Law school exams are usually exercises in issue spotting. Buried within the fact scenarios are various legal issues. The student earns points by identifying those issues and discussing how they should be resolved.  Sequence also matters.  It makes sense to walk through threshold issues, such as jurisdiction, first. 

Goins v. Saint Elizabeth Medical Center, Inc., 2024 U.S. App. LEXIS 1547 (6th Cir. Jan. 22, 2024), would be a swell issue spotter on a law school exam. It is an interesting, albeit unpublished, Sixth Circuit case regarding PREP Act preemption. It also presents questions of lower court and appellate jurisdiction. 

And it all arrives in the form of a medical malpractice case. The plaintiff had received her second dose of Moderna Covid-19 vaccine. A couple of days later, she was admitted to a hospital emergency room because of unusual swings in her blood sugar that “flummoxed” the doctors. One of the doctors used a needle to take a biopsy sample from the plaintiff’s pancreas. 

And now we will pause for a brief interlude that explains why the PREP Act was arguably at issue.  According to the plaintiff, some of her doctors (but not the one performing the biopsy) stated that her symptoms could have been a reaction to the Covid-19 vaccine. 

Got that?

After the biopsy, the plaintiff began to experience severe abdominal pain. This pain appeared to result from the biopsy.  It is possible that her spleen was nicked during the biopsy. The plaintiff had a tough time of it, undergoing a lengthy recovery.  Then she sued Moderna, the pharmacy administering the vaccine, the doctor who performed the biopsy, and the doctor’s medical practice. The complaint included causes of action for negligence, battery, and negligent hiring  

The plaintiff filed the complaint in Kentucky state court.  But Moderna successfully removed the case to federal court under 28 U.S.C. section 1442(a) because Moderna had been acting under the direction of a federal officer. Then the defendants moved to dismiss the complaint because the defendants were immune from suit under the PREP Act. As we have discussed several times before in this blog, the PREP Act provides that a “covered person” shall be immune from liability with respect to all claims involving the use of a “covered countermeasure.”  Manufacturing and administering a Covid-19 vaccine is the most obvious “countermeasure,” so dismissal of the claims against Moderna and the pharmacy was a foregone conclusion. Adios.

But what about the claims against the doctor and his practice for the allegedly negligent biopsy?  After dismissing the claim against Moderna (the party who initially created federal jurisdiction) and the pharmacy, what was left against the doctor and medical practice was “an ordinary malpractice suit brought under Kentucky law, by a Kentucky plaintiff, against Kentucky defendants.”  For that reason, the district court exercised its discretion under 28 U.S.C. section 1367(c) to remand the case to state court. But it stayed the remand to permit the doctor and medical practice to appeal the denial of their motion to dismiss. 

Did the Sixth Circuit have appellate jurisdiction?  Usually the denial of a motion to dismiss is not appealable. It is not a final order. The typical route is to proceed  with the case and then re-raise any issues after a final judgment.  But there is an exception for certain collateral orders. Still, should the case ever have been in federal court?

The answer to that preliminary question is Yes. The Sixth Circuit held that the case was properly removed to federal court on the basis of federal officer jurisdiction because the vaccine manufacturer participated in Operation Warp Speed. That program involved the type of coordination with the government necessary to treat the manufacturer as functionally acting under a federal officer.  At each step of the way, the manufacturer worked under the “direction and control” of the federal government so that its vaccine would be available quickly. 

So far so good. 

Next, the court addressed appellate jurisdiction under the collateral order doctrine. That doctrine permits appeal of a non-final order if that order (1) is conclusive, (2) on an “important” issue separate from the merits of the action, and (3) is effectively unreviewable on appeal from a final judgment.  Sixth Circuit law is clear that a private entity may immediately appeal an order denying an affirmative defense of statutory immunity when the statute provides immunity from suit, as opposed to immunity simply from liability. Immediate review of a decision denying immunity from suit helps “to make good on the deal between the government and the immunized entity, because the core point of immunity is its possessor’s entitlement not to have to answer for his conduct in a civil damages action.”  Accordingly, the appeal by the doctor and his medical practice could go forward. 

That’s where the good news for the doctor and medical practice defendants ends. The Sixth Circuit affirmed the district court’s denial of the motion to dismiss because the allegations of the complaint did not clearly tie the claimed medical malpractice to any vaccine-related medical care. The question was whether it was “definitively ascertainable” from the allegations of the complaint that the biopsy addressed a vaccine side effect.  Reference to vague speculation by other doctors that the blood sugar swings might have been caused by the vaccine was simply not enough. There must be some plausible factual allegation that the Covid-19 vaccine caused the plaintiff’s symptoms before medical treatment comes within the preemptive ambit  of the PREP Act. Notably, the complaint did not allege that the doctor-defendant even knew the plaintiff had received the Covid-19 vaccine. Thus, the complaint did not allege a “covered countermeasure” that would require dismissal under the PREP Act. 

If jurisdiction comes first in the analysis, policy usually comes last. In Goins, the court  rejected the defendant’s argument for PREP Act immunity anytime medical treatment addressed symptoms that had not been ruled out as vaccine sequelae.  The court observed that “[w]hen 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. “