Gloria Smith v. United States

USCA11 Case: 22-13645 Document: 28-1 Date Filed: 08/07/2023 Page: 1 of 15

[DO NOT PUBLISH]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 JORDAN, JILL PRYOR, and BRANCH, 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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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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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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6 Opinion of the Court 22-13645

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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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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10 Opinion of the Court 22-13645

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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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.