Smith v. United States

1

GLORIA SMITH, Plaintiff-Appellant, v. UNITED STATES OF AMERICA, Defendant-Appellee, DR. KENNEDY OKERE, Defendant.

No. 22-13645

United States Court of Appeals, Eleventh Circuit

August 7, 2023

DO NOT PUBLISH

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.

OPINION

PER CURIAM:

Appellant Gloria Smith brought a lawsuit against the United States under the Federal Tort Claims Act, alleging that Dr. Kennedy Okere, a doctor at the Curtis V. Cooper Primary Health Center ("CVC"), a federally-supported health center committed medical malpractice. According to Smith, Okere prescribed a medication that caused her to have a severe allergic reaction and be hospitalized. 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 expert'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 decisions to exclude her expert's opinion and to grant summary judgment to the government. After careful consideration, we affirm.

I.

Smith who suffers from high blood pressure, received medical care at CVC. In 2016, Smith was prescribed an ACE inhibitor, a type of medication used to treat high blood pressure. After taking 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 approximately two weeks, Smith's condition improved, and she was released 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 aspirin.

Smith sued the United States, bringing a claim for medical malpractice under the Federal Tort Claims Act, 28 U.S.C. §§ 1346, 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 opinions she would be relying on in the case. In his expert report, Cornwell 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 entire opinion on causation consisted of one sentence, which stated that "[w]ithin a reasonable degree of medical certainty, the aforementioned negligent acts and omissions of CVC and . . . Okere caused . . . Smith to suffer a severe, life-threatening adverse 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 determining 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 causation consisted of a single sentence and was entirely "devoid of factual 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 causation was excluded, the court should grant summary judgment. It explained under the Federal Tort Claims Act, Georgia law governed 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 entitled to summary judgment because Smith would have no expert testimony regarding causation.

Smith opposed the government's motions to exclude Cornwell's causation opinion and for summary judgment. With her 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 between ACE inhibitors and angioedema. He explained that it was "well accepted and documented in the medical community that lisinopril can cause angioedema" and that "0.1-0.7% [of] patients prescribed 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 publications 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 publications 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 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 issued an order and report and recommendation. The magistrate judge granted the government's motion to exclude Cornwell's causation 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 experience Cornwell was qualified to opine on whether Smith's allergic reaction qualified as angioedema. But the magistrate judge explained that "expertise in the diagnosis and treatment of a condition 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 indication 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 qualified to opine on causation.

The magistrate judge also concluded that Cornwell's methodology 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 magistrate judge explained that Cornwell could not conclude that lisinopril caused Smith's angioedema simply because she experienced the allergic reaction after taking the medication. The magistrate 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 factors 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 magistrate judge turned to the government's summary judgment motion. 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 testimony to establish that the breach of the applicable standard of care was the proximate cause of" her injury. Id. at 27. Because Cornwell's opinion on causation had been excluded, the magistrate judge recommended that the district court grant summary judgment.

Smith objected to the magistrate judge's order and recommendation. On the Daubert motion, she argued the magistrate...