Smith v. Secretary of Health and Human Services ( 2018 )

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
*************************
WILLIAM SMITH, *
* No. 15-1194V
Petitioner, * Special Master Christian J. Moran
*
v. *
* Filed: October 31, 2018
SECRETARY OF HEALTH *
AND HUMAN SERVICES, * Diagnosis; statement of treating doctors.
*
Respondent. *
*************************
PUBLISHED RULING ON PETITIONER’S
MOTION FOR FINDING OF FACT REGARDING DIAGNOSIS1
On January 26, 2018, petitioner moved for a finding of fact that “petitioner was
diagnosed with a Guillain-Barre syndrome (GBS) variant” following the administration of a flu
vaccination on March 14, 2014. Pet’r’s Mot. at 5. The respondent opposes petitioner’s motion,
noting that petitioner’s claim that he was diagnosed with GBS is not consistent with the medical
records filed in this case. Resp’t’s Resp., filed March 16, 2018, at 9. Based on a review of the
medical records, expert reports, and the statements from the petitioner’s treating physicians, the
undersigned finds that preponderant evidence does not exist to support petitioner’s claim that he
was diagnosed with GBS in the spring of 2014.
I. Factual Summary
Prior the vaccination in question, Mr. Smith had a complex medical history that included
type 2 diabetes. Mr. Smith was not compliant with the treatments prescribed for his diabetes and
1
Because this ruling contains a reasoned explanation for the action in this case, the
undersigned is required to post it on the United States Court of Federal Claims' website in
accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal
Management and Promotion of Electronic Government Services). This means the ruling will be
available to anyone with access to the internet. In accordance with Vaccine Rule 18(b),
petitioners have 14 days to identify and move to redact medical or other information, the
disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, the
undersigned agrees that the identified material fits within this definition, the undersigned will
redact such material before posting the ruling.
his disease was considered “uncontrolled.” Exhibit 4 at 12. He suffered from various symptoms
that were secondary to his diabetes, including ulcers and osteomyelitis in his toe, diabetic
neuropathy, and diabetic retinopathy. Exhibit 1 at 4, 6; exhibit 2 at 4; exhibit 3 at 3.
Two days before the vaccination in question, on March 12, 2014, Mr. Smith experienced
shortness of breath, signs of heart failure, swollen ankles, anemia, hypokalemia, and acute renal
failure. Exhibit 4 at 29-30. He was admitted to the hospital for these issues on March 13, 2014.
Id. at 31. On March 14, 2014, he was administered the flu vaccine into his right arm during the
course of his hospitalization. Exhibit 7 at 209.
On March 25, 2014, after being discharged from the previous hospitalization, Mr. Smith
was admitted to the Medina Hospital for sudden weakness in his legs that began that morning.
Exhibit 5 at 175-76. On admission, although it was noted that the etiology of the leg weakness
was uncertain, the physician remarked that Mr. Smith had recently been administered the flu
vaccine, which is “[one] of the risk factors for something such as GBS.” Id. at 176. During the
course of Mr. Smith’s admission to the Medina Hospital, his treating neurologist, Dr. Eric Baron,
noted that the possibility of GBS was part of Mr. Smith’s differential diagnosis and several tests
were run at Medina Hospital to try to determine whether GBS was the cause of Mr. Smith’s
symptoms. See exhibit 5 at 178. Based on the results from these tests, notably a test on Mr.
Smith’s cerebrospinal fluid (CSF), as well as Mr. Smith’s “mixed clinical picture,” Dr. Baron
decided to not move forward with treatment for GBS due to his “lower suspicion for GBS”
following examination and testing. Id. at 201.
On March 27, 2014, Mr. Smith was transferred from Medina Hospital to the main
campus of the Cleveland Clinic Hospital System because Medina did not have the necessary
diagnostic tools or care for Mr. Smith. Id. At the main campus, he was seen by Dr. Tina Waters,
Dr. Donika Patel, and Dr. Jessica Rundo, among others. On his initial evaluation by Dr. Waters,
she noted that the tests had been inconclusive in determining if Mr. Smith’s pathology was
central or peripheral in nature. Exhibit 9 at 19-20. She recommended additional testing,
including nerve conduction studies. Id.On March 30, 2014, while still admitted to the hospital, Mr. Smith woke up with
worsened weakness in his right leg and new weakness in his right arm. Exhibit 9 at 52. An MRI
revealed that Mr. Smith had suffered a stroke, which caused the additional weakness. Id.However, the cause of Mr. Smith’s initial symptoms remained unidentified. Id. at 58.
Additional medical testing was performed during the course of Mr. Smith’s stay at the
Cleveland Clinic main campus. These tests appeared to rule out GBS as the cause of Mr.
Smith’s symptoms. For instance, during a neuromuscular consultation with Dr. Patel on April 2,
2014, Dr. Patel noted that there was not strong evidence of an acute peripheral nerve injury
causing his symptoms. Exhibit 9 at 35. Instead, Dr. Patel concluded that Mr. Smith had “severe
generalized polyneuropathy” that she associated with Mr. Smith’s diabetes. Id. She concluded
that GBS was a “less likely” diagnosis. Id.2
Dr. Rundo also concluded, based on a second examination of Mr. Smith’s CSF as well as
the nerve conduction studies and a physical exam, that Mr. Smith was not suffering from an
acute peripheral nerve disease. Id. at 72.
Mr. Smith was discharged from the hospital on April 4, 2014, with a diagnosis of lower
extremity weakness and acute stroke. Exhibit 9 at 7. The discharge papers state that the treating
physicians did not have a definitive conclusion about the etiology of Mr. Smith’s condition, but
the record does state that “neuromuscular specialists were consulted, and they attribute the
symptoms to possibly diabetic neuropathy.” Id. at 9. Following his discharge, Mr. Smith was
transferred to an inpatient rehabilitation facility at Lodi Community Hospital (LCH).
On intake at LCH, the records show that Mr. Smith’s chief complaint was that he had
suffered from GBS and a stroke. Exhibit 8 at 32. The records even state that Mr. Smith was
“diagnosed with Guillain-Barre syndrome” and should no longer be administered the flu vaccine.
Id. at 32, 44. However, the source of this information and other references to GBS from the
LCH records is not obvious. It is also notable that subsequent medical records from Dr. Cullen,
Mr. Smith’s primary care physician, incorporated GBS into Mr. Smith’s past medical history.
See, e.g., exhibit 11 at 6, 7.
II. Expert Reports
Dr. Thomas Morgan, the petitioner’s expert, opined that based on his examination of the
medical records, Mr. Smith suffered from post-vaccination immune-related acute motor-sensory
axonal polyneuropathy (AMSAN). Exhibit 16 at 3. Dr. Morgan stated that this is a variant of
GBS. Id. Dr. Morgan came to this conclusion on the basis that Mr. Smith had an abrupt onset of
paralysis in his lower extremities. Id. at 4. In support of his conclusion, Dr. Morgan stated that
Mr. Smith’s diabetic neuropathy had not presented in that manner previously and thus it was not
likely that the symptoms experienced following the flu shot were consistent with being
secondary to the diabetes. Id. He further stated that the EMG findings were consistent with
AMSAN / GBS. Id.In a rebuttal report, the government’s expert, Dr. Daniel Feinberg, stated that it was
“clear from the medical records, that Mr. Smith did not have transverse myelitis or Guillain
Barre syndrome.” Exhibit A at 3. He stated that the constellation of his poorly controlled
diabetes, acute congestive heart failure, and acute renal failure superimposed upon severe
diabetic neuropathy resulted in the acute leg weakness that Mr. Smith experienced. Id. Dr.
Feinberg further evaluated the objective tests that were performed on Mr. Smith (EMG, NCS,
CSF, and MRI) and concluded that these tests were not consistent with GBS. Id.Addressing Dr. Morgan’s report specifically, Dr. Feinberg stated that “Mr. Smith’s
course was not consistent with AMSAN at all.” Id. at 4. Dr. Feinberg contrasted Mr. Smith’s
mild proximal weakness with the severe paralysis expected in AMSAN. Id. Dr. Feinberg
concluded by saying that he agreed with the treating physicians insomuch as AMSAN was not a
possible diagnosis. Id.3
In a rebuttal report, Dr. Morgan addressed both Dr. Feinberg’s report as well as the
undersigned’s request for diagnostic criteria for AMSAN / GBS. More specifically, Dr. Morgan
stated that Mr. Smith met the “general criteria” for GBS, including subacute classic paralysis that
was symmetric in both legs, a loss of reflexes in the lower extremities, and an abnormal EMG /
NCS. Exhibit 23 at 1. Regarding Dr. Feinberg’s report, Dr. Morgan stated that he disagreed
with Dr. Feinberg’s conclusions, but did not elucidate why beyond noting that he thought that
the medical testing was consistent with chronic kidney disease, but not end stage kidney disease.
Id. at 2. Again, Dr. Morgan noted that he interpreted the findings from the EMG and NCS as
being consistent with AMSAN / GBS. Id. Dr. Morgan ended his report by saying that his
opinion is “consistent with the opinions of [Mr. Smith’s] treating neurologist, Dr. Baron” as well
as the opinion of Dr. Tina Waters. Id.In a supplemental report, Dr. Feinberg addressed the undersigned’s question regarding
how Mr. Smith’s pre-existing medical conditions may have resulted in leg weakness. In this
supplemental report, Dr. Feinberg stated that nerve injury occurs in 60-100% of patients with
end-stage renal disease. Exhibit C at 1. He also noted that diabetes causes polyneuropathy in
45% of patients, though he noted that glycemic control may prevent peripheral neuropathy in
patients with diabetes. Id. Relating back to Mr. Smith, Dr. Feinberg noted that Mr. Smith’s
diabetes was labelled as uncontrolled as early as 2009 and that he had symptoms consistent with
uncontrolled diabetes (toe ulceration and osteomyelitis). Id. (citing exhibits 1, 4). Dr. Feinberg
also notes that Mr. Smith had already experienced documented diabetic neuropathy and
retinopathy. Exhibit C at 1 (citing exhibits 2, 3). Based on the fact that Mr. Smith already had
two significant disorders that have a strong association with neuropathy and that his course was
not consistent with AMSAN / GBS, Dr. Feinberg concluded that Mr. Smith suffered from
peripheral neuropathy secondary to uremia and poorly controlled diabetes. Exhibit C at 1.
III. Opinions of Mr. Smith’s Treating Physicians
An evaluation of the parties’ briefs and the expert reports submitted in Mr. Smith’s case
emphasized the fact that the parties held different interpretations of how Mr. Smith’s treating
physicians characterized his disease. Compare Pet’r’s Mot. at 4 (noting that Dr. Morgan’s
opinion that Mr. Smith suffered from AMSAN / GBS was consistent with the opinion of Mr.
Smith’s treating neurologists) with Resp’t’s Resp. at 4-6 (noting that Mr. Smith’s treating
physicians did not diagnose Mr. Smith with GBS). Because of the importance of the opinion of
treating physicians, especially as it pertains to questions of diagnosis, the undersigned ordered
the parties to jointly draft letters to Mr. Smith’s treating physicians, seeking information that
may prove helpful for the question at bar. See order, issued Apr. 27, 2018 (citing 42 U.S.C. §
300aa-12(d)(3)(B) (authorizing special masters to seek information)).
During a status conference held on May 17, 2018, the parties reported that they had sent
letters to Drs. Baron, Waters, Patel, and Rundo. Ultimately, the parties were able to obtain
information from only Dr. Baron and Dr. Rundo.
4
In his letter, Dr. Baron reported evaluating Mr. Smith at Medina Hospital, the small
community hospital, on March 25, 2014, and March 27, 2014. Exhibit 25. He stated that only
preliminary testing was performed at Medina Hospital and that Mr. Smith was transferred to the
main campus of the Cleveland Clinic on March 27, 2014 because Medina was not set up for
advanced testing and potential treatment that Mr. Smith might need. Id. However, Dr. Baron
stated that while GBS was a diagnostic possibility at that time, “there were no test results which
suggested GBS” prior to Mr. Smith’s transfer to the main campus. Id. Dr. Baron did state that
he evaluated the notes from the treating physicians at the main campus and concluded that:
there were no test results that suggested GBS as the cause of his symptoms
(negative spinal fluid and EMG / NCV results), and they felt his comorbid
medical issues / decompensation combined with diabetic neuropathy were the
most likely culprits of his symptoms, not GBS, in addition to a small stroke found
on subsequent testing.
Id. Dr. Baron concluded by qualifying his opinion as being based on his interpretation of the
records from the main campus and that additional information would need to come from a
member of the neurology team that treated Mr. Smith at the main campus of the Cleveland
Clinic. Id.
Fortunately, a member of that team, Dr. Rundo, also provided helpful information in
response to the parties’ request. Dr. Rundo reported that “Mr. Smith was not, in fact, diagnosed
with Guillain-Barre syndrome during his hospital stay.” Exhibit 26. She noted that Mr. Smith’s
CSF testing was normal on two different tests, which effectively ruled out GBS as a diagnosis.
Id. She further stated that Mr. Smith’s leg weakness was attributable to his diabetic neuropathy
and stroke, though she noted that myelitis could not be completely ruled out. Id. Dr. Rundo
concluded her letter by stating that she could not comment on whether the flu vaccine caused or
contributed to Mr. Smith’s GBS since Mr. Smith was not diagnosed with GBS. Id.
In a status conference held following the filing of the letters from Dr. Rundo and Dr.
Baron, petitioner stated a desire to file a rebuttal from Dr. Morgan, his expert. See order, issued
Sep. 5, 2018. The undersigned granted the petitioner 30 days to do so. Id.
In his rebuttal, Dr. Morgan stated that he disagreed with the opinions of Dr. Baron and
Dr. Rundo. Exhibit 27 at 1. Dr. Morgan implicitly questioned the qualifications of both doctors
by highlighting that their specialties were related to headaches and sleep disorders, respectively.
Id. He continued by noting that both physicians did not address the fact that some of Mr.
Smith’s symptoms were consistent with AMSAN / GBS. Id. Dr. Morgan concluded his rebuttal
by criticizing Mr. Smith’s two neurologists for not rendering medical opinions to a reasonable
degree of medical probability. Id. at 2.
5
IV. Analysis
Mr. Smith claims that the flu vaccination he received caused him to suffer from GBS or a
variant of GBS. As a result, Mr. Smith has an affirmative burden to show that he has the injury
he claims he has. See Lombardi v. Sec'y of Health & Human Servs., 656 F.3d 1343, 1353 (Fed.
Cir. 2011); see also Hibbard v. Sec'y of Health and Human Servs., 698 F.3d 1355, 1365 (Fed.
Cir. 2012) (“[i]f a special master can determine that a petitioner did not suffer the injury that she
claims was caused by the vaccine, there is no reason why the special master should be required
to undertake and answer the separate (and frequently more difficult) question whether there is a
medical theory, supported by ‘reputable medical or scientific explanation,’ by which a vaccine
can cause the kind of injury that the petitioner claims to have suffered.”)
The Federal Circuit has advised special masters to afford the opinions of treating
physicians a level of deference. See Capizzano v. Sec'y of Health & Human Servs., 440 F.3d
1317, 1326 (Fed. Cir. 2006). This guidance appears especially apt when considering questions
of diagnosis as opposed to causation. In the undersigned’s estimation, no person is better
qualified to opine on Mr. Smith’s condition in 2014 than the physicians that treated him at that
time. It is worth noting that Mr. Smith has, himself, advocated for the importance of the treating
physicians’ opinions regarding his diagnosis. See Pet’r’s Mot., filed Jan 26, 2018, at 4 (“the
treating physicians’ opinions deserve significant weight in finding petitioner’s diagnosis of
Guillain Barre syndrome”).
Based on the medical records and the reports of Dr. Morgan and Dr. Feinberg alone, the
undersigned was inclined towards finding that Mr. Smith did not meet his burden to establish
that he suffered from his alleged injury. The notes from the medical records failed to indicate
that any of Mr. Smith’s physicians concluded, based on their observations and testing, that Mr.
Smith had GBS / AMSAN instead of neuropathy associated with his diabetes or his stroke. In
fact, numerous records explicitly stated that his treating physicians interpreted the objective
findings as being inconsistent with GBS.
While there are records that indicate that Mr. Smith was diagnosed with GBS, these
records do not indicate that those conclusions were made by the physicians that actually treated
him. In fact, the records are unclear as to who exactly made the GBS conclusion at all and,
based on the records, it appears that they simply could have been incorporating the patient’s own
account of his medical history. Accordingly, the records must be weighed appropriately in
comparison to those records that convey first-hand accounts of the opinions of his treating
physicians. See Castaldi v. Sec'y of Health & Human Servs., No. 09-300V, 2014 WL 3749749,
at *11 (Fed. Cl. Spec. Mstr. June 25, 2014) (“the records of treating physicians can be questioned
and the weight afforded to them depends on whether the physician is noting her own
observations or merely recording statements made by the patient”), mot. for rev. denied, 119
Fed. Cl. 407 (2014). Cf. Dobrydnev v. Sec'y of Health & Human Servs., 566 F. App'x 976, 983
(Fed. Cir. 2014) (a special master may refrain from crediting the finding of a doctor who
obtained an inaccurate history).
6
The addition of direct statements from Drs. Rundo and Baron put to rest any ambiguity in
the records and, accordingly, any uncertainty about the undersigned’s ruling on petitioner’s
motion. The petitioner has moved for the undersigned to find, as a matter of fact, that Mr. Smith
was “diagnosed with a Guillain Barre syndrome variant.” Pet’r’s Mot., filed Jan. 26, 2018, at 5.
The statements from Drs. Rundo and Baron make this finding of fact untenable. While Dr.
Morgan attempted to rebut the statements from the treating physicians, his last report did little to
undermine their conclusions. In fact, the report undermined his own opinion insomuch as Dr.
Morgan, who had previously asked the undersigned to credit the opinions of Mr. Smith’s treating
physicians, now sought to discredit those same physicians and their medical opinions.
V. Conclusion
For the aforementioned reasons, Mr. Smith’s motion for a finding of fact that he was
diagnosed with GBS is DENIED. The undersigned tentatively finds that Mr. Smith did not
suffer the injury he alleged, but instead manifested a disease course that was consistent with his
pre-existing chronic conditions as well as with the stroke he experienced during the course of his
hospitalization.
Accordingly, Mr. Smith is ORDERED to file a status report on his next steps in this case on
or before Friday, November 30, 2018.
IT IS SO ORDERED.
s/Christian J. Moran
Christian J. Moran
Special Master
7