OFFICE OF SPECIAL MASTERS
No. 95-686V
(Filed: July 20, 1998)
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SHEILA GARD-VALDEZ, | * | |
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Petitioner, | * | TO BE PUBLISHED |
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v. | * | |
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SECRETARY OF HEALTH AND | * | |
HUMAN SERVICES, | * | |
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Respondent. | * | |
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* * * * * * * * * * * * * * * * * * * * * * * * * * * |
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Bruce McGagin, Sacramento, California, appeared for petitioner.
Mark Rogers, Department of Justice, Washington, D.C., appeared for
respondent.
DECISION
HASTINGS, Special Master.
This is an action seeking an award under the National Vaccine Injury
Compensation Program(1) (hereinafter "the
Program") . I conclude that petitioner is not entitled to such an award.
I
FACTUAL BACKGROUND
Sheila Gard-Valdez, the petitioner in this case, was born in 1956. Throughout the
1980's and early 1990's, petitioner often sought medical treatment for a number of
different symptoms, including joint and muscle aches, fatigue, abdominal and bowel
problems, poor sleep, panic attacks, anxiety, and depression. (See, e.g.,
Ex. 9(2) at pp. 1-60.) On October 19, 1992, she received a
rubella vaccination. Two weeks later, on November 2, 1992, petitioner visited a physician,
Dr. Bush, and reported a rash. (Ex. 1, p. 5.) The following day, she returned to report
that she was "aching all over." (Id. at 6.) On November 5, she again
visited Dr. Bush, who examined her joints and noted "no dramatic swelling, but just a
faint puffiness of the PIP joints in her fingers, and basically hurts all over, without
major objective changes." (Id. at 7.) Dr. Bush recorded his
"impression" at that visit as "[r]ubella, secondary to immunization with
diffuse arthritis associated." (Id.)
Petitioner visited Dr. Bush again on November 11, 1992, and he recorded that her rash
and arthritis were gone, with no joint swelling, but that she was still a "little
achy" in the joints. (Id. at 8.) On November 18, she visited Dr. Bush and
again reported joint aching, while he recorded that upon examination her joints were
"perfectly normal." (Id. at 9.) On December 2, petitioner visited the
same medical office, but this time saw Dr. Bush's partner Dr. Scalapino, who took a
thorough history and performed his own detailed examination. (Id. at 10-12.) He
recorded that petitioner reported generalized joint pain and was "tender" over
certain finger joints, but that he could find "no hint of synovitis."(3) (Id. at 11.) Dr. Scalapino recorded his
"impression" at that visit that petitioner had "[g]eneralized arthritis and
arthralgias following rubella vaccination," but that he had assured her that the pain
would likely resolve. (Id.) He added that she had a "hint of
fibromyalgia."(4) (Id.)
Over the following years, petitioner has continued to routinely seek
medical attention for chronic pain and various other symptoms. These reported symptoms
have often included pain and tenderness in the joints of her hands and feet, but at most
examinations no objective evidence of swelling or other joint changes has been observed by
her physicians. No definitive cause for these joint symptoms or petitioner's additional
chronic pain symptoms has been identified. A number of petitioner's physicians, however,
have concluded that, as Dr. Scalapino first suggested in the notation above, petitioner
suffers from the "fibromyalgia syndrome."
II
STATUTORY BACKGROUND
Under the Program, compensation awards are made to individuals who have suffered
injuries after receiving certain vaccines listed in the statute. There are two separate
means of establishing entitlement to compensation. First, if an injury specified in the
"Vaccine Injury Table," originally established by statute at § 300aa-14(a) and
since modified administratively (as will be discussed infra), occurred within the
time period from vaccination prescribed in that Table, then that injury may be presumed
to qualify for compensation. § 300aa-13(a)(1)(A); § 300aa-11(c)(1)(C)(i); §
300aa-14(a). If a person qualifies under this presumption, he or she is said to have
suffered a "Table Injury." Alternatively, compensation may also be awarded for
injuries not listed in the Table, but entitlement in such cases is dependent upon proof
that the vaccine actually caused the injury. § 300aa-13(a)(1); §
300aa-11(c)(1)(C)(ii).
One of the vaccinations covered under the Program is the rubella
vaccination. § 300aa-14(a)(II). In the Vaccine Injury Table as originally enacted,
arthritis was not listed as a Table Injury for any vaccination. Therefore, an
individual seeking compensation for arthritis had to demonstrate by evidence that his or
her arthritis was vaccine-caused. However, the Table was administratively modified,
effective as to Program petitions, such as this one, filed between March 10, 1995, and
March 24, 1997. Under that modification, "chronic arthritis," if incurred under
certain specified circumstances, was established as a "Table Injury" for the
rubella vaccination. See 60 Fed. Reg. 7678 (1995); 42 C.F.R. § 100.3(a)(II.b)(A)
and § 100.3(b)(6).(5)
III
ISSUES FOR DECISION
The primary issue in this case is whether petitioner has suffered a condition in her
hands and feet qualifying as a "chronic arthritis" Table Injury under the
above-described regulatory change to the Vaccine Injury Table. In addition, as an
alternative argument, petitioner contends that her hand and foot symptoms since 1992 have
been "actually caused" by her rubella vaccination.
The evidence introduced into this proceeding consists of numerous
documentary exhibits introduced by both parties, plus oral testimony of petitioner, her
expert witness, and respondent's expert witness at an evidentiary hearing held on May 28,
1997. After careful consideration of all the evidence of record, I must reject both
arguments of petitioner, for the reasons that I will discuss in detail in parts IV and V
of this Decision, below.
IV
"TABLE INJURY" ISSUE
A. Introduction
The first issue is whether petitioner has demonstrated(6)
that it is "more probable than not" that she has suffered the Table Injury known
as "chronic arthritis." The regulatory language that is applicable to this
petition(7) defines the Table Injury "chronic
arthritis" as follows:
(6) Chronic Arthritis. (i) For purposes of paragraph (a) of this section,
chronic arthritis may be found in a person with no prior history of arthropathy (joint
disease) on the basis of:
(A) Medical documentation, recorded within 30 days after the onset, of objective signs
of acute arthritis (joint swelling) that occurred within 42 days after a rubella
vaccination; and
(B) Medical documentation (recorded within 3 years after the onset of acute arthritis)
of the persistence of objective signs of intermittent or continuous arthritis for more
than 6 months following vaccination.
(ii) For purposes of paragraph (a) of this section, the following shall not be
considered as chronic arthritis: Musculoskeletal disorders such as diffuse connective
tissue diseases (including but not limited to rheumatoid arthritis, juvenile rheumatoid
arthritis, systemic lupus erythematosus, systemic sclerosis, mixed connective tissue
disease, polymyositis/dermatomyositis, necrotizing vasculitis and vasculopathies and
Sjogren's Syndrome), degenerative joint disease, infectious agents other than rubella
(whether by direct invasion or as an immune reaction), metabolic and endocrine diseases,
trauma, neoplasms, neuropathic disorders, bone and cartilage disorders and arthritis
associated with ankylosing spondylitis, psoriasis, inflammatory bowel disease, Reiter's
syndrome or blood disorders.
(iii) Arthralgia (joint pain) or stiffness without joint swelling shall not be viewed
as chronic arthritis for purposes of paragraph (a) of this section.
42 C.F.R. § 100.3(b)(6). Petitioner argues that the condition that she has reported in
her hands and feet since November of 1992 qualifies under that Table Injury category of
"chronic arthritis." Respondent disagrees. After careful consideration, I find
that petitioner has failed to demonstrate that it is "more probable than not"
that she suffered from "chronic arthritis" as defined in the Table language set
forth above.
To begin with, I note that, in essence, the Table requires that a petitioner's case
satisfy four distinct elements: (1) an absence of a pre-vaccination history of
"arthropathy (joint disease);" (2) medical documentation of "objective
signs of acute arthritis (joint swelling)" occurring within 42 days of vaccination;
(3) medical documentation of the "persistence of objective signs of intermittent or
continuous arthritis" for at least a six-month period; and (4) an absence of one of
the diagnoses listed at part (ii) of 42 C.F.R. § 100.3(b)(6). Petitioner's case seems
clearly to comply with the fourth element. As to the first two elements, there is no
obvious answer as to whether petitioner's case complies. As to the first element,
petitioner did have a significant history of pre-vaccination complaints of joint and
muscular pain, but no history of actual arthritis. Does this constitute a history
of prior "arthropathy (joint disease)?" The answer is unclear. As to the second
element, petitioner on November 5, 1992, 16 days post-vaccination, was found by her
physician to have "no dramatic swelling, but just a faint puffiness of the PIP joints
in her fingers." (Ex. 1, p. 7.) Does that observation of "puffiness"
constitute "medical documentation * * * of objective signs of acute arthritis (joint
swelling)"? It probably does, especially because Dr. Bush added the impression of
"diffuse arthritis." But again the answer is less than perfectly clear.
However, it is unnecessary for me to reach definite conclusions as to whether
petitioner's case complies to those two initial elements. That is because I conclude that
petitioner has failed to show that it is "more probable than not" that
her case satisfies the third element, i.e., "[m]edical documentation
(recorded within 3 years after the onset of acute arthritis) of the persistence of
objective signs of intermittent or continuous arthritis for more the 6 months following
vaccination." Even this issue is not wholly free from doubt; a rational argument can
be made on petitioner's behalf. But in the final analysis, the evidence on this issue does
not preponderate in petitioner's favor.
B. Summary of both parties' arguments
Petitioner's argument is that she has experienced chronic arthritis, meeting the
requirement of this third element, in the joints of her hands and feet. She points to the
above-mentioned "puffiness" observed in her fingers on November 5, 1992; the
fact that since that time she has frequently reported pain in her joints; and the fact
that at a number of physician visits it has been noted that she was "tender" at
joint areas. In addition, petitioner relies upon the report of a visit she made on
September 1, 1995, to the physician who has served as her expert witness in this case, Dr.
M. Eric Gershwin, an expert in rheumatology. At that visit, it was recorded that
petitioner had "mild swelling at [her right index] finger's MP and PIP joints."
(Ex. 17, p. 25; see also Ex. 17, p. 5, which seems to be the actual office note of that
visit.) At the evidentiary hearing in this case, Dr. Gershwin opined that in his view the
history of the "puffiness" in petitioner's fingers observed by her physician on
November 5, 1992, the "mild swelling" that he himself (Dr. Gershwin) observed in
two finger joints on September 5, 1995, plus the frequent notations by physicians of pain
and tenderness in petitioner's joints during the interim period, justify the conclusion
that petitioner experienced intermittent arthritis over the three-year period after her
rubella vaccination. As to the "medical documentation" required by the Table
language with respect to the arthritis experienced since the initial acute episode in
November of 1992, Dr. Gershwin points to his own observation of "mild swelling"
in two finger joints on September 1, 1995, plus a number of physician notations that
petitioner's joints were "tender" upon examination.
Respondent's expert Dr. Robert Simms, also a specialist in rheumatology, disagrees with
Dr. Gershwin. Dr. Simms acknowledges that petitioner's symptoms reported in early November
of 1992, including rash, pain in many joints, and perhaps the "puffiness"
observed in her fingers on November 5, 1992, may have constituted a reaction to her
rubella vaccination. But he does not view petitioner's history since that time as one of
intermittent or continuous arthritis. He notes that in petitioner's extensive
medical records of the period since November of 1992, there is no evidence of swelling
in any joint, with the exception of the single observation by Dr. Gershwin on September 1,
1995. As to the petitioner's many complaints of joint pain and tenderness during that time
period, Dr. Simms believes that these are attributable not to arthritis but to the
syndrome known as "fibromyalgia syndrome," with which petitioner has been
diagnosed.
Dr. Simms explained that, as illustrated in respondent's Exhibits C through I filed on
April 22 and May 9, 1997, in recent years the medical profession has generally accepted
the existence of a syndrome known as "fibromyalgia syndrome" (hereinafter
sometimes "FMS"). In this syndrome, persons generally report pain in many
different fibrous tissue areas of their bodies (e.g., muscles, ligaments, tendons).
To fit within the syndrome, multiple areas of the body must be involved--often the
patients report that they "ache all over"--and the patients must be found to be
especially sensitive to pressure at all or most of 18 specific "tender points"
located at various fibrous tissue areas. Persons with FMS often, though not always, also
report a number of other chronic or recurring symptoms, including pain in the joint areas,
fatigue, sleep difficulty, "irritable bowel syndrome," headaches, non-cardiac
chest pain, numbness and tingling in their extremities, the feeling of swollen
extremities (but usually without any actual observable swelling), high stress,
depression, and anxiety. As to the cause of FMS, there are a number of theories,
but at this time, the cause is still not well-understood.
Dr. Simms points out that petitioner's medical history for many years prior to
her rubella vaccination included not only joint complaints but a number of other symptoms
that might indicate the early stages of FMS. He finds that her symptoms in recent years
clearly indicate FMS, as some of petitioner's own treating physicians have concluded. He
believes that petitioner's ongoing reports of pain and tenderness in her hand and foot
joints are simply a part of her FMS, and do not indicate arthritis.
C. Discussion
1. Scope of "objective signs of * * * arthritis"
To begin with, the experts disagreed as to the appropriate interpretation of the phrase
"objective signs of * * * arthritis" set forth in the Table. Dr. Gershwin
initially seemed to indicate that if a person had in a joint any of five signs--i.e.,
heat, redness, swelling, pain, or loss of function--that would constitute "objective
signs of arthritis." (Tr. 64.) He then seemed to clarify that explanation by
indicating that while a patient's own report of joint pain alone (i.e.,
"arthralgia") would not necessarily indicate arthritis, if a physician examined
the joint and found it "tender," meaning that the patient reported or exhibited
pain when the physician squeezed the joint, then that finding of tenderness would
constitute objective evidence of arthritis. (Tr. 65-66.)
Dr. Simms, on the other hand, seemed to take a much narrower view of what constitutes
"objective signs of * * * arthritis." Dr. Simms took strong issue with Dr.
Gershwin's suggestion that joint tenderness by itself would constitute an "objective
sign" of arthritis. (E.g., Tr. 97-98.) Dr. Simms also seemed to indicate that
only a finding of "synovitis," which means inflammation of the synovial
membrane, a particular part of the joint, would in his view constitute objective evidence
of inflammatory arthritis. (Tr. 94-95, 123-27.)
After consideration of both parties' arguments on this point, I find that I cannot
fully accept either party's interpretation of the phrase "objective signs of
arthritis." Rather, the wording of the statute itself suggests a middle ground. In
part (A) of 42 C.F.R. § 100.3(b)(6)(i), the word "arthritis" is immediately
followed by the parenthetical "joint swelling." I conclude therefrom that
"objective signs of arthritis," as used in the Table, means "objective
signs of joint swelling." It is true, of course, that when the word
"arthritis" is used again in part (B) of 42 C.F.R. § 100.3(b)(6)(i), it is not
followed by any parenthetical. But it is my inference that the Table drafters intended
this two-word "definition" of arthritis--i.e., "joint
swelling"-- to also apply to the word "arthritis" when it is used again in
part (B).
In light of this statutory language, then, it appears that Dr. Simms' suggested
interpretation of the phrase "objective signs of arthritis" is too strict.
There need not necessarily be a finding of "synovitis"--i.e., swelling of
the synovium, a particular part of the joint. Any form of joint swelling would seem to be
enough. But, on the other hand, Dr. Gershwin's view that a physician's report of joint
"tenderness" qualifies as an "objective sign of arthritis" seems to be
too broad. If a physician reports only tenderness, that means that the physician
did not observe joint swelling. Moreover, it seems doubtful that a physician's
notation of mere "tenderness" qualifies as an objective sign. Unlike
swelling, which a physician can actually observe, "tenderness" means that the
patient reports pain upon pressure, which would seem to put tenderness into the
realm of a "subjective" sign, rather than an "objective" sign.(8)
Thus, I conclude that medical documentation of "objective signs of arthritis"
does occur whenever upon examination (not upon the mere report of a patient)
a physician recorded the observation of joint swelling.(9)
It does not occur, however, when a physician merely notes joint tenderness.
2. Application to petitioner's case
Having made the above determinations as to the scope of the term "objective signs
of arthritis," I must apply those determinations to petitioner's case. Pursuant to
part (B) of 42 C.F.R. § 100.3(b)(6)(i), do petitioner's medical records contain medical
documentation of the "persistence" of "intermittent or continuous" joint
swelling? A close review shows that after the initial "puffiness" in
petitioner's finger joints observed on November 5, 1992, the medical records of
petitioner's physician visits over the next three years contain only one notation of joint
swelling--i.e., the notation of Dr. Gershwin on September 1, 1995, of "mild
swelling" in two joints of a single finger. (Ex. 17, p. 25.) Many other records
contain evidence of joint pain or tenderness, but none document swelling.
The question then becomes, does this single 1995 notation of mild swelling in two
joints of one finger, in conjunction with the notation of "puffiness" on
November 5, 1992 (which could also be interpreted as mild swelling), indicate a
"persistence" of "intermittent or continuous" joint swelling? I
conclude that it does not. There obviously was not "continuous" joint swelling
throughout the nearly three-year period between November 5, 1992, and September 1, 1995.
And, in my view, the words "persistence" and "intermittent," while
certainly requiring much less than a "continuous" presence of objective
symptoms, do require more than one observation of joint swelling over a three-year period.
Those words imply that the joint swelling must be seen on multiple, separate occasions.
That is simply not the case here.
In this regard, it should be noted that there exist records of many visits of
petitioner to physicians at which joint pain was reported and a specific physical
examination of petitioner was made, but no joint swelling was recorded. See,
e.g., records of visits on November 11, 1992 (Ex. 1, p. 8); November 18, 1992 (Ex.
1, p. 9); December 2, 1992 (Ex. 1, p. 11); January 15, 1993 (Ex. 3, p. 6); May 6, 1993
(Ex. 6, pp. 2-3); January 13, 1994 (Ex. 6, p. 5); February 16, 1994 (Ex. 11, p. 6);
February 17, 1994 (Ex. 17, p. 15); April 21, 1994 (Ex. 7, p. 2); June 3, 1994 (Ex. 18, p.
21); June 15, 1994 (Ex. 15, pp. 3-4); June 17, 1994 (Ex. 16, p. 62); and October 19, 1994
(Ex. 16, p. 57). This circumstance refutes the suggestion of Dr. Gershwin that there might
indeed have existed intermittent swelling episodes, but by chance those episodes simply
never occurred on the days when petitioner visited her physicians. Given the number of
these visits, Dr. Gershwin's suggestion simply seems unlikely. Moreover, I find this
suggestion legally irrelevant in any event. That is, my interpretation of the Table Injury
requirement of "medical documentation" of "objective signs" of the
"persistence" of "intermittent" arthritis is that there must be
multiple examples when a physician did observe actual swelling during the
three-year post-vaccination period. And that simply did not happen, for whatever reason,
in petitioner's case.
In short, for all the reasons discussed above, I conclude that
petitioner has not demonstrated that she has experienced a case of "chronic
arthritis" falling within the Vaccine Injury Table.
V
ISSUE OF "ACTUAL CAUSATION"
The second issue is whether petitioner has demonstrated that it is "more probable
than not" that the pain symptoms in her hands and feet since 1992 were actually
caused by her rubella vaccination. As to this contention of "actual
causation," I will begin by setting forth, in Part A of this section of this
Decision, a summary of information relating to this issue that I have received in prior
Program cases. In Part B, I will discuss some legal points. Finally, in Parts C and D, I
will discuss the factual specifics of this case.
A. Medical background: The general issue of the relationship between
the rubella vaccine and chronic joint symptoms
The issue here--i.e., whether a person's chronic joint problems were caused by a
rubella vaccination--is not unique to this case. Rather, a large number of cases under the
Program have involved similar claims, and, until 1995, no "chronic arthritis"
Table Injury existed. Accordingly, upon assignment by the Chief Special Master, in 1992 I
undertook an inquiry into the general medical/scientific issue of whether rubella
vaccinations can cause persistent joint pain and related joint symptoms, and, if so, in
what circumstances. That inquiry involved extensive research into the relevant medical
literature, as well as evidentiary hearings in which I heard the testimony of a number of
qualified medical experts. The history of that inquiry was set forth in an Order filed in
70 Program cases on January 11, 1993, and will not be repeated here. See Ahern
et al. v. Secretary of HHS, 1993 WL 179430 (Fed. Cl. Spec. Mstr. January 11, 1993). (I
will hereinafter refer to that Order as the "Omnibus Order." Also, I will at
times refer to my inquiry described above concerning the general issue of the relationship
between the rubella vaccine and joint symptoms, including the extensive evidentiary
hearings that I conducted, as the "Omnibus Proceeding.") As a result of that
inquiry, for reasons also fully explained in the Omnibus Order, I reached the conclusion
that if a person's chronic arthritis or similar joint symptoms arose under a certain set
of circumstances, it might reasonably be concluded--absent any additional evidence--that
it is "more likely than not" that such symptoms were vaccine-caused. As
explained in the Omnibus Order, this conclusion was based upon evidence showing that a
large number of persons have experienced histories of joint symptoms which follow a
typical pattern. This pattern involves, inter alia, the onset of significant,
observable swelling in multiple joints between one and six weeks after a rubella
vaccination, followed by some period of remission or reduction in symptoms, but still
later by a recurrence or persistence of more swelling, or simply pain, in the same joints.
In general, I concluded that if a particular petitioner's history of joint symptoms falls
into this pattern, and there is no other apparent cause for the symptoms, then one could
reasonably--subject to any additional evidence introduced in future Program cases--attribute
the chronic symptoms to the vaccination.
It has been questioned whether it is appropriate for me to apply evidence obtained
during the Omnibus Proceeding to the individual cases of petitioners who did not
themselves participate in that Proceeding. I have addressed this issue at length in Wagner
v. Secretary of HHS, No. 90-2208V, 1997 WL 617035, at *3, footnote 4 (Fed. Cl. Spec.
Mstr. Sept. 22, 1997). Moreover, in their post-hearing briefs both parties to this case
indicated their view that it is appropriate that I apply the Omnibus Proceeding
information to this case.(10) Accordingly, I have
evaluated petitioner's case in light of the evidence received and the conclusions reached
in the Omnibus Proceeding.
B. Legal considerations
It should be noted initially that in analyzing a contention of "actual
causation," the presumptions available under the Vaccine Injury Table are, of course,
inoperative. It is clear that the burden is on the petitioner to show that in fact the
vaccination in question "more probably than not" caused the injury. Hines v.
Secretary of HHS, 940 F.2d 1518, 1525 (Fed. Cir. 1991); Carter v. Secretary of HHS,
21 Cl. Ct. 651, 654 (1990); Strother v. Secretary of HHS, 21 Cl. Ct. 365, 369-70
(1990), aff'd per curiam, 950 F.2d 731 (1991); Shaw v. Secretary of HHS, 18
Cl. Ct. 646, 650-51 (1989). Thus, the petitioner must supply "proof of a logical
sequence of cause and effect showing that the vaccination was the reason for the injury. A
reputable medical or scientific explanation must support this logical sequence of cause
and effect." Strother, 21 Cl. Ct. at 370; Hasler v. United States, 718
F.2d 202, 205-06 (6th Cir. 1983), cert. denied, 469 U.S. 817 (1984); Novak v.
United States, 865 F.2d 718, 724 (6th Cir. 1989). Temporal association alone is not
sufficient. Strother, 21 Cl. Ct. at 370; Shaw, 18 Cl. Ct. at 650-51;
Carter, 21 Cl. Ct. at 654. Moreover, simple "similarity of petitioner's injury to
injuries listed on the Table does not show causation in fact. Encephalitis, seizure
disorders, and other Table Injuries can have causes other than the administration of a
vaccine." Strother, 21 Cl. Ct. at 370.
The briefs filed in this case, however, suggest that there is confusion as to the
effect of the Omnibus Order, described above, on the petitioner's burden of showing that
her problems were vaccine-caused. Petitioner's counsel seems to believe that there are two
completely different, separate methods of demonstrating "actual causation"--i.e.,
(1) actual causation under the approach detailed in my Omnibus Order, and (2)
"traditional cause-in-fact"(11) analysis. (See
petitioner's brief filed March 13, 1998, pp. 15, 18.) Respondent, on the other hand,
suggests that "the analytical framework set forth in the omnibus order * * * does not
require specific evidence of vaccine causation in a particular case." (See
respondent's brief filed on March 6, 1998.) It seems appropriate, then, that I attempt
here to resolve this confusion.
In fact, there is in my view no distinction whatsoever between the
"traditional" approach to proving "actual causation" and the approach
that I adopted in the Omnibus Order. In the Omnibus Order, I was merely outlining a particular
way in which a petitioner could carry her "traditional" burden of showing
"actual causation." I was explaining that if a petitioner could show that her
history fit factually within a certain pattern, then that showing, combined with the
medical opinion evidence that I heard in the Omnibus Proceeding, would (in the absence
of additional medical opinion evidence) justify a conclusion that the petitioner's injury
was vaccine-caused. In other words, I was merely providing a "short-cut" by
which the traditional requirements of "actual causation" could be
satisfied without the need for redundant medical expert testimony in every case; in
effect, the expert testimony taken in the Omnibus Proceeding would serve as the
expert opinion concerning the "actual causation" issue for the petitioner in
the particular case.
Therefore, the petitioner in this case is erroneous in suggesting that there are two
conceptually different methods of demonstrating "actual causation." At the same
time, the respondent is wrong in her suggestion that the analytical framework of my
Omnibus Order "does not require specific evidence of vaccine causation in a
particular case." To the contrary, my Omnibus Order framework does require
"specific evidence of vaccine causation" in every case, as is plainly
required under the statute. In each case, a petitioner must offer specific factual
evidence that his or her medical history falls within a particular pattern. Then,
applying the medical opinion evidence taken in the Omnibus Proceeding to the facts
of the particular case, I may be able, in appropriate cases, to make a specific finding
that there is evidence supporting the conclusion that it is "more probable than
not" that that particular petitioner's condition was vaccine-caused.(12)
Thus, I have clarified above, I hope, my position as to how the approach set forth in
the Omnibus Order fits squarely within the "traditional" legal approach to
"actual causation." Next, I will address briefly a thornier legal topic--i.e.,
the two different legal approaches to "actual causation" under the Program
that emerged in the recent Wagner case. The two different approaches are explained
in detail in Wagner v. Secretary of HHS, 37 Fed. Cl. 134 (Fed. Cl. 1997)
(hereinafter Wagner I) and Wagner v. Secretary of HHS, No. 90-2208V, 1997 WL
617035 (Fed. Cl. Spec. Mstr. Sept. 22, 1997) (hereinafter Wagner II), and will not
be repeated here. To summarize the divergence of analysis between the two opinions, in Wagner
II, I set forth the view that in ruling upon a claim of "actual causation,"
a Program factfinder is authorized to consider all the evidence of record; in Wagner
I, on the other hand, a judge of this court concluded that in ruling upon an
"actual causation" claim the factfinder is forbidden to consider evidence
concerning a possible non-vaccine cause of the injury if that possible cause constitutes
an "idiopathic" factor"--i.e., one of unknown cause.
In this case, respondent argues, among other things, that petitioner's chronic hand and
foot complaints are symptoms of a condition called "fibromyalgia syndrome"
(FMS), rather than being vaccine-caused. And it is essentially undisputed that FMS is a
syndrome of unknown cause, so that under Wagner I, I would be precluded from
considering evidence concerning FMS in resolving petitioner's "actual causation"
claim in this case. Accordingly, I asked the parties to address in their post-hearing
briefs the question of whether the outcome of this case depended upon whether I applied
the approach of Wagner I or the approach of Wagner II.
In response, both parties to this case suggest that it is not necessary for me
to choose between the two differing approaches, because the case should come out the same
under either approach. Not surprisingly, each side argues that it should prevail
regardless of which legal approach is applied. After careful consideration, I agree with
the view that the issue of which Wagner opinion is correct is ultimately
unimportant here, because I conclude that petitioner has failed in this case to
demonstrate "actual causation" whether I follow Wagner I or Wagner II.
That is, whether I disregard the evidence as to FMS or consider it, my ruling would be in
respondent's favor.
I do note, however, that, because of the two differing analytical frameworks set forth
in the two Wagner opinions, I will divide my discussion of the evidence relevant to
the "actual causation" issue in this case into two general sections, below.
Thus, in part C of this section of this opinion, I will analyze only that evidence that
would be relevant under a Wagner I approach, disregarding the evidence with respect
to FMS. Then, in part D, I will discuss the FMS evidence, demonstrating how consideration
of that evidence would strengthen the conclusion that petitioner's joint complaints in
recent years are probably not vaccine-caused.
C. Factual analysis of this case under Wagner I
1. Introduction
Turning to the particular facts of petitioner's case, I begin by observing that
apparently the bulk of the energy of the petitioner's counsel and expert in this case must
have been focused upon the Table Injury theory, because the record shows relatively little
evidence with respect to the "actual causation" issue. To be sure, Dr. Gershwin
clearly stated that he believes that petitioner's hand and foot pain since 1992 has been
vaccine-caused. And he did explain in a very brief and summary fashion his theory in that
regard--i.e., that the rubella vaccination has affected petitioner's immune system
in such a fashion that when she is exposed to various antigens, her own immune system
reacts inappropriately and causes her joint pain. (See Tr. 73-76.) However, Dr. Gershwin
did not really explain why he thought that the rubella vaccine could so effect
petitioner's immune system. He did not cite any significant medical literature supporting
his theory. He did cite to one article, which petitioner filed. (Ex. 24, filed on June 16,
1997.) That brief article, however, essentially presents only a theory that
vaccines in general might trigger autoimmune disorders. There is no focus on the
rubella vaccine in that article, and the article's conclusion itself stresses that the
data summarized in the article merely "suggests" that some unnamed vaccines
"may in rare cases" induce autoimmune disorders, and that "for the time
being no conclusions can be drawn." (Id. at 3.)
In short, were the evidence for petitioner's "actual causation" argument in
this case confined to the evidence actually presented by petitioner herself in this
proceeding, I would have to reject her argument immediately, as wholly insubstantial and
totally unpersuasive.
However, as explained above, this case was pursued in the understanding that the
evidence gathered in the course of the Omnibus Proceeding would be applied to this
case. And in the Omnibus Proceeding I was presented with evidence sufficient to indicate
that cases of chronic joint symptoms which arose in particular circumstances,
chiefly involving the onset of symptoms one to six weeks after a rubella
vaccination, could be considered (in the absence of additional relevant facts) to be
"more probably than not" vaccine-caused. Therefore, it is appropriate that I
analyze whether the evidence introduced in this particular proceeding combined with
the evidence received in the Omnibus Proceeding justifies a conclusion that petitioner's
chronic hand and foot pain has been vaccine-caused. After a complete analysis(13) in that regard, I conclude that the combined evidence does not
support such a conclusion.
2. Analysis under the Omnibus Order criteria
In the Omnibus Order, I stated that based upon the evidence taken in the Omnibus
Proceeding, I could conclude that a petitioner's chronic joint symptoms were "more
probably than not" caused by that petitioner's rubella vaccination if the
petitioner's history met all of a specific set of criteria. The second of those
criteria was as follows:
2. The petitioner had a history, over a period of at least three years prior to the
vaccination, of freedom from any sort of persistent or recurring polyarticular joint
symptoms.
Ahern, 1993 WL 179430 at *13.(14) Applying that
criterion to this case, I find that petitioner's condition clearly is disqualified under
that criterion. That is, petitioner's medical records demonstrate that in the years
proceeding her rubella vaccination she did report joint complaints, including
complaints concerning her hands and feet, to her physicians on a number of occasions.
For example, petitioner's medical records indicate that just three months prior to her
rubella vaccination, on October 19, 1992, petitioner reported multiple joint complaints.
On July 16, 1992, she reported tingling and pain in her left knee, right elbow, neck, and
lower back, and, most important here, "constant numbness" in her right toes.
(Ex. 10, p. 4.) Another history given by petitioner also states that at some unspecified
time in 1992, petitioner had numbness in her right foot. (Ex. 3, p. 11.) A record dated
July 9, 1992, reports shoulder and neck discomfort. (Ex. 1, p. 2.) And a record dated July
13, 1992, reports right foot numbness, extending to her ankle. (Ex. 1, p. 3.)
I have found no other reports of joint complaints within the three years
immediately preceding petitioner's rubella vaccination, but going back only slightly more
than three years shows a considerable history of joint complaints, again with some such
notations relating specifically to the hands or feet. For example, on September 20, 1989,
petitioner reported "vague stiffness." (Ex. 9, p. 51.) On May 26, 1989, she
reported leg stiffness, as well as pain in "almost every place in her body."
(Ex. 9, p. 48.) Another record also confirms that petitioner experienced "joint
stiffness" and pain "almost every place" in May of 1989. (Ex. 3, p. 11.) On
May 9, 1988, petitioner reported "cramps in the hands" and "pins and
needles in the feet * * * and hands." (Ex. 9, p. 40.) Another report describes
"pins and needles" in her "hands and feet" in 1987. (Ex. 3, p. 10.) On
October 8, 1986, petitioner reported pain in her right wrist, along with her shoulders,
neck, and right knee. (Ex. 9, p. 29.) Another record indicates that also in 1986,
petitioner had an episode in which she thought that her knuckles were swollen. (Ex. 3, p.
10.) And, going back to even earlier medical records, there exist notations of back pain
in 1983 (Ex. 1, p. 72; Ex. 9, p. 11), and "aches on occasion" in her "bones
and joints" in 1982 (Ex. 9, p. 2).
This considerable history of pre-vaccination joint complaints means that petitioner
fails the criterion #2 set forth above. To be sure, the experts who testified before me in
the Omnibus Proceeding explained that this criterion would have to be applied to any
particular case with an element of judgment as to the extent and severity
of the pre-vaccine history. For example, one episode of a single swollen joint after
trauma would not constitute a disqualifying factor. (See, e.g., Ahern, 1993
WL 179430 at *18, fn.10.) But the history of the petitioner in this case, particularly the
reports of multiple joint complaints including the toes in July of 1992, so
recently prior to the vaccination in question, seems very significant. When those 1992
reports are combined with the extensive, repeated history of joint complaints from
the late 1980's, there is clearly a history that casts doubt upon the theory that
petitioner's post-vaccination joint complaints are a totally new phenomenon, related to
the vaccination. That is, as the experts in the Omnibus Proceeding explained, the
existence of significant pre-vaccination joint symptoms similar to the post-vaccination
symptoms greatly reduces the likelihood that the post-vaccination symptoms were
vaccine-caused. And those Omnibus Proceeding experts indicated that even joint symptoms
predating the rubella vaccination by more than three years could be a
disqualifying factor in a particular case. (Id.) In this case, Drs. Gershwin and
Simms disagreed upon whether petitioner's pre-vaccination joint history cast doubt upon
the theory that her recent joint pain is vaccine-caused. I found Dr. Simms to be vastly
more persuasive on this point, in his argument that petitioner's pre-vaccination history was
quite significant and does cast doubt upon the theory that her post-vaccination
joint symptoms were vaccine-caused.(15)
In short, evaluating petitioner's medical records based upon the testimony of Dr. Simms
in this case and the experts who testified in the Omnibus Proceeding, I conclude that
petitioner's pre-vaccination history is not sufficiently free from joint symptoms
to qualify her under the criterion #2 set forth above.
This failure to satisfy criterion #2 is clearly enough by itself to mean that
petitioner has failed under the Omnibus Order approach to show that her joint symptoms
since 1992 have been a result of her rubella vaccination. That is, as stressed in the
Omnibus Order, it must be kept in mind that even the basic theory that the rubella vaccine
does cause chronic joint symptoms is a controversial one. That is, as conceded by
even the experts who testified for petitioners in the Omnibus Proceeding, the evidence
that the rubella vaccine causes chronic joint symptoms is limited. Even those petitioners'
experts acknowledged that the causal connection is not "medically proven,"
because the type of extensive, repeated, "controlled" epidemiologic studies on
the issue, which could "medically prove" the connection, have not been done.
Thus, as I explained in the Omnibus Order, even when a particular petitioner's case seems
to fall clearly within the general pattern of chronic rubella-associated arthropathy
described in that Order, it can still only be said to be slightly more probable than not
that the particular petitioner's symptoms were vaccine-caused. Therefore, to the extent
that a particular petitioner's history deviates in any significant way from that general
pattern, the probability that such person's symptoms were vaccine-caused therefore slips
to less than 50%, or less than "more probable than not."
Moreover, there are other significant ways in which the petitioner's case deviates from
the general pattern that would be most indicative of vaccine-caused joint symptoms. For
example, in the classic post-vaccine joint symptom case as described in the Omnibus
Proceeding, there is a record of clear arthritis--i.e., quite noticeable
swelling--in multiple joints, observed by a physician within the first several
weeks post-vaccination. In petitioner's case, in contrast, the only physician observation
during the acute stage described "no dramatic swelling, but just a faint
puffiness" of a few finger joints. (Ex. 1, p. 7.) In addition, over the ensuing 5 1/2
years, there have been only two instances of a physician reporting swelling in
petitioner's joints (in both cases in finger joints),(16)
both by the physician who has served as petitioner's expert witness in this case. These
circumstances are relevant because the experts who testified during the Omnibus Proceeding
indicated that the more dramatic the swelling during the acute stage, the greater would be
the chance for chronic symptoms to follow, and also that the more frequent and clear the
actual swelling in the chronic stage, the stronger the inference that there truly is
rubella-caused arthritis rather than discomfort caused by one of the legion of other
potential sources of chronic joint pain. In this case, then, the marginal nature of the
acute-stage "puffiness" and the almost total lack of swelling observations since
that time are additional factors militating against a conclusion that petitioner's chronic
symptoms are vaccine-caused.
A final point in this regard concerns the fact that petitioner points to a pair of
physician's notations in petitioner's records and argues that such notations support
petitioner's "actual causation" theory. See the notation of Dr. Bush on November
5, 1992, of "rubella, secondary to immunization" (Ex. 1, p. 7), and the notation
of Dr. Macchello on April 15, 1993, that petitioner has "chronic arthritis/arthralgia
most likely 2º [secondary to] rubella vaccine." (Ex. 3, p. 15.) Of course, I note
that in this case as in all Program cases, I view the opinions of a petitioner's actual
regular treating physicians with great respect. But after careful review, I conclude that
these two opinions offer little support to petitioner's "actual causation"
argument in this case.
First, Dr. Bush's notation is not really of any relevance to the issue here of whether
petitioner's chronic joint pain has been vaccine-caused. Dr. Bush's comment was
made only 17 days after her vaccination during petitioner's "acute" phase of
rash and generalized aching, which, as even Dr. Simms acknowledges, probably did
constitute a reaction to her vaccination.(17)
Dr. Macchello's notation, on the other hand, is of greater significance, since it was
made some six months post-vaccination, long past the typical duration (one week to a few
weeks) of an ordinary, transient rubella vaccine reaction. The fact that Dr. Macchello
stated such an opinion as to causation is of evidentiary value. However, Dr. Macchello was
obviously at a disadvantage compared to those physicians who treated petitioner at a later
date, or those who have testified in this case. Dr. Macchello only had access to six
months of petitioner's post-vaccination history, which is significant because the longer
petitioner goes without observable swelling, the more questionable is the causal link to
her vaccination. Moreover, it is unclear whether Dr. Macchello was aware of petitioner's
history of pre-vaccination joint complaints.
Moreover, the brief opinions recorded by other physicians who treated petitioner at later
times tend to support the contrary conclusion, that there likely was no
causal relationship between petitioner's rubella vaccination and her chronic symptoms. For
example, Dr. Dozier, a neurologist, wrote in February of 1994 that petitioner's problem
seemed to be "myalgia [muscle pain] of unknown cause," and was not
"typically arthritic." (Ex. 11, p. 7.) This opinion that petitioner's pain is
muscular and not arthritic in nature obviously cuts against the notion that petitioner's
symptoms are vaccine-caused. Also, Dr. Nagy, an internist, noted in April of 1994 the
opinion that petitioner's condition is "not related to" her rubella
immunization. (Ex. 16, p. 54.) Finally, Dr. White, a board-certified rheumatologist who
evaluated petitioner's joint complaints regularly in 1993 and 1994, and then was asked to
examine petitioner again in 1997, stated that he "cannot make a diagnosis of * * *
rubella-associated arthritis." (Resp. Ex. K, filed on January 22, 1998, p. 1.)
In short, for all the reasons set forth above, even setting aside the evidence with
respect to FMS, I find that petitioner clearly has failed to demonstrate that it is
"more probable than not" that her chronic hand and foot pain since 1992 has been
vaccine-caused.(18)
D. Additional factual analysis of evidence concerning fibromyalgia syndrome
Finally, I note that if the analysis of Wagner II is correct, and therefore I am
authorized as factfinder to consider the evidence concerning the "fibromyalgia
syndrome" (FMS), there would be even more reason for rejecting petitioner's
"actual causation" argument.
1. Petitioner has FMS
The first issue in this regard is whether it can be fairly said that petitioner's
condition fits within the fibromyalgia syndrome. I conclude that it can, for a number of
reasons. First, a number of petitioner's treating physicians so concluded. For example, as
early as December 2, 1992, Dr. Scalapino analyzed petitioner's history and suggested that
she had a "hint of fibromyalgia." (Ex. 1, p. 11.) Dr. White, the board-certified
rheumatologist who evaluated petitioner at a number of visits in 1993 and 1994, reached at
that time the conclusion that petitioner has FMS. (Ex. 6, pp. 2, 4, 5; Ex. 17, p. 14.) He
reached the same conclusion after examining her again in 1997. (Resp. Ex. J filed Aug. 8,
1997, p. 2; Resp. Ex. K filed Jan. 22, 1998, p. 1.) In addition, another physician's note
dated February 17, 1996--it is not clear who the physician was--indicates
"fibromyalgia" as the physician's assessment (see notation at lower left-hand
corner after the abbreviation "A/P," which likely stands for
"assessment/plan"). (Ex. 17, p. 15.) And on February 1, 1994, Dr. Chang noted
that petitioner "has a history of fibromyalgia syndrome." (Ex. 16, p. 44.)
In addition, I found respondent's expert in this proceeding, Dr. Simms, to be
convincing in explaining why he agrees with those treating physicians that petitioner has
FMS. I found persuasive, for example, the explanation that a diagnosis of FMS may be
well-justified on the fact that an individual has particular tenderness at a significant
number of the classic FMS "tender points," even if the number of tender
points located falls short of the number 11 necessary for inclusion in formal FMS studies.
(See Tr. 92-93, 101-102, 104-107, 121-123.) As Dr. Simms explained, a
board-certified rheumatologist, such as Dr. White who treated petitioner, is qualified to
make the diagnosis based upon the overall history of the individual along with a finding
of tenderness at a reasonable number of the classic tender points. (Id.)
Moreover, after scrutinizing the articles concerning FMS filed by respondent at Exs. C
through I, and then studying petitioner's medical records, I find that her history
contains documented examples of many of the primary and secondary indicia of FMS. These
include evidence of the classic, defining symptoms of FMS--i.e., diffuse muscle
pain, "aching all over," and special sensitivity at the "tender point"
areas. See, for example, a report of pain "in almost every place in her body" on
May 26, 1989 (Ex. 9, p. 48); diffuse muscle pain ("myalgia") on February 16,
1994 (Ex. 11, p. 7); Dr. White's enumeration of petitioner's tender points of May 6, 1993
(Ex. 6, p. 3, lower right-hand corner--see discussion of this notation at Tr. 44-45;
101-102; 104-107); and Dr. Scalapino's notation of "tender trigger points up and down
the spine" on December 2, 1992 (Ex. 1, p. 11).
Petitioner's records also include many examples of the "secondary" symptoms
that are not part of the definition of FMS but are very often experienced on a chronic
basis by FMS patients, such as fatigue, sleep difficulties, "irritable bowel
syndrome," non-cardiac chest pain, numbness and tingling, depression, anxiety, and
panic attacks. For example, petitioner has reported sleep problems (Ex. 9, p. 28; Ex. 16,
p. 57); fatigue (Ex. 6, p. 3; Ex. 9, pp. 17, 18, 20, 28; Ex. 17, p. 3); irritable bowel
problems (Ex. 9, pp. 8, 9); non-cardiac chest pain (Ex. 9, pp. 18, 33); and numbness and
tingling ("pins and needles," "parasthesias") (Ex. 1, p. 3; Ex. 3, pp.
3, 10, 11, 12; Ex. 9, p. 40; Ex. 10, p. 4). She also has experienced the type of
psychological symptoms often associated with FMS, including reports of stress, anxiety,
panic attacks, and depression. (Ex. 3, pp. 5, 10, 11, 12; Ex. 9, pp. 38, 40, 45, 51, 60.)
For all these reasons--the most important being the opinion of the board-certified
rheumatologist Dr. White--I am persuaded that Dr. Simms is correct in asserting that it is
reasonable to assign petitioner to the category of FMS patients.
2. Additional discussion
The fact that petitioner's case fits within the FMS category, thus, is additional
reason to doubt that petitioner's difficulties with her hands and feet since 1992 have
been vaccine-caused. It might be theoretically possible, of course, for a person to have
both FMS and a chronic vaccine-caused joint condition. But the existence in
petitioner of FMS, a very common syndrome, makes it much more difficult to determine the
cause and even the nature of any joint symptoms that petitioner has. That is, as Dr. Simms
testified and the medical literature filed in this case confirms, with FMS it is quite
common for patients to have a "feeling" of swelling in the joints, or to have
pain in fibrous tissues very close to the joints that is mistaken for joint pain
itself. This makes it very difficult to distinguish between actual joint pain and FMS
tissue pain close to the joints. In the total circumstances of this case, I am persuaded
that it is more likely that petitioner's chronic joint complaints are a reflection of her
FMS than that they are vaccine-caused.
One important point in this regard is that petitioner experienced many of her FMS-like
symptoms, enumerated above at p. 17 of this Decision, during the years prior to her
rubella vaccination. Thus, obviously, her FMS itself cannot be attributed to her
vaccination. Moreover, one example stressed by Dr. Simms from petitioner's pre-vaccination
history is particularly illuminating. That is, one medical record indicates that in 1986
petitioner went to a physician complaining of a swollen knuckle, but the physician found
no swelling. (See Ex. 3, p. 10.) Dr. Simms indicated that this sort of incident--i.e.,
to report a feeling of joint swelling and pain, but to have a physician find no
objective evidence of injury--is typical not only of FMS patients in general, but also of petitioner's
own post-vaccination history. (Tr. 87-88.) This point adds to the likelihood that
petitioner's recent hand and foot complaints are symptoms of FMS rather than the result of
her rubella vaccination.
In sum, the evidence as to FMS, if considered appropriate for
consideration concerning the "actual causation" issue, would add even more
weight to the conclusion that petitioner has not made a successful "actual
causation" showing in this case.(19)
VI
CONCLUSION
It is, of course, very unfortunate that petitioner suffers from chronic ailments,
including the pain in her hands and feet. She is certainly deserving of sympathy for those
symptoms. As the above discussion indicates, however, I must conclude that petitioner does
not qualify for a Program award, under either of her two theories. Absent a timely
motion for review of this Decision, the Clerk of this court shall enter judgment
accordingly.
______________________________
George L. Hastings, Jr.
Special Master
1. The applicable statutory provisions defining the Program are found at 42 U.S.C. § 300aa-10 et seq. (1994 ed.). Hereinafter, all "§" references not otherwise designated will be to 42 U.S.C. (1994 ed.).
2. Petitioner filed records divided into exhibits 1 through 7 with the petition, and Exhibits 8 through 20 on September 13, 1996. "Ex. __" references, unless otherwise noted, will be to those exhibits.
3. "Synovitis" is defined as inflammation of the synovial membrane, which is a part of a joint. Dorland's Illustrated Medical Dictionary (27th ed. 1988), p. 1649. See also Tr. 123-125.
4. "Fibromyalgia syndrome," as will be discussed at length in the pages to come, is a relatively common syndrome, of unknown cause, in which a person reports pain in multiple areas of the body, and often other related symptoms, but no objective evidence of injury is detectable by the physician.
5. "C.F.R." references in this opinion are to the 1996 edition of the C.F.R.
6. Petitioner bears the burden of demonstrating the facts necessary for entitlement to a Program award by a "preponderance of the evidence." § 300aa-13(a)(1)(A). Under that standard, the existence of a fact must be shown to be "more probable than not." In re Winship, 397 U.S. 358, 371 (1970) (Harlan, J., concurring).
7. It may be noted that another administrative revision to the Vaccine Injury Table was promulgated in 1997. See 62 Fed. Reg. 7685, 7688 (1997) (to be codified at 42 C.F.R.). That revision did make some minor changes to the Table definition of "chronic arthritis," but those changes are not applicable to this case, since such changes only apply to Program petitions filed after March 24, 1997. Moreover, it does not appear that those minor changes would change the result in this case in any event.
8. Moreover, I note that part (iii) of 42 C.F.R. § 100.3(b)(6) specifies that "[a]rthralgia (joint pain) * * * without joint swelling shall not be viewed as chronic arthritis." And, as noted above, a report of joint "tenderness" means merely that the patient reports joint pain upon pressure.
9. Could there be other possible "objective signs of arthritis" in addition to specific physician observations of "joint swelling"? Bone scan evidence, for example? It is unnecessary for me to reach that question in this case. It is necessary only for me to conclude that physician reports of "joint tenderness" do not qualify as "objective signs of arthritis."
10. Further, while I have included this part V(A) in this opinion
in the interest of thoroughness, in order to make it clear that the evidence in this case
was evaluated in light of my experience gained in the course of the Omnibus Proceeding, I
also note that even had I based my ruling in this case strictly upon the
evidence introduced in this proceeding alone, my ruling would have been the same.
It may be also noted that as a result of the Omnibus Proceeding and subsequent proceedings in individual cases, thus far a significant number of cases, each involving allegations of joint symptoms caused by a rubella vaccination, have been fully or partially resolved. In 66 cases, prior to this case, I have given written or informal oral rulings concerning the issue of whether a petitioner's chronic arthropathic symptoms were vaccine-caused. In 14 of those 66, I found that the petitioner failed to make the required "causation" showing. (See, e.g., Awad v. Secretary of HHS, 1995 WL 366013, No. 92-79V (Fed. Cl. Spec. Mstr. June 5, 1995).) In the other 52, I concluded that the requisite showing of causation was made. (See, e.g., Long v. Secretary of HHS, 1995 WL 470286, No. 94-310V (Fed. Cl. Spec. Mstr. July 24, 1995).)
11. I understand the terms "actual causation" and "causation-in-fact" to be synonyms. They both refer to the method of proof by which a petitioner shows by scientific evidence that vaccination A caused injury B, as permitted under § 300aa-11(c)(1)(C)(ii). This method, of course, is the alternative to proof of causation via the Table Injury route.
12. Of course, I recognize that certain medical studies published since I issued the Omnibus Order have added to the available evidence on the issue of whether the rubella vaccine causes chronic arthritis. See Bilotti v. Secretary of HHS, No. 92-429V, 1998 WL 78717, at *4 (Fed. Cl. Spec. Mstr. Jan. 20, 1998). There has been no need for me to consider in this case the two studies discussed in Bilotti, since, as will be seen, I must reject petitioner's case as failing even under the criteria originally set up in my Omnibus Order. However, in future cases I will, of course, continue to evaluate the evidence submitted in the Omnibus Proceeding in light of any additional evidence submitted by the parties.
13. In this particular analysis, in compliance with Wagner I, I am excluding and disregarding evidence with respect to FMS.
14. In any analysis under Wagner I, of course, I would not apply the sixth criterion set forth in my Omnibus Order, which Wagner I found to be improperly restrictive.
15. It is worthy of note that Dr. Gershwin first seemed to argue that petitioner's pre-vaccination history was more or less typical of the ordinary aches and pains that most people experience. (See, e.g., Tr. 11, 34-35.) But I found this suggestion to seem preposterous on its face, and Dr. Simms took strong issue with it. Eventually, Dr. Gershwin was forced to back off from that assertion and to acknowledge that petitioner's pre-vaccination history is typical not of an "average" individual, but of the type of patient who is routinely seen by a rheumatologist. (Tr. 35-37.)
16. I have already described above the fact that Dr. Gershwin's note of September 1, 1995, reported mild swelling in two finger joints. In addition, during the hearing held on June 20, 1997, Dr. Gershwin was present with petitioner, and stated that on that day he observed swelling in two of the petitioner's fingers. (Tr. 79.) (Because Drs. Gershwin and Simms were both testifying by telephonic conference call, Dr. Simms could not also view petitioner's fingers on that day.) I note that based upon this representation of Dr. Gershwin at the hearing, at the conclusion of the hearing I asked the parties to jointly select a rheumatologist to examine petitioner again, to determine whether she was experiencing actual joint swelling. They picked Dr. White, who examined petitioner on July 8, 1997, and found no joint swelling.
17. As explained in the Omnibus Order (1993 WL 179430 at *4), it is well accepted that the rubella vaccine causes transient short-lived episodes of arthritis in perhaps 15% of adult vaccinees. The controversial question, rather, is whether that vaccine causes chronic arthritis. It should be noted, moreover, that the acute reaction of the petitioner in this case, though in fact probably vaccine-caused, does not qualify petitioner for a Program award, because there is no good evidence that the effects of this problem lasted for at least six months. See § 300aa-11(c)(1)(D)(i).
18. In this regard, I note that I have closely considered Dr. Gershwin's testimony concerning petitioner's positive antinuclear antibody (ANA) test. However, I found the testimony of Dr. Simms, who asserted that this result was not significant to the issue of vaccine-causation (see, e.g., Tr. 95-97), to be substantially more persuasive.
19. I note that in two other cases in which the petitioners had FMS, I declined to find that the petitioners had chronic vaccine-caused joint symptoms. See Johnson v. Secretary of HHS, No.
92-478V, 1995 WL 61536 (Fed. Cl. Spec. Mstr. Jan. 31, 1995), aff'd 33 Fed. Cl. 712 (1995), aff'd 99 F.3d 1160 (Fed. Cir. Oct. 30, 1996); Awad v. Secretary of HHS, No. 92-79V, 1995 WL 366013 (Fed. Cl. Spec. Mstr. June 5, 1995).