Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca10-88-02302/USCOURTS-ca10-88-02302-1/pdf.json

Parties Involved:
Charles Graham
Appellee
Michelle Graham
Appellee
Tammy Graham
Appellee
Wyeth Laboratories
Appellant

Document Text:

PUBLISH 

FILED 

U-<1ited States Court of Appeals 

·remh Circuit 

JUN 2 5 1990 

ROBERT L. f!OECKER 

Clerk 

UNITED STATES COURT OF APPEALS 

FOR THE TENTH CIRCUIT 

MICHELLE GRAHAM, an infant under the) 

age of eighteen who sues by her ) 

parents, guardians, and next friends,) 

Charles Graham and Tammy Graham, ) 

) 

Plaintiffs-Appellees, ) 

vs. 

WYETH LABORATORIES, DIVISION OF 

AMERICAN HOME PRODUCTS CORPORATION, 

) 

) 

) 

) 

) 

) 

Defendant-Appellant. ) 

No. 88-1337 

No. 88-2302 

No. 89-3066 

No. 89-3121 

APPEAL FROM THE UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF KANSAS, Case No. 85-1481 

Albert J. Knopp, of Baker & Hostetler of Cleveland, Ohio, Wayne 

c. Dabb, Jr., Mary M. Bittence, and J. Jeffrey Zimmerman, 

Attorneys for Appellant. 

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 Appellee. 

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Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 1 
('. 

Ted M. Warshafsky of Warshafsky, Rotter, Tarnoff, Gesler, 

Reinhardt & Block of Milwaukee, Wisconsin, Attorneys for 

Appellee. 

Before SEYMOUR, Circuit Judge, MOORE, Circuit Judge, and GARTH, 

Circuit Judge.* 

Garth, Circuit Judge: 

This appeal arises as a result of a $15,000,000 verdict 

against Wyeth Laboratories (Wyeth), the manufacturer of a DTP 

vaccine. It presents us with a number of evidentiary and legal 

questions. The most significant of these are: (1) should 

judgment NOV have been granted to Wyeth? (2) Are state tort 

awards for the improper manufacture of vaccines preempted by 

federal regulation? (3) Does Kansas allow for tort awards based 

upon strict liability or the negligent manufacture of an 

"inherently unsafe" vaccine? (4) Were a number of Wyeth's experts 

improperly excluded from testifying at the trial? (5) What is the 

correct procedure for t~e use, redaction and admission of 

"learned treatises" as evidence under Fed. R. Ev. 803(18)? And 

(6) was Wyeth entitled to post-judgment relief when one of 

Graham's experts recanted much of his testimony in subsequent 

*· The Honorable Leonard I. Garth, Senior United States Court of 

Appeals Judge for the Third Circuit, sitting by designation. 

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Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 2 
court proceedings? Other less significant allegations of error 

have also been raised, and will be addressed in the course of 

this opinion. 1 

Our standard of review in reviewing a denial of motion 

for judgment NOV has been prescribed as follows: 

The standard for determining whether to 

grant a motion for a Judgment N.O.V., as for 

a directed verdict, is not whether there is 

literally no evidence to support the party 

opposing the motion, but whether there is 

evidence upon which the jury could properly 

find a verdict for that party. The court may 

not weigh the evidence, pass on the 

credibility of witnesses, or substitute its 

judgment for that of the jury. Rather, it 

must view the evidence most favorably to the 

party against whom the motion is made and 

give that party the benefit of all reasonable 

inferences from the evidence. On appeal, we 

employ the same standard of review as does 

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 

1. One additional issue raised was whether one of Graham's 

counsel should be disqualified based on a conflict of interest. 

That issue will not be addressed here. At oral argument, we 

ruled that the conflict precluded representation of Graham by the 

firm of Michaud & Hutton of Wichita, Kansas. We announced that 

our ruling would be the subject of an opinion to be filed. Oral 

argument was then presented by Graham's co-counsel, attorney 

Warshafsky, of Warshafsky, Rotter, Tarnoff, Gesler, Reinhardt & 

Bloch, of Milwaukee, Wisconsin. 

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Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 3 
discretion"; see In re International Coating 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 deference 

but ultimately review de nova.") 

We will affirm the denial of judgment NOV, reverse the 

denial of the motion for a new trial, and remand to the district 

court for a new trial on all issues. Additionally, 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 

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Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 4 
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 infants 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 pertussis whole cell 

vaccine. It is the pertussis component of the vaccine that is 

the subject of this litigation and which allegedly caused the 

severe reaction suffered by Graham. While Graham contends that 

the pertussis component of this vaccine could have been safer, 

and 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. 2 

The DTP vaccine containing the "whole cell" pertussis 

vaccine was licensed by the FDA in 1949. Due to the widespread 

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 Hinman 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) . 

5 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 5 
use of the vaccine in this country, pertussis has virtually been 

eradicated. However, because of the persistent nature of the 

pertussis bacterium, there is a continuing and substantial risk 

of epidemics if the use of the vaccine was to be discontinued 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. 3 

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, excrete 

soluble toxins insolable [sic] by medical 

research. The toxin is inactivated with 

formaldehyde and transformed 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 

recipient, even though it has lost its own 

poisonous qualities. 

This is not the case, however, with [the 

pertussis component]. [The pertussis 

vaccine] is a so-called whole cell vaccine 

because it contains whole killed pertussis 

organisms. The whole organism is used 

because the pertussis organism contains 

fifteen or sixteen different antigens, and 

medical science has yet to isolate the one 

3. For an extensive comparison of the various countries' 

practices, and the epidemiological results, see Loveday v. 

Renton, (Queens Bench, England) March 31, 1988 (available on 

Lexis, No. 1982 L 1812). 

6 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 6 
that stimulates protection against the 

disease. 

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 or severe. Mild reactions may include swelling, 

fever, irritability, and crying spells. Severe reactions can 

perhaps include encephalopathy, 4 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 indicated 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 business and sold its Tri-Solgen vaccine to Wyeth. 

According to Graham, 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. 

4. "Any disease of the brain", Stedman's Medical dictionary, 5th 

ed. ( 1982) • 

7 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 7 
Wyeth has made no further attempts to license a fractionated cell 

5 vaccine and no such vaccine is licensed in this country today. 

Moreover, pharmaceutical companies are prohibited from marketing 

a product absent a license -- to do so would constitute a 

criminal offense; (21 u.s.c. §§ 33l(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 vaccine 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 irreversible neurological condition known as encephalopathy 

which caused retardation and prevents Graham from ever leading a 

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 

acellular vaccine as well; see Loveday. supra note 2, at 43-47. 

8 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 8 
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 

6 injury because, vaccines, under applicable Kansas law, are to 

be treated as inherently dangerous products and thus the vaccine 

manufacturers are deemed immune from liability. 7 

8 The district court determined according to Kansas law 

that Graham could proceed on its negligence theories. In the 

district court's summary judgment opinion, however, it held for 

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, 1484-86 

(D. Kansas 1987) for the district court's analysis of all the 

pre-trial issues. 

9 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 9 
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 comment (k) defense. The court 

therefore permitted Graham 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 compensatory 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 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 

denials was taken as well. 

II. 

10 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 10 
We turn first to Wyeth's contention that the district 

court erred in denying Wyeth's motion 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 

cell 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 experienced 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 

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Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 11 
vaccination (Tr. 1587-1588, 1619); that endotoxin can injure 

blood vessels from the inside out (Dr. Zahalsky) (Tr. 302-307, 

313-320); and that endotoxins can cause stroke (Dr. Guggenheim) 

(Tr. 3801-3803, 3870-3877). 

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. Yazzie 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 properly, the evidence would 

result in a finding of no causal connection between the DTP 

vaccine and Graham'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 Graham 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 causation. 

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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 Wyeth's preemption claim, 9 

and its determination that Wyeth's defense of adequate warning 

was a jury function. See Graham v. Wyeth Laboratories, 666 F. 

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 (5th 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). Weragree 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 standards for licensing. 

13 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 13 
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 motions, 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. 

With respect to Wyeth's §402A Comment (k) defense the 

Kansas Supreme Court has recently addressed this issue in Johnson 

v. American Cyanamid, 718 P.2d 1318 (Kan. 1986) and, as this 

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Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 14 
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 underlying 

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 eliminate, the danger of their products. The comment (k) 

exemption is granted in the case of "inherently dangerous" 

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 presented as to whether 

15 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 15 
the "unsafety11 of the vaccine produced by Wyeth was 

"unavoidable." 

The district court read Johnson to require a 

determination 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 

' d t t A 1 ' J h t h ' . t 10 JU gmen sage. pp ying o nson o sue a circums ance, th e 

10. Johnson v. American Cyanamid, 718 P.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 

determination. 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. 11 see Moe v. Avians Marcel DassaultBreguet 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 

(continued ... ) 

16 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 16 
district court then permitted Graham to proceed on a "design 

defect" theory, both as to negligence and strict liability, 

stating: 

[C]omment k's application does not 

shield the seller of a product from 

negligence claims. Such a result fits 

within the policy of comment k -- i.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 

manufacturer 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 

10. ( ... continued) 

prohibited by comment (k) from proceeding on a strict liability 

design defect theory. 

This is as well 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.) 

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Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 17 
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. 

In view of these rulings, and particularly its summary 

judgment determination, we construe the jury's response to the 

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Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 18 
"design defect" interrogatory as well as to the negligence 

charge11 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, 

, f 12 1n ra. 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 

reduction of endotoxin levels was technologically 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 

11. Special verdict form question 3 asked: 

3. In March of 1980, was defendant Wyeth 

negligent in connection with testing, 

designing, and/or warning in regard to its 

DTP whole cell vaccine, which was the legal 

cause of plaintiff's injuries? 

The jury answered "Yes." 

12. In that section we refer to Wyeth's newly discovered 

evidence of miscalculation made by Graham's experts as to 

endotoxin levels. 

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Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 19 
an opportunity to address itself to any such new instructions 

that will be given at a new trial. 

III. 

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. 

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, 13 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 

13. The deposition of Dr. Cibis took place the morning he 

testified. The district court judge attended parts of the 

deposition. 

20 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 20 
originally, and without the benefit of a CT scan, diagnosed 

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 

testifying, ruling that for any expert who testified as to 

causation the expert had to be knowledgeable about the workings, 

nature and medical literature concerning endotoxins. (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 relevant 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 reasonable; 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 at the 

time of the original examination) had to remove from the jury 

21 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 21 
significant evidence that Wyeth's vaccine was not responsible for 

h I d , t, 14 Gra ams con i ion. 

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 witness 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 

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. 

22 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 22 
within the knowledge of the average layman absent expert 

testimony. Thus the evidentiary issue presented to the district 

court concerned Dr. Cibis' qualifications as an expert to give 

testimony as to whether Graham suffered a stroke prior to her 

, , , 15 receiving DTP vaccine. 

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 physicians. Dr. 

Cibis, upon the recommendation of Dr. Hertenstein, Graham's 

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 

determine 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. 

23 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 23 
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 (congenital 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) . 

The minute the (expert] says: "I have no 

wherewithal in the field of neurology, I have 

no appreciation 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 vaccination -- testimony that if 

24 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 24 
believed by the jury would have resulted in a verdict that Wyeth 

was not liable. It deprived Wyeth of a primary defense that it 

was not liable, due to an intervening cause (i.e., that a prevaccination 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 experts 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 rights16 of the 

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 

proceeding which does not affect the 

substantial rights of the parties. 

(continued ... ) 

25 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 25 
defendant Wyeth, particularly when other expert testimony bearing 

on the same defense was also excluded. 

B. 

Dr. Breck.bill, another physician called by Wyeth, was a 

specialist in pediatric radiology. Dr. Breck.bill's credentials 

as a pediatric radiologist were detailed during his examination, 

and are extensive. On May 12, 1987, Graham underwent a CT head 

scan under the direction of Dr. Breck.bill. He determined that 

she had suffered 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 practitioners 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 

16. ( •.. continued) 

See,~, 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). 

26 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 26 
himself with the testimony 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 for 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 time. An extensive cross-examination 

occurred. On redirect examination, Wyeth inquired as to whether 

it was still Dr. Breckbill's opinion that Graham's stroke 

occurred before February 20, 1980 (the date of Dr. Cibis's 

examination). That question elicited an objection from Graham's 

counsel: 

The following colloquy took place: 

MR. WARSHAFSKY [Graham's attorney]: I object 

on the grounds that with the totality of the 

examination and now with what the Doctor had 

to examine and his background, I don't think 

the Doctor is qualified to give the opinion. 

THE COURT: Sustained. 

27 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 27 
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. 

(Tr. 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 it's raised, and now I rule 

on it. 

MR. HERRINGTON: I'd like to make a proffer, 

your Honor, outside the hearing of the jury. 

(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 

28 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 28 
right fixed17gaze 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. 

29 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 29 
certified pediatrician, reviewed Graham's medical history 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. 

Hertenstein's examination and 11 weeks old at the time of Dr. 

Cibis'J 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 excluded 

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 effect of the 

district court's ruling was to prevent the jury's consideration 

of Dr. Deitch's confirmation that Dr. Hertenstein might not have 

initially recognized the manifestations of a stroke even though 

30 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 30 
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 

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 disclosed to Dr. Cibis, he 

indicated that, given what he now perceived from the CT scan, he 

would now have diagnosed Graham as having suffered a stroke prior 

to his original examination. 

31 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 31 
Supporting Dr. Cibis' diagnoses was Dr. Brackbill, 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-

. t, . . 18 vaccina ion 1nJury. 

While we obviously cannot, and do not, find that 

Graham's DTP vaccination occurred after she had suffered 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' testimony is considered alone, or is 

considered in conjunction with the exclusion of the testimony of 

Drs. Brackbill, and Deitch, we are satisfied that the district 

court prevented the jury from hearing the opinion of these 

experts on the cause of Graham's injury. Moreover, as we have 

earlier observed, an error of this magnitude inevitably had to 

prejudice Wyeth's defense, and cannot be deemed harmless. 

18. We do not elaborate on the district courts'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. 

32 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 32 
IV. 

Wyeth also argues that the district court abused its 

discretion when it admitted an American Medical Association 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 document was so 

fatal to Wyeth's case that Wyeth was obliged to move for a 

mis . t . 1 19 r1.a . 

The Report's first sentence stated its objective: 

In an effort to ensure an adequate and 

uninterrupted supply of vaccines for mandated 

pediatric immunization and to encourage the 

continued timely administration of these 

vaccines, the American 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 

19. The district court characterized the AMA Report as "the 

smoking gun we have been looking for ••. " (Tr. 1627) and denied 

Wyeth's motion. 

33 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 33 
only one remaining supplier of DTP -- a supplier who might be 

unable to obtain insurance renewal. 

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 

probabilities 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 vaccine)." 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 

34 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 34 
the margin, the one and one-half paragraphs of text redacted by 

the district court.~ 

Wyeth objected to the admission of the Report in its 

entirety, claiming that the Report was neither a scientific nor a 

20. The redacted material read as follows: 

In an effort to ensure an adequate and 

uninterrupted supply of vaccines for mandated 

pediatric immunization and to encourage the 

continued timely administration of these 

vaccines, 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 Association'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 seriously injured by mandated 

vaccines. There was considerable urgency 

since the number of national suppliers for 

one of these vaccines (diphtheria-tetanuspertussis, or DTP) decreased from three to 

one. There also was a reasonable possibility 

that the sole remaining supplier would be 

unable to obtain insurance renewal. 

The concern with DTP vaccine resides 

with its pertussis cell components, which 

occasionally induce severe neurological 

injury. In order to prepare an appropriate 

information base on potential pertussis 

vaccine injuries in the context of 

Congressional consideration of vaccine injury 

compensation legislation, •.. 

American Medical Association Ad Hoc Panel Report, "Pertussis 

Vaccine Injury," 254 JAMA 3083 (December 6, 1985). 

35 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 35 
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 exhibit, 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 

f F d R E 'd 803(18) •

21 

0 e . . Vl. • Wyeth also claimed that in order to 

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: 

* * * 

(18) Learned treatises. To the extent called to the 

attention of an expert witness upon cross-examination or relied 

upon by the expert witness in direct examination, statements 

contained in published treatises, periodicals, or pamphlets on a 

subject of history, medicine, or other science or art, 

(continued ... ) 

36 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 36 
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 publication. 

Significantly, Dr. Gilmartin did not testify that the Report 

it~elf was a reliable authority or that it constituted a learned 

treatise. Moreover, because the Report did not deal 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 obj~ction was to 

the sua sponte redaction of a portion of the Report which 

21. ( ... continued) 

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. 

37 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 37 
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 

foundation 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 district 

court's subsequent action in sua sponte redacting a significant 

portion of the Report stands on a different footing. After Wyeth 

had objected to the relevancy of the Report because the panel had 

not established 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 statement 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 

38 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 38 
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 distorted 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 awthing mentioned in the first 

paragraph. (Tr. 1629). 

* * * 

THE COURT: You can take out the first 

paragraph which gives rise to the reason it 

[the Report) was formulated, ostensibly, 

because they were about the formation of some 

kind of a compensation program. After the 

first paragraph, there isn't a thing in this 

paper you can't go into. (Tr. 1667). 

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. 

39 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 39 
* * * 

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. i631) the entire redacted 

Report was given to the jury for their study during 

deliberations. What the last provision in Fed. R. Evid. 803(18) 

seeks to preclude by prohibiting the receipt of the written 

exhibit into evidence is described in Weinstein's Evidence as: 

To insure that the jurors will not be unduly 

impressed 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 1803(18) [02]. 

Thus, as Wyeth contends in its brief on appeal -- a 

contention with which we agree: 

40 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 40 
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 Congressional 

consideration of vaccine injury compensation 

legislation. 

The redaction of such material made the 

redacted report prejudicially [sic] 

misleading. By excluding 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." 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. 

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 

(plaintiff's medical expert) over Wyeth's 

objection, which appeared to establish that 

the AMA had concluded that DTP causes 

encephalopathy, when there is no scientific 

evidence establishing such causation. 

(Wyeth br. at 88-1339, p. 51) (Internal citations omitted). 

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 

41 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 41 
in contravention of Fed. R. Evid. 803(18). We need not decide if 

this abuse 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 (Ors. 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. 

42 

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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. 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; In re International Coating 

Applicators, 647 F.2d 121, 124 (10th Cir. 1981). 23 

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 

(continued ... ) 

43 

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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 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. Zahalsky, both misstated24 in their testimony to the 

Graham jury, the results of Dr. Geier's experimenta~ion 

respecting the levels of endotoxin in Wyeth's DTP vaccine. This 

23. ( ... continued) 

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 reconsideration -- 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 

judgment 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. 

24. We assume that any error that occurred in Ors. Geier's and 

Zahalsky's testimony was due to unintentional mathematical 

miscalculation. 

44 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 44 
evidence was addressed to Wyeth's alternative defense: that DTP 

vaccine could not have caused Graham's stroke. Both of Wyeth's 

60(b) motions concerned 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 endotoxin. 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, including those allegedly suffered by Graham. 

Dr. Geier stated that the "[m]ore the endotoxin, the more severe 

[the] reaction" (Tr. 892). Specifically, Dr. Geier stated that I 

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 appeared that Dr. Geier had erred in 

his computation of the toxicity of 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: 

45 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 45 
(Tr. 468). 

Q: Your initial estimate of this Lederle 

[DTP vaccine] made by Wyeth was that it had 

240 micrograms per milliliter, and then on 

subsequent reflection 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. 

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 

testimony 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: 

25. In the cases of McLean v. Wyeth, 86-4077 (W.D. Ark. 1988), 

Cavallo v. Wyeth, Circuit Court, Milwaukee County, Milwaukee, 

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 Addendum of 

Exhibits, Volume I, 89-3066. 

46 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 46 
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 micrograms 

per mil[lilleter]. 

(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 Graham 

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 

47 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 47 
* * * 

(6) Any other reason justifying relief from 

the operation of the judgment. 

The district court denied Wyeth's motions for postjudgment 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 evidence. 

48 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 48 
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 {5th 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 evidence did not meet the test of 

materiality and that even with this new evidence, a new trial 

would probably not produce a different result. 

49 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 49 
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. 26 Nor did it find that this 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 assertions 

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 

27 of the results. 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 

26. See Rosebud Sioux Tribe v. A. & P. steel, Inc. 733 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 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. 

50 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 50 
Wyeth DTP vaccine (Geier 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 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 testified in support of her claim. 

51 

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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 Graham's claim -- the 

allegedly high endotoxin toxicity 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 

l l th • ht t h h d th ' 28 

eves, e case mig no ave even reac e e 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 c'omment (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 all but negligence claims. We hold that the 

district court's perception of this testimony as not being 

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. Connaught 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. 

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material was an improper exercise of the district court's 

discretion. Contrary 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. Mechanex, 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 determination 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 normally accorded to a trial judge on these matters. 

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,0 

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 conditions under which the experiment is made will so distort 

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 precept 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 unfairness 

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 

54 

Appellate Case: 88-2302 Document: 01019880111 Date Filed: 06/25/1990 Page: 54 
',_ 

"to prevent the judgment from becoming a vehicle of injustice," 

see United States v. Walus, 616 F.2d 283, 288 (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 "probabilities." The test is whether the 

new evidence introduced _would probably produce a new verdict. We 

are satisfied, after having examined in detail the arguments 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 discovered evidence were 

satisfied by Wyeth when it discovered 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 

judgment and by granting Wyeth a new trial. 29 Because it did 

not do so, we will reverse the orders of the district court 

29. Having determined that Wyeth has satisfied the requirements 

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). 

55 

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~ 

. \' 

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. 

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