In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. [redacted]V
January 16, 2009
Reissued redacted on January 21, 2009
To Be Published
* * * * * * * * * * * * * * * * * * * * * * * * *
JANE DOE/29, Personal Representative *
of the Estate of DECEDENT, **
Petitioner, *
v. * Entitlement; Hep B vaccine;
* two months later, Devic’s Disease
SECRETARY OF THE DEPARTMENT * (a variant of MS) then death
OF HEALTH AND HUMAN SERVICES, *
*
Respondent. *
* * * * * * * * * * * * * * * * * * * * * * * * *
Clifford J. Shoemaker, Vienna, VA, for petitioner.
Linda S. Renzi, Washington, DC, for respondent.
MILLMAN, Special Master
RULING ON ENTITLEMENT1
The original petitioner filed a petition on April 3, 2000, under the National Childhood
Vaccine Injury Act, 42 U.S.C. §300aa-10 et seq., alleging that hepatitis B vaccinations
administered on April 20, 1998 and May 20, 1998 caused her unspecified injury. She later
alleged multiple sclerosis (MS). Petitioner died on May 21, 2008. The cause of death was
reported as “Complications of demyelinating disorder (probable Devic’s Disease).” P. Ex. 32, p.
12. The case continues with the personal representative of decedent’s estate as petitioner.
On December 8, 2008, respondent filed a Rule 4(c) Report and Request for Ruling on the
Record. Respondent determined not to expend further resources defending this case and asked
the undersigned to rule on the existing record.
FACTS
Decedent was born on December 4, 1961.
On April 20, 1998, she received her first hepatitis B vaccination. Med. recs. at Ex. 8, p.
On May 20, 1998, decedent received her second hepatitis B vaccination. Id.
On July 26, 1998, two months after her second hepatitis B vaccination, decedent noted
retro-orbital pressure in her left eye followed by decreased visual function. Med. recs. at Ex. 1,
p. 51. Initial pressure sensation improved with antihistamines. Id.
On July 27, 1998, she noted a curtain over the superior visual field in her left eye which
gradually progressed. She saw Dr. Linda Angell on July 30, 1998 on an emergency basis. She
told Dr. Angell she had a gray spot field of vision with sudden onset. Med. recs. at Ex. 6, p. 24.
She had no history of headache, dizziness, or previous blurred vision, diplopia, numbness or
weakness, of even a transient nature. Med. recs. at Ex. 1, p. 51.
On July 28, 1998, decedent saw Dr. James Rawlinson with a field defect in the lateral
aspect of her left eye. She had had two previous episodes where both eyes were affected which
lasted a day or two. She recalled no headache afterwards. She had mild discomfort in her eyes.
Med. recs. at Ex. 8, p. 95.
On August 4, 1998, decedent saw Dr. Eric R. Eggenberger for a neuro-ophthalmologic
evaluation and he diagnosed her left eye with retrobulbar optic neuropathy, most logically optic
neuritis. Id.
On September 8, 1998, decedent saw Dr. Rawlinson with leg pain and weakness. Med.
recs. at Ex. 8, p. 96. She had a two-week history of intermittent weakness in her left leg. On one
occasion, it gave out and she started to fall but caught herself. Recently, she had some mild
discomfort in her right calf. Id.
On September 18, 1998, decedent saw Dr. Rawlinson with leg pain and vision problems.
She had complete resolution of her visual disturbances after taking IV steroids followed by a
Prednisone taper. Med. recs. at Ex. 8, p. 97. The pain in her left calf resolved on the Prednisone.
She had been off Prednisone for two weeks and began experiencing visual disturbances similar to
her prior experience which seemed to be primarily a field defect and her vision seemed darker in
the lateral aspect of her left eye. She also had some mild discomfort above the eye and some
nasal congestion, but no purulent drainage and no sore throat or ear pain. Decedent questioned if
her multiple sclerosis symptoms were due to her receiving hepatitis B vaccine on April 20, 1998
and May 20, 1998. She became symptomatic for the first time on July 14, 1998. Id.
On January 25, 1999, decedent had an MRI scan of her brain which was negative. Med.
recs. at Ex. 1, p. 65. There was an abnormal signal in the upper cervical spinal cord which was
improved when compared to a previous MRI of December 31, 1998. Id. Dr. David I. Kaufman
diagnosed neurologic syndrome involving decedent’s optic nerves and spinal cord. The cause
could be Devic’s syndrome (neuromyelitis optica) secondary to MS. However, sarcoid or other
etiologies could not be eliminated. Id. Decedent also had a right lumbosacral radiculopathy
most likely corresponding to a right L5-S1 nerve root abnormality. A mildly axonal primary
motor peripheral polyneuropathy might be possible. Id.
On June 25, 1999, decedent saw Dr. Daniel L. Murman, a neurologist. Med. recs. at Ex.
1, p. 69. She had been hospitalized in April for significant worsening of her myelitis resulting in
quadriparesis and sensory loss below the cervical region. On June 15, 1999, decedent developed
blurring of her right eye. Id.
Other Submitted Material
Petitioner filed exhibit 17, neurologist Dr. Carlo Tornatore’s expert report, dated October
9, 2007. He states that it is biologically plausible for hepatitis B to cause demyelination because
vaccines are composed of organic compounds of viral or bacterial origin, whether recombinant or
otherwise, whose purpose is to initiate an immune response in the recipient. Ex. 17, p. 6. But if
any of the vaccine antigens shares a homology with the recipient’s antigens, the host’s immune
response will attack both the vaccine antigens and the host’s antigens, resulting in an
autoimmune response. Ex. 17, pp. 6-7. This concept is also known as molecular mimicry and is
well-established in immunology. Dr. Tornatore refers to three filed articles (P. Exs. 19-21). Ex.
17, p. 7. He concludes that hepatitis B vaccine caused decedent’s MS.
Petitioner filed a supplemental report from Dr. Tornatore, dated November 25, 2007. P.
Ex. 22. He thought that the decedent’s onset of demyelinating optic neuritis might have occurred
approximately 18 days after her hepatitis B vaccination, although the medical records reflected a
two-month interval. Id.
Petitioner’s exhibit 20 is an article entitled “A study of molecular mimicry and
immunological cross-reactivity between hepatitis B surface antigen and myelin mimics” by D-P
Bogdanos, et al., 12 Clin & Develop Immunol 3:217-24 (2005). The authors begin their article
with the statement: “Molecular mimicry based on amino acid similarities shared by viral and self
antigens has long been proposed as a pathogenic mechanism for autoimmune disease . . . .” Id. at
217. They conducted tests involving hepatitis B vaccinees to see if there were cross-reactivity
between hepatitis B vaccine surface antigen and myelin mimics in normal subjects and found
there was such reactivity for a limited time period without the subjects having clinical symptoms.
Respondent did not file an expert report.
DISCUSSION
This is a causation in fact case. To satisfy her burden of proving causation in fact,
petitioner must offer "(1) a medical theory causally connecting the vaccination and the injury; (2)
a logical sequence of cause and effect showing that the vaccination was the reason for the injury;
and (3) a showing of a proximate temporal relationship between vaccination and injury.” Althen
v. Secretary of HHS, 418 F. 3d 1274, 1278 (Fed. Cir. 2005). In Althen, the Federal Circuit
quoted its opinion in Grant v. Secretary of HHS, 956 F.2d 1144, 1148 (Fed. Cir. 1992):
A persuasive medical theory is demonstrated by “proof of a logical sequence of
cause and effect showing that the vaccination was the reason for the injury[,]” the
logical sequence being supported by “reputable medical or scientific
explanation[,]” i.e., “evidence in the form of scientific studies or expert medical
testimony[.]”
In Capizzano v. Secretary of HHS, 440 F.3d 1274, 1325 (Fed. Cir. 2006), the Federal
Circuit said “we conclude that requiring either epidemiologic studies, rechallenge, the presence
of pathological markers or genetic disposition, or general acceptance in the scientific or medical
communities to establish a logical sequence of cause and effect is contrary to what we said in
Althen. . . .”
Without more, "evidence showing an absence of other causes does not meet petitioners'
affirmative duty to show actual or legal causation." Grant, supra, at 1149. Mere temporal
association is not sufficient to prove causation in fact. Id. at 1148.
Petitioner must show not only that but for the vaccine, the decedent would not have had
Devic’s Disease, a variant of MS, but also that the vaccine was a substantial factor in bringing
about her Devic’s Disease. Shyface v. Secretary of HHS, 165 F.3d 1344, 1352 (Fed. Cir. 1999).
Here, the decedent’s onset of Devic’s disease (a variant of MS) was two months after her
second vaccination. In Werderitsh v. Secretary of HHS, No. 99-319V, 2006 WL 1672884 (Fed.
Cl. Spec. Mstr. May 26, 2006), the undersigned ruled that hepatitis B vaccine can cause MS and
did so in that case. However, the onset interval after vaccination in Werderitsh was one month.
Dr. Roland Martin, respondent’s expert, testified in Werderitsh that an appropriate temporal
interval for an immune reaction would be a few days to three to four weeks. Werderitsh was one
of the four paradigm cases in the Omnibus hepatitis B vaccine-demyelinating illnesses
proceeding involving multiple sclerosis, transverse myelitis, Guillain-Barré syndrome, and
chronic inflammatory demyelinating polyneuropathy.
But in Pecorella v. Secretary of HHS, No. 04-1781V, 2008 WL 4447607 (Fed. Cl. Spec.
Mstr. Sept. 17, 2008), this one-month limit on the appropriate time interval between vaccination
and illness became extended to two months. In Pecorella, petitioner alleged causation of
transverse myelitis two months after she received hepatitis B vaccine. Respondent, as in the
instant action, preferred not to expend any more resources in defending the case and asked for a
ruling on the record. The undersigned had previously ruled in another paradigm cases in the
Omnibus hepatitis B vaccine-demyelinating illnesses proceeding, Stevens v. Secretary of HHS,
No. 99594, 2006 WL 659525 (Fed. Cl. Spec. Mstr. Feb. 24, 2006), that hepatitis B vaccine could
cause transverse myelitis and did in that case. In Pecorella, the undersigned ruled for petitioner.
Since the Pecorella decision, the undersigned has accepted that the medically appropriate
time frame for causation in the hepatitis B vaccine-demyelinating illnesses cases is now up to
two months after vaccination.
In the instant action, decedent’s onset of Devic’s Disease, a variant of MS, is either 18
days (her and petitioner’s recollection of onset, but not reflected in the medical records) or two
months (reflected in the medical records) after vaccination. If onset is 18 days, decedent fits
within the old accepted time frame of three to 30 days between vaccination and onset. If the
onset is two months, decedent fits within the new accepted time frame of two months set in
Pecorella.
Petitioner’s expert neurologist, Dr. Carlo Tornatore, discussed in his reports the concept
of molecular mimicry as the biologically plausible medical theory underlying the first prong of
causation. There is a logical sequence of cause and effect in petitioner’s having received the
vaccination and then experiencing optic neuritis, the first symptom of her Devic’s Disease, a
variant of MS. As discussed, the onset after vaccination is appropriate to prove causation,
whether the onset is 18 days or two months after vaccination.
Petitioner has prevailed on the issue of entitlement. The medical records during
decedent’s final hospitalization reflect that she died from demyelinating disease. Not only did
decedent have a vaccine injury, but also her death was vaccine-related.
CONCLUSION
Petitioner is entitled to reasonable compensation. The undersigned hopes that the parties
may reach an amicable settlement and will have a telephonic status conference soon with the
parties to discuss further proceedings.
IT IS SO ORDERED.
January 16, 2009 s/Laura D. Millman
DATE Laura D. Millman
Special Master
Laura D. Millman
Miss Millman was appointed Special Master on April 25, 1991, and entered duty on May 31, 1991. She graduated from the City College of New York receiving a B.A. degree cum laude in English in 1966, from Herbert H. Lehman College receiving a M.A. degree in English in 1971, and from the Fordham University School of Law, receiving a J.D. degree cum laude in 1976. Miss Millman was a member of the Law Review and published an article and a note. She received the Stillman Prize for the highest cumulative grade average in her law section.Miss Millman formerly served as a Trial Attorney under the Attorney General's Honors Program in the United States Department of Justice, Civil Division, from 1976 to 1978 in New York, and in the Torts Branch from 1978 to 1988 in Washington, DC. Miss Millman is a member of the bars of New York, the District of Columbia, and Maryland. She is a member of the District of Columbia Bar Association.
Information obtained from the U.S Court of Federal Claims Website
717 Madison Place, NW
Washington, DC 20005
202-357-6400
Permission to utilize this information was Obtained from the United States Court of Federal Claims
DISCLAIMER
Please make sure to check with your Doctor, Neurologist before making any medical decision. Information on this site is information found during the Founder & CEO's research of Devic's Disease. This disease has been known about in Europe since the 1800"s and was thought to be an Asiatic Disease. However, this disease is also common in Africa as well as Asia.
