motion, the court will assume the plaintiff's condi- tion was caused by the pertussis vaccine. Wyeth furnished medical practitioners who pur- chased the vaccine with pamphlets describing contra- indications and possible adverse reactions to the drug’s use. The pamphlet in use at the time of Michelle Graham’s immunization stated, in pertinent part: The below-listed serious, and occasionally fatal, ad- verse reactions have bzen reported following admin- istration of pertussis-vaccine-containing prepara- tions. The incidence of these reactions is unknown, but they seem to be exceedingly rate . 1. Severe temperature elevations—10S5°F. or higher. 2. Collapse with rapid recovery. 3. Collapse followed by prolonged prostration and a shock-like state. 4. Screaming episodes characterized by a prolonged period of peculiar crying during which the infant cannot be comforted. 5. Isolated convulsion(s) with or without fever. 6. Frank encephalopathy with changes in the level of consciousness, focal neurological signs, and con- vulsions with or without permanent neurological and/or mental deficit. 7. Thrombocytopenic purpura. The occurrence of sudden-infant-death syndrome (SIDS) has been reported following administration of DTP. The significance of these reports is unclear. It should be kept in mind that the three primary immunizing doses of DTP are usually administered to infarts between the age of 2 and 6 months and that approximately 85 percent of SIDS cases occur in the period 1 through 6 months of age. . 49a Occurrence of any of the following signs, symptoms, or conditions following administration is a contrain- dication to further use of this product and/or per- tussis vaccine as the single antigen: fewer ove1 103°F (39°C); convulsion(s) with or without accom- panying fever; alterations of consciousness; focal neurological signs; screaming episodes (also call screaming fits); collapse; thrombocytopenic purpura. The presence of an evolving or changing neurologic disorder is a contraindication to use. (Emphasis added.) The pamphlet also contained a sec- tion entitled “Precautions”; Wyeth’s precautions did not advise the doctor to determine the child’s personal or family history of central nervous system disease or convulsions. Nor was the-doctor advised as to treating adverse reactions. Prior to the administration of the vaccine to Michelle Graham, Mrs. Graham was given some materials to read about the vaccine and was asked to sign a consent form. The information was prepared by the Missouri Depart- ment of Health and discussed the possible “side effects” from the vaccine, stating: “Rarely, about once in every 100,000 shots, inflammation of the brain (encephalitis) or brain damage may occur. Death may occur, even more rarely.” The form warned that some children should not take the vaccine without consulting a doctor, including “[t]hose who have had convulsions or other problems of the nervous system,” and “[t]hose who have had serious reactions to DTP shots before.” The form invited the parent to ask questions prior to signing. Mrs. Graham did have questions about the possibil- ity of side effects. The nurse told her that the figures were “just statistics” and that “[i]t didn’t really happen.” When Mrs. Graham asked the nurse what would happen if she decided against having Michelle immunized, she 50a was told that the state would have her immunized and would then place her in a foster home. Mrs. Graham agreed to the vaccine because she though she had no choice. As a result of Michelle Graham’s severe and perma- nent injuries, plaintiffs filed suit in this court seeking compensation from Wyeth Labs. The thrust of plaintiffs’ claims against Wyeth is that Wyeth has the technical know-how to develop (or design) a safer, yet equally efficacious, fractionated cell pertussis vaccine, but has refused to do so due to the increased manufacturing costs. Plaintiffs further assert that Wyeth has the tech- nical ability to quantify the endotoxin level of each “batch” of vaccine produced, but has failed to do so. In this regard, plaintiffs contend the degree of endotoxin varies from vial to vial and lot to lot. Plaintiffs assert that Wyeth knew the reported risk factors of the whole cell vaccine were inaccurate and that the incidence of ad- verse reactions was actually much greater. Plaintiffs assert defendant had a duty to accurately disclose to the medical practitioner the inherent hazards of DPT, the contraindication to administering the vaccine, the alter- natives to the whole cell vaccine, the likely results of refusing the vaccine, the antidotes to and treatment for adverse reactions to the vaccine, and early warning signs of an adverse reaction. Plaintiffs further assert Wyeth should have warned the medical practitioner to take a family history of the patient prior to administering the vaccine. As previously stated, plaintiffs proceed on theories of strict liability and negligence for design defect and failure to warn, breach of implied warranties, and intentional misrepresentation. In ruling on a motion for summary judgment, the trial court conducts a threshold inquiry of the need for trial and grants summary judgment where no genuine issue of material fact exists and the moving party is entitled to judgment as a matter of law. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, ___, 106 S.Ct. 2505, RR Cece Re ee a it ol ite dk fe ld ae re S5la 2511, 91 L.Ed.2d 202, 213 (1986). The court is to be concerned with the sufficiency of the evidence, not its weight. Casper v. C.IL.R., 805 F.2d 902, 904 (10th Cir. 1986). Essentially, the inquiry is “whether the evidence presents a sufficient disagreement to require submission t9 a jury or whether it is so one-sided that one party must prevail as a matter of law.” Anderson, 477 U.S. at ___., 106 S.Ct. at 2512, 91 L.Ed.2d at 214. There is no genuine issue for trial unless there is sufficient evi- dence —significantly probative or more than merely co- lorable—favoring the nonmoving party for a jury to return a verdict for that party. 477 U.S. at ___., 106 S.Ct. at 2511, 91 L.Ed.2d at 212. Where there is bit one reasonable conclusion as to the verdict and reasonable minds would not differ as to the import of the evidence, summary judgment is appropriate. 477 U.S. at ___., 106 S.Ct. at 2511, 91 L.Ed.2d at 213. The mnovant’s burden under Fed.R.Civ.P. 56 is to make an initial showing of the absence of evidence to support the nonmoving party’s case. Windon Third Oil and Gas v. Federal Deposit Ins., 805 F.2d 342, 345 (10th Cir. 1986). To show an absence of material fact, the movant must specify those portions of “the pleadings, depositions, answers to interrogatories and admissions on file, together with affidavits if any.” Fed.R.Civ.P. 56(c). “[C]onclusory assertions to aver the absence of evidence remain insufficient to meet this burden.” Win- don, 805 F.2d at 345 n. 7. The opposing party may not rest upon mere allegations or denials in the pleadings, but must set forth specific facts supported by the kinds of evidentiary pleadings listed in 56(c) which demon- strate a genuine issue remaining for trial. Anderson, 477 U.S. at ___, 106 S.Ct. at 2511, 81 L.Ed.2d at 213. The evidence of the nonmoving party is deemed true and all reasonable inferences are drawn in his favor. Windon, 805 F.2d at 346. 52a I. The Preemption Doctrine The doctrine of federal preemption arises from the Supremacy Clause of the United States Constitution: The Constitution and the laws of the United States which shall be made in pursuance thereof... shall be the supreme law of the land; and the judges in every state shall be bound thereby, anything in the laws of any state to the contrary notwithstanding. U.S. Const., Art. VI, cl. 2. Federal law may preempt state law in any of three ways: First, in enacting the federal law, Congress may explicitly define the extent to which it intends to pre-empt state law. E.g., Shaw v. Delta Air Lines, Inc., 463 U.S. 85, 95-96, 77 L.Ed.2d 490, 103 S.Ct. 2890 [2898-99] (1983). Second, even in the absence of express pre-emptive language, Congress may indicate an intent to occupy an entire field of regu- lation, in which case the States must leave all regulatory activity in that area to the Federal Gov- ernment. E.g., Fidelity Federal Savings & Loan Assn. v. De la Cuesta, 458 U.S. 141, 153, 73 L.Ed.2d 664, 102 S.Ct. 3014 [3022] (1982); Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 91 L.Ed. 1447, 67 S.Ct. 1146 [1152] (1947). Finally, if Congress has not displaced state regulation entirely, it may nonetheless pre-empt state law to the extent that the state law actually conflicts with federal law. Such a conflict actually arises when compliance with both state and federal law is impossible, Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142- 143, 10 L.Ed.2d 248, 83 S.Ct. 1210 [1217] (1963), or when the state law “stands as an obstacle to the accomplishment and execution of the full purpose and objectives of Congress.” Hines v. Davidowitz, 312 U.S. 52, 67, 85 L.Ed. 581, 61 S.Ct. 399 [404] 53a (1941). See also Fidelity Federal Savings & Loan Assn., supra, [458 U.S.] at 153, 73 L.Ed.2d 669, 102 S.Ct. [at 1222] 3014. Michigan Canners and Freezers Assoc. v. Agricultural Marketing and Bargaining Board, 467 U.S. 461, 469, 104 S.Ct. 2518, 2523, 81 L.Ed.2d 399 (1984). [1-6] Congressional intent to occupy a field may be either express or implied. Hurley, 651 F.Supp. at 997. Congress may evidence its intent to occupy a field expressly by words in the statute itseif, or in the statute’s legislative history. Silkwood v. Kerr-McGee, 464 U.S. 238, 249-50, 104 S.Ct. 615, 621-22, 78 L.Ed.2d 443 (1984). In the absence of express preemption, there is a strong presumption that Congress did not intend to displace state law. Maryland v. Louisiana, 451 U.S. 725, 726, 101 S.Ct. 2114, 2118, 68 L.Ed. 2d. 576 (1981); Palmer v. Liggett Group, 633 F.Supp. at 1173; see also Silkwood, 464 U.S. at 251, 104 S.Ct. at 623. (“[The Legislature’s] silence takes on added significance in light of Congress’ failure to provide any federal remedy for persons injured. . . . It is difficult to believe that Congress would, without comment, remove all means of judicial recourse for those injured. . . .”) However, certain factors may exist in narrow instances from which courts will infer that Congress intended to pre- empt state law in a particular field. For instance, the scheme of the regulation may be so pervasive that courts will infer a congressional intent to occupy the field. Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 67 S.Ct. 1146, 1152, 91 L.Ed. 1447 (1947). Or, the nature of the subject matter may be one which demands exclusive federal regulation in order to achieve national uniformity and courts will assume the federal law precludes en- forcement of state laws on the same subject. Florida Lime & Avavado Growers, Inc. v. Paul, 373 U.S. 132, 143-44, 83 S.Ct. 1210, 1217-18, 10 L.Ed.2d. 248 (1963). Or finally, courts may determine that enforcement of 54a state law in a particular case may stand as an obstacle to the accomplishment of the purposes and objectives of Congress. Hines v. Davidowitz, 312 U.S. 52, 67, 61 S.Ct. 399, 404, 85 L.Ed. 581 (1941). See also Pattern v. Lederle Laboratories, 655 F.Supp. 745, 747 (D.Utah 1987); Hurley, 651 F.Supp. at 997. In this case, defendant does not contend there has been express preemption. Rather, defendant contends that congressional intent to occupy the field of safety regulation in drug design, testing, and labeling should be implied from the pervasive scheme of the regulations the Food and Drug Administration (FDA) has promul- gated pursuant to the authority granted under the Public Health Services Act (PHSA), 42 U.S.C. § 215 et seq. and the Federal Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seg. Defendant further argues that an award of damages pursuant to state common law is “regulatory” in effeci, and so must be deemed pre- empted. See San Diego Building Trades Council v. Garmon, 359 U.S. 236, 247, 79 S.Ct. 773, 780, 3 L.Ed.2d. 775 (1959).3 In effect, defendant argues that it 3. The Garmon decision involved federal regulation which, unlike the FDA at the time of Michelle Graham’s injury, provided its own avenue for redress. This fact has caused at least one court to reject Garmon as authority that state tort remedies are “regula- tions”. See Palmer v. Liggett Group, Inc., 633 F.Supp. 1171, 1175 (D.Mass. 1986) (relied on Silkwood for proposition that compensa- tory awards have indirect and not regulatory-effect on defendant’s behavior; “a lawsuit as the instant designed to compensate a victim of defendant’s allegedly wrongful behavior, cannot be deemed a regulation . . .”). See also MacGillivray v. Lederle Laboratories, F.Supp. , No. 85-0422-JB, slip op. (D.N. Mex. Feb. 5, 1987) (the state tort law at issue here is remedial and compensatory in nature; its purpose is not regulatory and does not directly conflict with any aspect of th» federal regulatory scheme . . . Nor would a State law damage claim necessarily frustrate the federal objectives behind the federal laws at issue here. . . . A tort judgment against a drug manufacturer may in fact accelerate the development of better, safer products. . . . Imposing a burden on the sale in the form of potential liability for defective design is distinguishable from a 55a would be improper for a lay jury to decide issues delegated to the expertise of a federal agency, and that any recovery based on tort theories would be inconsis- tent with the experts’ previous informed decisions. This court recognizes that the FDA’s regulations of prescription drugs is indeed far-reaching, if not perva- sive. The DPT vaccine is a prescription biologic subject to the provisions of the FDCA and the PHSA and the regulations promulgated thereunder. The FDA regula- tions encompass the licensing, production, testing, dis- tribution, labeling, review and approval of all drugs and biologicals. See generally, 21 C.F.R. §§ 211, 310 et seq., 600 et seq. Each DPT manufacturer must be licensed, 21 C.F.R. § 601.1, and must submit detailed descrip- tions to the FDA which define the process used to manufacture the vaccine, 21 C.F.R. § 601.2. The FDA must then review and approve the manufacturing pro- cess. 21 C.F.R. § 601.25. The FDA also issues an “establishment license” by conducting inspections of the manufacturers’ facilities and prescribing certain personnel qualifications. 21 C.F.R. $§ 600.20, 211, subpart B. Specific tests are required for each batch of vaccine, the results of which must be submitted to the FDA for review. 21 C.F.R. §§ 610.1, 610.2. Further, the pertussis element of DPT can be produced only in conformity with 21 C.F.R. §§ 620.1-620.7. As to the “label” or “package insert”, the FDA requires that the following information must be provided for a pharma- ceutical product: (1) the composition of the product; (2) the product’s administration schedule; (3) when the product’s usage is indicated and contraindicated; and (4) the product’s potential adverse reactions which have been associated with the product’s use. 21 C.F.R. state seeking to exert actual control over the mode of manufacture or distribution of a specific product.”). This court need not reach the issue of whether tort remedies “regulate” however, as it finds no implied intent to preempt. 56a §§ 610.60-610.65. The language used is subject to FDA approval, 21 C.F.R. §§ 1, 201; 50 Fed.Reg. 51108 (1985), and, once approved, the language cannot be changed without FDA approval; C.F.R. § 601.12.4 Fur- ther, most states including Kansas, require a child to be vaccinated with DPT prior to entering public school. See K.S.A. 72-5209. [7,8] The Supreme Court has held that federal regulations have “no less preemptive effect than federai statutes.” Fidelity Federal Savings & Loan Assn. v. De la Cuesta, 458 U.S. 141, 153, 102 S.Ct. 3014, 3022, 73 L.Ed.2d 664 (1982). Thus, if the administrator promul- gates regulations intended to preempt state law, a court’s inquiry is limited and should “not disturb the agency’s accommodation ‘unless it appears from the statute or its legislative history that the accommodation is not one the Congress would have sanctioned.’” Patten v. Lederle Laboratories, 655 F.Supp. at 747 (quoting United States v. Shimer, 367 U.S. 374, 381-82, 81 S.Ct. 1554, 1559-60, 6 L.Ed.2d 908 (1961)) (emphasis added). It cannot be overemphasized that only Congress has the power to preempt state law. Rice, 331 U.S. at 230, 67 S.Ct. at 1152. “[T]he federal government does not always speak with one voice and it is the intent of Congress that determines the scope of the preempted field. In such situations, the pronouncements of Con- gress must control over contrary statements by admin- istrators.” Patte:7, 655 F.Supp. at 750. In order to find congressional intent to preempt state tort remedies, this court would have to conclude that the 4. The regulations as to labeling do not specify mandatory wording, but are limited to the subject matter required. In Muzatko v. International Playtex, Inc. ___ F.Supp. —___, No. 85-C-1540 (E.D.Wis. May 14, 1987), the court stated “[b]lecause tampon manufacturers are permitted discretion with respect to drafting their warnings, the court does not believe that the contents of the warnings constitute a ‘requirement’ as that term was intended by Congress to be preempted.” At 57a federal regulations were promulgated with the intent to exempt drug manufacturers from tort liability. This court cannot find that such an intent is implicit in the regulatory scheme governing the manufacture and dis- tribution of DPT. To the contrary, Congress has recently clarified its intent that regulations should mot preempt state tort remedies for victims of vaccine-related inju- ries. Such intent was manifested in the “National Child- hood Vaccine Injury Act”, which -will be more fully explained herein. Moreover, FDA regulations of pre- scription drugs are generally viewed as setting minimum standards, both as to design and warning. See, e.g., Brochu v. Ortho Pharmaceutical Corp., 642 F.2d 652 (1st Cir. 1981); Salmon v. Parke-Davis & Co., 520 F.2d 1359 (4th Cir. 1975); Griffin v. United States, 500 F.2d 1059 (3d Cir. 1974); Mac Gillivray v. Lederle Laborato- ries, 667 F.Supp. 743, 746 (D.N.Mex. 1987); Toner v. Lederle Laboratories, 112 Idaho 328, 732 P.2d 297, 311 n. 12 (1987) (“FDA certification represents only the FDA’s opinion, albeit an informed one, of the safety and efficacy of the drug. Regrettably, drugs occasionally prove not so safe as the FDA first believed.”); Wooderson v. Ortho Pharmaceutical Corp., 235 Kan. 387, 681 P.2d 1038, cert. denied, 469 U.S. 965, 105 S.Ct. 365, 83 L.Ed.2d 301 (1984); Feldman v. Lederle Laboratories, 97 N.J. 429, 479 A.2d 374 (1984); Barson v. E.R. Squibb & Sons, Inc., 682 P.2d 832, 836 (Utah 1984); Ferrigno v. Eli Lilly & Co., 175 N.J.Super. 551, 420 A.2d 1305 (1980); Bristol-Myers v. Gonzales, 548 S.W.2d 416 (Tex.Civ. App.1976); McEwen v. Ortho Pharmaceutical Corp., 270 Or. 375, 528 P.2d 522 (1974); Stevens v. Parke-Davis & Co., 9 Cal.3d 51, 107 Cal.Rptr. 45, 53, 507 P.2d 653, 661 (1973). {9, 10] FDA certification is evidence, but not con- clusive evidence, of the drug manufacturer’s reasonable- ness; the trier of fact may assign FDA approval the weight it deserves. See O’Gilvie v. International Playtex, Inc., 821 F.2d 1438 (10th Cir. 1987) (in affirming a jury 58a instruction from this court that FDA standards regard- ing tampons’ Toxic Shock Syndrome warnings are “mi- nimal”, the court stated, “{c]ompliance [with FDA stan- dards] is not dispositive under Kansas law if the plaintiff shows that a reasonable manufacturer would have done more.” Thus, before a court can conclude that federal regulations—which traditionally set minimum stan- dards—have preempted the ability of states to protect their citizens through the judicial process, “courts should wait for a clear statement of congressional intent to work such an alteration.” Ferebee v. Chevron Chemical Co., 736 F.2d 1529, 1543 (D.C.Cir.), cert. denied, 469 U.S. 1062, 105 S.Ct. 545, 83 L.Ed.2d 432 (1984). [11] As previously stated, Congress has recently clarified that by promulgating regulations regarding vaccines, state tort remedies were not intended to be preempted. On November 14, 1986, Congress enacted the National Childhood Vaccine Injury Act (NCVIA) which added a new title to the Public Health Service Act of November 14, 1986, Pub.L. No. 99-660, 100 Stat. 3743. The NCVIA establishes a program for vaccine research, requires—for the first time—the reporting to federal officials of injuries resulting from routine child- hood vaccines, and sets up a program to compensate persons who sustain vaccine-related injuries or death. The NCVIA is intended to achieve optimal prevention of infectious diseases through immunization, while also achieving optimal prevention against adverse reactions to vaccine. Thus, the NCVIA is premised on Congress’ recognition of the “potential hazards of . . . vaccines and ... the serious— and sometimes deadly — consequences they can have. This is particularly true with regard to the pertussis vaccine which is most commonly administered as part of a series of immunizations known as DPT... .” H.Rep. No. 908, 99th Cong., 2d Sess., pt. 1 at 6 (1986), reprinted in 1986 U.S. Code Cong. & Admin. News 6287, 6344, 6347. 59a The legislative history clearly reveals that Congress began with the assumption that, in the absence of the NCVIA, state tort law has— and would continue—to apply: [Fjor the relatively few who are injured by vac- cines—through no fault of their own—the opportu- nities for redress and restitution are limited, time- consuming, expensive, and often unanswered. Currently, vaccine-injured persons can _ seek recovery for their damages only through the civil tort system or through a settlement arrangement with the vaccine manufacturer. Over time, neither approach has proven satisfactory. Lawsuits and set- tlement negotiations can take months and even years to complete. Transaction costs — including at- torneys’ fees and Court payments —are high. And in the end, no recovery may be available. Yet futures have been destroyed and mounting expenses must be met. — This approach has also been ineffective for the manufacturers of childhood vaccines. This has be- come especially true in more recent years as the number of lawsuits — particularly those concerning the DPT vaccine —has increased. Id. (emphasis added.) Thus, the House Committee acknowledged that damages may be recovered in a judicial setting notwithstanding the FDA’s exclusive regulatory authority over drug design, testing and label- ing. In fact, one of the main purposes of the NCVIA was to remedy the shortcomings of the traditional tort rem- edies. Under the new act, vaccine injury victims are divided into three groups: (1) those injured by a vaccine administered more than eight years before the enact- ment; (2) those injured by a vaccine administered less than eight years before the enactment; and (3) those 60a injured by a vaccine administered after the Act’s enact- ment. The first group is not eligible under the NCVIA, but the Act makes “no changes from current law in such persons’ legal rights or remedies.” Jd., U.S. Code Cong. & Admin. News at 6354. The second group is eligible for compensation, but may instead choose to pursue a civil tort action. /d., 1986 U.S. Code Cong. & Admin. News at 6355. The third group must complete the Act’s compen- sation proceeding and reject its judgment before pursu- ing a civil action; however, a civil action is not fore- closed. See Patten v. Lederle, 655 F.Supp. at 749. The NCVIA further evinces a congressional intent that civil tort actions were—and are—permissible de- spite compliance with the FDA regulations. (The defen- dant herein has argued that tort remedies may be pursued against a drug manufacturer only when there is evidence that regulations were violated.) Under the new act, there is a presumption that the vaccine contained proper direction and warning if the manufacturer com- plied with the applicable regulations. However, a plain- tiff may overcome the presumption by clear and con- vincing evidence that the manufacturer failed to use due care despite its compliance. Patten, 655 F.Supp. at 749. The Patten court concluded that because “the act was intended to increase the barriers to recovery of damages, it is fair to assume that Congress believed that the presumption it created did not exist under pre-Act law.” 655 F.Supp. at 749. In this regard, it was stated in the legislative history “the establishment of these standards are the only new requirements that affect State law regarding actions for vaccine-related injuries or death; all other aspects of State law remain unchanged.” 1986 U.S. Code Cong. & Admin. News at 6366. In sum, in enacting the NCVIA Congress clearly evidenced a willingness to allow state tort remedies for vaccine-related injuries, despite broad federal regula- tion, and despite the manufacturers’ compliance there- with. 6la The defendant argues that the enactment of the NCVIA is just another indication of congressional intent to control every aspect of prescription biologics: “The national interest in regulating the production of these vital medicines is so complete that Congress recently passed a Bill which bars civil actions based on injuries allegedly associated with federally regulated and state mandated vaccines. . . .” (Def.’s Memo. in Support of Motion for Summ. Judg. at 17.) In light of this court’s previous discussion of the NCVIA, it is sufficient to state simply that defendant’s argument is untenable. Defendant also relies on the Hurley decision, previ- ously cited, wherein the Eastern District Court of Texas found an implied congressional intent to preempt state tort actions. Hurley also involved the DPT vaccine. Defendant urges this court to find, as did the Hurley court, that: (1) the comprehensive nature of the FDA regulations evidences preemptive intent; (2) the nature of the DPT design and labeling relegates exclusive federal regulation in order to achieve uniformity vital to federal and national interests; and (3) state regulation (in the form of state tort remedies) would seriously and irreconcilably conflict with the federal statutory and regulatory scheme. The court finds the Hurley decision unpersuasive for two reasons. First, and primarily, the Texas court did not refer to the NCVIA, and thus did not address or discuss Congress’ clear statements found in the legisla- tive history of that Act. Second, this court cannot agree that state tort remedies “conflict with” the regulatory scheme. While the Hurley court found that “a state common law determination that DPT design and man- ufacture is defective will seriously and irreconcilably conflict with the federal regulatory scheme and the national policies of immunization, adequate protection and supply of DPT” and “in effect will chill the efforts of the federal government to ensure that all U.S. children 62a are immunized and frustrate Congress’ intent in foster- ing such programs,” 651 F.Supp. at 1006, this court believes to the contrary that by allowing a tort action such as this to proceed the national goal of optimum vaccine safety is actually enhanced. While Congress intends vaccines to be at least as uniformly safe as the FDA regulations require, there has never been a con- gressional intent that innocent victims of adverse reac- tions should be precluded from being compensated or from demonstrating that the vaccines could be even safer thereby encouraging additional efforts on the part: of the vaccine manufacturers.> Uniformity is a goal to be achieved in the interest of more fully protecting citizens from unsafe products—it is mot to be achieved by sacrificing public health. However, the Hurley court held that uniformity was the ultimate goal in any case, stating, “[tlhis decision is not to be construed to mean necessarily that defendants’ DPT vaccine is not defec- tive in fact, or that defendants’ actual method of produc- tion is free from scrutiny. The court’s holding merely finds that federal law as to defendants’ design and labeling of DPT preempts plaintiffs’ state tort claims in this respect.” Such a holding is, in effect, an abrogation of traditional tort law. In addition to Hurley, defendant cites only two other cases where courts have found federal preemption of DPT vaccine victims’ tort claims. See Abbot v. American Cyanamid, No. 86-857-A (E.D.Va. Mar. 9, 1987); and Morris v. Parke-Davis & Co., No. 82-5296-RJK (C.D.Cal. Sept. 19, 1985) [Available on WESTLAW, DCT data-base]. However, the Morvis court has since withdrawn its finding of preemption, and entered a new order finding no preemption. Morris v. Parke-Davis & Co., 667 F.Supp. 1332 (C.D.Cal.1987). The majority of 5. The right to bring such lawsuits takes on added significance in view of the fact that most states, including Kansas and Missouri, require children to be immunized prior to attending public schools. The states have a great interest in compensating children who are victims of the vaccines and encouraging drug manufacturers to provide the safest possible vaccines. 63a federal courts which have considered this issue have found there is no implied preemption of state tort remedies. See Patten, 655 F.Supp. 745 (thoroughly discusses the NCVIA and finds it evidences congres- sional intent mot to preempt); Smith v. Wyeth Labora- tories, No. 84-2002 (S.D.W.Va. Aug. 21, 1986); Jeski v. Connaught Laboratories, No. A-84-CA-395, (W.D.Tex. Dec. 18, 1986); Milam v. American Cyanamid, No. 4-85-92-K (N.D.Tex. Oct. 15, 1986). For the reasons stated, this court concludes that plaintiffs’ claims are not preempted by federal law. II. The Application of Kansas Law Defendant argues that under Kansas law as stated in Johnson v. American Cyanamid, 239 Kan. 279, 718 P.2d 1318 (19886), it is entitled to summary judgment as to each of plaintiffs’ claims. Defendant argues that in cases involving prescription biologics, which by their nature are “unavoidably unsafe,” the public policy of Kansas, as set forth in Johnson, requires that such products be immune from challenge in the courts for defects in design. Defendant further argues that, pursu- ant to Johnson, this court must find the warning ade- quate as a matter of law. In Johnson, the plaintiff contracted polio after his young daughter received her polio vaccine. Although the manufacturer, defendant Lederle Laboratories, knew such a consequence was possible, the plaintiff was never warned of this possibility. The doctor, who was also a named defendant at the trial level, had been advised by Lederle as follows: Paralytic disease following the ingestion of live polio- virus vaccines has been reported ... in some in- stances, in persons who were in close contact with subjects who had been given live oral polio virus vaccine. Fortunately, such occurrences are rare... . 64a The estimated risk of vaccine-induced paralytic disease occurring in vaccinees or those in close contact with vaccinees is extremely low. A total of approximately 30 of such cases were reported for the 8 year period covering 1963 to 1970, during which time 147,000,000 doses of the vaccine were distrib- uted nationally. 239 Kan. at 288, 718 P.2d 1318. The plaintiff brought an action in state court for design defect and failure to warn. The jury found no liability on the part of the plaintiff or the defendant doctor. The jury found defendant Lederle liable on all claims, awarding $2 million in actual damages and $8 million in punitives. On appeal, the Kansas Supreme Court, in a 4-3 decision, reversed the verdict in its entirety, finding no liability on the part of Lederle. The court first discussed the history of the polio vaccine in some detail. As noted by the court, there are only two types of polio vaccines in existence — the Sabin vaccine and the Salk vaccine. The Sabin vaccine —which uses a live virus—was developed later than the “killed” Salk vaccine, and is the only type used in this country today. The court noted that the Salk vaccine is somewhat less efficacious than the Sabin vaccine, and that “[v]irtually all of the Western world utilizes the Sabin vaccine over the Salk vaccine in its public health programs.” 239 Kan. at 283, 718 P.2d 1318. Nevertheless, the plaintiff had contended that defendant Lederle was strictly liable for design defect by virtue of using the Sabin-type vaccine rather than the Salk-type vaccine. In finding the defendant free from strict liability on the design defect claim, the Kansas court adopted com- ment k to Section 402A of the Restatement (Second) of Torts. Comment k provides: k. Unavoidably unsafe products. There are some products which, in the present state of human ——— ee 65a knowledge, are quite incapable of being made safe for their intended and ordinary use. These are - especially common in the field of drugs. An out- standing example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidably high degree of risk which they involve. Such a product, properly prepared, and accompa- nied by proper directions and warning, is not defec- tive, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of the lack of time and opportunity for sufficient med- ical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recog- nizable risk. The seller of such products, again the qualification that they are properly prepared and marketed, and proper warning is given [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385020_2841%3A2. Public record. Not legal advice.