W.C. v. Sec'y of Health & Human Serv., 07-456V

• Decision Date: 22 July 2011
• Docket Number: No. 07-456V,07-456V
• Parties: W. C., Petitioner, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent.
• Court: U.S. Claims Court

W. C., Petitioner,

v.SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent.

No. 07-456V

United States Court of Federal Claims

Filed: July 22, 2011

Vaccine case; off-table claim involving multiple sclerosis allegedly caused by flu vaccine; alternative significant-aggravation off-table claim; entitlement issues; statutory criteria for redaction of identity or medical files and information; unwarranted invasion of privacy

Sylvia Chin-Caplan and Meredith Daniels, Conway, Homer, & Chin-Caplan, P.C., Boston, Massachusetts., for petitioner. With them on the brief was Ronald C. Homer, Conway, Homer, & Chin-Caplan, P.C., Boston, Massachusetts.

Debra A. Filteau Begley, Trial Attorney, Torts Branch, Civil Division, United States Department of Justice, Washington, D.C., for respondent. With her on the brief was Tony West, Assistant Attorney General, Mark W. Rogers, Acting Director, Torts Branch, Vincent J. Matanoski, Acting Deputy Director, Torts Branch, and Gabrielle M. Fielding, Assistant Director, Torts Branch, Civil Division, United States Department of Justice, Washington, D.C.

OPINION AND ORDER¹

LETTOW, Judge.

Petitioner, W. C., seeks review of two decisions by a special master — one denying him compensation under the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, § 311, 100 Stat. 3743, 3755 (1986) (codified, as amended, at 42 U.S.C. §§ 300aa-1 to -34 ("Vaccine Act")), and another denying his motion to redact portions of the decision denying him compensation.

Mr. C. alleges that his receipt of a flu vaccine in December 2004 caused the onset of his multiple sclerosis or, alternatively, significantly aggravated his existing, but at the time asymptomatic, multiple sclerosis. See W. C. v. Secretary of Health & Human Servs., No. 07-456(Fed. Cl. Spec. Mstr. Feb. 22, 2011), ECF No. 68 ("Entitlement Decision") at 2.² The special master found that Mr. C. had developed multiple sclerosis before receiving the flu vaccine, but then also determined the record "d[id] not support a finding that Mr. C[.] ha[d] established . . . a medical theory causally connecting the flu vaccine to an aggravation of multiple sclerosis." Entitlement Decision at 24.

Subsequently, Mr. C. filed a motion requesting redaction of his name from the Entitlement Decision, pursuant to 42 U.S.C. § 300aa-12(d)(4)(B) and Vaccine Rule 18(b). Alternatively, Mr. C. moved that the decision be redacted to conceal the details of his medical condition. Both of petitioner's motions for redaction were denied. See W. C. v. Secretary of Health & Human Servs., No. 07-456 (Fed. Cl. Spec. Mstr. Mar. 16, 2011), ECF No. 73 ("Redaction Decision") at 4.

In this court, petitioner seeks reversal of both of the special master's decisions, while respondent supports both decisions.

FACTS

A. Mr. C.'s Medical History

Mr. C. received the flu vaccination on December 13, 2004, when he was thirty-four years old. See Entitlement Decision at 2. Before December 13, Mr. C. was not displaying any clinical symptoms of neurological problems and described himself as healthy. Id.

On December 24, 2004, Mr. C.'s left arm and hand became numb. Entitlement Decision at 2. He also noticed numbness on the left side of his head and face. Id. The special master noted in the Entitlement Decision that both the petitioner's and the government's experts agreed that "Mr. C[.]'s report of numbness [was] the first expression of his neurological problem." Id. at 2-3.

Five days later, on December 29, Mr. C. saw his family doctor, Deborah Darrington, who recommended that Mr. C. undergo an MRI. Entitlement Decision at 3.³ The MRI wasperformed on December 30, 2004, with and without a contrast agent. Id. A contrast agent, for example, gadolinium, can be used to determine if there is an existing breach in the blood-brain barrier. Id. at 9. Gadolinium is injected into a person's blood. If there is an existing breach, the gadolinium enters the brain, and lesions⁴ in the brain appear "enhanced" on the MRI. Id. When there has been damage to the blood-brain barrier, but the body has repaired the damage at least to the extent that the breach no longer exists as an active matter, lesions will no longer appear enhanced. Id.

Dr. Jason Arthur, the interpreting physician, reported,

Scattered nonspecific T2 high signal lesions are noted in the deep white matter. Findings on MRI in conjunction with the patient's clinical history suggest multiple sclerosis as a possible etiology. There is focal high T2 signal intensity lesion within the anterior aspect of the corpus callosum on the right and within the posterior body of the corpus callosum within the midline. There are no focal contrast enhancing lesions.

Ex. 1 at 27 (Report of Dr. Arthur (Dec. 30, 2004)) (quoted in Entitlement Decision at 3).⁵ Dr. Arthur's observation that there were "no focal enhancing contrast lesions" indicates that any blood-brain barrier disruption had healed prior to the MRI conducted on December 30th.

Mr. C.'s symptoms abated but then reappeared during a deer hunting expedition on January 8, 2005. Entitlement Decision at 3. That night, he lost most motor functions in his left hand and arm. Id. Two days later, Mr. C. saw a neurologist, John Hannam. Dr. Hannam commented, "[T]he MRI findings . . . conceivably could be explained by multiple sclerosis and it is possible that the recent onset of his left sided tingling and numbness represents the first clinical attack." Id. (quoting Ex. 1 at 34 (Notes of Dr. Hannam (Jan. 12, 2005))). Dr. Hannam also requested an analysis of Mr. C.'s spinal fluid. The analysis showed the absence of oligoclonal bands in the fluid. Dr. Hannam commented at the time, "[I]t remains unclear whether [Mr. C.] does or [does] not have [multiple sclerosis]." Entitlement Decision at 3 (quoting Ex. 1 at 50 (Notes of Dr. Hannam (Jan. 19, 2005))).

Five days later, Mr. C. called Dr. Hannam because someone had told him about Guillain-Barre syndrome, which may be caused by flu vaccines. Entitlement Decision at 3.⁶ Mr. C. informed Dr. Hannam that he had received a flu shot eleven days before his symptoms appeared. Id. Dr. Hannam responded that his clinical findings did not support a diagnosis of Guillain-Barre syndrome. Id. During the phone call, Mr. C. also reported that his symptoms were improving. Id.

Mr. C. returned to Dr. Hannam for an office visit on February 22, 2005. He reported some tingling in the tips of the finger of his left hand and "remain[ed] suspicious that there [was] a causal connection between his symptoms and receiving the flu shot." Entitlement Decision at 4 (quoting Ex. 1 at 50 (Notes of Dr. Hannam (Feb. 22, 2005))). Dr. Hannam told Mr. C. that the evidence indicated he did not have Guillain-Barre, but showed that he might have developed multiple sclerosis. Id. Dr. Hannam wrote in his notes that "if [Mr. C.] had [multiple sclerosis], [he] c[ould]n't blame it on the flu shot." Id. (quoting Ex. 1 at 50). Dr. Hannam recommended that Mr. C. consult with another doctor, Rifaat Bashir, who specialized in multiple sclerosis, and his family doctor, Dr. Darrington, concurred with Dr. Hannam's suggestion.

Mr. C. met with Dr. Bashir on March 22, 2005. At that time, he told Dr. Bashir that his "main symptoms are sensory and come on with exercise." Entitlement Decision at 4. Dr. Bashir conducted a neurological examination and concluded,

I believe that Mr. C[.] had [a] clinically isolated syndrome in December [2004] that gave him the sensory changes in his left upper extremity and neck. His head MRI scan is . . . consistent with a demyelinating disease. He could have had a single isolated event possibly related to his vaccination which he did receive about two weeks before the event. At this point in time, I am not absolutely sure whether he is going to progress to multiple sclerosis or not. If he develops another event in another area[,] th[e]n he certainly has the condition. Another way to arrive at the diagnosis would be to repeat his MRI scan of the head and cervical spine and see if he has any new lesions. If he does, one can make a diagnosis of . . . multiple sclerosis.

Ex. 1 at 46 (Letter from Dr. Bashir to Dr. Darrington (Mar. 22, 2005)).

Mr. C. had another MRI on March 23, 2005, which showed "[t]hree small foci of signal abnormality . . . show[ing] no mass-effect or pathologic-enhancement." Ex. 7 at 31. On April 6,2005, Mr. C. returned to Dr. Bashir, who reported that the MRI "showed findings consistent with [acute disseminating encephalomyelitis ('ADEM')]."⁷ Entitlement Decision at 4 (citing Ex. 7 at 9-10; Neil M. Davis, Medical Abbreviations 39 (12th ed. 2005)). Dr. Bashir ordered nerve conduction studies, which were normal, and an electromyography ("EMG"),⁸ which showed no evidence of denervation. Entitlement Decision at 4.⁹ At Mr. C.'s next appointment with Dr. Darrington, Mr. C. told her that "Dr. Bashir [felt] that [Mr. C.'s] symptoms could represent an acute [demyelinating] polyneuropathy . . . [or] could . . . represent early multiple sclerosis." Id. at 4-5 n. 1 (quoting Ex. 1 at 5 (Notes of Dr. Darrington (May 11, 2005))).¹⁰

Mr. C. had another MRI on June 28, 2005, which showed the same three lesions described in the March 23, 2005 MRI. Entitlement Decision at 5. The examining doctor also reported seeing a "new very ill-defined 7.9 mm focus of signal abnormality," which was the only lesion showing enhancement. Id. (quoting Ex. 7 at 25 (Report of Dr. Bashir for Exam Date June 28, 2005)). The doctor concluded Mr. C.'s condition "likely . . . represent[ed] [a]cute [d]isseminating [e]ncephalomyelitis since there ha[d] been interval worsening and not improvement" in the intervening months, but that a "white matter demyelineating process such as multiple sclerosis w[ould] have to be considered in the differential diagnosis." Ex. 7 at 26; see also Entitlement Decision at 5.

On June 28, 2005, Dr. Bashir sent a letter to Dr. Darrington, stating, "In view of the new area of enhancement[,] I think a diagnosis of...