# Appendix — Wyeth Laboratories v. Reyes > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385608_1037%3A2 ## Record - **Collection:** Supreme Court brief - **Document type:** Appendix - **Published:** January 1, 1974 - **Citation:** 419 U.S. 1096 ## Text la APPENDIX A UNITED STATES COURT OF APPEALS FOR THE FIFTH CIRCUIT October Term, 1972 No. 72-2251 D. C. Docket No. CA-70-B-115 Epiranio Reyes, Individually and as next Friend of Anita Reyes, a minor, Plaintiff-Appellee, versus ' Wyvern Lasoratorigs, a Division of American Home Products Corporation, a Delaware Corporation, Defendant-Appellant. Appeal from the United States District Court for the Southern District of Texas Before Brown, Chief Judge, and Wispom and Arnswortn, Circuit Judges. JUDGMENT This cause came on to be heard on the transeript of the record from the United Stafes District Court for the Southern District of Texas, and was argued by counsel: Ox Consiperation Wiitrtor, It is now here ordered and adjudged by this Court that the judgment of the said District Court in this cause be, and the same is hereby, affirmed ; It is further ordered that defendant-appellant pay to plaintiff-appellee, the costs on appeal to be taxed by the Clerk of this Court. July, 31, 1974 Issued as Mandate 2a OPINION [498 F.2d 1264 (5th Cir. 1974),] Diversity action against defendant which marketed trivalent oral polio vaccine. The United States District Court for the Southern District of Texas, Reynaldo G. Garza, J., entered judgment for plaintiff, and defendant appealed. The Court of Appeals, Wisdom, Cireuit Judge, held that where defendant which marketed unavoidably unsafe trivalent oral polio vaccine failed to provide par- ents of infant with either warning of risk of individualized medical judgment that treatment was necessary ‘and de- sirablg for infant, defendant was liable for failing to market its unavoidably unsafe product in such a way as to warrant [sic] parents of unreasonably dangerous condition. é Affirmed. Loyd E. Bingham, Jr., San Antonio, Tex., Eberle, Berlin, Kading, Turnbow & Gillespie, R. B. Kading, Jr., William J. MeKlveen, Boise, Idaho, for defendant-appellant. Daniel R. Murray, Chicago, IL, for American Academy of Pediatries, amicus curiae, William J. Curran, Boston, Mass., for Conference of State and Territorial Epidemiologists, amicus curiae. Rafael H, Flores, J. Perry Jones, MeAllen, Tex., for plaintiff-appellee, Before Brown, Chief Judge, and Wispom and Arnswortn, Circuit Judges, Wispom, Circuit Judge: | This produets liability case raises Significant questions concerning the seope of a drug manufacturer’s duty to warn ultimate consumers of dangers inherent in his pro- duct, ‘ . ‘ hee mg es now eBana 3a 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 prod- ucts liability law of Texas. In addition, Wyeth raises numerous procedural and evidentiary questions. The case was tried to a jury. The jury answered special interroga- tories (see Appendix A) and returned a verdict in favor of Reyes against Wyeth for the sum of $200,000. I, 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 in- dividuals to be afflicted during that year.’ Credit for this precipitous decline must go primarily to the medical re- searchers 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 publie health pro- grams for the administration of the vaccine. ' These statistics are drawn from official reports of the United States Publie 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). ae ee | 4a On May 8, 1970, Anita Reyes was fed two drops of Sabin oral polio vaceine by eye-dropper at the Hidalgo County Department of Health clinie 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 ‘fall liability in connection with immunization’’, The form contained no warning of any sort, and it is apparent from her testimony that she cither 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 MeAllen (Texas) General ITospital, where her disease was diagnosed as Type I paralytic poliomyelitis, See Appendix B, foonote 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 clinie on May &, 1970 was part of a ‘‘lot’’, No, 15509, prepared by Wyeth? Lot No. 15509 was trivalent oral polio vaccine that Wyeth had titered (mixed) from Types I, Il, and IIT 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 vaecine to the State Health Department which in turn transferred 400 vials to the Hidalgo County * The actual titering was performed by Wyeth Laboratories, Ine., a separately incorporated subsidiary of American Home Products, Ine. After this mixing process was complete the vaccine was shipped to American Home Products’ unincorporated Wyeth Labo- ratories Division for distribution, Since both the division and the subst iary are affiliates of appellant American Home Products, Ine. they are referred to interchangeably as ‘* Wyeth” in the text. 5a 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 cireular’’ provided by Wyeti 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 vaceine 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 Clinie 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. 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 vaecine, 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 pro- duced 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 tes- timony adduced on Wyeth’s behalf,* 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. 4 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 pos- wible source of the disease’’. 6a 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. II. 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. Krie 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 respon- sible 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.’ Texas courts recognize both tort and warranty theories of products lia- bility.’ This case was tried, briefed, and argued on appeal entirely on the tort theory of strict liability. Thus the differences between the two approaches,® and whatever * Gravis v. Parke-Davis & Co., Tex.Civ.App. 1973. 502 S.W.2d 863, 868-869; Cudmore vy. Richardson-Merrell, Ine. Tex.Civ.App. 1965, 398 S.W.2d 640, 644, writ ref. n. r. e., cert. denied, 1967, 389 U.S. 1003, 87 S.Ct. 705, 17 L.Ed.2d 542. * See Borel vy. Fibreboard Paper Products Corporation, 5 Cir. 1973, 493 F.2d 1076; reh. denied, 1973. * 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 swp- planted warranty as the dominant doctrine, Grinnell vy. Charles Pfizer & Co., Cal.Ct.App.1969, 274 Cal. App.2d 424, 79 Cal. Rptr. 369, 373, the outcome of produet 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 Labora- tories, 9 Cir. 1968, 399 F.2d 121, 126; Merrill, Compensation for Prescription Drug Injuries, 59 Va.L.Rev. 1, 31 (1973). 1. Lam ae coe owe moe 3.10 “ois ne Neos EAS -~ Lk ea a a ie CRS ase SASS — AS Ae Nop as EX DISA SRSERRER a ROE acs a A ita 7a contractual trappings of warranty have not been destroyed with the crumbling of the citadel of privity,’ 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),* and approved by the Supreme Court of Texas in McKisson v. Sales Affiliates, Tex.Sup.Ct. 1967, 416 S.W.2d 787.° 7 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.Rey. 791 (1966). *$ 402A. Special Liability of Seller of Product for Physical Harm to User or Consumer (1) One who sells any product in a defective condition unrea- sonably 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 prepa- ration 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. *The principle that sellers of food and drink for human con- sumption should be held to a high level of responsibility for any *‘corruption’’ in their wares is of inedieval 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.LJ. 1 (1965); Traynor, note 11, infra; Greenman v. Yuba Power Products, Inc., Cal. Sup.1963, 59 Cal.2d 57, 27 Cal.Revtr. Pee bait ety ete eee Tse oe Ditka 8a Basically, Section 402A subjects to liability the seller or manufacturer of a product sold ‘tin: a defective condition unreasonably dangerous’? to an ultimate user or consumer Whose person or property is physically harmed by the product."” Moreover, one who places defective goods in the stream of commerce will be liable ‘to the user or con- sumer even though he has exercised all possible eare in the preparation and sale of the product’’, Restatement (Second) of Torts, Section 402A, comment a. Yet imposi- tion of liability is by no means automatic; the elements tacit or explicit in Section 402.A*s mandate must be demon- strated to the trial court's satisfaction before the burden of the consumer’s loss will be imposed on the seller of the product: The plaintiff is faced with an arduous burden of proof, He must prove that: 1) the produet in question was defective; 2) the defeet existed at the time tie prod- ucts 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 con- sumer was injured or suffered damages; 2) and that the defect (if proved) was the proximate cause of the injuries suffered. (iravis v. Parke-Davis & Co., Tex.Civ. App.1973, 002 S.W.2d 863, 868. Although we do not embrace Gravis as the all-inclusive embodiment of Texas products liability law, 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 LJ. 1 (1973); Schattman. A Cause of Action for the Allergie Consumer, 8 Hou.L.Rey. 827 (1971). Although the Restatement speaks in terms of “sellers’’, man- ufacturers 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. 9a the framework it provides suggests 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 clement is to conclude that he proved the third, for properly understood, ‘defective con- dition’? has no meaning independent of ‘unreasonably dangerous’’; the two terms are essentially synonymous.” Thus if a product is unreasonably dangerous as marketed, the manufacturer may be held liable for injuries proxi- mately caused by what he has produced, whether or not it was manufactured exactly as intended, that is without a production “defect’’."= We do not understand this ap- proach to dispense with the principle that to prompt lia- bility a product must reach the consuming publie in a “defective condition’. Rather, by rephrasing the de- fectiveness requirement in terms of ‘‘unreasonable dan- ger’’, it becomes clear that the circumstances of marketing themselves can amount to a defect; the defect can be ex- trinsic to the product. All that we need determine here, 1 Borel v. Fibreboard Paper Products Corp.. 5 Cir. 1973, 493 F.2d 1076, 1087: Wade, Stries Tort Liability of Manufecturers, 19 Sw LJ. 5. 14-15 (1965): Keeton Produet Liabiliiy and the Mean- ing of Defect, 5 St.Mary's LJ. 36. 32 (1973). Justice Traynor goes still further. He has conclided that there is ne single satis- factory definition of ‘defect’ whieh wil bear universal applica- tion. See Traynor, The Ways and Meanings of Defective Products end Striet Liability. 32 Tenn Rey, 363. 357 (1965). 12 See, e.g. Alman Bros. Faris and Feed Mitl, Ine. v. Diamond Laboratories, Inc.. 5 Cir. 1971. 437 F.2d 1295, 1302: Ross v. Up- Richt. Inc.. 35 Cir. 1968, 402 F.2d 043, 946: Helene Curtis Indus- tries, Ine. ve Pruitt. 5 Cir. 167, 385 Ftd S41. 805, cert. denied, 1968, 391 ULS. 913, 88 S.Ct. 1806, 20 L.Ed. 2d 652. oho eatnet oat 10a then, is first, whether the vaccine was unreasonably dan- gerous, and second, whether the showing of proximat + causation was sufficient under Texas law. 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 con- dition 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 * and the Texas publie 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. in- advertently included in the mixture." Indeed, it is the presence of the living but attenuated Type I, I, and II] viruses which makes the Sabin vaccine so effective [See Appendix B]. 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 manufac- tured. Such products are not necessarily ‘unreasonably dangerous”’, for as this Court has long recognized in wrestling with product liability questions, many goods In a strict sense, Wyeth did not *‘make’’ or manufacture the vaecine 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 IIL monovalent vaecines manufactured by Pfizer, Ltd. In the context of this case, however, we do not be- lieve. nor did Wyeth argue, that this fact in any way affects its liability. % Thus this action « es not involve *‘defective’’ vaccine in the sane sense as did Gotisdanker v. Cutter Laboratories. CaLApp. 160, 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 vaec ine, lla possess both utility and danger. See, e.g., Ross v. Up- Right, Inc., 5 Cir. 1968, 402 F.2d 943, 946; Helene Curtis Industries, Ine. 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 602. -Rather, in evaluating the possible liability of a manufacturer for injuries caused by his inevitably hazard- ous 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 either ease, 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’’;?® or, to phrase it in terms of the seller’s re- ** 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. See note 27 supra. * 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. * See McClendon vy. Reynolds Electrical & Engin ring, 5 Cir. 1976, 432 F.2d 320, 323: Government Employees’ Insurance Co. ¥. Davis, 5 Cir, 1959, 266 F.2d 760, 765; 9 C. Wright & A. Miller, supra, © 2556 at 657-58. , ean eh ee | Seam 43a 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. 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 con.racted the disease should never have been presented to the jury, and, al- ternatively, that the trial judge’s definition of the term ‘‘epidemic’’ was erroneous. It ix manifest that both argu- ments 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. ‘7 Dr. Ramiro R. Casso, the Hidalgo County general practitioner who testi- fied as Reyes’s medical expert, referred to a medical dic- tionary to define ‘‘epidemic’’ as ‘‘ [disease] attacking many * Rivers v. Angf. A/B Tirfing, 5 Cir. 1971, 450 F.2d 12, 15; McGuire v. Davis, 5 Cir. 1971, 437 F.2d 570, 574. This definition, which appeared as part of the 1969 Recom- mendations 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 inore cases caused by the same polio virus type and oceurring within a four-week period in a circumscribed population such as that of a city, county or metro- politan area.”” a Te ee — i tk SC one a 4 wt PPrsdisenrewrissens. a é' 44a people in any region at the same time’’.* From a review of its comments during the trial it is apparent thas the court, properly, did not consider itself bound by either definition, ” although in its instructions to the jury the court employed a definition not unlike that read from the medical dictionary by Dr. Casso.” 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 vae- * 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 acceptéd dictionary by medical people.’” : ” 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. ” 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 you can take into consideration on whether or not there was any epidemic in the area. But for our pur- pose here I am going to tell you that under the law that the term epidemic is a relative term. and the quest’on of how many cases constitute an epidemic is a question . fact de- pending upon the prevailing circumstances, Th term epi- demie in its common and ordinary meaning apy.ies 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 epidemi. and that this girl got her paralytic polio from the wild virus as the defend- ant would let us view the evidence, because of the report of Dr. Nakano that there is probably a wild virus, then yon have to say by your verdict she did not contract the paralytic polio as a result of having taken the defendant's vaccine. 45a cine? In light of its importance, the trial judge submitted the ‘‘epidemic’’ issue to the jurors; they had heard the con- flicting testimony. He defined ‘‘epidemic’’ in terms per- tinent to determining the question of causation. He de- clined to use Wyeth’s ‘‘ epidemiological definition’’, a defini- tion that might have confused the jurors. He did not abuse his diserction in doing so. The substance of the charge was correct, and the appellants were not entitled to an instruction in the specifie terms they desired. 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 ixsue of ‘‘ relative risk’’. Wyeth insists that a definition of ‘med. cally 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. Yet whatever the ferm of the interrogatories, the link between ‘‘medically cognizable risk’’ and ‘‘duty to warn’’ was made clear by the court’s instructions.“ It appears 5 In explaining the interrogatories to the jury the court in- structed: Now if you find that she did get the polio from this vaecine ond not from a wild virus, then | must ask you do you find from a preponderance of the evidence that on May &, 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 Sth, 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 nnavoidably 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 warn- ing, to the consumer? And in that connection | tell you that the law is that if you find that the product was unreasonably we ee ee ee dered + RA Rie Sy elt Fae ta BPrriseaaronsrenswcwe. 46a to us that the challenged interrogatories were neither con- fusing nor misleading: “‘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’.’’ ‘“‘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’.’’ The terms [sie] ‘‘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 Wycth’s presentation of its case. 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 im- poses upon them a duty to use reasonable methods to inform the consumer of the nature of the product so that the con- sumer 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 unavoidably unsafe, that the records show that the vaecine 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? T 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. 47a 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, Wycth 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 pre- cisely 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. In two lengthy sections of its brief, Wyeth attacks the trial court’s summary of the evidence in the course of in- structing the jury and cites as prejudicial various com- ments advanced by the court during the trial. More spe- cifically, Wyeth excépts to the court’s comments on the evi- dence in explaining the first two interrogatories to the jury, * and the court’s discussion of the preponderance of 52 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 clinie 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 sum- marized 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 evi- dence relevant to the second interrogatory meritorious. Essentially, Wyeth seeks to reargue the court’s failure to employ its epidemi- ological definition of ‘‘epidemic’’ in the charge and summary. We have discussed that contention earlier in the opinion. oe ee 48a the evidence standard.” Wyeth -asserts that in each in- stance the court’s summary of the evidence unfairly em- phasized 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 com- menting 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, explan- atory comments are prejudicial only when the court fails to make clear to the jurors that they alone have the burden of decision. See Stuckey vy. Andrews, 5 Cir. 1957, 249 F.2d $28; 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 —_— —__—— *8 The ‘‘ preponderance of the evidence”’ instruction rendered by the court was scarcely novel, yet Wyeth contends that it was prejudiced by the éourt’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 evi- dence thet 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 ean 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 testi- mony. To the contrary, we find that offered in the midst of a lengthy and accurate charge explaining preponderance, such an explanaticu is laudable to the extent that it tends to concentrate the visicn of the jury on the preponderance of believable evidence rather than the numerical superiority of witnesses or exhibits. It certainly was not error. ~ . 49a the facts, the sole judges of the witnesses’ credibility. ™* Since we also conclude that the summaries and comments upon the evidence were basically fair, we find no ground for reversal here. 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 prej- udiced its case as to require reversal. We shall not at- tempt 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 gener- ally 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 follows 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 "4 The court admonished at the outset of its charge: Now you are the exclusive judges of the facts and the eredi- bility of the witnesses and the weight to be given to their testi- mony. 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 conducteof this trial if -. you have gotten any ideas that I am leaning one way or wother in this case | want you to dispel that from your mind because that was not my intention. I am very happy to have you decide the facets in the case and relieve me of that re- sponsibility. 50a 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 instruc- tion ® 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. V. In closing, we feel that we should comment on the import- ant policy considerations raised in the briefs of the amici curiae, the American Academy of Pediatries [AAP] and the Conference of State and Territorial Epidemiologists [CSTE]. Both insist that the holding we reached is ‘‘dan- gerous’’ to the nation’s preventive medicine programs and contravenes a strong public policy favoring large-scale par- ticipation in immunization efforts to combat infectious dis- ease. The crucial points of the argument are two: first, that any effort to warn vaccinees will be futile and fright- ening, leading only to confusion, and second, that a warning is unnecessary once epidemiologists have reached a deliber- ate medical judgment that universal vaccination is neces- sary. 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, ® the AAP in- sists that this renders any warnings futile. This argument assumes, of course, that the only options available are to in- gest 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 immu- nity or as a pregautionary prelude to ingesting oral vaccine. The AAP also insists ‘hat the warnings would be so com- plex or misleading as to confuse and frighten potential vaccinees, This is possible. Yet we believe that a warning 55 See note 54, supra. 6 67 Tex.Stat.Rev. § 209(a) (1971). 5la advising a patron of a public health clinie 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 sufficiently con- cerned to take the Salk vaccine innoculation. Others, per- haps 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 AAIP’s answer to this problem is to warn no one. That is no answer. 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 sus- ceptibilities. Recognition of this right counters the argu- ment advanced in the CSTE’s brief that once an epidemio- logical balancing of the risks of immunization has been made, no warning is required. Clearly, the rationale excus- ing 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: When... the risk qualitatively (e. g., death or major disability) ax 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. 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 ease is difficult, but by adding two elements to the Davis caleulus we conelude that a sufficient ‘‘true choice judgment’’ was involved here to lend strong policy support to our holding. First, the risk | 52a here was foreseeable statistically, although unknowable in- dividually. 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: Until Americans have a comprehensive scheme of social insurance, courts must resolve by a balancing process the head-on collison between the need for adequate re- covery and viable enterprises. . . . This lalancing 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. Helene Curtis Industries, Ine. 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.” *? See, e. g., Calabresi & Bass, Right Approach, Wrong Implica> tions: A Critique of MeKean 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 Insignificanee of Fore- sight, 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 Cal2d 453, 150 P.2d 436, 440 (Traynor, J., coneurring). 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 dis- tribution scheme does not appear to be likely. See Merrill, Com- pensation for Prescription Drug Injuries. 59 Va.L.Rev. 1, 102 (1973). i" Ng T Se ee ee ee FRO ea . - ’ 1 53a 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 na- tion’s public health scheme, and the dangers that their de- personalized medical treatment pose.* 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 pre- scription drug which is unavoidably unsafe, and as to which there is a certain, though small, risk throughout the popula- tion, there niust be cither a warning—meaningful and com- plete so as to be understood by the recipient—or an individ- ualized 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 con«e- quence of its failure to market its unavoidably unsafe prod- uct in such a way as to warn Anita’s parents of its unrea- sonably dangerous condition. The judgment is affirmed. APPENDIX A: INTERROGATORIES The interrogatories submitted to the jury and the jury’s ai: swers 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. ** See 56 Geo.L.J. 1016 (1968) ; 5 San Diego L.Rev. 422 (1968). d4a 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 poKo by taking Tri- valent 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 fol- lowing Interrogatory. 55a 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 compen- sate 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 vie- tims. They learned that polio is caused by an enterovirus which grows in the intestinal tract, but that the virus is in- troduced into the body orally, through the mouth. After entering the body, the virus reproduces rapidly in the ali- mentary 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 con- tracted polio; upwards of SO percent of the population is naturally immune to polio virus, and only about one of every hundred persons who experience the intestinal viral in- fection 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’’ wr ee 56a within the spinal column. Destruction of sufficient ‘‘grey matter’? will result in ‘‘motor neuron disease’’, that is, muscular paralysis. The initial problem facing researchers attempting to de- velop a vaccine—cultivation of a growth of polio virus in tis- sue 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 effec- tive protection, a vaccine would have to immunize the vaccinee to all three types. The first breakthrough resulted from the research of Dr. Jonas Salk. who perfected 2 “killed virus’? vaccine to be administered by innoculation, To produce this vaccine, polio virus is grown ina tissue eul- ture and clinically ‘‘killed’’, that is, rendered incapable of causing disease, [n killing the virus, however, no chemical alteration o¢eurs and when it is introduced ints the body in tae vaccine, the virus acts as an antigen to prompi the pro- duction of antibodies, Should a wild or virulent strain of polio virus enter the bloodstream, the antibodies ge ierated as a reaction to the vaccine will destroy it, and the vaccinee will avoid polio, In 1955 after extensive tests were conducted under the auspices of The National Foundation fo* Infantile Paraly- sis (March of Dimes) the researchers concluded that the Salk vaccine was effective and, if the virus were killed, com- pletely safe.” The Salk vaccine then becaine the primary * These are commonly referred to as Type T., Type IT and Type IIT, respectively. To the extent that*the differences among the three types are relevant, they are referred to in the text. It js undisputed, however, that Anita Reyes suffers from Type I polio. When Salk vaceine which inadvertently contained some unkilled virulent viral strains was released for use, however, as it, the “Cutter incident”? of 1955, several cases of vaceine-induced polioymelitis resulted. See, Gottsdanker y. Cutter Laboratories, Cal. App.1960, 182 Cal. App.2d 602, 6 Cal. Rptr. 320. —_ 57a weapon against polio. But the killed virus vaccine none- theless exhibited several drawbacks. It had to be injected by hypodermic needle, and a separate innoculation was re- quired 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 vae- cinee. 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. Aibert 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 ali- mentary 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 ‘triva- lent’’ oral vaccine can be produced which, upon ingestion, will provide protection against all three types of virus. Like its ‘‘killed virus’? predecessor, the Sabin vaccine was extensively tested worldwide to determine whether it was safe and effective for general nse. When favorable results were achieved, the vaccine was licensed for mannu- facture and sale in the United States by the Division of Biologie 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 authoyized to prepare and dis- tribute the vaccine only as a preseription drug. Irrespee- tive 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 38a ¥aceine is produced was obtained from Dr. Sabin by Pfizer, Ltd., of England, and is repeatedly reproduced by them ia a culture of monkey tissue. Reproduction is rapid, and the virus is frequently “‘harvested”’ and the vaccine pre- pared 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." If the vaccine meets D.B.S, _ Standards, it is released to the manufacturing laboratory, where the vaccine is titered or mixed, Despite careful preparation and testing, it is apparent that live virus oral polio vaccine eannot be stripped of all danger. As early as January 1961, a subeommittee 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 Commit- tee on Oral Poliomyelitis Vaceine, concluded that, at least where Type III oral vaccine was concerned, a causal con- nection 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.* By July 1964, with more data avail- able, the Surgeon General's Special Committee found that 15 cases of polio deemed compatible with vaceine 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 “! A more extensive discussion of the nature and complexity of the tests may be fuced in Griffin v. United States, E.D.P2.1972, 351 F.Supp. 10. See Davis v. Wyeth Laboratories, 9 Cir. 1969, 399 F.2d 121, 123-125. 59a of these,cases were caused by the vaccine’. 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 ean provide a definitive answer’, Rather, they employed a brief datalogue of symptoms ™ which they believed would separate those cases compatible with vaccine-causation from ffase clearly caused by wild strains, and would far- ther separate the **probable’’ vaccine-related cases from those merely possibly associated with it. * Report of the Special Advisory Committee on Oral Poliomye- litis Vaecine to the Surgeon General, Publie Health Service, 1964 at 4. A report by the Health, Education and Welfare Depart- ment '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. * As paraphrased in Reyes’ brief, these symptoms inelude : 1, An onset of illness between 4 and 230 days following. feeding of the specifie vaccine type in question and with!sie] an onset of paralysis not sooner than six days after the feeding. . Significant residual lower-noter-neuron paralysis. 4. Laboratory data not inconsistent with respect to multiplica- tion of the vaecine 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. to These compatible cases were further subdivided into **probable’’ and ** possible ’* cases employing the following guidelines for ** prob- able”’ cases: 1. Evidence of fever at onset of paralysis. 2. History of svstemic iilness preceding the development of pa- ralysis. “ 3. Clinical evidence of meningeal involvement manifested either bY? muchal rigidity or cerebrospinal fluid cell count greater than 10 ells per enhie milliliter. For a further discussion of the development of polio vaceine. avd the elaborate testing procedures, see, eg. Davis vo Wyeth Laboratories, Inc.. & 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. Ls 60a ~ APPENDIX B | VERNON'S EDUCATION CODE OF TEXAS - $2.09. Immunization | ~* (a) No person may, be admitted to any elementary or secondary school or institution of higher education unless he h&% been immunized against diphtheria, rubeola, rubella, tetanus, poliomyelitis, and smallpox, except as provided in * Subsection (e). 5, ons (b) Subject to the provisions of Subsection ¢) the State Board of Health may modify or delete any f the immu- _ hizations in Subsection (a) or may require injmunizations against additional diseases as a requirement for admission to any elementary or secondary school or institution of higher education. | (c) No form of immunization is required for a person’s admission to any elementary or secondary school or insti- tution of higher education when the person plying for admisdion submits to the admitting official either of the following: $1] | .- 2 (1) an affidavit signed by a doctor who i: duly regis- tered and licensed under the Medical Pra tice Act of Texas, in which it is stated that, in the do¢tor’s opin- ion, the immunization required would be injurious to the health and well-being of the applicant or any mem- ber of his family or household; or ont, ae (2) an affidavit signed by the applicant or, if_a minor, by his parent or guardian stating that the im- munization conflicts with the tenets and practice of a recognized church or religious denomination of which the applicant is an adherent or member; provided, however, that this exemption does not apply in times of emergency or epidemic declared by the Commissioner 5 of Health. 4 t sem & v4 (d) The State Department of Health shall provide the required immunizations to children in areas where no local provision exists to provide these services, REPENS Kec Bey, rae LEAL RGAE RO Ve Se pe by mie ’ 7 = i = eee 6la (e) A person may be provisionally admitted to an ele- mentary or secondary school or institution of higher edu- cation if he has begun the required immunizations and if he continues to receive the necessary immunizations as rapidly as is medically feasible. The State Department of Health shall promulgate rules and regulations relating to the provisional admission of persons to an elementary or secondary school or institution of higher education. Amended by Aets 1971, 62nd Leg., p. 702, ch. 67,0§ 1, eff. April 26, 1971; Subsec. (b) amended by Acts’ 1971, 62nd “Leg., p. 1442, ch. 398, § 1, eff. May 26,1971; Subsec, (e) added by Acts 1971, 62nd Leg., p. 1441, ch. 393, § 2, eff. May 26, 1971. een ge a) 62a ASPENDIX C PRESIDENTIAL DOCUMENTS Title 3—The President PROCLAMATION 4329 Immunization Action Week, 1974 By the President of the United States of America A Proclamation United States of America the one hundred ninety-ninth. . /s/ Geran R. Forp [FR Doe.74—24889 Filed 10-21-74;3:56 pm] FrpreraL Recisrer, Vo. 39, No. 206—Wepnespay, OctoBer 23, 1974 f i « oe --- --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385608_1037%3A2. Public record. Not legal advice.