Note

Permission to Destroy: How a Historical Understanding of Property Rights can Reign in Consent Searches

Consent searches are by far the most common tool to circumvent the Fourth Amendment’s warrant requirement. Though police officers have the property owner’s permission, the searches they conduct are not always harmless. Without probable cause or reasonable suspicion, consent searches have justified officers’ destruction of car parts, electronics, and shoes. Are officers allowed to damage property after receiving consent to search a person’s belongings? In some jurisdictions, a consent search becomes unreasonable when officers destroy property, entitling the owner to money damages in civil litigation or the exclusion of evidence in criminal prosecutions. In other jurisdictions, an owner’s consent means she has forfeited the right to have her property stay intact. This Note’s first contribution is identifying and examining this consequential circuit split.

To resolve Fourth Amendment ambiguities, the Supreme Court has increasingly turned to the common law in place at the Founding. The mishandling and destruction of colonists’ personal property by British soldiers acting pursuant to general warrants and writs of assistance helped to spur the Revolutionary War. This Note’s second contribution applies Founding-era evidence to consent search doctrine. By drawing on colonial records, this Note offers an originalist argument for restraining consent searches.

Introduction

Just before daybreak on March 31, 2011, ten law enforcement officials arrived at the Chicago apartment where Jai Crutcher and Christopher Colbert, brothers by adoption, lived with their families.1 1.Colbert v. City of Chicago, 851 F.3d 649, 652 (7th Cir. 2017); id. at 661 (Hamilton, J., concurring in part and dissenting in part).Show More The officers told Crutcher they were there to conduct a parole check, and Crutcher consented to the search.2 2.Id. at 652 & n.1 (majority opinion) (“The terms of Crutcher’s release required him to ‘refrain from possessing a firearm or other dangerous weapon,’ ‘consent to a search of [his] person, property, or residence under [his] control,’ and ‘comply with any additional conditions the Prisoner Review Board has or may set as a condition of [his] parole or mandatory supervised release including, but not limited to: ELECTRONIC MONITORING FOR DURATION.’” (alterations in original)).Show More As the police moved through the house, their search quickly turned destructive. In testimony that Judge David Hamilton of the U.S. Court of Appeals for the Seventh Circuit called “disturbing,” the brothers described “the fright of their children as officers broke holes in the walls, cut open a couch, [and] tore doors off of cabinets.”3 3.Id. at 661 (Hamilton, J., dissenting in part). Both the majority and dissenting opinions recounted the facts in the light most favorable to the plaintiffs because the case was on appeal from a grant of summary judgment for the defendants. Id. at 654 (majority opinion); id. at 661 (Hamilton, J., dissenting in part). Therefore, the account of property damage recited here came from the plaintiffs’ perspective. In the officers’ depositions, they “claimed they did not remember many of the events of March 31, 2011.” Id. at 662.Show More In total, the officers damaged, dismantled, or destroyed: a weight bench, clothing, the basement door, the stairs, bedroom dressers, an electronic tablet, a stereo, a television, photographs of Crutcher’s grandmother, wall insulation, a kitchen countertop, and shelf hinges.4 4.Id. at 661, n.1 (Hamilton, J., dissenting in part); id. at 652–53 (majority opinion).Show More The officers tracked dog feces through the house during their search.5 5.Id. at 652 (majority opinion).Show More One officer allegedly “unholstered his firearm and threatened to shoot Crutcher’s six-week-old puppy before leaving the dog outside, where it was lost.”6 6.Id. at 661 (Hamilton, J., dissenting in part).Show More Crutcher and Colbert subsequently brought a § 1983 civil rights suit against the City of Chicago and four individual officers for violating their Fourth Amendment rights.7 7.Id. at 653–54, 656 (majority opinion).Show More The district court dismissed the complaint, the Seventh Circuit affirmed, and the brothers were left to foot the bill.8 8.Id. at 654, 661. Most courts have held that harms like these do not violate the Takings Clause or related provisions of state constitutions, making this Note’s proposal all the more important. See Lech v. Jackson, 791 Fed. App’x. 711, 719 (10th Cir. 2019); see also Maureen E. Brady, The Damagings Clauses, 104 Va. L. Rev. 341, 394–95 (2018) (describing several instances in which the government compensated property owners for police-inflicted damage).Show More

Whether, or how, property damage should affect the reasonableness of a consent search has divided the lower courts. In some jurisdictions, property damage has no effect on the legality of a consent search or potential remedies. In other jurisdictions, when police damage property, a search that began with the owner’s permission becomes per se unreasonable. In still others, officers may damage property so long as they do not render it unusable. Drawing on Founding-era evidence and the common law, this Note argues that mishandling and destroying property during consent searches would have been anathema to the Constitution’s Framers. This Note is the first to use the Fourth Amendment’s history to answer whether consent searches are constitutional when they involve property damage. Academics and advocates have frequently attacked the lax “voluntariness” requirement of consent searches, and they rightly note that many individuals agree to invasive searches without knowing they have the right to refuse.9 9.See, e.g., James C. McGlinchy, Note, “Was that a Yes or a No?” Reviewing Voluntariness in Consent Searches, 104 Va. L. Rev. 301, 303 (2018); Gerard E. Lynch, Why Not a Miranda for Searches?, 5 Ohio St. J. Crim. L. 233, 237, 245 (2007); Marcy Strauss, Reconstructing Consent, 92 J. Crim. L. & Criminology 211, 212 (2001); Oren Bar-Gill & Barry Friedman, Taking Warrants Seriously, 106 Nw. U. L. Rev. 1609, 1661–62 (2012).Show More But the scope of consent searches is just as important and is more likely to be taken up by the Supreme Court.10 10.While the Supreme Court has explicitly rejected a requirement that consent be given knowingly or intelligently, the Court has said relatively little about the scope of consent searches. See, e.g., Schneckloth v. Bustamonte, 412 U.S. 218, 227 (1973). In addition, Justices on the Court today often find government overreach when private property is concerned. See, e.g., Cedar Point Nursery v. Hassid, 141 S. Ct. 2063, 2072 (2021) (holding that a California regulation giving union organizers access to farm workers constitutes a per se physical taking); Ala. Ass’n of Realtors v. Dep’t of Health and Human Servs., 141 S. Ct. 2485, 2489 (2021) (per curiam) (concluding that a federal eviction moratorium intruded on property owners’ right to exclude).Show More

Part I introduces consent searches, explaining their significance and situating them in Fourth Amendment doctrine. Part II describes how different circuits have addressed the question of property damage during consent searches and dissects their underlying reasoning. Part III uses Founding-era evidence to advocate limitations on consent searches. Part III also offers a workable test—one in accord with the primacy of property rights during the Founding—for identifying property damage that exceeds the scope of consent searches. Finally, Part IV anticipates and responds to objections.

  1. Colbert v. City of Chicago, 851 F.3d 649, 652 (7th Cir. 2017); id. at 661 (Hamilton, J., concurring in part and dissenting in part). ↑
  2. Id. at 652 & n.1 (majority opinion) (“The terms of Crutcher’s release required him to ‘refrain from possessing a firearm or other dangerous weapon,’ ‘consent to a search of [his] person, property, or residence under [his] control,’ and ‘comply with any additional conditions the Prisoner Review Board has or may set as a condition of [his] parole or mandatory supervised release including, but not limited to: ELECTRONIC MONITORING FOR DURATION.’” (alterations in original)). ↑
  3. Id. at 661 (Hamilton, J., dissenting in part). Both the majority and dissenting opinions recounted the facts in the light most favorable to the plaintiffs because the case was on appeal from a grant of summary judgment for the defendants. Id. at 654 (majority opinion); id. at 661 (Hamilton, J., dissenting in part). Therefore, the account of property damage recited here came from the plaintiffs’ perspective. In the officers’ depositions, they “claimed they did not remember many of the events of March 31, 2011.” Id. at 662. ↑
  4. Id. at 661, n.1 (Hamilton, J., dissenting in part); id. at 652–53 (majority opinion). ↑
  5. Id. at 652 (majority opinion). ↑
  6. Id. at 661 (Hamilton, J., dissenting in part). ↑
  7. Id. at 653–54, 656 (majority opinion). ↑
  8. Id. at 654, 661. Most courts have held that harms like these do not violate the Takings Clause or related provisions of state constitutions, making this Note’s proposal all the more important. See Lech v. Jackson, 791 Fed. App’x. 711, 719 (10th Cir. 2019); see also Maureen E. Brady, The Damagings Clauses, 104 Va. L. Rev. 341, 394–95 (2018) (describing several instances in which the government compensated property owners for police-inflicted damage). ↑
  9. See, e.g., James C. McGlinchy, Note, “Was that a Yes or a No?” Reviewing Voluntariness in Consent Searches, 104 Va. L. Rev. 301, 303 (2018); Gerard E. Lynch, Why Not a Miranda for Searches?, 5 Ohio St. J. Crim. L. 233, 237, 245 (2007); Marcy Strauss, Reconstructing Consent, 92 J. Crim. L. & Criminology 211, 212 (2001); Oren Bar-Gill & Barry Friedman, Taking Warrants Seriously, 106 Nw. U. L. Rev. 1609, 1661–62 (2012). ↑

  10. While the Supreme Court has explicitly rejected a requirement that consent be given knowingly or intelligently, the Court has said relatively little about the scope of consent searches. See, e.g., Schneckloth v. Bustamonte, 412 U.S. 218, 227 (1973). In addition, Justices on the Court today often find government overreach when private property is concerned. See, e.g., Cedar Point Nursery v. Hassid, 141 S. Ct. 2063, 2072 (2021) (holding that a California regulation giving union organizers access to farm workers constitutes a per se physical taking); Ala. Ass’n of Realtors v. Dep’t of Health and Human Servs., 141 S. Ct. 2485, 2489 (2021) (per curiam) (concluding that a federal eviction moratorium intruded on property owners’ right to exclude). ↑

Vagueness and Nondelegation

The void-for-vagueness doctrine and the nondelegation doctrine share an intuitive connection: when Congress drafts vague statutes, it delegates lawmaking authority to courts and the executive. In three recent cases, the Supreme Court gave expression to this link by speaking of the doctrines using nearly identical vocabulary. Notably, Justice Gorsuch suggested that as the nondelegation doctrine waned during the second half of the twentieth century, vagueness replaced it,—doing much of the doctrinal work that nondelegation would have done otherwise.

This Note tests that historical claim, and in doing so, offers two main contributions. First, it concludes that as a historical matter, Justice Gorsuch tells only part of the story. Although early vagueness doctrine in the late 1800s had strong streaks of nondelegation, vagueness doctrine of the post-New Deal era did not. The latter vagueness instead turned toward protecting individual rights and preventing racial discrimination by state and local governments. Here, nondelegation concerns were absent.

But the Roberts Court has rebooted the early vagueness doctrine that did indeed incorporate nondelegation. Modern vagueness cases thus resemble early vagueness cases. In these cases, absent are questions of individual rights, replaced by a focus on the separation of powers. In effect, there are two vagueness doctrines, one focused on individual rights and another centered around the separation of powers. This Note thus offers its second contribution: categorizing the Court’s vagueness cases and recognizing the categories for what they are.

“[O]nce we lift the veil of the void-for-vagueness doctrine, the revelations can be far reaching.”1 1.Risa L. Goluboff, Dispatch from the Supreme Court Archives: Vagrancy, Abortion, and What the Links Between Them Reveal About the History of Fundamental Rights, 62 Stan. L. Rev. 1361, 1387 (2010).Show More

Introduction

Suppose Congress enacts a statute that reads as follows: “Any person engaging in morally blameworthy conduct or lacking good moral character shall be punished as provided by this Code.” Is this statute unconstitutional? If so, why? Is it because of the void-for-vagueness doctrine, under which vague criminal laws violate the Constitution’s due process protections? Or is it because of the nondelegation doctrine, under which Congress cannot delegate its Article I legislative power to the executive and judicial branches through unintelligible statutes?

Or is it both?

In three recent U.S. Supreme Court cases, decided within a year of each other, these two relatively dormant doctrines—vagueness and nondelegation—simultaneously reemerged. In United States v. Davis2 2.139 S. Ct. 2319, 2336 (2019).Show More and Sessions v. Dimaya,3 3.138 S. Ct. 1204, 1223 (2018).Show More the Court struck down provisions in the federal criminal code as void for vagueness, while in Gundy v. United States, the Court addressed a nondelegation challenge to Congress’s delegation of authority to the Attorney General.4 4.139 S. Ct. 2116, 2122 (2019).Show More

At first glance, vagueness and nondelegation appear more different than alike. The Court has located the nondelegation doctrine in the Constitution’s “Vesting Clauses”—the Article I, Article II, and Article III provisions which vest the legislative, executive, and judicial powers in their respective branches—while vagueness doctrine has its roots in fair notice concerns and the Due Process Clauses. Vagueness’s most prominent application has been in cases involving state and local vagrancy offenses and status crimes, while the nondelegation doctrine has been employed in largely conservative-libertarian projects aimed to rein in the ever-expanding administrative and regulatory state.

Despite these differences, the two doctrines share an intuitive connection: when legislatures draft vague statutes, they delegate lawmaking authority to other branches of government. The Court gave expression to this link in Dimaya, Davis, and Gundy, describing the two doctrines using starkly similar vocabulary and shedding light on their interrelatedness. In Dimaya, Justice Kagan referred to vagueness as the “corollary” of the separation of powers that undergirds the nondelegation doctrine.5 5.Dimaya, 138 S. Ct. at 1212.Show More In his Dimaya dissent, Justice Thomas noted that the “Court’s precedents have occasionally described the vagueness doctrine in terms of nondelegation.”6 6.Id.at 1248 (Thomas, J., dissenting).Show More Most notably, in Gundy, Justice Gorsuch argued that “most any challenge to a legislative delegation can be reframed as a vagueness complaint,” and that the Court’s “void-for-vagueness cases became much more common soon after the Court began relaxing its approach to legislative delegations.”7 7.Gundy, 139 S. Ct. at 2142 (Gorsuch, J., dissenting).Show More That is, as the Court backed away from using the nondelegation doctrine to police Congress’s delegation of its legislative power in the second half of the twentieth century, the Court began using vagueness to do the work that nondelegation would have done otherwise.

This Note picks up on the thread that Justice Gorsuch started in Gundy and explores the relationship between vagueness and nondelegation. In so doing, this Note offers two main contributions.

First, it concludes that as a historical matter, Justice Gorsuch’s claim about vagueness replacing nondelegation tells only part of the story. The Note looks to pre- and post-New Deal doctrinal development of both vagueness and nondelegation to conclude that while the doctrines have some overlap, Justice Gorsuch overstated their connection. The Court’s vagueness cases from the late 1800s, the early days of the doctrine, did indeed police legislative delegations. But the cases that came after 1937 did not. The Court instead began using vagueness to protect individual rights like free speech. It also wielded vagueness to protect racial minorities from invidious discrimination by state and local police. In these post-New Deal vagueness cases, federal nondelegation concerns were largely absent. This version of vagueness did not replace the nondelegation doctrine, which the Court largely discarded.

Still, the Roberts Court picked up where the early vagueness cases left off; nondelegation again entered the realm of vagueness. In modern vagueness cases, concerns of individual rights and free speech are absent. Also absent are issues of invidious racial discrimination. These cases instead emphasize the proper constitutional role of Congress, the executive, and the judiciary within the federal separation of powers. To the extent that the Court and Justice Gorsuch see an overlap between vagueness and nondelegation, it is this line of cases that they see.

In effect, there are two vagueness doctrines. One comprises the majority of the Court’s vagueness cases after the New Deal era, including the landmark case Papachristou v. City of Jacksonville. The second has its origins in the earliest vagueness cases. And although this latter doctrine subsided after 1937, the Court has revived it in recent cases like Dimaya and Davis.

This Note categorizes the Court’s vagueness cases into (1) Rights-Based Vagueness and (2) Structure-Based Vagueness. Although both categories of cases involve due process concerns, they diverge from there. Cases like Papachristou, and their emphasis on individual rights and equal protection, comprise Rights-Based Vagueness. In contrast, Structure-Based Vagueness is the vagueness that the Court employs in Dimaya, Davis, and Gundy. In these latter cases, the Court emphasizes nondelegation and the separation of powers. To the extent that vagueness and nondelegation converge, it is in the context of Structure-Based Vagueness. This Note thus offers its second contribution: categorizing the Court’s vagueness cases and recognizing the categories for what they are.

Recognizing Structure-Based Vagueness for what it is has important implications. Identifying this category adds analytical clarity to the literature on the intersection of vagueness and nondelegation, which to this point has remained cursory and underdeveloped. It further offers insight into how a vagueness doctrine that was previously wielded to address racial discrimination by local police has transformed into a vagueness doctrine that seemingly only has purchase in challenges to federal malum prohibitum crimes. This Note thus adds to the realist literature that views vagueness doctrine as a doctrinal makeweight, which can be reshaped to serve broader and unrelated judicial values and priorities.

Identifying Structure-Based Vagueness has practical consequences too. Structure-Based Vagueness offers common ground to criminal justice reformers and immigrant rights advocates on the one hand, and conservative-libertarians interested in curbing the power of the federal government on the other. By employing the rhetoric of separation of powers in their vagueness arguments, criminal justice reformers and immigrant rights advocates can win meaningful progressive victories from a Court enamored with nondelegation. Moreover, Structure-Based Vagueness offers a limiting principle to opponents of a more aggressive nondelegation doctrine. By tying Structure-Based Vagueness and its nondelegation component to their underlying rationales, skeptics of the nondelegation doctrine can cabin its application to only criminal and penal laws, reducing the potentially harmful impact that a more rigid doctrine would have on environmental, labor, and other economic regulations.

This Note proceeds in four Parts. Part I provides a brief summary of the vagueness and nondelegation doctrines and canvasses literature that addresses their intersection. It then summarizes the Court’s decisions in Dimaya, Davis, and Gundy and draws out Justice Gorsuch’s specific claim about the relationship between vagueness and nondelegation. Part II inspects the historical trajectory of both doctrines, beginning just before the Lochner era and ending with today’s Roberts Court. It uses this history to challenge Justice Gorsuch’s claim. Part III then categorizes vagueness into its two conceptions—Rights-Based Vagueness and Structure-Based Vagueness. Part IV explores the theory behind Structure-Based Vagueness and identifies future applications. A brief conclusion follows.

  1. Risa L. Goluboff, Dispatch from the Supreme Court Archives: Vagrancy, Abortion, and What the Links Between Them Reveal About the History of Fundamental Rights,
    62

    Stan. L. Rev.

    1361, 1387 (2010).

    ↑

  2. 139 S. Ct. 2319, 2336 (2019). ↑
  3. 138 S. Ct. 1204, 1223 (2018). ↑
  4. 139 S. Ct. 2116, 2122 (2019). ↑
  5. Dimaya, 138 S. Ct. at 1212. ↑
  6. Id. at 1248 (Thomas, J., dissenting). ↑

  7. Gundy, 139 S. Ct. at 2142 (Gorsuch, J., dissenting). ↑

Proving Causation in Clinical Research Negligence

Investigators conducting clinical research create a risk of harm to their human subjects. The common law recognizes a variety of duties that these investigators owe to their subjects. When they breach these duties, such as by negligently designing the study or failing to obtain informed consent, subjects who experience a negative outcome relative to not having participated in the study should be able to maintain a cause of action for negligence against the investigators.

Yet when researchers are negligent, it will often be impossible to show whether the study caused any individual subject’s injuries. The infamous SUPPORT study, in which researchers should have reasonably foreseen that they were exposing randomly selected infants to a higher risk of death, is one example. As the subsequent litigation over that study showed, traditional principles of causation operate to make it difficult or impossible for research subjects to pursue such claims against investigators. This is because the factual circumstances of most clinical research preclude individual plaintiffs from being able to show that their injuries were more-likely-than-not caused by their participation in the study.

The loss of chance doctrine developed in medical malpractice suits provides one potential solution for overcoming this causation problem. An even better solution, which provides optimal deterrence and as-good-as-possible compensation for injured subjects, would be for courts to adopt a theory of “marginal causation,” which permits proof of causation by the aggregate marginal damages suffered by plaintiffs as a group, as an extension of the existing doctrines of loss of chance and alternative liability.

Introduction

Human-subjects research is vital for advancing scientific and medical knowledge. In particular, the development of new drugs relies on studies carried out on human volunteers. The COVID-19 pandemic and the corresponding race to develop a vaccine have placed the risks and rewards of medical research in the spotlight.1 1.See, e.g., Carl Zimmer, Jonathan Corum & Sui-Lee Wee, Coronavirus Vaccine Tracker, N.Y. Times, https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.​html[https://perma.cc/MTG4-6P9H] (last visited Oct. 20, 2020).Show More While there is much concern about the safety of potential vaccines for the public,2 2.Katie Thomas, Experts Tell FDA It Should Gather More Safety Data on Covid-19 Vaccines, N.Y. Times (Nov. 9, 2020), https://www.nytimes.com/2020/10/22/health/covid-vaccine-fda-advisory-committee.html [https://perma.cc/A8AY-SFJE].Show More scant attention has been placed on the risks to participants in the preclinical trials, which include tens of thousands of volunteers.3 3.William A. Haseltine, The Risks of Rushing a COVID-19 Vaccine, Sci. Am. (June 22, 2020), https://www.scientificamerican.com/article/the-risks-of-rushing-a-covid-19-vaccine/ [https://perma.cc/QG6D-P26G].Show More Indeed, three COVID-19-vaccine clinical trials were halted due to safety concerns.4 4.Carl Zimmer, 3 Covid-19 Trials Have Been Paused for Safety. That’s a Good Thing., N.Y. Times (Nov. 23, 2020), https://www.nytimes.com/2020/10/14/health/covid-clinical-trials.htm​l [https://perma.cc/J377-L62Z].Show More Although nothing suggests that these studies have deviated from appropriate ethical standards,5 5.Id. Monitoring and reacting appropriately to adverse events are part of routine clinical research. SeeFDA, Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs—Improving Human Subject Protection 3–6 (2009), https://www.fda.gov/​media/72267/download [https://perma.cc/AE2L-ANDA].Show More the demand for a speedy solution and the prospect of financial reward create complicated ethical pressures.6 6.U.S. Dep’t Health & Hum. Servs., Explaining Operational Warp Speed (2020), https://www.nihb.org/covid-19/wp-content/uploads/2020/08/Fact-sheet-operation-warp-spee​d.pdf [https://perma.cc/94NK-MVJL]; Emily A. Wang, Jonathan Zenilman & Lauren Brinkley-Rubinstein, Ethical Considerations for COVID-19 Vaccine Trials in Correctional Facilities, 324 JAMA 1031 (2020); Euzebiusz Jamrozik & Michael J. Selgelid, COVID-19 Human Challenge Studies: Ethical Issues, 20 Lancet Infectious Diseases e198, e199–e202 (2020).Show More Besides these highly publicized Phase 3 trials, the National Institutes of Health (“NIH”) reports that there are currently 947 studies conducting human-subjects research on COVID-19.7 7.ClinicalTrials.gov, https://clinicaltrials.gov/ct2/results?cntry=US&Search=Apply&recrs=‌a&recrs=f&recrs=d&age%20_v=&gndr=&type=&rslt= [https://perma.cc/RC4E-CTK8] (last visited Oct. 1, 2021) (selecting “COVID-19” for “Condition or disease,” “United States” for “Country” and “Recruiting,” “Enrolling by invitation,” and “Active, not recruiting” from “Status”).Show More

Beyond COVID-19, NIH reports that there are 34,907 studies involving human subjects that are recruiting, enrolling, or active in the United States.8 8.ClinicalTrials.gov, https://clinicaltrials.gov/ct2/results?cntry=US&Search=Apply&recrs=‌a&recrs=f&recrs=d&age%20_v=&gndr=&type=&rslt= [https://perma.cc/XR6G-GPFA] (last visited Oct. 1, 2021) (selecting “United States” for “Country” and “Recruiting,” “Enrolling by invitation,” and “Active, not recruiting” from “Status”).Show More If carried out correctly, these studies, on COVID-19 or otherwise, will advance the collective knowledge of society, increase the quality of medical treatment, and save lives. But these studies also risk treating their human subjects as merely a means to a scientific end.9 9.Immanuel Kant, Groundwork for the Metaphysics of Morals 46–47 (Allen W. Wood ed. & trans., Yale Univ. Press 2002) (1785) (“The practical imperative will thus be the following: Act so that you use humanity, as much in your own person as in the person of every other, always at the same time as end and never merely as means.”).Show More An ethical violation of this nature is particularly insidious in the context of medical research, where subjects often place their trust in medical professionals. Yet clinical research differs from medical treatment because medical professionals conducting research are not acting for the benefit of any specific patient, but rather are attempting to generate scientific knowledge. Any benefit to a specific subject is incidental.10 10.See infraSection II.A.Show More

The history of medical research in the United States, including the forty-year failure of the Tuskegee Syphilis Study to obtain consent from, inform, or treat nearly 400 Black men infected with syphilis11 11.CDC, The Tuskegee Timeline, https://www.cdc.gov/tuskegee/timeline.htm [https://perm​a.cc/422Y-SUUX] (last visited Nov. 19, 2019).Show More shows that investigators in this country are capable of reprehensible research.12 12.Frederick Adams, ForewordtoVivien Spitz, Doctors from Hell: The Horrific Account of Nazi Experiments on Humans, at xv, xv–xxvii (2005).Show More Tort law ought to provide a safeguard against such ethical failures. But it fails to do so because satisfying the traditional requirements of causation is impossible for most clinical research. The loss of chance doctrine, familiar in the medical malpractice context, should be accepted as a means of satisfying causation in clinical research cases. The best way for tort law to address clinical research harms is to extend the canonical Summers v. Tice doctrine of alternative liability to loss of chance.13 13.33 Cal. 2d 80 (1948).Show More This Note calls this proposed approach “marginal causation.”

In Part I, this Note discusses the Surfactant, Positive Pressure, and Pulse Oximetry Randomized Trial Study (“SUPPORT study”), which is a salient instance of possible clinical research negligence. There are good reasons to believe that this study was negligent in its informed consent process and in its design. Yet institutional review boards approved the study and investigators conducted it. While negligence for the research was litigated in Looney v. Moore, the application of Alabama’s traditional causation doctrine by the trial and appellate courts prevented the plaintiff-subjects from even reaching a jury.14 14.18 F. Supp. 3d 1338 (N.D. Ala. 2014), aff’d, 886 F.3d 1058 (11th Cir. 2018).Show More

As Part II describes, there is a sufficient foundation existing in the common law for the courts of most jurisdictions to find that legal duties exist between investigators and subjects in clinical research and that their breach is legally cognizable. Nonetheless, the particular factual circumstances of clinical research preclude subjects from proving causation under traditional negligence doctrine. Investigators’ conduct itself shields them from liability when they negligently conduct their research on human subjects.

Part III explores a potential solution to the failure of traditional doctrine to address clinical research harms in the doctrine of loss of chance, which courts have developed in the face of similar challenges for plaintiffs in medical malpractice actions. It also discusses how the law of mass exposure torts provides a parallel for clinical research negligence. This Part concludes by suggesting that the factual circumstances of clinical research are best met through an extension of the canonical Summers v. Tice doctrine of alternative liability from defendants to plaintiffs. The theory, which this Note terms “marginal causation,” proposes that when a class of vulnerable plaintiffs can show that it collectively suffered a marginal aggregate injury because of a defendant’s conduct, common law courts should permit individual injured plaintiffs to recover for the likelihood that their injuries were actually caused by the defendant’s conduct.

  1. See, e.g., Carl Zimmer, Jonathan Corum & Sui-Lee Wee, Coronavirus Vaccine Tracker, N.Y. Times, https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.​html
    [

    https://perma.cc/MTG4-6P9H] (last visited Oct. 20, 2020). ↑

  2. Katie Thomas, Experts Tell FDA It Should Gather More Safety Data on Covid-19 Vaccines, N.Y. Times (Nov. 9, 2020), https://www.nytimes.com/2020/10/22/health/covid-vaccine-fda-advisory-committee.html [https://perma.cc/A8AY-SFJE]. ↑
  3. William A. Haseltine, The Risks of Rushing a COVID-19 Vaccine, Sci. Am
    .

    (June 22, 2020), https://www.scientificamerican.com/article/the-risks-of-rushing-a-covid-19-vaccine/ [https://perma.cc/QG6D-P26G]. ↑

  4. Carl Zimmer, 3 Covid-19 Trials Have Been Paused for Safety. That’s a Good Thing., N.Y. Times (Nov. 23, 2020), https://www.nytimes.com/2020/10/14/health/covid-clinical-trials.htm​l [https://perma.cc/J377-L62Z]. ↑
  5. Id. Monitoring and reacting appropriately to adverse events are part of routine clinical research. See FDA, Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs—Improving Human Subject Protection 3–6 (2009), https://www.fda.gov/​media/72267/download [https://perma.cc/AE2L-ANDA]. ↑
  6. U.S. Dep’t Health & Hum. Servs., Explaining Operational Warp Speed (2020), https://www.nihb.org/covid-19/wp-content/uploads/2020/08/Fact-sheet-operation-warp-spee​d.pdf [https://perma.cc/94NK-MVJL]; Emily A. Wang, Jonathan Zenilman & Lauren Brinkley-Rubinstein, Ethical Considerations for COVID-19 Vaccine Trials in Correctional Facilities, 324
    JAMA 1031

    (2020); Euzebiusz Jamrozik & Michael J. Selgelid, COVID-19 Human Challenge Studies: Ethical Issues, 20 Lancet Infectious Diseases e198, e199–e202 (2020). ↑

  7. ClinicalTrials.gov, https://clinicaltrials.gov/ct2/results?cntry=US&Search=Apply&recrs=‌a&recrs=f&recrs=d&age%20_v=&gndr=&type=&rslt= [https://perma.cc/RC4E-CTK8] (last visited Oct. 1, 2021) (selecting “COVID-19” for “Condition or disease,” “United States” for “Country” and “Recruiting,” “Enrolling by invitation,” and “Active, not recruiting” from “Status”). ↑
  8. ClinicalTrials.gov, https://clinicaltrials.gov/ct2/results?cntry=US&Search=Apply&recrs=‌a&recrs=f&recrs=d&age%20_v=&gndr=&type=&rslt= [https://perma.cc/XR6G-GPFA] (last visited Oct. 1, 2021) (selecting “United States” for “Country” and “Recruiting,” “Enrolling by invitation,” and “Active, not recruiting” from “Status”). ↑
  9. Immanuel Kant, Groundwork for the Metaphysics of Morals 46–47 (Allen W. Wood ed. & trans., Yale Univ. Press 2002) (1785) (“The practical imperative will thus be the following: Act so that you use humanity, as much in your own person as in the person of every other, always at the same time as end and never merely as means.”). ↑
  10. See infra Section II.A. ↑
  11.  CDC, The Tuskegee Timeline, https://www.cdc.gov/tuskegee/timeline.htm [https://perm​a.cc/422Y-SUUX] (last visited Nov. 19, 2019). ↑
  12. Frederick Adams, Foreword to Vivien Spitz, Doctors from Hell: The Horrific Account of Nazi Experiments on Humans, at xv, xv–xxvii (2005). ↑
  13. 33 Cal. 2d 80 (1948). ↑

  14. 18 F. Supp. 3d 1338 (N.D. Ala. 2014), aff’d, 886 F.3d 1058 (11th Cir. 2018). ↑

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