Christian Lewis v. Sheila D. Moore

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[PUBLISH]
IN THE UNITED STATES COURT OF APPEALS
FOR THE ELEVENTH CIRCUIT
________________________
No. 15-13979
________________________
D.C. Docket No. 2:13-cv-00733-KOB
BILLY RYAN LOONEY, etc., et al.,
Plaintiffs,
CHRISTIAN LEWIS,
By and through his parents, Bernita Lewis
and Earnest Thomas,
DRESHAN COLLINS,
By and through his mother, Sharrissa Cook,
JAYLEN MALONE,
By and through his mother, Nikida Sellers,
Plaintiffs - Appellants,
versus
SHEILA D. MOORE,
Director of the Office of the University of
Alabama Institutional Review Board,
FERDINAND URTHALER, M.D.,
Chairman of the University of Alabama
Institutional Review Board,
WALDEMAR A. CARLO, M.D.,
In his individual capacity,
MASIMO CORPORATION,
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DR. JOHN CARPENTER,
in his individual capacity, et al,
Defendants - Appellees,
INDIVIDUAL MEMBERS OF THE UNIVERSITY
OF ALABAMA INSTITUTIONAL REVIEW
BOARD, THE, etc., et al.,
Defendants.
________________________
Appeal from the United States District Court
for the Northern District of Alabama
________________________
(March 30, 2018)
Before WILSON, and JULIE CARNES, Circuit Judges, and HALL, * District
Judge.
JULIE CARNES, Circuit Judge:
Through their parents, Plaintiffs DreShan Collins, Christian Lewis, and
Jaylen Malone brought claims against Defendants for harms allegedly visited on
Plaintiffs when the latter were enrolled in a clinical study while being treated for
health issues accompanying their premature births. Defendants fall into three
groups: (1) Dr. Carlo, the physician who designed and ran the study; (2) Internal
Review Board (IRB) physicians who approved the study and the informed consent
*
The Honorable James Randal Hall, United States District Judge for the Southern District of
Georgia, sitting by designation.
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materials; and (3) Masimo Corporation, which manufactured medical equipment
used in the study.
Plaintiffs brought claims against the various Defendants for negligence,
negligence per se, breach of fiduciary duty, products liability, and lack of informed
consent. The district court granted summary judgment on all claims. Like the
district court, we conclude that Plaintiffs have failed to establish that participation
in the clinical study caused any injuries, which means that, under Alabama law, the
negligence, negligence per se, breach of fiduciary duty, and products liability
claims were properly dismissed.
Alabama law has not directly addressed the viability of the claim alleging
lack of informed consent. At issue is whether a plaintiff who claims that he did not
give informed consent to medical treatment provided as part of a clinical study
must show that he was injured as a result of that treatment. Based on our review of
analogous Alabama caselaw, we conclude that Alabama law requires that there be
an actual injury caused by the treatment. Accordingly, because Plaintiffs have
failed to establish that their lack of informed consent caused any actual injuries, the
district court appropriately granted summary judgment to Defendants on these
claims as well.
I. BACKGROUND
A. Factual Background
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The University of Alabama at Birmingham was the lead study site for a
national clinical research trial known as the Surfactant, Positive Pressure, and
Oxygenation Randomized Trial (“SUPPORT”). Designed by Dr. Carlo and
approved by the IBR Defendants, the SUPPORT study was created to analyze the
effects of differing oxygen saturation levels on premature infants. At the time of
the study, it was nationally accepted (and neither party contests) that the
recognized standard of care was to keep the oxygen saturation levels of low-birth-
weight infants at between 85% and 95%. This standard notwithstanding, it was
also known that a prolonged period of high oxygen saturation can result in oxygen
toxicity, which leads to an increased risk of “retinopathy of prematurity.” 1 On the
other hand, a prolonged period of low oxygen saturation can result in neuro-
developmental impairment and death. Given the difficulties of calibrating the
optimal oxygen range, the SUPPORT study sought to determine whether, within
the accepted standard of care, there was a more precise range of oxygen saturation
that would better reduce the risk of exposing an infant to either too much or too
little oxygen.
The SUPPORT study randomly divided eligible and enrolled premature
infants into two groups. One group was to be kept at an oxygen saturation level
1
Retinopathy of prematurity is a disease that occurs in premature babies. It causes abnormal
blood vessels to grow in the retina, and can lead to the retina detaching from the back of the eye,
resulting in blindness.
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between 85-89%, which is the low end of the standard-of-care range, while the
other would be kept at an oxygen saturation level between 90-95%, which is the
high end of that range. Further, to ensure double-blind data collection, the study
would employ specialized oximeters (manufactured by Masimo) that would
“mask” to an onlooker the true oxygen saturation levels of the infants. The
oximeters would, however, signal an alarm whenever an infant’s oxygen level
strayed below 85% or above 95%.
Publishing the results of the study in the New England Journal of Medicine,
the study authors concluded that infants in the high-oxygen group were more likely
to be diagnosed with retinopathy while infants in the low-oxygen group were more
likely to die. There was no statistically significant difference in the incidence of
neuro-developmental impairments between the high and low groups.
To enroll in the study, Plaintiffs’ guardians had to execute informed consent
documents that were drafted and approved by Defendants. After the study’s
completion, however, the Department of Health and Human Services authored a
letter questioning whether these informed consent documents had properly
disclosed all of the risks associated with enrollment in the SUPPORT study.
B. Procedural History
Plaintiffs filed the operative Fifth Amended Complaint in the United States
District Court for the Northern District of Alabama asserting claims against
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Defendants for negligence, negligence per se, breach of fiduciary duty, products
liability, and lack of informed consent. Plaintiffs allege that they suffered serious
injuries as a result of their participation in the study. Specifically, Plaintiffs Lewis
and Malone were assigned to the low-oxygen group, with prolonged periods of low
oxygen saturation being associated with neuro-developmental impairment and
death. Fortunately, neither infant died, but they did develop neurological issues.
Plaintiff Collins was assigned to the high-oxygen group, with prolonged high-
oxygen saturation being associated with retinopathy, which can lead to blindness.
Plaintiff Collins did develop retinopathy, but fortunately he did not suffer
permanent vision loss.
Following discovery, Defendants moved for summary judgment asserting
that, based on the undisputed material facts, Plaintiffs had failed to demonstrate
that participation in the SUPPORT study had caused the injuries alleged in the
Complaint. The district court agreed that Plaintiffs had failed to prove that their
injuries were caused by participation in the SUPPORT study, as opposed to being a
consequence of their premature births, and the court granted summary judgment to
Defendants.
II. STANDARD OF REVIEW
“We review de novo the district court’s grant of summary judgment.”
Greenberg v. BellSouth Telecomms., Inc., 498 F.3d 1258, 1263 (11th Cir. 2007).
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Summary judgment is appropriate “if the pleadings, depositions, answers to
interrogatories, and admissions on file, together with the affidavits, if any, show
there is no genuine issue as to any material fact and that the moving party is
entitled to judgment as a matter of law.” Fed. R. Civ. P. 56. Viewing the evidence
in the light most favorable to the nonmoving party, “[t]here is a genuine issue of
material fact if the nonmoving party has produced evidence such that a reasonable
factfinder could return a verdict in its favor.” Greenberg, 498 F.3d at 1263
(quoting Waddell v. Valley Forge Dental Assocs., Inc., 276 F.3d 1275, 1279 (11th
Cir. 2001)).
III. DISCUSSION
We agree that under applicable Alabama law, and taking all inferences in the
light most favorable to Plaintiffs, Plaintiffs have failed to show that enrollment in
the SUPPORT study caused their injuries. And although Alabama law has not
squarely addressed whether the absence of an actual physical injury caused by the
SUPPORT study dooms Plaintiffs’ claims based on Defendants’ failure to obtain
Plaintiffs’ informed consent to participate in that study, 2 we conclude that it does.
We first discuss the causation issue before turning to the informed consent claims.
A. Plaintiffs Have Presented Insufficient Evidence that the
SUPPORT Study Caused Plaintiff’s Alleged Injuries
2
To be precise, this type of claim actually alleges a lack of informed consent. For ease of
reference, however, we will often refer to this claim as an “informed consent claim.”
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The Alabama Supreme Court has made clear that, “to present a jury
question, the plaintiff in a medical-malpractice action must adduce some evidence
indicating that the alleged negligence (the breach of the appropriate standard of
care) probably caused the injury. A mere possibility is insufficient.” 3 Cain v.
Howorth, 877 So. 2d 566, 576 (Ala. 2003) (alterations omitted; emphasis in
original) (quoting Rivard v. Univ. of Alabama Health Servs. Found., P.C., 835 So.
2d 987, 988 (Ala. 2002)); see also Lyons v. Walker Reg’l Med. Ctr., 791 So. 2d
937, 942 (Ala. 2000); Golden v. Stein, 670 So. 2d 904, 907 (Ala. 1995). The
district court concluded that Plaintiffs had failed to show that it was their
participation in the SUPPORT study, as opposed to their premature births and
consequent low birth-weight, that caused Plaintiffs’ injuries. Defendants’ three
experts each recognized that the injuries suffered by Plaintiffs are consistent with
those that extremely low birth-weight infants experience. In other words extreme
prematurity, by itself, carries increased risks of the kinds of neuro-developmental
and respiratory impairments claimed by Plaintiffs. These experts opined that it is
more likely than not that Plaintiffs’ injuries were caused by their prematurity and
its related complications than by any participation in the SUPPORT study.
3
As discussed infra, the requirement that a plaintiff show that negligent medical treatment
caused the injury is found in the Alabama Medical Liability Act, Ala. Code § 6-5-480 et seq. and
§ 6-5-540 et seq. (1975).
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Indeed, Plaintiffs’ own expert, Dr. Hermansen, refused to opine that
Plaintiffs’ injuries were “probably” caused by participation in the SUPPORT
study. Instead, he would say only that the study “significantly increased the risk”
that Plaintiffs would suffer these alleged injuries. Dr. Hermansen never testified
that the SUPPORT study caused Plaintiffs’ medical ailments, or even that the
SUPPORT study probably caused the ailments; he opined only that the study
“significantly increased the risk” that they would suffer from such ailments. In
fact, in his subsequent deposition, Dr. Hersmansen could not identify any specific
alternative care that Plaintiffs should have had but did not receive because of the
study, or any specific medical condition that called for a change in oxygen-
saturation levels for any of the Plaintiffs.
An alleged “increased risk of harm” is not sufficient to survive summary
judgment under Alabama law, which requires proof that the alleged negligence
probably caused the injury. Cain, 877 So. 2d at 576. So strict is Alabama law on
this point that Alabama courts have even rejected “medical monitoring” claims, in
which plaintiffs allege that because prior medical procedures increased their risk of
future harm, they were “injured” by the need, going forward, to self-monitor in
order to detect future medical ailments. See Hinton ex rel. Hinton v. Monsanto
Co., 813 So. 2d 827, 829 (Ala. 2001) (plurality); see also Houston County Health
Care Auth. v. Williams, 961 So. 2d 795, 810–11 (Ala. 2006); S. Bakeries, Inc. v.
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Knipp, 852 So. 2d 712, 716–17 & n.7 (Ala. 2002). Admittedly, Plaintiffs do not
allege that participation in the SUPPORT study exposed them to some future harm.
Instead, they attempt to distinguish the above line of cases by describing their
injury as being the increased risk of harm they faced in the past. But this argument
only highlights the weakness of their position. Whether in the past or in the future,
Plaintiffs can show, at most, only an increased risk of harm, not a probability that
the alleged negligence actually caused any harm. See Knipp, 852 So. 2d at 716
(“Alabama has long required a manifest, present injury before a plaintiff may
recover in tort.”).4
In short, Plaintiffs have not provided evidence that the SUPPORT study
“probably” caused their injuries. For that reason, Plaintiffs’ negligence, negligence
per se, breach of fiduciary duty, and products liability claims are not viable under
4
The cases cited by Plaintiffs—Parker v. Collins, Waddell v. Jordan, and Murdoch v.
Thomas—do not save their claims, either. Collectively, these cases stand for the proposition
that: “the issue of causation in a malpractice case may properly be submitted to the jury where
there is evidence that prompt diagnosis and treatment would have placed the patient in a better
position than she was in as a result of inferior medical care. It is not necessary to establish that
prompt care could have prevented the injury or death of the patient; rather, the plaintiff must
produce evidence to show that her condition was adversely affected by the alleged negligence.”
Parker v. Collins, 605 So. 2d 824, 827 (Ala. 1992) (citing Waddell v. Jordan, 302 So. 2d 74
(Ala. 1974) and Murdoch v. Thomas, 404 So. 2d 580 (Ala. 1981)).
But the problem for Plaintiffs is the absence of any evidence that their conditions were
“adversely affected” by being placed in the SUPPORT study. Plaintiffs’ expert testified that the
SUPPORT study increased the risk that Plaintiffs’ conditions had been adversely affected, but
not that Plaintiffs’ conditions were (or even probably were) adversely affected by the study.
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Alabama law, and the district court correctly granted summary judgment to
Defendants.
B. Plaintiffs’ Informed Consent Claims also Require an Actual
Injury and Therefore Fail as Well
This leaves only Plaintiffs’ informed consent claims. Here, the issue is
whether Alabama law requires that Plaintiffs have an actual injury for such claims
to proceed. If it does, then Plaintiffs’ informed consent claims suffer from the
same defect as their other claims.
As discussed above, it is clear that for a negligence action predicated on
allegedly inadequate medical treatment, the plaintiff must show that he was injured
as a result of the particular treatment. Alabama law, however, has yet to explicitly
address the question whether proof of a medical injury is also required before a
plaintiff can claim that his consent to a medical procedure was not informed.
Specifically, if a plaintiff cannot prove that he suffered an injury as a result of a
particular medical procedure, can he still potentially prevail if he shows that the
doctor failed to obtain his informed consent to that procedure?
The answer to the question depends on how an informed consent claim is
characterized. If an informed consent claim is considered to be a type of medical
malpractice claim governed by the Alabama statute addressing such claims, then it
is clear that a plaintiff must show the existence of an actual injury resulting from
the procedure before he can raise a viable informed consent claim. If an informed
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consent claim is not classified as a malpractice type of claim—or, more
particularly, if an informed consent claim arising out of participation in a medical
study administered as part of the medical treatment does not constitute a
malpractice claim—then we must search through Alabama common law to figure
out just what kind of claim it is. And if, as Plaintiffs argue, an informed consent
claim arising out of a medical study is neither a malpractice nor a negligence
claim, then we (or they) must find some category in which to pigeonhole the claim
so that we can determine its elements.
Alabama law, however, does not expressly tell us whether such an informed
consent claim is subject to the same requirements as a malpractice or negligence
claim, nor does it speak to what the elements of such a claim would be if the claim
finds no home in the malpractice/negligence camp. For that reason, we sought the
guidance of the Alabama Supreme Court in this case as to the proper interpretation
of its state’s law on this question. Specifically, we certified this question to the
Alabama Supreme Court, as the final arbiter of Alabama law. Looney v. Moore,
861 F.3d 1303 (11th Cir. 2017). The Alabama Supreme Court, however, declined
to answer our certified question. See Lewis v. Moore, No. 1160893 (Ala. Sept. 7,
2017) (Order declining to answer certified question). That being so, we now make
our best effort to predict how the Alabama Supreme Court would decide this
question were it required to decide the issue. See State Farm Mut. Auto. Ins. v.
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Duckworth, 648 F.3d 1216, 1224 (11th Cir. 2011) (where, in a diversity
jurisdiction case, a state supreme court has issued no decision directly on point,
“we must anticipate how the Supreme Court would decide [the] case. . . .This
process is not exact; often we must draw our decision from comparisons to
analogous cases.”).
We begin by examining medical malpractice claims generally. A medical
malpractice claim under Alabama law requires proof of an actual injury. The
Alabama Medical Liability Act (AMLA), Ala. Code § 6-5-480 et seq. and § 6-5-
540 et seq. (1975), “applies in any action for injury or damages or wrongful death,
whether in contract or in tort, against a health care provider for breach of the
standard of care.” Ex parte Vanderwall, 201 So. 3d 525, 533 (Ala. 2015)
(quotations and alterations omitted). The term “standard of care” is defined as
“such reasonable care, skill, and diligence as other similarly situated health care
providers in the same general line of practice, ordinarily have and exercise in like
cases.” Ala. Code § 6-5-542(2). As to proving a breach of that standard:
A breach of the standard of care is the failure by a health care provider
to comply with the standard of care, which failure proximately causes
personal injury or wrongful death. This definition applies to all
actions for injuries or damages or wrongful death whether in contract
or tort and whether based on intentional or unintentional conduct.”
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Id. (emphasis added). In short, the text of the statute requires a “personal injury or
wrongful death” before a medical malpractice action5 can be viable.
Indeed, the Alabama Supreme Court has emphasized this requirement in its
own interpretation of the AMLA. For example, in Houston County, plaintiffs in a
putative class action sued a medical center based on the latter’s action in
potentially exposing the plaintiffs to fungal spores. The plaintiffs had suffered no
physical injury but argued that the exposure to a potential harm was, by itself, the
injury. Applying the AMLA, the Alabama Supreme Court disagreed, stating,
“Under current Alabama caselaw, mere exposure to a hazardous substance
resulting in no present manifestation of physical injury is not actionable under the
AMLA where the exposure has increased only minimally the exposed person’s
chance of developing a serious physical disease and that person has suffered only
mental anguish.” Houston County, 961 So. 2d at 810–11. As such, any plaintiffs
who had not actually suffered an infection or other adverse effects from the
exposure had “not suffered a legal injury.” 6 Id. at 811. Thus, Houston County
5
The AMLA only applies to claims against “a health care provider.” Ala. Code § 6–5–548(a).
The Alabama Supreme Court has explained: “Section 6–5–542, Ala. Code 1975 defines a
‘health care provider’ as ‘[a] medical practitioner, dental practitioner, medical institution,
physician, dentist, hospital, or other health care provider as those terms are defined in Section 6–
5–481.’ Section 6–5–481(8) in turn defines ‘other health care providers’ as ‘[a]ny professional
corporation or any person employed by physicians, dentists, or hospitals who are directly
involved in the delivery of health care services.’” Ex parte Vanderwall, 201 So. 3d at 533.
6
The Court did recognize, however, that those patients who had undertaken operations to
remove the infected medical component because of the risk of infection “would have standing to
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makes clear that claims governed by the AMLA require a showing of an actual
physical injury. See also Crutcher v. Williams, 12 So. 3d 631, 648 (Ala. 2008)
(holding that, under the AMLA, a plaintiff must prove that a delay in treatment
“proximately and probably caused actual injury to the plaintiff”).
The next question then is the extent to which the AMLA’s requirement that
an injury occur applies when a claim does not rest on negligent medical treatment,
but instead on an assertion that in performing treatment to which the plaintiff had
consented, the medical care provider conveyed inadequate warnings that thereby
rendered the patient’s consent to be uninformed. On the one hand, there are
indications from Alabama caselaw that the “injury” requirement of the AMLA
applies to informed consent claims, just as it does to traditional medical
malpractice claims based on negligent treatment. In Houston County, the Alabama
Supreme Court stated as a general matter that all of the claims in the case,
including claims for lack of informed consent, were “governed by the Alabama
Medical Liability Act” because they “allege a ‘medical injury’ arising in the
context of their patient-hospital relationship as the basis for each of their claims.”
Houston Cty., 961 So. 2d at 810. Indeed, the Alabama Supreme Court has
“consistently held that it is the substance of the action, rather than the form, that is
bring an action.” Id. at 812. Seemingly, the need for subsequent surgery to remedy or diminish
the potential harm arising from the original surgery is deemed the injury.
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the touchstone for determining whether an action is actually one alleging medical
malpractice” and that “informed-consent claims brought against physicians and
surgeons are governed by the AMLA.” Mock v. Allen, 783 So. 2d 828, 832 (Ala.
2000), abrogated on other grounds by Ex parte Vanderwall, 201 So. 3d 525 (Ala.
2015); see also Ex parte Mendel, 942 So. 2d 829 (Ala. 2006) (analyzing the scope
of plaintiff’s allowable discovery for a lack of informed consent claim under the
AMLA’s discovery rules); Collins v. Ashurst, 821 So. 2d 173, 176 (Ala. 2001), as
modified on denial of reh’g (Nov. 30, 2001) (noting that the AMLA “provides the
applicable standard of care that governs all actions against the health-care
providers specified in the act”).
Moreover, it seems a bit incongruous that a patient subjected to negligent
medical treatment is required to show that the treatment caused his injury, while a
person whose only beef is that he was not fully informed of the risks of a
procedure could prevail even if he suffered no injury at all. On the other hand, in
describing the elements necessary to prove an informed consent claim, Alabama
cases have neglected to mention “an injury” in the list of those elements.
Specifically, in Giles v. Brookwood Health Services, Inc., 5 So. 3d 533, 553–54
(Ala. 2008), and Phelps v. Dempsey, 656 So. 2d 377, 377 (Ala. 1995), the Alabama
Supreme Court explained:
The elements of a cause of action against a physician for failure
to obtain informed consent are: (1) the physician’s failure to inform
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the plaintiff of all material risks associated with the procedure, and (2)
a showing that a reasonably prudent patient, with all the
characteristics of the plaintiff and in the position of the plaintiff,
would have declined the procedure had the patient been properly
informed by the physician.
Giles, 5 So. 3d at 553–54 (quoting Phelps, 656 So. 2d at 377); see also Mendel,
942 So. 2d at 837 (reciting this same standard). Noticeably missing is any
requirement that the undisclosed risk actually materialize or that any injury
actually occur.
But drawing a conclusion that injury is not required for an informed consent
claim, based on the absence of any mention of the need for injury in the above
cases, is a shaky proposition because in each of the above cases there clearly was
an injury, and a serious one. So, there was no cause for the court in those cases to
focus on the need for injury as an element of the claim, and instead the opinions
explored the standards governing whether consent was informed. For example, in
Giles the plaintiff argued that she had not been adequately informed that either of
her ovaries might be removed in an operation when the physician removed the
“wrong” ovary. 5 So. 3d at 533. Likewise, in Phelps, the plaintiff suffered a post-
operative infection that eventually required the amputation of a significant portion
of his foot. In suing based on the absence of informed consent, the plaintiff argued
that he was not adequately apprised of the risk of a post-operative wound infection.
There was no dispute that the plaintiff had been injured. 656 So. 2d at 377.
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Finally, in Mendel, the plaintiff, who argued that he was not adequately informed
about his dentist’s multiple suspensions and revocations,7 was injured when the
dentist punctured the floor of the plaintiff’s right maxillary sinus during an
operation. Mendel, 942 So. 2d at 832. Thus, in the above cases, the courts had no
need to consider whether an injury of the type encompassed by the undisclosed risk
had to be proved before a plaintiff could state an informed consent claim because
in each case the existence of a physical injury formed the basis of the plaintiffs’
claims. 8
For the same reason, the case earlier cited in support of the argument that
Alabama courts require proof of injury as part of an informed consent claim—
Houston County—suffers from the same lack of persuasive punch. To repeat,
Houston held that the AMLA, which requires proof of an injury, applies to an
informed consent claim. But like Phelps, Giles, and Mendel, there was a physical
injury in Houston County. Thus, the Alabama Supreme Court had no need to
examine whether an informed consent claim lacking a physical injury should be
7
Notably, however, Mendel did not decide whether such a theory would be actionable; it only
ruled on the appropriate scope of discovery for such claims under the AMLA.
8
The same is true of the two cases cited by Phelps following its articulation of the elements of a
lack of informed consent claim. See Fain v. Smith, 479 So. 2d 1150 (Ala. 1985) (plaintiff injured
by complications resulting from a pulmonary arteriogram); Fore v. Brown, 544 So. 2d 955 (Ala.
1989) (plaintiff suffered a perforation in his lower esophagus as the result of an esophagus
dilation which was performed during an esophagogastroduodenoscopy).
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analyzed differently with regard to the need for proof of an injury than cases
alleging simply negligent medical treatment.
In short, each party can point to Alabama caselaw in support of an argument
favoring the party’s respective position on the need to prove injury when asserting
an informed consent claim. Defendants, however, have a ready analytic hook to
support their argument that an injury is required: the AMLA and Alabama
common law governing negligence actions, which Defendants argue govern this
action. To bolster their argument that no injury is required, Plaintiffs thus need to
be able to identify some analogous type of claim not requiring injury into which
they can pigeonhole their own claim.
Plaintiffs have attempted to do so. They argue that an informed consent
claim is akin to the tort claim of intentional battery, and that the latter requires no
injury. See Harper v. Winston Cty., 892 So. 2d 346, 353 (Ala. 2004) (“[A]n actual
injury to the body is not a necessary element for an assault-and-battery claim”); see
also Erin Sheley, Rethinking Injury: The Case of Informed Consent, 2015 B.Y.U.
L. Rev. 63 (2015) (“The most critical pragmatic difference between the battery and
negligence standards is that the latter, unlike the former, depends on the existence
of the physical injury.”). The Alabama Supreme Court has recognized that the
AMLA does not apply when an actual battery has occurred. In Ex parte
Vanderwall, the Alabama Supreme Court determined that AMLA did not govern
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assault and battery claims against a physical therapist who had allegedly groped a
patient’s breasts and genitals during a treatment session. 201 So. 3d at 537–38,
reh’g denied (Feb. 19, 2016). According to Vanderwall, the “the AMLA is not just
concerned with who committed the alleged wrongful conduct or when and where
that conduct occurred, but also with whether the harm occurred because of the
provision of medical services.” Id. at 537 (emphasis in original). But because
“there was no therapeutic or medical reason for [defendant-doctor] to touch
[plaintiff-patient’s] breasts or her genitals in the course of treating her for back
pain” then the “allegation of injury does not stem from the provision of medical
services,” and it is therefore not governed by the AMLA. Id. at 538.
Nevertheless, Defendants argue, and we agree, that there is an obvious
distinction between an intentional touching by a medical provider that was never
consented to by the patient (being groped) and a touching via medical treatment
that the patient had agreed to, albeit without knowing all the pitfalls that the
treatment might entail. In fact, Alabama law has distinguished between “lack of
consent” (or “no-consent”) claims and “lack of informed consent” claims. In Cain
v. Howorth, 877 So. 2d 566 (Ala. 2003), citing to a body of caselaw from other
jurisdictions, the Alabama Supreme Court recognized that “[t]he law distinguishes
between a total lack of consent for the contested act (battery) and the lack of
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informed consent (negligence).” Id. at 580–81 (internal quotation marks omitted). 9
Because the plaintiff in Cain had only argued a “lack of consent” claim, rather than
a “lack of informed consent” claim, the Alabama Supreme Court concluded that it
did not need to decide whether the plaintiff could establish the latter claim under
the facts of the case. Id. at 581. See also Black v. Comer, 38 So. 3d 16, 28 (Ala.
2009) (noting that Cain “distinguish[ed] between a claim of a lack of consent to
the performance of a medical procedure and a claim of a ‘lack of informed
consent’”).
Unlike the patients in the medical battery cases, Plaintiffs here acknowledge
that they consented to the specific conduct by medical providers about which they
now complain. Plaintiffs instead assert that their consent was not intelligently
given, as a result of the incomplete information offered to them by these medical
providers. If such claims sound in “negligence” rather than “battery” under
Alabama law, regardless of whether the medical treatment is part of a clinical
9
Many jurisdictions follow the rule that “a claim under the informed consent doctrine must be
pled as a tort action for negligence, rather than as one for battery or assault.” Molé v. Jutton, 846
A.2d 1035, 1042 (Md. 2004) (collecting cases); see also E. Haavi Morreim, Medical Research
Litigation and Malpractice Tort Doctrines: Courts on A Learning Curve, 4 HOUS. J. HEALTH L.
& POL’Y 1 (2003) (“[I]nformed consent doctrine evolved away from battery during the 1960’s
and ‘70s when courts decided that, so long as the patient gave some sort of consent, the
inadequacies of disclosure such as failing to mention a particular risk must be addressed as
negligence.”); Jaime Staples King & Benjamin W. Moulton, Rethinking Informed Consent: The
Case for Shared Medical Decision-Making, 32 AM. J. L. & MED. 429, 438–39 (2006) (“The shift
from battery to a negligence standard reflected judges’ sentiments that a judgment of battery was
inappropriate for the nature of the offense, as physicians did not intend to harm the patient, rather
they failed to provide enough information.”).
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study, then Defendants seemingly have the winning argument when they contend
that these claims require that an actual injury have resulted. This is so because
Alabama law requires an actual injury for negligence claims. See S. Bakeries, 852
So. 2d at 716 n.7 (“It is a basic principle of tort law that in negligence cases, the
plaintiff must suffer actual injury.”).
Indeed, from our review, Defendants’ position is consistent with the
majority of other courts that have addressed this issue, which hold that informed
consent claims sound in negligence and thus require an actual injury. 10 That the
majority view appears to support Defendants’ position is significant because when
10
See, e.g., Canterbury v. Spence, 464 F.2d 772, 790 (D.C. Cir. 1972) (“No more than breach of
any other legal duty does nonfulfillment of the physician’s obligation to disclose alone establish
liability to the patient. An unrevealed risk that should have been made known must materialize,
for otherwise the omission, however unpardonable, is legally without consequence. Occurrence
of the risk must be harmful to the patient, for negligence unrelated to injury is nonactionable.”);
Wachter v. United States, 689 F. Supp. 1420, 1422 (D. Md. 1988) (applying Maryland law);
Hales v. Pittman, 576 P.2d 493, 499 (Ariz. 1978); Cobbs v. Grant, 502 P.2d 1, 11–12 (Cal.
1972); Barcai v. Betwee, 50 P.3d 946, 959–60 (Haw. 2002); Davis v. Kraff, 937 N.E.2d 306,
315–16 (Ill. App. Ct. 2010); Funke v. Fieldman, 512 P.2d 539, 548–49 (Kan. 1973); LaCaze v.
Collier, 434 So. 2d 1039, 1048 (La. 1983); Downer v. Veilleux, 322 A.2d 82, 92 (Me. 1974);
Harnish v. Children’s Hosp. Med. Ctr., 439 N.E.2d 240, 244 (Mass. 1982); Reinhardt v. Colton,
337 N.W.2d 88, 95–96 (Minn. 1983); Jamison v. Kilgore, 903 So. 2d 45, 48–49 (Miss. 2005);
Turek v. Saint Elizabeth Cmty. Health Center, 488 N.W.2d 567, 573 (Ne. 1992); Smith v. Cotter,
810 P.2d 1204, 1209 (Nev. 1991); Howard v. Univ. of Med. & Dentistry of N.J., 800 A.2d 73,
79–80 (N.J. 2002); Amodio v. Wolpert, 861 N.Y.S.2d 799, 801–02 (N.Y. App. Div. 2008);
Nickell v. Gonzalez, 477 N.E.2d 1145, 1148 (Ohio 1985); Scott v. Bradford, 606 P.2d 554, 559
(Okla. 1979); Hook v. Rothstein, 316 S.E.2d 690, 704 (S.C. 1984); Hightower v. Baylor Univ.
Med. Center, 348 S.W.3d 512, 517 (Tex. Ct. App. 2011); Bertsch v. Brewer, 640 P.2d 711, 715
(Wash. 1982); see also Cochran v. Wyeth, Inc., 3 A.3d 673, 680 (Pa. Super. Ct. 2010) (“[T]his
Court is unable to locate any authority that has refused to adopt the proximate cause principle
enunciated in Canterbury and Downer. In informed consent cases, it appears to be well-settled
and without debate that the non-disclosed risk must manifest itself into actual injury in order for
a plaintiff to establish proximate causation.”).
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state law is not clear on an issue, “we generally presume that Alabama courts
would adopt the majority view on a legal issue in the absence of indications to the
contrary.” Bobo v. Tenn. Valley Auth., 855 F.3d 1294, 1304 (11th Cir. 2017).
Based on all the above, we conclude that Alabama law requires an actual
injury for informed consent claims in this context. To summarize, we know that
the AMLA generally requires an actual injury for medical malpractice actions.
And the Alabama Supreme Court has specifically applied the AMLA to informed
consent claims in cases like Houston County. Even if the AMLA did not apply to
Plaintiffs’ claims, Alabama law suggests that informed consent claims constitute
negligence actions. Further, Alabama common law requires an actual injury to
maintain a negligence cause of action—and in the specific context of informed
consent claims, so do the majority of other courts. Finally, although it is true that
in cases discussing informed consent claims, the Alabama Supreme Court did not
list actual injury as a required element for those claims, there was no dispute in
those cases that an actual injury existed, and the court was focusing on what
constitutes informed consent. Thus, we do not consider the omission of “injury”
from the list as dispositive.
In short, because Plaintiffs have offered no evidence to show that the
SUPPORT study caused any actual injuries, they cannot state a claim for lack of
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informed consent. The district court therefore correctly granted summary
judgment to Defendants.
CONCLUSION
For the above reasons, we AFFIRM the district court’s grant of summary
judgment to Defendants.
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