# Petition for a Writ of Certiorari — Wyeth Laboratories v. Reyes > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385608_1037%3A1 ## Record - **Collection:** Supreme Court brief - **Document type:** Petition for a Writ of Certiorari - **Published:** January 1, 1974 - **Citation:** 419 U.S. 1096 ## Text “* acme CuUUis te . IN THE os Supreme Court of the United States OctTosprer TERM, 1974 No@4-501' WyerruH LABORATORIES, a division of American Home Products Corporation, a Delaware corporation, Petitioner, v. Errranio Reyss, individually and as next friend of Anita Reyes, a minor, Respondent. PETITION FOR A WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE FIFTH CIRCUIT ~ CLark M. CLIFFORD _ Tuomas D. FINNEY, JR. THomaAs RICHARD SPRADLIN CLIFFORD, WARNKE, GLASS, McILwaIn & FINNEY 815 Connecticut Avenue, N.W. Washington, D. C. 20006 R. B. Kapine, JR. WILLIAM J. MCKLVEEN EBERLE, BERLIN, KapiInG, TURN- Bow & GILLESPIE, CHARTERED 300 North Sixth Street Post Office Box 1368 Boise, Idaho 83701 Counsel for Petitioner October 29, 1974 Press or Byron S. ADAMS PRINTING, INC., WASHINGTON, D. C. — TEE LED LI PLT ELE ELE AIOE EE SE SOEY GLY MEY INDEX Page Petition For A Writ oF CERTIORARI TO THE UNITED States Court oF APPEALS FOR THE I‘reTH CrrcuiT.. 1 BE OT TCT E RT TCOEETET ETT ETT ET 1 NS eddy ca kniwks ons aed ein an% 6b 0645465 2 QUESTIONS PRESENTED 2.0.02 cccccescccnccesesccaces 2 ConsTITUTIONAL, STATUTORY, AND FEDERAL REGULATIONS EE cd ha prkabha sade e eke W ane eb ated eacde i 3 STATEMENT OF THE CASE ............ rr eee ee oe 6 REASONS FOR GRANTING THE WRIT ............20e000- 8 A. Congress Has So Pre-empted the Field of Law Applicable to Labelirg of Prescription Biologi- eal Drug Products That It Was Error for the Courts Below To Dispose of this Case Solely on the Basis of Local Tort Law ............. 8 B. The Decision of the Court of Appeals is in Conflict with Applicable Texas Law and Public Policy on the Important Question of Whether the Manufacturer of a Prescription Drug has a Duty to Warn the Ultimate Consumer of Pos- sible Risks Involved in Taking the Drug...... 15 SIE a 5s 0a ba chad eNO CKO FRE WN OREN e . 5055 26 Appenpix A—Reyes v. Wyeth Laboratories, 498 F.2d a Pe sh ek haan nat oek bane ean e eens la Appenpbix B—Vernon’s Education Code of Texas, § 2.09 60a Apprenpix C—Presidential Proclamation 4329, Jimmuni- zation Action Week, 1974, October 21, 1974 [39 Fed.Reg. 37629 (Oct. 23, 1974)] ................ 62a ii Index Continued AUTHORITIES C'AsEs: Page \ Algoma Plywood & Veneer Co. v. Wisconsin Employ- ment Relations Board, 336 U.S. 301 (1949) ...... 12 Davies Warehouse Co. v. Bowles, 321 U.S. 144 (1944) 11 Davis v. Wyeth, 399 F.2d 121 (9th Cir. Eee 22, 23 Garner v. Teamsters Union, 346 U.S, 485 (1953) ...... 12 Gravis v. Parke-Davis & Co. 502 S.W.2d 863 (Tex.Civ. App.—Corpus Christi, 1973) ............... 19, 20, 25 Karp v. Cooley, 493 F.2d 408 (Sth Cir. 1974) ... .20, 21, 25 McDermott v. Wisconsin, 228 U.S. 115 (1913) ........ Northern Pacific Ry. Co. v. Washington, 222 U.S. 370 CEE Suen hae Voda tes cuidate ou eielacete ls 12 Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir. Rane na ached kuna ies ceed bak tee 1, 2, 7, 14, 16, 17, 18, 19, 21, 22 Savage v. Jones, 225 U.S. 501 (1912) ................ 2 Second Employers’ Liability Cases, 223 U.S. 1 (1912) 12 Southern Ry. Co. v. Reid, 222 U.S. 424 (1912) ........ 12 Texas & Pacific Ry. Co. v. Abilene Cotton Oil Co., 204 Ses SED oi Svat ta teed ater pc, ol, 12 Wilson v. Scott, 412 S.W.2d 299 (Tex. BTS Avi esess 20 STATUTES AND REGULATIONS: Oe SIMA FIED 4 kin a he vn eck Set rene eke 2 Federal Food, Drug, and Cosmetie Act of 1938, 52 Stat. 1040 (1938) as amended, 21 U.S.C. §§ 301, et seq. GUOOEs ca chdes we ea We der ehenh concceueucueeuc: 2, 8, 11 ck. SEP RE I ar ia nl O 10 cogs lh. EE PETE EOL FO et Dea 3, 4, 8,9 cyte cea gs Eee Par eT En ee a sna a tls 4,8 Public Health Service Act, 58 Stat. 702 (1944) as amended, 42 U.S.C. §§ 262 et seq. (1970) ........ 2,9 See. 351 iG SURES SEEN AD SEND SSE vie od esc s co sepene Vernon’s Educational Code of Texas $2.09 .......... 6, 16 Be ee oo 8 vo Se a a a ba eae ECE ba wh van 5, 10 Be re BO oo sks oh eae 6 is eas a heb whe ek 4,8 Presidential Proclamation 4329, Immunization Action Week, 1974, October 21, 1974 [39 Fed.Reg. 37629 [Ams My OUR E 565s ee adaet acs co chkues uk 17, 62a i LEE EL EOL Met AF PLR L YALE COLI ELLA LENT TORY BY DS ° Pie ee Eg Ss, see recesrsgyse ae: @ ~ Index Continued iii : Page \ MISCcRLLANEOUS: Be, WOR Ds Os Oe Saeko cc beeen denivndns 16 Center for Disease Control, Annual Poliomyelitis Sum- mary—1970, at 1-4 (September 30, 1971) ...... .6, 24 Center for Disease Control, Morbidity and Mortality Weekly Reports—1963-1970 ................206. 17 New York Times, October 10, 1974 at 10, col. 3 ....... 25 Report of the Surgeon General’s Special Advisory Committee on Oral Poliomyelitis Vaccines, 190 AMA Journal ai 49-51 (Oct. 1964) .............. 16 wre dues 5 evi tem nenecrsmcer ton LEMS DERE L ELAINE LEELA LEELES LILES ENGEL EAE AE ES AE LCL la BER ARE "IMS POEL TA LGA INCAS aaa ee - ‘ ert IN THE Supreme Court of the United States OcToBER TERM, 1974. No. — \ Wyernu LABORATORIES, a division of American Ifome Products Corporation, a Delaware corporation, Petitioner, v. Errranio Reyes, individually and as next friend cf Anita Reyes, a minor, : Respondent. PETITION FOR A WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE FIFTH CIRCUIT The petitioner, WYETH LaBorATORIES, prays that a writ of certiorari issue to review the opinion and © judgment of the United States Court of Appeals for the Fifth Circuit rendered in these proceedings on July 31, 1974. OPINION BELOW The opinion of the Court of Appeals is reported as Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir. 1974), and appears at Appendix A, infra, at pp. 2a, et I 2 seq. The case was tried to a jury in the United States District Court for the Southern District of Texas, | Brownsville Division, and that court did not render an opinion. JURISDICTION The judgment of the Court of Appeals was entered on July 31, 1974, Appendix A, infra, at p. la. This petition for certiorari was filed less than 90 days from the date aforesaid. The jurisdiction of this Court is invoked -ulider 28 U.S.C. § 1254(1). QUESTIONS PRESENTED 1. Whether, by enactment of the Federal Food, Drug, and Cosmetie Act of 1938, 52 Stat. 1040 (1938), as amended, 21 U.S.C. §§ 301, ct seq. (1970), and the Public Health Service Act, 58 Stat. 702 ¢ 1944), as amended, 42 U.S.C. §§ 262, et seq. (1970), Congress has so pre-empted the field of law applicable to the labeling of prescription biological drug products that it was error for the courts below to dispose of this case solely on the basis of local tort law. 2. Whether the Court of Appeals contravened the public health policy of the State of Texas and of the United States and erred in its application of Texas law by holding, in the face of statutorily expressed public policy of Texas to the contrary and in disregard of the holding in the only Texas case in point, that under Texas law a manufacturer of a prescription drug, used to immunize large segments of the population against paralytic polio. is required to warn the ultimate con- sumer of the dangers of vaccination, even though ad- mittedly adequate warnings hove been given to the physician-administrators of the state public health facility dispensing the drug. 3 CONSTITUTIONAL, STATUTORY, AND FEDERAL REGULATIONS INVOLVED The Public Health Service Act provides: See. 351. (b) No person shall falsely label or mark any package or container of any virus, serum, toxin, antitoxin, vaccine, blood, blood component or de- rivative, allergenic product, or other product aforesaid; nor alter any label or mark on any package or container of any virus, serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenie product, or other product aforesaid so as to falsify such label or mark. * * * (g) Nothing contained in this chapter shall be construed as in any way affecting, modifying, re- pealing, or superseding the provisions of the Federal Food, Drug, and Cosmetic Act.’ [42 U.S.C. § 262(b), (g) (1970).] The Federal Food, Drug, and Cosmetic Act provides at Sections 502 and 503: ‘See, 502. Misbranded drugs and devices. A drug or device shall be deemed to he mis- branded— (a) If its labeling is false or misleading in any particular. * * * (f) Unless its labeling bears (1) adequate direc- tions for use; and (2) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner 4 and form, as are necessary for the protection of users: Provided, That where any requirement of clause (1) of this paragraph, as applied to any drug or device, is not necessary for the protection of the public health, the Secretary shall promul- gate regulations exempting such drug or device from such requirement.” [21 U.S.C. § 352( a),(f) (1970).] * * * “Sec. 503. Exemptions in ease of drugs and devices, * * * (b)(2) Any drug dispensed by filling or refill- ing a written or oral prescription of a practitioner licensed by law to administer such drug shall be exempt from the requirements of section 502, except paragraphs (a), (i) (2) and (3), (k), and (1), and the packaging requirements of para- - graphs (g), (h), and (p), if the drug bears a label containing the name and address of the dispenser, the serial number and date of the prescription or of its filling, the name of the prescriber, and, if stated in the prescription, the name of the patient, and the directions for use and cautionary state- ments, if any, contained in such prescription. This exemption shall not apply to any drug dispensed in the course of the conduct of a business of dis- pensing drugs pursuant to diagnosis by mail, or to a drug dispensed in violation of paragraph (1) of this subsection.”’ [21 U.S.C. § 353 (b) (1970).] The provisions of 21 C.F.R. § 1.106 are in pertinent part as follows: “$ 1.106 Drugs and devices; directions for use. (a) Adequate directions for use. ‘Adequate directions for use’? means directions under which the layman can use a drug or device safely and for the purposes for which it is intended. Di- 5 rections for use may be inadequate because (among other reasons) of omission, in whole or in part, or incorrect specification of: (1) Statements of all conditions, purposes, or uses for which such drug or device is intended, including conditions, purposes, or uses for which it is prescribed, recommended, or suggested in its oral, written, printed, or graphic advertising, and conditions, purposes, or uses for which the drug or device is commonly used; except that such statements shall not refer to conditions, uses, or purposes for which the drug or device can_ be safely used only under the supervision of a practitioner licensed by law and for which it is advertised solely to such practitioner. (b) Eremption for prescription drugs. A drug subject to the requirements of section 503(b) (1) of the act shall be exempt from section 502(f) (1) if all the following conditions are met: * * * (4) Any labeling, as defined in section 201(m) of the act, whether or not it is on « ¢ within a pack- age from which the drug is to be dispensed, .. . contains: (i) Adequate information .. . under which practitioners licensed by law to administer the drug can use the drug safely and for the pur- poses for which it is intended... .”’ The language of 21 C.F.R. § 1.2 is as follows: **§ 1.2 Labeling; label; definitions. (a) Labeling includes all written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in inter- state commerce. (b) ‘Label? means* any display of written, printed, or graphic matter on the immediate con- — es | ROE ae OH a 6 tainer of any article, or any such matter affixed to ‘any consumer commodity or affixed to or appearing upon a package containing any consumer com. modity.”’ The relevant statute of the State is Vernon’s Eduea- tion Code of Texas, Section 2.09, which provides in part as follows: ‘““No person may be admitted to any elementary or secondary school or institution of higher eduea- tion unless he has been immunized against .. . poliomyelitis... . except as provided in Sub- section (¢).” The complete text of § 2.09 is reproduced in full at Appendix B, infra, at pp. 60a-61a. STATEMENT OF THE CASE On May 8, 1970, Anita Reyes, an 8-mouth-old infant, received a dose of trivalent ora] polio vaccine at a State of Texas County Health Department Clinie in Hidalgo County, Mission, Texas. The vaccine was administered in the course of an epidemie as declared by the United States Government through the Center for Disease Control as a part of an epidemic control program conducted pursuant to the recommended policy of the Center for Disease Control in Atlanta, Georgia. Of the 33 cases of polio reported throughout the Nation during the year 1970, 22 occurred in Texas. All but one of these eases occurred in the Rio Grande Valley, where Anita Reyes resides, an area of concen- trated Mexican-American population; and 1 out of every 3 of the Texas cases were in ] lidalgo County. Center for Disease Control, Annual Poliom yelitis Summary—1907, at 1-4 (Sept. 30, 1971). 7 The vaccine Anita received was part of 400 vials manufactured and shipped by Petitioner in interstate commerce in accordance with Federal law and regula- tions. It was shipped by the Texas Department of Health in Austin, Texas, to the Hidalgo County Health Department, and had been purchased by the Texas Health Department under a competitive bid from Peti- tioner, Wyeth Laboratories. Wyeth Laboratories is a division of American Home Products Corporation and is the distribution outlet for Wyeth Laboratories, Ine., a wholly owned subsidiary of American Home Products. Each vial of this vaccine contained a “package cir- eular’’ detailing the dangers associated with taking the vaccine. The registered public health nurse at the Mission Health Clinie of the Hidalgo County Health Department had read the package insert. No warning of the inherent danger, characterized by the Court of Appeals as “statistically miniscule’? (498 F.2d at 1274), was given by the public health nurse to Anita’s mother. Approximately twenty days after she received the vaccine, it was determined that Anita had contracted Type I paralytic polio. Respondent, Epifanio Reyes, filed suit individually, and as next friend of his minor daughter, Anita Reyes, against Petitioner is the Federal District Court for the Southern District of Texas, Brownsville Division, with jurisdiction based on diversity of citizenship. The jury concluded that Petitioner’s vaccine was the cause of Anita’s polio and rendered a verdict against Petitioner. On appeal, the United States Court of Appeals for the Fifth Circuit held Petitioner liable under Texas products liability law for failing to warn Anita’s parents of the danger inherent in the vaccine. ‘ 5 n fi aa Ree ese hint. Sante et. on Peet ne eee ‘ ; ee Bitiswcsssesernss NS See a ear 8 REASONS FOR GRANTING THE WRIT A. Congress Has So Pre-empted the Field of Law Applicable to This case involves an important question of Federal Supremacy which has never before been specifically considered by this Court. The manner in which this question is resolved will have a profound impact on publie health care throughout our Nation, particularly on national programs of disease prevention. Section 502(a) of the Federal Food, Drug, and Cosmetic Act provides that a drug shall be deemed to be misbranded if its labeling is false or misleading in any particular, 21 U.S.C. §352(a). A drug will also be deemed misbranded according to Section 502( f) if its labeling does not bear ‘**(1) adequate directions for use; and (2) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health ... .”? 21 U.S.C. § 352(f). By Federal regulation, 21 C.F.R. § 1.106(a), the term ‘adequate directions for use” as used in Section O02(f) of the Act means ‘directions under which the layman can use a drug or device safely and for the purposes for which it is intended.” These require- ments, however, are not applicable to prescription drugs beeause of the provisions of Section 503 of the Act. That section exempts from the ‘‘directions for use’’ requirements of Section 902(f) any drug which is dispensed on the order of 4 practitioner licensed by law to administer such drug. This exemption of pre- scription drugs is further reflected in 21 C.F.R. § 1.106 (a) (1), which states that the ‘directions for use’? re 9 quirements shall not apply ‘‘to conditions, uses, or pur- poses for which the drug or device can be safely used *, only under the supervision of a practitioner licensed by - law and for which it is advertised solely to such prac- titioner.”” The provisions of Section 502(a) pro- hibiting false or misleading labeling remain applicable to prescription drugs. The foregoing provisions are not the only Federal laws regulating the labeling of biological drug products. The Public Health Service Act, 58 Stat. 702 (1944), as amended, 42 U.S.C. §§ 262, et seq., contains detailed requirements on the licensing, labeling, and marketing of any virus, serum, toxin, antitoxin, vaccine, or similar biological product in interstate commerce, Section 351 (g) provides explicitly, however, that: ‘Nothing contained in this Act shall be construed as in any way affecting, modifying, repealing, or superseding the pro- visions of the Federal Food, Drug, and Cosmetic Act.”’ 42 U.S.C. § 262(g). It has not been and cannot be alleged that the labeling which Petitioner provided with its trivalent polio vac- cine in this case was in any way false or misleading. It was the standard labeling developed with approval of Federal officials through long experience, and it was properly shipped in interstate commerce to the public health officials in charge of the immunization program out of which this case arose. That labeling, as required by Federal law, was directed to health professionals and contained all necessary directions and warnings. Because of the scientific and medical complexities sur- rounding this vaccine, as with any prescription drug product, adequate labeling could have been directed only to health professionals and not to the ultimate lay consumer. 10 The courts below would have the manufacturer at- tempt to provide some form of written information to the lay consumer regarding the use of this vaccine. Without question any such statement would amount to “labeling” under Federal law and regulations. That term is defined at Section 201(m) of the Act as meaning “‘all labels and other written, printed, or graphie matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article,” The term is further explained by Federal regulation at 21 C.F.R. § 1.2: “$1.2 Labeling; label; definitions. (a) Labeling includes all written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in inter- state commerce. (b) ‘Label’ means any display of written, printed, or graphic matter on the immediate con- tainer of any article, or any such matter affixed to any consumer commodity or affixed to or ap- pearing upon a_ package containing any con- sumer commodity.”’ The court below has committed a fundamental error which, if not corrected, will have a profoundly adverse impact upon public health immunization programs in the future. In its attempt to equate the situation in this case with the sale of over-the-counter drugs, and draw therefrom a duty on the part of the manufacturer to provide labeling providing laymen with ‘adequate directions for use’’ of trivalent oral polio vaccine, the Court of Appeals’ decision threatens to wreak havoe with our Nation’s health care delivery system. ee hee TOLLS LOL ALLEL Oe q 11 Erroneously, and contrary to Federal law, the Court of Appeals has assumed that the manufacturer, or anyone other than trained an@ licensed health pro- fessionals dealing directly with their patients, can provide ‘‘adequate directions for use”’ for prescription drug products which are meaningful to laymen, many of whom may be of limited educational background. This case does not involve the purchase of a common analgesic or an antacid at a local drug store. It in- volves the administration by public health authorities in an epidemic situation of a potent and, complex vac- cine properly manufactured and shipped in inter- state commerce pursuant to Federal law. The decision to conduct mass immunization in this ease was made by public health authorities. The pro- fessional labeling accompanying the vaccine in ques- tion was made available by Petitioner to those authori- ties. The inherent risk involved in administering the vaecine was known to them. No representative of Peti- tioner was present during administration of the vac- cine, and it would stretch the bounds of credibility to suggest that it should be otherwise. The entire context of the Federal Food, Drug, and Cosmetic Act, as it concerns the labeling of prescrip- tion drug products, shows without question that Con- gress intended to pre-empt this area of interstate commerce. While the extension of Federal control into traditionally local matters is always a delicate exercise of legislative authority and requires aeccom- modation between the needs of central control and the maintenance of local institutions, where the intent of Congress is clearty to pre-empt the field in matters re- garding interft:te commerce that intention must prevail. Davies! Warehouse Co. v. Bowles, 321 US. 12 ’ 144 (1944). No one will question that where State and Federal laws do not overlap, a State’s jurisdiction is unimpaired. Id.; Algoma Plywood & Veneer Co. v. Wisconsin Employment Relations Board, 336 U.S. 301 (1949). But as this Court has als» noted in a related context involving the predecessor of the Federal Food, Drug, and Cosmetic Act: “*... [I]t is equally well settled that the State may not, under the guise of exercising its police power or otherwise, impose burdens upon or discriminate against interstate commerce, nor may it enact legislation in conflict with the statutes of Congress passed for the regulation of the subject, and if it does, to the extent that the state law interferes with or frustrates the operation of the acts of Congress, its provisions must yield to the superior Federal power given to Congress by the Consti- tution. Texas & Pacific Ry. Co. v. Abilene Cotton Oil Co., 204 U.S. 426; Northern Pacific Ry. Co. vy. Washington, 222 U.S. 370; Southern Ry. Co. vy. Reid, 222 U.S. 424; Second Employers’ Liability Cases, 223 U.S. 1; Savage v. Jones, supra, 533.’’ McDermott vy. Wisconsin, 228 U.S. 115, 131-132 (1913). Therefore, where Congress has taken jurisdiction of a particular matter or type of controversy affecting interstate commerce, the States, through their courts, may be precluded from adjudging the controversy and extending their own forms of relief. Garner v. Team- sters Union, 346 U.S. 485 (1953). In the situation now at hand the purpose of Congress is clear and manifest. The labeling of prescription drug products shipped in interstate commerce is subject entirely to Federal law and regulation, and the States are without power to impose contrary restraints in this area. When the manufacturer of a prescription drug 22a NORIO ALA alate it UB OT ts we or Ge RR ns Powe fk 13 product has complied fully with the provisions of Fed- eral law regarding the Jabeling of that product, he has completed his obligation to the public. Indeed, he should have no other obligation to the public with re- gard to prescription drug labeling than to comply. with Federal law, whether that obligation be asserted in the form of criminal sanctions or civil or tort liability. Moreover, throughout the Federal statutes and regula- tions on this subject there is an inherent recognition of the sanctity to be accorded the doctor-patient relation- ship. No drug manufacturer is required or even allowed under Federal law to interpuse himself be- tween doctor and patient. The decision of the Court of Appeals below, if left standing, would not only violate Federal policy as promulgated by Congress and the Secretary of Health, Education, and Welfare but weuld also inevitably breed a new form of liability suit brought by individ- uals against drug manufacturers based on unavoidable injuries due to inherent risks in taking prescription medication on the advice of health professionals. Such a result would alter in a fundamental way the health eare delivery system in this Nation. Manufacturers, not health professionals, would be ultimately respon- sible for the administration of prescription drugs to individual patients. The effect of the Court of Appeals’ decision would be to remove the public health physician in particular from the relationship between the patients of a public health clinic and the manufacturers whose drugs are used to further the goals of such an institution. To the class of persons dependent upon the services pro- vided by a publie health clinic, the lower court's de- cision would have a devastating impact. These per- 14 sons would be faced with a choice which they are un- prepared to make and which would be made for them if they had the financial resources to. seek health care from a private physicia&. This is true because, as Petitioner has repeatedly emphasized, in the adminis- tration of polio vaccine there is no basis for the in- ; dividualized medical judgment on which the court be- | low rests its decision. This fact was either ignored or never understood by the Court of Appeals. For the Nation as a whole, but particularly for large agricultural states such as Texas with a significant num- ber of poorly educated migrant laborers among whom the incidence of communicable diseases such as polio is tragically high, the lower court’s conclusion that DS a ee public health authorities cannot play a meaningful role in administering prescription drugs used in immuniza- ; tion programs will have serious repercussions because i of the increased likelihood of communicable disease epidemics. This is especially true should manufac- turers of polio vaccine be forced to discontinue its sale to public health institutions because of the problem of insuring that adequate warnings are given. The Court of Appeals’ reference to cost-benefit analysis cuts both ways. Also, the lower court’s suggestion that the manufacturer’s loss ‘‘be passed on to the public in the form of price increases to [its] customers,” 498 F.2d at 1294, is an unrealistic assessment. Public health institutions are by far the largest-volume purchasers of Petitioner’s vaccine, and they are finaneed by State and Federal governments which have neither the inten- tion nor the authority to become the manufacturer’s insurers. The assumption of necessary and unavoidable risk in the case of administration of any potent prescription EOL LOLI ELL ERED LOLS POSE LLL EEL II Yn Bs PME LEI IM LOL IER IO GENS SIO LE LE RON DOB er eee ee ee ee eS 15 drug is a medical judgment to be made by the health professional in dealing with his patient. To place that risk at the door of drug manufacturers will, among other things, have a chilling effect on their ability to cooperate with public health officials in epidemic sit- uations such as that in this case. It is Federal policy to leave the decision on administration of drugs similar to the vaccine here to individual health professionals in the context of their own relationships with their pa- tients—even in public health situations. That policy ' is clearly seen in the Federal statutes and regulations. It is a policy which the decisions below would destroy. B. The Decision of the Court of Appeals Is in Conflict with Applicable Texas Law and Federal and State Public Policy on the Important Question of Whether the Manufacturer of a Prescription Drug Has a Duty to Warn the Ultimate Consumer of Possible Risks Involved in Taking the Drug. This case merits review because of the significant public health ramifications which will flow from the lower court’s holding that the manufacturer of a pre- scription drug, administered in the course of a Fed- erally approved State program designed to immunize segments of the population against a highly communi- cable disease, is required to warn the ultimate consumer of the danger inherent in the drug, even though an adequate warning has already been given to the physicians in charge of the public health facility which dispenses the drug. The importance of this issue can- not be overstressed, since it is certain that the impact on future operations and decisions of public ‘health authorities—both State and Federal— will be disrup- tive not only with respect to the administration of polio vaccine, but also with respect to other drugs adminis- tered in public health clinies or in the course of publicly sponsored mass immunization programs. e ee eee Tile tee gi SEO NA te SRT NE a Ce en 16 The Court of Appeals failed to follow applicable Texas law, and ignored the very strong public policy of the State of Texas in preventing the spread of com- municable disease. Review by this Court is needed ty correct this misapplication of State law, and to avoid the serious adverse effects which it is certain to produce, There can be no doubt that Texas has a strong interest in preventing the spread of communicable diseases. In order to implement this policy, Texas law requires that students be immunized against cer- tain communicable diseases, including poliomyelitis. ’ Vernon’s Education Code of Texas § 2.09 (1971), [See Appendix B, infra, pp. 60a-61a.] The success of such programs of immunization in virtually eliminating epidemics of poliomyelitis is well known. As the Court of Appeals recognized, much of the credit for the elimination of polio from the United States is due to the combined efforts of Federal and State public health authorities and the manufacturers of polio vaccine. 498 F.2d at 1270. Substantial par- ticipation in such immunization programs by the Fed- eral Government indicates the national importance of these efforts.’ The current poliey of the Federal Goy- For the past 10 years, the United Staies Publie Health Service, an agency of ine Department of Health, Education, and Welfare, has advocated the use of oral polio vaccines to combat the threat of poliomyelitis and has played a substantial role in encouraging mass immunization programs. See Report of the Surgeon General's Special Advisory Committee on Oral Poliomyelitis Vaccines, 190 A.M.A. Journal at 49-5] (October 1964). This policy has been frequently reiterated. See, eg. 16 A.M.A. Journal (Angust 1967); 18 A.M.A. Journal (October 1969); 2] ALA. Journal (June 1972). In line with this Federal poliey the United States Public Health Service through the Center for Disease Control jn Atlanta, Georgia, has been an active participan‘ in watching for PVE TAO ee ee pi a lll ie tae _e Ce 7 3 f 2 eee ee ere et 17 * ernment is manifested by a recent proclamation in which the President of the United States urged ‘‘all parents, educators, and medical personnel to exert re- newed efforts during this week and throughout the year to immunize every American child against diseases for which vaccines are available.’’ Presidential Procla- mation 4329, Immunization Action Week 1974, October 21, 1974 [39 Fed. Reg. 37629 (Oct. 23, 1974) ; See Ap- pendix C, infra, p. 62a.] In an epidemic situation the public health physician has only one choice to halt the spread of communicable disease. That choice is mass immunization. Under the Couwt of Appeals’ decision below the manufac- turer of the prescription drug to be used in the immuni- zation. program would be required to interfere with that « hoice by carrying a warning to the ultimate con- sumer, The effect of that holding would be to undermine the ability of public health physicians to act decisively aud effectively to control threatened epidemics, such as the situation which existed in Hidalgo County in 1970. The polio vaccine administered here was not defee- tively manufactured. It was ‘*exactly what its makers and the Texas public health authorities intended it to be.’’ 498 F.2d at 1273. Even so, there remained the chance—established statistically at ranges from 1 in 1 million to 1 in 16 million— that one ingesting the vac- and in helping state and local authorities control outbreaks of poliomyelitis. (For examples of this participation refer to the official publication of the Center for Disease Control, Morbidity and Mortality Weekly Report, for the following weeks: July 2s, 1963 (Pennsylvania); Angust 2. 1963 (Walker County.