K.A. v. Sec'y of Health & Human Servs.

Decision Date17 October 2022
Docket Number16-989V
PartiesK.A., Petitioner, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent.
CourtCourt of Federal Claims

Not To be Published

Redacted Version Issued for Publication: February 10, 2023 [1]

Robert J. Krakow, Law Office of Robert J. Krakow, P.C., New York NY, for petitioner.

Nina Ren, Trial Attorney, Torts Branch, Civil Division, United States Department of Justice, Washington, DC, for respondent. With her were Heather L. Pearlman, Assistant Director, Torts Branch, C. Salvatore D'Alessio, Acting Director, Torts Branch, Brian M. Boynton, Principal Deputy Assistant Attorney General, Civil Division.

REDACTED OPINION

MARIAN BLANK HORN JUDGE.

On August 11, 2016, petitioner K.A. filed a petition for compensation with the National Vaccine Injury Compensation Program (Vaccine Program), under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1-300aa-34 (2018) (Vaccine Act), for an off-Table injury. See 42 U.S.C. § 300aa-11(c)(1)(C)(ii) (2018). Petitioner claimed that an August 12, 2013 Tetanus Diphtheria acellular-Pertussis (Tdap) vaccination caused him to experience Guillain-Barre syndrome. On April 18, 2022, Chief Special Master Brian H. Corcoran denied petitioner's claim for an award of compensation, finding that petitioner had not shown, by a preponderance of the evidence, that he was entitled to compensation. Subsequently, petitioner filed a Motion for Review of the Chief Special Master's decision denying his claim pursuant to Rule 23 and Rule 24 of the Vaccine Rules of the United States Court of Federal Claims (2021) (Vaccine Rules) in the United States Court of Federal Claims.

FINDINGS OF FACT

On August 12, 2013, petitioner, a medical researcher, received the Tdap vaccine, when he was fifty-one years old. Prior to receiving the vaccine, petitioner had a medical history of high cholesterol, hypertension, and a chronic leg condition. Following his vaccination, on September 1, 2013, petitioner was admitted to the North Shore

University Hospital Emergency Department in Manhasset, New York and petitioner reported that he had experienced three days of flu-like symptoms, including dry cough, chills, and swelling of his throat. The medical professionals treating petitioner noted that he appeared neurologically sound and was not in distress, although they observed petitioner displaying many common symptoms of an upper respiratory infection or influenza like illness (URI/ILI), including fever, chills weakness, nasal discharge, congestion, dyspnea, and cough. Petitioner was discharged the following day on September 2, 2013, and petitioner maintains that he continued to experience a fever through September 3, 2013.

On September 4, 2013, petitioner was discovered in his driveway complaining of numbness on his left side, and was transported via ambulance to the emergency department at St. Francis Hospital in Roslyn, New York. Emergency responders noted that petitioner walked with an "unsteady gait" and that he had been treated for flu-like symptoms recently. The same day, September 4, 2013, petitioner was admitted to St. Francis Hospital for further evaluation. Medical records from petitioner's September 4, 2013 visit to St. Francis Hospital indicate that petitioner stated

[t]he current episode started in the past 7 days. The problem occurs intermittently. The problem has been unchanged. Associated symptoms include weakness. Pertinent negatives include no numbness. Nothing aggravates the symptoms. He has tried nothing for the symptoms. [P]atient presents to the emergency department for evaluation of weakness of the left arm leg and face. Patient states symptoms are [sic] originally began approximately 5 days ago when he was attempting to climb a hill and noticed weakness in the left leg. Patient then states that he developed incoordination of the left face when attempting to brush his teeth this morning. Patient denies loss of sensation however states he has a tingling sensation diffusely over the left side of his body. There are no specific modifying factors. Severity of symptoms mild to moderate.

(alterations added). With regard to his neurological symptoms, petitioner's admitting physician Dr. Subash Viswanathan reported that petitioner was "unable to forcefully closed [sic] left eye. Left face shows mild weakness. Otherwise cranial nerves 2-12 intact. There is subjective weakness of the left arm and left leg. However patient is able to move both extremities with good strength. There is no sensory deficit." (alteration added). Dr. Viswanathan also noted

Pt [patient] had the "flu" 2 weeks ago, not receiving abx [antibiotics]. Denies recent travel or diarrhea. Was an URI. The past week first noted left leg weakness while climbing. Had presented to NSUH [North Shore University Hospital], where he works doing bench research on HIV [Human Immunodeficiency Virus] nephropathy, where he was admitted. CT [Computed tomography] chest was negative. After discharge he has been noting a weakness and numbness of the left face/arm/leg. He denies any vision change but there is some burning sensation in the left eye. He noted toothpaste dripping from the left mouth while brushing his teeth. He also complains of bloating and unable to make a BM. His BP [blood pressure] has been high.

(alterations added). CT scans of petitioner's brain and chest did not yield any significant abnormalities. Lab results indicated, however, that petitioner had the antibodies for the West Nile Virus, which indicated that he had contracted West Nile Virus at some point in the past.

On September 4, 2013, Dr. Michael Han, another treating physician, indicated "[m]uch of his [petitioner's] symptoms and findings are non-specific, though bifacial weakness is most prominent and perhaps most helpful in narrowing down differential. A major consideration would be AIDP [Acute Inflammatory Demyelinating Polyneuropathy]/GBS (Guillan [sic] Barre Syndrome) with all the above features, including potential autonomic dysfunction." (alterations added). Dr. Han also indicated that petitioner had suffered a "recent URI [upper respiratory infection] 2 weeks ago." (alteration added). During his stay at St. Francis Hospital, petitioner complained primarily of weakness. Petitioner also reported to Dr. Han that he had experienced flu like symptoms two weeks prior, and that he developed left leg weakness and difficulty climbing over a small hill near his home shortly thereafter.

On September 5, 2013, Dr. Teresa Deangelis, a neurologist, examined petitioner and reported that "[a] major consideration would be AIDP/GBS (Guillain Barre Syndrome)." Dr. Deangelis likewise noted that petitioner had experienced "recent URI 2 weeks ago." Dr. Deangelis' treatment notes indicate that she started petitioner on a five-day course of intravenous immunoglobulin therapy on September 5, 2013, which is a blood product used to treat patients with antibody deficiencies, including neurological disorders such as Guillain-Barre syndrome. On September 6, 2013, petitioner went through a rheumatology consult with Dr. William Given, who indicated that petitioner "states that he was well until about 2 weeks ago when he developed NP [nonproductive] cough, pharyngitis, malaise, and elevated temperature." (alteration added). Dr. Given reported that it appeared that petitioner "developed weakness and paresthesias[2] following what appears to be a viral illness a couple of weeks ago." (alteration added). On the same day, September 6, 2013, petitioner had an infectious disease consult with Dr. Dava Klirsfield. Dr. Klirsfield's assessment indicated: "Patient with bell's palsy, left sided weakness and hyporeflexic, recent tetanus shot and flu-like illness, imaging shows a dermoid in occipital bone on right, suspect a demyelinating disorder[3] possibly post viral or post vaccine." (alteration added). Dr. Klirsfield's assessment also indicated that petitioner's positive West Nile Virus antibodies test had "unclear significance," and ordered additional laboratory testing. On September 10, 2013, following two consistent lumbar punctures, Dr. Doina Glodan diagnosed petitioner with "Guillain-Barre syndrome post recent viral URI." Petitioner remained at St. Francis Hospital until September 17, 2013, at which time he was discharged to Glen Cove Hospital, a rehabilitation facility in Glen Cove, New York. Petitioner's medical records from his date of discharge indicate that petitioner stated that he "[f]eels like he is getting better. No new complaints." While at Glen Cove Hospital, petitioner received physical therapy, occupational therapy, and commenced a speech therapy program.

On September 22, 2013, petitioner's medical records indicate that "he developed acute right facial weakness with right hemiparesis, and CAT scan of the head revealed no new acute pathology, and the patient after contacting primary neurology was transferred to North Shore University Hospital for further investigation and treatment." Treatment notes from North Shore University Hospital state that petitioner displayed increased lethargy, weakness, and right sided numbness and tingling that started two to three days prior, with trace reflexes and worsened right-side issues. Petitioner's admittance documents from North Shore University Hospital indicate that he was experiencing "new onset of R [right] side numbness/tingling weakness in the setting of recently diagnosed of [sic] AIDP." (alterations added).

On September 24, 2013, petitioner began plasmapheresis treatment.[4] Petitioner's treatment notes state that, as a result of the plasmapheresis treatment, petitioner exhibited "significant improvement" in strength and respiration. According to petitioner's medical records, thereafter, on September 26,...

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