# Record and brief — Davis v. United States > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385008_0478%3A0 ## Record - **Collection:** Supreme Court brief - **Document type:** Record and brief - **Published:** January 1, 1982 - **Citation:** 455 U.S. 919 ## Text UOIag Office - Supreme Court, U.S. FILED 81-644 AUG 25 1981 No, ALEXANDER L STEVAS. a = ed IN THE SUPREME COURT OF THE UNITED STATES October Term, 1981 GLYNN RICHARD DAVIS, Petitioner, vs. UNITED STATES OF AMERICA, Respondent, PETITION FOR A WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT Robert M, Tyler, Jr. (Counsel of Record) Blaine F, Evans ELAM, BURKE, EVANS, BOYD & KOONTZ P.O. Box 1559 Boise, ID 83701 Telephone: (208) 343-5454 ADLER, BARISH, LEVIN & CRESKOFF Rohm & Haas Building 8th Floor, Lafayette Building 6th & Market Streets Philadelphia, PA 19106 Telephone: (215) 923-8900 Attorneys for Petitiener 1, Where the federal government has unique knowledge of potential risks to the health of citizens who participate in gov- ernment programs, what is the nature and scope of the government's duty to inform the public of those risks? 2. Whether accrual of a cause of ac- tion within the meaning of 28 U.S.C. § 2401(b) is deferred where plaintiff's failure to discover the cause of his in- jury within two years of incurring it re- sults from the government's acts in con- cealing information essential to his cause of action? 3. Whether the concealment doctrine tolls the statute of limitations, 28 U.S.C. § 2401(b), where plaintiff's failure to sue within two years of incurring an injury results solely from the government's mis- representations to the public and failure to produce decuments sought by a subpoena served on the government? 4. Whether the principles of equity applicable to statutes of limitations pre- clude the government from asserting a lim- itations defense where the government has concealed from the plaintiff information necessary to predicate his claim against the government? ii TABLE OF CONTENTS QUESTIONS PRESENTED . OPINIONS BELOW. JURISDICTION, STATUTES AND REGULATIONS. STATEMENT OF THE CASE . JURISDICTION IN THE COURT OF FIRST INSTANCE . REASONS FOR GRANTING THE WRIT . I. Il. ITl. In the context of the statute of limitations to the Federal Tort Claims Act, this case pre- sents an important question of federal law concerning the na- ture and scope of the govern- ment's duty to inform the pub- lic of risks associated with government programs which en- courage mass citizen participa- tion. are ae The decision below conflicts with this Court's decision of United States v. Kubrick, 100 $.Ct. 352 (1979). * The decision below conflicts with settled federal law which tolls statutes of limitations where the government conceals from a plaintiff evidence which is crucial to his cause of hs + ee o> 6 oe 6 6 IN iii 17 18 49 25 35 CONCLUSION. . . 2. 2 6 ee © © © 8 42 APPENDICES Appendix A. A-1 Appendix B. A-19 Appendix C. A-21 Appendix D. A-22 Appendix E. A-25 Appendix F. A-27 Appendix G. A-51 Appendix H. A-56 Appendix I. A-59 Appendix J. A-62 Appendix kK. A-82 Appendix L. A-98 Appendix M. A-113 Appendix N. A-124 Appendix Oo. A-129 iv TABLE OF AUTHORITIES Cases: Camire v. United States, 535 F.2d 749 (2a C Cir. 1976). ' ave Davis v. Wyeth Laboratories, Inc., 399 F.2d 121, 123 (9th Cir. 1968) Gicas v. United States, 508 F.Supp. 217 (E.D.Wis. 1981) United States v. Kubrick, 100 S.Ct. 352 (1979). Marshall v. Kimberly-Clark Corp., 625 F.2d 1300 (5th Cir. 1980) Public Service of New Mexico v. General Electric Co., 315 F.2d _ oh gs ie gelatine Rahn v. United States, 222 F. SupP 775 (S.D.Ga. 1961). . Bie Spevack v. United States, 390 F.2d 977 (Ct.Cl. 1968). Toal v. United States, 438 F.2d 222 (2d Cir. 1971) Pages 25, 24, 37 38 Pages Statutes: Federal Tort Claims Act, 28 U.S.C. |S: Se Beare ; . 17 Federal Tort Claims Act, 28 U.S.C. ie oS a ’ gttccie ee ae National Swine Flu Act of 1976, a ce omeeee. ar EEn sé 6-60 et we 8 22 Regulations: 42 C.F.R. § 73.114(b)(1)(iii) .. . 6, 7 vi No. IN THE SUPREME COURT OF THE UNITED STATES October Term, 1981 GLYNN RICHARD DAVIS, Petitioner, vs. UNITED STATES OF AMERICA, Respondent. PETITION FOR A WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT OPINIONS BELOW The Opinion of the Ninth Circuit Court of Appeals was entered on April 20, 1981, and has been reported at 642 F.2d 328 (9th Cir. 1981). (Appendix A.) The district court's order on defendant's motion for Summary Judgment was entered on March 29, 1977 (Appendix D), and is not reported. The district court's judg- ment granting the government summary judgment was entered on the same day. (Appendix E. ) JURISDICTION The judgment of the Ninth Circuit Court of Appeals was entered on June 22, i981. (Appendix C.) The order of the Ninth Circuit denying a timely petition for rehearing and rejecting the sugges- tion for rehearing en banc was entered on May 28, 1981. (Appendix B.) The jurisdiction of this Court is invoked under Title 28, United States Code, Section 1254(1). STATUTES AND REGULATIONS The federal tort claims act, 28 U.S.C. § 2401(b) which provides: A tort claim against the United States shall be forever barred unless it is presented in writ- ing to the appropriate Federal agency within two years after such claim accrues or unless action is begun within six months after the date of mail- ing, by certified or registered mail, of notice of final denial -2-.= of the claim by the agency to which it was presented. The Federal Tort Claims Act, 28 U.S.C. § 1346(b) which provides: Subject to the provisions of chapter 171 of this title, the district courts, together with the United States District Court for the District of the Canal Zone and the District Court of the Virgin Islands, shall have exclusive jurisdiction of the civil actions on claims against the United States, for money damages, accruing on and after January 1, 1945, for injury or loss of property, or personal injury or death caused by the negligent or wrongful act or omission of any employee of the Government while acting within the scope of his office or em- ployment, under circumstances where the United States, if a private person, would be liable to the claimant in accordance with the law of the place where the act or omission occurred. 42 C.F.R. 73.114(b)(1)(iii). (Appendix 0.) STATEMENT OF THE CASE Participating in the federal govern- ment's campaign to eliminate paralytic poliomyelitis, petitioner Davis took Type III oral polio vaccine at a mass immuniza- tion clinic conducted in West Yellowstone, Montana in March, 1963. Within four weeks of ingesting the vaccine he was paralyzed from the waist down and has continuously remained in that condition. (Appendix F, p. A-28.) The mass immunization plan was con- ceived by an advisory committee estab- lished in 1960 by the Surgeon General. ‘The committee formulated a plan to create mass immunization centers throughout the country, and in March, 1962, the Surgeon General, acting on behalf of the Public Health Service, issued recommendations for the use of the Sabin oral vaccine. As part of the program, representatives of the Public Health Service held meet- ings with local public health officials and medical personnel in communities throughout the United States. Davis vy. Wyeth Laboratories, Inc., 399 F.2d 121, 123 (9th Cir. 1968). The vaccine involved was Sabin oral vaccine which consisted of three separate types: Types I, II, and III. Each type was designed to immunize the person inocu- lated from contrac’ ng polio from a cor- responding type of polio virus. Id. at 122. Unlike the predecessor Salk vaccine, the Sabin vaccine utilized live virus. In addition to creating the immuni- zation clinics, the federal government controlled the licensing and testing of the vaccine through the Division of Bio- logics Standards (DBS) of the National Institutes of Health, an arm of the United States Department of Health, Education and Welfare. The government licensed three companies to manufacture the vac- cine, including Wyeth Laboratories, Inc., which produced Lot 35, from which Davis was vaccinated.’ ‘In 1964 Davis sued Wyeth on the basis of diversity jurisdiction. The trial court ceoere ca ae against “3 and the Ninth ircuit rever . Davis yeth, ° That case was settl w chéut a sec ~ trial. . Government regulations required each manufacturer, after producing a let, to perform prescribed tests on it and submit the test results, together with a sample from the lot, to the DBS, where the gov- ernment performed additional tests to determine its safety, potency, ane purity. If the lot satisfied government standards, the DBS authorized its dissemination te the public. | Dr. Ruth Kirschstein was the DBS pathologist responsible for supervising the government testing. Her deposition was taken on October 21-22, 1965 in the Davis v. Wyeth litigation, and on May 12, 1975, in the instant litigation. (The former deposition is hereinafter referred to as Kirschstein Dep. I and the latter, as Kirschstein Dep. II.) The critical test which DBS per- formed on each iot was the neurovirulence test, in which a sample from a vaccine let was injected into the brain or spinal eolumn ef a test animal. After destruc- tion of the animal following an observa- tien peried, a section of tissue was removed from the brain or spine and sub- jected to a histelogic examination to determine the number and severity of lesions, or deviations from the norm. Lesions were graded on an increasing scale of severity from 1 to 4. (Kirsch- stein Dep. I, p. 103.) The occurrence of lesions in the test lot was then compared te a reference strain of vaccine main= tained by the DBS pursuant toe 42 C.F.R. § 73.114(b)(1) (iii), which provided that a test lot was satisfactory for manufac- ture only if “a comparative analysis of the test results demonstrates that the neurevirulence of the test virus pool dees not exceed that of the NIH Reference Attenuated Polio Virus." Wyeth's Lot 35 was subjected te two tests. Prior te Dr. Kirschstein's depo- sition in October, 1965, she was served = 7. . with a subpoena directing the DBS to produce all its records pertaining to Lot 35. Yet at this deposition she failed to preduce the results of a second neurevi- the lot. (Kirschstein Dep. II, pp. 21-25, 30, 33-34.) The results ef the second test, included as Appendix I hereto, that the lot never should have been re- leased. (Appendix G.) Indeed, the re=- sults ef this second test on Lot 35 showed the first grade 4 lesion recorded by the DBS testing (Appendix G), which was the most severe on the DBS range of severity. Because the government failed to preduce the results of the second test at Dr. Kirsehstein's deposition in 1965, it was only fertuiteusly that Davis was informed ef these facts in 1973 by an attorney representing another person who had contracted polio from taking the vaccine. (Appendix F, p. A-31.) When Davis obtained this crucial information, he promptly filed suit against the govern- ment alleging negligent release of Lot 35. (Appendix F, pp. A-31-32.) He had earlier sued Wyeth on the theory of strict liability for failure to warn of the risk that a person could centract polio from ingesting the Sabin vaccine. In that case, Davis had no evidence of any defect in Lot 35 because ef the government's concealment of the results of the second test, and was able te effer only epidemiclogical proof that the vaccine had caused his disease. (Appendix F, p. A=42.) Indeed, the Ninth Cireuit Court ef Appeals, which ruled in Davis's favor in the Wyeth litigation, believed that the Lot satisfied government standards. Davis v. Wyeth, supra, 399 F.2d at 123. Of course, the court like Davis had access to only the first test preduced at Dr. Kirschstein's deposition in 1965. | The record is replete with evidence that Davis aggressively sought to deter- mine the cause of his paralysis, yet he was repeatedly told that it was impos- sible to prove that a particular case of polio was caused by the vaccine and that cases which showed a possible epidemiolog- ical link with the vaccine were not asso- ciated with any particular lots. (Appen- dix F.) Davis's affidavit attached as Appen- dix F describes in detail his efforts to learn the cause of his injury. Only three months after contracting the disease he began to write letters to epidemiolo- gists and other scientists and to review literature on polio contained both in medical journals and government publica- tions. (Appendix F.) He wrote to the «10 Director of the Food and Drug Administra- tion and the Public Health Service. He corresponded with the Administrator of National Health and Welfare in Canada and in the summer of 1964, wrote to Dr. Sabin himself, who responded that there was absolutely no way that he could have contracted polio from the vaccine. (Ap- pendix F, pp. A-38-39.) In July, 1964, Davis's attorneys consulted with Dr. Salk, developer of the predecessor vac- cine, and he too, was unable to state that there was any association of partic- ular vaccine lots with inducement of the disease. (Appendix F, p. A-39.) Ina letter to the Washington State Department of Health which Davis wrote in October, 1963, he stated that not one of nearly 20 doctors who had examined him would ac- knowledge that his paralysis could have been caused by the vaccine. (Appendix A, p. A-16.) = ll - Davis's conscientious review of the literature proved no more fruitful. A June, 1963 article by Dr. Gelfand, Chief of the Enterovirus Unit of the Communica- ble Disease Center, stated that "it re- mained impossible to decide whether or the oral vaccine. ..." (Emphasis ad- ded.) (Appendix M, p. A-121.) The same article stated that "[Njo evidence has composed of these strains, had ever prevent." (Emphasis added.) (Appendix F, p. A=35.) In addition to medical journals, Davis, beginning only a few months after the onset of his disease, thoroughly read the documents which the government dis- tributed concerning the issue of possible asteciation ef polio with ingestion of the oral vaccine. s 12 « Sometime in 1962 the Surgeon General, Dr. Luther Terry, formed a Special Oral Poliomyelitis Vaccine Advisory Committee (Committee) comprised of some of the world's foremost experts on epidemiology and virology. The Committee included scientists working both within and with- out the federal government. Some of the members were Dr. Ernest Ager, an epidemi- clogist employed by the Washington Depart- ment of Health; Dr. Albert Sabin, the creator of the oral vaccine; and Dr. Roderick Murray, director of the DBS. (Appendix L, pp. A-106-108. ) The findings of the Committee's meetings, held from August, 1962 through July, 1964, were published in the Commit- tee's reports, as well as reports and press releases issued by the Surgeon General. The meeting of September 15, 1962 was described in the September 20, 1962 technical report authored by the Surgeon General. (Appendix J.) This was one of several reports that the Committee published after September 3, 1962, the date of completion of the second neurovi- rulence test on Lot 35. The September 20 report related that the Committee had reviewed data concern- ing the occurrence of polio cases after administration of the oral vaccine and had examined those cases which it consid- ered not inconsistent with a vaccine relationship. The report noted that the vaccine administered to those cases was from several lots not produced by a single manufacturer. The Committee was able to conclude only that the reported cases were “clinically consistent with paralytic poliomyelitis and with laboratory findings which could not exclude a possible rela- tionship to the administration of oral vaccine." Thus, this Committee, composed of some of the world's most eminent ex- perts on polio, could do no more than acknowledge its inability to exclude a »14 bey fow Lestous of polfowyel itis b + average Lesion scove in ates most distant ices t+ elatest inoculation site 2 + mild c * Total wath: totel leston score ever .ourber of ecal.cys Fe eadewstole eeusee ws. weet sole 09-V rlovecd ok neculur/ se ef — Resuit of teursvirulence ‘tose of Pelluvives Vacelne tn Mhecus Konkeyy ft yeth_—4t We. __ pa 2s3tt_. by jntrathelante _tneculagion — tlter-teg 10 aS ee rage by pes Test deored o¢__ pw byt —_--- eris/6> Auceulated/monkey 32.009,,090_.._ (3) _ __(2) Dace of inoculation == if SF . saaratsetes (**) =| Compatible. , Rbraren 51; W | M o| 7/16 lie | Seese 22 _ (**) | Compatible. BP 37| wi M 0; 7/23 {a of omer 16}; — a= — | Compatible. Lanes 49| W | M o| «eis 4} +90 |...... 26| O _ Il & IIT} Compatible. 10...--- i) WM | Ol lye) 8] as [ccc is} — - — | Compatible. OS a sca 36' WiM 0| 715 | Pte eee 21| Oo - T& Il | eRe: 48| W F 0 ait Oa: Be eed 7 | III | Vaccine like...... 111 | Compatible. a 39; W M 0 1 4 4 aa 23} IIl | Vaccine like......) — Compatible a 6; Wi] M 0 Ph. Mea el 27 Wild like......... on Exeluded 15 52| W | M 0} 6/26 4| 52 19| Hi | Vaccine like222.2-) if | Compatible Mi 610! & 4| 6/12 Are {ewe oe ay eeeenenee Tee ee **In process. we Key fer severity : a — Key for CRegative test, outtboty les : 2=Miuor involvement. ba yt 4= Gieability. Virus chargcter. wie Ly by the modified Weeker and i= dixabled ( wheelchair, extensive bracing). tests. Con-idered me} toy accine-induyed disease cases clinically tndistinguisbaple f lomselitis with some significant residue! partigels and tobscarian eausine bot tasemeteenes Cite the pasate ct cattine selatani 94 lt nn ne £6 2¢. 68 S66@.0¢8 sees APPENDIX K SUPPLEMENT TO PSU 273 December 21, 1962 Statement Released from the Office of the Surgeon General, December 19, 1962. Report of the Special Advisory Com- mitee on Oral Poliomyelitis Vaccine to the Surgeon General. December 18, 1962 Line Listing of Cases Considered by the Committee. Reprinted with Permission of Surveillance Section Epidemiology Branch Communicable Disease Center U.S.P.H.S. A-81 A. Statement Released to the Press by the Office of the Surgeon General Communities planning immunization campaigns against poliomyelitis are urged to move ahead, using all three types of Sabin oral vaccine with particular em- phasis on children and young adults, Surgeon General Luther L. Terry of the Public Health Service announced today. Dr. Terry said that this is the re- gommendation of the Surgeon General's Special Advisory Committee on Oral Po- liomyelitis Vaccine which concluded its fifth meeting this year on December 18, and that he has accepted the Committee's recommendations. The Committee stressed that special attention be given to children because they comprise the population group "in whom the danger of naturally occurring poliomyelitis is greatest and who serve A-82 as the natural source of poliomyelitis infection in the community." "The Committee feels and I whole- heartedly agree that of greatest im- portance is planning for the continuing vaccination of oncoming generations," the Surgeon General said. "This is the only way we will succeed in eradicating polio permanently." The Surgeon General quoted the re- commendation of the Committee with respect to vaccinations among adults: "Because the need for immunization diminishes with advancing age and be- cause potential risks of vaccine are be- lieved by some to exist in adults, especially above the age of 30, vaccina- tion should be used for adult only with the full recognition of its very small risk. Vaccination is especially re- commended for those adults who are at higher risk of naturally occurring disease; A-83 for example, parents of young children, pregnant ‘iin persons in arn sit- uations and those planning foreign travel." Dr. Terry presided at the two-day meet- ing at which committee members reviewed all cases of suspected polio-like illness currently known to have been associated with the administration of oral polio virus vaccine of all three types in non- epidemic areas. "In the oral and the Salk vaccines we have two established weapons against polio and we can, I believe, look forward to the day when polio is finally eliminated in this country," the Surgeon General stated. "With a total of around 650 cases reported this year, compared to almost 58,000 a decade ago, it is clear we are well on our way." In commenting on the work of his Advisory Committee, Dr. Terry said: “The meticulous care with which members of this committee-- all experts in the scientific disciplines A-84 involved in the use of vaccines--have watched and evaluated developments in the widespread use of oral poliomyelitis vaccines is exemplary." They are render- ing an invaluable service in advising us. Members of the Surgeon General's Com- mittee are: Dr. David Bodian, The Johns Hopkins School of Medicine; Dr. John Fox, Public Health Research Institute of the City of New York; Dr. Archie L. Gray, Secretary and Executive Officer, Mississippi State Board of Health; Dr. William MCD. Hammon, University of Pittsburgh; Dr. Hugh Hussey, Dean, School of Medicine, George- town University; Dr. Alexander Langmuir, Public Health Service, Communicable Disease Center, Atlanta, Georgia; Dr. Roderick Murray, Public Health Service, National Institutes of Health, Bethesda, MD; Dr. John Paul, Yale University School of Medicine; Dr. Albert Sabin, University A-85 of Cincinnati; Dr. Edward D. Shaw, Uni- versity of California School of Medicine; and Dr. Joseph E. Smadel, Public Health Service, National Institutes of Health, Bethesda, Md. The report of the committee's find- ings and recommendations is attached. B. Report of the Special Advisory Committee on Oral Poliomyelitis Vaccine to the Surgeon General, PHS. December 18, 1962 The Committee met to review all cases of suspect polio-like illness currently known to have been associated with the administration of oral poliovirus vaccine of all three types in non-epidemic areas. These included, in addition to cases pre- viously considered, 25 cases newly dis- covered among persons fed vaccine and four cases among individuals in contact with vaccinated persons. Some of the cases pre- viousiy accepted as “compatible” have been dropped from this category because of A-86 additional clinical and laboratory evi- dence that has become available. New cases have been added to the “compatible” group where careful review has justified such action. It should be emphasized that the com- mittee does not consider that an individual case can be proved to be caused by the vac- cine and no laboratory test has thus far provided a definitive answer. However, it has attempted to decide for each case whether or not it is *oenpetibie" with the possibility of having been induced by the vaccine. Cases have been judged as “compatible” when three criteria were met: (1) onsent within a period (4-30 days after feeding) consistent with a reasonable in- cubation period; (2) an illness clinically consistent with paralytic polio; and (3) laboratory findings which do not exclude a vaccine relationship. On the basis of data now available the total number of cases associated in time A-87 with the direct administration of Type III vaccine and considered by a committee majority as “compatible” is now ll, of which 8 are over 30 years of age. Four cases were excluded as clearly unrelated to Type III vaccination; and seven cases were considered inconclusive as to a possible vaccine relationship. The total number of cases associated with the administration of Type I vaccine and considered as “compatible” is seven, of which 4 are over 30 years of age. Ten cases were excluded; six were considered inconclusive. None of the three Type II associated cases was judged to be “compatible”. It should be noted that the total number of doses of oral vaccine given in non-epidemic areas during 1962 is approxi- mately 31 million Type I, 19 million Type II and 15 million Type III. Hence, the maximum potential risk for Types I and A-88 III is of the order of one per million or less Overall, but higher for those over 30 years of age. For Type II there is still no indication of risk. Consideration of the four cases in unvaccinated persons in household con- tact with vaccinees resulted in two being judged “compatible” and two "excluded". One additional “compatible” case occurred in a nonhousehold contact. Considering the large amount of vaccine administered and the known frequency of vaccine virus spread from vaccinated to unvaccinated persons, particularly within homes, it is concluded that contact spread has posed no significant hazard. It is therefore recommended: (1) that community plans for immunization be encouraged, using all three types; wie (2) that immunization be emphasized for children in whom the danger of natur- ally occurring poliomyelitis is greatest A-89 and who serve as the natural source of poliomyelitis infection in the community. Because the need for immunization dimin- ishes with advancing age and because po- tential risks of vaccine are believed by some to exist in adults, especially above the age of 30, vaccination should be used for adults only with the full recognition of its very small risk. Vaccination is especially recommended for those adults who are at higher risk of naturally occur- ring disease; for example, parents of young children, pregnant women, persons in epidemic situations and those planning foreign travel. Of greatest importance is the continu- ing vaccination of oncoming generations. C. Cases Considered by the Special Advisory Committee As stated in the report of the Advisory Committee, all known cases of suspect polio- like illness associated in time with the A-90 administration of the three types of oral polio vaccines outside of epidemic areas were reviewed. The line listings which appear below categorize the cases for consideration as occurring after the ad- ministration of Type I, Type II or Type III vaccine. Thus any case with onset more than 30 days after one type of vaccine administration but within 30 days of a second type received 2 reviews. Two cases, as indicated in the listing, were considered both as primary vaccinees and as contacts of vaccinees. All cases considered have been listed in previous P.S.U. reports except for ten cases from California which have not yet been officially reported. These were considered from a special report prepared and submitted to the Committee by the California State Department of Public Health. The Committee appraisal on each individual case is indicated, based on the criteria listed in their report. A-91 76-V Cases of Polio-lixe Illness Following Oral Polio Vaccines Occurring Outside of Epidemic Arcas in 1962 - Reviewed ty the Surgeon General's Advisory Committee on Policnyelitis Vace.nes I. Cases Follcwing Type I Vacci-e Strate calif. Calif. (sR) Calif. (XR) calif. Calif. Ceiif. Calif. (Na) Calif. Calif.(NR) Calif.(@m) Caiif. (NR) Calizt. (NWR) Caliz.(sR) Calif.(wR) Calif. (ur) Til. lowe Mess. Mass. Ace 8 ll 32 42 ZRSCLKRMIERAKEKMe KK rx . zum > ee poe of tn hg ~O@MOF“wUYUOaUNCONOOrS euu mr frow Feeding o ~_ ak a 27) 2(4) (14) 8(11) 18(19) 25(26) 740) 22(25) ~2(12) 14(23) ~4(8) ~8(E) $(13) (97) a 48 9(11) 4(6) (9) (27) 16(30) No Specizen 0 No Isolate Obtained te In Process Isolate Character ue site 32% Non-Vacc. like (3 Specimens) Vaccine-like (1 Specicen) Vaccine-like Antibody Response I Inconclesive T 1 I Inconciusive ** Incenclusive Iaconclusive Inconclusive Inconclusive Inconclusive mee we I I, i Vaccine-like Inconclusive Cocnittee Cxcluded Incenclusive Corpat-dle Cocpatable Ceapacible Cozpativle? Excluded Inconclusive Excluccd Excluded Excluded Excluded Inconclusive Excluded Coapacible Compatible Compatible Excluded Incenclusive £6-W - Wo Specicen I. Cases Following type 1 Vaccine (Continued) © Ho Isolate Obrained ** In Process Days from Feeding of orv Doses to Illness Virus Isolate Antibody Committee Szste Age Sex IPV I Ill. ‘Type Character Response Appraisa} sy.ay 3 «(8 (23) I Non-Vace.Like 1 Excluded Ohio 1% #86© ce) 28(43) 1415) - I"t Incoaclusive Zena. (2) 1 4(11) I WNon-Vecc.Like I, Il, III. Incoxclusive wash.6 6 Ms 4 (37) (5) I Vaccine-Like I Excluded 1. The number in parenthesis indicates interval from feeding to onset of paralysis. 2. (8K) California cases not yet officially reported but consicered from s special teport submitted by the California State Departaent of Public Health. 3. Considered a “compatible” case if laboratory work in process is not inconsistent with a vaccine relationship. 4. Wumber in parenthesis following State-designation corresponds with the number of the case in the technical report of the Surgeon General - Septexber 20, 1962. 5S. Specizen taken two days after patient received Type II vaccine. 6. Also considered (and listed) with relation to Type III vaccine. v6-V =- Ne Specimen © No Isolate Obtained *#* In Process State Ags Sex _IPv I — —- Neb “2% | 4 90 Ohie{3) a 2 a , — Ge pol Ohi 67M 0 (64 (8) (36) 0 1 Also considered and listed with relation to Type III vaccine Antibody Response Incon. Incon. Comittce Appraisal Inconclusive Excluded Inconclusive S6-V } ~ aresate Obeained ITI. Cases Following Ives ZI Vaccine em In Frecees frou of OFV Days Peeding State Ase Sex PV. t Response Mess. 4 Ms 4 $4(64) 26(36 0 - Mass. sa C=~$0) 26(29) C) 1, I!, U1 Chico 67 += 0 64 (8) 36) 0 Incon, Ohic(io? 16 M OO 28(43 1(15) - Ill onieQll)* 33 Nu O 21(25) 0 I, lit Oregor.(12) 43 F 0 34(38) 7(11) III Vaccine-like I, II, III Oregon(13) 39 M&M o 8 s50(sl 23(24) III Yaccine-like Incon. Orcson(l4) 6 4M 0 (54 (27) I —— Incon. III Vaccinc-like ae S38 “(3 19(20) III Vaccine-like Incon. -— & IiI Vaccine-like Incon. Wash.(16)> 6 M 4 (37 (s) I Vaceine-like I 1 Type II vaccine fed 8 days before specimen collected - aoe par soe = paveer with relation to Type II vaccine Alse consider 3 isted) th relation to T vacc 4+ Also cozpatible with Type I houschold eenesee weed wt Cormittce Apgrsisah Excluded Inconciusive Compatidic Compatidle Coxpatible Co-patitle Cozpatitle patible Incorclusive laconclusive Compe tible Incen-:lusive Inconcl uscive Ircorclusive Inconclusive Corps itle Compattole Comyatitle Excluded Cenpatible Exdl uded Excluded 96-WV Cesce Aueng Movadheld Contents of Yacein Age Sex _1PY_ 21 M 0 42 F 4 is/iz ™M 0 29 M 0 6/fi2 & 0 Doses to Onset of IlInexs t iL wu ! (26 ‘ss (25 ” Qs) (55 (25) (69 (33) 1 Contact in adjacent apartzent - No Specizer 0 io Isolate Crcaionl #* In Mrecess Virug Trolate Antitedy Type Character Resrons> I We I I Intermediate I to non-vaccine like II Vaccine-like II III Vaccine-lixe - Cormnittee Aprreis2 Excluded Excluded Corpatible Corpatible Cenpatibiec APPENDIX L SUPPLEMENT TO POLIOMYELITIS SURVEILLANCE REPORT NO. 285 September 30, 1964 ASSOCIATION OF PARALYTIC DISEASE II.* III.* Iv.* WITH ORAL POLIO VACCINES Press Release Report of a Special Advisory Committee on Oral Poliomyelitis Vaccine to the Surgeon General of the Public Health Service Comments on the Report of the Special Advisory Committee By Albert B. Sabin Paralytic Disease Associated with Oral Polis Vaccines, By D. A. Henderson, J. J. Witte, L. Morris, and A. D. Langmuir Listing of Reported Cases of Para- lytic Poliomyelitis Occurring A-97 Within 30 Days After Receiving the Oral Poliomyelitis Vaccines, 1961- 1964 Appearing in The Journal of the American Medical Association dated October 5, 1964. A-98 HUNTFER--WO 2-2125 U. S. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE Public Health Service Washington 25, D. C. FOR IMMEDIATE RELEASE HEW-C60 Wednesday, September 23, 1964 A special advisory committee to the Surgeon General of the Public Health Service, Department of Health, Educa- tion, and Welfare, urged today renewed drives by local communities during the fall and winter to vaccinate the younger age group against poliomyelitis. The report was prepared by a special advisory committee on oral poliomyelitis vaccine and was made public today by Surgeon General Luther L. Terry. A-99 The committee's report said that the age groups to be immunized and the vaccine chosen for use should be determined lo- cally. The committee said, however, that in its view the oral vaccination of persons over 18 should "generally be recommended only in those situations in which unusual exposure to poliomyelitis might be anti- cipated, such as epidemics, entry into military service, and travel to other countries." The committee recommended strongly the immunization of infants during their first year of life and the routine im- munization of all children on entering school. Dr. Terry, in releasing the report, said that the Public Health Service was accepting the committee's recommendations. He pointed out that the shift in emphasis away from adults toward the younger age groups was forecast in a committee report A-100 of December 1962. The advisory committee at that time emphasized the importance of concentrating on the immunization of the younger age groups and noted a “very small risk" incident to the use of oral vaccine in persons 30 years of age and over. The current committee report also re- commends alteration in the sequence of administering monovalent vaccines, with Type II the first to be given. The newly- recommended order is Type II, I, and III. Dr. Albert Sabin, developer of the oral vaccine and a member of the committee, filed a report dissenting from the commit- tee’s recommendations and calling for the continued immunization of all age groups. The Service is making available the full text of both reports to State Health Of- ficers, professional organizations, and other interested agencies, Dr. Terry said. A-101 The committee's recommendations were based on an exhaustive analysis of 87 reported cases of "“polio-like illness associated with the administration of oral vaccines" which have occurred in non-epidemic areas since December 1961. These cases were considered by the committee on the basis of whether or not they were "compatible with the possibility of having been induced by the vaccine." I concluded that it is not possible to prove that any individual case was caused by the vaccines and that no labo- ratory tests available can provide a definitive answer. Nevertheless, the committee said, “Considering the epi- demiological evidence developed with respect to the total group of ‘compati- ble' causes, the committee believes that at least some of these cases were caused by the vaccine." A-102 The committee's recommendations were based on an exhaustive analysis of 87 reported cases of "polio-like illness associated with the administration of oral vaccines" which have occurred in non-epidemic areas since December 1961. These cases were considered by the committee on the basis of whether or not they were "compatible with the possi- bility of having been induced by the vaccine." It concluded that it is net rersible to prove that any individual case was caused by the vaccines and that no labo- ratory tests available can provide a definitive answer. Nevertheless, the committee said, "Considering the epi- demiological evidence developed with respect to the total group of ‘compati- bie’ causes, the committee believes that at least some of these cases were caused by the vaccine." A-103 The extent of the “risk factor", ac- cording to the report, is, for Type III, only 1 case in 2.5 million doses adminis- tered; for Type I, only 1 in 6 million; and for Type II, only 1 in 50 million. With respect to the very minimal risk, ‘Dr. Terry emphasized that there should be no apprenhension whatsoever among those who have already taken the oral vaccine. In its analysis of the 87 cases, the committee found 57 which they considered “compatible.” The “compatible” cases, the report said, occurred largely among adults. Most were widely scattered throughout the country. The onset of illness fell between 4 and 28 days following vaccine administration. "There was no soparest association of cases with specific lots of vaccine or vaccines produced by a particular manu- facturer," the report added. A-104 In urging a renewed effort to vaccinate those still susceptible, most of them poorly-immunized children in economically- depressed population groups, the commit- tee cited the spectacular decline of polio during recent years. The decline has been from an annual rate of 14.6 cases per 100,000 during 1950-54 to a rate of 1.8 for 1957-61. This repre- sents a decrease of 88 percent. "On the basis of reports to date, less than 150 cases of paralytic poliomyelitis may be anticipated for the entire year (of 1964)," the report added. In commenting on this phase of the report, Surgeon General Terry said: "When you compare this year's record low with the 54,000 cases of polio re- ported in 1952, the triumph against polio is an historic achievement in preventive medicine. This great victory has been made possible by the work of two A-105 extraordinarily dedicated scientists-- Dr. Jonas Salk and Dr. Albert Sabin--and it has come to pass through the devoted efforts of hundreds of organizations and thousands of individuals,” Dr. Terry said. The Surgeon General added: "I heartily and enthusiastically endorse the committee's primary recommendation that every effort be made for the continuing vaccination of infants and younger age groups. Only through this means can we achieve total victory over polio." Dr. Terry praised the committee for a “painstaking, conscientious and thorough report in the public interest." Members of the Committee were: Dr. Ernest A. Ager, State Department of Health, Olympia, Washington Dr. David Bodian, The John Hopkins University, Baltimore, Maryland Dr. Gordon C. Brown, University of Michigan School of Public Health, Ann Arbor Dr. Alice D. Chenoweth, Childrens Bureau, Washington, D.C. A-106 Dr. Geoffrey Edsall, Massachusetts Department of Public Health, Boston Dr. John P. Fox, Public Health Re- search Institute of New York, New York Dr. James L. Goddard, Communicable . Disease Center, Public Health Service, Atlanta, Georgia Dr. A. L. Gray, Mississippi State Board of Health, Jackson Dr. William McD. Hammon, University of Pittsburgh, Pa. Dr. Donald A. Henderson, Communicable Disease Center, Public Health Service, Atlanta, Georgia ‘Dr. David T. Karzon, Childrens Hospital, University of Buffalo, New York, (unable to attend) Dr. Alexander D. Langmuir, Communicable Disease Center, Public Health Service, Atlanta, Georgia Dr. Theodore A. Montgomery, California State Department of Public Health, Berkeley Dr. Roderick Murray, National Institutes of Health, Public Health Service, Betheada, Maryland Dr. Albert Sabin, The Childrens Hospital Research Foundation, Cincinnati, Ohio Dr. Edward B. Shaw, University of Cali- fornia School of Medicine, San Francisco A-107 Dr. Paul F. Wehrle, University of Southern California School of Medicine, Los Angeles A-108 Number of Cases Figure V PARALYTIC POLIOMYELITIS OCCURRING WITHIN 30 DAYS OF OPV INTERVAL BETWEEN VACCINATION AND ONSET December |, 196! through June 27, 1964 1 5 12° EPIDEMIC AREAS RECEIVED Type | 10 Type tl Type tll 8 Trivolent 6 4 2 0 NON- EPIDEMIC AREAS * 12 - 10 - WRARGA : SK : mit Bom ew eS ear Intervals by 3-Day Periods *coses considered compatible by committee A-109 OTT-W Paralytic Poliomyelitis Cases (Non-Epidemic Areas) With Onsets Less than 30 Days After Receiving OPV I. Cases Adjudged “Compatible” by Special Advisory Committee A. Cases Following Type I State 1961 SP NK. Ve 1962 Calif. Calif. Calif. Calif. Calif. Calif. Tl. lowa B. Cases Following Type II 1962 Ariz. 1964 Se Cc. County Chautauqua Chautauqua Santa Clara Alameda San Francisco Santa Clera San Mateo San Diego Stephenson Story Gibson Yakina Chippewa Bartow Pr. Georges Maricopa Lenoir 49 zz EM EFEMNEETMNEVNEEZT ET Doses PV Type Fed 6-14 et et et et et ee ee — Interval (Days) OPV to Onset 12 28 Isol. 60-Day* Status a ee wn VeuvuUn wuu & TItt-wv C. Cases Following Type II! State County 1962 Mich. Branch Mich. Midland Neb. Dougias Ned. Douglas Neb. Dodge Keb. Lancaster Neb. Cherry Neb. Phelps Neb. Lincoln Neb. Keya Paha Ohio Portage Ohio Cuyahoga Okia. Logen Oreg. Washington Oreg. Benton 1963 Calif. Sacramento Calif. Los Angeles Calif. Napa Calif. Shasta Calif. Los Angeles Mass. Middlesex Mass. Middlesex Minn, hennepin Pa. Schuykill Pa. Del aware Pa. Delaware Ss. Cc. Spartanburg Tenn. Mont gomery Texas Bexar Idaho(NOR) Utah(NOR) Sevier EREEEEEEECEEEEEE EVES TEMEEEKTME Doses Type Interval (Days) Onset Mad Fed CPV to Onset 7-1S 4 (2) If! 16 7-20 t) Il 22 7-1 5 Ill 7 7-16 0 Ill 22 7-23 0 Il 1s 8-S cr 8-12 53 II 7 or 14 8-15 0 Ir 10 8-16 4 Il 19 8-24 0 Il 19 9-3 3 Ill 16 6-& 0 lll 15 7-18 0 Ill 24 8-7 0 Il! 17 5-5 0 Il! 7 6-26 0 Il! 19 1-24 t) Ill ll 3-1 () Il 20 3-23 s Il! 13 3-26 3 Il. 16 12-10 S or 6 Il! 20 $-28 Unk It 8 6-7 4 I1I 19 $-27 0 Il 14 6-8 0 i! 14 11-21 © Il! 2s 41-21 t) Il! 2s 12-18 0 It 10 6-16 () Ill 10 1-25 0 11! 12 4-12 Unk Il! 26 c.4-30 4 Il! c.9 60-Day* Statu; ee VeuUvVauuuwuuwuw een euwUevVucwenveun & & APPENDIX M ORAL VACCINE: ASSOCIATED PARALYTIC POLIOMYELITIS, 1962 Henry M. Gelfand, MD, Atlanta UNTIL RECENTLY, there was .almost | universal agreement that living attenua- ted, oral poliovirus vaccine (OPV) com- posed of the Sabin strains is safe, both to the primary vaccinee and to his con- tacts. This reputation for safety was won on the basis of the use of OPV in millions of persons in the US and many other countries. Although the thorough- ness of routine reporting of morbidity and of special surveillance for possible vaccine-induced cases of paralytic polio- myelitis differed greatly among the various programs, no evidence had been adduced to show that this vaccine, com- posed of these strains, had ever caused the disease it was designed to prevent. A-112 From July through November, 1962, a small number of cases which had followed the use of oral vaccine came to light and they have cast some doubt on the safety of OPV in adult vaccinees. This cluster of cases was intensively studied and discussed in a series of meetings by a Special Advisory Committee on Oral Polio- ‘“myelitis Vaccine to the Surgeon General, USPHS. This Committee concluded in its 1 that "...there report of September 20, is sufficient epidemiological evidence to indicate that at least some of these cases have been caused by the type III vaccines." After considering new case reports accumulated during the following few months, and additional laboratory 2 data, in its report of Dec 18, the Committee recommended: Chief, Enterovirus Unit, Communicable Disease Center, USPHS, Department of HEW. Based on a presentation at the Annual Meeting of the Association of Teachers of Preventive Medicine, Miami, Fla., Oct 14, 1962. A-113 which this conclusion was based discuss ' some "...(1) that community plans for immunization be encour- aged, using all three types; and, (2) that immunization be emphasized for children in whom the danger of naturally eccurring poliomyelitis is greatest and who serve as the natural source of poliomyeli- tis infection in the commun- ity. Because the need for immunization diminishes with advancing age and because potential risks of vaccine are believed by some to exist in adults, especially above the age of 30, vaccination should be used for adults only with the full recognition of its very small risk. Vaccination is especially recommended for those adults who are at higher risk of naturally occurring disease; for example, parents of young children, pregnant women, persons in epidemic situations and those planning foreign travel. Of greatest importance is the continuing vaccination of oncoming generations." It is the purpose of the present communication to review the data upon analysis and evaluation of the signifi- A-114 and to theoretical problems in cance of OPV-associated paralytic polio- myelitis. Only cases accepted as "compa- tible with the possibility of having been induced by the vaccine” and included in the two reports just cited will be consi- dered in this article. A summary of some pertinent details relating to these cases is presented in Table 1. Other cases of paralytic poliomyelitis followed the use of OPV in 1962 and were considered by the Committee. A majority of the Committee believed these to be clearly incompatible with the possibility of vaccine induction or as "inconclusive" - on clinical, epi- demiologic, or laboratory grounds. Still other cases which had followed the use of OPV were not considered to be part of this investigation, because they had occurred in epidemic settings where vaccine had been used as a control mea- sure. Under those circumstances, new cases are expected for several weeks after vaccination. A-115 The compilation of the data in Table 1. was made possible by the work of hundreds of practicing physicians and others in the epidemiology and laboratory divisions of the various state health departments and of the Communicable Disease Center of the Public Health Service. The Surgeon General has grate- fully acknowledged their contri-. {[cjommunity, all three types were in ex- tensive use at about the same time, if the country is considered as a whole. The pecdeniiant association of "compat- ible" cases with Type 3 OPV is apparent. Other Laboratory Data. - The diffi- culties and limitations of characteriza- tion of poliovirus strains as a tool for the solution of problems of OPV-case association have been discussed. All that can be said is that those patients from whom "vaccine-like" virus strains were isolated were almost certainly ex- creting the progeny of vaccine viruses. A-116 Unfortunately, no naturally occurring poliovirus strains of the same type were available from the same localities for comparative tests. However, only rarely are “vaccine-like" strains found where OPV has not been used. 27 In those few instances in which monkey intracerebral tests were performed, the results con- firmed that the fecally excreted viruses were attenuated. Neither antigenic nor virulence tests added appreciably to epidemiologic analysis. The most useful application of antigenic strain differentiation would be in the testing of a virus isolate ob- tained from tissues from a fatal case. The recovery of a "vaccine-like" strain from the brain or spinal cord would be almost certain evidence for incriminating the vaccine as the causative agent, even if all other evidence were equivocal. Since there have been no fatal cases in the aggregate under investigation in A-117 1962, no‘CNS strains have been available for testing. The inclusion of each case in a problem group must be predicted on the failure to detect concurrent infection with another potentially paralytogenic agent. As already mentioned, no nonpol- iovirus infection was demonstrated, by isolation of virus or serologic change, in any single case included in the pre- sent investigation. However, it must be remembered that the finding of random infections with other enteroviruses might be mere coincidence in the opposite Girection. Each instance of dual infec- tion would have to be considered in the light of our present incomplete know- ledge. Greater understanding will deve- lop with accumulating experience. Comment and Summary We expected and we have found that cases of paralytic poliomyelitis occur in A-118 temporal relationship with the widespread use of OPV, particularly if it is used during the summer season. It is the responsibility of the appropriate author- ities to establish and maintain polio-~ myelitis surveillance of a very high standard and to examine reports of vac- cine-associated disease critically and objectively, making maximum use of all available clinical, laboratory, and epidemiologic data. .The Poliomyelitis Surveillance Unit of the Communicable Disease Center, with its long history of experience in this field, performed this task in the US in 1962 with extraordinary skill and speed. However, it was ham- pered in some instances by delays in reporting by the patients themselves, attending physicians, hospitals, and local public health agencies. After close examination, it was possible to eliminate many cases from serious consideration of a causal rela- A-119 tion to vaccine on the basis of incorrect or uncertain diagnosis, the recovery of a poliovirus not fed as vaccine, too long or too short an interval between vaccina- tion and the disease onset, or some other factor. There was then left a residuum of suspicious cases. Such a collection of cases was hard to evaluate. They had been diagnosed clinically as "poliomyelitis," they had occurred after use of OPV at an interval compatible with the incubation period, and the only demonstrable infection was with a poliovirus of the type fed as vaccine. This triad of circumstances constituted the basis for considering them “compatible with vaccine-induced disease." Occurring, as they did, in a rather random and sporadic manner, they might have remained only a suspicion and & puzzle if the aggregation of cases had not presented certain epidemiologic features that appeared significant. A-120 There were three characteristics of this group of cases that appeared most meaningful to the Surgeon General's Special Advisory Committee on Oral Polio- myelitis Vaccine: the adult age distri- bution of "compatible" cases, the fre- quent interval of one to four weeks between vaccination and onset of symp- toms, and the predominance of cases after use of Type 3 OPV as compared with Types 1 and 2. Although it remained impossible to decide whether or not an individual case had been caused by the oral vaccine, this constellation of findings suggested that, as a group, at least some of these cases had been causally related to OPV. Because of the widespread interest in possible vaccine-associated cases in the US, in 1962, and the zealous activities of the Poliomyelitis Surveillance Unit, it is unlikely that any significant number of suspicious cases went unrepor- ted. Since it can be concluded only that A-121 at least some of the "compatible" cases were one case per 4.4, 0, and 1.4 million "attack rates" express the maximum poten- tial risk associated with the use of these vaccines; the actual risk may be considerably less. These rates were one case per 4.4, 0, and 1.4 million vaccines for OPV wr 1, 2, and 3, respectively. Since a complete course of OPV consists of the administration of all 3 types, these rates must be added to produce a "combined maximum potential risk" of one case per 1.04 million complete immuniza- tions. The combined maximum potential risk, moreover, was not felt equally by all age groups; in 12 of the 18 "compatible" cases the patients were more than 30 years of age. With only one "com-. A-122 APPENDIX N Boise, Idaho June 26, 1964 Air Mail Pierce Gardner, M.D. Assistant Chief Poliomyelitis Surveillance Unit Communicable Disease Center Atlanta, Georgia 30333 DAVIS, Glynn Dear Doctor Cardner: Mr. Glynn Davis developed a paralytic illness within a thirty-day period follow- ing the administration of Type III oral poliomyelitis vaccine. He may have had one or two injections of poliomyelitis vaccine (Salk) in prior years. Dates of vaccination and illness are as follows: Oral poliomyelitis vaccine -- Type I February 3, 1963 Type III March 17, 1963 » Onset of illness April 12, 1963 Onset of paralysis April 14, 1963 A-123 Hospitalized at Ashton Memorial Hospital April 17, 1963 Transferred to Idaho Falls LDS Hospital April 24, 1963 Transferred to Elks Convalescent Center, Boise May 14, 1963 Transferred to VA Hospital, Boise June 13, 1963 Enclosed are hospital and physician examinations at the time of admission of Mr. Davis to the Idaho Falls LDS Hospital on April 24, 1963, and a con- sultation after his transfer to Boise. Doctors John S. McMillan and Maurice M. Burkholder practice the specialty of internal medicine. Spinal fluid tests are as: follows: During hospital- ization at Ashton April 24, 1963 Pressure 165mm 96mm Jugular pressure --- 254mm, rapid fall to 136 WBC 60 78 Polys 64% 3% A-124 Sugar -- 66 mgs % Protein -- 40 mgs % Pandy Pos oo Wasserman -- Neg. Mr. Davis was released from the Veterans Administration Hospital in the early fall of 1963 and has continued with physiotherapy treatment at the Veterans Administration Hospital on an outpatient basis until the present time. Physiotherapy will be discontinued during the week of June 29, 1964, and muscle evaluations at time of admission and during the week of June 29, 1964, will be obtained and forwarded. His diagnosis at the Veterans Administration Hospital is paralytic poliomyelitis (old defini- tion of “inflammation of grey matter of spinal cord") etiology undetermined. The paralysis of the right triceps has disappeared. The present involve- ment is limited to below the knees with A-125 weakness of the anterior muscle group of the right lower leg and both an- terior and posterior muscle groups of the left leg. He continued to show im- provement of muscle function and appar- ent return of muscle use from a flaccid paralysis state. He now walks with a left leg brace, elastic aid to prevent foot drop on the right, and crutches. There are unusual circumstances con- cerning the clinical course and the in- conclusive laboratory findings in this case. A flu like illness may have been present among residents of West Yellow- stone as noted by Mr. Davis. There were sensory changes found by one consultant. There has been an apparent recovery of partial muscle function over an extended period of time. The etiology of this case of paralysis has not been determined and a large number of virus deseases are to be considered. The present diagnosis of A-126 lower neuron disease with paralysis -- etiology unknown -- is the continuing diagnosis by this office of this inter- esting case. Sincerely yours, PREVENTIVE MEDICINE DIVISION John A. Mather, M.D. Director Enclosures A-127 APPENDIX O 43 C.F.R. § 73.114(b) (1) (iii) provides: (iii) DETERMINATION OF NEUROVIRULENCE. At the conclusion of the observation period comparative histopathological examinations shall be made of the lumbar cord, cervical cord, lower medulla, upper medulla and mesencaphalon of each monkey in the groups injected with virus under test and those injected with the NIH Reference Attenuated Poliovirus, except that for animals dying during the test period, these examinations shall be made immediately after death. The animals shall be examined to ascertain whether the distribution and histological nature of the lesions are characteristic of poliovirus infection. A comparative evaluation shall be made of the evidence of neurovirulence of the virus under test and the NIH Reference Attenuated Poliovirus with respect to (a) the number of animals showing lesions characteristic of polio- virus infection, (b) the number of animals A-128 showing lesions other than those character- istic of poliovirus infection, (c) the severity of the lesions, (d) the degree of dissemination of the lesions, and (e) the rate of Occurrence of paralysis not attributable to the mechanical injury re- sulting from inoculation trauma. The virus pool under test is satisfactory for polio- virus vaccine manufacture only if at least 80 percent of the animals in each group survive the observation period and if a comparative analysis of the test results demonstrate that the neurovirulence of the test virus pool does not exceed that of the NIH Reference Attenuated Poliovirus. The “NIH Reference Attenuated Poliovirus" was designated by regulation to be Type I poliovirus. 42 C.F.R. § 73.111. It was referred to herein as the "reference strain." The regulation specifically refers to "virus pool" under test. Both the district A-129 court and the briefs filed with this court treat “virus pool” and “lots” interchange- ably. We continue this treatment. 43 C.F.R. § 73.114(b) (1) (iii) is a regulation promulgated by the Surgeon General pursuant to the Public Health Service Act, 43 U.S.C. § 201 et seq.; see 43 U.S.C. § 262(d). A-130 ‘UoNISoddg T Office - Supreme Co = FIL urt, U.S. ED 3 In the Supreme Court of the OcTOBER TERM, 1981 GLYNN RICHARD DAVIS, PETITIONER Vv. UNITED STATES OF AMERICA ON PETITION FOR A WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT - MEMORANDUM FOR THE UNITED STATES IN OPPOSITION Rex E. Lee Solicitor General Department of Justice Washington, D.C. 20530 (202) 633-2217 STEVAS. TABLE OF AUTHORITIES Cases: Rahn v. United States, 222 F.Supp. 775 ....... 6 Spevack v. United States, 390 F.2d 977 ........ 6 Toal v. United States, 438 F.2d 222 .........+. 6 United States v. Kubrick, 444 U.S. PEE Kanddeehb cc ebsadusecoscocceeeces 2, 3-4, 5 Statute: Federal Tort Claims Act, 28 U.S.C. ED 60k hecdncsinkeversoccavescaseces 1,2 Inu the Supreme Court of the Hnited States OcTOBER TERM, 1981 No. 81-644 GLYNN RICHARD DAVIS, PETITIONER A UNITED STATES OF AMERICA ON PETITION FOR A WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT MEMORANDUM FOR THE UNITED STATES IN OPPOSITION 1. The question presented in this case is whether peti- tioner’s claim under the Federal Tort Claims Act is barred by the applicable two-year statute of limitations, 28 U.S.C. 2401(b). Petitioner filed his administrative claim in 1973 seeking damages for injuries he suffered in 1963, allegedly as a result of the government's negligence in its administra- tion of a nationwide program for mass immunization against poliomyelitis, using the Sabin oral vaccine (Pet. App. A-! to A-4). The vaccine was licensed and tested by the Division of Biological Standards (DBS), a part of the Department of Health, Education, and Welfare, and it was administered at state and local immunization centers (Pet. App. A-I to A-2). Petitioner was administered Type II] Sabin vaccine at an immunization center in March 1963; within 30 days he was paralyzed from the waist down and manifested other 2 symptoms of polio (id. at A-2). In 1964, petitioner brought suit against Wyeth Laboratories, Inc., manufacturer of the vaccine he had ingested (ibid.).' In 1965, during the course of that litigation, Wyeth noticed the deposition of Dr. Ruth Kirschstein, the chief of the pathology section of Viral Immunology, DBS, accom- panied by a subpoena duces tecum ordering her to bring to the deposition all records relating to the DBS testing of vaccine Lot No. 03503. The vaccine petitioner ingested was from this lot. Dr. Kirschstein brought records document- ing one neurovirulence test on the lot which indicated that the results fell within acceptable limits (Pet. App. A-2 to A-3). Petitioner alleges that not until 1973 did he learn, from an attorney engaged in another lawsuit, that a second neurovirulence test had been performed on Lot No. 03503 and that the results of that test exceeded acceptable limits (id. at A-4). Petitioner filed an administrative claim under the Tort Claims Act in Apri! 1973 and brought this action in the United States District Court for the District of Idaho in April 1974 (Pet. App. A-4). The district court granted the government’s motion for summary judgment, ruling that the action was barred by the applicable two-year statute of limitations, 28 U.S.C. 2401(b) (Pet. App. A-22 to A-24). The court of appeals affirmed, with one judge dissenting (Pet. App. A-I to A-18). The court concluded that petition- er’s claim had accrued in April 1963 and that it therefore was time-barred. Relying on United States v. Kubrick, 444 U.S. 111 (1979), the court reasoned (Pet. App. A-11; foot- note omitted): 'In that action the district court ruled in favor of the manufacturer, but the court of appeals reversed and remanded. Davis v. Wveth Laboratories, Inc., 399 F.2d 121 (9th Cir. 1968). The case was settied by the parties prior to a second trial (Pet. App. A-2 n.1). 3 [ Petitioner] was aware in April, 1963, that he had been injured and that the Sabin vaccine was the likely cause of his injury. With knowledge of the fact of injury and its cause, [petitioner] was at the time of his injury placed on the same footing as other negligence plaintiffs. The court of appeals rejected petitioner’s contention that the limitations period was tolled by the government's alleged fraudulent concealment of the results of the second neurovirulence test during the October 1965 deposition of Dr. Kirschstein.2? The court noted (id. at A-12) that the allegation was irrelevant because, by that time, the two-year period for filing the tort elaim had already expired. As to the government's conduct during that two-vear period, the court acknow:edged that the government might have been negligent in its publication of reports on the vaccine, but it held that the government's failure “to ascertain and publish the fact of its negligence” did not amount to fraudulent concealment (ibid.). 2. The decision of the court of appeals is correct and does not conflict with decisions of this Court or of other courts of appeals. Both lower courts held that petitioner's claim for injuries sustained in 1963 was barred by the statute of limitations. Further review of this fact-bound question is unwarranted. a. Contrary to petitioner's contention (Pet. 25-35), the decision below is entirely consistent with United States v. Kubrick, supra. As the Court noted in Kubrick, the general rule is that a claim under the Federal Tort Claims Act “accrues at the time of the plaintiff's injury.” 444 U.S. at ?The appendix to the petition contains a typographical error: the court of appeals referred to the October 1965 deposition. not to the “October, 1/975, deposition™( Pet. App. A-12; emphasis added). See 642 F. 2d 328, 331. 4 120. A number of courts have held that in medical malprac- tice cases, in which the injury may not manifest itself until long after it has been inflicted, the claim should be deemed to accrue only later, when the victim discovers both the injury and its cause. /d. at 120-121 & n.7. Kubrick rejected any extension of this “discovery” rule, however, and it thus reversed a decision extending the accrual period until the plaintiff became aware, not only of his injury and its cause, but also of the fact that his injury had been negligently inflicted. /d. at 123. Even assuming that the “discovery” rule applies to this case, the court of appeals correctly held that petitioner's claim was time-barred. Petitioner contracted polio in April 1963, not long after he was given the vaccine; and according to his own affidavit (Pet. App. A-32 to A-33; emphasis in original), he “began an intensive search in approximately June, 1963, to determine why I was given a vaccine that would give me the disease instead of preventing it.” Peti- tioner does not contend that the government’s involvement in the vaccine program— in particular its responsibility for testing the lots of vaccine—was unknown to him at that time. Hence, like any victim with a potential claim for negligent injury, he knew that he had been injured, he knew (or at least had strong reason to suspect; see Pet. 28) the cause of the injury (the vaccine). and he knew the identity of those with responsibilities respecting the causative agent (the government and the vaccine manufacturer, Wyeth Laboratories, Inc.). He was, in fact, sufficiently sure of the connection between the vaccine and his injury to bring suit against Wyeth in 1964 for, inter alia, negligent manufacture of the vaccine and breach of an implied warranty that the vaccine was fit for use (see Davis v. Wyeth Laboratories, Inc., 399 F. 2d 121, 125 ‘9th Cir. 1968)). Kubrick does not, as petitioner contends, warrant extend- ing the accrual time for his claim against the government 5 until he became aware of test results that would support an allegation that Lot No. 03503—the lot of vaccine from which the dose administered to him came—was negligently approved for use by the government. Kubrick held only that a malpractice claim accrues when the victim knows the existence of his injury and its cause; it does not suggest that the limitations period begins to run only after the claimant has accumulated proof of the precise manner in which the injury was inflicted and the way in which the mechanism relates to the possible negligence of the potential defendant.’ b. There is similarly no merit to petitioner's argument (Pet. 35-42) that the limitations period was tolled by fraudu- lent concealment. As the court of appeals correctly con- cluded, the period had run before October 1965, when the alleged act of fraudulent concealment occurred in connec- tion with Dr. Kirchstein’s deposition in the suit against Wyeth. Petitioner’s reliance on government reports respecting the mass immunization program is also misplaced. The September 1962 report stated (Pet. App. A-76) that some of the I! polio cases following the administration of Type III Sabin vaccine (the type administered to petitioner) might have been caused by the vaccine. The December 1962 report stated (id. at A-87) that, while the committee issuing the report did not think that any individual polio case could be “proved to be caused by the vaccine,” because no “defini- tive” answer had been supplied by any laboratory test, the committee nonetheless concluded that some of the cases it ‘Under petitioner's theory, the limitations period for suits arising out of airplane crashes could be extended indefinitely. and would not begin to run until after the claimant had assembled evidence of pilot crror. negligent maintenance, negligent manufacture. and the like. Such a theory essentially negates the whole purpose of a statute of limitations. See United States v. Kubrick, supra, 444 U.S. at 125. 6 had studied were “ ‘compatible’ with the possibility of having been induced by the vaccine.” The court of appeals correctly held (Pet. App. A-12) that the limited findings in these reports, while perhaps indicating that “the govern- ment was negligent in maintaining and publishing records,” did not amount to fraudulent concealment. Indeed, as the court noted (id. at A-12 n.10), the reports served as “addi- tional notice to [petitioner] of the government’s involve- ment in his claim.” Accordingly, it properly held that there was no ground for extending the period for accrual of petitioner's claim.‘ It is therefore respectfully submitted that the petition for a writ of certiorari should be denied. Rex E. Lee Solicitor General JANUARY 1982 ‘The “concealment” cases on which petitioner relies (Pet. 37-38) are inapposite. In Toal v. United States, 438 F. 2d 222 (2d Cir. 1971), and Rahn v. United States, 222 F. Supp. 775 (S.D. Ga. 1963), the courts merely held that the plaintiffs’ malpractice claims accrued when they first learned that they had suffered injuries from medical treatment and did not merely suffer from the effects of the accidents that caused them to seek treatment in the first place. If petitioner had been led to the reasonable belief that there was no connection between the vaccine and his disease, those cases might be pertinent. In Spevack v. United States, 390 F. 2d 977 (Ct. Cl. 1968), the court held only that a claim for improper use of a trade secret did not accrue until the plaintiff was on notice that the government had actually used it. DOJ-1982-01 joug A\deY SJOU0N NO | MIS SUPT ETIE UUUTL, Use FILED NOV 25 1981 ALEXANDER L. STEVAS, No. 80-644 CLERK IN THE Supreme Couri of the United States OCTOBER TERM, 1981 G.D. SEARLE & COMPANY, Petitioner, VS. SUSAN COHN and WALTER COHN, Respondents. ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT PETITIONER’S REPLY BRIEF WILLIAM P. RICHMOND Davip W. CARPENTER SipLey & AUSTIN One First National Plaza Chicago, Illinois 60603 (312) 853-7000 RAYMOND M. TIERNEY, JR. MICHAEL P. MURPHY SHANLEY & FISHER 550 Broad Street Newark, New Jersey 07102 (201) 643-1220 Attorneys for Peti:ioner a ee TABLE OF CONTENTS TABLE OF AUTHORITIES .........-eeeeeeeeeeees The New Jersey Tolling Statute Imposes An Undue, Discriminatory, And Impermissible Burden On Inter- ED vc cncgceeeeséeed tb boseosnseee A, Fer Be ec cc cccccccccccccccccsecs B. Impermissible Discrimination And Excessive The Only Way Unregistered Foreign Corporations Can Obtain The Benefit Of The Statute Of Limita- tions Is To Submit To A Licensing Scheme And Gen- erally Consent To Suit In New Jersey............ A. Submission To A Licensing Scheme Is The Only Way Of Registering An Agent In New Jersey . B. In Any Event, New Jersey Law Improperly Con- ditions The Availability Of The Statute Of Limitations On A Corporation’s General Con- sent To Suit In The State ..........eeeeees CONCLUSION on ccccccccccccccccccsccccccecccces il TABLE OF AUTHORITIES CASES Adam v. Saenger, 303 U.S. 59 (1938)........ Allenberg Cotton Co. v. Pittman, 419 U.S. 20 Sees cdnaceabescdedescceccetcdesece Davis v. Farmers’ Co-operative Equity Co., 262 Eb | MPPPPTTTTTTTTT TTT TTT eee Eli Lilly & Co. v. Sav-On-Drugs, 366 U.S. 276 Pe Sebuddcesdescccocccecsccocecce Exxon Corp. v. Governor of Maryland, 437 U.S. SEF GENTE ccewececcesccccccccccececess Great Atlantic & Pacific Tea Co. v. Cottrell, 424 PEs cebdecccocccescecccocce Grow Farms Corp. v. National State Bank, 167 N.J. Super. 102, 400 A.2d 535 (1979)...... Hughes v. Oklahoma, 441 U.S. 322 (1979) ... Hunt v. Washington Apple Advertising Comm'n, PAPI. SEO ETOVEP cc cccccccccceesesees International Shoe Co. v. Washington, 326 U.S. Pe nd Rac cedbesececoccccccessées Internatieual Text-book v. Pigg, 217 US. 9%i | RPE PPPTTTITICIITITT TTT TT Tree ee Lewis v. BT Investment Managers, Inc., 447 U.S. BE CHORE ac ceddocccccccceccessecescccs Litton Industrial Systems, Inc. v. Kennedy Van Saun Corp., 117 N.J. Super. 52, 283 A.2d 551 GRE I FED Consddccccccccccececess National Equipment Rental, Ltd. v. Szukhent, BUS Chas FEE CUUSED ccccccccccccccccceds =f a a 29 11 4, 6,7 11,12 Neirbo Co. v. Bethlehem Shipbuilding Corp., Ltd., 308 U.S. 165 (1939)........ceeeees Pennsylvania Fire Ins. Co. v. Gold Issue Mining Ca., 243 U.S. 93 (1917) .cccccccccccccces Philadelphia v. New Jersey, 437 U.S. 617 COPTER ccccccccscvcccciccccccesosccces Pike v. Bruce Church, Inc., 397 U.S. 137(1970) . Scanapico v. Richmond, F.&P. R.R. Co., 439 F.2d 17 (2d Cir. 1970)(en banc) .......... Shaffer v. Heitner, 433 U.S. 186 (1977) ...... Sioux Remedy Co. v. Cope, 235 U.S. 197 CUP U es cccovccccepcccccoccoesescceese United States v. Kubrick, 444 U.S. 111 (1979).. Velmohos v. Maren Engineering Corp., 83 N.J. 282, 416 A.2d 372 (1980) ....... see eeeees Western & Southern Life Insurance Co. v. State Board of Equalization, _. U.S. ~~, 49 U.S.L.W. 4542 (May 26, 1981) ........... World-Wide Volkswagen Corp. v. Woodson, 444 UB. FBS (ISSR) « ccviccccccccccccesccccs MISCELLANEOUS New Jersey Ct. R. 4: 4-4(C) 2... cece eceeees New Jersey Statutes Annotated, 14A:4-1...... 14A:4-5...... 14A:13-1 et seq. 14A:13-2..... 54: 10A-2 .... ww Ow ww © --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385008_0478%3A0. Public record. Not legal advice.