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 (lisinopril) that caused her to have a severe allergic reaction and be hospitalized.

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.”

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.”

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 challenged the district court’s decisions to exclude her expert’s opinion and to grant summary judgment to the government.

The United States Court of Appeals for the Eleventh Circuit (“Federal Appellate Court”) held in its August 7, 2023 Opinion: “The district court did not abuse its discretion when it excluded Cornwell’s opinion as unreliable based on his failure to consider alternative possible causes of Smith’s angioedema. Certainly, ACE inhibitors, like lisinopril, may cause angioedema. But the record 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-inflammatory 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 indicates 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 concluded that Cornwell’s causation opinion was unreliable. See Williams 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 plaintiff’s] condition” because “[t]his fundamental methodological failure undermined the soundness of [the expert’s] causation opinions”).”

Source Gloria Smith v. United States of America, Case No. 22-13645.

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