Sixth Circuit Says Providers Can’t Use PREP Act Immunity to Deflect Medical Malpractice Claim
- February 02, 2024
A physician failed to show he performed an endoscopy and biopsy on a patient to address a side effect of the COVID vaccine for purposes of claiming her subsequent medical malpractice action was barred under the Public Readiness and Emergency Preparedness (PREP) Act, a federal appeals court held.
In an unpublished opinion, the Sixth Circuit affirmed the lower court’s remand of the medical malpractice claim against the physician and his practice group to a Kentucky trial court.
Several days after her second dose of the Moderna COVID vaccine, Lisa Goins was admitted to the hospital with unusual swings in her blood sugar. Dr. Joel Warren examined Goins during her hospital stay and performed an endoscopy and biopsy to rule out a pancreatic tumor. He diagnosed Goins with a noncancerous pancreatic abnormality. According to Goins, unspecified doctors stated her symptoms "could have been" a reaction to the COVID vaccine.
Following the endoscopy and biopsy, Warren experienced increasing abdominal pain that ultimately required emergency surgery to repair a ruptured spleen, which allegedly was nicked during the procedure that Warren performed.
Goins sued Warren and his provider group, Tri-State Gastroenterology, for medical malpractice, as well as other defendants, including Moderna, for negligence in a Kentucky trial court. Defendants removed the action to federal court. The district court dismissed the action against Moderna and the other defendants, except Warren and Tri-State, under the PREP Act.
The PREP Act provides that, upon a declaration by the Department of Health and Human Services Secretary, “a covered person shall be immune from suit and liability under Federal and State law with respect to all claims for loss” that involve “the administration to or the use by an individual of a covered countermeasure.”
Because it dismissed the lawsuit against Moderna based on PREP Act immunity, the court remanded to the state trial court to consider the medical malpractice action against Warren and Tri-State under Kentucky law. The providers appealed, alleging they also were entitled to immunity under the PREP Act because the endoscopy and biopsy addressed a side effect of Goins’ COVID vaccine.
Under the PREP Act, a “covered countermeasure” includes medical care to address a side effect of the affirmative countermeasure—in this case, the COVID vaccine. But the appeals court found none of the allegations specific to Warren suggested he was treating Goins for a purported reaction to the vaccine.
While the complaint indicated that certain unnamed doctors suggested the swings in Goins’ blood glucose could have been caused by the COVID vaccine, there was no evidence Warren even knew she had received the vaccine, the appeals court said. Warren diagnosed Goins with a non-specific pancreatic abnormality. He never identified the 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,” the Sixth Circuit wrote.
Goins v. St. Elizabeth Med. Ctr., Inc., No. 22-6070 (6th Cir. Jan. 22, 2024).