{"id":10,"date":"2009-05-08T14:12:27","date_gmt":"2009-05-08T21:12:27","guid":{"rendered":"http:\/\/www.kindleylaw.com\/?page_id=10"},"modified":"2017-05-20T20:59:24","modified_gmt":"2017-05-21T01:59:24","slug":"law-review-article","status":"publish","type":"page","link":"https:\/\/www.kindleylaw.com\/?page_id=10","title":{"rendered":"Law Review Article"},"content":{"rendered":"
Wisconsin Law Review, 1998<\/span><\/p>\n Comment<\/span><\/p>\n *1595 THE FIT BETWEEN THE ELEMENTS FOR AN INFORMED CONSENT CAUSE OF ACTION AND THE SCIENTIFIC EVIDENCE LINKING INDUCED ABORTION WITH INCREASED BREAST CANCER RISK<\/span><\/p>\n By John Kindley [FNa1]<\/span><\/p>\n Copyright 1998 by The Board of Regents of the University of Wisconsin System; Reprinted by permission of the Wisconsin Law Review.<\/span><\/p>\n 1998 WILR 1595<\/span><\/p>\n (Cite as: 1998 Wis. L. Rev. 1595)<\/span><\/p>\n TABLE OF CONTENTS<\/span><\/p>\n I. Introduction 1596<\/span><\/p>\n II. The Basics of Informed Consent 1605<\/span><\/p>\n III. The Scientific Evidence 1609<\/span><\/p>\n A. A Plausible Biological Hypothesis 1609<\/span><\/p>\n B. Studies Supporting the Hypothesis 1611<\/span><\/p>\n C. The Admissibility of Expert Testimony Based on Scientific Evidence 1614<\/span><\/p>\n IV. Existence of a Duty\/Materiality of the Evidence 1617<\/span><\/p>\n A. The Probable Consequences of Developing Breast Cancer 1618<\/span><\/p>\n B. The Increased Probability of Developing Breast Cancer : 1619<\/span><\/p>\n C. The Probability of a Causal Link Between Induced Abortion and Breast Cancer 1621<\/span><\/p>\n 1. Consideration of Alternative Explanations 1623<\/span><\/p>\n 2. Consistency of the Association 1625<\/span><\/p>\n 3. Strength of the Association 1626<\/span><\/p>\n D. The Materiality of \u201cPotential\u201d Risks 1627<\/span><\/p>\n V. Causation of Injury 1629<\/span><\/p>\n A. Burden of Proof and Standard of Persuasion 1630<\/span><\/p>\n B. Cancer Causation 1632<\/span><\/p>\n C. Decision Causation 1639<\/span><\/p>\n VI. Disregard of Plaintiff\u2019s Rights as an Independent Injury 1641<\/span><\/p>\n VII. Conclusion 1644<\/span><\/p>\n *1596 [T]here is just nothing wrong with telling the American people the truth.<\/span><\/p>\n Allen v. United States [FN1]<\/span><\/p>\n I. Introduction<\/span><\/p>\n In 1994, an epidemiological study on the relationship between induced abortion and breast cancer risk, published in the Journal of the National Cancer Institute, [FN2] made national headlines. [FN3] Dr. Janet Daling and a team of researchers at Seattle\u2019s Fred Hutchinson Cancer Research Center reported that \u201c[a]mong women who had been pregnant at least once, the risk of breast cancer in those who had experienced an induced abortion was 50% higher than among other women.\u201d [FN4] When women underwent abortions before the age of eighteen or at age thirty or older, the study found more than a twofold (150%, or 110% higher, respectively) increase in risk. [FN5] Since an average American woman\u2019s lifetime risk of developing breast cancer is already about twelve percent, [FN6] a twofold increase would imply an \u201cabsolute effect\u201d [FN7] from a single *1597 induced abortion that is comparable to the risk of lung cancer from long-term, heavy smoking. [FN8]<\/span><\/p>\n The Daling study is just one of many published since 1957 showing a statistical link between induced abortion and the occurrence of breast cancer. [FN9] In October 1996, the British Medical Association\u2019s Journal of Epidemiology and Community Health published a \u201ccomprehensive review and meta- analysis\u201d of all previously published studies including data specifically on induced abortion and breast cancer incidence. [FN10] Lead author Dr. Joel Brind, Professor of Endocrinology at Baruch College in New York, and three co- authors from the Hershey Medical Center at Penn State University found twenty- three studies in the worldwide literature, nineteen of which indicate increased risk. [FN11] The meta-*1598 analysis [FN12] of these studies showed an overall \u201codds ratio\u201d or \u201crelative risk\u201d of 1.3, [FN13] meaning that the risk of breast cancer among those who had experienced an induced abortion was thirty percent higher than among women who had not. [FN14]<\/span><\/p>\n If this risk increase reflects a causal link, then its impact on world health is substantial. In 1986, four prominent epidemiologists criticized in The Lancet a study\u2019s suggestion that the increasing incidence of breast cancer among Swedish women was due to oral contraceptive use: \u201cThis reasoning overlooks the more likely role of other factors, especially induced abortion. Induced abortion before first term pregnancy increases the risk of breast cancer.\u201d [FN15] Among American women, forty-three percent will have an abortion at some point in their lives, if current rates *1599 are sustained. [FN16] Bernadine Healy, M.D., former director of the National Institutes of Health, warns: \u201cSome 1.5 million women undergo abortion in this country each year; if the breast cancer connection is valid, we will be seeing a continuous rise in breast cancer in this country for many years into the future.\u201d [FN17] The incidence of breast cancer among American women has in fact been rising for the last several decades. [FN18]<\/span><\/p>\n Dr. Stuart Donnan, editor-in-chief of the Journal of Epidemiology and Community Health, expressed his convictions concerning the abortion-breast cancer (ABC) link in an editorial about the Brind meta-analysis:<\/span><\/p>\n Some readers may consider that the calculation made by Brind and colleagues of possible numbers of breast cancers following\u2013conceivably caused by\u2013 induced abortion is alarmist. It is certainly true that a relative risk of only 1.3 adds up to a large absolute increase in risk with a very high prevalence of the underlying factor. However, in the light of recent unease about appropriate but open communication of risks associated with oral contraceptive pills, it will surely be agreed that open discussion of risks is vital and must include the people\u2013in this case the women\u2013concerned. I believe that if you take a view (as I do), which is often called \u2018pro- choice,\u2019 you need at the same time to have a view which might be called \u2018pro- information\u2019 without excessive paternalistic censorship (or interpretation) of the data. [FN19]<\/span><\/p>\n Nevertheless, these views contrast sharply with the disclosure practice of most abortion providers, as exemplified by the following statement by Planned Parenthood Federation of America (PPFA):<\/span><\/p>\n The possible link between induced abortion and breast cancer is a theory whose principal promoters oppose abortion regardless of its safety. The theory awaits conclusive confirmation by medical researchers. While Planned Parenthood believes that *1600 women should have access to information about all factors that influence the risk of disease, PPFA also believes that women deserve information that is medically substantiated and untainted by a political agenda. Because the research community has not reached a consensus on breast cancer and abortion, Planned Parenthood advises women who are considering terminating a pregnancy that there is no currently demonstrated health risk from abortion that would warrant basing a decision on that factor alone. [FN20]<\/span><\/p>\n Planned Parenthood justifies this position\u2013while acknowledging the biological plausibility of a causal link [FN21]\u2013by pointing to the National Cancer Institute and the American Cancer Society, [FN22] which have called *1601 the body of research on the ABC link \u201cinconclusive.\u201d [FN23] According to the National Cancer Institute, \u201cavailable studies do not permit definite conclusions about the relationship between breast cancer and either spontaneous or induced abortions,\u201d [FN24] while the American Cancer Society has described induced abortion as a factor that \u201cmay be associated with increased breast cancer risk.\u201d [FN25]<\/span><\/p>\n The purpose of this Comment is to show that the current level of scientific evidence linking induced abortion with increased breast cancer risk is sufficient to support an ethical and legal duty to disclose fully the risk to women who are considering pregnancy termination. The Comment approaches this goal by examining the relationship between this evidence and the elements for a medical malpractice claim alleging failure to obtain \u201cinformed consent.\u201d<\/span><\/p>\n At its core, the common law doctrine of informed consent imposes a legal duty on the physician to inform her patient of significant facts about a proposed procedure so the patient can choose intelligently whether to consent. [FN26] Recognizing that the patient\u2019s lack of vital information about a procedure renders her apparent consent meaningless, [FN27] the duty to inform is grounded in respect for the patient\u2019s right to self-*1602 determination. [FN28] The doctrine\u2019s historical genesis in the law of assault and battery highlights the essential role of this dignitary interest in the law of informed consent. [FN29] In the often quoted words of Justice Cardozo, \u201c[e]very human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient\u2019s consent commits an assault, for which he is liable in damages.\u201d [FN30]<\/span><\/p>\n In addition to facilitating compensation for injured parties, establishing the duty to disclose the ABC link by demonstrating the viability of a civil claim for damages based on breach of that duty has at least three corollary advantages.<\/span><\/p>\n First, civil law articulates a standard of persuasion (in Wisconsin, \u201cto a reasonable certainty by the greater weight of the credible evidence\u201d [FN31]) that is more in tune with the informational needs of patients than is the much higher standard apparently now applied by abortion providers, who await \u201cconclusive confirmation\u201d of the link by a \u201cconsensus\u201d of \u201cmedical researchers.\u201d [FN32]<\/span><\/p>\n Second, as Judge Weinstein observed in In re \u201cAgent Orange\u201d Product Liability Litigation, [FN33] the standard of persuasion (\u201dgreater than 50%\u201d) required for compensation of injuries is \u201cfar higher\u201d than that required for prospective regulatory purposes. [FN34] Therefore, *1603 demonstrating that many plaintiffs should be able to meet the higher burden required for compensation highlights the compelling need for legislative and administrative action mandating disclosure of the ABC link.<\/span><\/p>\n Third, the politically sensitive nature of abortion and breast cancer [FN35] suggests the judiciary, through the adversarial system, may be the governmental branch initially best equipped to bring to light the true weight of the scientific evidence. Federal and state legislatures and administrative agencies have thus far failed to ensure that women are *1604 informed of the ABC link. The 1995 Wisconsin Act regulating informed consent for abortions, [FN36] for example, requires abortion providers to give patients state-printed materials describing the medical risks commonly associated with induced abortion. [FN37] The Act also requires the state to be \u201cdiligent\u201d in providing informational materials that are \u201cobjective,\u201d \u201caccurate,\u201d and \u201ccurrent.\u201d [FN38] Nevertheless, the pamphlet published by the Wisconsin Department of Health and Family Services, and distributed to abortion providers in April 1998, fails to mention breast cancer as a medical risk associated with induced abortion. [FN39]<\/span><\/p>\n This Comment focuses on the elements for a cause of action predicated on negligence, which has replaced battery as the theory of liability most commonly applied to informed consent cases. [FN40] Negligence traditionally requires four elements: duty, breach, causation, and injury. As applied to an informed consent claim, these four elements require the plaintiff to establish: (1) the physician had a duty to disclose information; (2) which she failed to disclose; and that (3) this failure to disclose was a legal cause of (4) the plaintiff\u2019s injury. [FN41] The causation element of an informed consent claim includes two sub-elements: the physician\u2019s failure to disclose was a legal cause of the plaintiff\u2019s decision to undergo the procedure (decision causation), and the procedure was a legal cause of the plaintiff\u2019s injury (injury causation). [FN42]<\/span><\/p>\n Part II provides an exposition and comparison of the two prevalent standards for determining which risks a physician has a duty to disclose. This Part concludes that both the \u201creasonable physician\u201d and \u201creasonable patient\u201d standards come down to the issue of \u201cmateriality,\u201d and that whether a risk is material or not is ultimately a question for the trier of fact.<\/span><\/p>\n *1605 Part III reviews the scientific evidence of the ABC link and explains why it survives both the Frye and the Daubert test for admissibility of expert testimony. Since admissibility under either standard focuses solely on principles and methods, not on generated conclusions, this Part concludes that the scientific evidence of the ABC link is clearly admissible as a basis for expert testimony, despite the lack of \u201cgeneral acceptance\u201d for the conclusion that abortion increases breast cancer risk.<\/span><\/p>\n Part IV assesses the \u201cmateriality\u201d of the risk posed by the ABC link by separating the risk into three interrelated components: (1) the probable consequences of developing breast cancer; (2) the increased probability that breast cancer will develop, assuming that the statistical association reflects a causal link; and (3) the probability that the statistical association does reflect a real, biological link. Emphasizing that \u201cpotential\u201d risks are actual risks for patients facing a decision, this Part concludes that the ABC link is likely to be significant in the decision-making process of a reasonable patient, and therefore must be disclosed.<\/span><\/p>\n Part V discusses how a plaintiff may establish legal causation by convincing the trier of fact, to a reasonable certainty by the greater weight of the credible evidence, both that the defendant\u2019s failure to inform was a \u201cdeciding factor\u201d in her choice to undergo the abortion, and that the abortion was a \u201cbut for\u201d component of the causal mechanism that produced her breast cancer.<\/span><\/p>\n Part VI discusses legal theories that recognize that the failure to inform is a dignitary harm, which may support a punitive damage award independently of establishing decision causation and injury causation.<\/span><\/p>\n Part VII concludes that all elements for an informed consent civil action can be satisfied for many plaintiffs whose breast cancer risk was increased by an induced abortion without their knowledge or consent.<\/span><\/p>\n II. The Basics of Informed Consent<\/span><\/p>\n Two opinions by the Kansas Supreme Court in Natanson v. Kline [FN43] were the first explicitly to apply negligence theory, rather than battery theory, to an informed consent case, largely because the plaintiff had only alleged negligence. [FN44] In doing so, the court imported from the traditional cause of action for negligent medical treatment two elements that have since become controversial in the informed consent context: the requirement of proving causation, discussed below in Part V, and a duty *1606 standard determined largely by professional practice. [FN45] Under this \u201creasonable physician\u201d standard:<\/span><\/p>\n The duty of the physician to disclose . . . is limited to those disclosures which a reasonable medical practitioner would make under the same or similar circumstances . . . . [T]he physician\u2019s choice of plausible courses should not be called into question if it appears, all circumstances considered, that the physician was motivated only by the patient\u2019s best therapeutic interests and he proceeded as competent medical men would have done in a similar situation. [FN46] Like the ordinary medical malpractice case, the plaintiff was required to produce \u201cexpert testimony of a medical witness\u201d to establish that the defendant\u2019s disclosures failed to meet the professional standard. [FN47]<\/span><\/p>\n Although adopting this seemingly natural extension of negligence principles, Natanson strongly reiterated, in language echoing the early battery cases, that the physician\u2019s duty to disclose is grounded in the patient\u2019s right to \u201cthorough-going self-determination.\u201d [FN48] In the landmark 1972 case of Canterbury v. Spence, [FN49] the District of Columbia Circuit Court determined that the logic of this right required a rejection of the \u201creasonable physician\u201d standard in favor of a more patient-centered approach. [FN50] The court thus formulated the \u201creasonable patient\u201d standard, under which the physician must inform her patient of all \u201cmaterial\u201d risks, defined as those to which \u201ca reasonable person, in what the physician knows or should know to be the patient\u2019s position, would be likely to attach significance . . . in deciding whether or not to forego the proposed therapy.\u201d [FN51] The court described risk disclosure as a \u201cnon-medical judgment,\u201d making the application of the special standard based on professional custom unnecessary and inappropriate. [FN52] The most *1607 important corollary for a plaintiff of this change in standards was the replacement of expert witnesses with the lay jury as \u201ccertifiers\u201d of what information ought to be disclosed. [FN53]<\/span><\/p>\n In Scaria v. St. Paul Fire & Marine Insurance Co., [FN54] the Wisconsin Supreme Court followed Canterbury in adopting the reasonable patient standard and explicitly rejected the notion that the physician\u2019s duty to disclose is necessarily limited to a \u201cself-created custom of the profession.\u201d [FN55] Extrapolating from this language and citing Learned Hand\u2019s observation that \u201ca whole calling may have unduly lagged\u201d in the adoption of practices appropriate to new information, [FN56] Professor Theodore Schneyer argued that Canterbury, Scaria, and related cases should be read principally as a \u201cprecaution against the danger that medical disclosure practices are being influenced by personal or professional interests other than those of immediate patients and therefore are biased indicators of the information reasonable patients would find valuable in deciding whether to consent to proposed treatment.\u201d [FN57] Professor Schneyer discussed, as an example of judicial response to such bias, the case of Reyes v. Wyeth Laboratories, [FN58] in which the Fifth Circuit held the manufacturer of a polio vaccine liable for its failure to warn a child\u2019s parents of the less than one in a million chance that the vaccine would cause polio in the child. The court rejected a policy judgment by the state department of health that disclosure of the remote risk might be significant to some patients, and for that very reason, should be withheld to ensure the success of public health efforts to immunize the population against polio. [FN59] This policy judgment by state public health officials had formed the prevailing practice among physicians of not informing their patients of the risk of polio. [FN60]<\/span><\/p>\n *1608 The principal way in which the reasonable patient standard protects against such bias is by lifting the plaintiff\u2019s burden of producing expert testimony concerning disclosure practices. [FN61] On the other hand, which standard is applied in a particular jurisdiction does not generally determine the substance of what must be disclosed. [FN62] Under the reasonable patient standard, evidence of professional practice is still relevant and material in determining what the reasonable patient would want to know. [FN63] Conversely, the reasonable physician standard does not deny the patient\u2019s fundamental right to self-determination, but assumes that the interaction of doctors and patients will ordinarily result in customary disclosure practices that adequately correspond to the needs of those served. [FN64] Even where a whole group of physicians has \u201cunduly lagged\u201d in the adoption of disclosures appropriate to new information, application of the reasonable physician standard does not necessarily mean that the defective custom of that group determines the scope of disclosure required. [FN65] Although under this standard the plaintiff must produce expert testimony concerning what a reasonable physician would have disclosed under similar circumstances, a physician-witness generally need not be a specialist in the field in which she is giving her opinion. [FN66]<\/span><\/p>\n In sum, whether the duty to warn is initially viewed from the perspective of a reasonable physician or of a reasonable patient, the question should essentially come down to whether a reasonable patient would consider the information material. In other words, a reasonable physician presumably informs her patient of all risks a reasonable person in the patient\u2019s position would likely consider significant in making her decision. Unfortunately, \u201c[t] here is no bright line separating the significant from the insignificant.\u201d [FN67] Both the reasonable physician and *1609 reasonable patient standards are of \u201climited value . . . in determining the proper scope of disclosure in a specific situation.\u201d [FN68] Materiality must therefore be determined on a case-by-case basis by the trier of fact. [FN69] According to the Wisconsin Supreme Court, \u201c[w]henever the determination of what a reasonable person in the patient\u2019s position would want to know is open to debate by reasonable people, the issue of informed consent is a question for the jury.\u201d [FN70]<\/span><\/p>\n III. The Scientific Evidence<\/span><\/p>\n The scientific evidence of the ABC link is relevant in proving two elements of the contemplated informed consent cause of action. First, it establishes the existence and magnitude of the risk posed by the ABC link, and therefore the physician\u2019s duty to disclose the risk. Second, it tends to make it more probable that the failure to inform and subsequent abortion were legal causes of the plaintiff\u2019s breast cancer.<\/span><\/p>\n The scientific evidence of the link includes numerous epidemiological studies, a meta-analysis of those studies, [FN71] and an experimental study on laboratory animals. [FN72] A plausible biological hypothesis, based on known facts about pregnancy and breast cancer, explains why induced abortion would be expected to increase breast cancer risk.<\/span><\/p>\n This Part first describes the biological explanation for the ABC link. It then discusses the epidemiological and experimental evidence supporting the link, and demonstrates that this evidence would be an admissible basis for expert testimony.<\/span><\/p>\n A. A Plausible Biological Hypothesis<\/span><\/p>\n Biologic plausibility is an important factor in judging the likelihood that a statistical association reflects a causal link. [FN73] The biologic plausibility of the ABC link rests on its consistency with existing knowledge about the \u201chormonal disruption that occurs when a woman\u2019s *1610 pregnancy is interrupted.\u201d [FN74] Two independent hormonal effects are implicated: the cancer-promoting effect of early pregnancy and the protective effect of late pregnancy. [FN75]<\/span><\/p>\n Within a few days after a woman conceives, her body begins to secrete large quantities of estrogen, a hormone that causes \u201cimmature\u201d breast cell tissue to grow. [FN76] These proliferating cells are in a transitional state and thus especially susceptible to carcinogenic stimuli and cancerous mutations. [FN77] \u201cThe more the cells proliferate, the greater the chance that a replication will go awry, producing a cancerous cell.\u201d [FN78] Most other acknowledged risk factors for breast cancer are likewise associated with estrogen exposure, including early first menstruation and late menopause. [FN79] On the other hand, miscarriage, which has generally not been statistically associated with an increased risk of breast cancer, [FN80] typically occurs when estrogen levels fail to rise above normal, non-pregnant levels. [FN81]<\/span><\/p>\n In late pregnancy, other hormones induce the breast tissue to differentiate into mature, milk-producing cells that are no longer susceptible to potentially cancerous growth. [FN82] \u201cIt is known that having a full-term pregnancy early in a woman\u2019s childbearing years is protective against breast cancer.\u201d [FN83] Delaying this protective, differentiating effect of a completed pregnancy presumably \u201cincreases the time period during *1611 which undifferentiated breast tissue can accumulate potentially [cancerous] mutations.\u201d [FN84]<\/span><\/p>\n Induced abortion, therefore, increases a woman\u2019s risk of breast cancer in two independent ways: first, by subjecting the breasts to a prolonged high dosage of estrogen, which may promote tumor growth as well as the proliferation of immature, vulnerable cells; and second, by abrogating a completed pregnancy\u2019s protective effect. [FN85] Strictly speaking, the pregnancy itself, not its termination, increases the estrogen exposure. However, the induced abortion not only forgoes the protective effect, but does so at a time when estrogen overexposure has left the breasts with an abnormally high number of cells vulnerable to cancerous growth.<\/span><\/p>\n The plausibility of this biological explanation for the statistical association between induced abortion and breast cancer is admitted even by those reluctant to draw a causal inference. According to Dr. Clark Heath, Vice President of the American Cancer Society, if the division and maturation of the breast cells are \u201cinterrupted at a stage early on, perhaps that will lead to an increased risk of cancer, of carcinogenesis, which is more frequent when cells are rapidly dividing and are young.\u201d [FN86] Planned Parenthood acknowledges that \u201c[i]nterruption during the first trimester of a first pregnancy causes a cessation of cell differentiation, which may result in a subsequent increase in the risk of cancerous growth in these tissues.\u201d [FN87]<\/span><\/p>\n B. Studies Supporting the Hypothesis<\/span><\/p>\n A 1980 landmark study on laboratory animals by Jose and Irma Russo [FN88] is regularly cited for the biologic hypothesis that an abortion forestalls the protective effect of breast cell differentiation in late pregnancy, thereby increasing the risk of cancer. [FN89] The authors reported *1612 that seventy-seven percent of rats whose first pregnancy was artificially aborted developed breast cancer after subsequent exposure to a chemical carcinogen, compared to zero percent of similarly exposed rats in the control group whose pregnancy was carried to term. [FN90] Seventy-one percent of rats that were never allowed to get pregnant developed breast cancer after the same carcinogen exposure. [FN91] Russo and Russo also noted in 1980 that \u201cepidemiologic observations indicate that there are factors that exert either a protective or a stimulating influence on the development of breast cancer in women. Among the protective factors are a first full-term pregnancy before 24 years of age . . . . Among the risk factors are . . . abortion.\u201d [FN92]<\/span><\/p>\n Since the publication of the 1996 Brind meta-analysis, [FN93] six out of the eight epidemiological studies that have become available indicate a positive statistical association, [FN94] bringing the total to twenty-five out of thirty-one. Seventeen of the twenty-five positive studies are \u201cstatistically significant,\u201d a technical term meaning that the data provide at least ninety- five percent certainty that the association is not simply due to random error. [FN95] Nevertheless, Dr. Mads Melbye, the lead author of a 1997 cohort study reporting no overall positive association, [FN96] told the Wall Street Journal, \u201cI think this settles it. Definitely\u2013there is no overall increased risk of breast cancer for the average woman who has had an abortion.\u201d [FN97] This extraordinary claim, [FN98] echoed in the New England *1613 Journal of Medicine editorial accompanying the study [FN99] was based on the study\u2019s large sample size and on its preclusion of possible recall bias. [FN100] However, Drs. Joel Brind and Vernon Chinchilli argued in a letter to the New England Journal of Medicine that serious errors of misclassification and data adjustment in the Melbye study had likely masked a statistically significant risk increase. [FN101] Moreover, the Melbye study itself reported that \u201c[w]ith each one-week increase in the gestational age of the fetus . . . there was a 3 percent increase in the risk of breast cancer,\u201d from a 0.81 relative risk associated with induced abortion at less than seven weeks of gestation, up to a statistically significant 1.89 relative risk associated with induced abortions after eighteen weeks of gestation. [FN102] Melbye et al. reported that this trend was itself statistically significant, [FN103] and concluded:<\/span><\/p>\n Induced abortion had no overall effect on the risk of breast cancer, but we found a statistically significant increase in risk among women with a history of second-trimester abortion. The fact that such an increase did not affect the overall result clearly indicates that it is based on small numbers and therefore requires cautious interpretation. The increased risk among women who had had second-trimester abortions finds biologic support in experiments in rats and is in line with the hypothesis of Russo and Russo.<\/span><\/p>\n . . . .<\/span><\/p>\n We cannot explain why a very early induced abortion was associated with a slight, although insignificant, decrease in risk. [FN104]<\/span><\/p>\n *1614 C. The Admissibility of Expert Testimony Based on Scientific Evidence<\/span><\/p>\n Prior to the United States Supreme Court\u2019s decision in Daubert v. Merrell Dow Pharmaceuticals, Inc. [FN105] in 1993, the dominant approach to determining the admissibility of expert testimony was the so-called \u201cgeneral acceptance,\u201d or Frye, test. In the course of deciding whether to admit expert testimony based on the results of a polygraph test, the court in Frye v. United States [FN106] stated: \u201c[W]hile courts will go a long way in admitting expert testimony deduced from a well-recognized scientific principle or discovery, the thing from which the deduction is made must be sufficiently established to have gained general acceptance in the particular field in which it belongs.\u201d [FN107]<\/span><\/p>\n The Daubert Court affirmed that the focus of the admissibility inquiry must remain \u201csolely on principles and methodology, not on the conclusions that they generate.\u201d [FN108] In addition, Daubert theoretically extended even further the lengths to which the courts should go in admitting expert testimony deduced from a \u201cscientific principle,\u201d by holding that under the Federal Rules of Evidence, \u201cgeneral acceptance\u201d of the relied-upon principle was no longer a necessary precondition to admissibility. [FN109] Daubert is therefore widely viewed as representing a move beyond a rigid adherence to scientific orthodoxy in favor of a rule that more accurately reflects the dynamic nature of science. [FN110]<\/span><\/p>\n Daubert thus requires the judge to determine \u201cnothing less\u201d than whether the methods relied on by the expert for his testimony are \u201cscientific.\u201d [FN111] \u201cGeneral acceptance\u201d can still be an important factor in making this determination. [FN112] The Court also mentioned three other factors that judges ruling on admissibility might take into account: whether the method employed by the expert has been subjected to peer review and publication; whether it can be and has been tested; and whether the known or potential rate of error is acceptable. [FN113] However, *1615 these factors do not constitute a \u201cdefinitive checklist or test,\u201d nor is each factor necessarily applicable in every case. [FN114]<\/span><\/p>\n \u201cPeer review\u201d refers to the process by which scientific journals normally screen submissions for methodological error. [FN115] Publication in a peer- reviewed journal is a \u201csignificant indication\u201d that a study is \u201ctaken seriously by other scientists,\u201d [FN116] and that its methods are \u201cgenerally accepted\u201d as sound by the scientific community. [FN117] The thirty-one epidemiological studies of the ABC link, as well as the Brind meta-analysis and the Russo and Russo animal study, were all published in recognized scientific journals and based on generally accepted scientific methods.<\/span><\/p>\n As noted by the Third Circuit, \u201c[t]he reliability of expert testimony founded on reasoning from epidemiological data is generally a fit subject for judicial notice; epidemiology is a well-established branch of science and medicine, and epidemiological evidence has been accepted in numerous cases.\u201d [FN118] Although individual epidemiological studies are subject to criticism, such claims of methodological error or bias go to the weight rather than the admissibility of testimony based on those studies. [FN119]<\/span><\/p>\n Some courts have regarded statistical significance as critical to a study\u2019s admissibility. [FN120] However, statistical significance should not be confused with the practical significance of a research finding for public health. [FN121] The Utah federal district court noted in Allen v. United States that \u201c[t]he cold statement that a given relationship is not \u2019statistically significant\u2019 cannot be read to mean \u2018there is no probability of a relationship.\u201d\u2018 [FN122] An epidemiologist whose sample size was too small to reveal an association with ninety-five percent certainty might still be ninety or eighty percent confident that the association measured is not due to random error. Thus, \u201c[p]eremptorily rejecting all studies that are not statistically significant would be a cursory and foolish judgment, *1616 particularly if there are multiple studies tending to show a consistent effect.\u201d [FN123]<\/span><\/p>\n The epidemiologic technique of meta-analysis, [FN124] although not without critics in the epidemiological community, [FN125] is regularly employed in peer-reviewed scientific journal articles. [FN126] Dr. Brind\u2019s meta-analysis was admitted into evidence as the basis for his expert testimony in a 1996 lawsuit. [FN127] Dr. Clark Heath, Vice President of the American Cancer Society, appeared as an expert witness for the opposing party. [FN128] While testifying that \u201cstatistical associations, however statistically significant they may seem to be, don\u2019t guarantee a biologic association,\u201d Dr. Heath admitted that Dr. Brind\u2019s report is \u201cquite extensive and the statistical coverage of the papers and the literature that bear on the induced abortion question is quite thorough.\u201d [FN129] Dr. Janet Daling of the Fred Hutchinson Cancer Research Center has likewise described Dr. Brind\u2019s meta-analysis as \u201cvery objective and statistically beyond reproach.\u201d [FN130]<\/span><\/p>\n Although experiments on animals are generally viewed as less probative than epidemiological studies of human populations, [FN131] the Russo and Russo study should also be admissible as a basis for expert testimony. A federal district court in Longmore v. Merrell Dow Pharmaceuticals, Inc. [FN132] admitted animal studies as evidence of causation, despite an opposing epidemiological record of more than thirty-five studies finding no statistically significant causal link. [FN133] The court reasoned that an epidemiological study might label an observed association as statistically insignificant, even though the \u201ccertainty that the observed increase is related to its hypothetical cause rather than mere *1617 chance is still far more likely than not.\u201d [FN134] The court concluded that the defendant\u2019s epidemiological evidence did not \u201coverwhelm\u201d the admissibility of the animal studies because such studies are also generally relied upon by experts in determining causal links. [FN135]<\/span><\/p>\n IV. Existence of a Duty\/Materiality of the Evidence<\/span><\/p>\n The scope of the physician\u2019s duty to warn extends to all material risks. A risk is material if a reasonable patient, in what the physician knows or should know to be the patient\u2019s position, would be likely to attach significance to the risk in deciding whether or not to forego the proposed procedure. [FN136] This standard is distinct from the issue of causation, triggering the physician\u2019s duty to warn even when disclosure of the risk would not in fact have caused the particular patient to forego the procedure. [FN137]<\/span><\/p>\n Although the standards are different, both inquiries imply a weighing of the risks posed by the procedure against the seriousness of the condition being treated. Consequently, the fact that induced abortion is ordinarily an elective procedure, which is rarely necessary to preserve the life or health of the mother, is important in framing both the questions of materiality and of causation. [FN138] Furthermore, while the social and economic pressures of an unplanned pregnancy may often result in a decision to abort despite information about the increased risk of breast cancer, such pressures do not preclude a woman from attaching significance to the risk in deciding whether to undergo the procedure.<\/span><\/p>\n Having established the evident but important point that induced abortion is a choice, this Part analyzes the nature of the risk posed by the ABC link. It suggests that a trier of fact is likely to find that the ABC link is a material risk in light of other risk factors that are acknowledged and disclosed by government agencies and in light of similar fact patterns in past informed consent actions. To facilitate the analysis, this Part separates the risk posed by the ABC link into three interrelated *1618 components: (1) the probable consequences of developing breast cancer; (2) the increased probability that breast cancer will develop, assuming that the statistical association reflects a causal link; and (3) the probability that the association does reflect a real, biological link. This Part concludes by addressing the likely significance of \u201cpotential\u201d risks to the decisions of reasonable patients.<\/span><\/p>\n A. The Probable Consequences of Developing Breast Cancer<\/span><\/p>\n The first component is well-defined and uncontroversial: breast cancer is a potentially debilitating and deadly disease. According to the American Cancer Society, twenty percent of women die within five years after a diagnosis of breast cancer, while the ten-year mortality rate is thirty-seven percent. [FN139] Many women who develop breast cancer must undergo a breast amputation, or mastectomy, in order to prevent the cancer from spreading. [FN140] These potential consequences of developing breast cancer are ingrained in the national consciousness. The prevention of breast cancer is a high priority for the federal government and many women\u2019s groups. The fear of this disease is therefore very reasonable, and for most women quite real.<\/span><\/p>\n Whenever the possible consequences of a procedure are extremely serious, the courts will generally find a duty to disclose the risk. [FN141] The question of foreseeability and duty, including the duty to warn, is not one of mathematical probability alone:<\/span><\/p>\n The odds may be a thousand to one that no train will arrive at the very moment that an automobile is crossing a railway track, but the risk of death is nevertheless sufficiently serious to require the driver to look for the train . . . . As the gravity of the possible harm increases, the apparent likelihood of its occurrence need be correspondingly less. [FN142]<\/span><\/p>\n *1619 B. The Increased Probability of Developing Breast Cancer<\/span><\/p>\n The second component of the risk posed by the abortion-breast cancer link is roughly defined by the magnitude of \u201crelative risk\u201d measured in the epidemiological literature. Relative risk is the ratio of the incidence of disease in exposed individuals compared to the incidence in unexposed individuals. [FN143] A relative risk of 1.5 would mean that the risk of breast cancer is increased by fifty percent in women who have undergone an induced abortion, while a 2.0 relative risk would indicate that exposed individuals are twice as likely to develop breast cancer as unexposed individuals. [FN144]<\/span><\/p>\n The Brind meta-analysis of the worldwide epidemiological literature on the ABC link reported an overall 1.3 relative risk. [FN145] A 1989 study on New York women by Howe et al. found a 1.9 relative risk. [FN146] The risks are higher in certain subgroups of women. Two studies by Laing et al. in 1993 and 1994 on African-American women indicated relative risks of 3.1 and 2.44 respectively. [FN147] The 1994 Daling study, while finding an overall relative risk of 1.5, reported a relative risk of 2.5 when the abortion was done before age eighteen and a relative risk of 2.1 when procured over age thirty. [FN148] The Daling study also reported that a woman with a family history of breast cancer who had had an abortion was 1.8 times more likely to develop breast cancer than a woman with a family history who had not. [FN149] When a woman with a family history underwent the abortion at age thirty or older, her relative risk was 3.7. [FN150] If the abortion occurred prior to age eighteen, her relative risk was immeasurably high, since all twelve such women in the study had developed breast cancer. [FN151]<\/span><\/p>\n The above figures represent the risk elevation associated with induced abortion independently of, and in addition to, the known increased breast cancer risk of delaying the protective effect of a first full-term pregnancy, except for those from the Daling study, which included both effects. [FN152] Although these studies separated out as a confounding factor the effect of delaying a first full-term pregnancy in order to isolate the independent *1620 effect of an induced abortion, both effects are relevant in determining the actual risk elevation associated with aborting a pregnancy. A woman contemplating abortion is already pregnant. If the pregnancy is not artificially interrupted, she will benefit from the natural protective effect of a completed pregnancy. Therefore, the total risk increase associated with an induced abortion should be measured relative to the reduced average lifetime risk of a woman who has completed a pregnancy, rather than to that of a woman who has never been pregnant. The bottom line is that a woman considering abortion has two alternatives, and that her lifetime risk of breast cancer is significantly affected by which alternative she chooses. Consequently, if the plaintiff was under age thirty and had not yet had a full-term pregnancy at the time of the abortion, the risk increase associated with delaying a first full- term pregnancy should be factored in. A summary of the results of twenty-three previous studies of this effect estimated that a woman who completes her first pregnancy at age thirty or later has a ninety percent greater risk of breast cancer than a woman who completes her first pregnancy before the age of twenty. [FN153]<\/span><\/p>\n The real significance of a relative risk increase depends upon the background risk which is increased. For example, although smoking increases the risk of lung cancer by a factor of 10.0, the background risk of lung cancer for nonsmokers is very low. [FN154] By contrast, an average American woman\u2019s lifetime risk of breast cancer is about twelve percent. [FN155] A 1.3 relative risk increase from an induced abortion would therefore indicate about a four percent increase in absolute terms. Estimating a twenty-five percent mortality rate, [FN156] this figure would suggest that about 1 out of 100 women who have had an induced abortion die from breast cancer attributable to the abortion.<\/span><\/p>\n According to the American Civil Liberties Union, \u201ceven a 1 in 10,000 risk of death must always be disclosed.\u201d [FN157] The courts have *1621 likewise generally found that a physician must inform her patient of risks of such magnitudes. [FN158] In Hartke v. McKelway, [FN159] for example, the District of Columbia Circuit Court affirmed that the jury could conclude that a three in 1000 chance that a laparoscopic cauterization performed to prevent pregnancy would fail was a material risk, given the plaintiff\u2019s history of pregnancy- related health problems and the availability of other alternatives. [FN160]<\/span><\/p>\n C. The Probability of a Causal Link Between Induced Abortion and Breast Cancer<\/span><\/p>\n The probability that the statistical association between induced abortion and breast cancer reflects a biologic relationship is the third and most critical risk component, on which the previous two depend for relevance. The causality of the increased risk associated with induced abortion\u2019s delay of a full-term pregnancy\u2019s protective effect is not controversial, and alone supports a duty to inform. On the other hand, the scientific community has not yet reached a consensus on whether induced abortion has a stimulating biologic effect on the development of breast cancer in women.<\/span><\/p>\n \u201c[E]pidemiology cannot prove causation,\u201d [FN161] nor can it quantify statistically the likelihood of a causal link. [FN162] Rather, \u201ccausation is a judgment issue,\u201d [FN163] and making such judgments is arguably not part of science at all. [FN164] Deciding how much data is needed to justify a public *1622 health effort is \u201cstrongly influenced by economic and political considerations as well as by societal values.\u201d [FN165]<\/span><\/p>\n Furthermore, \u201c[m]ost researchers are conservative when it comes to assessing causal relationships, often calling for stronger evidence and more research before a conclusion of causation is drawn.\u201d [FN166] In the context of the ABC link, one might expect this conservative tendency to be strengthened by researchers\u2019 apprehension that declaring a causal relationship between abortion and breast cancer could have serious societal and political consequences. Moreover, an individual epidemiologist\u2019s natural reluctance to draw a conclusion not held by most peers, especially when epidemiology cannot prove that inference, is readily understandable. These extra motivations to avoid premature judgments and to wait for greater certainty potentially widen the gap between the standard of proof implicitly applied by the epidemiologist and the standard of proof required in civil litigation. [FN167] Therefore, the fact that many epidemiologists decline to infer a causal link between induced abortion and breast cancer should not dissuade a lay juror from drawing such a conclusion if she finds herself convinced by a preponderance of the available evidence.<\/span><\/p>\n
\n<\/span><\/p>\nEXECUTIVE SUMMARY of \u201cThe Fit Between the Elements for an Informed Consent Cause of Action and the Scientific Evidence Linking Induced Abortion with Increased Breast Cancer Risk,\u201d by John Kindley, published in Volume 1998 of the Wisconsin Law Review, at Pages 1595-1644:<\/span><\/h3>\n
The purpose of this article is to show that the current level of scientific evidence linking induced abortion with increased breast cancer risk is sufficient to support an ethical and legal duty to disclose fully the risk to women who are considering pregnancy termination. The article approaches this goal by examining the relationship between this evidence and the elements for a medical malpractice claim alleging failure to obtain informed consent.<\/span><\/h3>\n
An informed consent cause of action generally requires the plaintiff to establish the following four elements: (1) the physician had a duty to disclose information; (2) which he or she failed to disclose; and (3) this failure to disclose was a legal cause of (4) the plaintiff\u2019s injury.<\/span><\/h3>\n
Depending on the jurisdiction, the physician\u2019s duty to disclose extends either to all risks which a reasonable physician would disclose under the same or similar circumstances, or to those which a reasonable patient would be likely to attach significance in deciding whether or not to forego the proposed treatment. Whether the duty to warn is initially viewed from the perspective of a reasonable physician or of a reasonable patient, the question for the jury should essentially come down to whether a reasonable patient would consider the information material to her decision.<\/span><\/h3>\n
The article assesses the materiality of the risk posed by the abortion-breast cancer link by analyzing the scientific evidence in terms of three interrelated components: (1) the probable consequences of developing breast cancer; (2) the increased probability that breast cancer will develop, assuming that the statistical association reflects a causal link; and (3) the probability that the association does reflect a real, biological link. Emphasizing that even \u201cpotential\u201d risks are actual risks for patients facing a decision, the article argues that the abortion-breast cancer link is likely to be significant in the decision-making process of a reasonable patient, and therefore must be disclosed to women considering abortion.<\/span><\/h3>\n
The article then discusses how a plaintiff may establish legal causation by convincing the jury by a preponderance of the evidence both that the defendant\u2019s failure to inform was a \u201cdeciding factor\u201d in her choice to undergo the abortion, and that the abortion was a \u201cbut for\u201d component of the causal mechanism that produced her breast cancer.<\/span><\/h3>\n
The article also discusses legal theories which recognize that the failure to warn is a dignitary harm in and of itself, which may support a punitive damage award independently of establishing causation or actual physical injury. The article argues that such a lawsuit would be particularly justified for a woman who was intentionally not informed of the abortion-breast cancer link, and who must now live with the knowledge that her risk of breast cancer has been increased without her consent.<\/span><\/h3>\n
The article concludes by suggesting that not only women considering abortion, but also any woman who might have an abortion in her past or future, has a need and a right to know the truth about this serious health threat.<\/span><\/h3>\n
\n<\/span><\/p>\n