CHAPTER 9 Liability in Clinical Trials Research

A series of highly publicized lawsuits have shaken the world of research on human subjects. In 1999, Jessie Gelsinger died as a result of gene therapy provided in a study at University of Pennsylvania Children’s Hospital.¹ The case quickly settled. The next year, University of South Florida and Tampa General Hospital paid $3.8 million to settle a class action suit filed by patients who claimed that they had received insufficient informed consent for various research protocols in which they had enrolled. In Robertson v. McGee (2001),² 13 patients at Oklahoma University Health Science Center sued in federal court for damages they claim to have received as a result of participation in a clinical trial. The case later settled. The same year, five patients sued researchers at Fred Hutchinson Cancer Center in Seattle, Washington. While a jury cleared investigators in the death of four study participants, it awarded damages in the death of a fifth.³ A related class action suit on behalf of 82 additional research subjects against investigators is pending.⁴ In 2001, Kernke v. The Menninger Clinic Inc.⁵ involved the inpatient trial of a new medication for schizophrenia. During the trial a participant wandered off from a clinic-sponsored outing and died from exposure. Finally, in 2003, a North Carolina psoriasis patient sued his dermatologist for injuries he believed he received as a result of participation in a clinical trial.⁶ The parties settled the suit for an undisclosed amount of money.

Lawsuits involving human research are not new, but they are on the rise. And while there is currently no demonstrable trend, many observers believe that plaintiffs’ attorneys have discovered a new and potentially profitable ground for litigation. A research participant who believes that he or she has been injured or wronged as a result of participation in a research study has several different targets. Research participants may sue the study sponsor, study investigator, medical school, hospital, research center, group practice, or other institution connected with the study, as well as the institutional review board (IRB) that reviewed and approved the study. Although multiple defendants will undoubtedly be named in any research-related suit, the primary and ever-present target of such litigation will likely be the physician-investigators who actually conduct the research study. This chapter will outline and discuss the legal elements and viability of lawsuits brought by participants against physician-investigators who conduct clinical trials.

ISSUES

Legal Bases of Research Liability

Attorneys will frequently name every potential cause of action they can reasonably identify in order to increase the chance of winning. Thus far, plaintiffs in suits against physician-researchers have asserted claims under a parade of legal theories, including: intentional infliction of emotional distress; outrage; battery; intentional misrepresentation; fraud; the violation of federal research regulations; breach of the right to be treated with “dignity”; medical malpractice; and professional negligence. The relative novelty of human subjects research litigation increases the likelihood that multiple and creative causes of action will be alleged in every case for some time. This practice will undoubtedly continue until a critical mass of suits, successful and unsuccessful, has been litigated sufficiently to uncover the most appropriate and viable causes of action. Until that time, much of the commentary and prognostication regarding lawsuits against researchers must remain guarded.

Potential Actions Against Physician-Researchers

Many potential causes of action claimed against investigators, while theoretically viable, might reasonably be disregarded as highly speculative or easily dismissed on other grounds in most instances.

Intentional Infliction of Emotional Distress

“Intentional infliction of emotional distress” requires: (1) extreme and outrageous conduct that exceeds the bounds of decency; (2) intent to inflict emotional distress or reckless action when it was certain that emotional distress would result; (3) emotional distress so severe that no reasonable person could be expected to endure it; and (4) a causal connection between the defendant’s actions and the emotional distress. Although these elements may be present in some isolated research cases, they are not likely to match the facts of a claim against a typical physician-investigator even if a case can be made that he or she acted in a cursory, careless, or negligent manner. Thus, it seems unlikely that suits based on “intentional infliction of emotional distress” will be either broadly successful, or very common.

Outrage

The tort of “outrage” also requires the plaintiff to prove four elements: (1) that the defendant’s conduct was atrocious, intolerable, and so extreme and outrageous as to exceed the bounds of decency; (2) that the defendants acted with the intent to inflict emotional distress or acted recklessly when it was certain or substantially certain that emotional distress would result from the conduct; (3) that the defendant’s actions caused the plaintiff to suffer emotional distress; and (4) that the emotional distress was so severe that no reasonable person could be expected to endure it. “Outrage” is a cause of action that is rarely sustained, very difficult to prove in those jurisdictions where it is accepted, and would ordinarily not fit the facts of the typical clinical trials lawsuit.

Violations of the DHHS Regulations Governing Research—the So-Called “Common Rule”

Some suits appear to base their claims directly on violations of the DHHS regulations governing research—the so-called “Common Rule” ⁷—and similar FDA regulations.⁸ But the Common Rule, FDA guidelines, and other federal research guidelines do not explicitly create causes of action as plaintiffs sometimes assert. Therefore, it will probably not be possible for plaintiffs to rely on violation of the Common Rule or the FDA regulations, in and of themselves, as a cause of action. Federal regulations, however, may be legally relevant in other ways that will be discussed below.

Misrepresentation and Fraud

“Misrepresentation and fraud” requires an intentional misrepresentation of a material fact by the defendant on which the plaintiff justifiably relies to make his or her decision. The case against the researchers at the University of Oklahoma was based in part on fraud. The plaintiffs claimed that the investigator convinced participants that the study vaccine was a treatment rather than an unapproved drug that was being tested solely for toxicity. The Gelsinger case as well contained a fraud claim based on the allegation that physician-investigators withheld information regarding their financial interests and the fact that previous subjects had died. At first glance, the elements of fraud seem to fit the relationship between the research subject and investigator relatively well. A research subject consents to participate in a study after the investigator informs him or her of the conditions of participation. It is reasonable for subjects to rely on the investigators’ representations made during the informed consent process when making the decision whether or not to participate. But on closer examination, and when litigated, misrepresentation and fraud claims may be harder to maintain. For example, to support the claim, the research subject must demonstrate that the investigator made a false representation “knowing it to be false” or in “reckless disregard” for its falsity. While this may of course be true in some claims, the far more likely situation will probably involve carelessly inadequate information or explanations in the informed consent process. Such failures of consent are potentially actionable (most notably through negligence, discussed below), but they do not fit easily under the rubric of fraud.

Battery

Several research suits have included claims of “battery” against investigators. To prove the legal claim of “battery,” a plaintiff must show that the defendant was responsible for an intentional, unwanted, unconsented touching that was either harmful or offensive. There are clear benefits to the research subject plaintiffs in pursuing a battery cause of action. Typically, experts are not required to prove battery as they are in negligence cases. In addition, a plaintiff need not prove actual or tangible damages at all, in order to collect a monetary award. He or she must only demonstrate the unconsented, offensive touching. Finally, juries are allowed to award punitive damages in battery cases. Punitive damages are not available in ordinary negligence cases. The elimination of these evidentiary hurdles and the potential for punitive damages make battery an attractive suit in research litigation in which damages may be hard to demonstrate and the standard of care hard to prove. But ordinarily, battery actions in medical and quasi-medical contexts are successful only where there has been a complete absence of consent, rather than inadequate consent, and thus are quite rare and difficult to maintain. In research litigation, an inadequate informed consent document or process, rather than the absolute absence of consent, is far more likely to characterize the typical research suit scenario.

Violation of Right to be Treated with Dignity — “Dignity Tort” Claims

Some suits have also included a claim that the physician-investigator had violated the research subjects’ “right to be treated with dignity.” At present, there is no recognized tort encompassing the “right to be treated with dignity.” Instead, these series of suits represent plaintiffs’ attorneys’ attempt to pioneer a new cause of action. According to the suits, the “right to be treated with dignity” in clinical trials is predicated on the Nuremberg Code, the World Health Organization’s Declaration of Helsinki, the Belmont Report, federal research guidelines, the common law, and federal and state constitutions.

“Dignity tort” claims that appear in current litigation contend that harms resulting from violations of autonomy and dignity should be compensated, even in the absence of actual injury. Like battery, plaintiffs’ attorneys are understandably drawn to the “dignity” tort because it absolves them of the duty of demonstrating that the physician-researcher’s actions caused the research participant injury, a key hurdle in many research suits. But despite the hopes of the litigants and their attorneys, the proposed “dignity tort” will undoubtedly fail. The supposed dignity tort is only vaguely articulated in the pleadings and justified only broadly and generally on a range of highly indistinct and questionable grounds. Such a claim would almost certainly have to be created out of whole cloth by the courts. In such rare cases where the law recognizes a technical invasion of an individual’s rights or a breach of duty on the part of the defendant in the face of no demonstrable injury, courts sometimes, yet rarely, award only “nominal” damages, e.g., one dollar. Therefore, despite the enthusiasm of plaintiff subjects and the concerns of defendant investigators, breach of dignity will probably play relatively little role in future research litigation.

None of the foregoing discussion should be read to imply that suits based on any one of these legal theories will invariably fail. Any theory, under certain conditions, could be successful. However, the most appropriate and most viable claim will ordinarily be a variant of professional negligence, i.e., research malpractice. Thus, when evaluating research investigators’ legal risk and the future path of litigation, attention should be focused predominantly on how suits will unfold as professional negligence actions.

Suits Based on Negligence

Most research subject claimants will find viable claims only under some theory of negligence—specifically professional negligence. In order to construct a successful negligence action, a plaintiff must demonstrate, by a “preponderance of the evidence” (more likely than not), that the defendant had a duty toward the plaintiff; the duty was breached; the plaintiff suffered harm or damage; and that the breach was the proximate cause of the harm the plaintiff suffered.

Duty

The first element of the negligence claim—duty—will be relatively easy to demonstrate in the vast majority of research cases. After all, even strangers interacting in society have some “duty” to other individuals, even if the content of that duty is relatively modest. It is inescapable that investigators have some manner of duty toward their subjects; it is the content of the duty that will be in dispute. The content of a defendant’s duty depends on the source of the duty and the nature of the relationship between the physician and plaintiff. Part of the physician-researcher’s duty has its origin in the physician–patient relationship and the fact that, in clinical trials, medical care is provided for subjects. In addition, it should be fairly easy to demonstrate that the creation of the researcher–participant relationship creates a duty specific to that relationship. A special duty may attach because the research participant relies on and trusts the physician-investigator’s superior knowledge before agreeing to participate in a research project. Participants depend on the physician-investigator to choose and recommend an appropriate study, to properly explain the study, to inform them of the relevant and material issues, and to appropriately conduct the study. Researchers’ distinct duty to study participants might also emanate from the protocol and the clinical trial contract that the investigator agreed to follow, and the informed consent document and process conducted with the participant.⁹ Whatever the ultimate justification, physician-investigators who recruit patients to enter research trials will invariably be found to have a duty to research participants intrinsically related to their status as researchers. The nature and precise content of this duty, and its breach, will be harder to articulate.

Breach of Duty (Standard of Care)

Demonstrating the second element of the negligence claim—breach of duty—will probably be conceptually and practically difficult, as well as initially unpredictable. There is little relevant case law, or substantial trial court experience available, regarding the construction of a “standard of care” for physician-researchers. Strangers in society, absent any special relationship, have only the duty to act “reasonably” toward one another—i.e., to act as a reasonable person would in the same or similar circumstances. But special relationships between individuals in society create special or additional duties depending on the nature of that relationship. Employers have a duty to provide a safe workplace for their employees. Shopkeepers have a duty to maintain a safe environment for their customers. Professionals of any ilk, physicians, attorneys, architects, engineers, have the duty to act according to the “standard of care” of their calling—as a reasonably prudent professional in the field would act under the same or similar circumstances. Ordinarily, experts in the relevant profession are required to offer evidence of the “standard of care” in the particular enterprise and whether it has been breached. Consequently, expert testimony will play the central role in determining the content of the duty to which physician-researchers will be held—i.e., the “standard of care” against which the physician-researcher’s performance will be measured.

Because research suits against physician-researchers are a form of professional negligence—i.e., research malpractice—the use of expert witnesses will ordinarily be required. Expert witnesses secured by plaintiffs and defendants will be likely expected to describe and explain the complicated dual character of the relationship between the physician-researcher and the research participant. After all, physician-researchers cannot be held strictly and merely to the traditional medical malpractice “standard of care” and the duty to act in the best interests of their patients. On the one hand, much of clinical research does not conform to medical standard of care, nor is it always in the absolute best interest of the participants (e.g., placebo-controlled trial designs pairing an experimental drug against a placebo may be offering a choice between two ineffective treatments). On the other hand, a physician-researcher inescapably assumes additional duties beyond those of a mere practicing physician. As one commentator has explained, “we need to cultivate a conception of the moral identity of the physician-investigator that integrates the roles of the clinician and the scientist without giving predominance to the one or the other.” According to this view, physician-researchers “should be prepared to sacrifice scientific rigor when necessary to protect patients from exposure to severe suffering or disproportionate risks of harm,” but they “should also be permitted to ask subjects to tolerate ‘minor risks and mild-to-moderate discomfort … to conform to scientific protocols.’”¹⁰

In order to describe the content of the standard of care required of physician-researchers, courts will undoubtedly rely on expert testimony to construct a legal expectation that merges the duties of a researcher with those of a practicing physician. Because the case will typically involve medical issues, a physician expert will probably be required. An additional requirement will be knowledge and understanding of the customary practice/standard of care of physician-researchers. An expert may claim this knowledge by virtue of private study, education, or formal training. Knowledge and understanding of physician-researchers’ standard of care might derive also from the prospective expert’s own experience in conducting, designing, and monitoring trials, or from other administrative or regulatory experience in the running of clinical trials.

The most useful and credible expert witness, of course, will be a physician-researcher who has conducted clinical trials and can claim first-hand knowledge of prevailing practices. In the Hamlet (2003) case, for example, the plaintiff claimed that the defendant physician-researcher was negligent by failing, in conducting the experiment, to perform proper and careful practices and procedures in accordance with the standards prevailing in the community in which defendants practiced and pursued pharmaceutical studies at the time. In short, the defendant has been sued for failing to act in accordance with the customary practice of physicians who conduct research. The description and content of the standard will undoubtedly vary somewhat from expert to expert and case to case, especially in the absence of widespread litigation and clarifying case law. But some insight is possible.

The physician-researcher’s legal duty to a research participant (standard of care) will be based on a constellation of interlocking considerations defined, articulated, and explained by the testimony of expert witnesses; these include: (1) prevailing medical practice; (2) adherence to the study protocol; (3) applicable policies, codes, and guidelines; (4) relevant statutes and regulations; (5) physician-researcher duties outside the protocol, applicable codes, and guidelines and policies.

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