|
Article Excerpt
I. INTRODUCTION
An unacknowledged problem exists in the realm of human subject experimentation: criminal acts are being committed seemingly without consequence. The individuals escaping punishment are no ordinary individuals; rather, they are medical researchers whose exalted social status combined with the social benefits of their research appear to immunize them from punishment. Consider the following examples: (1)
Pregnant women become unwitting guinea pigs in an experiment testing a medication to prevent miscarriages. As a result, their daughters and sons are at higher risk for cancer. The researchers are never prosecuted. (2)
A patient becomes an unwitting participant in an experiment to test the safety and effectiveness of an ocular implant. Before implanting the device, the researcher tells him that it is "quite safe" and a "tried and true method" of vision correction, rather than the truth--that the FDA has not approved the device. The victim suffers permanent damage to his eye) The researcher is never prosecuted.
A healthy twenty-four-year-old woman participates in an asthma study. Doctors ask her to inhale a drug without telling her that this is an experimental use of the drug, previous inhalations resulted in death, and the FDA has not approved the procedure. She dies. (4) The researchers are never prosecuted.
This Article addresses the significant, yet largely unexplored, question of why medical researchers escape criminal punishment: Whereas other actors who violate bodily integrity and autonomy are routinely punished with convictions for assault, fraud, and homicide, researchers walk away from similar crimes unsanctioned. (6) This Article is meant to begin a conversation that considers why criminal sanctions are not utilized in the context of human subject research and scrutinizes whether criminal punishment is an important, but overlooked, mechanism for protecting the dignitary interests of human subjects. Given the rise in human subject experimentation as a result of biotechnology research, this is a critical and timely question.
This Article examines two forms of intentional misconduct. Each, like the illustrations above, involves a researcher's purposeful and deliberate failure to obtain consent, thereby violating an individual's interest in self-determination and autonomy. The first type of misconduct is that of researchers who conduct experiments on individuals without their knowledge. The second is that of researchers who deliberately fail to disclose to individuals the known and obvious risks of participation in an experiment. This occurs, for example, when a researcher intentionally fails to utilize, or significantly alters, an approved informed consent document. The misconduct involves acts that the criminal law typically punishes: intentional, deceptive, and non-consensual contact with the person of another. (7) These acts are customarily prosecuted because they violate one of our most cherished entitlements--freedom from intentional and nonconsensual contacts with our person. (8)
There is no question that informed consent is lacking in these cases. (9) I focus upon these "easy" cases of non-disclosure in order to center full attention on the question I seek to consider: why culpable acts in human experimentation, which eliminate an individual's right to make informed choices about what will be done to her body, are not punished. While other forms of misconduct in human subject research exist, (10) and will be the subject of future articles, the fact that these straightforward cases of misconduct do not result in criminal punishment demonstrates the need to explore the initial question of why the criminal sanction is overlooked.
This Article provides the first framework for understanding why research misconduct in the form of deceit and violations of bodily integrity currently escapes criminal punishment. The framework has two components, which I label "idealization bias" and "social benefit bias." (11) Idealization bias refers to the difficulty individuals may have in viewing researchers, who are often doctors, (12) as criminals deserving of punishment. Social benefit bias refers to the hypothesis that research misconduct is often ignored or forgiven because of the perceived societal value of the research.
This Article posits that idealization and social benefit bias may affect decision-making in ways that can result in researchers being immunized from criminal punishment. This implicit immunity is harmful because the state's failure to punish researchers creates expressive harms by displaying attitudes towards victims and perpetrators that negatively affect the values of autonomy and dignity in medical research. While sanctions outside the criminal context do exist, these alternatives not only lack the same expressive impact, but also may inadequately police criminal harm.
This Article unfolds in five parts. Part II discusses idealization and social benefit bias. Part III scrutinizes the expressive role of criminal punishment and the shortcomings of alternative sanctions. Part IV discusses the utility of imposing punishment. Part V addresses arguments against use of the criminal sanction and examines considerations that can guide policy. The Conclusion argues that criminal punishment can restore the protection of dignity and autonomy in human subject research.
II. THE TWO BIASES
This Part explores whether cognitive biases can explain why culpable medical researchers escape criminal punishment. It draws from the lessons of social cognition research, which contribute to our understanding of how individuals process information and draw conclusions. (13) The research demonstrates that people regularly employ "schemas" to quickly categorize and assimilate information. (14) A schema can be "conceptualized as a mental structure which contains general expectations and knowledge of the world." (15) It "represents knowledge about a concept ..., including its attributes...." (16) Stereotypes are the best-known example of a schema. (17) Essentially, schemas provide a mechanism for people to make quick predictions, decisions, or judgments about the overwhelming amount of information they encounter. (18)
Despite the necessity of employing schemas, they create the risk of biased decision-making because they "guide what we attend to, what we perceive, what we remember and what we infer." (19) The two subparts that follow delineate two possible biases that may result from the schema we apply to researchers and to the work that they perform. These biases create the risk of faulty decision-making in the human subject research context and, thus, may explain the failure to utilize the criminal sanction to punish culpable medical researchers. The purpose of identifying these potential biases is to call attention to the possibility of their existence and encourage further empirical inquiry. Idealization bias is explored in Subpart A; Subpart B discusses social benefit bias. The words doctor and researcher are used interchangeably in this Part because the researchers engaged in human subject research are more often than not medical doctors. (20)
A. IDEALIZATION BIAS
"[D]octors are revered as nearly godlike...." (21)
Role schemas, as the name suggests, help people decide what conduct to expect from those in certain roles. (22) Generally, people do not expect criminal behavior from a doctor, despite substantial documentation of the commercialization of science and medicine (23) and the incentives this creates for misconduct. (24) Instead, doctors are often placed on a pedestal. (25) They are perceived as healers and altruistic, honest actors who toil tirelessly for the betterment of mankind. Evidence of this schema can be seen in television portrayals and public opinion polls. (26) In 2006, for example, a nationwide public opinion poll found that doctors and scientists are amongst the most trusted of occupations and professions. (27) In fact, doctors are the most trusted occupation and scientists among the top three, above police officers and professors. (28)
The role schema applied to doctors and researchers creates the risk of an idealization bias. This bias may affect how the acts of researchers are judged. Individuals may interpret the culpable acts of researchers as innocent mistakes or, at most, negligence, rather than as criminal. Hence, the idealization of doctors may explain the reluctance to prosecute them when they are involved in research misconduct.
The evolution of tort doctrine in informed consent cases provides some evidence of this bias. Prior to the 1960s, courts strongly protected an individual's autonomy interests by recognizing the torts of assault or battery against doctors who either failed to adequately inform their patients about the risks of treatment or failed to abide by the consent obtained. (29) The attitude of courts during this period is best expressed by Justice Cardozo's oft-quoted language: "Every 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's consent commits an assault, for which he is liable in damages." (30)
By recognizing the torts of assault or battery in informed consent cases, courts placed the individual's right to self-determination at the fore. Doctors were held liable for violations of consent, whether or not the patient suffered any physical harm, because "the essence of the plaintiff's grievance consists in the offense to the dignity involved in the unpermitted and intentional invasion of the inviolability of his person...." (31) The doctor's good or bad faith was irrelevant because the injury justifying compensation was to the patient's right to be free from non-consensual contact with her person. (32)
However, in the 1960s and 1970s, courts began to shield doctors from battery liability because they presumed that doctors were acting in good faith and for the benefit of the patient. As one court put it:
We believe that medical treatment beyond the scope of a patient's consent should not be considered as an intentional tort or species of assault and battery as it has been viewed in the past. The doctor in a malpractice case is ordinarily not an actor who intends to inflict an injury on his patient and any legal theory which presumes that intent appears to be based upon an erroneous supposition. Instead, the doctor is not one who acts antisocially as one who commits assault and battery, but is an actor who in good faith intends to confer a benefit on the patient. (33)
Idealizing doctors in this fashion caused courts to view the consequences of battery liability as overly punitive. (34) For example, if found liable in battery, a doctor might be required to pay damages out of pocket because malpractice insurance would not be available for "an arguably 'criminal' act." (35) Additionally, the possibility of an award of punitive damages raised concerns. (36) Since courts presumed that doctors were acting in good faith and for the benefit of the patient, these outcomes seemed unduly harsh. Thus, courts began to treat non-consensual encroachments upon the sanctity of the body as a form of medical malpractice sounding in negligence. (37) The concern for doctors appeared to overshadow considerations of individual dignity, autonomy, and self-determination.
The courts' idealization of the medical profession persists even in cases involving researchers who act in bad faith. For instance, Heinrich v. Sweet (38) was a class action lawsuit filed on behalf of terminally ill brain cancer patients who were subjects in radiation experiments without their knowledge. (39) The patients thought they were receiving treatment and were unaware of the deception until a government report uncovering the experiments was published over forty years later. (40) The plaintiffs sued in battery, alleging that the defendants "intentionally injected the class' decedents with toxic substances and irradiated the class' decedents without consent." (41) The researchers acted in bad faith. The victims had not agreed to become research fodder, or to be injected with the experimental radioactive substance. However, despite evidence of intentional deceit, the court dismissed the battery claim and held that the action should be treated as a form of medical malpractice or negligence. (42)
Even in negligence cases, glimpses of idealization bias are present. The majority of jurisdictions utilize the "medical custom" standard as the basis for imposing liability. (43) In determining whether the right to informed consent is breached, the focus of the inquiry is on what the medical community believes is reasonable to disclose. (44) Reliance upon medical community standards assumes that the community will always act in good faith and in furtherance of the best interests of the patient.
A growing number of jurisdictions utilize a standard that focuses upon the information a reasonable person would want to receive in determining liability. (45) The question asked is whether a reasonable person would have consented to the procedure if he or she had been given the undisclosed information. The use of the reasonable person standard again reflects a concern for the idealized doctor because the standard was chosen to protect doctors from the vindictive patient by avoiding placing doctors "in jeopardy of the patient's hindsight and bitterness." (46) A subjective standard would recognize that the patient, not the doctor, has the fight to decide what is in his or her best interest. (47)
That we idealize doctors, even those acting in bad faith, demonstrates the efficacy of idealization bias. Indeed, such reverence overshadows concern for the patient's right to make informed decisions about what is done to her person and relegates protection of the individual's interests in her bodily integrity to a secondary status. (48) The idealization phenomenon is not new. For example, the long-standing therapeutic exception to informed consent allows doctors, in their sole discretion, to withhold information from a patient if they believe the information would cause psychological harm and thus hurt the patient's physical well-being. (49) This exception implicitly assumes doctors acting in good faith and failing to disclose relevant information, not to serve their own ends, but for the benefit of the patient.
Importantly, idealization bias can be overcome in individual cases. (50) After all, some doctors are prosecuted for criminal conduct. However, when these prosecutions occur, there is usually an explanation for why the role schema was conquered. In some cases, the person's role as a doctor was merely coincidental to the conduct. (51) In others, alternative schemas were more salient. For example, the so-called War on Drugs likely "primes" prosecutors and law enforcement to be ever vigilant for evidence of improper drug distribution. (52) Hence, doctors are prosecuted for allegedly improperly prescribing narcotic painkillers to patients. (53) In these cases, the power of the War-on-Drugs prime can explain the ascendance of the drug-dealer schema over the doctor schema. In sum, when doctors are prosecuted, it appears that alternative schemas are more salient and thus defeat idealization bias. (54)
B. SOCIAL BENEFIT BIAS
Another explanation for the failure to prosecute culpable researchers is that they are engaged in socially beneficial research. (55) Researchers perform a service that society believes is worthy, beneficial, and important. Generally, our society accepts the practice of human subject research, despite the fact that serious injury and death can result, (56) because it may lead to cures or treatments for devastating diseases. (57) The desire to foster research that holds the promise of substantial potential benefits may create a willingness to turn a blind eye to intentional misconduct or an unawareness that one's interpretation of conduct is influenced by the motivation to encourage research. (58) This is what I refer to as social benefit bias.
Social cognition research establishes that an individual's motivations can play a significant role in determining "which concepts, beliefs, and rules we apply to a judgment; we may be especially likely to apply those that are congruent with our goals." (59) In fact, motivations may be the most important factor affecting the schema an individual adopts. (60) The failure to punish culpable researchers may stem from fear that punishment would stymie medical research that we are motivated to promote. This desire to advance research may affect how decision-makers interpret researchers' conduct and victims' harm.
Perhaps the best example of social benefit bias, and its close relationship to idealization bias, is Moore v. Regents of the University of California, a case involving surreptitious research. (61) Mr. Moore had a rare and deadly cancer known as hairy-cell leukemia in his spleen. (62) He sought treatment from Dr. David Golde, a prominent cancer specialist at the UCLA Medical Center. He gave Dr. Golde permission to conduct a splenectomy (the surgical removal of his spleen) to treat his leukemia. After the successful procedure, (63) Moore moved to Seattle. (64)
When Dr. Golde asked Moore to return for follow-up treatments, Moore was not suspicious. For the next seven years, Moore dutifully flew from Seattle to California every few months, and underwent sometimes painful medical procedures that included withdrawing samples of "blood, ... skin, bone marrow aspirate, and sperm." (65) He made the trek because Dr. Golde asserted that the procedures were medically necessary (66) and that only he could perform them. (67) Neither assertion was true.
What Moore did not know was that prior to his surgery, Dr. Golde had developed research and financial interests in Moore's cells. (68) The procedures Dr. Golde performed after the successful surgery had nothing to do with treating Moore's leukemia, which was in remission. Instead, Dr. Golde was actively conducting research on Moore's cells solely for financial gain and commercial advantage. Dr. Golde exploited the doctor-patient relationship to ensure that he had exclusive access to Moore's cells. (69) When Moore specifically asked Dr. Golde whether there was any possible research interest or financial benefit in his bodily substances, Dr. Golde repeatedly told him no and "actively discouraged such inquiries." (70) In fact, Dr. Golde went so far as to say that "there was no commercial or financial value" in Moore's tissue. (71)
Dr. Golde never asked Moore for express consent to the removal of his blood and tissue. (72) However, at the close of seven years, Dr. Golde asked him to sign a consent form giving UCLA permission to use the withdrawn tissue for research purposes. (73) Dr. Golde presented the consent form as a mere formality and Moore signed. (74) However, Moore became suspicious when, after he later declined to sign a similar consent form, Dr. Golde offered to pay for his airfare and accommodations at a ritzy Beverly Hills hotel. (75)
Moore hired a lawyer. (76) During his investigation, the lawyer discovered that Dr. Golde had obtained a patent on the cell line developed from Moore's cells. (77) He learned that Dr. Golde had a contract with a biotechnology company that gave Dr. Golde stocks and financing worth more than $3.5 million to "commercially develop" and "scientifically investigate" the cell line. (78) The market value of the cell line was predicted to reach $3 billion. (79) Upon learning of the deception, Moore said that he felt "violated for dollars," "invaded," and "raped." (80) Moore sued Dr. Golde for conversion. (81) His lawsuit was dismissed by the trial court, reinstated by the court of appeals, and finally made its way to the California Supreme Court.
Over strongly worded dissents, the majority refused to extend conversion liability to Moore's situation. It acknowledged that the tort of conversion would protect individual autonomy. (82) However, the court decided against extending the theory to the medical research context because recognition would "create[] disincentives to the conduct of socially beneficial research" that was "of importance to all of society...." (83) In so holding, the court touted protection of "innocent researchers" despite the fact that Dr. Golde was not an innocent researcher acting in good faith. (84)
Invocation of the innocent researcher ideal demonstrates the sometimes intimate relationship between the social benefit and idealization biases. The entire court agreed that Dr. Golde deliberately failed to obtain consent in order to mine Moore's body for cells in furtherance of Dr. Golde's financial interests. Despite this, the majority's primary concern was to avoid stymieing socially useful conduct. (85)
The Moore decision marks an unwillingness to recognize insults to human dignity that result from intentional fraud. What appears to distinguish the Moore case from a typical assault or fraud case, (86) customarily subject to the criminal sanction, is the potential social benefit of the researcher's conduct and a fear that recognition of Moore's interests would stymie future research.
Researchers engaged in intentional misconduct have taken advantage of social benefit bias, intentionally or unintentionally, to deflect attention away from their bad acts, demonize the victim, and shape public opinion. They have become "availability entrepreneurs" (87) who can package events to benefit from social benefit bias. For example, in defending against accusations that his surreptitious mining of Moore's body was for his own financial benefit, Dr. Golde stated: "If there is economic gain, it will be to the people of California." (88) Dr. Golde's attorney described Moore to others as "an ingrate." (89) "Golde saved Moore's life.... 'Most people would embrace the doctor with...
|
