We’ll admit it: this post is written out of pure jealousy. Last week, Tauber authored a post on vaccines and set a record for DDL blogpost “hits.” It was a good, useful post, but we doubt all of the tens of thousands of hits came from legal scholars. The post made it to Reddit, and many of the comments went off on the availability of fried butter, fried Oreos, and fried anything at state fairs. This was fascinating stuff. But, of course, it was the political dimension that launched the vaccine post into the stratosphere. Because of COVID-19, where one stands on vaccines now plays a role in defining whether one is on Team X or Y (or Team Red or Blue). That is a depressing fact of life. To enlist science or anti-science in aid of base political objectives seems about the dumbest thing since innovator liability or the parallel claim exception to express preemption. But there it is, so here we go, reporting on a recent Vaccine Act decision by the Pennsylvania Superior Court.
The case is Sullivan v. Holy Redeemer Hospital and Med. Center, 2021 PA Super. 191 (Pa. Super. Ct. Sept. 24, 2021), and it brings more light than heat to the subject. That is, the Sullivan court got the vaccine issue right. It got it right by reversing a bad decision by the trial court. The plaintiff was a nurse manager who had been administered a tetanus vaccine (so all you COVID controversialists can rest easy for now) and experienced serious and long-term shoulder pain. She sued the hospital for medical malpractice. The defendants moved to dismiss the claim on the theory that it was barred by the exhaustion of remedies requirement Vaccine Act. The plaintiff argued that her injury was not “vaccine-related” under the Vaccine Act, because the negligence was in the injection, rather than the content of the vaccine. The trial court denied the motion to dismiss, and the defendants filed an interlocutory appeal. The Superior Court reversed the trial court’s ruling and directed that the case should be dismissed for lack of subject matter jurisdiction by virtue of the Vaccine Act’s exhaustion of remedies requirement.
Before suing, a plaintiff is required to seek compensation through the Vaccine Act’s mechanisms. Why? The Superior Court observed that the purpose of the Vaccine Act was “two-fold: to expedite compensation for vaccine injuries and to protect vaccine manufacturers from litigation that jeopardized the vaccine supply.” A person who claims to have suffered an injury after receiving a vaccine covered by the Vaccine Act “may obtain compensation from the Program without proving any negligence or defect by proving that the vaccine caused the injury or by demonstrating that her injury is an injury listed as associated with that vaccine in the Vaccine Injury Table created under the Vaccine Act, which creates a presumption of causation.” Vaccine injuries are taken out of the civil tort system and are funneled into a non-litigation system in which recoveries are easier and smaller. Again, why? Isn’t this process a recognition that litigation is too expensive, too unpredictable, and, ultimately, constitutes a disincentive for innovation and manufacture of medical products?
Why confine a more efficient, predictable system to vaccines? To be sure, vaccines deal with contagious diseases, so social externalities are much more of a concern. Society needs people to get vaccinated, and needs to remove barriers to both the supply and demand sides. Fear is the enemy. And, as we are seeing right now, it is a formidable enemy. So is stupidity. All that being said, society has an interest in the development of all sorts of medical prophylactics and therapies. We have written frequently on vaccine preemption. Here, for example. We even have a vaccine cheatsheet. We have long thought that the vaccine system should cover other medical treatments. Perhaps it could be extended to oncology drugs. Then other medical products. Eventually, we would have to switch our legal practice to antitrust, corporate control battles, or commercial disputes. Or we could beg the Chester County DA’s office for a job prosecuting DUIs, shoplifters, and weenie-waggers. We’d be okay with that.
But back to the Sullivan case. That the plaintiff’s shoulder injury was caused by alleged negligence in the injection, rather than by anything inherent in the vaccine itself, doesn’t matter because these type of shoulder injuries are included on the Vaccine Act’s table of compensable injuries. The allegation that the plaintiff suffered reflex sympathetic dystrophy (RSD) syndrome to her shoulder does not remove the claim from the Vaccine Act, and in fact RSD claims have been compensated. Even if RSD was somehow out of bounds, the other injuries the plaintiff alleged are Vaccine Act reimbursable. Those injuries were all sustained “in association with the vaccine.” As the Sullivan court held, “[a]n injury is vaccine-related and is subject to the Vaccine Act if the vaccine was a cause of the injury, even if the only tortious conduct alleged against the defendant is unrelated to the content of the vaccine.”
The regulatory history concerning the Vaccine Injury Table confirmed that claims for shoulder injuries from a negligently administered vaccine are claims for vaccine-related injuries that are subject to the Vaccine Act. In July 2020, the Trump HHS proposed removing shoulder injuries from the Vaccine Act. Under that proposal, the plaintiff’s end run around the exhaustion requirement would have succeeded. But that proposal never became law. In April 2021, the Biden HHS rescinded the proposed revision and left shoulder injuries as being associated with vaccines. In rescinding the proposal, HHS stated that it did so “because it is concerned that [the revision] would have a negative impact on vaccine administrators” and noting that the removal of conditions from the Vaccine Injury Table “could negatively impact the vaccine administrators carrying out this massive COVID-19 vaccination campaign by increasing their exposure to liability for administering non-COVID vaccines.” So, you see, we ended up talking about COVID after all. (We criticized the HHS effort to remove shoulder injuries from the Vaccine Act here, and reported on its ultimate failure here.)
Now bring on Reddit.