Marvin: You might be interested in this information from a 2000 brief.
2000 WL 34237919 (Pa.Super.) (Appellate Brief)
Superior Court of Pennsylvania.
In Re: Maria Isabel DURAN an Incapacitated Person.
Appeal of: Larry M Johnson, the Health Care Agent Appointed by Maria Isabel Duran in Her Durable Power of Attorney for Health Care.
No. 00805WDA00.
October 17, 2000.
Appeal from the Order of the Court of Common Pleas of Allegheny County, Orphans’ Court Division, No. 5169 of 1999 1-31-00
Brief for Amicus Curiae Watchtower Bible and Tract Society
Margaret K. Drayden, ID #68706, 206 Onyx Avenue, Pittsburgh, PA 15210, (412) 488-7250
. Commentary on the Christian prohibition of bloodRespect for this plain Scriptural directive amongst early Christians is well documented. In the second century, when persecutors of the early Christians falsely accused them of cannibalistically eating their own children, a young Christian woman named Biblis explained: “How can we eat infants--we, to whom it is not lawful to eat the blood of beasts.” W. Jones, The History of the Christian Church 106 (n.p. 1837); Eusebius, in I The Ecclesiastical History 26 (Loeb Classical Library 1980). Commenting on similar accusations, the early Latin theologian Tertullian contrasted the Romans’ practice of drinking blood and eating it in their foods with the Christians’ abhorrence for blood:
Let your unnatural ways blush before the Christians. We do not even have the blood of animals at our meals, for these consist of ordinary food.... At the trials of Christians you offer them sausages filled with blood. You are convinced, of course, that the very thing with which you try to make them deviate from the right way is unlawful for them. How is it that, when you are confident that they will shudder at the blood of an animal, you believe they will pant eagerly after human blood?
Tertullian, Apologetical Works 32-33 (R. Arbesmann trans. 1950); Tertullian, Apology 53 (Loeb Classical Library, T. Glover trans. 1931). A third-century Roman lawyer, Minucius Felix, wrote: “For us it is not permissible either to see or hear of human slaughter; we have such a shrinking from human blood that at our meals we avoid the blood of animals used for food.” M. Felix, Octavius 409 (Loeb Classical Library 1977); see also IV The Ante-Nicene Fathers 192 (A. *10 Roberts & J. Donaldson eds. 1956). As Bishop John Kaye commented on the historical evidence of the practices of the early Christians: “The Primitive Christians scrupulously complied with the decree pronounced by the Apostles at Jerusalem, i abstaining from things strangled and from blood.” J. Kaye, The Ecclesiastical History of the Second and Third Centuries 146 (3d ed. London 1845). 3
With the merging of the Roman state and the Christianity practiced during the reign of Constantine in the fourth century, the first signs of deviation from the unqualified Biblical prohibition of blood began to appear. According to one authority:
[lin the New Testament, instead of there being the least hint intimating that we are freed. from the obligation, it is deserving of particular notice that at the very time that the Holy Spirit declares by the apostles (Acts xv) that the Gentiles are free from the yoke of circumcision, abstinence from blood is explicitly enjoined, and the action thus prohibited is classed with idolatry and fornication. After the time of Augustine, the rule began to be held merely as a temporary injunction. It was one of the grounds alleged by the early apologists against the calumnies of the enemies of Christianity that, so far were they from drinking human blood, it was unlawful for them to drink the blood even of irrational animals. Numerous testimonies to the same effect are found in after ages. (Bingham, Origines Ecclesiasticae, book xvii, chapter v. section xx).
I McClintock and Strong’s Cyclopcedia of Biblical, Theological and Ecclesiastical Literature 834 (reprint 1981).
Despite this non-Scriptural dilution of the Bible’s plain command, “in succeeding centuries down to the Middle Ages, we encounter unexpected echoes of this early ‘abomination’ [of blood], due unquestionably to the decree [in Acts 15:29].” G. Ricciotti, The Acts of the Apostles 243 (1958). “[T]he precepts hereby set down in a precise and methodical manner [in Acts 15] are qualified as indispensable, giving the strongest proof that in the apostles’ minds this was not a *11 temporary arrangement, or a provisional measure.” E. Reuss, La Bible: La Thdologie Johannique 163 (1879).
One such historical ‘echo’ of the decree in Acts 15:29 was the Trullan council (known as the Quinisext Council) held at Constantinople in 692. Canon LXVII of this council stipulated that “[t]he eating of the blood of animals is forbidden in Holy Scripture. A cleric who partakes of blood is to be punished by deposition, a layman with excommunication.” C. Hefele, A History of the Councils of the Church, from the Original Documents 232 (1896).
In 792, Pope Gregory III “forbade the eating of blood or things strangled under threat of a penance of forty days.” H. Percival, The Seven Ecumenical Councils of the Undivided Church, in XIV A Select Library of Nicene and Post-Nicene Fathers of the Christian Church 93 (New York 1900). And about 100 years after that, Regino, the abbot of Prum (Germany), showed that the Biblical prohibition of blood was observed in his day:
The apostles’ letter sent from Jerusalem advises that these things must necessarily be observed. (Acts 15) Also, [Christians must abstain from eating] something caught by a beast, for that too is likewise strangled; and from blood, that is, it must not be eaten with blood.... At the same time, this must also be considered: that a thing strangled, and blood, are viewed in the same way as idolatry and fornication. Wherefore, it should be proclaimed to all what a grievous sin it is to eat blood, since it is placed together with idols and fornication. If anyone shall violate these commands of the Lord and the apostles, let him be suspended from the communion of the church until he should appropriately repent.
Regino, Libri Duo de Ecclesiastics Disciplinis et Religione Christiana [Two Books Concerning the Ecclesiastical Teachings and the Christian Religion], in 132 Patrologiae Latina cols. 354, 355 (J. Migne ed. Paris 1853).
In the twelfth century, Otho, the bishop of Bamberg, explained to converts in Pomerania “that they should not eat any thing unclean, or which died of itself, or was strangled, or sacrificed to idols, or the blood of animals.” I Tertullian 109 (C. Dodgson trans, n.p. 1842). Martin Luther also recognized the implications of the first-century directive on blood:
Now if we want to have a church that conforms to this council (as is right, since it is the first and foremost council, and was held by the apostles themselves), we must teach and insist that henceforth no prince, lord, burgher, or peasant eat geese, doe, stag, or pork cooked in *12 blood And burghers and peasants must abstain especially from red sausage and blood sausage.
41 Luther’s Works (Church and Ministry III) 28 (E. Gritsch ed. n.d.). John Calvin too observed that the original prohibition given to Noah “had been given to the whole world immediately after the Flood.” 2 J. Calvin, Commentary on the Acts of the Apostles 50 (J. Fraser trans. 1966). And seventeenth-century theologian Etienne de Courcelles was equally convinced that Christians should abstain from blood. Speaking of Acts 15:28, 29, he said:
The apostles, by their decree, wished to remedy the ignorance of these persons [i.e., the Gentile converts]; whereby relieving them of the yoke of circumcision and other legal precepts, they nonetheless advised that those things must be retained that were already observed from antiquity by the foreigners remaining among the Israelites, [things] such as were transmitted to Noah and his sons.
de Courcelles, Diatriba de Esu Sanguinis Inter Christianos [Discourse Concerning the Eating of Blood Among Christians], in Opera Theologica 971 (Amsterdam 1675).
As mentioned, by the latter hail of the seventeenth century, experiments in transfusion practice were under way. Bartolomeo Santinelli, an Italian physician, wrote this about these new medical experiments in view of the injunction in the book of Acts:
Although indeed the prohibition of the use of blood would have in view only that man should not eat it, for which reason it would seem to pertain less to our cause, nonetheless the purpose of that injunction is contrary to today’s transfusion [practice], so that the one who employs it would appear to oppose God who extends clemency.
B. Santinelli, Confusio Transfusionis, sive Con. finatio Operationis Transfundentis Sanguinem de Individuo ad Individuum [A Confounding of Transfusion, or A Refutation of the Operation of Transfusing Blood from Individual to Individual] 130, 131 (Rome 1668). Likewise, Thomas Bartholin, a seventeenth-century professor of anatomy at the University of Copenhagen, wrote:
Those who drag in the use of human blood for internal remedies of diseases appear to misuse it and to sin gravely.... Cannibals are condemned. Why do we not abhor those who stain [their] gullet with human blood?...
Similar is the receiving of alien blood from a cut vein, either through the mouth, a thing that is recommended for senile hectic fever, or by instruments of transfusion, a thing that, contrived through the devisings of the moderns, already has come almost into disuse, when it scarcely has become known in the world. The authors of this operation are held in terror by the divine law, by which eating of blood is prohibited.
*13 T. Bartholin, De Sanguinis Abusu Disputatio lA Disputation Concerning the Misuse of Blood] 140-41, 142-43 (Frankfurt 1676).
In the next century, Sir Isaac Newton expressed his understanding of the use of transfused blood in view of the Scriptures:
This law [of abstaining from blood] was ancienter than the days of Moses, being given to Noah and his sons, long before the days of Abraham: and therefore when the Apostles and Elders in the Council at Jerusalem declared that the Gentiles were not obliged to be circumcised and keep the law of Moses, they excepted this law of abstaining from blood, and things strangled, as being an earlier law of God, imposed not on the sons of Abraham only, but on all nations.
I. Newton, The Chronology of Antient Kingdoms Amended 184 (Dublin 1728). As another eighteenth-century scientist concluded:
The prohibition to eat blood, given to Noah, seems to be obligatory on all his posterity.... If we interpret this prohibition of the apostles by the practice of the primitive Christians, who can hardly be supposed not to have rightly understood the nature and extent of it, we cannot but conclude, that it was intended to be absolute and perpetual.
2 The Theological and Miscellaneous Works, &c. of Joseph Priestley 376, 379 (reprint 1972). And John Wesley, the founder of Methodism, commented on Acts 15:29 by giving six reasons, including the prohibition given to Noah, why the consumption of blood “was never permitted the children of God from the beginning of the world.” J. Wesley, Explanatory Notes upon the New Testament (London 1754).
Similar expressions are found in nineteenth century commentaries on the Holy Scriptures. “This prohibition of eating blood, given to Noah and all his posterity, and repeated to the Israelites... has never been revoked, but, on the contrary, has been confirmed under the New Testament, Acts xv.; and thereby made of perpetual obligation.” 1 J. Benson, The Holy Bible, Containing the Old and New Testaments 43 (New York 1839). Baptist theologian Andrew Fuller made the following comment on the original blood prohibition given to Noah at Genesis 9:3, 4:
This, being forbidden to Noah, appears also to have been forbidden to all mankind; nor ought this prohibition to be treated as belonging to the ceremonies of the Jewish dispensation. It was not only enjoined before that dispensation existed, but was enforced upon the Gentile Christians by the decrees of the apostles, Acts XV.20 Blood is the life and God seems to claim it as sacred to himself.
*14The Complete Works of the Rev. Andrew Fuller 751 (n.p. 1842); see also A. Clarke, The Holy Bible, containing the Old and New Testaments (New York 1856) (“After the deluge it was prohibited as we find above; and, being one of the seven Noahic precepts, it was not eaten previously to the Mosaic law This command is still scrupulously obeyed by the oriental Christians, and by the whole Greek Church; and why? Because the reasons still subsist.”). And finally,
There was room for no other conclusion than the one which [the apostle] James deduced, that they should impose on the Gentiles, so far as the class of restrictions under consideration were concerned, only those necessary things which were necessary independent of the Mosaic law. Idolatry, with all the pollutions connected with it, was known to be sinful before the law of Moses was given; and so was fornication. The eating of blood, and, by implication, of strangled animals, whose blood was still in them, was forbidden to the whole world in the family of Noah. In the restrictions here proposed by James, therefore, there is not the slightest extension of the law of Moses, but a mere enforcement upon the Gentiles of rules of conduct which have ever been binding, and were to be perpetual. They are binding to-day as they were then. To deny this would be to despise the combined authority of all the apostles, when enjoying upon the Gentile world, of which we form a part, restrictions which they pronounce necessary.
J. McGarvey, A Commentary on Acts of Apostles (Lexington, Ky. 1872)
As for any so-called ‘Christian liberty’ permitting exception to the Biblical directive, clergyman William Jones responded:
Nothing can be more express than the prohibition, Acts XV.28, 29. Can those who plead their “Christian liberty” in regard to this matter point us to any part of the Word of God in which this prohibition is subsequently annulled? If not, may we be allowed to ask, “By what authority, except his own, can any of the laws of God be repealed?”
W. Jones, The History of the Christian Church 106 (n.p. 1837).
Thus, “[t]he implication seems very clear that we are still to respect the sanctity of the blood, since God has appointed it to be a symbol of the atoning blood of Jesus Christ. Therefore it is not to be consumed by any believer who wishes to be obedient to Scripture.” G. Archer, Encyclopedia of Bible Difficulties 86 (1982).
b. Uncertainty of transfusion practice
The uncertainty and sharp differences of opinion that pervade the practice of medicine in general apply with full force to transfusion practice. Blood transfusion is simply one example of an intervention which, although marked with great uncertainty and danger, has enjoyed widespread use. Cf. Shultz, *19 From Informed Consent to Patient Choice, 95 Yale L.J. 219, 270-72 & n.230 (1985) . “[T]here is a surprising paucity of data to guide decisions about transfusions.” Ely & Bernard, Transfusions in Critically Ill Patients, 340 New Eng. J. Med. 467, 467 (1999). “All too often... clinicians administer blood without giving much thought to the indications for its use, the proper dose required, and the potential adverse consequences.” Kew & Gorlin, Red Cell Transfusion, in Hematology of Infancy and Childhood 1786 (D. Nathan & S. Orkin eds., 5th ed. 1998). “Blood is usually administered by physicians with the nearly unchallenged view that failure to transfuse would have dire consequences. Evidence supporting that view is difficult to obtain.” Kitchens, Are Transfusions Overrated?, 94 Am. J. Med. 117, 117 (1993).
Despite more than 5 decades of established practice, doctors still do not agree about precisely when and why they should transfuse red cells and how efficacy can be assessed.... For most areas of surgical practice the lack of incontrovertible proof of benefit from red-cell transfusion, despite subjective impressions, might seem disquieting. After all, what widely available drug could be used under such imprecise circumstances.?
Napier, Towards More Rational Use of Red Cells, The Lancet, May 21, 1994, at 1280.
“[D]ara to guide the clinicians’ decisions as to when to give transfusions to patients are scant.” Carson &Chen, In Search of the Transfusion Trigger, Clinical Orthopaedics & Related Res., Dec. 1998, at 30, 33. As a result, “the optimal transfusion practice for various types of critically ill patients with anemia has not been established.” Hebert et al., A Multicenter, Randomized, Controlled Clinical Trial of Transfusion Requirements in Critical Care, 340 New Eng. J. Med. 409, 409 (1999); see also Ellison & Silberstein, A Commentary on Three Consensus Development Conferences on Transfusion Medicine, 8 Anesthesiology Clinics No. Am. 609, 624 (1990) (“There is a surprising, even appalling, lack of adequate studies on the value of and indications for the blood products in question. This lack is in contrast to the usual wellcontrolled studies that have accompanied the introduction of other therapeutic maneuvers.”).
“Evidence shows that blood products, like other health care resources, are often used inappropriately, but the reasons for this have not been well studied.” Salem-Schatz, et al., Influence of Clinical Knowledge, Organizational Context, and Practice Style on Transfusion Decision Making, 264 JAMA 476, 476 (1990) (abstract). The United States Congress’ Office of Technology *20 Assessment (OTA) Task Force has observed that “data by which to evaluate the overall appropriate use of blood products do not exist, in many cases because of lack of scientific precision concerning when a component or derivative should be administered.” U.S. Congress, Office of Technology Assessment Task Force, Blood Technologies, Services, and Issues 121 (1988) [hereafter OTA Task Force, Blood Technologies]; see also Donovan, Practice Variation: Implications for Neonatal Red Blood Cell Transfusions, 133 J. Pediatrics 589, 589 (1998) (“Despite the paucity of evidence demonstrating benefit, RBC [red blood cell] transfusions are given frequently to infants in the neonatal intensive care unit.”).
The National Institutes of Health (NIH) has observed that “the literature is remarkable for the absence of carefully controlled, randomized trials that would permit definitive conclusions regarding perioperative transfusion practice.” National Institutes of Health, Consensus Conference: Perioperative Red Blood Cell Transfusion, 260 JAMA 2700, 2701 (1988). The longobserved practice of transfusing patients up to ‘normal’ blood counts before administering anesthesia preliminary to surgery has been described as “a myth” whose origin is “cloaked in tradition, shrouded in obscurity, and unsubstantiated by clinical or experimental evidence.” Zauder, How Did We Get a “Magic Number” for Preoperative Hematocrit/Hemoglobin, Level?, in Perioperative Red Cell Transfusion: Program and Abstracts (June 27-29, 1988). Thus, “[a]n extensive review of all relevant clinical literature on clinical transfusion trials, risks, and benefits found no conclusive evidence of benefit from erythrocyte [red blood cell] transfusion.” Spence, Anemia in the Patient Undergoing Surgery and the Transfusion Decision, Clinical Orthopaedics & Related Res., Dec. 1998, at 19, 24.
This uncertainty is not limited to the use of red cells. Platelet and fresh-frozen plasma transfusion practices also have been criticized. In 1987, the NIH observed: “Clinical decisions regarding platelet transfusion are hampered by an insufficient number of properly controlled trials, by imprecise methods of evaluating clinical need, and by uncertain methods for measuring effects.” National Institutes of Health, Consensus Conference: Platelet Transfusion Therapy, *21 257 JAMA 1777, 1777 (1987). Ten years later, this uncertainty had not abated: “Despite a recent National Institutes of Health consensus conference on platelets, the role of platelet transfusions, especially those given prophylactically to forestall bleeding, remains controversial.” Kruskall, The Perils of Platelet Transfusions, 337 New Eng. J. Med. 1914, 1914 (1997). As for fresh-frozen plasma (FFP), in 1985 the NIH noted: “The administration of FFP has increased dramatically in recent years despite the paucity of definitive indications for its use.” National Institutes of Health, Consensus Conference: Fresh-Frozen Plasma, 253 JAMA 551, 551 (1985). Thirteen years later, Gunter and Luban still observed that “FFP is one of the most overused plasma products.” Gunter & Luban, Basics of Transfusion Medicine, in Pediatric Critical Care 877, 882 (B. Fuhrman & J. Zimmerman eds., 2d ed. 1998).
One explanation for this persistent uncertainty was offered by Swisher and Petz:
[M]any medical students and residents learn what they... know about blood transfusion by the process of “chaining.” Chief residents pass along what they have learned, which was gathered in an entirely unsystematic way, to the assistant residents who then in turn teach the interns and medical students as they rotate through the various clinical services. The teaching is usually unsystematic and largely in the context of the transfusion management of individual patients. Consequently, many physicians enter their definitive careers with a shallow and narrow understanding of the appropriate management of one of their most important therapeutic tools.
Swisher & Petz, Overview and General Principles of Transfusion Medicine, in Clinical Practice of Transfusion Medicine 1, 4 (L. Petz et al. eds., 3d ed. 1996). These observations corroborated an earlier survey which found that “[d]eficiencies in knowledge of transfusion indications were widespread” and that “physicians with the least knowledge demonstrated the greatest confidence” in their transfusion orders. Salem-Schatz et al., Influence of Clinical Knowledge, Organizational Context, and Practice Style on Transfusion Decision Making, 264 JAMA 476, 479, 482 (1990).
In view of the widespread uncertainty of transfusion practice and the subjectivity this necessitates, it should come as no surprise that transfusion practices vary widely from doctor to doctor and hospital to hospital. “It is clear that significant variability exists in the transfusion practice of *22 physicians. This is driven more by the physician’s ‘transfusion trigger’ than by the patient’s physiologic need for blood.” Corwin et al., Efficacy of Recombinant Human Erythropoietin in the Critically Ill Patient, 27 Critical Care Med. 2346, 2349 (1999). “The variability in transfusion practice between individual physicians and institutions is striking Our finding that almost half of all transfusion events were performed for either no identifiable indication or low hematocrit alone is consistent with a lack of an understanding blood transfusion indication.” Corwin et al., RBC Transfusion in the ICU: Is There a Reason?, 108 Chest 767, 769 (1995) .
“[T]he use of blood products varies widely from institution to institution and from country to country, [suggesting] that the practice of blood transfusion is primarily determined by the local environment, perhaps by the dominant surgeon(s).” Wolf & Gold, Current Practice of Blood Transfusion in Cardiac Surgery, in Blood Conservation in Cardiac Surgery 3, 5 (K. Krieger & O. Isom eds. 1998); see also Mongan, Tranexamic Acid and Aprotinin Reduce Postoperative Bleeding and Transfusions During Primary Coronary Revascularization, 87 Anesthesia & Analgesia 258, 263 (1998) (“The major factor affecting transfusions... was institutional practice.”); Stehling et al., A Survey of Transfusion Practices Among Anesthesiologists, 52 Vox Sanguinis 60, 61-62 (1987) (survey of anesthesiologists “confirm[ed] the existence of wide variations in transfusion practices It would appear that many transfusion practices are based on habit rather than scientific data.”).
As the OTA Task Force concluded, a key element in the controversy surrounding the appropriate use of all blood products “is that criteria for clinical use are often unclear. Thus, practice at the bedside relies on anecdotal reports and evidence from inadequate trials.” OTA Task Force, Blood Technologies, supra, at 127.
There is tremendous variability in transfusion practice between individual physicians and institutions, as well as widespread deficiency in knowledge about transfusion risks and indications among physicians.... Much of this transfusion behavior reflects physician practice style, ie, “transfusion trigger,” rather than an actual physiological requirement for blood. *23 Neustein et al., The Role of Erythropoietin in Jehovah’s Witnesses Requiring Cardiac Surgery, 7 J. Cardiothoracic & Vascular Anesthesia 95, 101 (1993); see also Ely & Bernard, Transfusions in Critically Ill Patients, 340 New Eng. J. Med. 467, 467 (1999) (“The use of transfusions in critically ill patients varies widely... an estimated 66 percent of transfusions are administered inappropriately.”); Renton et al., Use of Blood Products in Cardiac Surgery, 12 Perfusion 157, 157 (1997) (“there remain large variations in the use of blood products for similar groups of patients treated in different institutions”).
Even with the growing awareness of blood dangers and efforts to minimize blood use, “current transfusion practice is highly variable” suggesting “that many physicians’ practice styles remain unchanged and that unnecessary transfusion remains a problem.” Welch et al., Prudent Strategies for Elective Red Blood Cell Transfusion, 116 Annals Internal Med. 393, 395 (1992) . More recently, other researchers observed:
The most important finding from this five-hospital study is the striking differences in RBC [red blood cell] transfusion practice for CABG [coronary artery bypass graft] cases.... We believe that the effects of the specific hospital on blood transfusion practices are the result of deeply ingrained institutional differences in training and hierarchical practices within the hospitals.
Surgenor et al., The Specific Hospital Significantly Affects Red Cell and Component Practice in Coronary Artery Bypass Graft Surgery: A Study of Five Hospitals, 38 Transfusion 122, 131, 132 (1998). “The fact that variations... exist from clinician to clinician and from place to place indicates that the state of knowledge necessary to define best practice beyond a reasonable doubt has not yet been reached for transfusion.” Murphy, What Should Trigger a Transfusion?, in Alternative Approaches to Human Blood Resources in Clinical Practice 9, 9 (S. Sibinga et al. eds. 1998).
Thus, although it may sound extreme to say so, clinical practice and the medical literature confirm that transfusion practice is largely a matter of habit resting on anecdotal assumption and guesswork. See Kevy & Gorlin, Red Cell Transfusion, in Hematology of Infancy and Childhood 1785 (D. Nathan & S. Orkin eds., 5th ed 1998) (“the rationale for the use of blood components is *24 based on limited research or anecdotal information”); Thomson et al., Blood Component Treatment: A Retrospective Audit in Five Major London Hospitals, 44 J. Clinical Pathology 734, 736 (1991) (“overuse of blood components has been attributed to misconceptions of their value, lack of knowledge of the situations in which their use cannot be justified, and underestimation of the incidence and magnitude of possible complications”). These disturbing realities prompted one multi-center study to conclude that “inappropriate transfusion practice continues at a significant proportion at leading academic institutions. A more rational approach to transfusion practice at the institutional level is clearly warranted, especially given the significant costs and hazards associated with transfusion therapy.” Stover et al., Variability in Transfusion Practice for Coronary Artery Bypass Surgery Patients Despite National Consensus Guidelines, 88 Anesthesiology 327, 332 (1998).
Numerous reported legal cases involving Witness patients corroborate the uncertainty of medical opinion in transfusion practice. In each of the cases in the note below, the patient was successfully managed without blood despite attending physicians’ dire predictions that blood was or would be necessary to save the patient’s life or avoid serious injury. 4
*25 c. Hazards attd complications of transfusion practice
For many years practitioners have acknowledged that blood transfusions are unavoidably hazardous and potentially lethal.
Blood transfusion is associated with a 35-percent greater risk of serious bacterial infection and a 52-percent greater risk of pneumonia. Postoperative infections are costly. The risk of bacterial infection may be the most common life-threatening effect of allogeneic blood transfusion.
Carson et al., Risk of Bacterial Infection Associated with Allogeneic Blood Transfusion Among Patients Undergoing Hip Fracture Repair, 39 Transfusion 694, 694 (1999).
Blood transfusions... have a negative long-term impact, contributing to numerous posttransfusion clinical phenomena, including increased risk of infections, complicated wound healing, and acceleration of local growth and/or dissemination of tumors. Moreover, they are associated with the activation of latent viruses and graft-versus-host disease.
It is clear that blood transfusions should be viewed as the transplantation of cellular and soluble elements and that they cause substantial alterations in the immune responsiveness of recipients.
Grzelak et al., Blood Transfusions Downregulate Hematopoiesis and Subsequently Downregulate the Immune Response, 38 Transfusion 1104, 1104 (1998).
Infectious agents, including viruses, bacteria, and parasites, can be transmitted by human blood products. Of major importance are viruses such as human immunodeficiency virus types 1 and 2 (HIV-1/2), hepatitis B virus (HBV), hepatitis C virus (HCV), and human T-cell lymphotropic virus types I and II (HTLV-1/11). Also, other viruses such as cytomegalovirus, Epstein-Bart virus, human parvovirus B19, and hepatitis A and G viruses can be transmitted by blood products. Various methods are used to prevent transmission of bloodborne agents to recipients, such as donor selection, testing donated blood for various infectious agents, and viral inactivation of plasma derivatives. With all these precautionary measures, the estimated risk for infection by screened blood components in Europe and the United States is approximately 1 in 50,000 to 1.6 million (for HBV, HCV, and HIV-1/2) transfused blood components.
Vrielink & Reesink, Transfusion-Transmissible Infections, 5 Current Opinion Hematology 396 (1998) (abstract).
*26 The transfusion of blood products can cause numerous serious complications, even death, and blood products should be considered potentially dangerous drugs.... Because infection with HIV causes active disease and ultimately death, transmission of this infectious agent must be viewed with great concern.... Transmission of the infectious agents for hepatitis is among the most serious risk of blood transfusions.... Approximately half of patients who contract posttransfusion hepatitis C infection develop a chronic form of the disease. Many of those patients eventually develop significant liver dysfunction, including cirrhosis.
Fakhry & Sheldon, Blood Transfusions and Disorders of Surgical Bleeding, in Textbook of Surgery, 118, 124, 125 (D. Sabiston & H. Lyerly eds., 15th ed. 1997).
“In patients undergoing hip replacement or spine surgery, the postoperative infection rate with allogeneic blood transfusion appears to be 7- to 10-fold higher than with autologous blood or no transfusion.” Blumberg, Allogeneic Transfusion and Infection: Economic and Clinical Implications, 34 Semi nars Hematology 34 (1997).
Perioperative blood transfusion was found to be associated with increased rates of bacterial infection in patients recovering from abdominal, cardiac, or orthopedic surgery and in burn victims. The application of multivariate statistics indicated that blood transfusion is a major risk factor for infection, independent of other factors
....
... [W]e found blood transfusion to be specifically related to increased risk of respiratory tract infections including pneumonia, abdominal infections including infect5ed hematomas, and septicemia. The relationship with infections may explain the increased postoperative mortality rates for transfused patients and thus the association with poor survival rates in transfused cancer patients.
Houbiers, Transfusion of Red Cells Is Associated with Increased Incidence of Bacterial Infection Aider ColorectalSurgery, 37 Transfusion 126, 126, 131 (1997).
For patients undergoing surgical procedures, the receipt of homologous blood increases the risk of postoperative infectious complications. Patients with malignancies have significantly increased recurrence and mortality rates when removal of their tumor is accompanied by the administration of blood.... Experimental studies, in addition to replicating the clinical studies, have documented that transfusion inhibits wound healing. Blood transfusion, the oldest form of transplantation, causes profound and prolonged alterations in immune function....
Tartter, Immunologic Effects of Blood Transfusion, 24 Immunological Investigations 277, 277 (1995).
The threat of transmission of hepatitis and AIDS has become a sobering reality, and serious attention to risks and benefits has become part of the decision-making process when ordering *27 blood products. Similarly, recent evidence associates immunosuppression and postoperative infection with the quantity of banked blood that patients receive.... Recent evidence strongly suggests that blood transfusion correlates positively and independently with the risk of infection in several groups of patients.... The immunosuppressive effects of blood transfusion are now becoming known.... A significant association has been found between perioperative blood transfusion and early recurrence of colorectal cancer.... Finally, the risk of infectious disease transmission through blood transfusions remains a critical issue. The risk of transmission of HIV-I and HTLV-1/II by transfusion of seronegative blood is now estimated to be 1 in 60,000 units of blood The risk of contracting viral hepatitis is estimated at 1%-3% of transfusion recipients.
Mann et al., Changes in Transfusion Practices in Burn Patients, 37 J. Trauma 220, 221 (1994).
Both medical and public opinion would probably rank HIV transmission as the prime complication of donor blood, but in fact the single biggest cause of mortality remains transfusion of the wrong pack of blood, potentially resulting in major ABO incompatibility. Such incidents arise either from mislabelling of the crossmatch sample, or confusion of two patients at the time of transfusion. There is no formal reporting system for either major transfusion errors or ‘near-miss’ events, but a recent survey suggests that the risk of such an incident is approximately 1/30 000 units transfused....
Williamson, Homologous Blood Transfusion: The Risks and Alternatives, 88 Brit. J. Haematology 451, 451 (1994).
Moreover, it is not only the numerous hazards and potential complications that are of concern, but the number of exposures to foreign blood and the consequent increase in risk that must also be taken into consideration.
[T]he risk of disease transmission is stated as risk per donor exposure, or per blood component unit administered. It is important to realize that a risk so stated of I in 420,000 units, for example, becomes I in 42,000 if an individual patient is given 10 units (420,000/10), and so on. Since many patients who are transfused are exposed to more than one unit, this is an important factor in assessing risk.
Wolf & Gold, Current Practice of Blood Transfusion in Cardiac Surgery, in Blood Conservation in Cardiac Surgery 3, 7 (K. Krieger & O. Isom eds. 1998).
Reports about the serious, potentially fatal hazards and complications of blood are legion. The following are just a sample:
