WISDOM, Circuit Judge:
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.
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.
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
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.
The vaccine given Anita Reyes in the Mission clinic on May 8, 1970 was part of a "lot", No. 15509, prepared by Wyeth.
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
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.
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. Thompkins, 1938, 304 U.S. 64, 58 S.Ct. 817, 82 L.Ed. 1188.
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.
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.
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 suggest a useful analysis for the issue of Wyeth's liability here.
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.
a) Unreasonable Danger and the Duty to Warn
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
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"
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.
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".
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.
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 "[s]ince 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
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.
Although there is no question that Sabin oral vaccine is licensed for sale only as a prescription drug,
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.
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.
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).
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
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.
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.
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,
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 at 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.
To the instant analysis, these principles present no dilemma, for the effect
b) Proximate Cause
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".
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.
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.
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.
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 possibility of injuries and
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.
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.
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:
480 S.W.2d at 606.
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.
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,
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.
a) The Impeachment of Dr. Fox
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
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.
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.
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;
Wyeth also urges that even if permitting the impeachment was proper, counsel for Reyes failed to lay the proper foundation for the impeachment and
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.
b) The Exclusion of Dr. Nakano's Opinion
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:
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.
c) The Admission of Exhibit 13
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.
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
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.
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:
We are less sanguine than the appellants in assuming that Texas courts would not admit this exhibit as a business record.
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 at 395.
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.
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.
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
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 at 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.
d) The Sufficiency of the Evidence
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.
The yardstick against which such motions must be measured is a federal one:
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.
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 demination was within the jury's prerogative;
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".
Federal courts apply their own rules
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.
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.
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.
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.
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.
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
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,
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
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.
Citing a recent Texas statute which requires that all Texas schoolchildren receive polio vaccine,
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:
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.
Moreover, there is a third policy factor at work here, overlooked by the amici:
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.
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
The judgment is affirmed.
APPENDIX A: INTERROGATORIES
The interrogatories submitted to the jury and the jury's answers are as follows:
INTERROGATORY NO. 1
Do you find from a preponderance of the evidence that Anita Reyes received a polio vaccine from Defendant Wyeth's Lot No. 15509?
The Jury will answer "She did" or "She did not".
We, the Jury, answer: She did.
INTERROGATORY NO. 2
Do you find from a preponderance of the evidence that Anita Reyes contracted paralytic polio as a result of having taken Defendant's vaccine?
The Jury will answer "She did" or "She did not".
We, the Jury, answer: She did.
If you answered this "She did not", then you need not answer any other issue.
INTERROGATORY NO. 3
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?
The Jury will answer "There was a risk" or "There was not a risk".
We, the Jury, answer: There was a risk.
INTERROGATORY NO. 4
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?
The Jury will answer "There was a risk" or "There was not a risk".
We, the Jury, answer: "There was a risk.
If you have answered either or both Interrogatories No. 3 and 4 "There was a risk", then you will answer the following Interrogatory.
INTERROGATORY NO. 5
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?
The Jury will answer "They failed" or "They did not fail".
We, the Jury, answer: They failed.
INTERROGATORY NO. 6
What sum of money, if paid now in cash, would compensate Anita Reyes for the injuries sustained by her?
The Jury will answer in dollars and cents.
We, the Jury, answer: $200,000.00.
APPENDIX B: POLIOMYELITIS
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
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.
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.
Like its "killed virus" predecessor, the Sabin vaccine was extensively tested
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.
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.
Comment h provides in pertinent part:
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.
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.
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:
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.
But see footnote 50.
The court later added:
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.
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.
These compatible cases were further subdivided into "probable" and "possible" cases employing the following guidelines for "probable" cases: