Appendix — Wyeth-Ayerst Laboratories Division of American Home Products Corp. v. Graham

Supreme Court brief1990

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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

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APPENDIX A (court of appeals decision dated June

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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]

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

| | 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

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

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.

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

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).

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).

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)).

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.

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.

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.

) 11. Special verdict form question 3 asked:

16a

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.

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.

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.

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.

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.

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.”

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.

Whether or not the full Report was admissible in

evidence within the ambit of Fed. R. Evid. 803(18), the ~

f eiitniia

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.

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 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

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.

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

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

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 where the

situation calls for it, is not to be held to strict liability

for unfortunate consequences attending their use,

merely because he has undertaken to supply the

public with an apparently useful and desirable prod-

uct, attended with a known but apparently reason-

able risk.

The Kansas Supreme Court found that the Sabin-type

polio vaccine is “unavoidably unsafe” and entitled to

comment k immunity as a matter of law. The court

noted that “[t]he remote risk of contact polio is inherent

in the Sabin-type vaccine and cannot be eliminated,” but

66a

that it is an “apparently useful and desirable product

attended with a known but apparently reasonable risk.”

239 Kan. at 285-86, 718 P.2d 1318. The court observed

that “[t]he trial judge should have heard the evidence on

the issue of [comment k’s application] outside the pres-

ence of the jury and made the determination thereon.”

239 Kan. at 286, 718 P.2d 1318.

Having concluded that as a matter of law the

defendant could not be held strictly liable for a defect in

design, the court reasoned “this leaves only the possible

liability of the adequacy of the warning provided by the

manufacturer.” Jd. In this regard, the court first ob-

served the drug manufacturer’s duty is “to adequately

warn the physician of a known risk.” Id. (citing Wooder-

son v. Ortho Pharmaceutical Corp., 235 Kan. 387, 681

P.2d 1038. Because the test used in determining warn-

ing issues is “reasonableness”, the court reasoned that

the plaintiff must show negligence on the part of the

manufacturer. The court quoted at length from Kear! v.

Lederle Laboratories, 172 Cal.App.3d 812, 218 Cal.Rptr.

453 (1985), in support of this proposition. In Kearl, the

court found that “[j]ust as liability for failure to warn of

product risk is based on negligence, the adequacy of a

warning is also judged under a_ reasonableness

standard... .”

The Johnson court began its analysis of the warning

by noting that the plaintiffs doctor had been warned of

the precise “adverse reaction” from which plaintiff suf-

fered: “This, then, is not a failure to warn question, but

rather a question of the adequacy of the warning.” 239

Kan. at 288, 718 P.2d 1318. The court then analyzed

and rejected each of plaintiff's arguments for finding the

warning inadequate. In effect, the court reweighed the

evidence presented at trial. The court found that nothing

in the warning was misstated (“plaintiff did not chal-

lenge [the risk figures given] directly”), or omitted (“the

warning clearly states the scientific fact that some

persons in close contact with vaccines may develop a

67a

paralytic disease from such contact... . It hardly takes a

medical degree to know that a person immune to the

virus cannot acquire the disease.”). Id. at 288, 289, 718

P.2d 1318. An additional factor which the court noted in

finding the warning adequate was that “[t]he warning

given ... had been approved by the Federal Drug

Administration and was consistent with an overwhelm-

ing bulk of the current medical opinion.” Jd. at 289, 718

P.2d 1318. The court concluded that the warning was

adequate as a matter of law, and that the trial court erred

by failing to direct a verdict in defendant’s behalf.

The dissent took issue with the majority’s finding

that the warning was adequate as a matter of law,

challenging the court’s right to reweigh evidence or pass

on the credibility of witnesses. 239 Kan. at 291-303, 718

P.2d 1318 (Prager, J., dissenting).

A. Design Defect

The defendant argues that in Johnson the Kansas

Supreme Court held that amy prescription biological

vaccine is “unavoidably unsafe” as matter of law, and

thus this court must find Wyeth free from liability for

design defect. In this court’s view, however, the Johnson

decision is not — nor is it intended to be —so far reaching.

In Johnson, the Kansas Supreme Court adopted

comment k to Restatement (Second) of Torts §402A.

Section 402A imposes strict liability on a product man-

ufacturer “who sells any product in a defective condition

unreasonably dangerous to the user... .” Strict liability

differs from negligence in that it obviates the need to

show the manufacturer acted unreasonably, or, in other

words, that he knew or should have known of the risk

posed by the product. Strict liability in a products case

focuses only on whether the product was defective,

thereby imputing knowledge of the defect to the manu-

facturer.

68a

[12] Comment k recognizes that some products,

such as certain drugs, are so beneficial and necessary

that the manufacturer of these products should not, in

all instances, be held strictly liable for unforeseeable

harm. “Society wishes to encourage the manufacture of

ethical drugs, and the research and development of new

drugs. The imposition of strict liability would stifle these

goals.” Schwartz, Unavoidably Unsafe Products: Clari-

fying the Meaning and Policy Behind Comment K, 42

Wash. & Lee L.Rev. 1139, 1141 (1985). Under com-

ment k, if the drug is shown to be “unavoidably unsafe”

(i.e., highly beneficial, yet inherently and unavoidably

risky), the manufacturer cannot be held strictly liable for

design defect unless the vaccine is improperly manufac-

tured or contains an inadequate warning. Neither com-

ment k nor Johnson stands for the rule that all prescrip-

tion drugs are unavoidably unsafe as a matter of law. See

Toner v. Lederle Laboratories, 732 P.2d 297, 308 (“We

do not believe comment k was intended to provide nor

should it provide all ethical drugs with blanket immunity

from design defect claims.... [N]ot all drugs are so

perfectly designed that they cannot be made more pure

or more safe, or that there are not safer, suitable alter-

natives.”); contra Morris v. Parke-Davis & Co., No.

82-5296 (C.D.Calif. Sept. 19, 1985) [Available on

WESTLAW, DCT database]. Johnson addressed oniy

the Sabin-type polio vaccine, finding that particular

vaccine to be unavoidably unsafe. In doing so, the court

considered that while there was evidence of a somewhat

safer alternative (the Salk-type vaccine), this alternative

was not as efficacious. The court clearly recognized that

whether or not the vaccine was “unavoidably unsafe”

was an issue needing resolution (“[t]he trial judge

should have heard the evidence on this issue outside the

presence of the jury and made the determination the-

reon”), and not simply a tautology. Thus, the court did

not find that drugs by definition are unavoidably unsafe.

—— Te

69a

The Kear decision, cited with approval in Johnson,

suggests the following approach in determining whether

a given drug is unavoidably unsafe:

In our view, the decision as to whether a drug,

vaccine, or any other product triggers unavoidably

dangerous product exemption from strict liability

design defect analysis, poses a mixed question of

law and fact and can be made only after evidence is

first taken, out of the jury’s presence, on the rele-

vant factors to be considered. [Citations omitted.] A

trial court should take evidence as to: (1) whether,

when distributed, [footnote omitted] the product

was intended to confer an exceptionally important

benefit that made its availability highly desirable;

(2) whether the then-existing risk posed by the

product both was “substantial” and “unavoidable”;

and (3) whether the interest in availability (again

measured as of the time of distribution) outweighs

the interest in promoting enhanced accountability

through strict liability design defect review. In de-

termining the first aspect of the second factor (i.e.,

whether the risk posed was substantial”) a court

should consider whether, at the time of distribution,

the risk posed permanent or long-term disability

(e.g., loss of body functions, organs, or death) as

opposed to mere temporary or insignificant inconve-

nience (e.g., skin rash, minor allergic reaction, etc.).

In determining the second aspect of the second

factor (i.e., whether the risk posed was “unavoida-

ble”) a court should consider (i) whether the prod-

uct was designed to minimize —to the extent scien-

tifically knowable at the time it was distributed — the

risk inherent in the product, and (ii) the availabil-

ity —again, at the time of distribution —of any alter-

native product that would have as effectively accom-

plished the full intended purpose of the subject

product.

70a

218 Cal.Rptr. 453, 464. See also, Toner v. Lederie

Laboratories, 732 P.2d 297, 305-09 (“Clearly, the com-

ment contemplates a weighing of the benefit of the

product against its risk . . . the weighing must be done at

the time the product is distributed to the plaintiff. ...

[T]he design must be as safe as the best available testing

and research permits. ... Knowledge of the product’s

risks based on reliable and obtainable information is

imputed to the seller.”).

[13,14] This court is convinced that such factors

must be considered before a court can determine

whether a given drug falls within comment k’s protec-

tion. In this case, the issue cannot be resolved as a

matter of law at the summary judgment stage. Although

defendant contends the whole cell DPT vaccine posed

an unavoidable risk of severe injury, this is hotly con-

tested by plaintiffs. Plaintiffs have submitted the affida-

vit of one of their experts, a Dr. Zahalsky, who will testify

that Wyeth had the capability to produce a safer vaccine.

Plaintiffs claim that Wyeth’s own records substantiate

this contention. Accordingly, there is an issue of mate-

rial fact as to whether the “unsafety” of the DPT vaccine

manufactured by Wyeth was unavoidable.

{15] Even if this court had concluded—or were

eventually to conclude — that the vaccine is “unavoidably

unsafe,” the plaintiffs could still pursue their design

defect claim under a negligence theory. Syllabus 7 1 to

Johnson states:

Although in standard products liability litigation

plaintiff may utilize a strict liability design defect

theory, such strict liability cause of action must be

prohibited for public policy reasons where the prod-

uct complained of is an unavoidably unsafe product

within the purview of comment k to § 402A of

Restatement (Second) of Torts (1963). In such

special circumstances, plaintiff may proceed on a

design defect theory only on the basis of negligence.

ehttiht ite L

7Tla

It is noteworthy that in the body of the opinion, negligent

design defect is never mentioned or discussed, although

this court understands it was a theory pursued at trial

level. While the court is aware that Kansas is not a

“syllabus state”) i.e., the body of the case, not the

syllabus, controls in case of conflict), the court is also

aware that the Kansas Supreme Court justice who

authors an opinion also writes its syllabus. Thus, while

negligent design defect was not directly addressed in

Johnson, there is at least limited authority — contained in

the syllabus—that finding a drug to be “unavoidably

unsafe” does not preclude the jury from considering the

manufacturer’s reasonableness. Quite clearly, by com-

ment k’s own terms, the comment bars only strict liabilty

claims—i.e., that the product was “defective” and “un-

reasonably dangerous.” Specifically, the comment states

that the manufacturer of an “unavoidably unsafe” prod-

uct is not to be held to strict liability. .. .” (Emphasis

added.) The cases which have addressed the issue are in

agreement that even though a product is deemed “un-

avoidably unsafe,” the plaintiff may proceed under a

negligence cause of action. Toner, 732 P.2d at 310,°6

Kearl, 218 Cal.Rptr. at 465; Feldman v. Lederle Labora-

tories, 479 A.2d 374, 381; Stone v. Smith, Kline &

French Laboratories, 447 So.2d 1301, 1303 (Ala.1984).

Accordingly, this court must conclude that comment 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

6. The Idaho Supreme Court heard the Toner case on ques-

tions certified from the Ninth Circuit Court of Appeals, including:

Under Idaho law, do the principles set forth in Restatement

(Second) of Torts § 402A comment k, apply to strict liability and

negligence claims, and in particular to the claims in this suit? 779

F.2d 1433. Thus, the Idaho court’s finding that comment k does not

preclude the assertion of a claim for negligent design defect is-in

effect-the law of the Ninth Circuit.

72a

dangerous, and requiring the plaintiff to prove negli-

gence, 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. Toner, 782 P.2d at 310; Feldman, 479 A.2d at

385-86. Thus, in a case such as this where both theories

(strict liability and negligence) are asserted, the evi-

dence 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.

B. Adequacy of Warning

[16] Even if the evidence in this case shows that

Wyeth used the best available vaccine and the product

was “unavoidably unsafe,” it will not be entitled to

comment k immunity if it did not provide an adequate

warning.’ Johnson, 239 Kan. at 286, 718 P.2d 1318; see

also Brochu v. Ortho Pharmaceutical Corp., 642 F.2d

652, 657 (ist Cir.1981); Reyes v. Wyeth Laboratories,

498 F.2d 1264, 1276 (Sth Cir.), cert. denied, 419 U.S.

1096, 95 S.Ct. 687, 42 L.Ed.2d 688 (1974); Davis v.

Wyeth Laboratories, Inc., 399 F.2d 121, 128-29 (9th

Cir.1968); Yarrow v. Sterling Drug, Inc., 263 F.Supp.

159, 163 (D.S.D.1967), affd. 408 F.2d 978 (8th

Cir.1969); Toner v. Lederle, 732 P.2d at 305; Kearl, 218

Cal.Rptr. 465. The comment thus recognizes that while

some products are inherently dangerous, the user has a

right to know of these inherent risks so that he can make

an informed decision; in the absence of such warning,

the product is deemed to be defective.

7. Because Mrs. Graham was warned that brain damage could

result from the vaccine, the issue before the court is not failure to

warn, but rather, adequacy of the warning. See Johnson, 239 Kan.

at 288, 718 P.2d 1318.

| ;

Weteess ,

73a

An adequate warning is one that is reasonable under

the circumstances. Wooderson v. Ortho Pharmaceutical

Corp., 235 Kan. 387, 400, 681 P.2d 1038. A warning

may be inadequate in factual content, the expression of

facts, or in the method by which it is conveyed. Jd. In the

case of mass innoculations, vaccinees must be

informed,® in clear and simple terms, by the manufac-

turer of: (1) the reasonably foreseeable risk inherent in

the product; (2) reasonable available alternative prod-

ucts (if any) and the reasonably foreseeable risks posed

by such alternatives; and, in appropriate cases, (3) the

reasonably foreseeable results of remaining untreated.

See Johnston, 239 Kan. at 292, 718 P.2d 1318 (Prager,

J., dissenting); Unthank v. United States, 732 F.2d

1517, 1521 (10th Cir.1984). The manufacturer’s duty is

to warn of all potential dangers which it knew, or in the

exercise of reasonable care should have known, to exist.

This duty is a continuous one, requiring the manufac-

turer to keep abreast of the current state of knowledge.

Wooderson, 235 Kan. at 405, 681 P.2d 1038.

[17] To impose liability on the defendant for inade-

quate warning, the plaintiff must show negligence on the

part of the manufacturer. Johnson, 239 Kan. at 286, 718

P.2d 1318. Accordingly, plaintiffs are precluded from

8. Generally, in the case of prescription drugs, the manufac-

turer’s duty is to adequately warn the physician of known risks.

Johnson, 239 Kan. at 286. This is known as the “learned interme-

diary” rule. However, there is authority that when a vaccine is

dispensed at a clinic without close supervision by a physician, the

manufacturer’s duty to warn extends to the vaccinee. In Johrson,

the vaccine was administered by a doctor, and the court found that

“undez such circumstances” the learned intermediary rule applied.

In the case at bar, the vaccine was administered by a nurse at a

clinic. However, the plaintiffs herein seem to assume the learned

intermediary doctrine applies.

In any event, a manufacturer is directly liable to t 1e patient

when the warning to the “learned intermediary” is inadequate.

Wooderson, 235 Kan. at 400, 681 P.2d 1038.

74a

asserting a claim of strict liability for failure to warn and

summary judgment will be entered for defendant on

that claim.

[18] Defendant argues that the warning given was

adequate as a matter of law. In this regard, defendant

urges the court to find that Johnson is directly on point

and requires a finding of adequate warning. This ccurt

cannot agree.

Johnson must necessarily be limited to its facts on

the warning issue. As previously stated, the adequacy of

a warning turns on its reasonableness under the circum-

stances. The Johnson court found that under the cir-

cumstances before it, reasonable minds could not differ

on the adequacy of the warning. Johnson does nothing

to change the factual nature of the inquiry.

It is well established in Kansas that whether a

warning is adequate is an issue for the trier of fact.

Wooderson, 235 Kan. at 409, 681 P.2d 1038. Moreover,

the testimony of experts in the field should be consid-

ered. Siruta v. Hesston Corp., 232 Kan. 654, 659 P.2d

799 (1983).

In this case the plaintiffs will offer evidence that the

warning misstated the statistical incidence of severe

reactions, failed to adequately identify the level of endo-

toxin in each vial or lot, and failed to state that persons

with a family or personal history of seizures or central

nervous system disorders should forego immunization

and seek further medical evaluation prior to vaccination.

Although defendant adamantly challenges these allega-

tions, these are clearly issues which must be resolved by

the trier of fact.

Defendant further argues that the court should find

it non-negligent per se as the warning given had been

approved by the FDA. However, as previously stated,

FDA standards are minimum standards. While the

FDA’s approval is a factor to be considered by the jury, it

does not establish non-negligence per se. The Johnson

decision is not to the contrary: the FDA’s approval of the

75a

warning was only one of the several factors it considered

in finding the warning adequate as a matter of law.

Finally, the defendant argues that this court must

grant summary judgment on the warning claim because

the inadequacy of the warning was not the proximate

cause of Michelle Graham’s injuries. In this regard,

defendant asserts that Mrs. Graham based her decision

to have her baby immunized solely on the nurse’s

remarks indicating that she had no other choice.

However, the defendant’s argument fails to recog-

nize the rule that if a jury finds a warning inadequate,

causation is presumed. Wooderson, 235 Kan. at 410, 681

P.2d 1038. In other words, it is presumed that an

adequate warniig would be heeded by the patient. /d.

Thus, in this case, if an adequate warning had been

given (assuming arguendo that the one given was

inadequate), it is possible the nurse would have not said

the things she did, or perhaps would have suggested

alternatives. This, though, is a matter of pure specula-

tion; hence, the presumption.

The defendant argues the fact that Mrs. Graham

initially hesitated because of her concern with adverse

reactions proves the warning she received was adequate.

This —again—is entirely speculative. While such evi-

dence is certainly admissible, it does not require a

finding that the warning was adequate as a matter of

law. In fact, it begs the question of whether Mrs.

Graham would have consented to the vaccine if the

warning had contained all that plaintiffs contend it

should have.

Accordingly, the issue of the warning’s adequacy is

factual and must be resolved by the trier of fact.

C. Breach of Warranty and Misrepresentation

[19] Because the court does not grant summary

judgment on the plaintiff's tort claims, the warranty

claims — at this point — are merely superfluous. As such,

76a

the court will deny defendant’s motion for summary

judgment as to these claims for the same reason set

forth above. In doing so, the court notes that by filing

this lawsuit the defendant was given sufficient notice,

under K.S.A. 84-2-607, of the alleged breach of war-

ranty. See Owens v. Glendale Optical Co., 590 F.Supp.

32 32 (S.D. 111.1984); Palmer v. A.H. Robins Co., Inc.,

684 P.2d 187 (Colo.1984); Goldstein v. G.D. Searls &

Co., 62 Ill.App.3d 344, 19 Ill.Dec. 208, 218, 378 N.E.2d

1083, 1089 (1978).

As to the misrepresentation claim, the defendant

argues only that plaintiffs are unable—as a matter of

law—to show reliance. As previously discussed with

regard to the adequacy of the warning, it is presumed

that additional warnings (or representations) would

have been heeded. Thus, the defendant’s argument is

without merit.

III. Conclusion

Vaccines such as the DPT vaccine play an important

and critical role in this society. Millions of lives are

saved. However, some innocent people—such as Mi-

chelle Graham—are grievously injured by these vac-

cines. The defendant has argued that the doctrine of

federal preemption precludes victims from seeking com-

pensation from the vaccine manufacturers. However,

this court finds that Congress did not intend to preclude

vaccine victims from bringing state tort lawsuits. The

fact that the vaccine manufacturer complied with FDA

regulations is evidence that should be considered by a

jury; however, these regulations set minimum stan-

dards. Manufacturers are not precluded from taking

steps to improve their vaccine, or to better inform as to

its dangerous propensities. In this case, the evidence

must be heard before it can be determined that the

whole cell vaccine was the safest and most efficacious

77a

available —in other words, that it was “unavoidably un-

safe.” And in any case, the adequacy of the warning is an

issue for the trier of fact. Thus, this court will not rule

that as a matter of law Michelle Graham will be denied

any recourse. This case will proceed to trial.

IT IS ACCORDINGLY ORDERED this 21 day of

July, 1987, that defendant’s motion for summary judg-

ment is granted as to plaintiffs’ claim of strict liability for

failure to warn, and is denied as to all remaining claims.

ORDER NUNC PRO TUNC

In its Memorandum and Order of July 21, 1987,

denying defendant’s motion for summary judgment, the

court applied the law of the State of Kansas. This was

done due to the parties’ stipulation, contained in the

pretrial order, that the law of Kansas would apply, even

though the infant plaintiff received her vaccination in

the State of Missouri.

RE eT eee

78a

APPENDIX C

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF KANSAS

MICHELLE GRAHAM, an Infant

Under the Age of Eighteen, Who

Sues By Her Parents, Guardians

and Next Friends, Charles Graham

and Tammy Graham,

Plaintiff,

7” No. 85-1481-K

WYETH LABORATORIES, a Division

of American Home Products

Corporation, a Pennsylvania

Corporation,

Defendant.

i ld ee ee ee a ee

VERDICT

We, the jury, being duly impaneled and sworn,

submit the following answers to the special interrogato-

ries propounded by the court:

1. Does the Wyeth whole cell DTP vaccine

cause or substantially contribute to the cause of

encephalopathy in children?

Yes ~ No

[If you answer No. 1 “yes”, please proceed to

answer No. 2; if you answer No. 1 “no”, have

your foreperson sign and date this verdict form

and notify the bailiff that you have concluded

your deliberations. ]

2. Does the DTP vaccine received by Michelle

Graham on March 17, 1980, cause or substantially

contribute to the cause of her encephalopathy?

Yes al No

79a

[If you answer No. 2 “yes”, please proceed to

answer No. 3; if you answer No. 2 “no”, have

your foreperson sign and date this verdict form

and notify the bailiff that you have concluded

your deliberations. ]

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?

Yes @ No _

4. In March of 1980, was the DTP whole cell

vaccine manufactured by Wyeth in a defective con-

dition unreasonably dangerous to persons as a result

of its design, which was the legal cause of plaintiff's

injuries?

Yes @ No _

5. In March of 1980, was the DTP whole cell

vaccine in a defective condition unreasonably dan-

gerous to persons as a result of inadequate warn-

ings, which was the legal cause of plaintiffs inju-

ries?

Yes ~ No _

[If your answer is “yes” to Nos. 3, 4 or 5, proceed

to next question; if your answer is “no” to Nos.

3, 4 and 5, then have your foreperson sign and

date this verdict form and notify the bailiff that

you have concluded your deliberations. ]

6. What is the total amount of damages sus-

tained by the plaintiffs as a result of the injuries to

Michelle Graham?

$15 million

Oct. 14, 1987 XXX

Date Foreperson

80a

APPENDIX D

No. 88-1337

IN THE UNITED STATES COURT OF APPEALS

FOR THE TENTH CIRCUIT

MICHELLE GRAHAM, et al.,

Plaintiffs-Appellees,

WYETH LABORATORIES, etc.

Defendant-Appellant.

ON APPEAL FROM THE UNITED STATES DISTRICT

COURT FOR THE DISTRICT OF KANSAS

BRIEF FOR THE UNITED STATES AS AMICUS CURIAE

OF COUNSEL:

RONALD E. ROBERTSON JOHN R. BOLTON

General Counsel Assistant Attorney General

Department of Health and

Human Services ' JOHN F. CORDES

WILLIAM G. COLE

CATHERINE C. LORRAINE Attorneys, Appellate Staff

Associate Chief Counsel Civil Division - Room 3631

for Enforcement Department of Justice

Food & Drug Administration Washington, DC 20530-001

5600 Fishers Lane Telephone: (202) FTS 633-5090

Rockville, MD 20857

TABLE OF CONTENTS

Page

Interest of the United States................... [84a]

SEO SsSER GSE 50560060 ob bb ced desesse [84a]

EAP sS si bb eeebbebsos6esbsvercccces [86a]

1. History and Epidemiology of Pertussis ..... [87a]

2. Development of the Whole Cell Pertussis Vac-

DLC sAbbh bese sdabesevcoesracscss [88a]

Be db e dss ccccccccscccbcvese [91a]

(@) EERtrected VACCIMCS,. 2.20 scccccccccces [92a]

(DB) ACSMUIAF VACCINES —....6 2 cccccccccsee [94a]

ETD ba cccccccrcecccrcccoseve [98a]

hb tarbets 66s bovecteecccovces [103a]

COPEEIOCUIS OF BOEVICS 2. occ ccc ccccccccccecees [104a]

82a

TABLE OF AUTHORITIES

Cases: Page

White v. Wyeth Laboratories, Inc., Nos. 52108 &

52564 (Court of Appeals of Ohio, Eighth Dis-

rl FU es CN obo cok ccnnsevunvenes [88a]

Loveday v. Renton and Another, No. 1982 L 1812

(Queen’s Bench) (March 30, 1988)......... [88a]

Statutes and Regulations:

Vaccination Assistance Act of 1962, 42 U.S.C.

FN Pete EET EEE COREE EOE ET CELE. [98a]

50 Fed. Reg. 51040-42 (1985)................. [83a]

ee UE ccc ccc cucccvcccetene [90a]

Miscellaneous:

“Acellular and Whole-Cell Pertussis Vaccines in

Japan,” Journal of the American Medical Asso-

ciation (March 13, 1987).............. [86a-92a]

Cherry, “The Epidemiology of Pertussis and Per-

tussis Immunization in the United Kingdom

and the United States: A Comparative Study”,

Current Problems in Pediatrics (1983) . [85a, 87a,

89a]

Himan and Koplan, Pertussis and Pertussis Vac-

cine: Reanalysis of Benefits, Risks, and Costs,

Journal of the American Medical Association

CORE B.S Fko dk cc bn ceoined inte [85a, 89a]

Kallings, Olin and Storsaeter, Placebo-Controlled

Trial of Two Acellular Pertussis Vaccines in

Sweden Protective Efficacy and Adverse

Events, The Lancet ( April 30, 1988)... [92a, 96a]

Manclark & Cowell, “Pertussis” in Germanier (ed.),

Bacterial Vaccines (1984) ........ [86a, 88a, 89a]

83a

Marwick, Pertussis Vaccines: Trials (and Tribula-

tions), JAMA, April 8, 1988................ [95a]

“Recommendation of the Immunization Practices

Advisory Committee,” Morbidity and Mortality

Weekly Report, United States Dep’t of H.H.S.,

FUN. Bas BO oil w vicinv tts bade aeme [86a, 93a, 94a]

Report of the Committee on Infectious Diseases,

American Academy of Pediatrics (1986). [85a, 93a]

United States Department of Health and Human

Services, “Pertussis and Pertussis Vaccines in

FE ES Sn cos cs ccccaedecrsececes [89a]

84a

IN THE UNITED STATES COURT OF APPEALS

FOR THE TENTH CIRCUIT

No. 88-1337

MICHELLE GRAHAM, et al.,

Plaintiffs-Appellees,

WYETH LABORATORIES, etc.,

Defendant-Appellant.

ON APPEAL FROM THE UNITED STATES

DISTRICT COURT

FOR THE DISTRICT OF KANSAS

BRIEF FOR THE UNITED STATES AS

AMICUS CURIAE

INTEREST OF THE UNITED STATES

The United States submits this amicus curiae brief

on behalf of the Department of Health and Human

Services (HHS), which maintains a longstanding na-

tional program to vaccinate all American children

against pertussis, or “whooping cough.” The purpose of

this brief is to provide the Court with background

information concerning the federal government’s role in

pertussis vaccination. The United States expresses no

opinion on the question whether federal law preempts

plaintiff's state tort remedies in this case.

INTRODUCTION

Federal public health authorities, including the

Food and Drug Administration (FDA), the Centers for

Disease Control (CDC), the National Institutes of

85a

Health (NIH), and other agencies, have, for almost forty

years, promoted vaccination of the populace with

diphtheria-tetanus-pertussis (DTP) vaccines containing

as one of their three components the so-called “whole

cell” pertussis vaccine.! These agencies have supported

use of this “whole cell” component because of its proven

value for millions of children, even though they recog-

nize that some observers have, in the past, claimed that

a small number of those vaccinated could suffer serious,

adverse side effects. These agencies are unaware of any

other pertussis vaccine produced in the world today that

has been adequately demonstrated to be both safer than

and as effective as the “whole cell” vaccine licensed for

sale by the FDA.

Pertussis is a serious disease which is most danger-

ous to its youngest victims. Before the introduction of

the “whole cell” vaccine, pertussis disabled and killed

! thousands of children annually in the United States.

After more than 40 years of widespread use of that

vaccine in this country, the disease has been brought

largely under control. Pertussis remains a significant

cause of infant deaths, however, in some other parts of

the world which lack such vaccination programs.? More-

over, the bacterium causing the disease persists even

where the disease is under controi, as in this country.

This leads to the probability of epidemics whenever the

1. Technically, “whole cell” pertussis vaccines produced by

different manufacturers are considered to be different vaccines

even though they are of the same basic design and meet the same

federal requirements. HHS believes that the “whole cell” vaccines

/ produced by licensed manufacturers are equally acceptable, safe,

; and effective products. For ease of discussion, “whole cell” vaccines

will be referred to in the singular throughout this brief.

2. See 50 Fed. Reg. 51040-42 (1985) (Report of the Panel on

Review of Bacterial Vaccines and Toxoids) (“Panel Report”). This

report, by a group of medical experts appointed by FDA to review

the safety, efficacy and labeling of all bacterial vaccines, contains a

thorough discussion of the disease, the developinent of the “whole

cell” vaccine, and the vaccine’s safety and efficacy.

ESS nT

86a

use of the vaccine declines significantly. The responsi-

ble federal health agencies have consistently recom-

mended that all children, excepting those with specific

medical contraindications, be inoculated.

Charles and Tammy Graham, on their own behalf

and on behalf of their child, Michelle, filed this suit in

federal district court in Kansas. The defendant is Wyeth

Laboratories, a division of American Home Products

Corporation. Wyeth formerly manufactured a “whole

cell” pertussis vaccine which it marketed as a part of a

DTP vaccine.3 The plaintiffs asserted that Michelle

suffers from a seizure disorder and encephalopathy (a

disease of the brain) caused by her DTP inoculation in

_ 1980. Their suit alleged claims of strict liability, negli-

gence and breach of implied warranties. The jury re-

turned a verdict against Wyeth, awarding $15,000,000

in compensatory damages.

“Whole cell” pertussis vaccine is made from whole

killed cells of Bordetella pertussis, the bacterial agent

that causes the disease. The vaccine contains sub-

stances which plaintiffs claimed were capable of causing

adverse reactions in vaccines. The plaintiffs here also

contend that Wyeth could have and should have manu-

factured and sold a different type of pertussis vaccine

less likely to cause adverse reactions.

DISCUSSION

HHS supports the continuing manufacture and

marketing of the “whole cell” vaccine because no alter-

native formulation has been adequately proven to be

both safer than and as effective as the “whole cell”

vaccine. HHS’s support for continued production of this

3. Although it is still licensed to do so, Wyeth no longer

manufactures or markets DTP. The only commercial suppliers of

the vaccine in this country today are Connaught, Inc. and a division

of American Cyanamid, Lederle Laboratories.

87a

product is consistent with the vigorous recommenda-

tions of all sectors of the medical community, both

public and private, which have carefully analyzed the

dangers of the disease and the benefits and risks asso-

ciated with the vaccine.

Experts still have not determined what part of the

whole B. pertussis cell used in the “whole cell” vaccine

provides immunity to the recipient. HHS, the govern-

ments of other nations, and numerous private firms are

actively seeking an improved vaccine that provides the

protection of the “whole cell” design. Until the time that

HHS is convinced that such an alternative vaccine has

been found, it will continue to advocate the use of

“whole cell” vaccine as a vital part of our nation’s public

health policy.

1. History and Epidemiology of Pertussis.

Pertussis, or whooping cough, is a highly contagious

disease caused by Bordetella pertussia, a bacterium.

Human beings are the only natural hosts of B. pertussis,

and infected individuals are the primary sources of

disease in susceptible persons. Transmission occurs via

droplets from the respiratory tract which are expelled

into the air by infected individuals. Up to 90% of

nonimmune household contacts acquire the disease.

Report of the Committee on Infectious Diseases, Amer-

ican Academy of Pediatrics (1986) (“The Red Book”).

Later stages of the disease are characterized by severe

and paroxysmal coughing which ends in a prolonged,

high-pitched crow (the whoop) that is occasionally ac-

companied by vomiting. Recovery may take many weeks

or months. The disease is most dangerous to infants and

young children. During the years 1940-1948, the mean

annual pertussis mortality rate for infants up to 12

months of age was 64 per 100,000 population, as com-

pared with only 6.4 per 100,000 children ages 1 through

4, and 0.2 for children ages 5 through 14. Cherry, “The

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Epidemiology of Pertussis and Pertussis Immunization

in the United Kingdom and the United States: A Com-

parative Study,” Current Problems in Pediatrics (1983)

(“Cherry”), p. 18. Complications of pertussis include

brain diseases, convulsions, partial lung collapse, sec-

ondary infections such as pneumonia, and permanent

developmental retardation. See generally Manclark &

Cowell, “Pertussis” in Germanier (ed.), Bacterial Vac-

cines (1984) (“Manclark & Cowell”), pp. 69-106.

In 1934, when this country suffered its worst per-

tussis epidemic, there were 265,000 reported cases of

pertussis and 7,500 related deaths. Hinman and Koplan,

Pertussis and Pertussis Vaccine: Reanalysis of Benefits,

Risks, and Costs, Journal of the American Medical

Association (“Hinman and Koplan”) (June 15, 1984). By

the early 1940s, pertussis was responsible for two and a

half times the number of deaths as all of the following

diseases combined: measles, mumps, rubella, diphthe-

ria, polio, meningitis, chicken pox, and scarlet fever.

While the use of pertussis vaccine has reduced the

number of deaths attributable to pertussis to approxi-

mately 10 per year (“Recommendation of the Immuni-

zation Practices Advisory Committee (ACIP),” Morbid-

ity and Mortality Weekly Report, (“MMWR”) U.S.

Dept. of H.H.S., July 12, 1985), the potential for epidem-

ics is still present. Hinman and Koplan, p. 3113.

2. Development of the Whole Cell Pertussis Vaccine.

B. pertussis was identified as the cause of whoop-

ing cough in 1906 at the Brussels Pasteur Institute. The

first vaccine against pertussis was licensed by the fed-

eral government in 1914. Additional developmental

changes were made in the “whole cell” vaccine we know

today starting in the 1920s. This research led to the

development of experimental vaccines and clinical trials

in the 1930s. In the early 1940s, pertussis vaccination

89a

became widespread, and, in 1944, the Council on Phar-

macy and Chemistry of the American Medical

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