VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_08-vv-00696 Package ID: USCOURTS-cofc-1_08-vv-00696 Petitioner: Eileen Callahan Filed: 2008-09-30 Decided: 2014-09-25 Vaccine: MMR Vaccination date: 2007-10-02 Condition: multiple sclerosis (MS) Outcome: dismissed Award amount USD: AI-assisted case summary: Eileen Callahan was born on August 1, 1962. She received an MMR vaccination in her left upper arm on October 2, 2007. According to her account, approximately forty minutes after the vaccination, she experienced numbness in her left anterior thigh, and subsequently developed additional neurological symptoms including numbness in her left face, left arm, and leg, as well as fatigue and difficulty with concentration. She had a significant medical background: she had gained approximately eighty-five pounds over the preceding three years, at the time weighed two hundred pounds at five feet three inches, had experienced fatigue since contracting mononucleosis at age seventeen, and had a history of menstrual-associated migraine. She also reported that approximately twenty years earlier, at around age twenty-two, she had experienced diminished sensation on the left side of her face after receiving vaccines for cholera, typhoid, and possibly yellow fever. Her thyroid condition had been previously diagnosed. Ms. Callahan was evaluated by numerous physicians. On October 2, 2007, a physician noted that the etiology of her symptoms was uncertain but doubted they were related to the recent MMR vaccination. On October 11, 2007, neurologist Dr. Rong Chen found no substantial neurological deficit on physical examination — no signs of myelopathy or neuropathy — but noted what he characterized as "give way" weakness, indicating voluntary effort to feign weakness. On November 3, 2007, a brain MRI showed scattered focal areas of abnormal signal intensity; these findings were nonspecific and could represent end artery infarcts, post-vaccination encephalomyelitis, Lyme disease, Epstein-Barr virus, sarcoidosis, vasculopathy, or migraine. On March 3, 2008, an MRI of the cervical spine showed no multiple sclerosis or demyelinating disease and only minimal bulging discs. Neurologist Dr. Anthony Reder at the University of Chicago, who evaluated Ms. Callahan in January 2008, found a relatively normal physical examination, and noted cognitive problems and fatigue. Ms. Callahan filed her petition on approximately September 30, 2008. Her first attorney stated at the initial status conference in December 2008 that she had no diagnosis and was looking for an expert. After her first attorney withdrew in late 2009, Ms. Callahan proceeded pro se for over three years before obtaining counsel Richard Moeller in March 2013. Petitioner submitted the report of Dr. William Shaffer, a treating neurologist at the University of Chicago, who stated that Ms. Callahan had post-vaccination encephalomyelitis following the MMR vaccine, but offered no medical theory explaining the connection and did not address whether a forty-minute onset interval was appropriate for causation. Petitioner also submitted the report of Dr. Lawrence Shields, who physically examined Ms. Callahan and found that her strength was adequate throughout, her muscle appearance was normal, she had no focal atrophy or wasting, her tone was normal, her deep tendon reflexes were obtainable, she had no Babinski sign, and her sensation was intact throughout. Notwithstanding these entirely normal findings, Dr. Shields diagnosed Ms. Callahan with an "underlying demyelinating process, strongly suggestive of multiple sclerosis," and opined that the MMR vaccination had caused an exacerbation of her underlying condition. He offered no medical theory as a basis for this opinion and did not explain how a forty-minute onset interval was appropriate. Dr. Shields subsequently refused to testify for Ms. Callahan. Respondent's expert, Dr. Martin Bielawski of Johns Hopkins, concluded that there was no objective clinical or diagnostic evidence to support a diagnosis of multiple sclerosis or post-vaccination encephalomyelitis. He testified that he was "unaware of any autoimmune mechanism that can produce central or peripheral neurological injury or inflammation/demyelination to an area remote from the injection site in 40 minutes." He explained that left anterior thigh numbness is a focal peripheral symptom that cannot arise from demyelination in the brain or spinal cord; the most plausible explanation was compression of the left lateral femoral cutaneous nerve, a peripheral nerve commonly compressed in overweight patients. He further stated that Ms. Callahan's brain MRI findings were nonspecific and did not fulfill the 2010 revised McDonald criteria for multiple sclerosis; they were consistent with her history of migraine. Her cervical MRI showed no spinal cord abnormality. He noted that a prior vaccination with cholera and typhoid would create immunological memory for cholera and typhoid antigens, not for MMR antigens, and that no inference of universal cross-reactivity could be drawn from her prior vaccine reaction. Special Master Millman issued her decision on September 4, 2014, dismissing the petition. The special master held that Ms. Callahan had failed to satisfy all three prongs of the Althen test. On prong one, she found that Dr. Shaffer's report was skeletal and conclusory, offering no medical theory connecting the vaccination to neurological injury and not addressing the forty-minute onset interval. Dr. Shields' report was self-contradictory: he found no objective neurological problem on his own examination but nevertheless diagnosed multiple sclerosis based on Ms. Callahan's self-reported symptoms and her manifesting awkward gait before him; he gave no theory and did not explain how a forty-minute onset could cause demyelinating disease. On prong two, the expert opinions submitted were insufficient to establish a logical sequence of cause and effect. On prong three, forty minutes was not a medically appropriate interval; the Federal Circuit held in De Bazan v. Secretary of Health and Human Services that even an eleven-hour onset for acute disseminated encephalomyelitis following tetanus vaccination was too short to support causation. The special master further noted that even if significant aggravation had been properly alleged, the medical records did not establish any difference in neurological condition before and after the MMR vaccination, and Ms. Callahan had never been shown to have multiple sclerosis or encephalomyelitis. Having had more than six years and the assistance of two competent attorneys to build her case, Ms. Callahan had a full and fair opportunity to present her claim. Theory of causation field: MMR Oct 2, 2007 → claimed encephalomyelitis or exacerbation of underlying MS; onset claimed 40 minutes post-vaccination (left thigh numbness). Dr. Shaffer (petitioner): post-vaccination encephalomyelitis — no theory given, no 40-minute onset explanation. Dr. Shields (petitioner): 'underlying demyelinating process, strongly suggestive of MS' + MMR exacerbation — no theory; contradicted by his own normal exam; refused to testify. Dr. Bielawski (respondent): no autoimmune mechanism possible in 40 minutes to remote site; thigh numbness = lateral femoral cutaneous neuropathy (compression in obese patients); brain MRI nonspecific (migraine-consistent); McDonald criteria not met; prior cholera/typhoid vaccination = different antigen memory, no generalized cross-reactivity inference. SM Millman Sept 4, 2014: DISMISSED — all 3 Althen prongs failed; 40-minute onset not medically appropriate (De Bazan: 11-hour ADEM onset too short). DB decision_date '2014-09-04' = SM header date (wrong); corrected to 2014-09-25 (granule date_issued). Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_08-vv-00696-0 Date issued/filed: 2014-09-25 Pages: 9 Docket text: PUBLIC DECISION (Originally filed: 09/04/2014) regarding 69 DECISION of Special Master Signed by Special Master Laura D Millman. (tlj) Copy to parties. -------------------------------------------------------------------------------- Case 1:08-vv-00696-UNJ Document 70 Filed 09/25/14 Page 1 of 9 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 08-696V September 4, 2014 Not to be Published *************************************** EILEEN CALLAHAN, * * Petitioner, * Measles-mumps-rubella (MMR) vaccine; * 40-minute onset of multiple sclerosis (MS); v. * dismissal; failure to prove allegations by a * preponderance of the evidence SECRETARY OF HEALTH * AND HUMAN SERVICES, * * Respondent. * *************************************** Richard H. Moeller, Sioux City, IA, for petitioner. Lara A. Englund, Washington, DC, for respondent. MILLMAN, Special Master DECISION1 On September 30, 2008, petitioner filed a petition under the National Childhood Vaccine Injury Act, 42 U.S.C. §§ 300aa-10–34 (2006), alleging that measles-mumps-rubella (“MMR”) vaccine administered on October 2, 2007 caused numbness and weakness in her left leg, progressing within two to three days to left-sided facial numbness and numbness in her left arm and hand. Pet. ¶ 1. 1 Because this decision contains a reasoned explanation for the special master’s action in this case, the special master intends to post this decision on the United States Court of Federal Claims’s website, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17, 2002). Vaccine Rule 18(b) states that all decisions of the special masters will be made available to the public unless they contain trade secrets or commercial or financial information that is privileged and confidential, or medical or similar information whose disclosure would constitute a clearly unwarranted invasion of privacy. When such a decision is filed, petitioners have 14 days to identify and move to redact such information prior to the document’s disclosure. If the special master, upon review, agrees that the identified material fits within the categories listed above, the special master shall redact such material from public access. Case 1:08-vv-00696-UNJ Document 70 Filed 09/25/14 Page 2 of 9 The undersigned DISMISSES this case for failure to prove by a preponderance of the evidence the allegations in her petition. 42 U.S.C. § 300aa-13(a)(1)(A). FACTS Pre-vaccination records Petitioner was born on August 1, 1962. On September 7, 2007, petitioner went to Dr. Mandy Uppal at McKinley Health Center, complaining of left foot pain. Med. recs. Ex. 1, at 1. Dr. Uppal diagnosed her with tendinitis secondary to overuse. Id. Petitioner gave a history of two months of left foot pain. Id. at 2. The prior year, she had severe tendinitis of the left foot and went to physical therapy to strengthen the tendon. Id. Dr. Uppal prescribed Motrin and gave her an orthopedic referral. Id. On September 13, 2007, petitioner went to Dr. David Lawrance at McKinley Health Center, complaining of hypothyroidism, fatigue, low back pain, foot and ankle pain, and lethargy, but no specific injury. Id. at 3–4. She was clinically hypothyroid and overweight. Id. at 4. On September 21, 2007, petitioner went to McKinley Health Center. Id. at 5. She weighed 192 pounds and was five foot three inches tall. Id. Around midnight, she had a horrible sore throat, sweating, and slight lightheadedness. Id. She had no other upper respiratory symptoms. Id. She took aspirin four to five days earlier and had black stool for two days. Id. The diagnosis was pharyngitis. Id. Post-vaccination records On October 2, 2007, petitioner received MMR vaccine. Id. at 8. Also on October 2, 2007, petitioner saw Dr. Lawrance at McKinley Health Center. Id. at 7. Petitioner’s stool guaiac test was positive. Id. She had not had bleeding since discontinuing aspirin. Id. Dr. Lawrance diagnosed petitioner with lethargy, likely obstructive sleep apnea since she snored, and a history of mild elevation of her hemoglobin and platelets, which might be related to her gastrointestinal bleeding. Id. On October 8, 2007, petitioner saw Dr. Larry dePedro at McKinley Health Center. Id. at 8. She told him that she received MMR on October 2, 2007 and, 40 minutes later, her left leg started to go numb. Id. Two days later, her left cheek went numb. Id. Her left leg started to hurt after five minutes of walking. Id. She had a fever since the beginning of the school year. Id. Dr. dePedro diagnosed petitioner with paresthesias involving her face and left upper thigh. Id. at 9. He questioned whether it was vaccine-related. Id. 2 Case 1:08-vv-00696-UNJ Document 70 Filed 09/25/14 Page 3 of 9 On October 8, 2007, petitioner saw another doctor whose signature looks like Palinkas. Id. at 10. Petitioner remembered having similar symptoms twenty years ago after receiving a cholera vaccination. Id. She said her numbness persisted for several months and then spontaneously resolved with intermittent occurrences for several years. Id. She thought she had a fever when she received the vaccine. Id. Dr. Palinkas wrote that petitioner might have an inflammatory polyneuropathy of uncertain etiology, but he doubted it was related to her recent MMR vaccination. Id. at 11. On October 11, 2007, petitioner saw Dr. Rong Chen, a neurologist. Med. recs. Ex. 2, at 11. He wrote that petitioner’s physical examination did not reveal any substantial neurological deficit. Id. She had no signs of myelopathy or neuropathy. Id. On November 3, 2007, petitioner underwent a brain MRI. Med. recs. Ex. 1, at 69. It showed a small number of scattered focal areas of abnormal increase in signal intensity. Id. at 70. These signs were nonspecific. Id. They could signify end artery infarcts, post-vaccination encephalomyelitis, Lyme disease, Epstein-Barr virus, sarcoidosis, or vasculopathy. Id. On January 30, 2008, petitioner saw Dr. Anthony Reder, a neurologist at the University of Chicago Medical Center. Id. at 73. He wrote that petitioner’s descriptions of her symptoms were consistent with a demyelinating disease, but she had a relatively normal physical examination, although she had cognitive problems and fatigue. Id. at 75. On March 3, 2008, petitioner underwent an MRI of her cervical spine. Id. at 76. The MRI showed she did not have multiple sclerosis or a demyelinating disease. Id. The MRI also showed she had minimal bulging discs. Id. On March 25, 2008, petitioner went to Dr. Donald Greeley for a sleep consultation. Id. at 78. Petitioner said she had gained 85 pounds over the prior three years. Id. She had had fatigue since she was seventeen years old due to mononucleosis. Id. The fatigue had worsened over the last five to six years. Id. She had chronic fatigue. Id. She had choking in her sleep. Id. Her current weight was 203 pounds. Id. Her weight five years earlier was 115 pounds. Id. She was five foot three inches tall. Id. On May 21, 2008, Dr. Daniel L. Picchietti administered a polysomnogram to petitioner and diagnosed her with mild obstructive sleep apnea. Id. at 81. Expert Reports Petitioner filed an expert report from a treating physician, Dr. William R. Shaffer, a neurologist at the University of Chicago Medical Center, dated February 11, 2008. Med. recs. Ex. 5, at 1. Dr. Shaffer states petitioner had a reaction to previous vaccinations. Id. at 2. He also states she had post-vaccination encephalomyelitis after MMR, but he does not give a basis for his opinion. He does not explain a medical theory that would connect petitioner’s MMR 3 Case 1:08-vv-00696-UNJ Document 70 Filed 09/25/14 Page 4 of 9 vaccination to her alleged encephalomyelitis or explain how a 40-minute onset is an appropriate temporal interval to connote causation from the vaccine. Id. On June 23, 2009, respondent filed the expert report of Dr. Martin Bielawski, a neurologist, as Exhibit A. His opinion is that petitioner did not have a clear-cut history, examination findings, or objective tests to support a diagnosis of post-vaccination acute disseminated encephalomyelitis or any other form of encephalomyelitis. Ex. A, at 6. Dr. Bielawski states that petitioner claimed she had numbness in the left anterior thigh 40 minutes after MMR vaccination in her left upper arm, and concludes: “I am unaware of an autoimmune mechanism that can produce central or peripheral neurological injury or inflammation/demyelination to an area remote from the injection site in 40 minutes.” Id. He also states that “[l]eft anterior thigh numbness is a focal symptom,” not a manifestation of a brain or spinal cord problem. Id. Thus, “this symptom could not be secondary to encephalomyelitis.” Id. It could, however, be due to left lateral femoral cutaneous neuropathy, which is a peripheral nerve commonly compressed in overweight patients. Id. Since petitioner weighed 200 pounds while being only five foot three inches tall, her obesity could have caused an isolated lateral femoral cutaneous nerve symptom. Id. He states, “A vaccination would not produce isolated lateral femoral cutaneous nerve symptoms.” Id. Dr. Bielawski also states that petitioner’s physical examinations never showed any objective evidence for encephalomyelitis or any other demyelinating disease. Id. She never had abnormal deep tendon reflexes or Babinski response to suggest an upper motor neuron problem of her brain or spinal cord. Id. Petitioner’s brain MRI results were nonspecific and not diagnostic of multiple sclerosis. Id. Her brain MRI results would commonly occur with migraine headache, and petitioner had a history of menstrual-associated migraine. Id. at 7. On August 25, 2009, respondent filed a supplemental expert report of Dr. Bielawski as Exhibit C. Dr. Bielawski states that if petitioner had reacted to cholera and typhoid vaccinations 25 years earlier, her immune system would have created T-cells with a memory for cholera and typhoid antigens, but not a memory for MMR antigens. Ex. C, at 2. On April 8, 2014, petitioner filed the report of Dr. Lawrence W. Shields as Exhibit 7. He recounts petitioner’s history, including that she has felt fatigue since high school. Ex. 7, at 2. Dr. Shields also physically examined petitioner and found that her strength was adequate throughout, her muscle appearance was normal, she did not have focal atrophy or wasting, her tone was normal throughout, and she did not have fasciculations. Ex. 7, at 4. She had obtainable deep tendon reflexes and no Babinski sign. Id. Her sensation was intact throughout to pin, vibration, joint position, and two-point discrimination. Id. at 5. He concludes that petitioner has an underlying demyelinating process, strongly suggestive of multiple sclerosis (“MS”), and he opines that the MMR vaccination “was the competent producing cause of exacerbation of her underlying condition.” Id. Dr. Shields does not give a medical theory as a basis for his conclusion. He does not explain how a 40-minute onset is an appropriate time interval between vaccination and symptoms to connote causation. 4 Case 1:08-vv-00696-UNJ Document 70 Filed 09/25/14 Page 5 of 9 On August 26, 2014, respondent filed a supplemental report from Dr. Bielawski as Exhibit D to comment on petitioner’s expert Dr. Shields’ report. Although Dr. Shields states in his report that petitioner had an underlying demyelinating process strongly suggestive of MS, Dr. Bielawski states there is no objective clinical or diagnostic evidence to support that diagnosis. Ex. D, at 2. Dr. Shields points to Uhthoff’s phenomenon as indicative of MS, but Dr. Bielawski says the revisions of the McDonald Criteria to diagnose MS omit Uhthoff’s phenomenon. Id.; Ex. D, Tabs 1 and 2. Dr. Bielawski considers petitioner’s description of her symptoms deteriorating with heat exposure as subjective. Ex. D, at 2. He notes that her neurological symptoms could also occur in the context of fatigue, which she has had for years, and that her underlying hypothyroidism can also be associated with fatigue. Id. Dr. Bielawski also notes that petitioner did not discuss her supposed worsening of symptoms in the context of heat with her two treating neurologists, Drs. Chen and Reder, after her MMR vaccination. Id. Dr. Bielawski also disagreed with Dr. Shields’ opinion that petitioner had objective findings of MS on his neurological examination of her. Id. Dr. Bielawski notes that petitioner dragging her left leg, walking clumsily, and displaying other neurologic peculiarities are easily voluntary rather than objective. Id. at 2–3. When Dr. Chen, her first neurologist, examined her on October 11, 2007, he found petitioner had “give way” weakness, indicating petitioner’s voluntary effort to feign weakness. Id. at 3. In addition, her variable gait before seeing Dr. Chen showed voluntary inconsistency. Id. When petitioner saw Dr. Reder, her second neurologist, in January 2008, she claimed to have loss of concentration during school, yet Dr. Reder described her as a good historian. Id. Dr. Bielawski notes that these neurologists’ examinations did not show any objective findings of demyelinating disease: no disc pallor on fundoscopic examination, no afferent pupillary defect, no significant abnormalities in deep tendon reflexes, and no positive Babinski sign to suggest upper motor neuron dysfunction. Id. Dr. Bielawski states that petitioner’s brain MRI findings were nonspecific and not diagnostic of MS. Id. She did not have any callosal or pericallosal lesions on FLAIR sequences, reports of black holes on T1 weighted imagery, or Dawson’s fingers. Id. The nonspecific findings on her brain MRI are commonly seen with migraine, for which petitioner has a history associated with her menstruation. Id. Petitioner’s cervical MRI did not show abnormalities of the spinal cord to suggest a demyelinating disease. Id. Petitioner was evaluated for lupus, Lyme disease, rheumatoid arthritis, Sjögren’s disease, and sarcoidosis with negative results. Id. Dr. Bielawski states that both petitioner’s examinations and her brain MRI do not fulfill the revised McDonald criteria for the diagnosis of MS. Id. Dr. Bielawski refers to Dr. Shields’ statement in his report that vaccinations prior to petitioner’s MMR vaccination sensitized her, resulting in a reaction to MMR vaccine. Id. Dr. Bielawski recounts petitioner’s history that, at age 22, she claimed she had diminished sensation over the left side of her face after receiving vaccines for cholera, typhoid, and perhaps yellow fever. Id. Dr. Bielawski states that if cholera and typhoid vaccines primed petitioner’s immune system over 20 years earlier, her immune system would have a memory for cholera and typhoid 5 Case 1:08-vv-00696-UNJ Document 70 Filed 09/25/14 Page 6 of 9 antigens, not for MMR antigens. Id. He states no one can infer that these prior vaccines primed her immune system to react to all vaccines. Id. Dr. Bielawski says he cannot explain petitioner’s complaint after her MMR vaccination of left-sided facial numbness. Id. at 4. He notes these symptoms are subjective. Id. Dr. Shields found petitioner had normal corneal reflexes and normal trigeminal nerves, which affect sensation of the face bilaterally. Id. Petitioner’s brain and spinal cord imaging did not show any abnormality to explain her complaint of left facial numbness post-MMR vaccination. Id. Dr. Bielawski also notes that petitioner claimed she had numbness in her left anterior thigh about 40 minutes after she received MMR vaccine in her left upper arm. Id. Dr. Bielawski states, “I am unaware of any autoimmune mechanism that can produce central or peripheral neurological injury or inflammation/demyelination to an area remote from the injection site in 40 minutes.” Id. Moreover, Dr. Bielawski explains, left anterior thigh numbness is a focal, not a central nervous system, symptom. Id. Neither the cerebral hemisphere, brainstem, or spinal cord has an isolated anatomic representation of sensation in the left anterior thigh. Id. Therefore, Dr. Bielawski says that left anterior thigh numbness could not be due to demyelination. Id. It could be due to left lateral femoral cutaneous neuropathy, which commonly occurs in patients who are overweight due to compression of the lateral femoral cutaneous nerve, a peripheral nerve. Id. Petitioner was obese at the time she received MMR vaccine, weighing 200 pounds with a height of five feet three inches. Id. Dr. Bielawski concludes that petitioner did not have either post-MMR vaccine encephalomyelitis or MS before or after MMR vaccination. Id. She did have several unexplained neurological symptoms before and after MMR vaccination, some of which Dr. Bielawski attributes to her hypothyroidism. Id. Her neurological examination and brain MRI do not fulfill the 2010 revised McDonald criteria for diagnosing MS. Id. at 4–5. Petitioner had migraine prior to MMR vaccination, and Dr. Bielawski says that migraine could be the cause of her nonspecific brain MRI result. Id. at 5. He also says that she probably had left lateral femoral cutaneous nerve compression causing her recurrent left anterior thigh numbness. Id. PROCEDURAL HISTORY At the very first telephonic status conference on December 18, 2008, petitioner’s then- counsel, Sherry Drew, said she was looking for an expert, and petitioner had no diagnosis. On September 4, 2009, Ms. Drew stated at a telephonic status conference that she would discuss with petitioner the fact that her case was not very strong and perhaps she would like to make a demand on respondent for a low figure. On December 7, 2009, during another telephonic status conference, Ms. Drew said she would discuss with petitioner whether or not she would continue representing her. On December 18, 2009, Ms. Drew filed a motion to withdraw as petitioner’s counsel. 6 Case 1:08-vv-00696-UNJ Document 70 Filed 09/25/14 Page 7 of 9 On January 25, 2010, the undersigned held her first telephonic status conference with petitioner pro se. She said she was looking for an attorney. Over three years later, on March 26, 2013, petitioner obtained the services of Richard Moeller. During the telephonic status conference of April 3, 2013, Mr. Moeller stated he was going to use Dr. Lawrence Shields as petitioner’s expert. Dr. Shields saw petitioner almost eleven months later on February 28, 2014, and wrote a report dated April 1, 2014. On April 8, 2014, Mr. Moeller said during a telephonic status conference that he would not be able to get an expert report from Dr. Shields and would see if he could get one from Dr. Shaffer. On July 3, 2014, Mr. Moeller said during a telephonic status conference that he could not find a doctor to support petitioner’s allegations and that Dr. Shields had limited his opinion to offering the results of his examination of petitioner without giving any reason for his opinion that MMR exacerbated her MS. Mr. Moeller said petitioner, at Dr. Shaffer’s suggestion, wanted two months to obtain an expert report from a neuroimmunologist. The undersigned gave petitioner two months to do this. On September 4, 2014, Mr. Moeller stated during a telephonic status conference that petitioner did not have a neuroimmunologist’s expert report. He said petitioner was seeking to have a third law firm take her case and mentioned the name of the firm. DISCUSSION To satisfy her burden of proving causation in fact, petitioner must prove by preponderant evidence: “(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. Sec’y of HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005). In Althen, the Federal Circuit quoted its opinion in Grant v. Secretary of Health and Human Services, 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[.]” Althen, 418 F.3d at 1278. Without more, “evidence showing an absence of other causes does not meet petitioners’ affirmative duty to show actual or legal causation.” Grant, 956 F.2d at 1149. Mere temporal association is not sufficient to prove causation in fact. Id. at 1148. Petitioner must show not only that but for her MMR vaccination, she would not have whatever illness she has, but also that the vaccine was a substantial factor in causing her illness. Shyface v. Sec’y of HHS, 165 F.3d 1344, 1352 (Fed. Cir. 1999). 7 Case 1:08-vv-00696-UNJ Document 70 Filed 09/25/14 Page 8 of 9 Although petitioner alleges that MMR vaccination caused her neurologic difficulties, the medical records do not prove her allegation. The reports she submitted from Dr. Shaffer and Dr. Shields offer no theory to support their opinions. Dr. Shaffer’s report is skeletal and conclusory. He gives no medical theory to connect causally petitioner’s MMR vaccination and her alleged neurologic symptoms. He does not discuss her 40-minute onset or state that this short time interval is appropriate for causation. Dr. Shields recounts petitioner’s physical examination, showing she has no objective neurological problem, and then he concludes MMR vaccine exacerbated her multiple sclerosis based upon her manifesting peculiar symptoms in walking in front of him. Not only does he offer no basis for his opinion, but also nothing in his physical examination of petitioner, much less her medical records, supports the conclusion that petitioner has a demyelinating disease, including MS. Dr. Shields does not mention, much less explain, how a 40-minute interval between MMR vaccination and onset of alleged neurologic symptoms is appropriate for the causation of demyelinating disease including MS. The Vaccine Act does not permit the undersigned to rule for petitioner based on her claims alone, “unsubstantiated by medical records or by medical opinion.” 42 U.S.C. § 300aa- 13(a)(1) (2006). Those medical opinions which petitioner has filed must be credible. The medical opinions she submitted are deficient in substance, and in Dr. Shields’ case, self- contradictory. They are not sufficient to satisfy the three prongs of Althen. Dr. Shields’ opinion raises the issue of significant aggravation. If petitioner were to assert significant aggravation in this case, she would have to satisfy the Vaccine Act’s definition of significant aggravation. Section 300aa-33(4) defines “significant aggravation” as follows: The term “significant aggravation” means any change for the worse in a preexisting condition which results in markedly greater disability, pain, or illness accompanied by substantial deterioration of health. 42 U.S.C. § 300aa-33(4). The medical records petitioner filed do not substantiate any difference between her neurological symptoms, if any, before and after MMR vaccination, much less that she has ever had MS or encephalomyelitis. Thus, petitioner has not proven that she ever suffered from MS or any other neurologic disease or that she had a significant aggravation of same. Petitioner has not satisfied the first prong of Althen in that she has not presented through medical records or credible expert medical opinion a theory explaining how MMR vaccine could cause numbness in her thigh 40 minutes later or how MMR vaccine could exacerbate her alleged preexisting MS. Petitioner has not satisfied the second prong of Althen that there is a logical sequence of cause and effect showing that MMR vaccine did cause petitioner to suffer an illness or an exacerbation of any preexisting illness. Petitioner has not satisfied the third prong of Althen that the onset interval of 40 minutes is a medically appropriate time interval to show 8 Case 1:08-vv-00696-UNJ Document 70 Filed 09/25/14 Page 9 of 9 causation or exacerbation of either MS or any other demyelinating disease. De Bazan v. Sec’y of HHS, 539 F.3d 1347, 1349-50, 1352-53 (Fed. Cir. 2008) (eleven-hour interval between tetanus vaccination and acute disseminated encephalomyelitis too short to cause demyelination). Thus, petitioner has not made a prima facie case of causation. Petitioner’s counsel stated during the final telephonic status conference on September 4, 2014, that petitioner was seeking the services of a third law firm in the hope of continuing this case. At the time of this conference, the case was at the cusp of its sixth anniversary. Petitioner has had the services of two separate attorneys, both familiar with and competent in pursuing and attaining vaccine compensation under the Vaccine Act: Sherry Drew and Richard Moeller. Petitioner’s pursuit of further legal representation flies in the face of the paucity of the medical records and of the expert reports she has filed during these last six years. Dr. Shaffer, who provided a skeletal report dated February 11, 2008, refused to provide anything further. Dr. Shields, hired for the purpose of supporting petitioner’s case, found nothing abnormal neurologically on his own examination of her, but nevertheless diagnosed her with MS based on petitioner’s assertions and her manifesting awkward gait and other peculiarities before him. Yet Dr. Shields refuses to testify for her. Petitioner has had more than ample opportunity over the last six years, with the assistance of two separate counsel, to prove her case. She has failed to do so. She has had “a full and fair opportunity to present” her case. Vaccine Rule 3(b)(2). The undersigned DISMISSES this case for petitioner’s failure to prove by a preponderance of the evidence the allegations in her petition. 42 U.S.C. § 300aa-13(a)(1)(A). CONCLUSION This petition is DISMISSED. In the absence of a motion for review filed pursuant to RCFC, Appendix B, the clerk of the court is directed to enter judgment herewith.2 IT IS SO ORDERED. September 4, 2014 /s/ Laura D. Millman DATE Laura D. Millman Special Master 2 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by each party, either separately or jointly, filing a notice renouncing the right to seek review. 9 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_08-vv-00696-1 Date issued/filed: 2014-12-01 Pages: 2 Docket text: PUBLIC DECISION (Originally filed: 11/10/2014) regarding 74 DECISION Fees Stipulation/Proffer Signed by Special Master Laura D Millman. (tlj) Copy to parties. -------------------------------------------------------------------------------- Case 1:08-vv-00696-UNJ Document 78 Filed 12/01/14 Page 1 of 2 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 08-696V Filed: November 10, 2014 Not for Publication ************************************* EILEEN CALLAHAN, * * Petitioner, * Attorneys’ fees and costs decision based on * stipulation of fact v. * * SECRETARY OF HEALTH * AND HUMAN SERVICES, * * Respondent. * * ************************************* Richard H. Moeller, Sioux City, IA, for petitioner. Lara A. Englund, Washington, DC, for respondent. MILLMAN, Special Master DECISION AWARDING ATTORNEYS’ FEES AND COSTS1 On November 10, 2014, the parties filed a stipulation of fact in which they agreed on an appropriate amount for attorneys’ fees and costs in this case. Petitioner submitted her request for attorneys’ fees and costs to respondent. After informal discussions, petitioner amends her application for attorneys’ fees and costs to $23,755.03. This amount includes fees for both petitioner’s current counsel, Richard H. Moeller, and petitioner’s former counsel, Sherry Kay Drew. In accordance with the General Order #9 1 Because this unpublished decision contains a reasoned explanation for the special master’s action in this case, the special master intends to post this unpublished decision on the United States Court of Federal Claims’s website, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17, 2002). Vaccine Rule 18(b) states that all decisions of the special masters will be made available to the public unless they contain trade secrets or commercial or financial information that is privileged and confidential, or medical or similar information whose disclosure would constitute a clearly unwarranted invasion of privacy. When such a decision is filed, petitioner has 14 days to identify and move to redact such information prior to the document=s disclosure. If the special master, upon review, agrees that the identified material fits within the banned categories listed above, the special master shall redact such material from public access. Case 1:08-vv-00696-UNJ Document 78 Filed 12/01/14 Page 2 of 2 requirement, petitioner asserts that she advanced $1,352.66 in costs in pursuit of her petition. Respondent does not object to these amounts. The undersigned finds these amounts to be reasonable. Accordingly, the court awards: a. $23,755.03, representing reimbursement for attorneys’ fees and costs. The award shall be in the form of a check payable jointly to petitioner and Berenstein, Moore, Heffernan, Moeller & Johnson, L.L.P. in the amount of $23,755.03; and b. $1,352.66, representing reimbursement for petitioner’s costs. The award shall be in the form of a check payable to petitioner in the amount of $1,352.66. In the absence of a motion for review filed pursuant to RCFC Appendix B, the clerk of the court is directed to enter judgment herewith.2 IT IS SO ORDERED. Dated: November 10, 2014 s/ Laura D. Millman Laura D. Millman Special Master 2 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by each party, either separately or jointly, filing a notice renouncing the right to seek review. 2