The LLT Lab’s template model for the National Vaccine Act currently contains one Rule Factor connected to prong 2 (a “logical sequence of cause and effect”), but could it be that Althen prong 3 (a “proximate temporal relationship”) deserves a Rule Factor of its own? This blog explores that question in the context of the Bowes v. Secretary of HHS decision, yet perhaps only time will tell whether a Rule Factor will be appropriate for prong 3.
What is a Rule Factor Anyway?
Rule Factors state relevant factors that the factfinder either may or should consider when making a finding, and “Rule” Factors (as contrasted with “Evidence” Factors) are established as a matter of law. For example, the Rule Factor attached to prong 2 states that “Medical records and medical opinion testimony are favored in vaccine cases, as treating physicians are likely to be in the best position to determine whether ‘a logical sequence of cause and effect shows that’ the vaccination ‘was the reason for’ the named injury (Capizzano, 440 F.3d at 1326).” After Capizzano was decided and this Rule Factor was established, a special master would give particular consideration to the medical statements of the physicians who actually treated the injured person.
The significance of the Capizzano Rule Factor can be seen in cases where a special master is faced with conflicting evidence between a treating physician and a non-treating expert witness who relies solely on cold medical records to form an opinion. The Rule Factor on prong 2 is important for practitioners to take note of when building their prima facie case because statements from a credible treating physician can tip the scale in favor of compensation for their clients.
The Capizzano Rule Factor also shows how important it is to be prudent when determining whether it is appropriate to add a Rule Factor to another Althen prong. A Rule Factor can play a decisive role in a particular case.
Adding a Rule Factor to Prong 3?
Prong 3 requires “a showing of a proximate temporal relationship between vaccination and injury.” (Althen, 418 F. 3d at 1278.) At first glance it would seem that a special master would need no further factor to help decide this prong, even in a tough case. However, while modeling the Bowes decision, I noticed specific language the special master cited from the Pafford decision regarding the evidence supplied by the petitioner on prong 3, and I began to wonder whether this language could constitute a new Rule Factor.
In relevant part, the wording from Bowes is: “The Pafford ruling … indicated that it is the petitioner’s burden to demonstrate a defined period after vaccination in which one would expect to see the symptoms of a vaccine-caused injury of the type in question.” (Bowes, OSM, p. 3.) Pafford held that, in the Pafford case, “the Special Master did not err in requiring specific evidence about a medically acceptable time frame linking the onset of [the] disease to the vaccinations at issue.” (Pafford, 451 F.3d at 1360.)
The special master in Bowes explained his finding on prong 3 in the following way: “[T]he first symptoms of Michael’s ATM [“acute transverse myelitis”] occurred about two weeks after his vaccinations, squarely within the time period during which medical experts would expect to see the human immune system respond to an invasive agent.” [Cite: p. 5; Source: Drs. Bellanti and Tornatore.] Clearly the record contained “specific evidence” about the “medically acceptable time frame.”
What should we make of this for deciding cases or modeling decisions in the future? I suggest that we at least consider the possibility of “requiring specific evidence about a medically acceptable time frame” as a Rule Factor under prong 3. Whether or not a petitioner in a particular case produces such evidence may tip the scales of probative value.
We can also formulate questions and hypotheses for future research. Under what conditions, for example, should “specific evidence” be required, and how specific must the evidence be? And does the wording in Pafford cited in Bowes suggest a shift toward relying on medically determined “proximate causation” — and perhaps a shift away from the basic tort standard set forth in Althen? Is Pafford a hybrid approach? Finally, will this “soft rule” about relevant factors evolve into a “hard rule” under prong 3? At this point, the answers to all of these questions are “undecided.”