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| [1] | UNITED STATES COURT OF APPEALS FOR THE FIFTH CIRCUIT |
| [2] | No. 72-2251 |
| [3] | 1974.C05.40385 <http://www.versuslaw.com>;
498 F.2d 1264 |
| [4] | July 31, 1974 |
| [5] | EPIFANIO REYES, INDIVIDUALLY AND AS NEXT FRIEND OF ANITA REYES, A MINOR,
PLAINTIFF-APPELLEE, v. WYETH LABORATORIES, A DIVISION OF AMERICAN HOME PRODUCTS CORPORATION, A DELAWARE CORPORATION, DEFENDANT-APPELLANT |
| [6] | Appeal from the United States District Court for the Southern District
of Texas. |
| [7] | Brown, Chief Judge and Wisdom and Ainsworth, Circuit Judges. |
| [8] | Author: Wisdom |
| [9] | WISDOM, Circuit Judge: |
| [10] | This products liability case raises significant questions concerning the
scope of a drug manufacturer's duty to warn ultimate consumers of dangers
inherent in his product. |
| [11] | In May 1970, slightly more than two weeks after she had received a dose
of Wyeth Laboratories' oral polio vaccine, eight-month-old Anita Reyes was
diagnosed as having paralytic poliomyelitis. Epifanio Reyes, Anita's father,
filed suit against Wyeth Laboratories, alleging that the live polio virus
in the vaccine had caused Anita's polio and that Wyeth was liable for her
injuries because it had failed to warn her parents of this danger. Wyeth
contends that it is not liable for Anita Reyes's injuries under the products
liability law of Texas. In addition, Wyeth raises numerous procedural and
evidentiary questions. The case was tried to a jury. The jury answered special
interrogatories (see Appendix A) and returned a verdict in favor of Reyes
against Wyeth for the sum of $200,000. |
| [12] | I. |
| [13] | Twenty or thirty years ago poliomyelitis was a dread disease that especially
attacked the very young. In 1952 alone, there were 57,879 reported cases
of polio in the United States; 21,269 of these resulted in crippling paralysis
to the victims. By 1970, when Anita Reyes contracted polio, the number of
those stricken by polio had diminished dramatically; she was one of just
33 individuals to be afflicted during that year.*fn1
Credit for this precipitous decline must go primarily to the medical researchers
who discovered the viral nature of the disease, and were able to isolate
and reproduce the virus in an inactivated or an attenuated form. See Appendix
B. But credit for this remarkable achievement must also be given to such
laboratories as Wyeth, which processed the polio vaccine, and to massive
federal-state public health programs for the administration of the vaccine. |
| [14] | On May 8, 1970, Anita Reyes was fed two drops of Sabin oral polio vaccine
by eye-dropper at the Hidalgo County Department of Health clinic in Mission,
Texas. The vaccine was administered to Anita by a registered nurse; there
were no doctors present. Mrs. Reyes testified that she was not warned of
any possible danger involved in Anita's taking the vaccine. Mrs. Reyes has
a seventh grade education, but her primary language is Spanish. She signed
a form releasing the State of Texas from "all liability in connection
with immunization". The form contained no warning of any sort, and
it is apparent from her testimony that she either did not read the form
or lacked the linguistic ability to understand its significance. About fourteen
days after the vaccine was administered, Anita Reyes became ill. On May
23, 1970, she was admitted to the McAllen (Texas) General Hospital, where
her disease was diagnosed as Type I paralytic poliomyelitis. See Appendix
B, footnote 59. As a result of the polio, at the time of trial Anita was
completely paralyzed from the waist down, her left arm had become atrophied,
and she was unable to control her bladder or bowel movements. |
| [15] | The vaccine given Anita Reyes in the Mission clinic on May 8, 1970 was
part of a "lot", No. 15509, prepared by Wyeth.*fn2
Lot No. 15509 was trivalent oral polio vaccine that Wyeth had titered (mixed)
from Types I, II, and III monovalent vaccine provided by Pfizer, Ltd. In
response to an order placed by the Texas State Department of Health on December
23, 1969, Wyeth shipped 3500 vials of Lot No. 15509 vaccine to the State
Health Department which in turn transferred 400 vials to the Hidalgo County
Health Department. The jury found that vaccine from one of these vials was
given to Anita Reyes. Included with every vial, each of which contained
ten doses of vaccine, was a "package circular" provided by Wyeth
which was intended to warn doctors, hospitals, or other purchasers of potential
dangers in ingesting the vaccine. Mrs. Lenore Wiley, the public health nurse
who administered the vaccine to Anita Reyes, testified that she had read
the directions on this package insert, but that it was not the practice
of the nurses at the Mission Health Clinic to pass on the warnings to the
vaccinees or to their guardians. She testified that she gave Mrs. Reyes
no warning before she administered the vaccine to Anita. |
| [16] | On October 7, 1970, Epifanio Reyes, individually and as next friend of
his minor daughter, brought this action on theories of strict products liability,
breach of warranty, and negligence. In his complaint he alleged that his
daughter had contracted polio from the live virus in Wyeth's vaccine, and
that Wyeth's failure to warn him or his wife that this might occur rendered
it liable for Anita's injuries. Wyeth's main line of defense was that Anita's
polio was not vaccine-induced at all. Wyeth produced experts who characterized
virus isolated from a specimen of stool taken from Anita on the day after
she was admitted to the hospital as "probably wild". This probability
was increased, according to epidemiological testimony adduced on Wyeth's
behalf,*fn3 by the fact that there was
a polio "epidemic" in Hidalgo County at the time Anita fell ill.
In effect, the jury rejected these theories in rendering a verdict for Reyes. |
| [17] | Wyeth asserts more than a score of separate grounds for reversal, each
accompanied by extensive argument and citation. We have considered all of
these contentions, but in this opinion we shall address only those challenges
which we regard as raising substantial questions. |
| [18] | II. |
| [19] | We turn first to the substantive issues raised by this appeal. Our inquiry
is bounded by the jury's finding that Wyeth's vaccine was the producing
cause of Anita Reyes's polio, and by those principles of products liability
law we conclude would be applied by the courts of Texas. Erie R.R. Co. v.
Tompkins, 1938,
304 U.S. 64,
58 S. Ct. 817,
82 L. Ed. 1188.
|
| [20] | The jury's finding that the Wyeth vaccine was responsible for Anita Reyes's
polio is less a conclusion than a starting point. Texas courts may hold
manufacturers of products which harm consumers liable for the injuries,
but, of course, manufacturers are not insurers.*fn4
Texas courts recognize both tort and warranty theories of products liability.*fn5
This case was tried, briefed, and argued on appeal entirely on the tort
theory of strict liability. Thus the differences between the two approaches,*fn6
and whatever contractual trappings of warranty have not been destroyed with
the crumbling of the citadel of privity,*fn7
need not detain us. Rather, we turn to the theory of strict products liability
as embodied in Section 402A of the Restatement (Second) of Torts (1965),*fn8
and approved by the Supreme Court of Texas in McKisson v. Sales Affiliates,
Tex.Sup.Ct.1967, 416 S.W.2d 787.*fn9 |
| [21] | Basically, Section 402A subjects to liability the seller or manufacturer
of a product sold "in a defective condition unreasonably dangerous"
to an ultimate user or consumer whose person or property is physically harmed
by the product.*fn10 Moreover, one who
places defective goods in the stream of commerce will be liable "to
the user or consumer even though he has exercised all possible care in the
preparation and sale of the product". Restatement (Second) of Torts,
Section 402A, comment a. Yet imposition of liability is by no means automatic;
the elements tacit or explicit in Section 402A's mandate must be demonstrated
to the trial court's satisfaction before the burden of the consumer's loss
will be imposed on the seller of the product: |
| [22] | The plaintiff is faced with an arduous burden of proof. He must prove
that: 1) the product in question was defective; 2) the defect existed at
the time the products left the hands of the defendant; 3) that because of
the defect the product was unreasonably dangerous to the user or consumer
(plaintiff); 4) that the consumer was injured or suffered damages; 5) and
that the defect (if proved) was the proximate cause of the injuries suffered. |
| [23] | Gravis v. Parke-Davis & Co., Tex.Civ.App.1973, 502 S.W.2d 863, 868.
Although we do not embrace Gravis as the all-inclusive embodiment of Texas
products liability law, the framework it provides suggests a useful analysis
for the issue of Wyeth's liability here. |
| [24] | All five elements, however, which constitute the Gravis requirements need
not be discussed here. There can be no question that Anita Reyes was injured,
so the fourth element is not in issue. Nor is the second, since the defect
alleged, failure to warn by the manufacturer, is by definition the manufacturer's
dereliction. Moreover, to find that the plaintiff proved the first element
is to conclude that he proved the third, for properly understood, "defective
condition" has no meaning independent of "unreasonably dangerous";
the two terms are essentially synonymous.*fn11
Thus if a product is unreasonably dangerous as marketed, the manufacturer
may be held liable for injuries proximately caused by what he has produced,
whether or not it was manufactured exactly as intended, that is without
a production "defect".*fn12
We do not understand this approach to dispense with the principle that to
prompt liability a product must reach the consuming public in a "defective
condition". Rather, by rephrasing the defectiveness requirement in
terms of "unreasonable danger", it becomes clear that the circumstances
of marketing themselves can amount to a defect; the defect can be extrinsic
to the product. All that we need determine here, then, is first, whether
the vaccine was unreasonably dangerous, and second, whether the showing
of proximate causation was sufficient under Texas law. |
| [25] | a) Unreasonable Danger and the Duty to Warn |
| [26] | We begin the inquiry by asking whether the vaccine was unreasonably dangerous,
that is, in a defective condition when Anita Reyes received it. It is clear,
of course that the vaccine was not itself defective. Wyeth Vaccine Lot No.
15509 was exactly what its makers*fn13
and the Texas public health authorities intended it to be: trivalent live-virus
Sabin oral polio vaccine. The live virus which the jury concluded caused
Anita's poliomyelitis was not inadvertently included in the mixture.*fn14
Indeed, it is the presence of the living but attenuated Type I, II, and
III viruses which makes the Sabin vaccine so effective [See Appendix B]. |
| [27] | Although the living virus in the vaccine does not make the vaccine defective,
it does make it what the Restatement calls an "unavoidably unsafe product",
one which cannot be made "safe" no matter how carefully it is
manufactured. Such products are not necessarily " unreasonably dangerous",
for as this Court has long recognized in wrestling with product liability
questions, many goods possess both utility and danger. See, e.g., Ross v.
Up-Right, Inc., 5 Cir. 1968,
402 F.2d 943,
946; Helene Curtis Industries, Inc. v. Pruitt, 5 Cir. 1967,
385 F.2d 841,
850, cert. denied, 1968,
391 U.S. 913,
88 S. Ct. 1806,
20 L. Ed. 2d 652.
Rather, in evaluating the possible liability of a manufacturer for injuries
caused by his inevitably hazardous products, a two-step analysis is required
to determine first, whether the product is so unsafe that marketing it at
all is "unreasonably dangerous per se", and, if not, whether the
product has been introduced into the stream of commerce without sufficient
safeguards and is thereby "unreasonably dangerous as marketed".*fn15
In either case, the applicable standard, as formulated in the Restatement,
is as follows: In terms of the user's interests, a product is "unreasonably
dangerous" only when it is "dangerous to an extent beyond that
contemplated by the ordinary consumer";*fn16
or, to phrase it in terms of the seller's responsibility, "so dangerous
that a reasonable man would not sell the product if he knew the risk involved".
See Borel v. Fibreboard Paper Products Corp., 5 Cir. 1973,
493 F.2d 1076,
1088; Helene Curtis Industries, Inc. v. Pruitt,
385 F.2d 841,
850; Wade, Strict Tort Liability of Manufacturers, 19 Sw.L.J. 5, 15 (1965). |
| [28] | In determining whether placing a commodity on the market is "unreasonably
dangerous per se", the reasonable man standard of the Restatement becomes
the fulcrum for a balancing process in which the utility of the product
properly used is weighed against whatever dangers of harm inhere in its
introduction into commerce. Obviously, use of an unavoidably unsafe product
always presents at least a minimal danger of harm, but only if the potential
harmful effects of the product -- both qualitative and quantitative -- outweigh
the legitimate public interest in its availability will it be declared unreasonably
dangerous per se and the person placing it on the market held liable.*fn17
Applying this standard here, the scales must tip in favor of availability.
The evil to be prevented -- poliomyelitis and its accompanying paralysis
-- is great. Although the danger that vaccinees may contract polio is qualitatively
devastating, it is statistically miniscule. On balance then, marketing the
vaccine is justified despite the danger. |
| [29] | Since Sabin oral polio vaccine is not "unreasonably dangerous per
se", we move to the second step of our analysis to determine whether
it is "unreasonably dangerous as marketed", for to conclude that
the maker of an unavoidably unsafe product did not act unreasonably in placing
it on the market is not to relieve him of the responsibility to market it
in such a way as to prevent unreasonable danger. In the case of a product
such as Sabin oral polio vaccine, this translates into a duty to provide
proper warnings in selling the product. As comment k to Section 402A instructs,
an unavoidably unsafe product is neither defective nor unreasonably dangerous
if such a product is "properly prepared, and is accompanied by proper
directions and warning".*fn18 Consequently,
the Restatement requires a seller who has reason to believe that danger
may result from a particular use of his product to provide adequate warning
of the danger in order that the product's potential for harm may be reduced.
Failure to give such a warning when it is required will itself present a
"defect" in the product and will, without more, cause the product
to be "unreasonably dangerous as marketed".*fn19 |
| [30] | Issue is joined then, on the question whether Wyeth was under a duty to
warn the parents of Anita Reyes that there was a possibility, however remote,
that she might contract polio from the drug designed
to immunize her. If such a duty existed, the vaccine was "defective"
and unreasonably dangerous as marketed, for such cautions as Wyeth advanced
did not, and were not intended to, reach the Reyes family. See Davis v.
Wyeth Laboratories, Inc., 9 Cir. 1968,
399 F.2d 121,
129. |
| [31] | Wyeth does not deny that its vaccine is "unavoidably unsafe",
or contend that it was unaware of the danger. Rather, the appellant contends
that if it had a duty to warn at all, that duty was discharged by the warning
contained on the package insert which accompanied the vials of vaccine sold
to the Texas State Department of Health. This is so, Wyeth asserts, because
the Sabin trivalent oral polio vaccine in issue here is a "prescription
drug", and those who prepare such drugs are not required to warn the
ultimate consumer. If the warning to the dispensing physician or authorities
(here the Texas and Hidalgo County Public Health Departments) was adequate,
Wyeth is not liable for any harm caused by the vaccine. Resolution of these
contentions is crucial; Wyeth concedes in its brief that "since it
is undisputed that Wyeth did not warn Reyes, but only the Texas State Department
of Health, a finding that the vaccine was not a prescription drug establishes
as a matter of law the defectiveness of the vaccine for purposes of a prima
facie case in strict products liability." |
| [32] | We cannot quarrel with the general proposition that where prescription
drugs are concerned, the manufacturer's duty to warn is limited to an obligation
to advise the prescribing physician of any potential dangers that may result
from the drug's use.*fn20 This special
standard for prescription drugs is an understandable exception to the Restatement's
general rule that one who markets goods must warn foreseeable ultimate users
of dangers inherent in his products. See Restatement (Second) of Torts,
Section 388 (1965). Prescription drugs are likely to be complex medicines,
esoteric in formula and varied in effect. As a medical expert, the prescribing
physician can take into account the propensities of the drug, as well as
the susceptibilities of his patient. His is the task of weighing the benefits
of any medication against its potential dangers. The choice he makes is
an informed one, an individualized medical judgment bottomed on a knowledge
of both patient and palliative. Pharmaceutical companies then, who must
warn ultimate purchasers of dangers inherent in patent drugs sold over the
counter, in selling prescription drugs are required to warn only the prescribing
physician, who acts as a "learned intermediary" between manufacturer
and consumer.*fn21 |
| [33] | Although there is no question that Sabin oral vaccine is licensed for
sale only as a prescription drug,*fn22
the district court, in its charge to the jury, noted that the vaccine was
not administered as a prescription drug at the Mission Clinic. The court
charged: "if you [the jury] find that a warning should have been given,
the warning had to be given to Anita and her parents, not to Mrs. Wiley,
that Public Health nurse, somebody else . . . The ultimate consumer is the
one that had to be warned." The district court apparently based this
instruction on the leading federal case in the area, Davis v. Wyeth Laboratories,
9 Cir. 1968,
399 F.2d 121.
In Davis, the plaintiff had allegedly contracted polio from Wyeth oral vaccine
distributed at a public clinic. The Ninth Circuit held that where no individualized
medical judgment intervenes between the manufacturer of a prescription drug
and the ultimate consumer, "it is the responsibility of the manufacturer
to see that warnings reach the consumer, either by giving warning itself
or by obligating the purchaser to give warning."
399 F.2d at 131.
Where there is no physician to make an "individualized balancing .
. . of the risks", the Court reasoned, the very justification for the
prescription drug exception evaporates. Thus, as in the case of patent drugs
sold over the counter without prescription, the manufacturer of a prescription
drug who knows or has reason to know that it will not be dispensed as such
a drug must provide the consumer with adequate information so that he can
balance the risks and benefits of a given medication himself. Moreover,
just as the manufacturer cannot make this choice for its ultimate consumers,
it cannot allow its immediate purchaser to choose for them. In sum, then,
the manufacturer is required to warn the ultimate consumer, or to see that
he is warned.
399 F.2d at 131.
|
| [34] | Wyeth does not resist the Ninth Circuit's holding in Davis, but asserts
that the instant case can be distinguished on four grounds. First, the appellant
argues, Davis received his vaccine during a mass immunization program, whereas
Anita Reyes ingested her vaccine at her parents' request. Second, Wyeth
stresses the fact that Davis received his vaccine from a pharmacist, but
Reyes's was administered by a public health nurse. Third, Wyeth's active
participation in the mass immunization program involved in the Davis case
is contrasted to its relatively passive role here. Finally, Wyeth urges
that unlike the situation in Davis, here it had no knowledge that the vaccine
would not be administered as a prescription drug. |
| [35] | None of these asserted grounds for distinguishing Davis justifies a different
result here. The first two arguments are admittedly distinctions between
Davis and the instant controversy, but they have no bearing on the rationale
of the Davis opinion. Whether vaccine was received during a mass immunization
or an on-going program, whether it was administered by nurse or pharmacist,
it was, in both these cases, dispensed without the sort of individualized
medical balancing of the risks to the vaccinee that is contemplated by the
prescription drug exception. The third and fourth asserted bases for distinguishing
Davis from this case are essentially the same: Wyeth took no active part
in the vaccination process here, and did not know that its vaccine would
be dispensed without procedures appropriate for distribution of prescription
drugs. |
| [36] | Were we to conclude that Wyeth neither knew nor had reason to know that
its vaccine would be dispensed without prescription drug safeguards, we
might be required to hold that the rationale in Davis is inapplicable here.
But Wyeth had ample reason to foresee the way in which its vaccine would
be distributed. A drug manufacturer is held to the skill of an expert in
his field, and is presumed to possess an expert's knowledge of the arts,
materials, and processes of the pharmaceutical business.*fn23
Included in such expertise must be a familiarity with practices and knowledge
common in the drug industry as to distribution and administration of pharmaceutical
products. |
| [37] | Neal Nathanson, Professor of Epidemiology at the Johns Hopkins University
School of Public Health and a witness for Wyeth testified that it was common
knowledge in the drug industry that "a great majority" of vaccinees
receive their Sabin vaccine in mass administrations or county clinics manned
at least in part by volunteers. Moreover, Dr. Nathanson agreed that it was
well known that such clinics were stocked primarily by sale of vaccine to
state health departments. These clinics, as Wyeth must be presumed to know,
dispense Sabin vaccine to all comers in an "assembly line" fashion;
there is often neither time nor personnel to make an "individualized
medical judgment" of the vaccinee's needs or susceptibilities. See
Davis v. Wyeth, supra,
399 F.2d at 131;
56 Geo.L.J. 1016, 1017 (1968); 5 San Diego L.Rev. 422, 428 (1968). |
| [38] | Viewed in this light, the present controversy, however it differs from
Davis factually, invites application of the Davis principles, and the conclusion
that Wyeth was under a duty to warn Anita Reyes's parents of the danger
inherent in its vaccine. Wyeth knew or had reason to know that the vaccine
would not be administered as a prescription drug, and therefore was required
to warn foreseeable users, or see that the Texas Department of Health warned
them. See Davis v. Wyeth, supra,
399 F.2d at 131;
cf. Helene Curtis Industries v. Pruitt, supra,
385 F.2d at 861.
Wyeth's failure to warn was a breach of its duty and made the vaccine "defective"
-- hence "unreasonably dangerous" -- as marketed. |
| [39] | Before moving to a consideration of causation, we pause to analyze two
possible arguments, one raised by Wyeth and one not, which appear to add
further conceptual problems in the "duty to warn" area. |
| [40] | The first may be disposed of quickly. Wyeth contends that whatever its
duty to warn, Mrs. Reyes assumed the risk that her daughter might contract
polio, or effectively released Wyeth, by signing a "release" purporting
to excuse the State of Texas from liability. Wyeth does not explain how
signing a form releasing the State could excuse Wyeth from performing a
duty to warn imposed on it by law, other than to cite the "unity of
release" rule, apparently under the assumption that the State of Texas
was its agent. Since we decline to adopt the district court's conclusion
that Texas was the agent of Wyeth in administering the vaccine, we need
not consider Wyeth's contention that the release signed by Mrs. Reyes also
applied to it. Moreover, although we agree that assumption of risk is a
proper defense to a product liability action in Texas (see Borel v. Fibreboard
Paper Products Corp.) one cannot assume a risk of which he is unaware. Shamrock
Fuel & Oil Sales Co. v. Tunks, Tex.Sup.1967, 416 S.W.2d 779, 786 and
n. 8. Since Mrs. Reyes was not cognizant of the danger inherent in the vaccine,
she could not have assumed the risk of its use. |
| [41] | Somewhat more troubling is a line of Texas cases involving unusual allergic
reactions to potentially dangerous products sold without a warning. These
decisions may be read for the proposition that only if the product, properly
prepared, will harm a substantial number of people will the manufacturer
be held liable for his failure to warn. See C. A. Hoover & Son v. O.
M. Franklin Serum Co., Tex.Sup.1969, 444 S.W.2d 596, 598; Alberto-Culver
Co., v. Morgan, Tex.Civ.App.1969, 444 S.W.2d 770, 776-777, writ ref. n.r.e.;
Cudmore v. Richardson-Merrell, Inc., Tex.Civ.App.1966, 398 S.W.2d 640, 644,*fn24
writ ref. n.r.e., cert. denied, 1967,
385 U.S. 1003,
87 S. Ct. 705,
17 L. Ed. 2d 542.
|
| [42] | Essentially these are foreseeability cases; the element they would require
to invoke strict liability doctrines is foreseeability. In these cases,
the manufacturer not only marketed the unavoidably unsafe product without
adequate warning and with the knowledge that it was inherently dangerous,
but the danger to any individual consumer was sufficiently significant and
knowable that (1) the manufacturer was cognizant of a need to warn so as
to prevent injury and (2) the consumer might or could have altered his conduct
in such a way as to lessen or avoid the danger. This ancipital coin of foreseeability
is the currency of these Texas cases. What they seek to avoid is the imposition
of liability for "abreactions", hypersensitive allergic reactions
so unique that the class of persons exposed to the risk is miniscule. See
Cudmore v. Richardson-Merrell, Inc., 398 S.W.2d 640, 644. In such cases,
warnings would be meaningless, since the manufacturer can convey nothing
meaningful to the allergic consumer unless the latter knows he has the allergy.
Without such knowledge, the consumer is apt to assume that he is not a member
of the minute susceptible class and to disregard the warning. See Alberto-Culver
Co. v. Morgan, 444 S.W.2d at 777. Thus with the utility of warning limited
and the susceptible class minute, the manufacturer is not required to foresee
that anyone will suffer an allergic reaction to his product, and is not
held liable. |
| [43] | To the instant analysis, these principles present no dilemma, for the
effect of the Sabin oral vaccine upon those who contract polio from it cannot
fairly be styled an "abreaction".*fn25
Although the danger of vaccine-induced polio to any one individual is small,
the risk appears to be distributed evenly among that substantial segment
of the population that is not naturally immune to polio. This is so because
the behavior of polio virus in those who contract the disease seems to suggest
more a reversion to virulence by the virus than a sensitivity in the vaccinee.
Thus, if an individual is a member of the significant susceptible class,
and his case should be one of those rare instances in which the vaccine
strain reverts to virulence, he may contract polio. This is not a case like
Cudmore, then, where the "appellant belongs to a class of people not
appreciable in number who are allergic to the drug," and in which a
warning would have been futile. 398 S.W.2d at 644. Rather, proper warnings
here would be addressed to a sizeable group and would be designed to alert
each of its members that although the incidence of vaccine-induced polio
is minute, he does belong to a substantial class, an unpredictable few of
which could contract polio from the vaccine. In light of such factors, the
Texas "abreaction" cases cannot dilute Wyeth's duty to warn here.
This view coincides with the objective of Section 402A to protect the consumer
by his standards of reasonableness in determining the manufacturer's duty. |
| [44] | b) Proximate Cause |
| [45] | Having concluded that Wyeth had a duty to warn Anita Reyes, and that,
dispensed without a warning, the vaccine was unreasonably dangerous, we
now turn to Wyeth's objections to the trial court's not instructing the
jury and not submitting an interrogatory on the issue of "proximate
cause". |
| [46] | As Wyeth correctly contends, there are two causation issues in most product
liability cases. The first is that of "producing cause": Was the
defendant's product the cause-in-fact of the plaintiff's injuries? More
specific is the question posed under the rubric of proximate causation:
Did the plaintiff's injuries result from the alleged "defect"
in the defendant's product? Unless the jury is given an opportunity to pass
upon both issues, Wyeth urges, the plaintiff has not made out a prima facie
case of product liability. If Wyeth is correct, reversal is required, for
the trial judge made it clear that he did not believe proximate cause to
be an issue in this controversy, and neither instructed the jury nor submitted
an interrogatory on the question.*fn26
We cannot concur in Wyeth's premise, however. The submission of interrogatories
accompanying a general verdict is within the discretion of the trial court.*fn27
Moreover, although an instruction on proximate cause is appropriate in most
products liability cases, a jury finding on the question was not required
here. |
| [47] | As a general proposition, both Texas Courts and this Court have required
that the plaintiff in a product liability suit prove not only that his injuries
were caused by the defendant's product, but that they resulted from an alleged
defect in the product.*fn28 Leading
commentators have concurred.*fn29 Yet
the rule in Texas that proximate cause must be specifically proved in products
liability cases is not immutable. In some circumstances, proximate cause
may be inferred as a matter of law or as a matter of fact. Procter &
Gamble Mfg. Co. v. Langley, Tex.Civ.App.1967, 422 S.W.2d 773, writ dismissed,
want of jurisdiction. In other cases, an instruction on producing cause
which omits a consideration of proximate cause may be sufficient. C. A.
Hoover and Son v. O. M. Franklin Serum Co., Tex.Sup.1969, 444 S.W.2d 596,
598. We believe, in light of the holding in Hoover and crucial dicta in
Technical Chemical Co. v. Jacobs, Tex.Sup.1972, 480 S.W.2d 602, that to
have omitted a specific proximate cause instruction here was not reversible
error. |
| [48] | Hoover was an action against a serum manufacturer by the owners of 25
Hereford calves which had become desperately ill after having been innoculated
with the defendant's antibiotic. The trial resulted in a verdict and judgment
for the plaintiffs, which was reversed and remanded by the court of civil
appeals because the trial court had submitted a special issue on "producing
cause" rather than "proximate cause", "and had thus
failed to require the element of foreseeability". The Supreme Court
of Texas reversed the court of appeals, and held that where, as here, the
injury's foreseeability was not in issue, the "producing cause"
instruction was sufficient. Much of the Supreme Court's brief opinion is
spent in distinguishing the issue presented in Hoover from that considered
in Cudmore v. Richardson-Merrell, Inc. Cudmore required that the jury consider
whether the defendant's product was the "proximate cause" of the
plaintiff's injuries rather than merely whether it was the "producing
cause", since the latter inquiry "omits entirely the element of
foreseeability. . . ." The Hoover court distinguished Cudmore on the
ground that it involved an "abreaction" to a "pure drug"
and thus foreseeability was a crucial issue. In such a case, a "proximate
cause" instruction is required. In Hoover, however, all twenty-five
innoculated cattle fell ill or died. The jury found that the cause of this
widespread illness was not an unforeseeable abreaction. Thus, concluded
the Texas Supreme Court, foreseeability was not in issue, and no proximate
cause instruction was required. |
| [49] | The Hoover rationale is applicable to the instant controversy. Although
this is, in a sense, a "pure drug" case like Cudmore, as we have
pointed out above, it involves no "abreaction". As we have also
concluded earlier, foreseeability -- both as to the possibilty of injuries
and the manner of dispensing the drug -- is not really in issue. In Hoover,
"foreseeability" was found by the jury; here it was established
as a matter of law. Hoover was not, of course, a "failure to warn"
case. The defect involved was intrinsic to the serum which felled the plaintiff's
cattle, a fact which may differentiate Hoover from extrinsic defect cases
where the product and defect are separable. See Keeton, Products Liability
-- Problems Pertaining to Proof of Negligence, 19 Sw.L.J. 26, 33 (1965).
Yet language in Technical Chemical Co. v. Jacobs, the recent Texas Supreme
Court examination of failure to warn, convinces us that even in this area,
a producing cause instruction will suffice in the circumstances of this
case. |
| [50] | Technical Chemical involved a suit against the manufacturer of a can of
freon which exploded in the plaintiff's hand as he attempted to put its
contents into the air conditioning unit of his automobile. It was apparent
from testimony adduced at trial that Jacobs, the plaintiff, inadvertently
and mistakenly attached a hose from the "high" pressure side of
his air conditioning compresser to the can of freon, rather than joining
a hose from the "low" pressure side, which was the proper procedure.
The can exploded, a possible result which the directions on the can's label
did not mention. Jacobs admitted, however, that he had not read the directions
on the can's label. In light of this fact, the jury refused to find that
Technical Chemical's failure to warn was a cause of Jacob's injuries. |
| [51] | In affirming the trial verdict, the Supreme Court of Texas held that it
was "incumbent upon the plaintiff to secure a jury finding that the
faulty labeling was a cause of the injury". This he had not done. 480
S.W.2d at 605. Moreover, a plaintiff who had not read such directions as
were provided could hardly expect the court to conclude that the manufacturer's
failure to provide further warnings caused his injury as a matter of law. |
| [52] | Although much of the Technical Chemical opinion speaks in absolute terms
of requiring proof that the defect caused the plaintiff's injuries, it also
recognizes how "speculative" testimony in this type of case is
likely to be and suggests an alternative approach, a legal "presumption
that an adequate warning would have been read". 480 S.W.2d at 606.
See Restatement (Second) of Torts, § 402A, comment j. As the court explained: |
| [53] | Such a presumption works in favor of the manufacturer when an adequate
warning is present. Where there is no warning, as in this case, however,
the presumption that the user would have read an adequate warning works
in favor of the plaintiff user. In other words, the presumption is that
Jacobs would have read an adequate warning. The presumption, may, however,
be rebutted if the manufacturer comes forward with contrary evidence that
the presumed fact did not exist. |
| [54] | 480 S.W.2d at 606. |
| [55] | Read together, Hoover and Technical Chemical suggest a test for cases
such as the one now before the Court: Where a consumer, whose injury the
manufacturer should have reasonably foreseen, is injured by a product sold
without a required warning, a rebuttable presumption will arise that the
consumer would have read any warning provided by the manufacturer, and acted
so as to minimize the risks. In the absence of evidence rebutting the presumption,
a jury finding that the defendant's product was the producing cause of the
plaintiff's injury would be sufficient to hold him liable. |
| [56] | Such a test makes sense in this case. The jury found that the defendant's
polio vaccine caused Anita Reyes's polio. Testimony by her mother as to
what she would have done, had proper warnings been provided, would have
been both speculative and self-serving. Thus we turn to the Technical Chemical
presumption that a warning, had it been given, would have been heeded. Buttressing
the presumption that Mrs. Reyes might have taken preventive steps is the
testimony of Reyes' expert, Dr. Ramiro Casson, that some pediatricians in
Hidalgo County, at least by the time of trial, had begun administering killed-virus
vaccine to infants in order to build up their level of antibodies before
feeding them the live-virus drug. Tending to rebut the presumption that
Mrs. Reyes would have behaved differently had she been warned was the fact
that she twice returned to the Mission Clinic for further doses of vaccine,
even after Anita contracted polio. Yet it is patent from her testimony that
Mrs. Reyes had not, even then, been informed of the danger of the polio
vaccine, and did not in fact understand what medication Anita was to receive.*fn30
The legal presumption suggested by the Technical Chemical opinion thus operates
here to provide the final element necessary to hold Wyeth Laboratories liable
for Anita Reyes' poliomyelitis. Aware of its unavoidable dangers and cognizant
that it foreseeably would not be dispensed as a prescription drug, Wyeth
nonetheless failed to warn Mrs. Reyes that its vaccine could cause polio
in some few of the millions receiving the medication. Administered without
a warning, the vaccine was "defective", hence unreasonably dangerous.
According to the test we have distilled above, we must assume in the absence
of evidence to the contrary that Anita's parents would have acted on the
warning, had it been given. Perhaps this would have prevented her polio.
It unquestionably would have avoided Wyeth's liability. |
| [57] | III. |
| [58] | Having concluded that Wyeth was properly held liable under substantive
law, we turn to procedural matters, specifically to Wyeth's objections to
the admission or exclusion of various testimony and exhibits, and to its
assertion that the evidence was insufficient to support the verdict for
the plaintiffs. |
| [59] | a) The Impeachment of Dr. Fox |
| [60] | Among the medical experts called to testify in Wyeth's behalf was Dr.
John D. Fox, Associate Dean and Professor of Epidemiology at the University
of Washington School of Public Health. On cross-examination, after Dr. Fox
had testified that Type III polio vaccine was less stable than either Type
I or Type II, counsel for the plaintiffs attempted to impeach his testimony
by reference to an uncertified transcript of an earlier trial in which Dr.
Fox had been called as a witness in Wyeth's behalf. There Dr. Fox had testified
that Type I polio vaccine was "unstable", with reference to its
"antigenic character", and Reyes's counsel attempted to show that
this earlier testimony contradicted Dr. Fox's testimony as to Type I's stability
here. Upon further inquiry, however, Dr. Fox was apparently successful in
explaining that his previous statement as to Type I's instability dealt
only with its "antigenic instability," that is, its tendency to
become an "unvaccine-like" strain, whereas his comments on the
instability of the Type III virus related to its propensity to cause polio
in monkeys or man. On appeal, Wyeth contends that this line of questioning
was improper and requires reversal, both because the testimony of an expert
cannot be impeached through the use of prior inconsistent statements and
because no proper foundation was laid. |
| [61] | We concur in Wyeth's conclusion that the law of Texas governs the conduct
of this type of impeachment. See Wright, Law of Federal Courts, § 94 at
412-15.*fn31 We cannot, however, read
the cases cited by the appellant as prohibiting cross-examination of expert
witnesses through the use of prior inconsistent testimony. Texas does not
bar impeachment of a lay witness through the use of testimony given by him
at a former trial.*fn32 |
| [62] | It is difficult to understand why this impeachment technique ought not
be available when the witness is an expert rather than a layman. Indeed,
it might be argued that prior inconsistency is a particularly appropriate
weapon for attacking expert testimony, since demonstration of the inconsistency
is designed not to show that the expert has erred, but that he is capable
of error. See Cirilo v. Cook Paint and Varnish Co., Tex.Civ.App.1972, 476
S.W.2d 742, 748, writ ref. n.r.e. Not surprisingly, then, Texas courts endorse
far-ranging cross-examination generally, and have permitted particularly
wide latitude in the interrogation of an adversary's expert. See Davidson
v. County of Harris, Tex.Civ.App.1970, 454 S.W.2d 830, 832, writ ref. n.r.e.
Thus in Hutson v. State, Tex.Cr.App.1956, 164 Tex.Cr.R. 24, 296 S.W.2d 245,
247-248, the prosecution was permitted to impeach the testimony of a county
sheriff as to the defendant's intoxication, by introducing a tape recording
(made shortly after the defendant's arrest) in which the sheriff voiced
an opinion contrary to that offered at trial. Also permitted in cross-examination
of real estate experts has been reference to earlier inconsistent appraisals
of land, the value of which is in issue.*fn33 |
| [63] | A similar standard should apply to expert medical testimony. Wyeth concedes
that a cross-examiner may properly inquire whether a medical expert has
previously testified on behalf of the party for whom he offers testimony.
But, Wyeth urges, any further foray into prior testimonial assertions is
forbidden by Texas law. We do not so read the Texas cases. To be sure, no
inquiry into the correctness of opinions expressed at earlier trials is
proper;*fn34 but an inconsistency, if
there is one, may be demonstrated. As we noted earlier, the purpose of such
impeachment is not to demonstrate that the expert has erred, but that he
is capable of error. An expert in medicine is not exempt from the use of
prior testimony to prove his fallibility. |
| [64] | Wyeth also urges that even if permitting the impeachment was proper, counsel
for Reyes failed to lay the proper foundation for the impeachment and that
therefore the court erred in allowing the cross-examination to proceed.
Texas courts and this Circuit have held that to impeach a witness by showing
a prior inconsistent statement, "a foundation must first be laid by
asking the witness whether he made the statement, giving him an opportunity
to admit or deny the statement, to correct his testimony, and to explain
the apparent contradiction".*fn35 |
| [65] | Yet it is Reyes's attempt to lay precisely such a foundation to which
Wyeth takes exception here. Dr. Fox's attention was drawn to his testimony
in Davis v. Wyeth Laboratories, Inc., 9 Cir. 1968,
399 F.2d 121,
and he was given an opportunity to examine the uncertified transcript relied
upon by Reyes, out of the sight of the jury and during a luncheon recess.
When court reconvened, under questioning by counsel for Reyes, Dr. Fox testified
that the transcript, although "somewhat inaccurate" did contain
the substance of his prior testimony. He then explained at length why his
former statements were in no way inconsistent with his testimony on direct
examination here. Wyeth continually objected to this attempt to lay a foundation
on the ground that no foundation had been laid. Overruling such objections
cannot constitute reversible error. |
| [66] | b) The Exclusion of Dr. Nakano's Opinion |
| [67] | Dr. James Nakano, a virologist and the Chief of the Poliovirus Strain
Characterization Laboratory in Atlanta, Georgia, was allowed to testify
that, based on his analysis of Anita's stool specimens, he had concluded
that the etiological agent causing her paralysis was probably a "wild
strain". The trial court, however, refused to allow Dr. Nakano, who
is not a physician, to advance his opinion as to "the probable cause
of Anita Reyes's paralysis". Asserting that this ruling constitutes
reversible error, Wyeth points out that another of its experts who is also
not a practicing physician was permitted to render an opinion as to the
cause of Anita's condition, as were several other experts who based their
conclusions on Dr. Nakano's laboratory findings. Aside from indicating that
any error in the exclusion of Dr. Nakano's testimony was probably harmless,
such arguments have little force. As we concluded in another Texas diversity
action: |
| [68] | Generally, the admission of . . . tendered expert testimony is a matter
within the sound discretion of the trial court, and the action of the trial
court in admitting or excluding such evidence will be sustained unless clearly
and manifestly erroneous. |
| [69] | Scott v. Fancher, 5 Cir. 1966,
369 F.2d 842,
844. It is at least arguable that the effect of a disease virus on a particular
human being whom he had not examined was outside of the scope of Dr. Nakano's
expertise. In any event, in light of all of the testimony on the issue,
the exclusion of his testimony was not so "clearly and manifestly erroneous"
as to constitute reversible error. |
| [70] | c) The Admission of Exhibit 13 |
| [71] | Wyeth vigorously excepts to the admission into evidence of Plaintiff's
Exhibit Number 13, a document purporting to detail the suspected and confirmed
cases of polio which occurred in Hidalgo County during 1970, on the ground
that counsel for Reyes failed to lay the proper foundation for admission
of the document under the "business records" exception to the
hearsay rule. |
| [72] | Exhibit 13 was first referred to during the cross-examination of Mrs.
Ruth McDonald, Director of Nursing for the Hidalgo County Health Department.
On direct examination, Mrs. McDonald testified that the County Health Department
kept statistics and records on communicable diseases and immunization of
the population in Hidalgo County and that her "employer" was Dr.
Copenhaver, director of the Public Health Unit in Hidalgo and Cameron Counties.
On cross-examination she was shown the challenged exhibit, and testified
that she had seen the report previously, "when it was made up".
Mrs. McDonald also identified certain writing on the exhibit as Dr. Copenhaver's
handwriting. This tended to link Wyeth with the vaccine given Anita Reyes.
The Exhibit was marked "Plaintiff's 13" for identification, but
was not offered in evidence. |
| [73] | The following day, Oscar Garza, another defense witness, who is a Health
Programs Specialist for the Texas State Department of Health, was confronted
with Plaintiff's Exhibit 13 on cross-examination. Exhibit 13 appeared to
bear a strong similarity to a list prepared by Mr. Garza, although Mr. Garza's
list evidently did not show all of the same entries, and exhibited none
of the handwriting previously identified as Dr. Copenhaver's. Mr. Garza
demonstrated a general familiarity with the information contained in Exhibit
13, but under interrogation by counsel for Wyeth, he testified that the
list was not a record prepared or retained in the regular course of business
of his office. Exhibit 13 was then offered in evidence by Reyes's counsel,
and Wyeth objected on the ground that a proper foundation had not been laid.
After a colloquy which revealed that the challenged exhibit had been appended
to Dr. Copenhaver's deposition in accordance with a request that he submit
all relevant records, the trial court decided that the record had been sufficiently
authenticated to justify admission. |
| [74] | The considerable Texas authority Wyeth marshals to support its position
is of little aid, for its assumption that Texas law controls our review
of the trial court's decision is erroneous. While state standards may be
found to apply to evidentiary issues in federal courts, such questions are
governed by federal standards in general, and by Fed.R.Civ.P. 43(a) in particular.
Bailey v. Kawasaki-Kisen, K.K., 5 Cir. 1972,
455 F.2d 392,
397. Rule 43(a) provides: |
| [75] | (a) Form and Admissibility. |
| [76] | In all trials the testimony of witnesses shall be taken orally in open
court, unless otherwise provided by these rules. All evidence shall be admitted
which is admissible under the statutes of the United States, or under the
rules of evidence heretofore applied in the courts of the United States
on the hearing of suits in equity, or under the rules of evidence applied
in the courts of general jurisdiction of the state in which the United States
court is held. In any case, the statute or rule which favors the reception
of the evidence governs and the evidence shall be presented according to
the most convenient method prescribed in any of the statutes or rules to
which reference is herein made. The competency of a witness to testify shall
be determined in like manner. |
| [77] | We are less sanguine than the appellants in assuming that Texas courts
would not admit this exhibit as a business record.*fn36
We are aware also that it is at least arguably admissible under the Federal
Business Records Act.*fn37 Yet neither
a protracted statutory analysis nor the precarious Erie ruminations characteristic
of such close cases is necessary to approve the admission of Exhibit 13
here. Rather, Rule 43(a), itself, perceived through the liberal prism of
our earlier decisions, furnishes the basis for Exhibit 13's admission. Plainly
enough, the Rule is a standard of admission not exclusion; all doubts are
to be resolved in favor of admissibility,*fn38
and even evidence not perceived as admissible when viewed through the receptive
trifocals of Rule 43(a), is not necessarily to be excluded.*fn39
This expansive standard was conceived in Monarch Insurance Co. v. Spach,
5 Cir. 1960,
281 F.2d 401,
411, and born in Dallas County v. Commercial Union Assurance Co., 5 Cir.
1961,
286 F.2d 388,
395, decisions which point the way to our approval of the admission of Exhibit
13 here. |
| [78] | In Monarch Insurance, the Court faced the difficulty of interpreting Rule
43(a)'s sanction of evidence admissible "under the rules of evidence
heretofore applied in the courts of the United States on the hearing of
suits in equity". On its face, this formula might be read as endorsing
admission of only that evidence admissible under specific pre-1938 equity
precedents. But the notion that in order to admit such evidence the court
must pore over ancient volumes in search of pre-Federal Rules dogma was
firmly interred, so far as this Court is concerned, by Monarch Insurance.
Judge, now Chief Judge Brown, writing for the Court, pointed out that the
district court sits as a court of equity, and the trial judge is not pinioned
to pre-1938 holdings: "his chief censor is the conscience of a Chancellor."
Dallas County v. Commercial Union Assurance Co.,
286 F.2d 388,
395.*fn40 Moreover, not only did Monarch
Insurance greatly expand the scope of evidence admissible within the strictures
of Rule 43(a), it also signalled the advent of a still more liberal standard
by suggesting that the Rule "does not purport to prohibit the admission
of other relevant material probative evidence which, in the considered exercise
of judicial wisdom, is trustworthy".
281 F.2d at 411.
|
| [79] | The other shoe was dropped a year later in Dallas County v. Commercial
Union Assurance Co., when we flatly held that a federal court is not required
to cram proffered evidence into one of Rule 43(a)'s pigeonholes in order
to find it admissible. Nor must the court find that the exhibit or testimony
is within a "readily identifiable and happily tagged" exception
to the hearsay rule to admit it.
286 F.2d at 398.
Rather, in the words of Dallas County, if the exhibit is "necessary
and trustworthy, relevant and material", the trial judge is free to
exercise his discretion and admit it, so long as he keeps the hearing within
reasonable bounds.
286 F.2d at 394,
398; Price v. United States, 5 Cir. 1964,
335 F.2d 671,
677. |
| [80] | From our review of the transcript it is plain that reception of Exhibit
13 posed no threat to the proper conduct of the trial. Neither party contests
the exhibit's materiality or relevance; indeed the damage which the appellants
allege resulted from its admission establishes those characteristics beyond
any doubt. Since Exhibit 13 was "necessary and trustworthy", it
was properly admitted under the liberal Dallas County standard. |
| [81] | Supporting this conclusion are several post- Dallas County decisions by
this Court. In Butler v. Southern Pacific Co., 5 Cir. 1970,
431 F.2d 77,
80, cert. denied, 1970,
401 U.S. 975,
91 S. Ct. 1196,
28 L. Ed. 2d 325,
a proffered report was held to be necessary because information in it went
"to the heart of the case" and it was trustworthy because it was
in the "direct financial interest" of the maker of the report
to prepare it accurately. In the other instance, Sabatino v. Curtiss National
Bank, 5 Cir. 1969,
415 F.2d 632,
636, cert. denied, 1970,
396 U.S. 1057,
90 S. Ct. 750,
759,
24 L. Ed. 2d 752,
trustworthiness was revealed both by the financial interest of the keeper
of the record in its accuracy, and the fact that it "was kept according
to a regular procedure of entries made contemporaneously with the events
it recorded". There was no question of necessity; the sponsoring witness
was dead. |
| [82] | So analyzed, the report at issue here was properly admitted. The report
of suspected and confirmed polio cases, inscribed with the word "Wyeth,"
was crucial in linking Wyeth to the vaccine which allegedly caused Anita
Reyes's polio. Although it does not appear from the record why Dr. Copenhaver
did not testify at trial, we do not believe that Reyes was required to demonstrate
his unavailability in order to meet the necessity test. Cf. Butler v. Southern
Pacific Co.,
431 F.2d 77,
80. There were also sufficient indicia of trustworthiness to justify admission.
Nurse McDonald testified that she had witnessed the report's preparation,
and that it was laden with Dr. Copenhaver's handwriting. The motivation
for accuracy in a record prepared by a public health official concerning
outbreaks of serious disease within an area committed to his charge is obvious.
A brand of expertise sufficient to insure accuracy may be assumed; there
can be no suggestion that in analyzing poliomyelitis cases Hidalgo County
Public Health officials were amateurish or careless. The notation as to
the origin of the lot number of the vaccine ingested by Anita Reyes shares
this reasonable presumption of accuracy. Exhibit 13, necessary and trustworthy,
met this Court's strictures for admission. |
| [83] | d) The Sufficiency of the Evidence |
| [84] | Finally, we confront the appellant's contentions that the trial court
erred in denying its motions for a directed verdict, for judgment notwithstanding
the verdict, and for a new trial. One argument urged by Wyeth in support
of this conclusion -- that there was no evidence that Wyeth had a duty to
warn Anita Reyes -- we discussed in dealing with the substantive law. Thus
here we need consider only the contentions that the evidence was insufficient
to support the verdict and judgment, that the verdict was the result of
passion and prejudice, and that it was against the clear weight of the evidence. |
| [85] | The yardstick against which such motions must be measured is a federal
one: |
| [86] | On motions for directed verdict and for judgment notwithstanding the verdict
the Court should consider all of the evidence -- not just that evidence
that supports the non-mover's case -- but in the light and with all reasonable
inferences most favorable to the party opposed to the motion. If the facts
and inferences point so strongly and overwhelmingly in favor of one party
that the Court believes that reasonable men could not arrive at a contrary
verdict, granting of the motions is proper. On the other hand, if there
is substantial evidence opposed to the motions, that is, evidence of such
quality and weight that reasonable and fair-minded men in the exercise of
impartial judgment might reach different conclusions, the motions should
be denied, and the case submitted to the jury. |
| [87] | Boeing Co. v. Shipman, 5 Cir. 1969,
411 F.2d 365,
374. As an appellate court, our sole function is to ascertain whether there
is a rational basis in the record for the jury's verdict; we are forbidden
to usurp the function of the jury by weighing the conflicting evidence and
inferences and then reaching our own conclusion.*fn41 |
| [88] | There was conflicting testimony as to the cause of Anita Reyes's polio.
In answer to a special interrogatory, the jury found, despite the testimony
of Wyeth's expert witnesses to the contrary, that Anita's polio was vaccine-induced.
Essentially Wyeth complains that the jury credited the testimony of the
physician who treated Anita Reyes rather than evidence offered by its parade
of experts. Presented with conflicting credible evidence, such a determination
was within the jury's prerogative; expert witnesses appear to assist in
the court's decision-making process, not to control it. Houston Natural
Gas Corp. v. Pearce, Tex.Civ.App.1958, 311 S.W.2d 899, 909, writ ref. n.r.e.;
see Steakley, Expert Medical Testimony in Texas, 1 St. Mary's L.J. 161-162
(1969). The rule is the same in the Fifth Circuit. See Alman Brothers Farm
& Seed Mill, Inc. v. Diamond Laboratories, Inc., 5 Cir. 1971,
437 F.2d 1295,
1298. The evidence for Wyeth was somewhat persuasive; there is no doubt
about it. The evidence for Reyes was substantial and at least as persuasive,
looking at the record coldly. Consequently, the trial court was guilty of
no error in denying Wyeth's motions for a directed verdict and judgment
n.o.v. Denial of a motion for a new trial will be reversed only upon showing
of clear abuse of discretion by the trial court, Davis v. Yellow Cab Co.,
5 Cir. 1955,
220 F.2d 790,
791. In light of the conflicting evidence, the denial of the motion reveals
no abuse here. |
| [89] | IV. |
| [90] | Finally, we come to a series of contentions under the general heading
of challenges to comments, instructions, and charges by the trial judge.
Some of these have already been considered. Remaining are Wyeth's objections
to specific instructions by the trial court, particularly: (1) its definition
of the term "epidemic," (2) its failure to define "medically
cognizable risk," and (3) its failure to instruct the jury as to the
issue of "relative risk". |
| [91] | Federal courts apply their own rules*fn42
in the manner and method of charging the jury. Where state rights are involved,
state law must, of course, be looked to for the substance of the instructions,
but the form of the charges and the language employed to convey the substance
are procedural, hence federal, concerns. See 9 C. Wright & A. Miller,
Federal Practice and Procedure, § 2255 at 651 (1971). Where as here, the
issues are submitted upon a general verdict to be accompanied by answers
to specific interrogatories, the Federal Rules provide simply that, "the
court shall give such explanation or instruction as may be necessary to
enable the jury to make answers to the interrogations and to render a general
verdict. . . ."*fn43 Not surprisingly,
then, while a litigant is entitled to have the trial judge advise the jury
of his theories and claims (to the extent they are supported by the evidence
adduced at trial), the actual form of the instructions is within the trial
court's discretion. Counsel cannot, therefore, require that an instruction
be rendered in the categorical language that he fancies would be most beneficial
to his cause.*fn44 |
| [92] | To requests for use of specific verbal formulae, definitions, or synonyms
a rule of reason should apply. Unadorned language comprehensible to the
average juror, not legal jargon, should characterize the instructions. Words
familiar to persons of average intelligence do not require definition.*fn45
In reviewing the linguistic choices made by the trial court, the charge
must be read as a whole. An ambiguous phrase or inaccurate clause does not
necessarily destroy an entire instruction. Delancey v. Motichek Towing Service,
Inc., 5 Cir. 1970,
427 F.2d 897,
901. Rather, the test is whether the charge, viewed as a whole, was sufficiently
clear and accurate to be understood by jurors of ordinary intelligence,
and to be applied by them to the evidence so as to reach a proper conclusion.*fn46 |
| [93] | Wyeth's objections to the instructions here do not present serious difficulties.
The appellant first contends that the issue whether there was a polio epidemic
in the Rio Grande Valley at the time Anita Reyes contracted the disease
should never have been presented to the jury, and, alternatively, that the
trial judge's definition of the term "epidemic" was erroneous.
It is manifest that both arguments center on the definitional dispute. Wyeth
produced eight expert medical and epidemiological witnesses, each of whom
testified that in his opinion a polio epidemic existed in Hidalgo County,
Texas in May 1970. To arrive at this conclusion, Wyeth's experts employed
an "epidemiological definition" of epidemic, according to which
two cases within a given city, county, or metropolitan area in a four week
period may constitute a polio epidemic.*fn47
Dr. Ramiro R. Casso, the Hidalgo County general practitioner who testified
as Reyes's medical expert, referred to a medical dictionary to define "epidemic"
as "[disease] attacking many people in any region at the same time".*fn48
From a review of its comments during the trial it is apparent that the court,
properly, did not consider itself bound by either definition,*fn49
although in its instructions to the jury the court employed a definition
not unlike that read from the medical dictionary by Dr. Casso.*fn50 |
| [94] | Here the question whether there was an epidemic in Hidalgo County during
the relevant period bore directly on an ultimate issue of fact: Did Anita
Reyes contract polio from a wild virus strain or from the defendant's vaccine?
In light of its importance, the trial judge submitted the "epidemic"
issue to the jurors; they had heard the conflicting testimony. He defined
"epidemic" in terms pertinent to determining the question of causation.
He declined to use Wyeth's "epidemiological definition", a definition
that might have confused the jurors. He did not abuse his discretion in
doing so. The substance of the charge was correct, and the appellants were
not entitled to an instruction in the specific terms they desired. |
| [95] | Wyeth objected to the trial court's failure to define the term "medically
cognizable risk" used in Interrogatories Nos. 3 and 4 and its failure
to charge the jury on the issue of "relative risk". Wyeth insists
that a definition of "medically cognizable risk" was necessary
to insure that the jury would realize that there had to exist some danger
or risk from the vaccine in order to conclude that Wyeth had a duty to warn. |
| [96] | Yet whatever the form of the interrogatories, the link between "medically
cognizable risk" and "duty to warn" was made clear by the
court's instructions.*fn51 It appears
to us that the challenged interrogatories were neither confusing nor misleading: |
| [97] | "INTERROGATORY NO. 3 |
| [98] | "Do you find from a preponderance of the evidence that on May 8,
1970, there was a medically cognizable risk that Anita Reyes might contract
paralytic polio by taking trivalent oral vaccine? |
| [99] | "The jury will answer 'there was a risk' or 'there was not a risk'." |
| [100] | "INTERROGATORY NO. 4 |
| [101] | "Do you find from a preponderance of the evidence that there was
a medically cognizable risk that Anita Reyes might contract paralytic polio
by taking the vaccine after March 31st, and before November 1, 1970? |
| [102] | "The jury will answer 'there was a risk' or 'there was not a risk'." |
| [103] | The terms "medically cognizable risk" is self-defining, clear,
and comprehensive to men of average intelligence; it need not be belabored
in jury instructions. Use of these interrogatories did not prejudice Wyeth's
presentation of its case. |
| [104] | Wyeth contends that the trial court should have instructed the jury to
consider the "relative risk" of contracting polio from the vaccine
as opposed to contraction from a natural source. This, Wyeth argues, would
have presented the question more fairly than did the charge on "medically
cognizable risk", for the jury would have weighed the probabilities
that Anita Reyes was paralyzed by vaccine-induced rather than "wild"
polio virus. Yet this is precisely the consideration invited by Interrogatories
3 and 4. The distinction, therefore, is verbalistic rather than substantial
and to have refused to charge in the words Wyeth preferred constitutes no
error. |
| [105] | In two lengthy sections of its brief, Wyeth attacks the trial court's
summary of the evidence in the course of instructing the jury and cites
as prejudicial various comments advanced by the court during the trial.
More specifically, Wyeth excepts to the court's comments on the evidence
in explaining the first two interrogatories to the jury,*fn52
and the court's discussion of the preponderance of the evidence standard.*fn53
Wyeth asserts that in each instance the court's summary of the evidence
unfairly emphasized Reyes's theory of the case at the expense of its own.
We disagree with Wyeth's assertion. Federal trial courts have a proper discretion
in summarizing and commenting upon the evidence in an effort to expedite
the jury's determination of factual issues. See, e.g., Trezza v. Dame, 5
Cir. 1967,
370 F.2d 1006,
1008-1009. Indeed, explanatory comments are prejudicial only when the court
fails to make clear to the jurors that they alone have the burden of decision.
See Stuckey v. Andrews, 5 Cir. 1957,
249 F.2d 828;
11 C. Wright & A. Miller, supra, § 2886 at 292-294 and n. 73. Here the
trial court went to great lengths to impress upon the jurors that they were
the exclusive arbiters of the facts, the sole judges of the witnesses' credibility.*fn54
Since we also conclude that the summaries and comments upon the evidence
were basically fair, we find no ground for reversal here. |
| [106] | Finally, Wyeth contends, in an argument bolstered by twenty-three detailed
references to the trial transcript, that the cumulative effect of the trial
court's comments on the evidence and sympathetic references to Anita Reyes
so prejudiced its case as to require reversal. We shall not attempt to consider
the challenged comments separately. We have examined the transcript from
beginning to end. We have paid particular attention to the court's instruction
to the jury. We hold that the court's comments were generally designed to
fulfill its responsibility to keep the trial progressing on course and at
a proper pace. A trial judge takes no vow of silence; he vows to follow
the law, to be fair, and to serve as an arbiter in the interests of justice.
See Nordmann v. National Hotel Co., 5 Cir. 1970,
425 F.2d 1103,
1109. We consider that the trial judge conducted a fair trial. Nevertheless,
we do not approve of the trial judge's over-frequent references to Anita
Reyes as "this little girl". It was obvious to all that Anita
was a little girl. And she was the victim of a great tragedy. But judges
must steel themselves to avoid any comment that a jury might construe as
bias in favor of any "little girl", or any injured claimant. Here,
a thorough examination of the transcript, consideration of the trial judge's
rectitude throughout the trial, and the trial judge's curative instruction*fn55
to the jury convince us that his references to Anita as "this little
girl" were not so harmful to Wyeth's cause as to constitute reversible
error. |
| [107] | V. |
| [108] | In closing, we feel that we should comment on the important policy considerations
raised in the briefs of the amici curiae, the American Academy of Pediatrics
[AAP] and the Conference of State and Territorial Epidemiologists [CSTE].
Both insist that the holding we reached is "dangerous" to the
nation's preventive medicine programs and contravenes a strong public policy
favoring large-scale participation in immunization efforts to combat infectious
disease. The crucial points of the argument are two: first, that any effort
to warn vaccinees will be futile and frightening, leading only to confusion,
and second, that a warning is unnecessary once epidemiologists have reached
a deliberate medical judgment that universal vaccination is necessary. These
public health policy questions cut across the law. We realize their importance. |
| [109] | Citing a recent Texas statute which requires that all Texas schoolchildren
receive polio vaccine,*fn56 the AAP
insists that this renders any warnings futile. This argument assumes, of
course, that the only options available are to ingest the oral vaccine at
the clinic or to eschew immunity. Obviously, however, one can choose to
be innoculated with killed-virus Salk vaccine, either to provide complete
immunity or as a precautionary prelude to ingesting oral vaccine. The AAP
also insists that the warnings would be so complex or misleading as to confuse
and frighten potential vaccinees. This is possible. Yet we believe that
a warning advising a patron of a public health clinic of the relative risk
of contracting polio from a "wild" source against the slight chance
of contracting it from the vaccine would not be terrifying or confusing.
Some would be sufficiently concerned to take the Salk vaccine innoculation.
Others, perhaps those who, like the plaintiff in Davis, have as great a
chance of contracting polio from the vaccine as contracting it from a wild
source, will undoubtedly be deterred from immunization. The AAP's answer
to this problem is to warn no one. That is no answer. |
| [110] | This position raises a policy consideration scarcely less urgent than
the need for mass immunization from disease; the right of the individual
to choose and control what risk he will take, in the absence of an individualized
medical judgment by a physician familiar with his needs and susceptibilities.
Recognition of this right counters the argument advanced in the CSTE's brief
that once an epidemiological balancing of the risks of immunization has
been made, no warning is required. Clearly, the rationale excusing warnings
to ultimate consumers of prescription drugs whose physicians have balanced
the risk for them, cannot be extended to a medical determination that statistical
probabilities justify universal immunization. In such cases, the test is
that outlined in Davis : |
| [111] | When . . . the risk qualitatively (e.g., of death or major disability)
as well as quantitatively, on balance with the end sought to be achieved,
is such as to call for a true choice judgment, medical or personal, the
warning must be given. |
| [112] |
399 F.2d at 129-130. Here,
the qualitative risk was great, the quantitative risk minute. The end sought
to be achieved -- immunization -- is important both to the individual and
society. Striking the balance in this case is difficult, but by adding two
elements to the Davis calculus we conclude that a sufficient "true
choice judgment" was involved here to lend strong policy support to
our holding. First, the risk here was foreseeable statistically, although
unknowable individually. Thus, unlike the abreaction cases, here there was
a basis for rational choice. Second, a choice here, if given, had an opportunity
to be efficacious, since reasonable alternatives to taking the oral vaccine
were available. Therefore, the choice was not so clear cut that even offering
the opportunity to choose was meaningless. |
| [113] | Moreover, there is a third policy factor at work here, overlooked by the
amici: |
| [114] | Until Americans have a comprehensive scheme of social insurance, courts
must resolve by a balancing process the head-on collision between the need
for adequate recovery and viable enterprises. . . . This balancing task
should be approached with a realization that the basic consideration involves
a determination of the most just allocation of the risk of loss between
the members of the marketing chain. |
| [115] | Helene Curtis Industries, Inc. v. Pruitt, supra,
385 F.2d at 862.
Statistically predictable as are these rare cases of vaccine-induced polio,
a strong argument can be advanced that the loss ought not lie where it falls
(on the victim), but should be borne by the manufacturer as a foreseeable
cost of doing business, and passed on to the public in the form of price
increases to his customers.*fn57 |
| [116] | Contrary to the assertions of the AAP and the CSTE, we feel strongly that
our holding is in accord with public policy considerations. We recognize
both the essential role the city health clinic and the rural county clinic
play in the nation's public health scheme, and the dangers that their depersonalized
medical treatment pose.*fn58 We do not
then, lay down an absolute duty to warn all who receive medication at public
clinics. Instead, we hold that in the case of a prescription drug which
is unavoidably unsafe, and as to which there is a certain, though small,
risk throughout the population, there must be either a warning -- meaningful
and complete so as to be understood by the recipient -- or an individualized
medical judgment that this treatment or medication is necessary and desirable
for this patient. Anita's parents received neither. Wyeth is therefore liable
for the consequence of its failure to market its unavoidably unsafe product
in such a way as to warn Anita's parents of its unreasonably dangerous condition. |
| [117] | The judgment is affirmed. |
| [118] | APPENDIX A: INTERROGATORIES |
| [119] | The interrogatories submitted to the jury and the jury's answers are as
follows: |
| [120] | INTERROGATORY NO. 1 |
| [121] | Do you find from a preponderance of the evidence that Anita Reyes received
a polio vaccine from Defendant Wyeth's Lot No. 15509? |
| [122] | The Jury will answer "She did" or "She did not". |
| [123] | We, the Jury, answer: She did. |
| [124] | INTERROGATORY NO. 2 |
| [125] | Do you find from a preponderance of the evidence that Anita Reyes contracted
paralytic polio as a result of having taken Defendant's vaccine? |
| [126] | The Jury will answer "She did" or "She did not". |
| [127] | We, the Jury, answer: She did. |
| [128] | If you answered this "She did not", then you need not answer
any other issue. |
| [129] | INTERROGATORY NO. 3 |
| [130] | Do you find from a preponderance of the evidence that on May 8, 1970,
there was a medically cognizable risk that Anita Reyes might contract paralytic
polio by taking Trivalent Oral Vaccine? |
| [131] | The Jury will answer "There was a risk" or "There was not
a risk". |
| [132] | We, the Jury, answer: There was a risk. |
| [133] | INTERROGATORY NO. 4 |
| [134] | Do you find from a preponderance of the evidence that there was a medically
cognizable risk that Anita Reyes might contract paralytic polio by taking
the vaccine after March 31st, and before November 1, 1970? |
| [135] | The Jury will answer "There was a risk" or "There was not
a risk". |
| [136] | We, the Jury, answer: There was a risk. |
| [137] | If you have answered either or both Interrogatories No. 3 and 4 "There
was a risk", then you will answer the following Interrogatory. |
| [138] | INTERROGATORY NO. 5 |
| [139] | Do you find from a preponderance of the evidence that the Defendant Wyeth
failed to warn the parents of Anita Reyes of the risk that you have found,
so that they could make their choice? |
| [140] | The Jury will answer "They failed" or "They did not fail". |
| [141] | We, the Jury, answer: They failed. |
| [142] | INTERROGATORY NO. 6 |
| [143] | What sum of money, if paid now in cash, would compensate Anita Reyes for
the injuries sustained by her? |
| [144] | The Jury will answer in dollars and cents. |
| [145] | We, the Jury, answer: $200,000.00. |
| [146] | APPENDIX B: POLIOMYELITIS |
| [147] | It was not until about 1950 that scientists and physicians really began
to understand how poliomyelitis attacks its victims. They learned that polio
is caused by an enterovirus which grows in the intestinal tract, but that
the virus is introduced into the body orally, through the mouth. After entering
the body, the virus reproduces rapidly in the alimentary tract, and when
it reaches the lower intestinal tract its growth causes what could be termed
an "infection". This does not mean that the individual "infected"
has contracted polio; upwards of 80 percent of the population is naturally
immune to polio virus, and only about one of every hundred persons who experience
the intestinal viral infection will later manifest clinical symptoms of
polio. When disease does result, medical scientists believe, the virus moves,
perhaps through the bloodstream, from the intestinal tract or alimentary
tract to the spinal column, where it attacks the anterior horn cells, the
"grey matter" within the spinal column. Destruction of sufficient
"grey matter" will result in "motor neuron disease",
that is, muscular paralysis. |
| [148] | The initial problem facing researchers attempting to develop a vaccine
-- cultivation of a growth of polio virus in tissue outside the body --
was solved by Dr. Enders at Harvard University in 1949. The scientists also
learned that polio virus was of three distinct types, and that to provide
effective protection, a vaccine would have to immunize the vaccinee to all
three types.*fn59 The first breakthrough
resulted from the research of Dr. Jonas Salk, who perfected a "killed
virus" vaccine to be administered by innoculation. To produce this
vaccine, polio virus is grown in a tissue culture and clinically "killed",
that is, rendered incapable of causing disease. In killing the virus, however,
no chemical alteration occurs and when it is introduced into the body in
the vaccine, the virus acts as an antigen to prompt the production of antibodies.
Should a wild or virulent strain of polio virus enter the bloodstream, the
antibodies generated as a reaction to the vaccine will destroy it, and the
vaccinee will avoid polio. |
| [149] | In 1955 after extensive tests were conducted under the auspices of The
National Foundation for Infantile Paralysis (March of Dimes) the researchers
concluded that the Salk vaccine was effective and, if the virus were killed,
completely safe.*fn60 The Salk vaccine
then became the primary weapon against polio. But the killed virus vaccine
nonetheless exhibited several drawbacks. It had to be injected by hypodermic
needle, and a separate innoculation was required for each type of polio
virus, as were repeated "booster" injections. Most importantly,
perhaps, the Salk vaccine failed to immunize the intestinal tract of the
vaccinee. Thus, individuals themselves immunized could still pass the virus
to non-immune persons with whom they came in contact. These limitations
led to efforts to produce a completely effective oral vaccine, the most
successful of which was that of Dr. Albert Sabin. Developed in the middle
and late 1950's, the Sabin oral vaccine introduced living but attenuated
polio virus into the recipient's system. An attenuated polio virus is one
which laboratory processes have rendered incapable of producing disease
(to the extent of attenuation), but which retains sufficient strength to
cause the production of antibodies to resist and destroy an attacking wild
or virulent polio virus in the vaccinee's alimentary tract. Three types
of "monovalent" vaccines were developed, one to deal with each
type of polio virus, but through a "titering" or mixing process,
a single "trivalent" oral vaccine can be produced which, upon
ingestion, will provide protection against all three types of virus. |
| [150] | Like its "killed virus" predecessor, the Sabin vaccine was extensively
tested worldwide to determine whether it was safe and effective for general
use. When favorable results were achieved, the vaccine was licensed for
manufacture and sale in the United States by the Division of Biologic Standards
of the National Institute of Health [D.B.S.], an arm of the Department of
Health, Education and Welfare. Wyeth Laboratories was among the three original
licensees who were authorized to prepare and distribute the vaccine only
as a prescription drug. Irrespective of which licensee prepares the vaccine,
it is derived from a common source: a seed virus obtained from Dr. Sabin.
The "seed virus" from which Wyeth Laboratories vaccine is produced
was obtained from Dr. Sabin by Pfizer, Ltd., of England, and is repeatedly
reproduced by them in a culture of monkey tissue. Reproduction is rapid,
and the virus is frequently "harvested" and the vaccine prepared
in separate "lots". At this point Pfizer conducts extensive tests
on each lot to ensure that it is safe and effective. Once satisfied by its
laboratory findings, Pfizer ships the lot of vaccine to the D.B.S., where
it is again subjected to rigorous testing.*fn61
If the vaccine meets D.B.S. standards, it is released to the manufacturing
laboratory, where the vaccine is titered or mixed. |
| [151] | Despite careful preparation and testing, it is apparent that live virus
oral polio vaccine cannot be stripped of all danger. As early as January
1961, a subcommittee of a Health, Education and Welfare Department Committee
on Poliomyelitis Control expressed concern about the "known potentiality
of reversion to virulence of live poliovirus vaccine." A year and one-half
later, both a subcommittee of the Association of State and Territorial Health
Officers and the Surgeon General's own Special Advisory Committee on Oral
Poliomyelitis Vaccine, concluded that, at least where Type III oral vaccine
was concerned, a causal connection exists between administration of the
vaccine and the occurrence of poliomyelitis in some adults. Thus a "small
but definite risk" attaches in feeding Type III oral vaccine to adults.*fn62
By July 1964, with more data available, the Surgeon General's Special Committee
found that 15 cases of polio deemed compatible with vaccine causation had
followed ingestion of Type I vaccine, 2 had followed ingestion of Type II,
and 36 had followed ingestion of Type III. The Committee concluded that
"at least some of these cases were caused by the vaccine".*fn63
This is not to say that the Special Committee concluded that these cases
were produced by the vaccine; to the contrary, the members cautioned that
"no laboratory tests available can provide a definitive answer".
Rather, they employed a brief catalogue of symptoms*fn64
which they believed would separate those cases compatible with vaccine-causation
from those clearly caused by wild strains, and would further separate the
"probable" vaccine-related cases from those merely possibly associated
with it.*fn65 |
| [152] | Disposition |
| [153] | The judgment is affirmed. |
|
|
|
| Opinion Footnotes | |
|
|
|
| [154] | *fn1 These statistics are drawn from
official reports of the United States Public Health Service. See Morbidity
and Mortality, Weekly Reports, Vol. 10, No. 53, Table 2, Page 4. (October
1962); Morbidity and Mortality, Weekly Reports, Vol. 19, No. 3, Table 2,
Page 4 (August 1971). |
| [155] | *fn2 The actual titering was performed
by Wyeth Laboratories, Inc., a separately incorporated subsidiary of American
Home Products, Inc. After this mixing process was complete the vaccine was
shipped to American Home Products' unincorporated Wyeth Laboratories Division
for distribution. Since both the division and the subsidiary are affiliates
of appellant American Home Products, Inc. they are referred to interchangeably
as "Wyeth" in the text. |
| [156] | *fn3 "Epidemiology", the field
of expertise of a number of Wyeth's experts, was defined in the defendant's
trial brief as a "specialized field of medicine dealing with public
health", which is "based on the observation of the occurrence
of disease and thereafter, by statistical methods trying to arrive at a
conclusion as to the possible source of the disease". |
| [157] | *fn4 Gravis v. Parke-Davis & Co.,
Tex.Civ.App.1973, 502 S.W.2d 863, 868-869; Cudmore v. Richardson-Merrell,
Inc., Tex.Civ.App.1965, 398 S.W.2d 640, 644, writ ref. n.r.e., cert. denied,
1967,
385 U.S. 1003,
87 S. Ct. 705,
17 L. Ed. 2d 542.
|
| [158] | *fn5 See Borel v. Fibreboard Paper Products
Corporation, 5 Cir. 1973,
493 F.2d 1076;
reh. denied, 1973. |
| [159] | *fn6 Strict liability is "hardly
more" than warranty stripped of its contractual trappings, Greeno v.
Clark Equipment Co., N.D.Ind.1965,
237 F. Supp. 427,
429. But if strict liability has supplanted warranty as the dominant doctrine,
Grinnell v. Charles Pfizer & Co., Cal.Ct.App.1969, 274 Cal.App.2d 424,
79 Cal.Rptr. 369, 373, the outcome of product liability actions, especially
where drugs are involved, does not appear to be a result of which theory
is relied upon by the parties. See Davis v. Wyeth Laboratories, 9 Cir. 1968,
399 F.2d 121,
126; Merrill, Compensation for Prescription Drug Injuries, 59 Va.L.Rev.
1, 31 (1973). |
| [160] | *fn7 See Prosser, The Assault Upon the
Citadel (Strict Liability to the Consumer), 69 Yale L.J. 1099, (1960); Prosser,
The Fall of the Citadel (Strict Liability to the Consumer) 50 Minn.L.Rev.
791 (1966). |
| [161] | *fn8 § 402A. Special Liability of Seller
of Product for Physical Harm to User or Consumer
(1) One who sells any product in a defective condition unreasonably dangerous
to the user or consumer or to his property is subject to liability for
physical harm thereby caused to the ultimate user or consumer, or to his
property, if (a) the seller is engaged in the business of selling such
a product, and (b) it is expected to and does reach the user or consumer
without substantial change in the condition in which it is sold. (2) The
rule stated in Subsection (1) applies although (a) the seller has exercised
all possible care in the preparation and sale of his product, and (b)
the user or consumer has not bought the product from or entered into any
contractual relation with the seller. |
| [162] | *fn9 The principle that sellers of food
and drink for human consumption should be held to a high level of responsibility
for any "corruption" in their wares is of medieval origin. Restatement
of Torts, (Second) Section 402A, comment b; Prosser, The Assault Upon the
Citadel (Strict Liability to the Consumer), 69 Yale L.J. 1099, 1103, (1960).
There is no point in rehashing the history of the products liability doctrine.
See, e.g., Professor Prosser's articles cited in Note 7, supra ; Ray, Wade,
P. Keeton, Noel, R. Keeton, and Whitmore, Products Liability -- A Symposium,
19 Sw.L.J. 1 (1965); Traynor, note 11, infra; Greenman v. Yuba Power Products,
Inc., Cal. Sup.1963, 59 Cal.2d 57, 27 Cal.Rptr. 697, 377 P.2d 897; Escola
v. Coca Cola Bottling Co., Cal.Sup.1944, 24 Cal.2d 453, 150 P.2d 436, 440
(Traynor, J., concurring). For recent articles on the Texas law of products
liability, see Holford, The Limits of Strict Liability for Product and Manufacture,
52 Tex.L.Rev. 81 (1973); Freedman, The Texas Politics of Today's Products
Liability, 5 St. Mary's L.J. 1 (1973); Schattman, A Cause of Action for
the Allergic Consumer, 8 Hou.L.Rev. 827 (1971). |
| [163] | *fn10 Although the Restatement speaks
in terms of "sellers", manufacturers of defective products are
also swept within its ambit, even where, as here, another party performs
the actual transfer of the offending product. See Section 402A, Comment
f. |
| [164] | *fn11 Borel v. Fibreboard Paper Products
Corp., 5 Cir. 1973,
493 F.2d 1076,
1087; Wade, Strict Tort Liability of Manufacturers, 19 Sw.L.J. 5, 14-15
(1965); Keeton, Product Liability and the Meaning of Defect, 5 St. Mary's
L.J. 30, 32 (1973). Justice Traynor goes still further. He has concluded
that there is no single satisfactory definition of "defect" which
will bear universal application. See Traynor, The Ways and Meanings of Defective
Products and Strict Liability, 32 Tenn.L.Rev. 363, 367 (1965). |
| [165] | *fn12 See, e.g., Alman Bros. Farm
and Feed Mill, Inc. v. Diamond Laboratories, Inc., 5 Cir. 1971,
437 F.2d 1295,
1302; Ross v. Up-Right, Inc., 5 Cir. 1968,
402 F.2d 943,
946; Helene Curtis Industries, Inc. v. Pruitt, 5 Cir. 1967,
385 F.2d 841,
855, cert. denied, 1968,
391 U.S. 913,
88 S. Ct. 1806,
20 L. Ed. 2d 652.
|
| [166] | *fn13 In a strict sense, Wyeth did
not "make" or manufacture the vaccine which caused Anita Reyes's
polio. The lot of trivalent vaccine was "titered" or mixed from
separate strains of Type I, Type II, and Type III monovalent vaccines manufactured
by Pfizer, Ltd. In the context of this case, however, we do not believe,
nor did Wyeth argue, that this fact in any way affects its liability. |
| [167] | *fn14 Thus this action does not involve
"defective" vaccine in the same sense as did Gottsdanker v. Cutter
Laboratories, Cal.App.1960, 182 Cal.App.2d 602, 6 Cal.Rptr. 320, an action
in which the producer of Salk "killed virus" vaccine was held
liable for the plaintiff's poliomyelitis caused by live virus inadvertently
present in its vaccine. |
| [168] | *fn15 This "per se as marketed"
distinction has been suggested by Dean Keeton. See e.g., Keeton, Products
Liability -- Inadequacy of Information, 48 Tex.L.Rev. 399, 406 (1970); Keeton,
Products Liability and Meaning of Defect, 5 St. Mary's L.J. 30, 38 (1973). |
| [169] | *fn16 Comment i to Section 402A elaborates:
I. Unreasonably dangerous. The rule stated in this Section applies only
where the defective condition of the product makes it unreasonably dangerous
to the user or consumer. Many products cannot possibly be made entirely
safe for all consumption, and any food or drug necessarily involves some
risk of harm, if only from over-consumption . . . . The article sold must
be dangerous to an extent beyond that which would be contemplated by the
ordinary consumer who purchases it, with the ordinary knowledge common
to the community as to its characteristics. |
| [170] | *fn17 Professor Wade suggests a rather
more complex calculus, with no fewer than seven variables:
Factors involved in making this determination include, among others,
the following: (1) the usefulness and desirability of the product, (2)
the availability of other and safer products to meet the same need, (3)
the likelihood of injury and its probable seriousness, (4) the obviousness
of the danger, (5) common knowledge and normal public expectation of the
danger (particularly for established products), (6) the avoidability of
injury by care in use of the product (including the effect of instructions
or warnings), and (7) the ability to eliminate the danger without seriously
impairing the usefulness of the product or making it unduly expensive.
19 Sw.L.J. at 17. Without elaborating, we believe that however scrutinized,
the oral polio vaccine was not "unreasonably dangerous per se",
for the reasons marshaled in the text. |
| [171] | *fn18 Comment k provides:
k. Unavoidably unsafe products. There are some products which, in the
present state of human knowledge, are quite incapable of being made safe
for their intended and ordinary use. These are especially common in the
field of drugs. An outstanding 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 itself invariably
leads to a dreadful death, both the marketing and the use of the vaccine
are fully justified, notwithstanding the unavoidable high degree of risk
which they involve. Such a product, properly prepared, and accompanied
by proper directions and warning, is not defective, 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 lack of time
and opportunity for sufficient medical 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 recognizable risk. The seller of such products, again with
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 product, attended with a known but apparently reasonable
risk. |
| [172] | *fn19 See Ford Motor Co. v. Russell
& Smith Ford Co., Tex.Civ.App.1971, 474 S.W.2d 549, no writ hist.; see
also, Rumsey v. Freeway Motor Minimax, Tex.Civ.App.1968, 423 S.W.2d 387,
393, no writ hist. Restatement (Second) of Torts, Section 402A, Comments
h and j (1965).
Comment h provides in pertinent part: h. A product is not in a defective
condition when it is safe for normal handling and consumption. If the
injury results from abnormal handling, as where a bottled beverage is
knocked against a radiator to remove the cap, or from abnormal preparation
for use, as where too much salt is added to food, or from abnormal consumption,
as where a child eats too much candy and is made ill, the seller is not
liable. Where, however, he has reason to anticipate that danger may result
from a particular use, as where a drug is sold which is safe only in limited
doses, he may be required to give adequate warning of the danger (see
Comment j), and a product sold without such warning is in a defective
condition. Comment j provides: j. Directions or warning. In order to prevent
the product from being unreasonably dangerous, the seller may be required
to give directions or warning, on the container, as to its use. The seller
may reasonably assume that those with common allergies, as for example
to eggs or strawberries, will be aware of them, and he is not required
to warn against them. Where, however, the product contains an ingredient
to which a substantial number of the population are allergic, and the
ingredient is one whose danger is not generally known, or if known is
one which the consumer would reasonably not expect to find in the product,
the seller is required to give warning against it, if he has knowledge,
or by the application of reasonable, developed human skill and foresight
should have knowledge, of the presence of the ingredient and the danger. |
| [173] | *fn20 See, e.g., Basko v. Sterling
Drug, Inc., 2 Cir. 1969,
416 F.2d 417,
426; Davis v. Wyeth Laboratories, 9 Cir. 1968,
399 F.2d 121,
130; Merrill, Compensating for Prescription Drug Injuries, supra note 6,
at 91. This approach has been adopted by at least one Texas court. See,
Gravis v. Parke-Davis, Inc., Tex.Civ.App.1973, 502 S.W.2d 863, 870. |
| [174] | *fn21 See, Schenebeck v. Sterling
Drug, Inc., 8 Cir. 1970,
423 F.2d 919,
922; Davis v. Wyeth, supra note 20,
399 F.2d at 130;
Sterling Drug, Inc. v. Cornish, 8 Cir. 1966,
370 F.2d 82,
85; Gravis v. Parke-Davis & Co., supra, note 20, 502 S.W.2d at 870,
56 Geo.L.J. 1016, 1018 (1968). |
| [175] | *fn22 See, Title 42 U.S.C. § 262(a);
42 C.F.R. §§ 73.200-73.240, 73.1020-73.1028. |
| [176] | *fn23 See, e.g., Wright v. Carter
Products, Inc., 2 Cir. 1957,
244 F.2d 53;
Johnston v. Upjohn Co., Mo.Ct.App.1969, 442 S.W.2d 93, 96; Bine v. Sterling
Drug Co., Mo.Sup.Ct.1968, 422 S.W.2d 623, 628; 2 F. Harper & F. James,
The Law of Torts § 28.4 (1956); 5 San Diego L.Rev. 422, 427 n. 18 (1968). |
| [177] | *fn24 There is considerable and respectable
authority at variance with the Texas position that immunizes a drug manufacturer
from liability to an idiosyncratic consumer. See, e.g., Davis v. Wyeth Laboratories,
supra note 20,
399 F.2d at 129;
Sterling Drug, Inc. v. Cornish, supra note 21,
370 F.2d at 85.
|
| [178] | *fn25 For a more detailed discussion
of various types of allergic reactions, and their legal significance, see,
Merrill, Compensating for Prescription Drug Injuries, 59 Va.L.Rev. 1 (1973);
Schattman, A Cause of Action for the Allergic Consumer, 8 Houston L.Rev.
827 (1971); Rheingold, Products Liability -- The Ethical Drug Manufacturer's
Liability, 18 Rutgers L.Rev. 947 (1964). |
| [179] | *fn26 A colloquy on requested instructions
between two attorneys for Wyeth and the court make the court's position
on the need to prove proximate cause clear:
MR. KADING: Then we believe that there should be an interrogatory between
number five and number six which makes this a matter of proximate cause.
In other words, to the effect asking the jury to find whether or not the
failure to warn was proximate cause of the consequences to this child
in view of the fact that even with warning they may have proceeded with
immunization, and in fact did so even after immunization here. And I suppose
for the purposes of the record I ought to ask the court to in effect resubmit
interrogatories that we submitted to the court before. MR. McKLVEEN: And
I think as to interrogatory number two dealing with producing cause rather
than causal cause the jury should be instructed that they should find
-- have to find first -- the product was not fit for the purpose for which
it was intended in order to get into proximate cause rather than producing
cause. THE COURT: Well, I have already stated at the beginning what my
feelings are in this case, that if there was a risk, if she did get it
from the vaccine, and you all failed to warn them about the risk so that
they could make a choice, that you are liable regardless. And I think
I have enough answers here. MR. FLORES: We have no objections. THE COURT:
I wouldn't mind giving the question of proximate cause but I don't think
it is necessary and you all tell me that you don't want it in there. |
| [180] | *fn27 The submission of interrogatories
accompanying a verdict is sanctioned by Fed.R.Civ.P. 49(b).
The trial judge's decision to submit the issues to the jury pursuant
to Rule 49(b) is within his discretion, and will be reversed only upon
a clear showing of abuse. See Abernathy v. Southern Pacific Co., 5 Cir.
1970,
426 F.2d 512.
|
| [181] | *fn28 E. g., Technical Chemical Co.
v. Jacobs, Tex.Sup.1972, 480 S.W.2d 602, 605; Kritser v. Beech Corp., 5
Cir. 1973,
479 F.2d 1089,
1091. |
| [182] | *fn29 E.g., Keeton, Products Liability
-- Inadequacy of Information, 48 Tex.L.Rev. 398, 413 (1970); Wade, Strict
Tort Liability of Manufacturers, 19 Sw.L.J. 5, 22, 25 (1965). |
| [183] | *fn30 On cross-examination, Mrs. Reyes
was asked about a card she had signed at the clinic which indicated that
she had returned after the onset of Anita's illness:
Q. And did you read that before you signed it? A. No, I didn't read it.
I just signed it. Q. I notice some other entries. Have you taken Anita
back for further immunization since the date of -- A. Yes. Q. What has
she been immunized for or vaccinated for since May 8, 1970? A. I don't
know. They just put it on there. Q. You just take her and they do it?
A. Yeah. They are the ones that know what they are going to put next. |
| [184] | *fn31 Professor Charles A. Wright
suggests that it may be necessary to look beyond the stark dictates of F.R.Civ.P.
43(a) to determine whether federal or state evidentiary standards ought
to be invoked in a given situation. Three types of evidentiary rules exist,
he postulates, and the choice between federal and state tests ought be made
on the basis of which type of rule a given bit of evidence invokes. First
are those rules which are of a merely "housekeeping" nature, here
federal standards can be applied without hesitation. Next are rules that
not merely regulate evidence, but are closely intertwined with the substantive
rights of the parties. Here state standards should be honored. Finally,
come state evidentiary rules specifically designed to effectuate an extrinsic
state policy. So long as the rules are successful in achieving that end,
they should be honored. The impeachment of an expert witness challenged
here, was, we conclude, so tied to Wyeth's attempt to prove its theory of
the case that substantive rights are at stake and Texas impeachment standards
must govern. See, C. Wright, Law of Federal Courts, § 94 at 412-415. |
| [185] | *fn32 Gabel v. Blackburn Operating
Corp., Tex.Civ.App.1969, 442 S.W.2d 818, 819, no writ hist.; Flowers v.
Central Power and Light Co., Tex.Civ.App.1958, 314 S.W.2d 373, writ ref.
n.r.e. |
| [186] | *fn33 See City of Garland v. Stevener,
Tex.Civ.App.1970, 462 S.W.2d 67, 69, writ ref. n.r.e.; City of Dallas v.
Holcomb, Tex.Civ.App.1964, 381 S.W.2d 347, 350, writ ref. n.r.e. |
| [187] | *fn34 Horton v. Houston & T.C.
Ry. Co., 1907, 46 Tex.Civ.App. 639, 103 S.W. 467, 469, writ ref.; Traders
& General Ins. Co. v. Robinson, Tex.Civ.App.1949, 222 S.W.2d 266, 269,
writ ref. |
| [188] | *fn35 Ray v. Gage, Tex.Civ.App.1954,
269 S.W.2d 411, 419, writ ref.; Robertson v. M/S Sanyo Maru, 5 Cir. 1967,
374 F.2d 463,
465, cert. denied, 1970,
400 U.S. 854,
91 S. Ct. 59,
27 L. Ed. 2d 91;
Burton v. United States, 5 Cir. 1949,
175 F.2d 960,
965, cert. denied,
338 U.S. 909,
70 S. Ct. 347,
94 L. Ed. 560.
|
| [189] | *fn36 The Texas policy on the admission
of business records is embodied in Article 3737e, Vernon's Ann.Texas Civil
Statutes (Supp.1974).
The statute is not specific as to the proof necessary to support a judicial
finding that its strictures have been met but at least one decision of
the Texas Supreme Court suggests that if the testimony of a "qualified
witness" supports an implied finding by the trial judge that the
records in dispute were made in the regular course of business and were
made at or reasonably near the time of the recorded act or event, the
statutory strictures will have been bridged. See University Savings &
Loan Assoc. v. Security Lumber Co., Tex.Sup.Ct.1967, 423 S.W.2d 287, 290.
Here, the testimony of Nurse McDonald supported the court's finding that
Exhibit 13 was a business record prepared in the regular course of the
business of the Hidalgo County Health Department at or near the time in
question. This is particularly true, in that Exhibit 13 was appended by
Dr. Copenhaver to his deposition pursuant to a request that he submit
copies of all of his records relevant to Anita Reyes's case. In light
of the considerable latitude Texas affords the trial judge in admitting
evidence, it is by no means clear to us that a Texas appellate court would
find the admission of Exhibit 13 to have been erroneous. |
| [190] | *fn37 The business records exception
to the hearsay rule is also addressed by federal statute. Title 28, United
States Code, Section 1732(a)
in pertinent part provides:
(a) In any court of the United States and in any court established by
Act of Congress, any writing or record, whether in the form of an entry
in a book or otherwise, made as a memorandum or record of any act, transaction,
occurrence, or event, shall be admissible as evidence of such act, transaction,
occurrence, or event, if made in regular course of any business, and if
it was the regular course of such business to make such memorandum or
record at the time of such act, transaction, occurrence, or event or within
a reasonable time thereafter. All other circumstances of the making of
such writing or record, including lack of personal knowledge by the entrant
or maker, may be shown to affect its weight, but such circumstances shall
not affect its admissibility. The resemblance of this federal provision
to the Texas statute is almost familial and the interpretation given it
by the court reveals a certain fraternity as well. Generally, testimony
by the custodian or another qualified witness that the records offered
were kept in the regular course of business and that they were prepared
at or near the time in issue is a predicate to admission under § 1732(a).
See, e.g., United States v. Middlebrooks, 5 Cir. 1970,
431 F.2d 299,
302, cert. denied, 1971,
400 U.S. 1009,
91 S. Ct. 569,
27 L. Ed. 2d 622.
Yet nowhere does the Act require that the foundation come from the individual
who kept the records or had supervision over them; all that need be established
is that the record was kept in the regular course of business. Sabatino
v. Curtiss National Bank, 5 Cir. 1969,
415 F.2d 632,
635, cert. denied, 1970,
396 U.S. 1057,
90 S. Ct. 750,
759,
24 L. Ed. 2d 752.
And, as Judge Thornberry suggests in his able analysis of Section 1732
in Sabatino, the determination whether a record has been kept in the regular
course of business should be made in light of the purposes of the statute:
The decisions excluding offered items indicate that the main reason for
the statutory language "in regular course of any business" is
to provide a check on trustworthiness, in that (1) the records must be
kept pursuant to some routine procedure designed to assure their accuracy,
(2) they must be created for motives that would tend to assure accuracy
(preparation for litigation, for example, is not such a motive), and (3)
they must not themselves be mere cumulations of hearsay or uninformed
opinion.
415 F.2d at 637.
Viewed in this way, the summary of suspected and confirmed polio cases
in Hidalgo County submitted by Dr. Copenhaver may well have been admissible
under the Act. The nature of the report itself and Nurse McDonald's testimony
that she had seen the report as it was being compiled at the County Health
Department indicate that it was routinely prepared. Obviously the Health
Department's motive for accuracy in recording data on so serious an illness
would be strong, and the data itself would reflect opinion from sources
well-informed. Since the trial court here chose to admit the report once
it was satisfied that the record was kept in the regular course of business,
that determination can be altered only upon a showing of abuse of discretion.
United States v. Middlebrooks, supra,
431 F.2d at 302.
Were we required to rely upon the Federal Business Records Act, we do
not believe that such an abuse would be found. |
| [191] | *fn38 Bailey v. Kawasaki-Kisen, K.K.,
5 Cir. 1972,
455 F.2d 392,
397; Household Goods Carriers' Bureau v. Terrell, 5 Cir. 1971,
452 F.2d 152,
160 (en banc); Butler v. Southern Pacific Co., 5 Cir. 1970,
431 F.2d 77,
79, cert. denied, 1971,
401 U.S. 975,
91 S. Ct. 1196,
28 L. Ed. 2d 325.
|
| [192] | *fn39 See, e.g., Price v. United States,
5 Cir. 1964,
335 F.2d 671,
677; Dallas County v. Commercial Union Assurance Co., 5 Cir. 1961,
286 F.2d 388,
394. |
| [193] | *fn40 Moreover, the fact that as an
action for damages this suit would not have sounded in equity at common
law does not prevent the district judge from admitting Exhibit 13 under
the "suits in equity" provision, if equitable principles would
have authorized its admission in an equitable action. See, e.g., Treharne
v. Callahan, 3 Cir. 1970,
426 F.2d 58,
62-63; Hope v. Hearst Consolidated Publications, Inc., 2 Cir. 1961,
294 F.2d 681,
688-690, cert. denied, 1962,
368 U.S. 956,
82 S. Ct. 399,
7 L. Ed. 2d 388;
9 C. Wright & A. Miller, Federal Practice and Procedure, § 2403 at 317
n. 39. |
| [194] | *fn41 Borel v. Fibreboard Paper Co.,
supra note 5,
493 F.2d at 1092;
Helene Curtis Industries, Inc. v. Pruitt, supra note 12,
385 F.2d at 850.
|
| [195] | *fn42 Barrett v. Virginian Ry. Co.,
1919,
250 U.S. 473,
39 S. Ct. 540,
63 L. Ed. 1092;
Nudd v. Burrows, 1875,
91 U.S. 426,
23 L. Ed. 286.
|
| [196] | *fn43 See note 27 supra. |
| [197] | *fn44 Delancey v. Motichek Towing
Service, Inc., 5 Cir. 1970,
427 F.2d 897,
902; Kayo Oil Co. v. Sammons, 5 Cir. 1963,
321 F.2d 729,
730. |
| [198] | *fn45 See McClendon v. Reynolds Electrical
& Engineering, 5 Cir. 1970,
432 F.2d 320,
323; Government Employees' Insurance Co. v. Davis, 5 Cir. 1959,
266 F.2d 760,
765; 9 C. Wright & A. Miller, supra, § 2556 at 657-58. |
| [199] | *fn46 Rivers v. Angf. Aì{/FN} Tirfing,
5 Cir. 1971,
450 F.2d 12,
15; McGuire v. Davis, 5 Cir. 1971,
437 F.2d 570,
574. |
| [200] | *fn47 This definition, which appeared
as part of the 1969 Recommendations of the United States Public Health Service's
Advisory Committee on Immunization Practice, is as follows: "An 'epidemic'
of poliomyelitis is defined as two or more cases caused by the same polio
virus type and occurring within a four-week period in a circumscribed population
such as that of a city, County or metropolitan area." |
| [201] | *fn48 This definition was the first,
of three, appearing in Dorlan's Illustrated Medical Dictionary, Twenty-Fourth
Edition, which Dr. Casso testified was "the most generally accepted
dictionary by medical people." |
| [202] | *fn49 For example, at the precharge
deliberations, the court observed:
You see, I don't think we are bound by what these doctors say, or the
government says, or what anybody says about the fact what an epidemic
is. But see footnote 50. |
| [203] | *fn50 The court instructed:
Now we are talking about epidemic and we have heard lots of testimony
here about two cases within thirty days or four cases within thirty days,
and all these doctors have testified to that. Some of them say for operational
purposes. Well, that's the evidence that you can take into consideration
on whether or not there was any epidemic in the area. But for our purpose
here I am going to tell you that under the law that the term epidemic
is a relative term, and the question of how many cases constitute an epidemic
is a question of fact depending upon the prevailing circumstances. This
term epidemic in its common and ordinary meaning applies to any disease
which is widely spread or generally prevailing at a given place and time.
That is what an epidemic is. You will be guided by that definition. Now
if you find that there was an epidemic and that this girl got her paralytic
polio from the wild virus as the defendant would let us view the evidence,
because of the report of Dr. Nakano that there is probably a wild virus,
then you have to say by your verdict she did not contract the paralytic
polio as a result of having taken the defendant's vaccine. |
| [204] | *fn51 In explaining the interrogatories
to the jury the court instructed:
Now if you find that she did get the polio from this vaccine and not
from a wild virus, then I must ask you do you find from a preponderance
of the evidence that on May 8, 1970, there was a medically cognizable
risk that Anita Reyes might contract paralytic polio by taking trivalent
oral vaccine. We have to view this as of May 8th, at that time. Did Wyeth
know that this trivalent oral vaccine that they were selling to the State
of Texas to immunize children was unavoidably dangerous -- I mean unreasonably
dangerous or unavoidably unsafe, and should they have advised the parents
of Anita of this risk? Did they know that their product was unreasonably
dangerous or unavoidably unsafe to be given in the southern tier of states
between the months of April and November or March and November, I mean?
Did they know that? And if they knew it or should have known it, did they
give them warning, to the consumer? And in that connection I tell you
that the law is that if you find that the product was unreasonably dangerous
or unavoidably unsafe, and that such condition was known to the defendant,
or in the exercise of reasonable care should have been known to the defendant,
the law imposes upon them a duty to use reasonable methods to inform the
consumer of the nature of the product so that the consumer may evaluate
whether or not he should use the product and take the risk. The court
later added: Now they say, the way I understand it from their evidence
here, that these people have failed to prove that this product was unreasonably
dangerous or unavoidable unsafe, that the records show that the vaccine
has worked in thousands and thousands of cases. On May 8th they didn't
think there was any risk of any kind, then they had no duty -- or could
not find out if there was a risk -- then they had no duty to warn because
if I don't know of a risk how can I warn anybody? I have to know of a
risk in order to have a duty to warn. So I either know about it or I should
have known about it. |
| [205] | *fn52 Compare interrogatories 1 and
2. In his summary of evidence relevant to the first interrogatory, the trial
judge made reference to the testimony of Dr. Louis Miller, a physician in
the employ of the United States Public Health Service whose testimony tended
to demonstrate that it was only Wyeth's vaccine that was available at the
Mission clinic on May 8, 1970, the day Anita Reyes received her vaccine.
Wyeth urges that since specific reference was not made to the testimony
of three witnesses whose recollections cast doubt on Dr. Miller's conclusion,
it was prejudiced by this summary. Aside from our conclusion in the text
that the trial court fairly summarized the evidence and specifically left
the factual decisions for the jury, it might be observed that the testimony
Wyeth relies upon does not appear to be probative of a conclusion contrary
to that reached by Dr. Miller.
Nor is the appellant's objection to the court's summary of evidence relevant
to the second interrogatory meritorious. Essentially, Wyeth seeks to reargue
the court's failure to employ its epidemiological definition of "epidemic"
in the charge and summary. We have discussed that contention earlier in
the opinion. |
| [206] | *fn53 The "preponderance of the
evidence" instruction rendered by the court was scarcely novel, yet
Wyeth contends that it was prejudiced by the court's admonition that the
jury ought not be influenced by the number of witnesses produced by either
party. The court instructed:
Preponderance of the evidence also means that it is the evidence that
you believe believable. Doesn't depend on numbers of witnesses because
ten people can sit up here and tell you that the horse he saw was black,
and one man can come up here and testify that the horse he saw was white.
And if you believe the man that says it was white then you can disregard
the ten that said it was black, see, if the reasons he gives for telling
you the horse is white seem more plausible to you, see, or preponderates.
So the number of witnesses has nothing to do with this. It is the quality
of the evidence and the reasons for the evidence that count. So that is
another way of telling you what preponderance of the evidence means. This
segment of the court's charge was error, Wyeth asserts, in that it abraded
the impact of Wyeth's extensive expert testimony. To the contrary, we
find that offered in the midst of a lengthy and accurate charge explaining
preponderance, such an explanation is laudable to the extent that it tends
to concentrate the vision of the jury on the preponderance of believable
evidence rather than the numerical superiority of witnesses or exhibits.
It certainly was not error. |
| [207] | *fn54 The court admonished at the
outset of its charge:
Now you are the exclusive judges of the facts and the credibility of
the witnesses and the weight to be given to their testimony. But the law
you must take from me for it would be a violation of your sworn duty as
jurors to take any other view of the law other than that as I give it
to you. Now during the trial of this case it has been necessary for me
to make rulings on objections. I have also asked some witnesses questions,
and during the conduct of this trial if you have gotten any ideas that
I am leaning one way or another in this case I want you to dispel that
from your mind because that was not my intention. I am very happy to have
you decide the facts in the case and relieve me of that responsibility. |
| [208] | *fn55 See note 54, supra. |
| [209] | *fn56 67 Tex.Stat.Rev. § 209(a) (1971). |
| [210] | *fn57 See, e.g., Calabresi & Bass,
Right Approach, Wrong Implications: A Critique of McKean on Products Liability,
38 U.Chi.L.Rev. 74 (1970); Calabresi, Some Thoughts on Risk Distribution
and the Law of Torts, 70 Yale L.J. 499 (1961); Morris, Enterprise Liability
and the Actuarial Process -- The Insignificance of Foresight, 70 Yale L.J.
554 (1961); 46 N.Y.U.L.Rev. 403 (1971); see also Escola v. Coca Cola Bottling
Co., Cal.Sup.1944, 24 Cal.2d 453, 150 P.2d 436, 440 (Traynor, J., concurring).
It can also be argued, of course, that since all society benefits from universal
immunization against infectious disease, the loss should be borne by the
local, state or federal government. Unless the doctrine of sovereign immunity
is significantly altered, however, such a loss distribution scheme does
not appear to be likely. See Merrill, Compensation for Prescription Drug
Injuries, 59 Va.L.Rev. 1, 102 (1973). |
| [211] | *fn58 See 56 Geo.L.J. 1016 (1968);
5 San Diego L.Rev. 422 (1968). |
| [212] | *fn59 These are commonly referred
to as Type I, Type II and Type III, respectively. To the extent that the
differences among the three types are relevant, they are referred to in
the text. It is undisputed, however, that Anita Reyes suffers from Type
I polio. |
| [213] | *fn60 When Salk vaccine which inadvertently
contained some unkilled virulent viral strains was released for use, however,
as in the "Cutter incident" of 1955, several cases of vaccine-induced
poliomyelitis resulted. See, Gottsdanker v. Cutter Laboratories, Cal.App.
1960, 182 Cal.App.2d 602, 6 Cal.Rptr. 320. |
| [214] | *fn61 A more extensive discussion
of the nature and complexity of the tests may be found in Griffin v. United
States, E.D.Pa.1972,
351 F. Supp. 10.
|
| [215] | *fn62 See Davis v. Wyeth Laboratories,
9 Cir. 1969,
399 F.2d 121,
123-125. |
| [216] | *fn63 Report of the Special Advisory
Committee on Oral Poliomyelitis Vaccine to the Surgeon General, Public Health
Service, 1964 at 4. A report by the Health, Education and Welfare Department's
Center for Disease Control indicates that for the year 1964, 20 of 56 reported
cases could be associated with vaccine ingestion. Center for Disease Control,
[Department of Health, Education and Welfare], 1964 Surveillance Report,
at 3. |
| [217] | *fn64 As paraphrased in Reyes' brief,
these symptoms include:
1. An onset of illness between 4 and 30 days following feeding of the
specific vaccine type in question and with [sic] an onset of paralysis
not sooner than six days after the feeding. 2. Significant residual lower-motor-neuron
paralysis. 3. Laboratory data not inconsistent with respect to multiplication
of the vaccine virus fed. 4. No evidence of upper motor neuron disease,
definite sensory loss, or progression or recurrence of paralytic illness
one month or more after onset. These compatible cases were further subdivided
into "probable" and "possible" cases employing the
following guidelines for "probable" cases: 1. Evidence of fever
at onset of paralysis. 2. History of systemic illness preceding the development
of paralysis. 3. Clinical evidence of meningeal involvement manifested
either by muchal rigidity or cerebrospinal fluid cell count greater than
10 cells per cubic milliliter. |
| [218] | *fn65 For a further discussion of
the development of polio vaccine, and the elaborate testing procedures,
see, e.g. Davis v. Wyeth Laboratories, Inc., 9 Cir. 1969,
399 F.2d 121;
Griffin v. United States, E.D.Pa.1972,
351 F. Supp. 10;
Stahlheber v. American Cyanamid Co., Mo.Sup.Ct.1970, 451 S.W.2d 48. |
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