The United States Court of Appeals for the Sixth Circuit (“Federal Appellate Court”) stated in its unpublished opinion filed on January 22, 2024: “When Dr. Joel Warren performed an endoscopy and biopsy on Lisa Goins, he was looking for an insulinoma—a tumor in her pancreas. He and his provider group, Tri-State Gastroenterology, claim on appeal that these procedures addressed a side effect of Ms. Goins’s COVID-19 vaccine. If that were so, the Public Readiness and Emergency Preparedness (PREP) Act, 42 U.S.C. § 247d-6d, would bar Ms. Goins’s medical malpractice suit against Dr. Warren and Tri-State. But the complaint did not plausibly contain those allegations, so it cannot now provide a basis for the PREP Act defense. Accordingly, we AFFIRM the district court’s order denying Dr. Warren and Tri-State’s motion to dismiss and remanding the case to the Boone County, Kentucky, Circuit Court.”
“The providers’ only argument on appeal is that Dr. Warren is immune from suit because the endoscopy and biopsy he performed on Ms. Goins addressed a side effect of her vaccine. The PREP Act extends immunity to “a covered person,” defined as a healthcare professional that administered the “covered countermeasure.” 42 U.S.C. § 247d-6d(a)(1), (i)(2)(B)(iv), (i)(8)(A). A “covered countermeasure” includes either an affirmative countermeasure that addresses the public health emergency itself, or medical care to address a side effect of the affirmative countermeasure. Specifically, the side effect provision defines a countermeasure as an FDA-approved “drug, . . . biological product, . . . or device” that is used “to diagnose, mitigate, prevent treat, or cure a serious or life-threatening disease or condition caused by” the affirmative countermeasure, here the COVID-19 vaccine. Id. § 247d-6d(i)(7)(A)(ii). So, the question is whether it is “definitively ascertainable from the allegations of the complaint” that the endoscopy and biopsy fit that provision because they addressed a vaccine side effect.”
“We recognize that diagnostic care is within the scope of the Act, and that the process of medical diagnosis is often uncertain. But we must evaluate the allegations in the complaint. Here they allege only that Dr. Warren diagnosed Ms. Goins with “non-specific slightly hyperechoic pancreatic parenchyma with no identifiable mass,” and never identifies this diagnosis as being a side effect of the vaccine.”
“[T]he providers would have us hold that the PREP Act immunizes any medical professional providing care to a patient who thinks their symptoms could be a reaction to a COVID-19 vaccine, no matter how far-fetched the self-diagnosis. When more than eighty percent of the country has received at least one dose of the COVID-19 vaccine, such a rule would too easily allow the dismissal of valid medical malpractice actions without any plausible factual allegation that the COVID-19 vaccine caused the underlying symptoms.”
Source Goins v. St. Elizabeth Med. Center, Inc., No. 22-6070.
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