*1 record of this matter be made the entire ORDERED attorney an at law of this part respondent’s file as permanent State; it is further Disciplinary respondent Over- reimburse
ORDERED
costs incurred
sight
appropriate
administrative
Committee
prosecution
this matter.
curiae American of Association (Tompkins, Executives Wachenfeld, attorneys). McGuire & Susan M. Wefing Sharko and Laura A submitted a brief on (Shan- College behalf of amicus curiae of American Pathologists Fisher, ley attorneys). & opinion of the Court was delivered
POLLOCK, J. Snyder Plaintiff Acquired William contracted Immune Deficien- (AIDS) cy Syndrome from a Bergen transfusion of blood that the Community (BCBC), non-profit bank, Blood Center a blood had provided Joseph’s Hospital. to St. BCBC is a member The defendant, (AABB), the American Association of Blood Banks an association of blood banks and blood-banking professionals. The primary issue is whether the AABB duty owed a of care to
273 AABB is entitled is whether Snyder. A further issue 2A:53-7. immunity under N.J.S.A. charitable thirty-percent Division, jury the AABB a found Law In the $405,000. $1,350,000, or damages of Snyder’s liable for A.2d 482 N.J.Super. affirmed. Appellate Division certification, 142 N.J. (1995). petition for AABB’s granted the We (1995), and now affirm. A.2d 1110 I surgery at 23, 1984, open-heart Snyder underwent August On surgery he re- During the in Joseph’s Hospital Paterson. St. including platelets, units of blood of several transfusions ceived Joseph’s. 29F0784, supplied to St. had which BCBC unit blood whether time, existed to determine no direct test At the (HIV), Immunodeficiency Virus Human was infected determination, howev- making that Other means cause of AIDS. immuno- enzyme-linked er, Starting in available. were test) (the blood enabled ELISA absorbent-assay-sereening test for HIV. to screen banks year, instituted that program “look-back” a nationwide
Under donor prospective who whether could determine banks development blood before had donated positive HIV tested sponsored program “look-back” part As of the ELISA test. donor of unit AABB, BCBC ascertained so informed year BCBC That same positive. was HIV 29F0784 turn, Snyder’s informed Joseph’s, Hospital. Joseph’s St. St. not otherwise Snyder, was doctor, who notified him 1987. who contracted AIDS. risk, has since positive. He tested HIV wife, (collectively Roslyn his Snyder and February In Division in the Law complaint “plaintiffs”), filed to as referred individuals, and other physicians Joseph’s, various against St.' “defendants”). (collectively as BCBC, described and the liability, breach sounding in strict asserted claims Plaintiffs strict-liability fraud. and consumer warranty, negligence, *5 claim, Snyder alleged that he had been transfused with a defective product through that blood could have been made safe available donor-screening techniques. According blood tests and to the AABB, however, plaintiffs, implementation resisted of those techniques. Snyder alleged tests and further that BCBC and the negligently contracting by AABB enhanced risk of had his AIDS failing implement procedures prevent to to HIV-infected donors giving plaintiffs’ AABB allega- blood. The denied essential tions and asserted immunity. the affirmative defense of charitable proceeding,
In an earlier
the Law Division
an
entered
order
plaintiffs
allowing
proceed
negligence
against
with their
claim
Further,
AABB.
plaintiffs
the court ruled that
were not
discovery
entitled
of BCBC’s blood-donor records.
Appellate
agreed
plaintiffs
The
Division
could maintain
negligence
Snyder
I),
their
Mekhjian (Snyder
action.
v.
290-93,
(1990).
N.J.Super.
Overruling
At eight-week the conclusion of an jury found that the AABB negligent surrogate had been in not recommending testing. Surrogate testing people to identifying refers for a risk disease by testing symptom for some or characteristic manifested majority people who have or are contracted at risk contract- ing 1980s, early the disease. In the surrogate one available test antibody HIV infected was hepatitis that for the to the B (the antigen antibody). core HBc jury further negligence found that the AABB’s was a causing Snyder substantial factor in contract It HIV. also found thirty-percent plaintiffs’ injuries. was liable for *6 court, Judge Writing for the Appellate Division affirmed. The that, interlocutory appeal, had the the court Pressler stated on care, Snyder duty of and that AABB owed determined the 282 precluded a different determination. the law ease N.J.Super. at 482. 659A.2d explained “unique dominant Appellate Division that the and control blood-banking the and the extent of its
role of requisite the relation over its institutional members” established recipients, blood-produet and “whose ship between the AABB A .2d482. safety paramount is its concern.” Id. 659 avowed “public policy Considering the involved and the concerns risk the blood-banking industry’s operation,” methods of implicit the reasonably chargeable with a that the “AABB is court determined recipients depend and duty care those whose life health of owed to 43-44, prudence and of its actions.” Id. at on the reasonableness A.2d 482. issue, charitable-immunity court that “al the reasoned On non-profit corporation engaged in neces though is a [the AABB] services, exclusively ‘organized for sary [it] and useful is not educational, charitable, purposes.’” Id. at religious, hospital or 2A:53-7). Accordingly, the (quoting A.2d N.J.S.A immunity. claim of charitable court denied AABB’s II A alleged duty of care to the the AABB’s Crucial assessment blood-banking industry in the in 1983-84. The blood- its' role sector, depends on voluntary which banking industry consists of sector, donors, paid voluntary depends which on and a commercial provides voluntary sector whole Generally speaking, donors. provides and commercial sector components, and blood blood plasma plasma and derivatives. voluntary the American Red Cross sector is
Central centers, banks, and the community hospital blood its blood AABB, every which includes almost blood bank in United voluntary rely public-spirited These banks States. do- Voluntary supply. commonly nors their blood blood banks separate components: plasma, platelets, donated blood into three red cells.
Dominating the commercial sector are or frac- manufacturers 1980s, plasma early tionators derivatives. fractionators . approximately eighty percent plasma collected do- paid voluntary provided remaining, twenty per- nors. The sector pool plasma cent. Fractionators from thousands of donors and process produce large plasma derivatives, it to batches such as *7 clotting hemophiliacs. enough factors for Each batch contains clotting patients. factor to treat of thousands Institute of Medi- cine, HIV Blood Supply: Analysis and the An Crisis Decision- of (1995) (the making Report). IOM regulations apply and
State federal to both sectors of the blood- banking (FDA), industry. Drug The Food and Administration an (PHS) agency of the Public Health in Service the United States Department (DHHS), of Health and Human inspects Services and licenses blood and banks other blood facilities. See 21 U.S.C.A 321(g)(1)(B) § (broadly defining “drugs” in- to include “articles cure, diagnosis, treatment, for in mitigation, tended use the or disease,” prevention of which includes and products); blood blood 360(b) § establishments, (requiring processing U.S.CA includ- banks, ing FDA); 262(e) register blood § to with the U.S.C.A (d) (as inspection (requiring licensing by delegat- and the FDA DHHS) by secretary ed of blood or blood-product facilities that commerce); (5) participate 5.10(a)(1), § interstate 21 C.F.R. (1995) (delegating authority secretary, to FDA vested the DHHS, Food, (21 and Drug PHS the and Cosmetic Act 301-95) §§ 262-63); and in §§ U.S.CA 42 U.S.C.A 21 C.F.R. 607.3(b) (1995) § (defining drug). Jersey, blood as a In New (DOH) Department of discharges Health responsibilities. similar (authorizing collection, See N.J.S.A. 26:2A-1 regulate DOH to blood). processing and distribution of A bank blood in New FDA and from both the operate without licenses Jersey cannot 262(a); 26:2A-4. § N.J.S.A 42 U.S.C.A DOH. of the AABB. the role background, we consider
Against this purpose incorporation, According to AABB’s certificate AABB is relating exchange to blood banks and blood and information of ideas to foster the high standards perfor- ... to advance and services!;] incorporate transfusion clearing house ... to function as banks[;] mance and service by encourage exchange [and] ... the development credits of blood and blood through information and research. education, blood banks public non-profit, scientific “professional, itself as AABB describes en- and institutions for individuals administrative association and banking, and and tissue many of blood gaged in the facets only organi- It is “the transplantation medicine.” transfusion banking blood transfusion exclusively to blood zation devoted 1980s, collected about early AABB centers services.” eighty percent of supply and transfused nation’s blood half of the mainly members were Its institutional patients. the blood non-profit blood centers. hospitals and Solomon, director, Joel According to the AABB’s executive develop and recommend AABB is “to purpose of the general help promote the banking, practice of blood standards on the for commu- health, programs ... conduct numerous and to public members and among organization and education nication mission discharges its educational at-large.” The public books, seminars, by publishing *8 and conducting workshops and journal, newsletters, peer-review pamphlets, and a Transfusion. Congress and States Additionally, AABB lobbies the United the administra- in and state legislatures participates federal and state rulemaking procedures. tive annually and accredits mem- inspects
Significantly, the AABB compliance with on accreditation It conditions ber institutions. and Trans- Blood Banks in published its Standards standards for Manual. in its Technical outlined procedures and Services fusion often AABB standards become report, According to the annual declared, the indus- it “leads the AABB has FDA standards. As try setting policy establishing practice in and standards for its in member blood banks the FDA.” excess government, Both the state and federal as well as the blood- industry, banking generally accept AABB standards as authorita- Consequently, throughout rely tive. nation banks the example, For those standards. BCBC relied on the AABB stan- developing operating procedures. dards in In its own the words Passaro, BCBC, Anthony Executive Director of the AABB’s basically standards in 1984 “were Bible of blood center.” inspections complement inspection by AABB’s the annual FDA. If a blood bank AABB loses its accreditation but retains its licenses, Jersey operate, FDA and New it can only continue to but practical significant problems. Hospitals and other blood prefer to banks work with AABB-aceredited institutions. advisory AABB guide- The also issues recommendations and BCBC, only part-time director, lines. which had medical AABB guidance assuring safety relied on the of its blood Wilkinson, supply. According director, to Dr. medical the BCBC’s Anthony Passaro, director, its executive BCBC followed the screening. AABB’s recommendations on AIDS Fur- thermore, any the BCBC would have followed other AABB recom- Dr. mendations. Wilkinson testified: screening If the A.A.B.B. had Q: recommended use a test for you laboratory have aids, would done so? you A: Yes. effect, To the same Mr. Passaro testified: [i]f Mr. Q. Passaro[,] the American Association of had Blood Banks recommended Bergen you you Blood personally Center County Community —not —that screening do a certain test for have been laboratory donors, would it done at the Blood Center? A. Yes. 1980s, early industry. led the blood Dr. Grady,
George expert blood-banking procedures F. an viruses, transfusion-related testified that the AABB had estab- setting as blood-banking lished itself the leader in standards. The AABB, moreover, was an active member of the FDA’s influential *9 the FDA on issues Advisory and advised Products Council Blood study of the FDA’s industry. In a recent concerning the blood Study AIDS, HIV Committee threat of response to the Committee) (the Through Blood and Blood Products Transmission 1980s, early “in the found that of Medicine of the Institute industry- upon analyses provided reliant appeared FDA too Advisory IOM Council.” of the Blood Products based members supra, at 15. Report, AABB. Dr. to the governmental noted deference
Others also Bank, Blood testi- Edgar Engleman, the director Stanford developing passive role the FDA took a fied deferring the AABB essentially guidelines, standards response Dr. blood-banking industry’s to AIDS. determining the expert runs a Asher, microbiologist who and blood Thomas govern- ... that “most state blood-products company, testified AABB stan- regulations the incorporate into their state ments cases, dards, are, standards for licens- in most the state [which] ing.” licenses, level, DOH, renewing blood-bank when
At the state inspec- in lieu of its own inspections accepted reports of 1984). 8:8-1.4(b) accepted (May DOH also N.J.A.C. tions. conducting obtaining histories medical AABB’s standards 21,1984). (May 8:8-5.2 of donors. N.J.A.C. physical examinations potential blood- 1983 memorandum Finally, in a December AIDS, general AABB’s liability transfusion-related bank frequently cited that “courts have AABB members counsel advised and we appropriate practice, standards as evidence AABB’s give to the recommendations courts will credence that the believe banking organizations.” by AABB and other blood jointly made organiza- tax-exempt private, emerges is of a picture that banks, of blood power operation over tion with substantial accept direction would That the blood banks including BCBC. organization. We it was their understandable: from the AABB is early during the power AABB’s exercise of next to the turn crisis. years of the AIDS
B report The first deficiency of severe immune among homosexu- 1985, als surfaced in approved 1981. the DHHS the ELISA Snyder test. received his transfusion in inquiry 1984. Our initial is whether the BCBC should have known in 1984 that blood and products carry could Answering ques- the HIV virus. requires tion consideration of the information available to the nature, cause, AABB about the and transmission of AIDS. It also involves consideration of the roles of AABB and of the Centers (CDC), public-health DHHS, Disease Control a branch of in diseases, investigating warning and such as AIDS.
The 1981, CDC first sounded the alarm about AIDS. In response rapidly to a spreading and immunological often fatal males, among disorder homosexual the CDC group, formed a subsequently known as the AIDS Task Force. The Task Force of epidemiologists knowledgeable consisted hemophilia, hep- about atitis, sexually-transmitted and diseases. From 1982 to played pivotal Task Force a publicizing role in the threat of AIDS to the supply. nation’s blood primary
The CDC’s alerting means of public- the medical and health communities of new through publication diseases is (MMWR). Morbidity Mortality Weekly Report Between July June 1981 and reported the CDC in the MMWR a rapidly cases, increasing totaling number of previously rare immunosuppression-related among ailments homosexual men and drug York, California, intravenous users New Jersey, New disease, Florida. AIDS, now known as extremely high had an mortality forty percent rate: of its victims had died. Data indicated, moreover, longer patient that the suffered from the disease, higher mortality Initially, rate climbed. AIDS only gay occurred By however, men. June groups other Seventy-five were at risk. percent patients gay AIDS were men, twenty (IV) percent users, were drug intravenous and five percent readily were not classifiable. began compile composite description
The AIDS Task Force officials had victims of the disease. Health learned AIDS long persistently lymph exhibited swollen nodes before the onset symptom depressed T- symptoms. of other One common was ratios, lymphoeyte helper-to-suppressor immunological an abnor- lymphocyte, mality that reflects a reduced count of a certain or symptom lympho- white blood cell. Another was a low absolute count, cyte suppression system. immune which indicates pneu- prominent The two most AIDS-associated diseases were Kaposi’s mocystis pneumonia and sarcoma. Before their occur- *11 patients, pneumocystis pneumonia Kapo- rence in AIDS both and extremely Pneumocystis pneumonia si’s sarcoma had been rare. type pneumonia previously only occurred in is a had severely immunosuppressed patients, undergoing such as those chemotherapy. Kaposi’s malignancy that cancer sarcoma is a skin elderly previously appeared exclusively had almost in men. Other lymphatic AIDS-related ailments included a form of cancer known non-Hodgkins lymphoma and as tuberculosis. patients' had
Not all suffered from the same diseases. Some others, sarcoma; pneumonia; Kaposi’s and still pneumocystis all, however, displayed the T- others suffered from both. Almost abnormality depressed lymphocyte ratio and counts. The cell clustering symptoms among drug and homosexual men IV abnormality in white blood cell counts led users and shared pointed single in to a the CDC to conclude 1982 that the evidence underlying a factor. disease with common explained presented expert Plaintiffs several witnesses who discovery products could evolution of the that blood and blood Francis, carry virologist the AIDS virus. Dr. Donald Force labora- epidemiologist, served as director of the AIDS Task tory early in and as assistant director of the CDC’s 1980s in that in 1982 the hepatitis-B effort the 1970s. He testified CDC in and in the pattern detected a the transmission of AIDS persons pattern at risk. The revealed identification of the infecting through early patients were others homosexual AIDS apparent period varying sexual contact. Also was an incubation years. postulated from several months to several CDC agent, June 1982 that the cause of the disease was an infectious such as a virus. Francis,
According AIDS, epidemiology to Dr. which users, primarily drug affected homosexuals and IV bore a remark- hepatitis Hepatitis able resemblance to that of B. B is a liver (from fetus) perinatally disease that is transmitted a mother to her byor either hepatitis sexual contact or blood. In an outbreak of B 1970s, major high-risk populations were homosexual men, users, drug hemophiliacs. TV Because it could be blood, hepatitis transmitted B transfusion-related had become public-health concern, particularly serious blood-banking to the industry. Simon,
Dr. expert blood-banking Ernest an and transfusion medicine, deputy as well as the director of the FDA’s blood division from 1976 to during also testified. He stated that “[sjeven 1980s, early percent to ten of individuals who were [subsequently] transfused ... dys- would show evidence liver probably transmissibility function related to hepatitis.” of viral Force, noting Members of the epidemiological AIDS Task similarity B, hepatitis between AIDS and feared that blood and *12 products carry blood could AIDS. 16,1982, July AIDS,
On after hemophiliacs developed three had published Francis, the CDC report. According landmark to Dr. report “brought speculation much of our about the disease to ... a transmissibility.” conclusion about its hemophili- The three acs, average unlike patient, AIDS were heterosexual men who Furthermore, drugs. did not they use IV did not fit within geographic observed New York-California distribution of AIDS patients. shared, however, They potential one risk: all three hemophilia treated their product with the blood known as Factor VIII, clotting a concentrated factor. The CDC focused on that factor. 16, 1982, MMWR, July report
In its in the the CDC concluded unknown, “[although the cause of is the occurrence [AIDS] among hemophiliac suggests possible three cases transmis- agent through products.” Study sion of an blood of the Factor manufacturing process VIII led CDC researchers to believe that a VIII, producing virus caused In AIDS. Factor fractionators would bacteria, larger agents, filter out infectious such as to reduce the filters, however, likelihood of trap contamination. The could not agents, explained smaller such as viruses. Dr. Francis that the agent realization that the infectious awas virus that could be flag greatly transmitted blood “was a red and concerned us potential about the for blood-borne transmission other thera- peutic products.” 27,1982, July meeting
On the PHS held a national of blood and blood-product collectors to discuss the At that threat AIDS. meeting, reported findings members of the CDC Task Force their blood-industry organizations, including the AABB. n Brandt, Jr., September Dr. Edward N. the assistant DHHS, secretary incorporating for health at issued a directive directive, July meeting. conclusions of the In that Dr. Brandt stated the recent occurrence of in three with [pneumocystis pneumonia] patients hemophi- underlying lia raises the whether seen in these question immunodeficiency etiology among groups has the same as other patients [pneumocystis pneumo- nia]. if There need to determine certain blood Factor particularly products, are risk factors for AIDS.
VIII, CDC, FDA, agencies, including Dr. Brandt instructed PHS (NIH), the National Institutes of Health to increase their efforts hemophiliacs to combat AIDS and to focus on the threat to the use of factor concentrate.
In November the CDC became concerned about doctors, nurses, special posed hospital risk that AIDS and other personnel exposed regularly Consequently, who were to blood. “hepatitis-B very the CDC alerted them that virus infections occur frequently among AIDS cases.” The CDC warned that “[a]t present, appears prudent hospital personnel it to use the same *13 caring patients caring for
precautions when for” AIDS as when patients hepatitis B. with
Throughout evidence continued to accumulate that that, agent reported as with blood-borne caused AIDS. The CDC men, spread hepatitis among gay virus the AIDS virus sexually by specialists was transmitted and blood. Vaccination CDC, FDA, “epidemiolo- from the and the NIH noted that the gy suggests of AIDS an unidentified and uncharacterized blood- underlying immunologic agent possible as a cause of the borne Moreover, doubling defect.” the total number AIDS cases was December, every By hemophiliacs six months. the number of diagnosed with AIDS likewise had doubled.
Thus, by pattern late for AIDS transmission was clear. suspected Dr. Francis testified that some but unconfirmed cases of transfusion-associated AIDS had surfaced October and Novem- 10, 1982, reported ber 1982. On December the CDC that an infant who at birth in March 1981 had received a number of developed symptoms. transfusions later AIDS-like The infant’s parents belong any group. did A not known risk donor of one developed of the units later AIDS. The CDC noted that “several .among features of the infant’s illness resemble those seen adults explained: with It AIDS.” etiology among unknown, AIDS remains but its occurrence reported drug sug- men, abusers, homosexual intravenous A persons hemophilia gests agent through it be caused an infectious transmitted or may sexually to blood or blood If the infant’s in this illness described exposure products. report following its occurrence of blood AIDS, from known AIDS receipt products infectious-agent case adds to the support hypothesis. etiologic agent If the transfusion contained an for AIDS, one must assume platelet agent
that the can be in the blood of a donor before onset of present symptomatic long. illness the incubation for such illness can be period relatively AIDS, long period Because of the incubation Force Task greatly feared that the undiscovered cases exceeded those reported. had been *14 later, reported
One week the CDC four cases of in AIDS infants age belonged high-risk under the of popula- two whose mothers tions, any but who had not received transfusions. an AIDS, suspected additional twelve cases of infant nine of the drug reported mothers were users. IV The CDC that the chil- dren could have infected “[transmission been the of an ‘AIDS child, agent’ shortly in mother either útero or after birth.” Francis, possibility, according “really That to Dr. in all of ftll[ed] here____ pieces puzzle epidemiolo- the of the of transmission The gy hepatitis of HIV now looked identical to B virus.” developed
Members of the CDC AIDS Task Force a model of explained: the cause and of Dr. Francis transmission AIDS. talking agent, [W]e’re about an viral that in of infectious, individuals, was the blood epidemiologic that had the same of blood-borne and ... sexual, pattern perinatal B transmission that virus that had, hepatitis destroyed specific lymphocyte, [white blood] in cell the immune specific system____ gay that ... The would be have this virus would be men and person likely drug intravenous users or their sexual contacts. c prospect at supply, Alarmed of AIDS the blood the CDC emergency workshop January called an in Atlanta for 1983. purpose meeting prevent was to ascertain how to through products. Repre- transmission of blood and blood AIDS AABB, Cross, government, sentatives of the American Red Banks, Community Hemophilia Council Blood the National Foundation, Force, Gay organizations the National Task and other meeting. attended the The AIDS Task Force was convinced that blood-transmissible, epidemiology AIDS was and that its mirrored B, hepatitis “involving high-risk groups the same proportions.” same presented disturbing
The Task Force also information about By supply. risk of the transmission of AIDS in the blood time, reported six CDC had cases of transfusion-associated study A gay AIDS. of 140 men with AIDS San Francisco donating previous revealed that at least ten had admitted blood in yet agent had not specific causative for AIDS years. Because identified, persons high risk asserted that the Task Force been not donate blood. for AIDS should three methods to screen out Force recommended The Task (1) questioning prospective donors to direct high-risk donors: (2) groups; they belonged high-risk detañed if determine to determine prospective histories of donors recording of medical (3) early symptoms; and institution any AIDS indications meth- testing Together, these three surrogate of coñected blood. high-risk donors from prevented blood from ods would have *15 surrogate testing supply. SpecificaHy, would entering the blood objec- by providing an complemented the other two methods have symptom-free high-risk donors who were tive test of blood activity drug or use. to admit to homosexual IV and reluctant recommendation, proposed the Task Force with that Consistent (core (1) core-antibody surrogate hepatitis-B test three tests: test), people had been or are infected which tested for who either (2) B; test, for the hepatitis the T-cell ratio which tested with immunological abnormality patients; specific common AIDS (3) test, absolute-lymphocyte tested for a and which reduced lymphocytes. level of Spira Dr. Thomas of the CDC Task Force conducted surrogate
study of various tests. He conclud- of the effectiveness identify majority people large ed that the core test would AIDS, contracting patients with the core or at risk of AIDS. Of men, eighty-eight percent gay that one-hundred test revealed users, drug eighty-seven percent of Haitians percent of IV and antibody. Seventy-nine positive hepatitis-B for the core tested group and bisexual not percent of the control of homosexual men significant high-risk group suffering from AIDS —the most —test- positive hepatitis B. This result was consistent with earlier ed high hepatitis-B among gay indicating levels of infection studies al., Schreeder, Hepatitis B in Homosexual Men: men. M.T. et Transmission, 146 and Factors Related to Prevalence Infection 1982). (July hepatitis B was Diseases 8 Because J. Infectious general population, uncommon in the the Task Force estimated healthy population percent remaining that five male would balance, positive. test On the Task Force concluded that the core promising. test was the most 4, 1983, January meeting,
At and other blood- banking representatives strenuously disagreed with the Dr. CDC. Bove, Joseph chairman of the AABB Committee Transfusion Disease, Transmitted stated that that he was unconvinced argued surrogate testing could transmit AIDS. He that was unnecessary questioning improper. that and direct was rejoined response
Dr. Francis that the AABB’s was “remark- ably recognized response “basically obstructive.” He as an deny attempt that there was a threat.” The AABB nonetheless persisted arguing surrogate testing questioning and direct rejection costly be too would of too much would lead meeting: blood. Dr. Francis described the [T]he reluctance and the inertia that we at CDC faced with the blood banks in meeting alarming got ... was so ridiculous and so that it to the of me point pounding shouting to on the table and these individuals as how literally many going it’s act. deaths take before will you saying, IAnd was do need do need do need when you ten, you twenty, you forty, get going to that then to act? level, we are you meeting This was a heated of this incredible counter balance of because very investigating seeing urgency those of us of the situation ... epidemic *16 banks, the for action onto the blood because they put responsibility presumably, urgency the ones that could that imbalance of this act, were there —the only negative disturbing a obstruction, us and the the from them was most response disturbing most in in time, one times health. my twenty years public Following meeting, The AABB criti- the lines hardened. questioning surrogate-blood testing. cized both direct-donor and 13,1983, AABB, joint January In a statement of the American Cross, Community Blood Banks Red and Council of described “insufficient,” “inconclusive,” the CDC data as the evidence possibility unproven.” that blood transmitted as “still AIDS Still, they urged, as the CDC Task Force had recommended that empha- their members take from donors detailed medical histories continued, sizing early symptoms. joint AIDS The statement however, not routine that the AABB and the others advise “[did] by laboratory screening program for implementation any AIDS time,” laboratory though at this even “there are blood banks nearly patients.” findings present that in all AIDS clinical are rejected organizations direct Finally, the AABB and the other preference as ineffective and as questioning of donors about sexual unjustifiable privacy.” escalating with an “invasion of Confronted virus and that surro- evidence that blood transmitted AIDS virus, presence the AABB gate testing would reveal the n increasingly intransigent. became Throughout to mount. On March the evidence continued 4, 1983, reported in that “the occurrence of the PHS MMWR finding among drug supports users” a that “blood AIDS IV among hemophilia products appear responsible or blood for AIDS for, recognized not recom- patients.” The PHS the need but did mend, surrogate testing. later, operating
A AABB a of standard month issued set only procedures required that the distribution of AIDS education- history screening. al and continued medical material to donors require surrogate testing question- or direct refused ing of donors. refusal, 4, 1983, testimony January Dr.
That like Bove’s at the meeting, CDC belied internal concerns within the AABB. In indicating December Dr. Bove wrote an internal memo growing “major problems that concern AIDS could cause collecting sector.” He that his “current best continued guess dealing agent is that we are with an infectious able to be spread products blood and blood and that individuals who large quantities receive of factor concentrate are at an increased January report, recently risk.” Dr. Bove noted that a probabili- discovered transfusion-related AIDS case “increases the ty may spread by recognized AIDS be blood.” He my “there is little doubt mind that additional transfusion patients hemophilia related eases and additional eases will *17 surface,” actively and that pursuing the CDC was more transfu- Consequently, sion-related cases. Dr. Bove advised that most can [before AABB] we do this situation is time ... will be buy obliged to our review current stance and move in the same direction as probably the commercial fractionators. that I mean it will be essential for us to By take high some active to screen out donor who are at risk of steps AIDS. populations Additionally, expressed Dr. Bove concern that “we do not want (or anything interpreted by that we do now to society by legal be authorities) agreeing concept yet as unproven —as —that by can spread AIDS be blood.” Dr. Bove stressed that the AABB correct,” medically must do may “whatever is but that “we have to more, do a little burying since we are accused of our heads Notwithstanding sand.” qualifications, recognized these Dr. Bove that blood carries the AIDS virus and that the AABB should actively high-risk screen donors. report 29, 1983,
In a dated March increasing Dr. Bove noted pressure government from the federal predicted and the CDC. He step probably the “next on the horizon will request be a mandatory screening institute a of donor blood.” Somewhat however, ambivalently, stated, Dr. Bove “that linking the evidence unconvincing.” AIDS to blood transfusion is For whatever rea- son, he and AABB accept could not the fact that blood can Yet, transmit the AIDS virus. in October in a memo Directors, AABB Board of Dr. Bove warned the board of forthcoming directors that a Dr. article James W. Curran and prestigious England others in the New Medicine Journal of eighteen documented cases transfusion-related AIDS. plasma industry, donors, paid which relies took a much plasma
more cautious developed view. Whenever a donor later AIDS, industry coagulation products would withdraw all made from that donor’s blood. FDA, approach,
Consistent with that in a March derivatives, plasma memorandum to licensed manufacturers of prohibited plasma suspected use of being “collected from donors transmitting being increased risk of used AIDS” produce already transmitting “derivatives known to have a risk of
290 treating diseases,” clotting used in as the factors
infectious such Thus, evidences the decision hemophilia. the memorandum donors, specifically sexu- government high-risk federal to exclude regulations already IV Existing excluded ally-aetive homosexuals. sum, recommendation reflected its drug In the FDA’s users. contamination of blood and blood growing concern about AIDS products. 1983, began to institute surro-
Beginning in some blood banks 1983, began testing January Dr. Thomas Asher gate testing. lymphocyte count at his commercial blood- all blood for total later, University fractionating facility. months the Stanford Seven the T-cell ratio test. Several Hospital blood bank instituted instituted the core test 1984. northern California blood banks any of these eases resulted from blood tested No AIDS meeting of the FDA’s Blood facilities. At a December 1983 Committee, Edgar Engleman, of Advisory Dr. director Products bank, rejected, reported that the bank had the Stanford blood results, high-risk two donors who should the basis of T-cell test materials, reading information have self-excluded after the AIDS anyway. but who elected to donate early reports published in 1984 addressed trans- Two influential 12, January article in fusion-associated AIDS. Dr. Curran’s 1984, article which England New Journal Medicine —the about Dr. the AABB board of directors October Bove had alerted through blood 1983—concluded that AIDS could be transmitted al., Curran, Acquired products. James W. et Immuno- blood (AIDS) deficiency Syndrome Transfusions, 310 Associated mth (Jan. 12, 1984); England 73-74 see New Journal Medicine (D.D.C.1987) Univ., Kozup Georgetown F.Supp. v. (describing definitive statement that AIDS was the article as the by agent). caused blood-borne Medicine, subsequent Internal anoth-
A article the Annals of journal, respected peer-review quantified the risks associated er hemophilia. The article with blood transfusion and treatment of stated: agent increasingly is caused an evidence indicates that the syndrome Present receiving through transfusions, be transmitted but risk to person may During 28 cases of transfusion-associated were syndrome small. very diagnosed Each more than 3 million ... in the United States. year, persons annual receive transfusions in the United States: thus for the crude rate 1 case 100,000 cases of the syndrome per recipients. reported approximates [James F. The Barker, W. Curran and Llewelyn Acquired Immunodeficiency Evolving Annals Associated with Syndrome Perspective, Transfusions: (Feb. 1984)]. Internal Medicine 298, 299 hemophiliacs far more severe:
The statistics for were diagnosed among [AIDS] The 12 cases of in 1983 with hemophilia persons *19 receiving of 1 an annual rate case per hemophiliacs antihemophilic represent high among the The rate result from may concentrates. relatively hemophiliacs is to several annually method of concentrate each hemophiliac exposed production: containing each from thousands of donors. lots, concentrate plasma pooled
[Ibid,] 13,1984, of the FDA’s Blood April telephone at a conference On Committee, following Advisory the FDA announced the Products position: organizations to use the anti-core The recent decision several blood and plasma recognition the of the limitations of test was a decision their with voluntary part excluding anti-core the lack of data to the that
the test and support premise have on the individuals from donor will any impact frequency positive pools later found to have AIDS. which donors are developed and At this it would seem reasonable to continue voluntary cooperative point, assessing of a of tests laboratory efforts aimed at the usefulness potential variety stage identifying in a value in individuals who are pre-clinical for their predictive screening it is that date, AIDS. On the basis of the information available possible generally to be more and tests other than anti-core may ultimately prove predictive improving and blood It would therefore be useful the blood safety products. screening testing tests. to the exclusion of other unwise to anti-core adopt Advisory Hepati- July In Products Committee’s the Blood Study Group (study group) reported Antibody Testing Btis Core study findings group consisted of eleven its on the core test. FDA, fractionators, major representing plasma members associations, majority blood-industry including the AABB. The AABB, rejected test. It study group, including the the core rejection of too would lead to the contended that the core test donors, many healthy sufficiently specific, and cost too was not Further, majority self-screening that was much. contended It minority adoption of the core test. working. A recommended self-screening working urged asserted that was not that sixty eighty percent high-risk core test would exclude donors. policy, minority aAs matter of concluded that concerns about safety outweighed diminishing sup- concerns about a blood ply or excessive costs. 24, 1984, Secretary April Margaret
On Heckler of the DHHS announced that researchers had isolated AIDS virus and had test, developed a blood test for that AIDS. She believed now test, known as the ELISA would be available within six months. fact, 4, 1985, approved the DHHS the ELISA test on March Snyder seven months after received his transfusion.
Ill Against background, we consider whether the Snyder duty analysis begins by recognizing owed of care. Our directly obtain, process, the AABB did not or transfuse the Thus, platelets Snyder infected that caused to contract AIDS. AABB had no immediate connection with either the donor or with Snyder. duty
The determination
ultimately
of the existence of a
Campo,
Crawn v.
question
policy.
136 N.J.
of fairness and
*20
501,
(1994);
Dunphy Gregor,
v.
99, 108,
A
136 N.J.
643
.2d 600
642
Gwinnell,
(1994);
Kelly
v.
538, 544,
A
96 N.J.
.2d 372
476 A.2d
Auth.,
Goldberg
(1984);
Housing
v.
578, 583,
38 N.J.
1219
186
(1962).
A.2d 291
An important, although
dispositive
not
consider
ation,
foreseeability
injury
is the
to others from the defendant’s
Lincoln-Mercury
conduct. Carter
Group,
v. EMAR
135 N.J.
(1994).
important
Blood and on the AABB for the safety supply. patient contemplating nation’s blood A surgery safety cannot assure the of blood drawn from others. Of others, necessity, patients rely AABB, including for that assurance.
Society has not responsibility thrust on the AABB its for the safety products. of blood sought and blood The AABB has and responsibility. years, cultivated that For it has dominated the establishment blood-banking industry. of standards for the To illustrate, January joint the AABB’s statement with the Red Community Cross and Council of Blood Centers endorsed the screening “prudent AABB-recommended measures appro- as and priate.” 31, 1983, release, In a press March Dr. Bove stated: acquiring
We would also like to assure the that the chance of AIDS public anyone remote____ through being a blood transfusion is taken to Every precaution assure that each unit of blood transfused is the safest possible. By conduct, banks, hospitals, words and the AABB invited blood patients rely and on the procedures. AABB’s recommended The AABB voluntary set the standards for blood banks. At all times, relevant it exerted practices considerable influence over the procedures banks, over its including member BCBC. On banks, behalf of itself and legisla- its member the AABB lobbies tures, participates proceedings, in administrative and works with governmental agencies setting health blood-banking policy. many respects, the AABB wrote the rules and set the standards voluntary blood banks. severity foreseeability
We next examine the of the risk that spread blood transfusions could severity the AIDS virus. The *21 mortality is a function of the risk of transfusion-related AIDS the mortality rate of rate. In the overall rate and the infection more who had forty percent, was but for those AIDS AIDS years, approached nearly 100 The per three the rate cent. than the increasing exponentially. example, For infection rate was by reported thirty-eight cases of transfusion-related AIDS CDC January reported six of that up from cases December people infected year. The that as more became CDC believed AIDS, supply the also increase. the risk to blood would Thus, could AIDS was the that blood transfusions transmit risk severe. Epidemiologists at the CDC
The risk also was foreseeable. that early as as 1982 the AIDS virus could be transmitted believed January by products. blood blood In Dr. Curran’s and that England Journal Medicine confirmed article the New transfusion, Thus, Snyder AABB received his the belief. before a foreseen that blood transfusion could transmit should have AIDS. argument the unpersuaded
We are AABB’s that because inconclusive, duty Snyder. it The evidence was owed no conclusiveness, give foreseeability, of harm suffices to rise not duty By 1983, ample supported a evidence of care. early conclusion that blood transmitted the AIDS virus. rapidly spreading, that AIDS fatal disease knew was healthy The apparently and that donors could infect others. products probably AABB also that blood and could knew transmit and that each infected blood donor could infect AIDS known, Thus, knew, many or should donees. the AABB have 1984 that of AIDS from blood transfusions was the risk infection devastating. agree with lower courts that the record We Snyder duty establishes that the AABB owed of care. public policy AABB claims considerations imposition duty extending negate fairness of a care Snyder. Specifically, the AABB contends it should not be taking “wrong involving of a found liable for side” debate AABB, public policy. According medical uncertainties *22 295 imposition liability constitutionally-protected of violates its right participate political argument process. in the The misses mark. doctrine,
The AABB the Noerr-Pennington relies on which generally considerations, of states that because First Amendment lobby government commercial interests that to influence do not violate antitrust v. Transp. Trucking laws. Motor Co. California Unlimited, 510-11, 611-12, 508, 609, 404 92 U.S. S.Ct. 30 L.Ed.2d (1972); 657, Pennington, 642 United Mine Workers v. 381 U.S. 669-70, 1593, 1585, (1965); 85 14 S.Ct. L.Ed.2d 626 Eastern R.R. Inc., 127, Presidents Noerr Freight, v. Motor 365 U.S. Conference 135-38, 529-30, (1961); 523, 81 5 see generally S.Ct. L.Ed.2d 464 4 Nowak, Ronald E. Rotunda E. on and John Treatise Constitution (1992). al Law: Substance Procedure 2d The 520.54 United Supreme beyond not States Court has extended the doctrine however, courts, applied field of antitrust. federal have Lower law, Noerr-Pennington including doctrine other areas of the See, liability. Indus., e.g., City tort South Dakota v. Kansas S. Inc., (8th Cir.1989) 40, 880 F.2d that (finding 50-51 defendant’s litigation protected Noerr-Pennington activities were under doc against contract); liability trine for tortious interference Home, Wells, Nursing Age Brownsville Golden F. Inc. v. 839 2d (3d Cir.1988) 155, (holding law, 160 that [the “as matter calling nursing individuals’] [the home’s] actions in violations to eliciting public attention of state and federal authorities and liability”); interest cannot serve as basis of tort Havoco of America, Hollobow, (7th Cir.1983) Ltd. v. 702 F.2d 648-51 (holding Noerr-Pennington that doctrine immunized defendant against liability right tortious interference based to com Commission); plain Exchange to Securities First Nat’l Bank (D.Minn. Bank, Marquette F.Supp. Omaha v. Nat’l 482 521 1979) (holding immunity Noerr-Pennington applicable applies claim); § also plaintiffs antitrust claim to 42 U.S.C.A Village 230-31, Supermarket Mayfair, N.J.Super. v. (Law Div.1993) (holding planning A.2d 1381 participation hearings against First protection board is afforded Amendment doctrine). But see Noerr-Pennington claims under
state tort Note, Zauzmer, Misapplication the Noerr The A. Robert Cases, Right Petition Pennington Doctrine in Non-Antitrust (1984) against application (arguing L.Rev. 1262-71 36 Stan. area). beyond antitrust Noerr-Pennington doctrine Noerr-Pennington doc- whether the need not determine We liability. AABB’s beyond to tort antitrust law trine extends *23 right petition government. The liability not rest on its does failing negligent for to recommend jury that the AABB was found testing, for the adopt surrogate and not its member banks on the FDA Blood lobbying participation efforts or its AABB’s brief, Noerr-Pennington doc- Advisory In the Board. Products apply. not trine does duty contra- alleges imposition that the of a AABB also
The fostering open on health issues. public policy of debate venes the duty chill imposition of such a would debate It warns that According to impair scientific discourse. public-health issues AABB, duty engender fear of imposition of a of care would the adoption in ill-conceived stan- liability that would result accept Finally, AABB contends that it did not the core dards. effect that such a test would test because of concerns about the availability and cost of blood. produce on the however, concerns, the AABB should not have diverted These safety paramount responsibility protect of the blood from its have led the supply. Recognition responsibility of that should carefully recipients from the AABB to consider more the risks against blood. balanced the devas- transfusion of infected When AIDS, duty imposition as of a tating risks from a disease such not, public opinion, in our offend the of care on the AABB does favoring scientific issues. policy open debate on controversial duty care is also to the determination of the AABB’s Relevant blood-banking governmental regulation in its role industry. than a trade association. In the AABB was more self-regulated governing body significantly of a indus- It was the AABB, try. example, told its member banks how to screen, obtain, compliance and distribute blood. To assure standards, its the AABB inspected accredited and its member example banks. The clearest of the AABB’s control in 1984 over its member banks emanates from the regulations 1984 DOH blood banks. regulations, required Under those DOH blood banks to meet both the FDA and AABB pertaining standards to medical physical histories and examinations of donors. N.J.AC. 8:8-5.2 1984). (May time, At that AABB standards were more stringent Furthermore, than those of accepted the FDA the DOH inspection reports in making inspections lieu of its own 8:8-1.4(b) renewing when (May blood-bank licenses. N.J AC. 1984). Thus, if a blood bank failed the annual AABB inspection on histories, taking of medical that bank could lose its license to sum, operate Jersey. in Jersey New least New advisory body. the AABB was not a mere It exercised control of banks, including its member BCBC. reflects, moreover,
As the record major the AABB player was a government both state and federal in setting policy in the 1980s. The AABB significant contends that because it had such a in setting public policy, role duty it should not owe a of care to a private party. disagree. We
Although overtones, the AABB’s mission doubtless has altruistic the bottom line is that represents the AABB its interests and those of its members. At stake for its members was a substantial regulation 1984, financial interest industry. of the In voluntary generated blood banks of approximately revenues one “ stated, billion dollars. As AABB director Gilbert ‘think Clark of tax-exempt not-for-profit. us as rather than We have to make a profit.’” Rock, Andrea Inside the Billion-Dollar Business of Blood, (March 153, 1986); Money Dorney, see also Linda M. Comment, Culpable Impunity: Conduct Industry The Blood Responsibility and the FDA’s Spread Through AIDS Products, (1994) 129, (reporting Blood 3 J. Pharm. L. 132 n. 34 program generated that American Red average profit Cross blood 1980-87). per year million big Blood is $38 business. agencies, AABB was not created governmental Unlike mandate. Nor pursuant government act to a It does not statute. govern- public or another branch of it accountable either to the exercised, AABB power much ment. No matter how governmental agency. Conse- inescapable fact is that it is not a protection quently, not defer to the AABB’s decisions we need resources, industry allocation of as we supply of the blood might agency defer to determinations. otherwise
Likewise,
reject
dissenting
col
we
the contention
our
317,
1060,
enjoyed
league, post at
676 A.2d at
only
act in
immunity, remaining liable
for the failure to
qualified
private
good
to the determination whether
faith. Relevant
immunity
quasi-govemmen
qualified
as a
association is entitled
relationship
entity
activities and its
tal
are both the association’s
recognized a
government.
case in which a court has
each
entity’s
immunity,
entity
performed quasi
private
claim of
had
pursuant
governmental grant
to a
of au
govemmental
functions
Dealers,
Sec.,
thority.
v. National Ass’n
Sec.
Austin Mun.
Inc.
(5th
Inc.,
Cir.1985),
involved the National Association
757 A.2d
(NASD),
self-regulatory
organization
of Securities Dealers
authority
Maloney
of the
Over-the-Counter
formed under
78o-3,
§
Market Act of
15 U.S.C.A
which amended the
§§
Exchange Act of
15 U.S.C.A
78a-7811. Con
Securities
...
gress empowered organizations like the NASD “to enforce
industry
legal
‘compliance by
with both the
members
Exchange
requirements
laid down in the
Act and the ethical
”
Sec.,
beyond
requirements.’
Mun.
going
standards
those
Austin
Pierce,
(quoting
Lynch,
Fenner &
supra,
299 physicians’ contract with DHHS review activities under Medi peer-review group congressional care. Because the a acted under ly-authorized quasi-prosecutorial contract to conduct a of review activities, physicians’ immunity court accorded it absolute Id. at 408-09; see also Citrano v. Allen Correctional tort claims. Ctr., (W.D.La.1995) F.Supp. 312, (granting qualified 891 317 im munity employees private corporation operating prison of under state). Corp. But see Manis v. Corrections contract with America, 302, (M.D.Tenn.1994) F.Supp. (finding 859 304-05 private corporation operating prison qualified was not entitled to 1983). U.S.C.A immunity Similarly, § from suit 42 under Ctr., County Counseling Sherman v. Four hospital in mental (7th 397, 405-06 Cir.1993), operating F.2d which was a court under basis, patient emergency fulfilling order to admit on an was public analogous hospital. Consequent function to that of a state ly, hospital qualified immunity the court extended to the from tort Id. at 406. liability. City City, Berends v. Atlantic on
The dissent
relies
66,
N.J.Super.
(App.Div.1993),
support
The facts of the Berends
August
which center on an
1986, airplane
City municipal airport,
crash at the Atlantic
differ
17, 1986,
significantly
present
May
from those
case. On
City
runways
airport
Atlantic
had closed one of two
at the
because
Berends,
supra,
N.J.Super.
safety
concerns.
at
city,
Manage
A.2d 972. Pursuant
to a contract
Pan Am
with the
(Pan Am)
Systems,
began
operate
airport
Inc.
ment
1986. Id.
at
June
the
71,
runway.
A.2d 972.
first
Id. at
defendants,
affirming summary judgment
Appel
for all
the
In
if “Pan Am had
hypothesized in dicta that even
late Division
authority
reopen
runway
should not be faulted
[it]
unilateral
the
city’s
keep
runway
the
closed
deferring to the
decision to
city’s
experience
operating
in
air
[the
based on the
extensive
Thus,
Appellate Division
port].” Id. at
Pan Am’s claim of
relates back to the
City,
experience” in
contract with Atlantic
which had “extensive
Am,
operating
airport.'
Pan
the AABB did not act
the
Unlike
pursuant
any governmental agency. Signifi
to a contract with
moreover,
cantly,
of Pan Am and
AABB in
the relative roles
respective
operated
airport
their
industries differed. Pan Am
regulation.
under strict federal and state
Id. at
The dissent cites several
private parties
good-faith performance of
immunity to
for their
Many
at 1060.
quasi-governmental
Post at
676 A.2d
tasks.”
immunity for
of the cases on which the dissent
relies involve
*27
Admittedly,
setting
the AABB’s activities
recommending practices,
conducting inspections
seem like
Furthermore,
governmental agency.
both the federal
those of a
Jersey
performance
on the AABB’s
government and New
relied
example,
regulations
FDA
allowed
those activities. For
they
rely
long as
were
on AABB standards as
blood banks
as,
with,
stringent
regulations.
as
FDA
consistent
and at least
606.100(d) (1984).
indicated, moreover,
previously
§
As
C.F.R.
1040, 1049,
278, 294,
incorporated
A.2d at
the DOH
supra at
histories and
regulations AABB standards
for medical
into its
FDA nor the DOH
Neither the
physical examinations of donors.
blood-banking
regulation of the
with the AABB for the
contracted
delegate
governmental agency
to the
industry. Nor did either
Thus,
industry.
the AABB
authority
regulate that
AABB the
authority.
governmental
acted without
benefit
urges
The dissent
AABB
we accord the
the benefit of
qualified immunity
imposing
public
without
on it the burdens of
majority
It
ways:
office.
contends that
seeks to
it both
“[t]he
have
duty
finding
liability
governmental
care and
because of the
AABB,
authority delegated
denying immunity
to the
but then
perceived
governmental
because of a
authority.”
lack of
Post at
316-819,
contrary
Although may decision,” the AABB “policy-bound have made a 318, post 1061, process at 676 A.2d at that to led that decision significantly governmental differed from that agencies. of Unlike agencies, the decisions of such the AABB’s decisions were not subject public scrutiny. 551-59, to §§ See 5 U.S.C.A 701-06 (federal Act, Administrative generally providing Procedure for public participation in rulemaking, public administrative access to records, agency judicial decisions); agency and review of federal (the N.J.S.A. -21 Jersey Open Act, 10:4-6 to New Meetings Public requiring advance opportunity public notice of and for the to bodies); (the meetings public attend N.J.S.A 52:14B-1 to -15 Jersey Act, New Administrative establishing public Procedure participation procedures requirements and rulemaking and cases). contested meetings The internal AABB yielded
303 surrogate testing open were not to the not to recommend decision meetings publicly of those available. public. Nor were minutes beyond safety and meetings extended blood Discussions at those appearance to maintain the supply to concerns about the need public unity among major organizations, growing blood supply, public image, and the AABB’s fear AIDS liability potential its in tort. attempt compare to the AABB to entities entitled
The dissent’s
qualified immunity
another
reason. Those other
fails for
safeguards
subject
procedural
or
entities are
to the strictures of
example,
discharge their
governmental oversight. For
arbitrators
review. Co
judicial
subject
procedures
and
duties
established
rey, supra, 691 F. 2d at 1210.
Similarly,
company that con
subject
prison
run
was
tracted with the
of Louisiana to
State
monitoring
statutory requirements
as state
contractual and
as well
Citrano, supra,
315;
F.Supp. at
La.Rev.Stat.
inspection.
891
subject
Ann.
§
functions
to the
39:1800.4. The NASD likewise
Exchange
and with
supervision of the Securities and
Commission
by Congress. Austin
self-regulation
system
in the
established
Sec.,
supra,
Finally, court-appointed
Mun.
757 F.2d
680.
bankruptcy
corporate
perform their statuto
trustees and
directors
v.
Weissman
subject
scrutiny.
rily-defined tasks
to the court’s
(S.D.N.Y.1985)
Hassett,
B.R.
(reviewing bankrupt
47
466-67
1106);
Superior
Latt v.
U.S.C.A
§
11
cy trustee’s duties under
Ct.,
Cal.Rptr.
(discussing role of court-
(Ct.App.1985)
308),
Corp.
Code
§
Cal.
acting pursuant
appointed director
(1985),
review
granted,
Cal.Rptr.
review
argued qualified immunity liability that it if it is entitled good argument faith. That for acted surfaced the first time Society the brief of amicus curiae American of Association Execu- A tives. remand for retrial under a standard that the AABB urged injustice plaintiff never would be an to a with tenuous a so hold on life. reject
Similarly, argument Society we of the American of Association Executives that the AABB is immune from tort liability Jersey “public under the New Tort Act as a Claims entity.” public N.J.SA 59:1-1 to 12-3. The Act declares that “a entity injury, injury for not liable an whether such aries out of public entity____” an act or omission of the N.J.SA 59:2-1. entity” State, any county, “Public is defined to “include[ ] the district, municipality, public authority, public agency, any political public body other subdivision or in the State.” N.J.SA plain language “public entity” 59:1-3. The of the definition of excludes the AABB.
Furthermore,
Legislature
did not create or authorize the
perform specific governmental
AABB to
purpose. Nor did the
AABB act under contract
public
with or at the direction of a
entity.
Rodriguez
Auth.,
Jersey Sports
Exposition
See
v. New
&
39, 45-46,
N.J.Super.
193
(App.Div.1983)
305 industry does not the AABB into ry authority over that transform immunity under public entity to the Tort Claims Act. a entitled to AABB standards and regulations in the DOH the Reference moreover, sovereignty to the inspections, does not extend state sum, correctly lower ruled AABB. In we conclude that the courts liability Tort the is not from under the Claims that AABB immune persons Act, duty ordinary that AABB a of care the owes members, products the receiving or blood from its that duty in this case. AABB breached that
IV N.J.S.A. 2A:53A-7 Turning immunity, issue of charitable to the provides: organized ... charitable, No for ... education- exclusively nonprofit corporation damages shall ... who any person al be liable or'hospital respond purposes agents]; damage negligence [the of or its shall from corporation suffer such not extend to however, that shall immunity liability any person provided, agents] damage negligence [or its shall from the such
who suffer corporation is one in and unrelated to and outside of the where such unconcerned person of such corporation____ benefactions statute, immunity non-profit corpora To under the obtain organized exclusively it for charitable must tion establish was Morristown, N.J.Super. purposes. Heffelfinger v. Town of 209 (Law Div.1985). 380, 383, determining whether A.2d 761 507 ... organization purpose, inquiry should an has a charitable “[t]he Stephen’s itself.” Parker v. St. entity focus on essence 317, 327, Corp., N.J.Super. 360 Dev. (App.Div. 579 A.2d Urban 1990). many socially performs useful and beneficial
The AABB
functions,
solely
religious,
organized
it is not
and devoted
but
educational,
charitable,
Consequently,
hospital purposes.
or
apply. Kirby v.
Columbian
charitable-immunity
does not
statute
Inst.,
(Co.1968).
205, 209-10,
N.J.Super.
Y matter, In resolving amicus briefs by this have we been assisted associations, professional including submitted several the Banks, American Society Association of Tissue the American Executives, College Association and the Pathologists. of American enlightened deliberations, Those briefs have our and we are grateful expressed for them. The associations have that concern imposition liability the on the AABB will inhibit them research, conducting issues, debating developing guidelines, and public communicating with Although appreciate officials. we that concern, produce opinion Fairly read, our need not that effect. opinion liability not our does visit on the AABB was on because it wrong the a side of scientific debate or it because communicated governmental its concerns to officials. recognize, moreover, development
We that of tests for infectious path diseases often follows an fraught indistinct debate, error, uncertainty, trial and and even failure. At some point however, process, participants recognize should that they enough have information act responsibly and that failure to irresponsible. act would be Professional associations public concerned with matters of organiza- health not are fraternal solely tions that exist for Playing the benefit of their members. health, protection vital role in the these associations inesca- are pably public imbued with interest. The associations’ commit- public ment to health liability should not immunize them from negligent discharge obligations. of their Nor should the enjoy immunity associations they stubbornly reject when persua- evidence, debate, unreasonably prolong sive and fail inform public their constituents threats to the health. charge against that the AABB led the direct
The record reveals surrogate testing. Viewed most favor- questioning of donors and AABB, that it was ably suggests to the the evidence concerned testing limited questioning such be of effectiveness that would products. A supply of and blood less and could diminish the blood surrogate testing that the AABB suggests favorable view resisted it not want to suffer the added inconvenience because did governmental and testing. assessing of such role of costs screening, involved the Com- private decisionmakers with donor require it was blood banks to mittee concluded “that reasonable [screening implement screening procedures male donors two these history activity screening males and for a of sexual with other January antibody] the anti-HBc 1983.” IOM donated blood for supra, Report, 6. record, jury could concluded the AABB
On have recognizing blood transmits HIV. unreasonably resisted an the AABB sacrifice uncontaminated That resistance led contaminated, readily that was but more supply of for one *32 if the AABB had not jury could have found that available. The BCBC, members, the would intransigent, particularly so its been Further, testing. jury have surrogate the could have instituted surrogate testing, if it would that had instituted found the BCBC unit have rejected Rejecting 29F0784. that could have Unit Sny- to of blood William prevented transfusion contaminated the Against this his and his life. It could have saved health der. liability on the background, imposition that of we believe reasonable. AABB is both fair and judgment Appellate affirmed. of the Division is
GARIBALDI, J., dissenting. duty of a is the recognizes, imposition “[t]he As this Court complex considers the relation- analysis of that conclusion a rather is, its parties, of foreseeabil- ship of the the nature the risk —that imposition duty of a would ity severity impact and —and 494, 503, Campo, 136 N.J. 643 public policy.” Crawn v. have on 308 (1994) 99, 108, (quoting Dunphy Gregor,
A.2d 600 v. N.J. (1994)). agree I majority relationship A.2d 372 with the that the parties finding of the and the severe nature of the risk mandate a (AABB) the American of Blood Association Banks owes a However, duty recipients. public policy, to of dictates specifically quasi-governmental in regulating nature of AABB duty blood banks lead me to conclude that AABB a had act good protected liability negligence. faith for mere I say fully “[a]nytime this aware that a court raises standard of duty legal safety care that defines the that is for the owed of others, implicitly part conduct,” Crawn, it a of immunizes supra, 136 N.J. at .2d 643 A but nevertheless conclude public policy requires qualified immunity grant a to AABB.
I grant immunity working The decision to promulgate those governmental “myriad rules is on a balancing based weighty argument. [factors] both sides Resolution of the issue a balancing involves in having citizen’s interest remedy wrong society’s for a suffered and in attracting interest office____” qualified persons public Centennial Land & Dev. Township Medford, Co. v. N.J.Super. 397 A.2d (Law Div.1979). Jersey government New and the federal both have resolved policy questions, by statute, those governmental difficult when agency official or is sued for such actions as those this case. Snyder might States, Mr. have sued the United the State of New Jersey, responsible or negligently the individual officers decid- ing implement surrogate testing, not to as the facts indicate that governmental no agency, including the United States Food and *33 (FDA) Drug Jersey Department Administration and New of (DOH), Health both of responsibility whom bore for regulating banks, surrogate testing. However, blood ever recommended any allegation absent wrongdoing, of constitutional such a case
309 of a defense of absolute would have been dismissed because immunity. against prohibits Act state tort suits
The Federal Tort Claims perfor “the exercise or government and its officials based on discretionary perform to exercise mance or the failure or 2680(a); § also 28 see 28 U.S.C.A. function.” U.S.C.A. against against to be suits 2679(d)(2)(deeming § all suits officials subject to the and all defenses available the United States explained, rule Supreme Court has this government). As the ” “judicial ‘secondguessing’ governmental of decisions prevents social, political policy.” in and United States “grounded economic Airlines), Empresa (Varig Aerea v. de Viacao Rio Grandense S.A. (1984). 797, 814, L.Ed.3d 674 104 S.Ct. 81 467 U.S. judges juries Immunity granted of a that and is because concern determine, policy hindsight, that a difficult with the benefit will wrong negligently made. that turned out be was decision decisions, policy courts protect governmental federal To such alleging responses negligent federal have dismissed lawsuits example, problems as For in C.R.S. medical such AIDS. new (8th States, Cir.1993), a former v. F.3d 791 D.B.S. United military during a transfusion at a contracted soldier AIDS sued, alleging The hospital 1983. soldier December military adopting standards negligent was the AABB/FDA 4, 1983, meeting. January Id. in March 1983 after issued screening of what determined that “the issue 794-95. court precisely type policy-bound decision procedures adopt through judicial scrutiny Congress to insulate from intended summary exception,” granted thus discretionary function 797; v. see also Lockett judgment government. Id. at (6th Cir.1991) States, (affirming dismissal F. 2d 630 United negli response contamination as challenging EPA to PCB claim (D.Nev. States, F.Supp. Prescott v. gent); United 1994) Energy Com alleging negligence by Atomic (dismissing suit exposure because setting radiation mission level authorized clearly ... analysis product of “were the extensive the levels *34 social, weighing balancing the of of involved and a number eco- political nomic and considerations based on then available scienti- data”). fic and medical Jersey adopted immunity.
New
has
similar
rule of absolute
public
liability
injury
N.J.S.A 59:2-3 relieves
entities from
for “an
resulting
judgment
from the exercise of
or
vested in
discretion
the
entity.”
provides
N.J.S.A
similar immunity
govern
59:3-2
to the
employee responsible
mental
for such
The
decisions.
statutes
provide
immunity
discretionary
“broad
acts which has also
adopted
[by]
government.”
been
...
59:2-3,
the federal
N.J.S.A
interpreted
This
protect
comment.
Court has
statute
“the
judgment
policy____
exercise of
or
in making
discretion
basic
upon proof that
actually
discretion
was
exercised
that level
who,
an
approaches, weighed
official
faced with alternative
policy
competing
considerations
made a conscious choice.”
49,
(1980).
Josey,
Costa v.
83 N.J.
The nub of the issue lies implicit Let them doctrine. immunity if left by any officials wholly unprotected public *35 of the enormous costs will have to shoulder an incorrect decision and they make gains, which there will be enormous decisions be correct and Let their liability. large. should a therefore, at them, Why, not but the by public will be captured gain?____ the One to restore way all the risks for none of the official take public officials enormous sums to compensate balance would be to public pay [proper] risks____ great the needed The other to restore way the them for liability is to release the public and official burdens between official rewards symmetry brought into In this the is or in way system official from whole liability, part. gain bearing capturing the full or since the official balance, question escapes government wrongs. for at cost of individual redress full albeit loss, Ed.1990) (5th ] and Materials on Torts 878-79 Cases [Richard A. Epstein, encourages efficient immunity restores the balance grant A of appropriate government decisions. concerns, including a additional identified several Courts have public-spirited individuals deter lawsuits would fear See, Regents v. Board e.g., Lister entering public service. of of (1976). 610, System, 72 240 N.W.2d Wis.2d Univ. of Wis. this important in cases such as particularly policy That concern is important and one, required to determine government is when “courts, utilizing standard policy, and questions public of difficult Costa, them.” to interfere with principles, ill-equipped are tort 415 A.2d337. supra, 88 N.J. at
II would be Jersey and the United States of New While the State course, case, AABB, is absolutely from suit in this immune organization that has private agency but a governmental not a However, while responsibilities. governmental certain assumed other immunity to the AABB or provide statutes do not specific volunteers, are reflective “statutory immunities private of related guide to the evolution may serve as a public policy and Crawn, at supra, 136 N.J. law immunities.” common that motivated Many policy concerns of the same A.2d 600. grant immunity public apply officials question to the immunity for the AABB. organization
The AABB
an
members,
with thousands of
including nearly
community
all of the
country
banks
this
and several thousand doctors.
It describes
seeking
itself as
“to
develop and recommend
practice
standards on the
of blood bank
ing,
help promote
health,
public
... and to conduct numer
programs
ous
for communication and
among organiza
education
public
tion
Ante at-large.”
members and the
All of the who serve on the AABB’s numerous commit- *36 perform tees and those uncompensated tasks are volunteers from top institutions, academic and research high-paid and not execu- only tives concerned with the bottom example, line. For Dr. Bove is a faculty member of the University at Yale and also serves as the Associate Director of Clinical Laboratories at Yale-New Ha- Hospital. Oberman, ven Dr. Harold another of defendant’s wit- nesses, has publications edited the AABB’s on blood bank stan- professor dards and is a pathology laboratory and director at University Michigan. Bell, Dr. Carol who served on several AABB committees appeared witness, and also as a is a clinical professor pathology University at of Southern California and at University Irvine, of California at as well as Director of Laborato- ries at Brotman Medical in Center California.
A blood
in
Jersey
bank
New
operate
cannot
without licenses
from both the FDA
and the DOH. Ante 276,
player in
government
both state and
setting
policy
federal
297,
in the 1980s.” Ante at
Ill private organization performs When a quasi-govemmental task that perform, the state would public policy otherwise have to requires grant immunity. Otherwise, of private organization “might all, well perform refuse” to thereby the task at “in ereasfing] the load on the strained resources” of the state. Sher Ctr., (7th County 397, man v. Four Counseling 987 F. 2d 406 Cir.1993). County, See also Warner v. Grand 57 F. 3d 967 (10th Cir.1995)(“If [private parties] permitted are not to raise the qualified immunity, they shield of might reject requests to aid functions.”). state in performing government officials As it does officials, public immunity alleviates expense the fear and litigation, the personal energy diversion of pressing from public issues, and the qualified private deterrence of parties serving public Sherman, supra, 406; interest. See Corey 987 F.2d at Exch., (6th v. New York Cir.1982); Stock 691 F.2d 1211 cf. Fitzgerald, 800, 814, Harlow v. 2727, 2736, 457 U.S. 102 S.Ct. (1982). L.Ed.2d Granting immunity non-profit associa governmental tions who have assumed some duties will ensure that, prospect litigation undaunted expense potential awards, damage they will perform continue to public the essential they service that well-positioned alone are good- undertake: faith development industry protect public standards to safety. health and
Many recognized courts have policy those concerns do apply private parties acting governmental in a capacity and have therefore immunity extended to them. City Berends v. City, N.J.Super. Atlantic (App.Div.1993), A.2d 972 an airplane attempting crashed while City to land at an Atlantic airport operated by that was Management Pan Am Systems, Inc.
315 (Pan Am). theory city’s Plaintiffs was that the decision to close runways dangerous had led to a condition down one of the two against court dismissed the claim the that caused the crash. The 59:2-3a,” city city enjoyed immunity because “the under N.J.S.A. 81, high-level policy judgment. at since the decision was a Id. against Pan Am: A.2d 972. The court also dismissed the claim engaged significant which, Pan Am in and made a contribution to the as we process from It Pan Am held, have shields the would be anomalous to city liability. punish postponing reopening the 4-22 when the resulted from runway postponement thoughtful multiagency its in a evaluation process participation professional the is which founded. upon city’s immunity [Id. 83, 972.] at 621 A.2d Similarly, punish AABB for its it would be anomalous to participation in a actions since its decisions resulted its immunity process government’s on which founded. ways, majority attempts distinguish Berends in
The
several
First,
majority
persuasive.
but none are
asserts that “Pan
immunity
governmental
Am’s claim of
relates back to the contract
Am,
City____
Pan
not act
with Atlantic
Unlike
did
any governmental agency.” Ante at
pursuant to a contract with
However,
298,
explicitly
panel
under strict federal and state
whereas
banking industry
governed
government
“more lenient”
was
course,
regulations. Ante at
In 987 F. 2d at the court conferred immunity private hospital that for on a was sued its actions treating patient. treating patient, hospital a was “fulfilling public duty” patient a a care for who would otherwise by public hospital. have been treated Id. at 406. Had the services, public hospital performed protect it the same “would be immunity,” by qualified and the court therefore reasoned that ed similarly protected encourage private hospital should be government. Similarly, private assistance to the Id. at 405. since Jersey immunity FDA New and the would be entitled to for surrogate testing, also decision not to conduct should given immunity making a decision that would otherwise be have been made DOH and FDA. immunity parties good- granted private have for their
Courts quasi-govemmental range in a performance faith tasks wide
317
contexts,
recognition
applicability
public
of the same
See,
Warner,
governmental
immunity.
e.g.,
policies requiring
immunity
§
supra,
(conferring
Craviolini
(1960)
arbitrators);
immunity
private
(recognizing tort
for
P.2d 611
Ct.,
(Ct.App.1985)(conferring
Superior
Cal.Rptr.
v.
212
380
Latt
immunity
corporate
court-appointed
“[i]t
tort
on
director because
patently
delegate
a court’s
... with civil
unfair to burden
liability
judicial
performed
judge exercising
for
acts
which
liable.”),
civilly
granted,
review
the same functions could not be
vacated,
851,
(1985),
Cal.Rptr.
223
215
This case
another context in which the
should
Court
grant
immunity
private
performing governmental
to a
actor
majority
distinguish
by noting
duties. The
seeks
those eases
recognized
private
“[i]n each case which a court has
entity’s
immunity,
entity
performed
claim
quasi-govem
had
pursuant
governmental grant
authority,”
mental functions
to a
ante at
676 A.2d at
while “the AABB acted without the
governmental authority.”
benefits of
Ante at
However,
unpersuasive
wrong
that claim is
for two reasons.
*41
First,
AABB
authorizing
acted under the benefit of
DOH
regulations promulgated
operate
in 1984 and
to
continues
under
regulations. Supra
current
at
DOH
Indeed, grant power many legislative was no there immunity. recognized quasi-goveramental cases where courts have Craviolini, Thus, supra, recognized quasi-judicial the court immunity, by public policy,” for who arbi- “bestowed architects contracts, private construction even disputes pursuant trate grant power government. no from the though there was public Similarly, the Ninth Circuit has held that P.2d at 613. judicial immunity, granted “prevent fear of policy in favor of decisions,” private influencing should extend to their suit *42 320
persons acting
quasi-judicial capacity pursuant
in a
“private
117,
agreement.” Lundgren, supra,
IV
ordinarily granted
immunity
Courts have
private
same
groups conducting quasi-governmental activity as that accorded to
government employees performing similar functions. For exam
Berends,
ple, in
supra,
given
Pan Am was
the same level of
immunity granted
City.
justified
to Atlantic
That result has been
public policy
grant
because the
immunity
behind the
of
is so
public
private
result,
similar in both the
context. As a
those
might
grant
immunity
cases
dictate a
of
“upon
absolute
to AABB
proof
actually
that discretion was
at
exercised”
the level of basic
policy,
“weighed
and that AABB
competing policy
consider
Costa,
in reaching
59,
ations”
its decision.
supra, 83
at
N.J.
415
However,
A.2d 337.
I conclude that
public policy
there are
requiring
interests
that AABB
only qualified
should receive
immu
nity
performance
functions,
for its
discretionary
of
protecting it
liability “providing
good
what
[it] do[es]
done
faith.”
Foundations,
Son, Inc.,
Bedrock
Inc. v. Geo. H. Brewster &
31
124, 142,
(1959)
Marsh,
N.J.
155 A.2d
(quoting
v.
Johnson
4,
(Sup.Ct.1912)).
N.J.L.
85 A 761
City
See also Bombace v.
Newark,
361,
(1991)
125 N.J
(defining good-
Qualified immunity is “the best attainable accommodation of
values,” Harlow,
competing
supra,
U.S.
As a
AABB to make
negligent decisions because it would bear none of the costs and
enjoy
Liability
negli-
some of the benefits of its decisions.
for
(the
standard),
any immunity
might
gence, without
Court’s
also
deter effective decisions—because most of the benefits of an
enjoyed by
public,
might
AABB decision are
AABB
hesitate
taking
appropriate
if
some
actions
its own benefit would not
cost,
great
if
be as
as the overall
even the overall benefit exceeds
878-79;
Epstein, supra,
Lundgren, supra,
that cost.
at
Cf.
(granting qualified immunity
F.2d at 118
to architect who arbitrat-
contractor,
rejected
disputes
ed
between an owner and
court
architect,
immunity
judges
accorded to
because
unlike
absolute
outcome). Qualified
judges, had some self-interest in the
immuni-
decisions,
ty
proper
allows AABB to make
relieved of some
liability,
imposes
against
but
a sufficient check
decisions
are
clearly wrong
by profit.
and motivated
majority
by
professes
concern for the difficulties faced
similarly-situated groups, recognizing
AABB
that the
and other
development
path fraught
of tests “often follows an indistinct
debate,
error,
uncertainty,
trial and
and even failure” and claims
just penalizing
taking wrong
AABB
that the Court is not
However, by defining a
position. Ante at
V Admittedly, by government the decision reached and the agencies appears negligent perspective health with the of 20/20 hindsight. know now that the AIDS virus is transmitted We unfortunately people, Snyder, and that like Mr. infect- were *44 through ed transfusions. In concerns about a diminished hysteria supply public pale and in the face of a blood blood However, recipient tragically infected with the AIDS virus. participants vigorous public in debate 1983-84 about the utility testing a clear of core did not have such view the future. expressed Opponents of the core test several concerns about core (1) testing: test a would exclude half-million blood donors who have-HIV, causing shortages panic did not as hundreds activity people engaged high-risk of thousands of who had in no (2) HIV; they fear that had contracted would the test would groups, many out members of'certain Asian ethnic screen because exposed hepatitis, though had been to even almost none were (3) HIV-positive; high-risk groups members of would come and they give impression blood under the that could then find out HIV; they perfect, whether had because the core test was not this supply. would result increased contamination of the blood (When introduced, government up the ELISA test was set testing specifically problem). alternative sites to avoid that important emphasize every governmental agency It agreed refusing surrogate testing. with AABB in Dr. use Conant, testing plaintiffs experts, surrogate one of testified that required by any agency, by any or or other was not state federal level, country in world. At the federal the FDA never testing Blood Products recommended core March its —in Advisory testing inap- Committee recommended that “such was propriate.” though Even Dr. Francis’s Task Force inside the (CDC) urged surrogate Center for Disease Control the use of Indeed, testing, itself never made such a recommendation. CDC Brandt, Health, Secretary for Dr. the U.S. Assistant Edward 15,1983, stated in a letter dated June (anti-core) antigen B [T]he had, test for core as you pointed antibody hepatitis carriers____ been as a screen for AIDS believe there is out, proposed possible general now a consensus in this area that anti-core is as by experts unsatisfactory screening a test AIDS carriers. for added) (emphasis ] [ Louria, professor University of Medicine and Dr. Donald Jersey, Dentistry explained government agencies of New that no because, required surrogate use of tests no article journal yet appeared arguing in peer-review had favor of core fact, testing. published In the few had found that the core studies public policy. test would not be effective and would be unsound (Dr. approved publication peer- in a Spira’s data had not been journal, many skeptical conclu- review scientists were of his sions).
Policy experts
required
public
risks to the
were
balance those
1983-84,
testing.
policy-
advantages
with the
all of the
against
testing
they
making agencies decided
core
because
deter
mined,
policy,
potential
as a matter of
that the
benefits to the
public.
public
testing
outweigh
from core
did not
the costs to the
just
“type
policy-bound
decision” that the federal
That is
*45
judicial scrutiny
governments “intended to insulate from
and state
discretionary
through
exception.”
function
D.B.S. v.
C.R.S.
States, supra,
VI
agree
majority that AABB is not entitled to charita-
I
with the
duty to
immunity.
agree
I also
that AABB does have a
ble
dissent, however,
recipients
products.
respectfully
I
of blood
ordinary
appropriate
majority’s finding
negligence
is the
of care to measure AABB’s conduct. Because of AABB’s
standard
banks,
regulating
quasi-governmental nature in
qualified immunity.
should be entitled to
adopt
AABB’s decision to
educational efforts and indirect donor
screening
surrogate testing
judg
instead of
was “the exercise of
Costa,
making
policy.”
supra,
ment or discretion in
basic
83 N.J.
that,
If AABB
HANDLER, POLLOCK, O’HERN, STEIN COLEMAN —6. For reversal & remandment —Justice GARIBALDI —1.
CORRECTED ORDER BISSELL, JR., SOMERVILLE, L. NICHOLAS who was 1971, having admitted to the bar of this State been convicted on with, all charged counts of a federal indictment that him inter alia, fraud, mail in violation of 18 U.S.C.A. financial aid