Smith v. Secretary of Health and Human Services

United States Court of Federal Claims·Decided November 29, 2018·No. 15-1194·Published

Opinion

In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS

************************* WILLIAM SMITH, * * No. 15-1194V Petitioner, * Special Master Christian J. Moran * v. * * Filed: October 31, 2018 SECRETARY OF HEALTH * AND HUMAN SERVICES, * Diagnosis; statement of treating doctors. * Respondent. * *************************

PUBLISHED RULING ON PETITIONER’S MOTION FOR FINDING OF FACT REGARDING DIAGNOSIS1

On January 26, 2018, petitioner moved for a finding of fact that “petitioner was diagnosed with a Guillain-Barre syndrome (GBS) variant” following the administration of a flu vaccination on March 14, 2014. Pet’r’s Mot. at 5. The respondent opposes petitioner’s motion, noting that petitioner’s claim that he was diagnosed with GBS is not consistent with the medical records filed in this case. Resp’t’s Resp., filed March 16, 2018, at 9. Based on a review of the medical records, expert reports, and the statements from the petitioner’s treating physicians, the undersigned finds that preponderant evidence does not exist to support petitioner’s claim that he was diagnosed with GBS in the spring of 2014.

I. Factual Summary

Prior the vaccination in question, Mr. Smith had a complex medical history that included type 2 diabetes. Mr. Smith was not compliant with the treatments prescribed for his diabetes and

1 Because this ruling contains a reasoned explanation for the action in this case, the undersigned is required to post it on the United States Court of Federal Claims' website in accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic Government Services). This means the ruling will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), petitioners have 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, the undersigned agrees that the identified material fits within this definition, the undersigned will redact such material before posting the ruling. his disease was considered “uncontrolled.” Exhibit 4 at 12. He suffered from various symptoms that were secondary to his diabetes, including ulcers and osteomyelitis in his toe, diabetic neuropathy, and diabetic retinopathy. Exhibit 1 at 4, 6; exhibit 2 at 4; exhibit 3 at 3.

Two days before the vaccination in question, on March 12, 2014, Mr. Smith experienced shortness of breath, signs of heart failure, swollen ankles, anemia, hypokalemia, and acute renal failure. Exhibit 4 at 29-30. He was admitted to the hospital for these issues on March 13, 2014. Id. at 31. On March 14, 2014, he was administered the flu vaccine into his right arm during the course of his hospitalization. Exhibit 7 at 209.

On March 25, 2014, after being discharged from the previous hospitalization, Mr. Smith was admitted to the Medina Hospital for sudden weakness in his legs that began that morning. Exhibit 5 at 175-76. On admission, although it was noted that the etiology of the leg weakness was uncertain, the physician remarked that Mr. Smith had recently been administered the flu vaccine, which is “[one] of the risk factors for something such as GBS.” Id. at 176. During the course of Mr. Smith’s admission to the Medina Hospital, his treating neurologist, Dr. Eric Baron, noted that the possibility of GBS was part of Mr. Smith’s differential diagnosis and several tests were run at Medina Hospital to try to determine whether GBS was the cause of Mr. Smith’s symptoms. See exhibit 5 at 178. Based on the results from these tests, notably a test on Mr. Smith’s cerebrospinal fluid (CSF), as well as Mr. Smith’s “mixed clinical picture,” Dr. Baron decided to not move forward with treatment for GBS due to his “lower suspicion for GBS” following examination and testing. Id. at 201.

On March 27, 2014, Mr. Smith was transferred from Medina Hospital to the main campus of the Cleveland Clinic Hospital System because Medina did not have the necessary diagnostic tools or care for Mr. Smith. Id. At the main campus, he was seen by Dr. Tina Waters, Dr. Donika Patel, and Dr. Jessica Rundo, among others. On his initial evaluation by Dr. Waters, she noted that the tests had been inconclusive in determining if Mr. Smith’s pathology was central or peripheral in nature. Exhibit 9 at 19-20. She recommended additional testing, including nerve conduction studies. Id.

On March 30, 2014, while still admitted to the hospital, Mr. Smith woke up with worsened weakness in his right leg and new weakness in his right arm. Exhibit 9 at 52. An MRI revealed that Mr. Smith had suffered a stroke, which caused the additional weakness. Id. However, the cause of Mr. Smith’s initial symptoms remained unidentified. Id. at 58.

Additional medical testing was performed during the course of Mr. Smith’s stay at the Cleveland Clinic main campus. These tests appeared to rule out GBS as the cause of Mr. Smith’s symptoms. For instance, during a neuromuscular consultation with Dr. Patel on April 2, 2014, Dr. Patel noted that there was not strong evidence of an acute peripheral nerve injury causing his symptoms. Exhibit 9 at 35. Instead, Dr. Patel concluded that Mr. Smith had “severe generalized polyneuropathy” that she associated with Mr. Smith’s diabetes. Id. She concluded that GBS was a “less likely” diagnosis. Id.

2 Dr. Rundo also concluded, based on a second examination of Mr. Smith’s CSF as well as the nerve conduction studies and a physical exam, that Mr. Smith was not suffering from an acute peripheral nerve disease. Id. at 72.

Mr. Smith was discharged from the hospital on April 4, 2014, with a diagnosis of lower extremity weakness and acute stroke. Exhibit 9 at 7. The discharge papers state that the treating physicians did not have a definitive conclusion about the etiology of Mr. Smith’s condition, but the record does state that “neuromuscular specialists were consulted, and they attribute the symptoms to possibly diabetic neuropathy.” Id. at 9. Following his discharge, Mr. Smith was transferred to an inpatient rehabilitation facility at Lodi Community Hospital (LCH).

On intake at LCH, the records show that Mr. Smith’s chief complaint was that he had suffered from GBS and a stroke. Exhibit 8 at 32. The records even state that Mr. Smith was “diagnosed with Guillain-Barre syndrome” and should no longer be administered the flu vaccine. Id. at 32, 44. However, the source of this information and other references to GBS from the LCH records is not obvious. It is also notable that subsequent medical records from Dr. Cullen, Mr. Smith’s primary care physician, incorporated GBS into Mr. Smith’s past medical history. See, e.g., exhibit 11 at 6, 7.

II. Expert Reports

Dr. Thomas Morgan, the petitioner’s expert, opined that based on his examination of the medical records, Mr. Smith suffered from post-vaccination immune-related acute motor-sensory axonal polyneuropathy (AMSAN). Exhibit 16 at 3. Dr. Morgan stated that this is a variant of GBS. Id. Dr. Morgan came to this conclusion on the basis that Mr. Smith had an abrupt onset of paralysis in his lower extremities. Id. at 4. In support of his conclusion, Dr. Morgan stated that Mr. Smith’s diabetic neuropathy had not presented in that manner previously and thus it was not likely that the symptoms experienced following the flu shot were consistent with being secondary to the diabetes. Id. He further stated that the EMG findings were consistent with AMSAN / GBS. Id.

In a rebuttal report, the government’s expert, Dr. Daniel Feinberg, stated that it was “clear from the medical records, that Mr.

Free access — add to your briefcase to read the full text and ask questions with AI

Smith v. Secretary of Health and Human Services, (uscfc 2018).

Smith v. Secretary of Health and Human Services (Smith v. Secretary of Health and Human Services) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

Related

Hibbard v. Secretary of Health & Human Services
698 F.3d 1355 (Federal Circuit, 2012)
Lombardi v. Secretary of Health and Human Services
656 F.3d 1343 (Federal Circuit, 2011)
Dobrydney v. Secretary of Health & Human Services
566 F. App'x 976 (Federal Circuit, 2014)