Dan’s Flaw

DAN’S [F]LAW: STATUTORY FAILURE TO ENFORCE ETHICAL BEHAVIOR IN CLINICAL DRUG TRIALS

By: Noah Lewellen,* Volume 99 Articles Submission Editor

I. INTRODUCTION

Paul, a sophomore at the University of Minnesota, bursts into a lecture hall, loudly claims to see monsters sitting in the seats, and offers his services in slaying them. The police are called, and Paul is restrained and delivered to a nearby hospital. At that hospital, a psychiatrist determines that Paul is a danger to others and recommends that he be prescribed neuroleptic medication. The doctor notes that Paul is unlikely to take his medication, and he should therefore be civilly committed. A judge agrees, but, as the wait for a bed in a commitment facility is long and the treating psychiatrist has already set forward a treatment plan for Paul, the judge stays his commitment as long as Paul agrees to follow the treatment plan and the recommendations of the doctor. The doctor, who lectures for a large pharmaceutical company and gets paid to recruit research subjects for clinical trials, recommends to Paul that he join one such trial.

Under the statutory scheme in place prior to 2009, Paul was put between a rock and a hard place—forced to choose either to sign up to take an untested clinical drug where he could be placed on a placebo, or be civilly committed for violating his treating psychiatrist’s treatment plan. The Minnesota legislature set out to solve this dilemma with the introduction and passage of Minnesota Statute 253B.095 subdivision 1(d)(4). Under this law, Paul would be “prohibited from giving consent to participate in a clinical drug trial while the [stay of commitment] court order is in effect.”[1] He would, however, still be required to follow the recommendations of his treating physician.[2] Rather than save Paul, however, the statute effectively makes Paul’s choice moot: be civilly committed for violating your treating psychiatrist’s orders, or be civilly committed for giving consent to participate in a clinical drug trial.

While the intent of the law was to protect a vulnerable population from being taken advantage of by unscrupulous doctors,[3] the effect of its language threatens the safety of the very population it set out to safeguard. The law does not hold that patients under stays of civil commitment are incapable of providing consent, thereby removing their ability to consent in clinical trials. Instead the law prohibits it. This leaves vulnerable patients who may be unaware of the contours of the law subject to a hidden catch-22 wherein they are considered capable of providing consent for unsafe clinical trials, but subject to punishment in the form of the revocation of their stay of commitment if they do. The law does not protect patients or disincentive treating physicians, but rather effectively punishes the very people it seeks to protect. It must be rewritten if it is to achieve its goal of enforcing ethical medical behavior and protecting the vulnerable population of the mentally ill.

This Essay will first describe the legal landscape of civil commitment in Minnesota and introduce the case of Dan Markingson, whose experience led to the passage of Minnesota Statute 253B.095 subdivision 1(d)(4), known as “Dan’s Law.”[4] It then discusses the problems with Dan’s Law: (1) absurd consequences resulting from poor statutory construction, (2) lack of incentive structure for reporting violations, (3) lack of incentive structure to actually enforce the law, and (4) lack of appropriate scope. In Part IV, I propose a rewording of Dan’s Law, explain how the change fixes the law to match the intent of its original drafters, and discuss why, in the face of no obvious problems thus far, the law should be changed as soon as possible.

II. THE CASE OF DAN MARKINGSON

Dan Weiss was, by all accounts, a promising young student who graduated in 2000 with an English degree from the University of Michigan.[5] In the three ensuing years, Dan changed. When his mother visited him in Los Angeles in 2003, Dan had changed his last name to “Markingson,” referred to mysterious events, and laid down various charms around his bed to “protect him from evil spirits.”[6]

Dan’s mother eventually convinced him to return to his hometown of St. Paul, Minnesota, but his behavior only worsened.[7] Dan began writing bizarre emails to his mother indicating that he was “eager to attend this storm and SLAY those who deserve slaying.”[8] Then, on November 12, 2003, Dan threatened to kill his mother, she called the police, and he was taken to Fairview University Medical Center.[9]

A. Civil Commitment Procedure

After an individual is reported to the police as being a threat to himself or others, he may be placed under an “emergency hold.”[10] Under this hold, the patient may be held against his will in a treatment facility for up to seventy-two hours.[11] Once an emergency hold is placed, the clock starts ticking and government cogs grind into motion to accommodate the short timeframe. A petition must be filed to provide a longer-lasting solution for a potentially harmful, mentally disturbed individual.[12] The petition may be started by anyone in the community with knowledge of an individual, but may also be started by the treating hospital itself.[13]

Pre-petition procedures are strictly outlined in law.[14] A pre-petition screening team interviews parties with knowledge of the patient and prepares a report for the petition.[15] A qualified psychiatrist or advanced practice nurse performs an exam and prepares a report with a diagnosis for the petition.[16] Finally, the petition must state actual events that show the patient is a threat to himself—through affirmative action or neglect of basic needs—or a danger to others.[17]

Once the petition is completed and filed, the county attorney’s office takes up the case for the petitioner and an attorney is provided for the respondent.[18] A second psychiatrist, independent from the first, then examines the respondent and provides a second assessment for the court.[19] The respondent may elect to choose their own psychiatrist for this second assessment.[20]

Before a commitment hearing, the parties attend a preliminary hearing to settle matters prior to court or to come to an agreement that does not necessarily involve commitment.[21] For example, a continuance might be granted, divergence into a community plan may be approved, or a stay of commitment may be issued.[22]

In the case of a stay of commitment, the respondent is released into the custody of an individual or agency with conditions that are intended to guarantee the care and treatment of the respondent.[23] If such a stay is to last beyond fourteen days of the initially-scheduled hearing, the issuing court must produce an order with “conditions the patient must meet to avoid revocation of the stayed commitment order and imposition of the commitment order.”[24] Violation of these conditions may result in a revocation of the order and result in the respondent’s later involuntary commitment.[25]

B. Dan’s Pre-Petition Screening and Stay of Commitment

Dan’s pre-petition screening was completed on November 14, 2003, two days after his admission to Fairview.[26] The pre-petition report made factual findings about Markingson’s delusional beliefs, including his belief that his mother was a lizard.[27] The pre-petition screening made two more critical findings: that Markingson was a threat to others,[28] and that he was unable to provide for himself the basic necessity of adequate medication.[29] The report also indicates that Markingson was diagnosed with a slew of mental disorders, including Psychosis and Mood Disorder.[30] The report’s preparer recommended a finding of mentally ill and rejected alternative plans that would have required voluntary participation.[31]

On November 20, 2003, Dan Markingson received a stay of commitment pending his completion of a treatment plan prescribed by Dr. Stephen Olson at Fairview Hospital at the University of Minnesota.[32] The order required as part of its conditions that Markingson cooperate with the treatment plan at Fairview University Medical Center until medically discharged and follow all of the aftercare recommendations of his treatment team.[33] On November 20, 2003, Markingson received the order to cooperate with Dr. Olson’s treatment plan.[34] The duration of the initial order is unclear from the record, but Minnesota law allows for a duration of six months without an extension, to a maximum of twelve months.[35] The day after receiving the order, Olson enrolled Markingson in the Comparison of Atypicals in First-Episode Schizophrenia (“CAFÉ”) study.[36]

C. Olson and the CAFÉ Study

At the time of Markingson’s stay of commitment, Olson had been working with AstraZeneca, a large pharmaceutical firm, for two years in various ways, including training representatives on the nature of psychotic disorders and working as an inpatient attending physician in a clinical study.[37] In fact, as of 2006, Olson had received nearly $150,000 from AstraZeneca.[38] The study was designed to compare the effectiveness of Seroquel to two other antipsychotic medications.[39] Patients in the CAFÉ study were randomly assigned one of the three antipsychotics in a double-blind clinical trial and were prohibited from taking other antipsychotics concurrently.[40] In contrast, patients in normal clinical care are not restricted to one antipsychotic medication and may be prescribed different drugs throughout their treatment.[41]

Olson began recruiting patients as the primary investigator for the CAFÉ study in 2002.[42] AstraZeneca contracted with the University of Minnesota to provide $16,362 for the recruitment of each subject.[43] Participation in the CAFÉ study resulted in $327,000 being transferred from AstraZeneca to the University of Minnesota’s Department of Psychiatry.[44] The CAFÉ study would later reveal that there is little to no difference between the effectiveness of Seroquel and the other antipsychotics.[45]

D. Dan in CAFÉ

Dan was discharged from the hospital in late 2003 while still enrolled in the CAFÉ study.[46] In January 2004, Markingson’s mother penned a letter to Olson to inform him that she feared that her son was contemplating suicide.[47] In April 2004, a social worker requested an extension to the court order placing Markingson under Olson’s care, despite Olson previously approving Markingson’s discharge from the hospital and the day treatment he was undergoing.[48] On May 8, 2004, Markingson committed suicide, “mutilat[ing] himself with a box cutter so violently that he nearly decapitated himself.”[49]

E. Fallout and Lack of Remedy

In January 2007, Dan’s mother, Mary Weiss, filed a complaint against AstraZeneca, the University of Minnesota, and the doctors involved in the study.[50] The complaint alleged medical negligence, negligence under Minnesota’s Patient’s Bill of Rights, negligence regarding the information known and released about Seroquel, fraud, unlawful trade practices, and breach of warranty.[51] The district court granted an order for summary judgment in favor of the defendants for a majority of the counts[52] because the University of Minnesota was statutorily protected by the state’s Tort Claims Act.[53] Weiss’ complaint failed to enunciate why AstraZeneca had a duty to indicate conflicts of interest of its participating physicians to patients, so those claims were dismissed with prejudice.[54] In fact, the only claim that survived summary judgment was a claim of malpractice against Olson. [55]

Markingson’s case caught the eye of University of Minnesota bioethicist Dr. Carl Elliott and Minnesota State Representative Karla Bigham. On May 4, 2009, Bigham introduced a bill to the Minnesota House to prohibit civilly-committed patients’ participation in clinical drug trials, and it was unanimously approved.[56] Mary Weiss testified in front of the House committee deciding on the bill that she believed it would protect the rights of the mentally ill in the future.[57] Dan’s Law became effective on August 1, 2009.[58]

III. DAN’S LAW: A FAILURE OF STATUTORY CONSTRUCTION

Dan’s Law inserted text into the language of Section 253B.095 regarding stays of commitment.[59] With the insertion, the section requires that any court order accompanying a stay of commitment include “a condition that the patient is prohibited from giving consent to participate in a clinical drug trial while the court order is in effect.”[60] The section also provides an exception that allows committed individuals to give consent to participate in drug trials upon recommendation by their treating psychiatrist as long as that psychiatrist is not conducting the trial.[61] The only statutory enforcement mechanism for violations of Dan’s Law is the revocation of the patient’s stay of commitment and their immediate civil commitment.[62]

Dan’s Law fails to adequately address the ethical issues raised by Markingson’s case. At best, it has no effect. At worst, it punishes the wrong party and encourages unethical behavior. The flaws in Dan’s Law fall into four main categories: incorrect assignation of punishment for violations, lack of incentive to report violations, lack of incentive to punish violations once discovered, and an insufficient breadth of scope.

A. At Worst, Dan’s Law Absurdly Punishes the Population it Was Designed to Protect

Dan’s Law could have been drafted to read that individuals under a stay of civil commitment are “incapable of providing consent” or “cannot consent” to be entered into clinical drug trials. This language would mirror other statutory language in Minnesota statutes reflecting individuals’ lack of capacity for informed decisions, such as in the case of release of health records when a patient is “unable to provide consent.” [63] Instead, the language used in the statute is unique among Minnesota’s myriad laws.

Dan’s Law requires a court to order that a “patient [under a stay of commitment] is prohibited from giving consent.”[64] The phrase, “prohibited from giving consent” does not appear in any other Minnesota statute.[65] The difference in the language is clear: one phrase indicates that an individual is literally incapable of providing consent and nothing that individual might do at the time could be construed as providing consent. The other phrase, present in Dan’s Law, forbids an otherwise-capable individual from providing consent. The ramifications of violating this prohibition are made clear in subdivision 5: revocation of release and subsequent civil commitment of the individual.[66]

This penalty does not protect a person on a stay of civil commitment from themselves and those looking to take advantage of them. It subjects them to punishment. Dan’s Law was intended to provide a solution to vulnerable individuals, not to corner them. The language of the law must be changed to avoid absurd consequences.

B. Victims and Perpetrators of Violations of §253B.095 Subdivision 1(d)(4) Have No Incentive to Report Such Violations, Meaning Harmful Practices Are More Likely to Occur

The patient has the most to lose by disclosing a violation of Dan’s Law. A violation of an order accompanying a stay of commitment can result in the revocation of the stay—that is, the patient can be involuntarily committed. [67] When a patient is recommended for enrollment in a study by his treating psychiatrist, he is faced with a false choice: (1) enroll in the study, thereby violating Dan’s Law’s prohibition on providing consent; or (2) defy a recommendation of his treating psychiatrist, thereby violating the conditions of his stay of commitment. Both of these options provide the possibility of a revocation of a stay if brought to a judge’s attention. The patient, therefore, has little incentive to report the result of either choice. More importantly, a mentally-ill patient is unlikely to fully understand the contours of the governing law.

The treating psychiatrist and institution also lack incentive to report violations of Dan’s Law. A psychiatrist may be given an exclusion for entering patients into a colleague’s clinical study, but cannot seek an exclusion for their own study. Under the current scheme, a psychiatrist reporting their patient’s consent to enter their own clinical study may result in the patient’s commitment at another treatment facility, thereby losing a potential research subject for which the psychiatrist might receive compensation from the sponsoring pharmaceutical company. In short, a treating psychiatrist would lose money by reporting a patient in violation of Dan’s Law. Moreover, a psychiatrist faces the disincentive to report patients because of the ethically dubious process of signing up a patient for a trial that the doctor believes the patient may not be competent to understand. This disincentive may run from the personal (a psychiatrist’s own conscience) to the professional (colleagues’ and ethicists’ opinions of the doctor and the doctor’s institution).

When neither of the two parties most intimately associated with violations of the law have any incentive whatsoever to report their own actions, harmful violations may be allowed to go unchecked. As was the case with Markingson, such unchecked violations may lead to morbid results. At worst, then, Dan’s Law actually creates reasons for Markingson’s case to reoccur in the future.

C. At Best, Dan’s Law is Toothless Due to Numerous Factors Disincentivizing Its Enforcement

Even if a case manager were to detect and report a violation of Dan’s Law, there is little incentive to do so. Commitment proceedings begin quickly, but commitment itself may be extremely drawn out.[68] Despite the expense of providing for individuals in hospital beds for months, society has a substantial interest in keeping mentally disturbed patients secluded from the general population and treated with neuroleptic medication if they have displayed behavior that indicates that they may be a danger to themselves or others. Thus, when a violation of a stay of commitment order occurs, the case manager is statutorily required to immediately report only “substantial” violations of the order.[69] This is a small attempt to balance the cost- and space-saving boons of stays of commitment with the public necessity to commit dangerous individuals.

Even with a “substantial” violation of an order, judges and mental health referees have discretion to continue the stay, rather than simply revoke it.[70] In many cases, judges may determine the stay to be the better option, mooting the enforcement provisions of Dan’s Law. Historically, there have been serious issues with the current system of involuntary commitment in Minnesota, especially regarding funding, bed space, and emergency-only—versus preventive or long-term—care.[71] Patients have sometimes been committed to facilities that simply cannot meet their treatment needs.[72] Some of these problems persist today: one recent report found major, systemic problems with the civil commitment process and Minnesota’s state security hospitals.[73] Alternatives to commitment, then, are preferable, and judges face decisions as to whether commit an individual for the benefit of their health and society or to provide an alternative that may be just as effective or potentially better. If the patient is receiving effective treatment and their condition is improving, switching their treatment plan to another location and another plan may not seem necessary and, in fact, may be detrimental to the patient. On the balance, judges are likely to err on the side of caution and keep whatever is working. Thus, violations of Dan’s Law may not warrant “punishment” unless they are truly detrimental to the patient.

This dilemma frames the difficult decision for a judge deciding whether or not to enforce Dan’s Law—either the judge enforces the law, revoking the stay order and committing the patient into a program which has long wait times and historically systemic problems, or the judge finds that a violation of Dan’s Law is not “substantial” enough to revoke the order and simply continues the stay. Detriment to the patient may be difficult to determine for the judge. Progress reports may come from the case manager, but also from the treating psychiatrist.[74] In this case, the treating psychiatrist has an incentive to not report declines in a patient’s health for similar reasons as to why they would not report a violation of Dan’s Law in the first place.[75] Thus, not only does the judge have to balance detriment of a violation with the benefit of treatment, those values may be skewed by a third party with a conflict of interest.

Judicial officers, despite their experience and training, are simply not equipped to accurately determine the best treatment plan for a patient—that is the position of the treating psychiatrist. Barring a recommendation from the psychiatrist for commitment, then, the balance generally weighs in favor of continuing a stay of commitment in the face of a potentially “insubstantial” violation of the order. This interpretation and system of enforcement necessarily rely on the construction of the law, which punishes the patient for such a violation.

D. Dan’s Law Lacks Appropriate Breadth

While Dan’s Law was Mary Weiss’s and Representative Karla Bigham’s brainchild inspired by the stay of commitment order of Dan Markingson, its enactment was meant to protect a vulnerable population: mentally ill individuals involved in the civil commitment process. As discussed above, it fails in protecting individuals and their rights when they are subject to a stay of commitment.[76] Importantly, however, it also completely fails to protect individuals who have actually been committed.

The situation is somewhat different for committed patients because they no longer have the axe of an executed commitment order hanging over their heads, unlike someone under a stay of commitment. Instead of the “stick” of impending commitment, committed patients have the “carrot” of release from that commitment. To be released, patients must generally show that they are competent in supervising their own appropriate medical care or that their needs may be met by community programs, rather than the strict overview of a treatment facility.[77]

Neither Dan’s Law nor any other civil commitment statutes forbid a committed individual from being enrolled in a clinical drug trial.[78] Allowing patients who have not met a relatively low bar of competency to be enrolled in a clinical trial without third party oversight provides an opportunity for the same ethical issues faced by Dan Markingson under a stay of commitment. Dan’s Law, therefore, suffers from a lack of breadth. Extending Dan’s Law as it is currently drafted to committed patients would, however, have little to no effect. Instead, a new law should be constructed that extends protection from being enrolled in a clinical trial to currently-committed patients.

IV. Modifying Dan’s Law and Reassigning Risk

A patient whose psychiatrist recommended their enrollment in a clinical trial prior to Dan’s Law was between a rock and a hard place. The patient is in an inferior bargaining position whereby failing to follow a psychiatrist’s recommendations may result in their involuntary commitment. Even if the psychiatrist does not make the clinical drug trial part of the treatment plan for the patient, the patient may yet feel pressure to comply with the psychiatrist’s informal recommendations. Putting the patient in a position where they must choose between their freedom from commitment and their psychological well-being does not serve society’s purposes in supporting civil commitment or stays of commitment. More importantly, violations of this law are difficult to detect,[79] unpopular to enforce,[80] and fail to provide incentives for parties in power to prevent these dilemmas.[81] A change is needed.

To address the current imbalance in risk, orders committing an individual and orders staying that commitment should be required to include the language: “pharmaceutical companies, treating institutions, and treating psychiatrists are prohibited from enrolling in clinical drug trials patients who are under a commitment or stay of commitment order provided by this chapter, subject to the exception found in 253B.095 subdivision 1(e).” Further, a new subdivision for enforcement should be added allowing the patient to be transferred to another psychiatrist, and subjecting treating physicians and trial supervisors who enroll patients in violation of the law to financial penalties. This narrowly-tailored statute would serve to affect enrollment only of patients under orders of commitment or stays of commitment and would not hinder other patients’ recruitment. This shifts risk to trial supervisors and treating psychiatrists and away from a vulnerable population of patients in the commitment process.

A. Reassignment of Risk to Parties in Power

The risk allocation in the new law would force trial supervisors to invest more resources in monitoring the patients in their drug trials and ensuring that no patients are subject to a hold of commitment or are currently committed. This cost may be contractually distributed between the psychiatrist, research institution, and pharmaceutical company, but, most likely, will be heavily focused on the psychiatrist. After all, the psychiatrist is the individual most likely to know the status of the patient and whether or not they are eligible for the drug trial.

Creating this incentive also reduces some of the ethical tension on the psychiatrist. Under the current scheme, treating psychiatrists risk nothing under Dan’s Law by signing their commitment-stayed or committed patients up for clinical drug trials, as there is no method for assigning liability to the psychiatrists under the law. Conversely, they have a significant amount of money to gain. Under the new scheme, the monetary incentive persists, but a new monetary disincentive arises in the form of liability.

Most importantly, the law shifts the burden of risk off of the individual who is most vulnerable: the individual under a stay of commitment. Focusing the responsibility for good behavior on the psychiatrist and trial supervisor aligns the law with its creators’ intent of codifying ethical medical supervision of patients unable to care for themselves.

B. Creation of Incentives for Reporting and Enforcing

Under the new statute, both patients and case managers have incentive to report violations. Patients have incentive to do so because it provides an escape from the Catch-22 of either following their psychiatrist-given recommendations (i.e., participation in the clinical trial) or being committed. Case managers have an incentive to report violations because a statutory violation for which the government may hold supervisory medical entities liable aligns with government interests of protecting residents’ health and safety. It would not result in a patient’s immediate commitment to a problem-ridden system, but would instead punish a psychiatrist for unethical behavior in the treatment of a vulnerable population.

C. Utility

It is unclear whether the newly-proposed language would have any effect on the current administration of civil commitment and stays of civil commitment. Generally, judges are reluctant to revoke stays of commitment, and it is unclear whether or not violating Dan’s Law in its current form would result in civil commitment. It is also unclear as to how much danger the law poses in its current form, given that only one case study has presented itself, and that from before the enacting of Dan’s Law.

The very nature of the language of the law as is, however, lends itself to cases going underreported or unnoticed, especially given the lack of incentives for treating psychiatrists and patients to report violations. The potential benefits of changing the law—preventing another tragedy and protecting a vulnerable population—outweigh the very minor drawbacks of changing the law. While some may argue there is only a theoretical benefit to changing the law’s language, there are no benefits, theoretical or otherwise, to keeping the law as it stands today.

V. CONCLUSION

The sad case of Dan Markingson exposed pressures facing psychiatrists treating patients under stays of commitment and demonstrated how such pressures can bring out unethical behavior that requires regulation. The fallout from his case, including the failed lawsuit and the swift enactment of Dan’s Law showed that the state of Minnesota disapproved of the behavior undertaken by Dr. Olson and the University of Minnesota. The intent of the law was to make sure Markingson’s case was never repeated.

Unfortunately, the law was poorly constructed. Instead of punishing trial supervisors, in practice it punishes no one (at best) or the patient (at worst). Should Markingson’s case have repeated itself in the past six years since the law’s enactment, it is unlikely there would have been a different legal outcome. As far as we know, no such case has occurred, but given the lack of incentives in place for reporting violations, it is possible that such a case has actually occurred and gone unnoticed. The impunity that exists under the current statutory regime for parties that have a duty to care for patients is ineffective at preventing another Dan Markingson.

My proposed solution replaces the current assignation of blame to the patient with liability for clinical drug trial supervisors—psychiatrists, research institutions, and pharmaceutical companies. This is, I believe, what the law intended to do in the first place: force parties that stand the most to gain from the current scheme to prevent another tragedy.