NORA BETH DORSEY, Special Master.
On February 22, 2012, Cassandra Burchett ("petitioner") filed a petition for compensation under the National Vaccine Injury Compensation Program ("the Program")
Respondent does not dispute that petitioner was diagnosed with GBS on April 1, 2010.
After a review of the entire record,
Therefore, even if petitioner had established her case by a preponderance of the evidence, her arguments fail because respondent has proven that petitioner's antecedent infection, not her vaccination, was the sole cause of her GBS. Accordingly, petitioner is not entitled to compensation and her petition must be dismissed.
Prior to the hearing, the parties filed a joint submission identifying (1) facts not in dispute; (2) facts in dispute; (3) issues not in dispute; and (4) issues in dispute. Jt. Sub. at 1-2. These are addressed in turn below.
Petitioner had her first episode of GBS when she was a child, and that episode of GBS is not in dispute. She was diagnosed with GBS on November 29, 1999, when petitioner was five years old. Jt. Sub. at 1.
The parties also stipulate that petitioner was diagnosed with and treated for viral gastroenteritis on March 19, 2010. Jt. Sub. at 1. Petitioner received the subject Gardasil vaccination on March 26, 2010, at the office of her primary care physician, Dr. Andrew Gellady.
On March 30, 2010, petitioner saw Dr. Gellady for headache, numbness of the extremities, and body aches that began on March 28, 2010.
On April 1, 2010, petitioner was admitted to All Children's Hospital ("ACH") "with a history of upper respiratory infection three weeks prior, acute gastroenteritis two weeks prior, and receipt of the HPV vaccine on March 26, 2010 .... a four-day history of progressive body muscle weakness, trouble walking, and a headache .... [as well as] emesis for the past day" Jt. Sub. at 2. At ACH, petitioner underwent a lumbar puncture to obtain a cerebral spinal fluid (CSF) sample. Assessment at that time was "lower extremity weakness, absent deep tendon reflexes, intact sensation, increased protein in the CSF, findings which are consistent with Guillain-Barré syndrome ... secondary to her recent viral illness and of note she did have a Gardasil vaccine 1 week ago."
Finally, the parties stipulate that petitioner was treated by Dr. Bunch, a neurologist, while hospitalized at ACH; that she developed a syndrome of inappropriate antidiuretic hormone secretion (SIADH), hemolytic anemia, adverse effects attributable to the IVIG treatment requiring a transfusion, and that her discharge diagnosis was GBS. Jt. Sub. 2; Pet'r's Ex. 1.7 at 471-72; Pet'r's Ex. 1.8 at 539, 541-42.
The parties dispute whether petitioner suffered from an upper respiratory infection between March 1 and March 19, 2010.
The parties stipulate that petitioner received a vaccine as set forth on the Vaccine Injury Table; that she was vaccinated in the United States; that she was diagnosed with GBS on April 1, 2010; that she suffered from the residual effects of her GBS for more than 6 months; and that she has not previously collected an award or settlement in a civil action regarding her alleged vaccine injury of GBS. Jt. Sub. at 2.
The parties dispute whether petitioner has presented preponderant evidence under
In addition to the facts to which the parties stipulated, the following facts are relevant. Some of the above facts are repeated to provide context and continuity.
Petitioner was born full term on August 13, 1994, and had no chronic medical problems in early childhood. Pet. at 1; Pet'r's Ex. 1.9 at 630. In November of 1999, when she was five years old, petitioner began experiencing lower extremity weakness which caused her to limp, to fall down repeatedly, and to be unable to get up after falling. Pet'r's Ex. 1.9 at 628. On November 29, 1999, petitioner was admitted to ACH, where she was started on IVIG therapy.
For the next ten years, petitioner had periodic infections, but there is no indication in her medical records that her GBS symptoms recurred. For example, on May 22, 2007, when she was 12 years old, petitioner was diagnosed with tonsillitis.
Petitioner was diagnosed with and treated for viral gastroenteritis by Dr. Gellady on March 19, 2010. Ex. 2.1 at 10. Her symptoms included vomiting, diarrhea, and headaches. She denied cough or head congestion.
Four days later, Tuesday, March 30, 2010, petitioner presented to Dr. Gellady. Pet'r's Ex. 2.1 at 7. Her symptoms were noted as beginning on "Sunday [March 28, 2010] — Headache; feet started going numb. Whole body aches — muscles. Hips and back. Both hands numb — tingles. Feet also."
The next day, March 31, 2010, petitioner returned to see Dr. Gellady. Pet'r's Ex. 2.1 at 6. Dr. Gellady noted that petitioner was "in a lot of pain. Can't walk. Hands and feet are numb. Back muscles are cramping. Legs are very sore .... [a]rms slightly sore. Can't bend over to touch her toes."
On April 1, 2010, petitioner's condition worsened and she was admitted to ACH. Pet'r's Ex. 1.7 at 464. Initial handwritten patient history and physical documented that "3 wks (weeks) ago →URI sx (symptoms)→cough/rhinnhea [sic][rhinorrhea]". Pe't'r's Ex. 1.9 at 608. The diagnosis was GBS, "possibly 2° to recent Giardisil [sic] vaccine and/or recent URI/AGE."
A history and physical admission note by Dr. Leslie F. Carroll on April 1, 2010, documented the following pertinent history:
Pet'r's Ex. 1.7 at 464-65.
Dr. Carroll performed a neurologic exam which showed that petitioner's upper extremities had strength 5/5 bilaterally with reflexes 2+ and symmetric, but no reflexes could be obtained in the lower extremities and motor strength in the lower extremities was diminished at 5 to 4/5. Pet'r's Ex. 1.7 at 466. Dr. Carroll's impression was GBS. "This may be secondary to her recent viral illness and of note she did have a Gardasil vaccine 1 week ago."
A neurology consultation was performed on April 2, 2010, by Dr. Shirley Terri Bunch. Pet'r's Ex. 1.7 at 471. Dr. Bunch noted that petitioner had a history of a URI 3 weeks ago, and gastroenteritis symptoms lasting for 24 hours two weeks prior to admission.
On April 4, 2010, Dr. Bunch documented that petitioner presented with "ascending weakness and loss of deep tendon reflexes after 2 viral illnesses in quick succession along with a Gardasil vaccination." Pet'r's Ex. 1.8 at 535. On April 7, 2010, Dr. Bunch noted that petitioner developed GBS, "thought to be related to a Gardasil infection."
Petitioner was discharged from the hospital on April 15, 2010, and was ordered to continue with physical and occupational therapy. Pet'r's Ex. 1.8 at 543, 562. The discharge summary was documented by Dr. Stefany B. Honigbaum, who wrote that petitioner had been admitted with a "presumed diagnosis of [GBS], given her CSF findings. This was thought to possibly be secondary to her recent URI illness, as well as her acute gastro and perhaps in part to the Gardasil vaccine received 1 week prior to this."
Petitioner saw Dr. Bunch for a follow-up office visit on May 6, 2010, for ongoing management of her GBS. Pet'r's Ex. 3 at 4. At this visit, Dr. Bunch documented that petitioner had GBS "secondary to a [sic] immunization with gardicil [sic]."
The parties dispute whether petitioner suffered from an upper respiratory infection between March 1 and March 19, 2010. Based on a review of the records and the testimony at hearing, the undersigned finds that petitioner did suffer from an upper respiratory infection approximately three weeks prior to the onset of her GBS.
GBS is a "rapidly progressive ascending motor neuron paralysis of unknown etiology, frequently seen after an enteric or respiratory infection."
The cause of GBS has not been definitively established but "[a]n autoimmune mechanism following viral infection has been postulated."
The symptoms of GBS "usually develop over several days." Tr. 16. The majority of cases are diagnosed based on clinical presentation, but electrodiagnostic and spinal fluid testing may also confirm the diagnosis. Tr. 18. The onset of the condition is confirmed by objective motor or autonomic dysfunction found on neurological examination, such as loss of deep tendon reflexes and motor weakness. Tr. 98; Pet'r's Ex. 14 at 1.
GBS is generally a monophasic illness, meaning that it occurs only once. Tr. 34. There are, however rare, cases of recurrent GBS. Tr. 34. In a Kaiser Permanente study of 550 verified cases of GBS, there was an incidence of 1.47 cases of GBS per 100,000 persons. Resp't's Ex. G at 3.
The Vaccine Act established the Program to compensate vaccine-related injuries and deaths. § 300aa-10(a). "Congress designed the Vaccine Program to supplement the state law civil tort system as a simple, fair and expeditious means for compensating vaccine-related injured persons. The Program was established to award `vaccine-injured persons quickly, easily, and with certainty and generosity.'"
Petitioner's burden of proof is a preponderance of the evidence. § 300aa-13(a)(1). The preponderance of the evidence standard, in turn, has been interpreted to mean that a fact is more likely than not.
To receive compensation under the Program, petitioner must prove either: (1) that she suffered a "Table Injury"—i.e., an injury listed on the Vaccine Injury Table—corresponding to a vaccine that she received, or (2) that she suffered an injury that was actually caused by the HPV vaccine.
Because petitioner does not allege she suffered a Table injury, she must prove that the HPV vaccine she received caused her injury. To do so, she must establish, by preponderant evidence: (1) a medical theory causally connecting the vaccine and her injury ("
The causation theory must relate to the injury alleged. Thus, a petitioner must provide a reputable medical or scientific explanation that pertains specifically to the vaccinee's case, although the explanation need only be "legally probable, not medically or scientifically certain."
Under Althen Prong One, petitioner must set forth a medical theory explaining how the received vaccine could have caused her alleged injury.
Petitioner's theory of causation must be informed by a "sound and reliable medical or scientific explanation."
Dr. Allan E. Rubenstein is a neurologist and clinical professor of neurology in pediatrics at New York University (NYU) Langone Medical Center in New York City. Pet'r's Ex. 11 at 5; Tr. 6. He obtained his medical degree from Tufts University Medical School in Boston and completed his internship and neurology residency at Columbia Presbyterian Medical Center, New York Neurological Institute, New York City. Pet'r's Ex. 11 at 1; Tr. 7-8. Dr. Rubenstein had postgraduate training in neurogenetics as well. Pet'r's Ex. 11 at 1; Tr. 10. He was an associate professor of neurology at Mt. Sinai School of Medicine from 1974 until 2009, at which time he moved to the NYU Medical Center. Pet'r's Ex. 11 at 3; Tr. 8-9. While at Mt. Sinai, he developed the autonomic function laboratory, and also started a clinic for neurofibromatosis, a genetic disease of the nervous system.
Here, Dr. Rubenstein reviewed petitioner's medical records, including records from her first episode of GBS when she was five years old. Pet'r's Ex. 10 at 3. Dr. Rubenstein agreed that petitioner had an upper respiratory infection (URI) about two weeks prior to her first episode of GBS in 1999.
Dr. Rubenstein's causation theory in this case is that petitioner had a viral infection (URI and/or GI), that the viral infection initiated the process of GBS recurrence via molecular mimicry, and that the HPV vaccine also contributed to the development of petitioner's recurrent GBS through some "unclear mechanism." Tr. 35-36; 62-63; 72. Dr. Rubenstein testified that Gardasil was "a contributing factor of unclear mechanism, but likely related to its induction of [the] immune response." Tr. 63-64, 112.
In his expert report, Dr. Rubenstein opined that
Pet'r's Ex. 10 at 2.
Dr. Rubenstein emphasized several times that he did not know the medical theory whereby petitioner's recurrent GBS was "stimulated or enhanced or somehow advanced" by the vaccination. Tr. 113. "[S]omehow — and I don't know exactly how — [the vaccine] likely stimulated the immune system to... recurrent [GBS]." Tr. 113. "[T]his patient had an — as do most if not all patients with [GBS], an exposure to a virus which, for reasons unclear, as opposed to other viral involvement, somehow had the potential to induce an autoimmune response against peripheral nerves and that the vaccination, in the process of promoting an immune response, not necessarily because there is a crossreacting antigen to Gardasil . . . . but likely the two — the two were both likely contributing factors, in my opinion, based upon the temporal relationship to onset." Tr. 62-63. "[W]hether [the mechanism] is due to stimulating the immune system to respond in a hyperactive way or encouraging the crosstalk between viral-induced responses in myelin components, I don't know the molecular mechanism, and I don't think that anybody does, but I think that there's any one of a number of possible and not unreasonable explanations to provide a theory for why the two [events (vaccination and virus)] are not coincidental." Tr. at 116.
In addition, Dr. Rubenstein testified that molecular mimicry did not play a role between a component of the HPV vaccine and petitioner's peripheral myelin, but rather, any mimicry that occurred stemmed from a viral infection. Tr. at 72.
Petitioner presented no research to support Dr. Rubenstein's theory that petitioner's GBS was stimulated or enhanced by the vaccination. Tr. 62-63. Dr. Rubenstein testified that "there's no research on such, but likely the two [both viral infection plus vaccination] — the two were both likely contributing factors, in my opinion, based upon the temporal relationship to onset." Tr. 62-63. Dr. Rubenstein cites an article by Souayah,
Moreover, Dr. Rubenstein conceded that if petitioner had not received the Gardasil vaccination, then his testimony would be that petitioner developed recurrent GBS from a viral infection.
Dr. Michael Kohrman is a pediatric neurologist at the University of Chicago. Resp't's Ex. E at 1; Tr. 132. He obtained his medical degree from Rush Medical College and completed his internship and neurology training at the University of Chicago, and had some additional neurophysiology training at the University of Illinois in Chicago. Resp't's Ex. E at 1-2; Tr. at 132-33. Dr. Kohrman is board certified in pediatrics and neurology, with a special competency in child neurology and added qualifications in clinical neurophysiology and sleep medicine. Resp't's Ex. E at 3; Tr. at 132. At the University of Chicago, his work is about 80% clinical and 20% scholarly, and he sees pediatric patients almost exclusively. Tr. at 133-34. Dr. Kohrman is currently the editor of the Journal of Pediatric Epilepsy and is on the editorial board of three other publications. Resp't's Ex. E at 11; Tr. at 134-35. Dr. Kohrman testified that he has seen over 100 children with GBS over the last 20 years, though he has never seen a case of recurrent GBS. Tr. at 133-34. His primary research area is pediatric epilepsy. Tr. at 135.
Dr. Kohrman opined that petitioner's recurrent GBS was caused by a viral infection via the theory of molecular mimicry. Tr. 139, 140-41, 145-46. He disagreed with Dr. Rubenstein's theory that Gardasil can cause an immune enhancement of virally-induced GBS, and he testified that he is not aware that such a theory has ever been discussed in the neurology or pediatric neurology community. Tr. 159. Moreover, he testified that there are no animal models to support Dr. Rubenstein's theory. Tr. 87-88, 160.
Further, as to the HPV vaccine, Dr. Korhman testified that there is "no evidence of homology ... to lead to molecular mimicry to produce [GBS]." Tr. 146; 151. But Dr. Kohrman conceded that he lacks a complete working knowledge on the issue of homology and acknowledged that the medical community has not researched whether there is homology between certain antecedent infections thought to be causally related to GBS. Tr. 173-74, 175-76.
Based on the findings described in the article by Slade, Resp't's Ex. K at 756,
In summary, Dr. Korhman disagreed with Dr. Rubenstein's theory that the HPV vaccine caused a "significant immune stimulus" leading to GBS because there is no increased risk of GBS in patients receiving the HPV vaccine. Dr. Kohrman was not aware of any immune system stimulation mechanism known to cause GBS after the HPV vaccine. Tr. 152. Dr. Korhman cited the Chao article, Resp't's Ex. C,
Several of petitioner's treating physicians documented the temporal association between the onset of petitioner's GBS and both the viral infections and the HPV vaccination.
Dr. Terri Bunch, petitioner's treating neurologist at ACH, noted in her April 2, 2010 neurology consultation that "[a]pproximately 3 weeks ago, [petitioner] had what was thought to be a URI and 2 weeks ago had gastroenteritis symptoms lasting for approximately 24 hours. On 3/26/10, she received Gardasil vaccine and 2 days following the vaccination began having headaches with low back pain." Pet'r's Ex. 1.7 at 472. On April 3, 2010, in a Neurology Progress Note, Dr. Bunch noted, "[a]pproximately 2 days after her vaccination with Gardasil, she began having numbness and tingling on her feet. She additionally had at least 2 viral syndromes and presented to the emergency room with blurred vision and weakness in her legs." Pet'r's Ex. 1.8 at 536.
In a Neurology Progress Note on April 4, 2010, Dr. Bunch noted "[t]he patient ... presented with ascending weakness and loss of deep tendon reflexes after 2 viral illnesses in quick succession along with Gardasil vaccination." Pet'r's Ex. 1.8 at 534. In a progress note on April 6, 2010, Dr. Bunch noted that just prior to her first symptoms, petitioner "had 2 significant viral illnesses and then received her Gardasil vaccination."
Similarly, Dr. Leslie F. Carroll noted that petitioner's GBS "may be secondary to her recent viral illness and of note she did have a Gardasil vaccine 1 week ago." Pet'r's Ex. 1.7 at 466. In the ACH discharge summary, Dr. Stefany Honigbaum noted that "[petitioner] was admitted to All Children's with a presumed diagnosis of Guillain-Barré syndrome, given her CSF findings. This was thought to possibly be secondary to her recent URI illness, as well as her acute gastro and perhaps in part to the Gardacil [sic] vaccine received 1 week prior to this." Pet'r's Ex. 1.8 at 541.
During the hearing, Dr. Kohrman called into question the treating physicians' findings as to the statements suggesting an association between the vaccine and petitioner's GBS, suggesting that Dr. Bunch "may not have read the entire chart prior to writing her [progress notes]," and criticizing Dr. Honigbaum because she ordered prednisone for petitioner even though it has been known to worsen GBS symptoms. Tr. 178-80.
Likewise, none of petitioner's treating physicians documented any theory or mechanism whereby the HPV vaccine enhanced the viral infections leading to petitioner's recurrent GBS, as proposed by Dr. Rubenstein. Nor did any treating physician set forth any other theory for how the HPV vaccination alone, or in concert with the viral infections, caused petitioner's GBS. The treating physicians merely documented a temporal association between petitioner's receipt of the HPV vaccine and the onset of her recurrent GBS. Dr. Kohrman testified that he has not heard of Dr. Rubenstein's "enhancement" theory discussed in the neurology or pediatric neurology community, Tr. 159, and that there are no animal models to support the theory. Tr. 87-88, 160.
Without evidence of a medical theory, the temporal relationship is not enough.
Under
In his expert report, Dr. Rubenstein opines that "it is more likely than not that Gardasil vaccination was the determining event ... possibly promoting an autoimmune event initially induced by a viral infection" which led to petitioner's GBS. Pet'r's Ex. 10 at 2. He explains that "[i]t is well known that vaccines can worsen or induce problems in patients with autoimmune disease, presumably by presenting an antigen which stimulates an overactive or dysfunctional immune system."
As discussed in
Dr. Rubenstein testified that the fact that petitioner had a prior episode of GBS put her at risk for recurrence, Tr. 39, and any viral upper respiratory or gastrointestinal infection could be associated with a recurrence of GBS. Tr. 40. He noted that after petitioner's initial episode of GBS, from 1999 until March 2010, she had subsequent viral infections but she did not develop a recurrence of her GBS. Tr. 40-45.
On March 19, 2010, petitioner had symptoms of a "diffuse viral infection, initially with symptoms of URI and subsequently with gastroenteritis." Pet'r's Ex. 10 at 1. On the evening of March 18, 2010, she had vomiting, diarrhea and headache. She was seen by Dr. Gellady on March 19, 2010, and diagnosed with viral gastroenteritis. Pet'r's Ex. 2.1 at 10; Tr. 44, 74. A week later, on March 26, 2010, petitioner received the HPV vaccine. On that same day, petitioner was noted to have very red eyes and was diagnosed with "possible bacterial conjunctivitis bilaterally." Pet'r's Ex. 2.1 at 9. Four days later, on March 30, 2010, Dr. Gellady documented that petitioner had nasal congestion, and exudate and redness of her tonsils (tonsil 1+ exudate and red).
Based upon the above chronology, Dr. Rubenstein opined that petitioner had her second episode of GBS, "2 weeks post viral symptomatology and within 5 days of Gardasil vaccination." Pet'r's Ex. 10 at 2. Dr. Rubenstein's opinion that petitioner's Gardasil vaccine contributed to her GBS is based on three reasons: (1) Gardasil is a rare but known antecedent to GBS; (2) petitioner's clinical course following Gardasil was "totally different from her first presentation" of GBS; and (3) an onset five days after vaccination is "consistent with previously reported cases of GBS following Gardasil."
Dr. Kohrman opined that petitioner's HPV vaccine did not cause her GBS. Tr. 139. Instead of the vaccination, Dr. Kohrman believed that one of the viral infections that occurred in the three weeks before onset was the most likely cause of petitioner's GBS. Tr. 141. When petitioner had her initial episode of GBS in 1999, the antecedent event was also a viral infection; namely, an upper respiratory infection. Tr. 141. Dr. Kohrman testified that in someone with recurrent GBS, like petitioner, where a virus initiated the process, it would be unlikely that a vaccine would play any causal role. Tr. 148. In his expert report, Dr. Kohrman states that he can "find no evidence in the literature that there is a cross reactivity between HPV vaccine and peripheral myelin." Resp't's Ex. D at 7. In addition, Dr. Kohrman states that there "is no evidence of significant aggravation of [petitioner's] recurrence of Guillain-Barré Syndrome by the vaccination with Gardasil."
Dr. Rubenstein admits that the mechanism is unclear by which the HPV vaccine, in this factual context, can cause GBS, and he could not articulate a logical sequence of cause and effect as to how the vaccine could cause and did cause petitioner's recurrent GBS. Dr. Rubenstein did not point to specific facts about petitioner's clinical course, or to any medical literature, to support his theories. Dr. Rubenstein's three reasons for why petitioner's HPV vaccine contributed to her GBS lack foundational support. As for the first reason that Gardasil is a known antecedent to GBS, Dr. Rubenstein relies on the Souayah article. But as noted above, the Souayah article does not speak to the situation where GBS occurs after two viral infections and a vaccination. As for his second reason, that petitioner's clinical course following Gardasil was "totally different from her first presentation," Dr. Rubenstein does not explain his assertion of how or why petitioner's second episode of GBS was different from her first episode. Even if one assumes this statement to be true, Dr. Rubenstein does not explain why it matters, or how it supports his theory of causation. As for the temporal association between vaccination and onset, this fact alone is insufficient upon which to conclude that the vaccination caused petitioner's GBS.
Accordingly, the undersigned finds that petitioner has failed to provide preponderant evidence that there is a logical sequence of cause and effect showing that the HPV vaccination was the reason for petitioner's recurrent episode of GBS.
Under
Dr. Rubenstein opined that petitioner had a recurrent episode of GBS "2 weeks post viral symptomatology and within 5 days of Gardasil vaccination." Pet'r's Ex. 10 at 2. Dr. Rubenstein testified that the symptoms of petitioner's GBS started to develop on March 30, 2010, Tr. 50, 53-54, and that petitioner had an "objective onset" of GBS on March 31, 2010, when a neurological examination showed that petitioner had no deep tendon reflexes, which would put the onset at five days. Tr. 98-100; Pet'r's Ex. 2.1 at 6.
In his expert report, Dr. Rubenstein, citing the Souayah article, states that the onset of GBS "within 5 days of vaccination is consistent with previously reported cases of GBS following Gardasil." Pet'r's Exhibit 10 at 2. With a viral gastroenteritis, Dr. Rubenstein also testified that one would expect onset of GBS symptoms within five days to several weeks. Tr. 70. In cases of recurrent GBS, however, Dr. Rubenstein testified that onset can be shorter, with a range from two to three days to six weeks. Tr. 68, 71. Dr. Rubenstein did not offer testimony about a medically acceptable timeframe specific to his theory that petitioner's GBS was caused by viral infection and enhanced by the Gardasil vaccination.
Dr. Kohrman testified that typically, in non-recurrent GBS cases, onset is "five-plus" days after an antecedent event. Tr. 153. Dr. Kohrman explained that the immune response requires time for the presentation of an antigen, for the antigen to be processed, and for there to be synthesis of antibodies. Tr. 153.
To opine about onset in cases involving recurrent GBS, Dr. Kohrman relied on the Slade article (4-42 days) and the Institute of Medicine ("IOM") report (five days to six weeks). Resp't's. Ex D at 6-7. Dr. Korhman explained that petitioner received her vaccine on March 26, 2010, and began having symptoms on March 28, 2010. He believes that the "two day interval" between petitioner's vaccination on March 26, 2010, and her first symptoms on March 28, 2010, is too short and inconsistent with the findings in the above-cited articles regarding onset.
The undersigned finds that the onset of petitioner's recurrent GBS was approximately March 31, 2010, when a neurological examination showed definitive symptoms in that petitioner had no deep tendon reflexes. Thus, onset occurred approximately three weeks after petitioner's URI symptoms, two weeks after acute gastroenteritis, and five days after the HPV vaccination was administered. These onset timeframes would be medically acceptable if petitioner's GBS were caused by a viral infection via the mechanism of molecular mimicry.
Here, however, petitioner failed to provide testimony of a medically acceptable timeframe for onset given petitioner's theory that both a viral infection and the vaccine played a causal role. Even assuming that the onset would be the same under petitioner's proposed theory, thus meeting her burden under
Petitioner's medical records establish, and the parties do not dispute, that petitioner was diagnosed with and treated for viral gastroenteritis on March 19, 2010.
Under the Vaccine Act, compensation shall be awarded where the petitioner demonstrates the requirements set forth under the Act by a preponderance of the evidence, and "there is not a preponderance of the evidence that the . . . injury . . . is due to factors unrelated to the administration of the vaccine." § 300aa-13(a)(1)(A)-(B). The Act provides that "factors unrelated to the administration of the vaccine" are those "which are shown to have been the agent . . . principally responsible for causing the petitioner's illness, disability, injury, condition or death."
Both parties' experts agree that a viral infection initiated petitioner's recurrent GBS via molecular mimicry. Tr. 72, 115-16, 161-62. Respondent's expert, Dr. Kohrman, further opined that a viral infection was the sole cause of petitioner's GBS recurrence, and that the HPV vaccine had no causal effect.
Through testimony and expert reports, both experts have identified molecular mimicry as a causal mechanism in this case and have agreed that, after being initiated by an infection, molecular mimicry can lead to recurrent GBS. Accordingly, the undersigned finds that respondent has proven, by a preponderance of the evidence, that one of petitioner's viral infections caused her GBS to recur. See Resp't's Exhibit G at 1.
In support of her argument that a viral infection was the sole cause of petitioner's injury, respondent notes that when petitioner initially contracted GBS in 1999, she had suffered a respiratory infection about two weeks prior. Resp't's Post Hearing Brief at 15; Jt. Sub. at 1. Respondent's expert, Dr. Kohrman, notes in his report that recurrent GBS is usually triggered by an upper respiratory infection. Resp't's Ex. D at 5 (citing Mossberg article).
Respondent also notes that petitioner's GBS did not recur after any of the numerous vaccinations she received between 1999 and 2010. Resp't's Post Hearing Brief at 15. Therefore, Dr. Kohrman opined that one of petitioner's documented infections (upper respiratory infection, acute gastroenteritis) which occurred during the three weeks preceding GBS onset, was the "predisposing factor causing the recurrence of Cassandra's polyneuropathy." Resp't's Ex. D at 8.
The medical literature also indicates that there is a well-known cause and effect relationship between upper respiratory tract infections and GBS. In the Mossberberg article cited by respondent (Resp't's Ex. H — see fn. 9), patients with recurrent GBS were examined to determine the long term course of the disease and to search for factors predisposing the patients to recurrence. Resp't's Ex. H at 157. Of the 11 patients with recurrent GBS that were examined, six had a preceding upper respiratory tract infection prior to the onset of their second recurrence. Of the total episodes of GBS that occurred, 24 of the 32 episodes were preceded by an upper respiratory tract infection.
The undersigned finds that respondent has proven, by a preponderance of the evidence, that one of petitioner's antecedent infections was the "but for" cause of petitioner's recurrent GBS.
Both parties' experts agree that the timing for a viral source for petitioner's recurrent GBS is medically appropriate. Dr. Rubenstein testified that, in cases of recurrent GBS, onset can take place within two to three days to six weeks. Tr. 68, 71. Dr. Kohrman opined that onset of recurrent GBS happens either from four to five days to six weeks. Resp't's Ex. D at 6-7.
The medical literature the parties submitted addresses the issue of timing. The authors of the Slade article stated that "8 of the confirmed cases [of Guillain-Barré syndrome] were within the 4- to 42 day window of biological plausibility." Resp't's Ex. K at 5; Resp't's Ex. D at 6-7. Likewise, the "Institute of Medicine determined that the plausible range of post-exposure latency for GBS to be 5 days to 6 weeks." Resp't's Ex. D at 6. In the Mossberg article, the authors found that the time from the triggering infection to the onset of RGBS [recurrent GBS] showed a tendency to shorten in successive episodes ... " Resp't's Ex. H at 4.
As noted above, the onset of petitioner's GBS was March 31, 2010. The parties stipulate that petitioner was diagnosed with and treated for viral gastroenteritis on March 19, 2010. Jt. Sub. at 1. Thus, onset took place between nine and fourteen days after petitioner was diagnosed with viral gastroenteritis.
Regarding the upper respiratory infection, the undersigned has found that petitioner experienced the URI approximately three weeks prior to the onset of her GBS on March 31, 2014. Thus, the timeframe as supplied by both petitioner's and respondent's expert is also medically appropriate for a URI.
In light of the above, the undersigned finds that respondent has provided preponderant proof that the onset of petitioner's recurrent GBS occurred within a medically timeframe in relation to one of her antecedent infections.
For the reasons discussed above, the undersigned finds that petitioner has not established entitlement to compensation and her petition must be dismissed. In the absence of a timely filed motion for review filed pursuant to Vaccine Rule 23, the clerk is directed to enter judgment consistent with this decision.
