MARY ELLEN COSTER WILLIAMS, Senior District Judge.
On August 5, 2014, Petitioner filed a claim for compensation under the National Vaccine Injury Compensation Program, alleging she sustained "joint pain in lower and upper extremities, radiating to upper torso" from a flu vaccination that she received on October 1, 2012. Pet. at 1. On December 17, 2018, the Special Master dismissed the petition, finding that Petitioner failed to prove both that she sustained a defined and recognized injury and that her symptoms endured for at least six months as required by the Vaccine Act.
Petitioner timely filed a Motion for Review on January 16, 2019. For the reasons stated below, Petitioner's Motion for Review is denied, and the Special Master's decision denying entitlement is sustained.
On October 1, 2012, Petitioner, a 60-year-old woman, received the flu vaccine, Fluarix. Petitioner's prior medical history included melanoma, a brain tumor, dyspnea, fatigue, and chronic low white blood cell count. Within a week after the vaccination, Petitioner began experiencing sharp shooting pain in her upper and lower extremities. Pet'r's Ex. 1 at 4. On October 16, 2012, Petitioner visited her primary care physician, Dr. Charles MacCallum, and reported soreness in her upper extremities, mobility issues and fatigue in her fingers, and Dr. MacCallum noted that Petitioner received the flu shot two weeks earlier. Pet'r's Ex. 7 at 196. Dr. MacCallum prescribed prednisone and ordered blood work, which returned positive for anti-nuclear antibodies (ANA) and a parvovirus antibody. Dr. MacCallum referred Petitioner to a rheumatologist, Dr. Aminda Lumapas, for myalgias and joint symptoms. Pet'r's Ex. 5 at 9.
At the time she received the vaccine, Petitioner was working as a Senior Physical Therapist at University Hospitals Ahuja Medical Center in Beachwood, Ohio. On October 15, 2012, at the direction of her supervisor, Petitioner visited the registered nurse at the corporate health department, Ms. Donna Gigliotti, who reported Petitioner's case to the Vaccine Adverse Event Reporting System ("VAERS"). In the VAERS report, Ms. Gigliotti stated that Petitioner experienced "joint pain in lower and upper extremities radiating to upper torso affecting [activities of daily living]" beginning on October 10, 2012, some 9 days after Petitioner received the vaccine. Pet. Ex. 4 at 1.
On October 28, 2012, Petitioner fell down the stairs at her home, fracturing her left ankle. Pet'r's Ex. 2 at 3-4. On November 1, 2012, Petitioner saw an orthopedist, Dr. Robert Corn, and reported that she fell because she "misjudged the bottom two steps [at her home]." Pet'r's Ex. 9 at 139. Records of this appointment contain no mention of pain or weakness in Petitioner's extremities and "only minimal distress other than her left ankle."
On January 3, 2013, Petitioner had a consultation with rheumatologist Dr. Lumapas and complained of painful joints and shooting pain throughout her lower extremities. Pet'r's Ex. 10 at 308. According to the medical records, Dr. Lumapas was unsure if these symptoms were related to the vaccination. Dr. Lumapas noted Petitioner's positive anti-nuclear antibodies ("ANA") and preexisting decreased white blood cell count and ordered additional bloodwork "concerning her [positive ANA]."
On January 8, 2013, Petitioner saw Dr. Corn, who released Petitioner to return to work on a limited basis after confirming that Petitioner's ankle had almost fully healed. Petitioner claimed that, upon returning to work on January 11, 2013, she continued to experience pain, though more in her hands and forearms than in her legs, and struggled to perform work tasks. Pet'r's Ex. 17 at 4-5.
Petitioner saw Dr. MacCallum again on January 14, 2013, and continued to complain of shooting pain in her hands and feet. Pet'r's Ex. 7 at 195. In a letter to Petitioner's employer seeking an exemption for Petitioner from future flu shots, Dr. MacCallum stated that Petitioner had "developed polyarthritis in her hands and feet after receiving a flu shot on [October 1, 2012]." Pet'r's Ex. 8 at 289. X-rays taken that day indicated mild marginal osteophytosis, and there was no radiographic evidence of inflammatory arthritis. Pet'r's Ex. 21 at 19; Pet'r's Ex. 6 at 24.
Petitioner had a follow-up appointment with Dr. Lumapas on January 17, 2013, and Petitioner reported that she was feeling better and having less difficulty manipulating her hands. Pet'r's Ex. 10 at 299. After reviewing the results of Petitioner's bloodwork, Dr. Lumapas wrote:
On February 1, 2013, Dr. Corn issued a Return to Work Authorization allowing Petitioner to return to work full time with no restrictions. Pet'r's Ex. 9 at 168. Petitioner saw Dr. MacCallum on September 14, 2013, complaining of strep throat and facial pain, and again on September 30, 2013, concerning anxiety, anger, stress, and a cold sore. Pet. Ex. 7 at 194, 192. Petitioner returned to Dr. MacCallum's office three times in December 2013, complaining of fatigue and gastrointestinal issues. Petitioner did not mention myalgias, joint pain, joint swelling, or other rheumatological issues at these visits. Pet'r's Ex. 26 at 5-9; Pet'r's Ex. 21 at 20-25.
Petitioner submitted one record of a medical assessment for 2014, from her annual employer-mandated tuberculosis screening on February 12, 2014, when she indicated that she did not suffer from "illness," "extreme fatigue," or "weakness." Pet'r's Ex. 21 at 9.
In 2015, Petitioner sought treatment for sinusitis and pain in her left hip that began when Petitioner fell in a parking lot on August 1, 2015, but she denied numbness, tingling, fever, chills, or any other neurological issues, and did not mention extremity pain or weakness, other than that relating to her hip. Pet'r's Ex. 26 at 4; Pet'r's Ex. 34 at 4, 7.
On December 8, 2015, Petitioner saw Dr. Lawrence Saltis, a neurologist at Western Reserve Health System, and reported "pain in feet and hands that started in 2012 after a flu vaccine." Pet'r's Ex. 32 at 1-2. This doctor's visit is the first time since Petitioner's January 14, 2013 visit with Dr. MacCallum that Petitioner mentioned that she felt joint or extremity pain related to the vaccination. According to records from this appointment, Petitioner notified Dr. Saltis that she had previously seen a rheumatologist, but that they didn't "hit it off."
On January 13, 2016, an MRI on Petitioner's spine revealed small, broad-based disc protrusions without significant spinal stenosis, and bilateral foraminal narrowing.
Petitioner submitted two "opinion letters" from Dr. MacCallum dated February 3, 2016, and June 24, 2016. Dr. MacCallum testified that he wrote the February 3, 2016 letter because Petitioner's counsel contacted him asking for his medical opinion on "some matters." Tr. 43. The letter states:
Pet'r's Ex. 31 at 1. At the time Dr. MacCallum wrote this opinion letter, he had not personally examined Petitioner for three years. Tr. 63. Dr. MacCallum testified:
Tr. 70-71. Dr. MacCallum was unaware that Petitioner had undergone nerve conduction studies in January 2016, that showed mild carpal tunnel syndrome but no other neurological deficits. Tr. 56.
Dr. MacCallum's second opinion letter records Petitioner's visit on June 24, 2016, to "discuss vaccines and paperwork." Pet'r's Ex. 35 at 2. In the "History of Present Illness" section, Dr. MacCallum provided a short explanation of Petitioner's symptoms and treatment in the three months following her October 1, 2012 vaccination, stating that:
At the hearing, Dr. MacCallum opined that the most plausible explanation for Petitioner's symptoms was an autoimmune reaction to the vaccine, but that, whatever that autoimmune reaction was, it was not GBS. Tr. 45. When asked why he believed that the vaccine caused Petitioner pain and weakness in her extremities, Dr. MacCallum stated that it was solely due to the temporal relationship between the vaccine and the symptoms. Tr. 73-74. After reviewing Petitioner's medical records, Dr. MacCallum testified that he believed that no other doctor had provided a definitive diagnosis of Petitioner's injury or indicated that Petitioner's symptoms were caused by the vaccination. Tr. 32-33, 42, 47-48.
Petitioner provided an expert report from Dr. Philip DeMio on February 10, 2016. Pet'r's Ex. 29.
Dr. DeMio based his diagnosis on "the time course in association with her . . . vaccination, and the "the lack of another temporally associated reasonable trigger."
On June 30, 2016, the Special Master ordered Petitioner to submit a supplemental expert report to address "the seeming inaccuracies and inconsistencies" in Dr. DeMio's first report, citing, among other things, Dr. DeMio's unsupported conclusion that treating physicians had performed "full medical work-ups, leading to findings of pathology on tests and exams" and had diagnosed Petitioner with autoimmunity and inflammatory arthritis. June 30, 2016 Order, ECF No. 55 at 1-2. The Special Master ordered Dr. DeMio to "include specific references to the exact medical records, test results, and literature upon which Dr. DeMio has relied in concluding that petitioner suffers from a vaccine-related injury."
On September 22, 2016, Dr. DeMio submitted a two-page supplemental report in which he diagnosed Petitioner with "autoimmunity, inflammation, polyneuropathy, and arthritis." Pet'r's Ex. 36 at 1. In the letter, Dr. DeMio recounted parts of Petitioner's history, including symptoms observed by Drs. MacCallum, Corn and Lumapas in the months after her vaccination, but inexplicably included multiple references to Petitioner as "employee."
In Vaccine Act cases, the Court of Federal Claims may: (1) uphold the findings of fact and conclusions of law and sustain the special master's decision; (2) set aside findings of fact or conclusions of law "found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law and issue its own findings of fact and conclusions of law;" or (3) "remand the petition to the special master for further action in accordance with the court's direction." 42 U.S.C. § 300aa-12(e)(2)(A)-(C) (2012);
Here, the Special Master determined that Petitioner did not establish a defined and recognized vaccine-related injury, and that, to the extent Petitioner's symptoms could constitute an injury, those symptoms did not persist for six months after the vaccination, as required for compensation under the Vaccine Act. Finally, the Special Master found that Petitioner failed to prove causation-in-fact under
The Special Master concluded that, while Petitioner proved that she suffered from several different symptoms following her vaccination, Petitioner did not prove by a preponderance of the evidence that she suffered from a "defined and recognized" injury. As an "initial step" before a special master determines whether a vaccine was the cause-in-fact of a petitioner's injury, the petitioner must first prove by a preponderance of the evidence that she suffers from a "defined" and "medically recognized" injury, not "merely . . . a symptom or manifestation of an unknown injury".
The record supports the Special Master's finding that, following her vaccination on October 1, 2012, Petitioner suffered from a series of symptoms — hand discomfort, weakness and pain in her lower and upper extremities, fatigue, and an ankle fracture from a fall, but that "no treating physician diagnosed [Petitioner] with GBS or any other definable injury or illness causally related to the flu vaccine." Dec. *20-21 (citing Pet'r's Ex. 1 at 3-4; Pet'r's Ex. 5 at 4; Pet'r's Ex. 7 at 195; Pet'r's Ex. 10 at 308). The Special Master found that, following her vaccination, Petitioner only received one credible possible diagnosis — polyarthritis as reflected in Dr. MacCallum's January 14, 2013 note. Pet'r's Ex. 8 at 289. However, as Petitioner's rheumatologist, Dr. Lumapas, determined, any reactive arthritis process that may have followed the vaccination had been resolved in less than four months' time — by January 17, 2013. Pet'r's Ex. 10 at 307.
The Special Master properly rejected Petitioner's argument that Dr. MacCallum, Petitioner's treating physician, and Dr. DeMio, Petitioner's expert, had diagnosed her with a defined and recognized injury. To the extent that Dr. MacCallum's February 2, 2016 opinion letter could be characterized as diagnosing Petitioner with Guillain-Barré Syndrome, the Special Master reasonably relied on Dr. MacCallum's testimony clarifying that he had made no such diagnosis. Tr. 35-36 ("I don't believe she had Guillain-Barré syndrome."); Tr. 39 ("I do not believe this was Guillain-Barré. Guillain-Barré is just a good example of a neurological disorder as an adverse reaction to a vaccination.").
So too, the Special Master reasonably rejected the diagnoses that Dr. MacCallum made in his June 24, 2016 letter — that Petitioner had polyarthropathy, muscular spasticity, and polyneuropathy related to her flu vaccine. The sole basis for these diagnoses was the temporal relationship between the vaccination and Petitioner's symptoms.
In a similar vein, the Special Master appropriately gave no weight to Dr. DeMio's three-page report diagnosing Petitioner with vaccine-related "autoimmunity with a minimally improved Guillain-Barré (sic) Syndrome, with severe persisting sequelae," and his two-page addendum, diagnosing Petitioner with "autoimmunity, inflammation, polyneuropathy, and arthritis." Pet'r's Ex. 29 at 2; Pet'r's Ex. 36 at 1. The Special Master properly determined that Dr. DeMio lacked the requisite medical expertise to render an opinion on Petitioner's injury, due to his lack of specialized training in the fields of autoimmune or neurological disorders. Dec. *25 (citing
In addition, the Special Master properly rejected Dr. DeMio's diagnosis and opinion based on the lack of evidentiary support in the record. While Dr. DeMio opined in his February 10, 2016 expert report that his diagnosis of vaccine-related GBS and autoimmunity was supported by "[Petitioner's] symptoms and their course of onset, plateauing, and some improvement, along with the results of her medical tests and treatment," his report, as the Special Master found, contained "no references to any objective testing, contemporaneous medical records, medical opinion of treating physicians, or medical literature to support this conclusion." Dec *22. Moreover, Dr. DeMio's supplemental report ignored both Dr. Lumapas' rheumatological assessment that Petitioner's symptoms had been resolved and Petitioner's January 2016 EMGs that revealed only a mild carpal tunnel syndrome. Because Dr. DeMio failed to offer an evidence-based assessment underlying his opinion, the Special Master did not abuse her discretion in affording his opinion no weight.
The Vaccine Act requires a petitioner to show by preponderant evidence that she "suffered from the residual effects or complications of such illness, disability, injury, or condition for more than 6 months after the administration of the vaccine." 42 U.S.C. § 300aa-11(c)(1)(D)(i). In
The Special Master properly found that that Petitioner no longer "suffered any ongoing sequela after February 2013 when [Petitioner] was released back to work full time." Dec. *23. Following her vaccination, Petitioner complained of pain in her joints and extremities during several doctors' visits, with the last complaint on January 14, 2013. However, on January 17, 2013, Petitioner reported to rheumatologist Dr. Lumapas that she was feeling much better and had no joint pain, and Dr. Lumapas determined that Petitioner's joint and muscle "symptoms . . . have now resolved." Pet'r's Ex. 10 at 299. Two weeks later, on February 4, 2013, Dr. Corn cleared Petitioner to return to work full time.
The Special Master reasonably found that February 2013, marked the last time Petitioner suffered from the residual effects of her alleged vaccine-related joint and extremity pain. From February 2013 until December 8, 2015, Petitioner had several visits with physicians complaining of a variety of other ailments, but she never complained of any joint or extremity pain, and in some cases affirmatively denied the existence of such pain.
After February 2013, Petitioner did not mention joint or extremity pain related to her vaccine until December 8, 2015, during a visit with Dr. Saltis. However, the record supports the Special Master's finding that the pain Petitioner reported to Dr. Saltis was not a residual effect of Petitioner's alleged vaccine-related injury. The Special Master reasonably relied on Petitioner's silence over the preceding three years, and in particular, Petitioner's failure to mention these symptoms the day before, in a December 7, 2015 visit with an orthopedist related to the hip injury that Petitioner sustained in the August 2015 fall. Dec. *23 (citing Pet'r's Ex. 34 at 4, 11). Finally, the record supports the Special Master's finding that Dr. Saltis himself made no association between Petitioner's complaints of pain and her flu vaccination.
The Court