Robert L. Petty v. United States

consequence dealing for competently for the court so with these judicial choice a Feola, complicated emotionally-charged forum.” United States v. U.S. often 685, 1255, 1264, are af- S.Ct. L.Ed.2d issues. The defendants’ convictions firmed. applies conclusion to The same Affirmed. The substantive offense Act. Mann transporting of a for is the woman Act crossing a line purposes, state

immoral jurisdiction

merely pros confers federal for purposes. The defendant’s knowl ecution PETTY, Appellee, Robert L. a line been edge of whether state has v. thus is irrelevant whether he crossed Act; otherwise, America, Mann has violated the a UNITED STATES argue ignorance geog defendant could Appellant. raphy as a Mann valid Act defense. Cf No. 83-1696. 217 F.2d

Batsell United Cir.1954) (Mann upheld Act conviction Appeals, United States Court of forced de where bad roads defendant to Eighth Circuit. through tour en route between Wisconsin Submitted Dec. 1983. towns). two Minnesota Because interstate knowledge necessary support is not Aug. Decided 1984. conviction, Mann Act neither is interstate Rehearing and Rehearing En Banc knowledge required to convict defendant Denied Nov. Act. conspiring to violate Mann for Feola, See United States U.S. sufficiently

The record supports knowingly that Burroughs verdict

joined conspiracy transport Callahan prostitution debauchery. After Sti

mac Callahan Burroughs introduced 16, Burroughs

December took Callahan where he sexually motel her. assaulted

Burroughs also told her he or Stimac up prostitute,

or Curran could set her as a cutting

and he how described “old ladies”

across forehead made them easier day, Burroughs

control. The next took house,

Callahan to Stimac’s where Bur

roughs days. Finally, resided for several

Burroughs met at least twice with Stimac

and Curran after Miller was arrested in

North Burroughs’ Carolina. role in the

whole ordeal was less than Stimac’s

Curran’s, participation and his lesser re

flected his shorter ac sentence and his

quittal on charge. all one but Yet his

involvement was so minimal as ab him culpability.

solve from all

Ill trial to make required court was

many difficult decisions over course three-week trial. commend the We Act, the Swine Flu 42 U.S.C. (1976), 247b(j)-(Z) in conjunction with the Act,

Federal Tort Claims 28 U.S.C. §§ 1346(b), court, 2671-80. The district Honorable Donald E. presiding, O’Brien found the United States liable under negli- gence and strict theories. $212,802.22 damages. awarded Pet- ty v. United (N.D. F.Supp. 1980). judgment Iowa was vacated on appeal and the case remanded to the dis- trict court with directions to express make determinations of the liabili- ty under v. United Iowa law. States, (8th Cir.1982). 679 F.2d 719 On remand, the district court found the United States liable under Iowa negligence law on and strict failing theories for provide Petty with an warning of the known risks of the swine flu vaccina- tion and damages reinstated the award. Petty States, United 592 F.Supp. (N.D.Iowa 1983). appeal This followed. appeal, On contends that the district findings court’s clearly were (1) erroneous in that: the risk of develop- ing serum sickness was foreseeable at the time the vaccine was administered; duty therefore no to warn law; (2) arose under Iowa if duty such a arose, the warning given was not inade- quate law; (3) under Iowa and if the warn- Hultman, L. Atty., Evan Rap- U.S. Ceder ing inadequate, the lack of an ade- ids, Iowa, McGrath, J. Paul Atty. Asst. quate warning proximate was not Gen., Mary McElroy Leach, Jeffrey Axel- cause Petty’s illness. The rad, Justice, D.C., Dept, Washington, for appeals also from the district court’s deci- appellant. holding sion drug manufacturer strictly Wiley Mayne, Mayne, John D. City, Sioux prior liable. Our opinion affirmed the trial Iowa, appellee. for finding that the swine flu shot did in fact Petty’s cause injuries. 679 F.2d LAY, Judge, Before Chief FLOYD R. finding This is the law of the case GIBSON, Senior Judge, Circuit and is not challenged appeal. BRIGHT, Judge. Circuit Petty received the swine flu shot on Oc- LAY, Judge. Chief 31, 1976, pursuant tober to the National Robert L. against filed suit Swine Flu Program,1 Immunization at a United compensatory damages States for vaccination operated by center the Sioux thorough 1. A more Act, discussion of the liability provisions facts can der the the United Judge Bright’s opinion. be found in earlier place States is substituted as the defendant in the F.2d at 722-24. For a more extensive discus- any "program participant," i.e. a vaccine man- history purpose sion of the of the Swine Flu ufacturer, injuries action Laboratories, Program, Inc., Sparks Wyeth see resulting Program. death from the Swine Flu (W.D.Okla. 1977), F.Supp. and Unthank v. 247b(k)(l)(B), (k)(3). 42 U.S.C. For actions (10th Cir.1984). United 732 F.2d 1517 Un- See, Department, e.g., City-Woodbury County Health Lakatosh v. injury lar sustained. Co., Diamond Alkali the direction of the Iowa State 208 N.W.2d Co., (Iowa Department. 1973); Health Prior to the inocula- Davis v. Coats 255 Iowa tion, Petty 13, 19, and “skimmed” a form received 119 N.W.2d Our flu, related information about swine prior opinion made it clear “an possible side effects of the vaccine and duty” undifferentiated to warn of the risks Reprinted Special p. Precautions. receiving and benefits of flu swine vac- infra 8, 1976, Petty began 6-7. On November cine was insufficient to establish numbness, experience aching, tingling liability for failure to warn joints. sensations his muscles and His specifically of serum sickness. 679 F.2d at hospital- condition deteriorated and he was question 728. The remanded was whether ized on November 1976. An initial di- serum sickness and its were rea- agnosis congestive heart failure was sonably and, so, foreseeable whether changed to serum sickness. At the time of government adequately warned of the risk. trial, original experienced still The district court on remand found that aching joints persistent and a lack of clearly facts of this case show that “[t]he strength. He has since recovered about dangers of serum sickness and abortive prior of his effectiveness. 75% neuropathy from flu vaccines were well Foreseeability community known the medical for a law, Under Iowa years prior to warn in number to 1976.” negligence triggered action F.Supp. at 690.2 The court based its find- foreseeability” particu- “reasonable testimony Hyden, of Dr. Clark program Hyden, Petty’s treating physician, based on the act or omission aof stated that participant, subject Petty’s symptoms the United States is to liabil- initial "were those of ascend- ity any ground theory program ing neuropathy, progress. on or that the but this did not It participant, Instead, subject the United States did not continue and is to laibil- become worse. it ity any ground away theory program submerged symp- or that the went or became in his participant myalgia arthralgia, toms of would be held liable under the and so it law started of the out but it did not continue.” Tr. state where the act or at 119-20. We omission occurred. 247b(k)(2)(A)-(k)(3). Hyden using are satisfied that Dr. Id. at was not § Where neuropathy” government depict specific "abortive ease, negligent a is held liable dis- for actions using program descriptive but rather was it as participant, government of a a has a phrase diagnosis in his right in the sense program participant; of that the action over that began neurological however, disease as a any condition but liability against sustained a progress did not as such. program participant liability theory, on a strict government At the trial level the asserted that government pro- sits "in the shoes” of the specific ailment that sustained was not gram participant and bears costs. See id. at because, regardless critical of whether it was 247b(k)(7). Concurrently, subjects § the Act neurological complication described as a or se- liability the United States to for its own acts or sickness, reaction,” rum it was a "severe of omissions under the strictures the Federal of adequately open- which he was warned. In his Act, accordingly, government’s Tort Claims trial, ing statement at counsel for the negligent is limited to actions. Id. at ment stated to the court: 247b(k)(2)(A). Now, "neurological compli- whether we said might get cations” or that he serum sickness appeal, government 2. On contests the dis- repercussions, reaction or autoimmune diagnoses apparent linking trict court's of serum sickness might possible be that he's neurological reactions. The complained following of the administration of primary appears thrust to be that there exists no immaterial, drug long is as as we said it neuropathy evidence that abortive is a known was a severe reaction. And I think that in disease or that in fact suffered from it or a going question terms of—without to the of disease; therefore, neurological evidence bear- symptoms, symp- causation of the that the ing government's neurologi- awareness of reaction; toms were in fact a severe government and the cal reactions is not relevant to the reasonable would admit that the foreseeability plaintiff of serum sickness. The complained he of a were severe reaction. neuropathy characterizes abortive aas nervous Thus, at trial no serious contention was made accompanies disorder that serum sickness. by or its witnesses that serum Explaining diagnostic his characterization of neurological symptoms sickness did not involve Petty’s neuropathy,” illness as an "abortive Dr. or affects. Bellanti, Poser, Although Dr. Charles and tious diseases. serum is not Joseph Dr. anymore, often Dr. Bellanti used testified Dr. Hattwick. same reaction—a serum sickness- record, we find that Upon review the recognized like disease—is one of the reac- supports testimony the district court’s to a tions vaccination. sickness and conclusion that serum recognized symptoms were a reaction case tried to court with jury, Flu vaccination. Serum sickness the Swine out a court sits as the exclusive Petty’s treating Dr. Hyden, defined was finder fact. The district court has the being Type 3 physician, hypersensi- resolving as “a task of conflicts in the evidence foreign protein is tivity appraising credibility, weighing reaction which a the evi dence, injected, evidently drawing sets ingested Although which inferences. reaction, may in a different trier of up antigen-antibody an which fact have found differently, pro- we conclude that on proteins certain the basis turn activates testimony presented there throughout an reaction sub inflammatory duce was stantia] support evidence to body. antigen excess district This called finding court’s that serum sickness and its complex Tr. disease or immune disease.” symptoms were foreseeable. We cannot Hyden that serum at 115-16. Dr. testified say finding that the court’s reflects that a long standing was a disease sickness clear mistake has been made. Fed.R.Civ.P. in the medical literature caused well known 52(a). Accordingly, we affirm the district protein, such as in the foreign when here, injected body. into the Dr. vaccine recipients warn vaccine Bellanti, immunologist and Director an the risk of serum sickness. Study Interdisciplinary the Center for sick- Immunology, similarly defined serum Adequacy Warning antigen-antibody complex that ness as an redness, swell- Finding inflammation and the risk results of serum sickness foreseeable, joints. generalized This disease we move now wit, days appeal, issue raised on was named serum sickness second government’s warning3 infec- whether the when horse serum was used treat protect people warning provided fol- One will from swine reads as shot most 3. The season; however, during next ei- lows: flu flu dosage may ther shot or a different second IMPORTANT INFORMATION required persons age you ABOUT INFLUENZA be for under If SWINE (FLU) regarding VACCINE and a such are under 25 notice (MONOVALENT) attached, not this information information is July you you provided will be wherever receive The Disease the vaccine. (flu) When is caused viruses. Influenza Possible Side Effects Vaccine chills, fever, they people get may flu have people Most will have no side effects from headache, dry cough Illness or muscle aches. However, at of vaccine. the site tenderness more, may days a week last several or or days. may the shot occur and last for several However, recovery complete com- is usual. fever, chills, people will also head- Some have may pneumonia plications lead or death ache, or within the first 48 muscle aches elderly people people. with some For the hours. heart, diseases, kidney lung, flu diabetes or or Special Precautions may especially serious. be drug, possibility any of As with vaccine or you unlikely have natural It potentially reactions exists. severe or fatal flu, against protection it has not swine since However, rarely flu vaccine has been associat- widespread in 45 human outbreaks caused with or reactions. In some ed severe fatal years. receiving people vaccine have had instances The Vaccine allergic very note You should care- reactions. give you it is will flu because The vaccine fully following precautions: Today’s killed flu vac- made from viruses. age under a should not Children certain fewer side effects than those used cines cause ask routinely flu vaccine. Please receive past. vac- In contrast with some other age is not about limitations if this information cines, during safely vaccine can be taken flu attached. pregnancy. inadequate specificity under Iowa law to lack of warn the relied on the of the warn- ing: plaintiff. adequacy To determine the of warning, given court plaintiff district relied on The consent form to the failed to set forth the known risk of

Iowa loss law: of of or organ function limb. This duty depends A to warn superior symptom major of serum is one sickness knowledge and is said to exist when one plaintiff’s damages. Thus, element of may reasonably danger injury foresee informed Iowa consent law could not damage knowledgeable or to one less relieve the defendant adequate warning danger unless dangers. failure to warn of known given. is this It reasonable foreseeabil- Petty clearly Id. at sustained dis- ity triggers obligation warn, abilities as those in sec- such described which must be determined the circum- 147.137(1). tion particular, Petty's each stances of case. symptoms included inflammation of the 592 F.Supp. (quoting Lakatosh v. Dia- (an heart organ) and of the heart muscle Co., mond Alkali 208 N.W.2d 913 causing impairment an of function and en- (Iowa 1973)). Having determined that the dangering warning, however, life. his The risk of serum sickness was makes specific no mention of this risk. foreseeable, thereby triggering contends that warn, adequacy the court then assessed the requires the statute risks be set forth under law. Iowa only terms,” general “in and that the warn ' Although “seriously questioning” ap- ing’s reference to or potentially “severe plicability of Iowa's Consent Informed Stat- fatal requirement. reactions” satisfies ute, (1975),4 Iowa Code 147.137 the dis- First, We must respectfully disagree. trict statutory court found that prereq- statute presumption mandates that the presumption uisites to a of informed con- informed writing consent arises if the “sets satisfied; therefore, sent were not the stat- forth in general pur terms the nature and utory presumption pose could not alleviate the procedure together ... with the risks____” government’s liability. primarily court known It all is not at clear that People allergy eggs with known presumption should this section shall create a only special receive the vaccine medi- given. informed consent A consent supervision. cal writing requirements meets of this section People delay getting with fever should vac- if it: gone. cinated until the fever is general 1. Sets forth in terms the nature People type who have received another purpose procedure procedures, or past days vaccine in should consult a risks, together any, with known physician taking before the flu vaccine. death, damage, quadriplegia, paraple- brain you any questions about or If flu flu gia, any organ loss loss of function of vaccine, please ask. limb, disfiguring or or scars associated with signed following registration also the procedure procedures, proba- such or with the form, was the which attached to information bility of such risk each determi- sheet: nable. REGISTRATION FORM Acknowledges that the disclosure of that I have read the above statement about swine ques- has been that information made and all flu, vaccine, special precautions. the and the procedure proce- tions about the asked or opportunity questions, I have had an to ask satisfactory dures have been answered a ... and understand the benefits and risks of manner. request given flu vaccination. I it be to signed by patient Is the for whom the person me or to the below of named whom I procedure performed, patient is to be or if parent guardian. am the or consent, any legal capacity reason lacks to 4. The Iowa Informed law Consent creates a signed by person legal authority a who has presumption of informed when consent the stat- patient to consent behalf on of that in those utory prerequisites are satisfied. The statute circumstances. provides: Iowa Code 147.137 writing any A consent medical or surgical procedure procedures or of course patient requirements care which meets the of sure, logical a description symmetry To be there is generality allowed for descrip- argument acceptance applies to the to the of the risk procedure also light specificity implies acceptance of death of the risk risks. In tion of the O’Brien, something Judge statutory language detailing certain less extreme. however, risks, finding contrary. a the statute does not made we find that only Id. at 692. The circuit court stated with the same allow risks be procedure. passed question on this affirmed a generality applicable to the did, Second, assuming finding inadequacy, that it for the in accordance with even below, Judge we find that O’Brien’s rationale. Unthank v. same reasons discussed (10th States, generality warning was insuffi- United 732 F.2d 1517 Cir. 1984). In encompass specific risk of se- Unthank the Tenth Circuit held cient to Thus, determining warning given Petty without that a identical to that rum sickness. statute,5 inadequate ap- we affirm was as a matter of law to applicability pre- plaintiff prise conclusion that the of the known risk of the district court’s statutory myelitis. a requisites to the creation of transverse See also Hasler v. States, F.Supp. consent were not presumption of informed United (E.D.Mich.1981), rev’d satisfied. causation (6th Cir.1983)(warn- grounds, 718 F.2d 202 government contends that the refer- The ings given plaintiff were minimal and potentially reac- “severe or fatal ence to person so bland that no reasonable would tions,” to ask coupled with the directive consider himself or herself to be in under Iowa law to questions taking danger drug); whatever from govern- discharge its to warn. States, No. Claxton v. United EP-78-CA- ment contends that the risk of death en- (W.D.Tex. 31, 1983) May (warning compasses risks such that inclusion lesser reasonable, wholly inadequate to inform specific risk would not have of a more prudent person risk of the known of severe recipients affected their de- enlightened neurological complications and was mis- to be inoculated. Some district cision leading presented in that it was as more of findings courts have made warning).7 than a disclaimer ment’s was reasonable.6 How- ever, presented in this are with Buttressed that serum case we known, risk, findings made a different trier of fact sickness was a foreseeable record, obviously apply- district court found that the information on an different adequately provided Petty did not ing the law of Iowa. sheet cases, see, e.g., questions applica- Overton v. are about the in GBS United 5. Serious raised Cir.1980), States, (8th bility example, of the statute. For it is not clear 619 F.2d 1299 court's recipient adequacy whether a vaccine in a mass immuni- discussion of the Second, "patient” undergoing "patient context is a contends that zation dictum. by subsequent care." Claxton is undermined Fifth Cir- rulings contrary in Daniels v. United cuit States, States, (11th Cir.1983) (warning 704 F.2d 587 704 F.2d 587 6. See Daniels United Cir.1983) law) law) (11th (Alabama (warning was reasonable under Alabama and in "reasonable"). States, following district courts F.2d Freeman v. United cir.1983) (risk potentially capsilitus that a severe also found of adhesive not foresee- encompasses specific enough warning). require fatal reactions more or reactions, able Both of distinguishable per- of the words such that the inclusion these cases are neurological super- applied disorders would have been suasive. law, In Danieb the court Alabama See, e.g., imposes v. United No. Butler a “reasonableness” stan- fluous. 18, 1983); however, (S.D.W.Va. law, May Gilroy applies a more strin- 80-3110 dard. Iowa 16, States, (M.D.Pa. gent patient No. 79-597 June United disclosure standard under rule. law); law, Claxton; 1983) (Pennsylvania applied v. United Bean Texas as did Freeman however, law). (D.Colo.1980) (Colorado F.Supp. that no warn- 533 567 the Fifth Circuit found plaintiff's malady possibility of the therefore, required, Fifth Circuit’s discus- government that Claxton does contends First, warning adequacy Petty's plaintiff of the is also support sion of the dictum, case. Syndrome is less we find that it relevant or Guillain-Barre and Claxton sustained (GBS). persuasive in Claxton. government dictum than Because the has conceded 1436

warn him of the risk of serum testimony, sickness. the court could find that hold that this inadequacy law, We government’s under Iowa informa- clearly accordance with Iowa law and is tion form inadequately specific, warned the supported by the evidence. known risk of serum sickness.9 Expert testimony supports Petty’s con- reject We also generality warning, tention that the of the contention that the reference to death en especially in the context of the compasses all risks and their effects on unprecedented promotional ment’s cam- grounds of Iowa law. We find that in this paign, was insufficient to have enabled Pet- case Iowa law would mandate that the ade ty give to an informed receiving consent to quacy of be assessed under Modell, physician the vaccine.8 Dr. and patient rule standard. Compare Cow advisory member of various committees to (Iowa man v. Hornaday, 329 N.W.2d 422 Administration, Drug the Pood and testi- 1983)(patient governs rule physician’s duty fied that the information form was more an to disclose the known risk of testicular attempt program to sell the than an unbi- atrophy healthy patient to seeking a vasec presentation ased of the vaccine’s risks and tomy purely reasons) for socio-economic particular, benefits. Dr. Modell testified with Grosjean Spencer, 685, 258 Iowa that “severe or potentially fatal reactions” (1966) 140 (professional N.W.2d 139 rule says nothing neurological about a reaction. governs physician’s duty to disclose risk of Hattwick, Similarly, Dr. Director of the peritonitis to severely patient). ill Under National Program, Influenza Immunization patient standard, rule an individual Center, Surveillance and Assessment must be advised of poten the inherent and on the Center for Disease Control staff of tial proposed treatment, hazards of the the Bureau of Epidemiology, testified that treatment, alternative methods the risks phraseology decisions were made “to en- alternatives, attendant to such and the like courage participation.” Because those in ly results of remaining untreated. See charge clearly were specific aware of the Cowman, 425; 329 N.W.2d at Canterbury neurological risks, it was Dr. Hattwick’s Spence, 787-88; 464 F.2d 772 at Cobbsv. they assessment must have deter- Grant, 229, Cal.Rptr. Cal.3d mined it prudent was more not to P.2d to disclose is mention or stress these risks. He testified only limited not to foreseeable that more specificity could have been con- risks, but also to material risks. See Cow fusing, by which he participa- meant that man, 329 N.W.2d at (quoting tion would have Wilkin hampered. Katz, been Dr. 606, 627, Vesey, son v. a Professor of R.I. Law and 295 A.2d Psychiatry at Yale University, (1972)). also testified that We have found attempt anwas participation induce risk of serum sickness and its inadequate recipients enable to ren- was known and subjected that the vaccine der an informed consent. On the healthy recipients basis of debilitating serious Although First, recognize campaign we the hard sell the informed consent form ... did not context, therefore, as it bears on the warn individuals that there was a one in one adequacy warning, emphasize we that we person hundred receiving thousand risk that a passing government’s good are not faith a flu shot would contract Guillain-Barre and promotional in its efforts or on the ultimate every that one in two million would die from necessity program. Second, the condition ... in the Swine Flu Government, program, the Federal in an un- 9. We also note that the has conced- precedented actively urged effort millions of ed that the swine flu vaccine can cause GBS. get Americans to flu vaccination shots and Order, Stipulation Paragraph and Final Pretrial campaign. funded the nationwide IX In Re Swine Flu and Products Immunization (June 20, Secretary 1978). Statement of Califano Liability Litigation M.D.L. No. Mise. No. If the dissent provid- is correct that the (D.D.C.1979). Explaining 78-0040 why the adequate apprise ed him of the risk provide compensation decided to sickness, why of serum we fail merely upon GBS see it sufferers an causa- inadequate apprise presentation, Secretary tion of the risk of GBS. Califano stated: idiosyn- situations and for some individual 679 F.2d at 723. Petty, See complications. Moreover, person crasies, who Petty healthy may necessary rely was a it to be vaccine, pre- thus voluntarily received the questions complete pic- to recipients’ was a sumably foregoing the vaccination clarify ture of risks and benefits or to risks Disclosure of the alternative. viable not such a situa- issues raised. This was significance” to a “of have been would given tion. Here the that was Ac- inoculated. decision to be vaccinee’s spark was insufficient to the concerns that risk of serum cordingly, find that the we engendered questions. would have More- symptoms was material and its sickness over, it seems unrealistic to believe that the and, argument to being justifiable no there anonymity of a immunization context mass patient rule stan- contrary, under atmosphere ques- an would foster which dard, have been disclosed. it should likely tions were to asked or answered be reject government’s con We thoroughly. reference to satisfies

tention that a death conclusion, we hold the district reason also. duty to warn for another its did not warning found this undifferentiated Were known, encompass specific, and materi warn, under satisfy duty to to symptoms al risk of serum sickness all risks requires disclosure of Iowa law supported by the evidence and is not be foreseeable, then the clearly Consequently, under erroneous. very hollow indeed. warn would become provide Iowa law it did not an virtually any treat result from Death can intelligent, in Petty basis for to make an Moreover, may the risk of death be ment. consent. formed remote, spe conceptually whereas a more warning detailing the known risk of cific Causation and its would serum sickness concretely to the risks recipients Petty more also must estab alert To recover assuming. How they actually were relationship the causal between the lish ever, warning given Petty made no to disclose and the government’s failure physiological source attempt to disclose Cowman, injuries he sustained. See to advise the possible reactions or relationship The at 426. causal N.W.2d recipients likely foregoing results Petty had when it can be shown that exists vaccination, alternative meth appropriately, he would have been warned and the risks attendant protection ods of again forgone the shot. We look Iowa requires the dis patient rule thereto. law. substantive an of these issues order to obtain closure traditionally under Iowa appears It vagueness consent. The informed satisfy subjec- law would have potential inadequacy, warning, and thus its lia- standard of causation establish tive placement of the warn is enhanced bility. Hayne, Peñn v. N.W.2d Precautions,” which im “Special (Iowa 1973). require This would estab- guarded these risks can be plies either that he, lishing Petty, would not Robert only special against, they apply or that vaccinated had he been ade- have been merely a disclosure here was cases. The court, how- broad, alleged quately warned. The district generic statement. ever, presumption seri applied here did more to dilute the a rebuttable it the risks at stake than did presumed ousness the causation issue. The court recipients of the existence of apprise the warned, that, adequately he had been Indeed, appears that assur it those risks. minimize the risk. have acted to See would was the motivation behind ing participation Laboratories, 498 F.2d Wyeth Reyes v. rather than an phraseology decisions Cir.1974). The court relied recipients of the effort to inform the risks. “hardsell” primarily flu approach to the swine immunization vagueness Finally, we find that the justify the use of a burden- program to mitigated by warning is not generic Finally, the shifting presumption. court questions. In some to ask invitation 1438 proximate cause issue. The district court Petty’s testimony

relied on find that the relied on the factual distinctions between pre- United had not the States rebutted physician-patient the sumption: present situation in Perin and the mass-immunizationcontext of Petty Mr. testified that warn- justify case to ings helped in the use of the they would have him that rebuttable presumption place in would him the more tradition- have enabled to make more subjective al Despite standard. the reaffir- judgment. testimony pro- informed This Cowman, mance in opinion vides the of Perin the basis this Court’s relevant Petty and that Mr. was in fact critical factual concerned distinctions between our an making about informed For case and justify pre- decision. Perin used to reasons, sumption present these Court concludes that not were In Cowman. plaintiff shown Cowman, has that the failure of contrast to Perin and we are properly presented the defendant to was the warn with a mass-immunization case. proximate plaintiff’s injuries. cause of There Petty, were viable alternatives for yet he received treatment without warn- F.Supp. at 592 ing apprising him of the and risks benefits appeal On the Government contends that and without an initial individualizedbalanc- prediction the district court’s that Iowa by risks benefits a learned by by would not abide Perin is undermined intermediary. Additionally, pub- is a there Supreme subsequent the Iowa Court’s reaf- policy lic favoring consideration allocating viability firmance of the Perin Cow- among the risk of loss the distributors who Cowman, man. 329 at 424. N.W.2d The can then absorb cost or distribute it government Petty contends that has not easily. Wyeth more Reyes See Labora- subjective satisfied the standard causa- cert, tories, 1264, (5th Cir.), 498 F.2d required by tion as The Perin. denied, 419 U.S. S.Ct. Petty’s testimony ment relies on that he did (1974);10 L.Ed.2d 688 id. at see also 1294n. neurological not know what disorders were 57 (recognizing view that burden should be alleged and his admission that the inade- by government born because quacies in the informed consent related to societal by benefit bestowed individuals re- matters enlightened that would not have vaccine). ceiving In sustaining government his decision. The also relies causal presumption, we are also influenced opportunity afforded to ask public sell” “hard relations cam- Second, questions. con- paign pursued by government. The Reyes applicable, tends that if is then the only campaign encouraged participation not opportunity questions to ask and Petty’s greatly but impact also minimized the testimony, suggests a warning warning. Lederle, See Givens v. enlightening, would not have been are suf- (5th Cir.1977); F.2d 1341 Reyes Wyeth ficient to presumption. rebut the causal In cert, Laboratories, (5th Cir.), 498 F.2d 1264 Reyes pre- the Fifth Circuit found that denied, 419 U.S. 95 S.Ct. sumption rebutted; however, no L.Ed.2d 688 given had been and no evidence rebutting presumption had been we Finally, affirm the district presented. The contends that presumption that the causal warning, allegedly because albeit inade- has not rebutted. been heeded, provided quate, and not warning, distinction no between as in inadequacy causal connection between the Reyes, inadequate warning unper an plaintiff’s injuries and the inadequacies present suasive. The in the rebutted. generic warning support here do not appli

We affirm the district court’s inference that would not have heeded cation of a presumption to the an adequate warning. rebuttable Reyes, justified adequate warning the Fifth Circuit been an also would have been presumption recognizing self-serving speculative. Reyes, causal that testimo- F.2d at ny as to had what would been done there 1281-82. inadequate part recipient Furthermore, the calculat- of the vaccine. because of Iowa, because it ambiguity presented of its terms and district court found that ed recipi- case, in terms the couched that lulled with the of the instant was facts would security. drug a false sense of Similar- strictly ent into hold the manufacturer liable opportunity ly, questions to ask does duty the for a of its breach to warn. The presumption. in itself the As rebut district relied on adoption court Iowa’s earlier, of a mass- anonymity the (Second) addressed Section 402A Restatement encourage immunization context does not Torts, Hawkeye Security see v. Ins. Co. nor the sufficient to questions was Co., 672, Ford Motor 174 684 N.W.2d incite me- spark necessary the concerns to (Iowa 1970), j thereto, and of comment see aningful questions. the district Finally, Quick Co., Cooley 221 Supply v. N.W.2d fact, found, finding that the as a (Iowa 1974), court 763 to reason that Iowa also had In so presumption not been rebutted. adopt would comment k to Section 402A. finding, apparently Petty’s the court found recognizes k products, Comment that some testimony that he would found more have unsafe; drugs, unavoidably such as are helpful, persuasive more than information however, outweigh their because benefits testimony by government. cited the the risks, properly prepared the and accom- may Although different triers of fact panied is, by proper warnings, product the conclusions, to different is sub- come there definition, neither defective nor unrea- support stantial evidence the record sonably dangerous. The swine flu vaccine finding say court’s that the and we cannot justified, would thus be classified as a but finding clearly court’s erroneous. the unavoidably product; however, unsafe be- 52(a). Fed.R.Civ.P. cause the inadequate, vac- the unreasonably dangerous, cine was render- government The that also asserts drug strictly manufacturer liable. distinguish district court’s attempt “program Because Merrill-National was a govern jurisdictional is Penn error. § participant,” 247b(k)(2)(B) 42 U.S.C. alleges approach that its ment “hardsell” includes, alia, (“program participant” inter within the ex discretionary function vaccine), the manufacturer of the swine flu Act, emption to the Federal 28 Tort Claims liability scheme of the Act Swine Flu § 2680(a) (1970); accordingly, those U.S.C. imposes on the United States. jurisdictional are not actions a valid basis § 247b(k)(7). at See id. imposition liability. for the actions of the President of the United his government States appeal, On contends that however, attempts to program, sell the duty drug manufacturer did not have a imposing not used as a liabili were basis argues It to warn. that section support the ty. The evidence was used to 247b(j)(l)(F), which authorizes the Secre- burden-shifting application presump of a tary develop implement and a written Thus, reliance on actions is not tion. these consent, statutorily places informed Accordingly, error. we find jurisdictional duty government.11 sole to warn on the negli a is liable under that Thus, any inadequacy defect or theory injuries gence for the he warning solely should be attributed as a result of his flu inocu sustained swine government. Because the li- lation. ability for its own acts or omissions Act, the Federal Tort assessed under Claims Liability Strict § 247b(k)(2)(A),Petty see 42 U.S.C. is limit- negligence ed to a claim. v. Alternatively, the district court found See Dalehite 15, manufacturer, 956, 346 drug Merrill-Na- United U.S. 73 S.Ct. that tional, duty had a ultimate to warn the L.Ed. 1427 clarify recognize duty We that both turers that the wanted to warn vaccinees, drug put had been manufacturers intended manufac- cases, duty Reyes polio to assume the See 42 U.S.C. ment to warn. turer in Davis would Rec., Rec., 247b(j)(l)(F); Aug. government); Cong. Cong. 1976 at see abo lie with the cf. (Rep. Rogers Aug. relating the manufac- at drug

We affirm the district court’s should relieve the manufacturer for any liability for the lack of holding impose duty that Iowa law would risk. Deluryea Winthrop See v. Lab- manufacturer, drug to warn on the oratories, (8th Cir.1983). 697 F.2d As to warn would extend matter, a factual we have found ultimate consumer in a mass-immunization supports evidence district find- See, Parke, e.g., case. Stanback Davis ing that serum sickness was foreseeable Co., (4th Cir.1981); & 657 F.2d 646-47 supported risk. Whether this Lederle, Givens F.2d 1341 Cir. however, evidence, is irrelevant to the 1977); Laboratories, Reyes v. Wyeth program participant’s liability for failure to cert, (5th Cir.), denied, F.2d 1264 419 U.S. under liability theory warn a strict 1096, 687, (1974); 95 42 S.Ct. L.Ed.2d 688 Iowa law. Inc., Laboratories, Wyeth Davis 399 v. government contends, As the the (9th 1968). Moreover, F.2d 121 we Cir. af Deluryea panel did find that a strict liabili finding firm the that Iowa would hold the ty action for failure to warn was similar to drug strictly manufacturer liable the for one negligence drugs based on where are duty this presented breach of with such a involved. This was based on Ar Co., Hawkeye Security case. 174 See Ins. law, kansas as reflected in the district (Iowa 1970); N.W.2d 672 Kehm v. Proctor instruction, jury injected which had Gamble, (8th Cir.1983); 724 & F.2d see 613 of foreseeability notions into the determina Co., Rodgers also Machinery Mfg. Aller liability. tion of strict apply Here we Iowa (Iowa 1978). 268 N.W.2d 830 recognizing law. While that the terminolo recognize We gy negligence in liability strict actions attempted statutorily has the assume may be similar terminology and that the vaccinees, duty however, to warn the we do in “rings negligence,” clearly recog Iowa the delegation thereby analytical not nizes find re distinction between the in duty two causes of action to warn cases. liability lieves the manufacturer from for Co., Rodgers Aller v. Machinery Mfg. 268 any resulting inadequacy warning. (Iowa 1978); N.W.2d 834-36 see also duty imposed warn is on the manu Plywood Champion Sterner United States in facturer and con mass-immunization Inc., 1352,1354(8th Cir.1975); Paper, 519F.2d text, where there is no learned intermedi Gamble, Kehm v. Proctor & cf. ary, duty recipi the the extends to ultimate (8th Cir.1983) C.J., F.2d 613 (Lay, concur Delegation ent of vaccine. duty the ring). Aller, In Iowa explicitly the court itself, not, does the relieve manufacturer recognized the difference between the two obligation, of its nor should it insulate the liability, theories of stating: liability from manufacturer for deficiencies liability plaintiff's proof In strict in the manner which the chosen interme concerns the (dangerous) condition of a diary duty. effectuates the manufacturer’s product designed which is or manufac- lines, Although on the side Merrill-National in particular tured way. negligence In knowledge assumed have had proof concerns reasonableness of ability issued and to have had the designing manufacturer’s conduct in warning. to affect the selling product as did. he Phil- defending against liability In own Co., lips v. Kimwood Machine 269 Or. acts or in the warning, omissions 485, 493-95, P.2d government argued duty it had no added). (emphasis Accordingly, Id. at warn of risk of serum sickness and its negligence liability focuses on whether the they because were not foreseea- defendant-manufacturer knew should government urges ble. The that for known of some harm foreseeable aris- drugs, involving negligence, warn cases ing from product. the use In con- liability functionally and strict are ana- trast, liability a strict action not on focuses action; therefore, lytically similar causes of knowledge, the manufacturer’s conduct or lack foreseeability marketed, same of the risk product, but on whether the as law, prod- on the Iowa defective. order to focus Under Merrill-Na actions, strictly tional been held in strict courts have would have liable uct product for its of a knowledge of the risk to the manu- distribution defective imputed proximately Petty’s injuries. caused See, e.g., Phillips v. Kimwood facturer. Accordingly, holding Co., addition to 525 P.2d at Machine 269 Or. at negligence, liable for its own question The relevant is then wheth- alternatively we hold United States de product persons harmful to er the “is so [or rivatively liable for Merrill-National’s liabil prudent manu- property] that a reasonable ity liability.12 strict U.S.C. knowledge [supplier] with this facturer § 247b(2)(A)(i). placed it on the market.” would not have v. Farmers Grain Termi- Robbins Union BRIGHT, Judge, dissenting. Circuit Ass’n, F.2d 795 n. 15 nal I dissent. I believe Cir.1977) (quoting Phillips v. Kimwood Petty being received before vaccinated was 16), Co., 525 at 1040-41 n. Machine P.2d adequate. Therefore United States is Aller, (equating 268N.W.2d at 836 see also negligence liable under either theo- test, Phillips’ emphasis with its ry liability theory propounded or the strict seller, consumer-expectations test with majority. Iowa). applied in assuming Even that serum sickness was case, Applied our we determine attending a foreseeable risk flu swine vac- liability under strict drug manufacturer’s cination, I think vaccinees received ade- knowledge of the liability, by assuming quate warning. The information form Pet- Then the issue is risk of serum sickness. that, ty any read stated with vaccine “[a]s manufacturer, with such whether drug, possibility poten- or or severe an unreason- knowledge, has distributed tially exists.” I do not think fatal reactions light com- ably dangerous product. specific warning, that a more either de- 402A, k the unreasonable ment of section scribing of serum sickness unavoidably unsafe dangerousness of this name, mentioning by that condition warning giv- product turns on whether the any purpose in would have served useful product adequately apprises en with the pro- mass inoculation the context of this dangers. This issue recipient of those that a small gram. Vaccinees were warned warning already has been resolved: accompa- reaction risk of severe or fatal inadequate apprise of the known majority receiving nied the vaccine. symptoms. of serum sickness and its risk dispute not the minimal nature of that does risk, warning had maintains that the should We have found that Merrill-National but potential that the itemized the adverse reac- to warn Yet, Ad- inadequate discharge duty. tions from the vaccine. was adequate warning, potentially of severe or “possibility ministered without an defective, directly, completely, flu hence fatal reactions” more the swine vaccine was lay per- for the unreasonably dangerous. graphically Had the manu- describes sickness, receiving the son the hazards of vaccine facturer warned serum presumably specific have had the itemization of adverse ef- warning would than a govern- agree by as one issued fects. I with same effect simply adopt our that have con- Accordingly, we with most of courts ment. issue, supra n. that a finding that the lack of an sidered the see earlier catalogue every compli- serious proximate cause of Pet- detailed warning was the might would cation that befall vaccinee ty’s injuries. p. supra 1437-39. See States, 732 F.2d holding also Unthank v. United does not defeat the see We note that this Cir.1984) holding congressional drug (alternatively manu- intent to immunize liability By exposure. derivately facturers from unlimited liable for manufacturer’s strict ment liability presented in the virtue of the scheme congressional intent to assure based on defending of both Swine Flu Act the burden by persons injured compensation for all damages resulting is borne action and the vaccination). flu swine 247b(2)(A)(i); United States. See 42 U.S.C. serving counterproductive, have been needlessly potential alarm vacci-

confuse or giving any

nees without them infor- more necessary making to the an in-

mation reject I therefore the ma-

formed decision.

jority’s speci- conclusion failure

fy potential adverse effects the vac- when, warning inadequate

cine makes the here, warning aptly vacci- apprised

as possibility

nees of harm. the overall adequate,

Because the negligent. is the Nor

government strictly theory liable under the unavoidably unsafe

.that vaccine danger- unreasonably

rendered defective or give

ous detailed the failure a more

warning.

I practical consequence think the impose stringent

court’s decision is so

warning requirement likely as render program future mass inoculation in-

feasible, how no matter desirable.

Accordingly, dissent. I ASSOCIATION,

STOP H-3 non Hawaii Land, profit corporation, Life of The non-profit corporation,

Hawaii Hui Ma Ko’Olau, Appellants,

lama Aina O DOLE, Secretary

Elizabeth H. as Department Transpor

United States tation, Ralph Segawa, as Divi Hawaii Engineer, Highways

sion Federal Ad

ministration, Ryokichi Higashion

na, Department as Director of the

Transportation Hawaii, of the State of

Appellees.

No. 82-4357. Appeals,

United States Court of

Ninth Circuit.

Argued and Submitted Nov. Aug.

Decided

Case Details

Case Name: Robert L. Petty v. United States

Court Name: Court of Appeals for the Eighth Circuit

Date Published: Nov 2, 1984

Citation: 740 F.2d 1428

Docket Number: 83-1696

Court Abbreviation: 8th Cir.