Gloria Smith v. USA

[DO NOT PUBLISH]
In the
United States Court of Appeals
For the Eleventh Circuit
____________________
No. 22-13645
Non-Argument Calendar
____________________
GLORIA SMITH,
Plaintiff-Appellant,
versus
UNITED STATES OF AMERICA,
Defendant-Appellee,
DR. KENNEDY OKERE,
Defendant.
____________________
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2 Opinion of the Court 22-13645
Appeal from the United States District Court
for the Southern District of Georgia
D.C. Docket No. 4:20-cv-00286-RSB-CLR
____________________
Before J ORDAN, JILL PRYOR , and B RANCH, Circuit Judges.
PER CURIAM:
Appellant Gloria Smith brought a lawsuit against the United
States under the Federal Tort Claims Act, alleging that Dr. Ken-
nedy Okere, a doctor at the Curtis V. Cooper Primary Health Cen-
ter (“CVC”), a federally-supported health center, committed med-
ical malpractice. According to Smith, Okere prescribed a medica-
tion that caused her to have a severe allergic reaction and be hos-
pitalized. To support her claim, Smith introduced testimony from
an expert who opined that the medication Okere prescribed caused
Smith’s allergic reaction. But the district court excluded the ex-
pert’s opinion under Daubert v. Merrill Dow Pharmaceuticals, Inc.,
509 U.S. 579 (1993), and then granted summary judgment to the
United States. On appeal, Smith challenges the district court’s deci-
sions to exclude her expert’s opinion and to grant summary judg-
ment to the government. After careful consideration, we affirm.
I.
Smith, who suffers from high blood pressure, received med-
ical care at CVC. In 2016, Smith was prescribed an ACE inhibitor,
a type of medication used to treat high blood pressure. After taking
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22-13645 Opinion of the Court 3
the medication, Smith had an allergic reaction and needed to go to
the hospital.
In December 2018, Smith was seen by Okere at CVC. At that
appointment, he prescribed the drug lisinopril, an ACE inhibitor,
to treat her high blood pressure. Inexplicably, Okere selected this
medication, despite multiple warnings in Smith’s medical records
stating that she was allergic to ACE inhibitors. For a four-month
period, Smith dutifully took lisinopril every day.
In the afternoon of April 8, 2019, Smith experienced a severe
allergic reaction. She felt her tongue swelling inside her mouth and
her throat closing. She immediately went to the hospital.
At the hospital, Smith was diagnosed with angioedema. An-
gioedema is a condition that involves the swelling of tissue in the
lips, tongue, face, hands, or feet. In rare cases, this swelling can lead
to airway obstruction and potentially death.
At the hospital, Smith’s condition initially improved. But she
quickly took a turn for the worse. She was admitted to the intensive
care unit and ended up in a medically induced coma. After approx-
imately two weeks, Smith’s condition improved, and she was re-
leased from the hospital. Medical records from the hospital show
that Smith reported taking several medications at home on the day
she experienced the allergic reaction, including lisinopril and aspi-
rin.
Smith sued the United States, bringing a claim for medical
malpractice under the Federal Tort Claims Act, 28 U.S.C. §§ 1346,
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4 Opinion of the Court 22-13645
2671 et seq.1 She alleged that Okere committed medical malpractice
by prescribing her lisinopril, which caused her allergic reaction.
During the litigation, Smith identified Dr. James Cornwell,
Jr., an experienced primary care physician, as an expert whose opin-
ions she would be relying on in the case. In his expert report, Corn-
well opined that Okere and CVC deviated from the applicable
standard of care. He explained that it was a “breach of the standard
of care to prescribe a medication to which the patient has a known
allergy or adverse reaction.” Doc. 33 at 8.2
In addition to providing an opinion on the standard of care,
Cornwell also opined about causation. In his expert report, his en-
tire opinion on causation consisted of one sentence, which stated
that “[w]ithin a reasonable degree of medical certainty, the afore-
mentioned negligent acts and omissions of CVC and . . . Okere
caused . . . Smith to suffer a severe, life-threatening adverse
1 The parties agree that the Federal Tort Claims Act provides the exclusive
remedy for Smith’s malpractice claim. Because Okere was a physician working
as a contractor for CVC and the facility was a federally-supported health cen-
ter, Okere is “deemed to be an employee of the Public Health Service.” See
42 U.S.C. § 233(g)(1)(A). Federal law specifies that the Federal Tort Claims Act
provides the “exclusive” remedy “for damage for personal injury . . . resulting
from the performance of medical . . . functions . . . by any . . . employee of the
Public Health Service.” Id. § 233(a), (g)(1)(A); see Allen v. Christenberry, 327 F.3d
1290, 1294 (11th Cir. 2003) (describing statutory scheme).
2 “Doc.” numbers refer to the district court’s docket entries.
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22-13645 Opinion of the Court 5
reaction, including angioedema, for which she required emergency
medical care and hospitalization.” Id.
The government moved to exclude Cornwell’s opinion
about causation under Daubert. First, it argued that Cornwell was
not qualified because he did not have any experience in determin-
ing the causes of angioedema. Second, it asserted that Cornwell’s
opinion about causation was not based on a reliable methodology.
According to the government, Cornwell’s “report display[ed] no
methodology on causation” because his entire discussion of causa-
tion consisted of a single sentence and was entirely “devoid of fac-
tual or analytical support.” Doc. 35 at 10 (internal quotation marks
omitted). The government pointed out that Cornwell did not
“note or rule out other possible causes for [Smith’s] illness.” Id. at
11.
The government argued that if Cornwell’s opinion on cau-
sation was excluded, the court should grant summary judgment. It
explained under the Federal Tort Claims Act, Georgia law gov-
erned because the allegedly negligent act—prescribing lisinopril—
occurred in Georgia. See 28 U.S.C. § 1346(b)(1). And under Georgia
law, to prove proximate causation for a medical malpractice claim,
a plaintiff must present expert testimony. If Cornwell’s opinion on
causation was excluded, the government reasoned, it would be en-
titled to summary judgment because Smith would have no expert
testimony regarding causation.
Smith opposed the government’s motions to exclude Corn-
well’s causation opinion and for summary judgment. With her
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opposition, she filed a supplemental affidavit from Cornwell. In the
affidavit, he provided more information about his qualifications,
including that he previously had treated between 20 and 30 patients
suffering from angioedema.
He also provided more details about the relationship be-
tween ACE inhibitors and angioedema. He explained that it was
“well accepted and documented in the medical community that lis-
inopril can cause angioedema” and that “0.1-0.7% [of] patients pre-
scribed ACE inhibitors experience angioedema.” Doc. 38-1 at 2. He
also noted that “angioedema is the second most common adverse
reaction to ACE inhibitors, behind dry cough.” Id. at 2–3. And he
observed that “patients who take ACE inhibitors can experience
the adverse effect of angioedema several months or even up to a
year after being prescribed the medication.” Id. at 3.
Cornwell attached to his affidavit several medical publica-
tions on which he had relied. These publications stated that other
medications, including nonsteroidal anti-inflammatory drugs such
as aspirin, could cause angioedema. Despite relying on these pub-
lications that recognized other medications could cause angi-
oedema, there was nothing in Cornwell’s affidavit showing that he
had considered whether another medication could have caused
Smith’s angioedema.
After reviewing Cornwell’s affidavit, the government again
argued that his causation opinion should be excluded under Daub-
ert. It continued to assert that he was not qualified to opine about
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22-13645 Opinion of the Court 7
the cause of Smith’s angioedema and that his causation opinion
was not based on a reliable methodology.
After the motions were fully briefed, a magistrate judge is-
sued an order and report and recommendation. The magistrate
judge granted the government’s motion to exclude Cornwell’s cau-
sation opinion under Daubert, concluding that Cornwell was “not
qualified to offer the causation opinion and that the opinion [was]
not reliable.” Doc. 50 at 12.
Regarding qualifications, the magistrate judge found that
Cornwell was not qualified to opine on the cause of Smith’s angi-
oedema. The magistrate judge accepted that based on his experi-
ence Cornwell was qualified to opine on whether Smith’s allergic
reaction qualified as angioedema. But the magistrate judge ex-
plained that “expertise in the diagnosis and treatment of a condi-
tion does not render a physician qualified to opine, in a scientifically
reliable manner, about the causes of those medical conditions.” Id.
at 14 (internal quotation marks omitted). Because there was no in-
dication that Cornwell had experience in determining the cause of
a patient’s angioedema, the magistrate judge concluded that Smith
failed to carry her burden of establishing that Cornwell was quali-
fied to opine on causation.
The magistrate judge also concluded that Cornwell’s meth-
odology was not reliable. The magistrate judge explained that
Cornwell had not explained how he arrived at his conclusion about
causation. Although there was a temporal relationship between
Smith taking lisinopril and experiencing angioedema, the
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magistrate judge explained that Cornwell could not conclude that
lisinopril caused Smith’s angioedema simply because she experi-
enced the allergic reaction after taking the medication. The magis-
trate judge also pointed out that the medical publications Cornwell
had relied on showed that a number of medications could cause
angioedema. Because Cornwell failed “to even consider other fac-
tors that could have been cause the cause of [Smith’s] angi-
oedema,” the magistrate judge found his methodology unreliable.
Id. at 21 (emphasis in original).
After excluding Cornwell’s causation opinion, the magis-
trate judge turned to the government’s summary judgment mo-
tion. The magistrate judge explained that Georgia law applied to
Smith’s Federal Tort Claims Act claim and that, under Georgia law,
to survive summary judgment Smith had to “present expert testi-
mony to establish that the breach of the applicable standard of care
was the proximate cause of” her injury. Id. at 27. Because Corn-
well’s opinion on causation had been excluded, the magistrate
judge recommended that the district court grant summary judg-
ment.
Smith objected to the magistrate judge’s order and recom-
mendation. On the Daubert motion, she argued the magistrate
judge erred in determining that Cornwell was not qualified to ren-
der a causation opinion and that his opinion was unreliable. She
also argued that because Cornwell’s causation opinion should not
be excluded, the district court should deny the government’s sum-
mary judgment motion.
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22-13645 Opinion of the Court 9
The district court overruled Smith’s objections. The court
began by reviewing the magistrate judge’s order granting the Daub-
ert motion. The court explained that it reviewed the magistrate
judge’s order under a deferential standard of review—asking
whether the decision was clearly erroneous or contrary to law—
because the Daubert motion was not a dispositive motion.
The district court then affirmed the magistrate judge’s deci-
sion to exclude Cornwell’s causation opinion for two independent
reasons: (1) he was not qualified to opine on the cause of Smith’s
angioedema, and (2) his methodology was not reliable. The court
explained that Cornwell’s methodology was unreliable because
there was “nothing to indicate that [] Cornwell considered any al-
ternative cause of [Smith’s] angioedema.” Doc. 58 at 7 (emphasis
in original). Although the district court reached this conclusion af-
ter applying a clearly erroneous standard, the court also stated that
it would have reached the same conclusion under a de novo stand-
ard of review.
After affirming the magistrate judge’s decision on the Daub-
ert motion, the district court adopted the recommendation to grant
the government’s summary judgment motion. This is Smith’s ap-
peal.
II.
“We review de novo the district court’s grant of summary
judgment, construing the facts and drawing all reasonable infer-
ences in favor of the nonmoving party.” Smelter v. S. Home Care
Servs., Inc., 904 F.3d 1276, 1284 (11th Cir. 2018). Summary
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judgment is appropriate if the record gives rise to “no genuine dis-
pute as to any material fact,” such that “the movant is entitled to
judgment as a matter of law.” Fed. R. Civ. P. 56(a). A genuine dis-
pute of material fact exists when “the evidence is such that a rea-
sonable jury could return a verdict for the nonmoving party.” An-
derson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986).
We review for abuse of discretion a district court’s decision
to exclude an expert’s testimony. See St. Louis Condo. Ass’n, Inc. v.
Rockhill Ins. Co., 5 F.4th 1235, 1242 (11th Cir. 2021). “The abuse of
discretion standard allows a range of choice for the district court,
so long as that choice does not constitute a clear error of judg-
ment.” Carrizosa v. Chiquita Brands Int’l, Inc., 47 F.4th 1278, 1296
(11th Cir. 2022) (alteration adopted) (internal quotation marks
omitted). “A district court necessarily abuses its discretion if it bases
a ruling on an erroneous view of the law or on a clearly erroneous
assessment of the evidence.” Id. (alteration adopted) (internal quo-
tation marks omitted).
IV.
Smith argues on appeal that the district court erred in ex-
cluding Cornwell’s opinion on causation and in granting the gov-
ernment’s motion for summary judgment. We address each issue
in turn.
A.
We begin with Smith’s challenge to the district court’s deci-
sion to grant the government’s Daubert motion and exclude
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22-13645 Opinion of the Court 11
Cornwell’s expert testimony on causation. We cannot say that the
district court abused its discretion.
“The admission of expert evidence is governed by Federal
Rule of Evidence 702, as explained by Daubert and its progeny.”
Rink v. Cheminova, Inc., 400 F.3d 1286, 1291 (11th Cir. 2005) (foot-
note omitted). Under Rule 702 and Daubert, in deciding whether to
admit expert testimony, a district court acts act as a “gatekeep[er].”
Id. (internal quotation marks omitted). To fulfill its obligation, a
district court must engage in a “rigorous inquiry” and determine
whether: (1) “the expert is qualified to testify competently regard-
ing the matters he intends to address”; (2) “the methodology by
which the expert reaches his conclusions is sufficiently reliable as
determined by the sort of inquiry mandated in Daubert”; and (3) the
expert’s testimony “assists the trier of fact, through the application
of scientific, technical, or specialized expertise, to understand the
evidence or to determine a fact in issue.” Id. at 1291–92 (internal
quotation marks omitted).
Regarding reliability, we have recognized that a district
court “may exclude expert testimony that is imprecise and unspe-
cific or whose factual basis is not adequate explained.” Cook ex rel.
Est. of Tessier v. Sheriff of Monroe Cnty., 402 F.3d 1092, 1111 (11th Cir.
2005) (internal quotation marks omitted). “Because the task of eval-
uating the reliability of expert testimony is uniquely entrusted to
the district court under Daubert, we give the district court consid-
erable leeway in the execution of its duty.” Rink, 400 F.3d at 1291
(internal quotation marks and citation omitted); see United States v.
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Pon, 963 F.3d 1207, 1219 (11th Cir. 2020) (explaining that the “def-
erence we show trial courts on evidentiary rulings is especially pro-
nounced in the Daubert context, where the abuse of discretion
standard places a heavy thumb . . . on the district court’s side of the
scale” (internal quotation marks omitted)). Of course, granting this
“leeway is not the same thing as abdicating appellate responsibil-
ity.” Pon, 963 F.3d at 1219–20 (internal quotation marks omitted).
Here, in excluding Cornwell’s causation opinion, the district
court found that his methodology was unreliable because he did
not consider any alternative cause of Smith’s angioedema. Smith
does not dispute that to provide a reliable opinion on causation, an
expert sometimes must expressly address and rule out other poten-
tial causes of the plaintiff’s injury. But Smith says that Cornwell was
not required to rule out alternative causes of Smith’s angioedema
in this case because there was “no evidence in this case of any cause
of . . . Smith’s angioedema[] other than the admittedly mis-pre-
scribed lisinopril.” Appellant’s Br. at 37–38 (emphasis added). We
disagree.
The district court did not abuse its discretion when it ex-
cluded Cornwell’s opinion as unreliable based on his failure to con-
sider alternative possible causes of Smith’s angioedema.3 Certainly,
3 The district court gave two separate reasons for excluding Cornwell’s causa-
tion opinion: because (1) it was unreliable, and (2) Cornwell was not qualified
to opine on causation. Because we conclude that the district court did not
abuse its discretion in excluding Cornwell’s opinion as unreliable, we do not
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22-13645 Opinion of the Court 13
ACE inhibitors, like lisinopril, may cause angioedema. But the rec-
ord shows that ACE inhibitors are not the only medications that
cause angioedema. Indeed, the medical publications that Cornwell
relied upon show that other drugs, including non-steroidal anti-in-
flammatory drugs (like aspirin), may cause angioedema. And the
record reflects that Smith took both lisinopril and aspirin at home
on the day of her allergy attack in 2019. Although Smith apparently
ingested multiple drugs that could cause angioedema, there is
nothing in Cornwell’s initial expert report or his affidavit that indi-
cates that he considered whether anything other than lisinopril
caused Smith’s angioedema. In these circumstances, we cannot say
that the district court made a clear error of judgment when it con-
cluded that Cornwell’s causation opinion was unreliable. See Wil-
liams v. Mosaic Fertilizer, LLC, 889 F.3d 1239, 1250 (11th Cir. 2018)
(affirming district court decision to exclude expert opinion that
“failed to meaningfully address other potential causes of [the plain-
tiff’s] condition” because “[t]his fundamental methodological fail-
ure undermined the soundness of [the expert’s] causation opin-
ions”).4
decide whether the district court abused its discretion in concluding that Corn-
well was not qualified to opine on causation.
4 On appeal, Smith also argues that the district court erred in granting the
government’s Daubert motion because the court reviewed the magistrate
judge’s decision to grant the motion under a clearly erroneous, instead of a de
novo, standard. Even assuming that the district court was required to review
the magistrate judge’s Daubert ruling under a de novo standard of review, there
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14 Opinion of the Court 22-13645
B.
Having concluded that the district court did not abuse its
discretion in excluding Cornwell’s opinion on causation, we also
affirm the district court’s decision to grant summary judgment to
the government.
In this action, Smith brought a claim against the government
under the Federal Tort Claims Act for medical malpractice. Liabil-
ity under the Federal Tort Claims Act is “determined in accordance
with the law of the place where the government’s act or omission
occurred.” Stevens v. Battelle Mem’l Inst., 488 F.3d 896, 899 n.3 (11th
Cir. 2007); see 28 U.S.C. § 1346(b)(1). Because Okere’s acts and
omissions occurred in Georgia, Georgia law governs.
Under Georgia law, to prevail on a medical malpractice
claim, a plaintiff must show: “(1) the duty inherent in the health
care provider-patient relationship; (2) breach of that duty by failing
to exercise the requisite degree of skill and care; and (3) that this
failure is the proximate cause of the injury sustained.” Knight v. W.
Paces Ferry Hosp., Inc., 585 S.E.2d 104, 105 (Ga. Ct. App. 2003). Geor-
gia law requires the plaintiff to present expert testimony establish-
ing that the medical professional’s breach of the standard of care
was the proximate cause of her injury. See Porter v. Guill, 681 S.E.2d
230, 235 (Ga. Ct. App. 2009). Given the exclusion of Cornwell’s cau-
sation opinion and Smith’s failure to present any other expert
was no error here. In its order, the district court expressly stated that even
under a de novo standard and considering the entire record, it would reach the
same conclusion.
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22-13645 Opinion of the Court 15
testimony on this issue, it follows that the government was entitled
to summary judgment. See McDowell v. Brown, 392 F.3d 1283, 1302
(11th Cir. 2004) (affirming grant of summary judgment on medical
malpractice claim arising under Georgia law after opinions from
plaintiffs’ experts were excluded under Daubert).
AFFIRMED.
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