Greene v. Sec'y of Health & Human Servs.

ROY GREENE, Petitioner, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent.

No. 11-631V

United States Court of Federal Claims

Reissued for Publication: February 12, 2020¹

January 28, 2020

Vaccine Act; Motion for Review; Tetanus-Diphtheria Vaccine; Brachial Neuritis; Causation; Althen Prongs Two and Three; Burden of Proof

Richard Gage and Kristen L. Blume, Cheyenne, WY, for petitioner.

Robert P. Coleman, III and Brittany A. Ditto, United States Department of Justice, Washington, DC, for respondent.

OPINION AND ORDER

SWEENEY, Chief Judge

Petitioner Roy Greene seeks compensation under the National Childhood Vaccine Injury Act of 1986 ("Vaccine Act"), 42 U.S.C. §§ 300aa-1 to -34 (2018), for an alleged vaccine-caused injury. Before the court is petitioner's motion for review of the special master's decision denying compensation.² As discussed below, the court denies petitioner's motion.

I. BACKGROUND

Petitioner filed a petition for compensation under the Vaccine Act on September 29, 2011, alleging that he developed brachial neuritis as a result of a July 22, 2009 tetanus-diphtheria ("Td") vaccination.³ He asserted two theories of recovery: first, that he was entitled to compensation pursuant to the Vaccine Injury Table, which provides that brachial neuritis that develops between two and twenty-eight days after receiving a vaccine containing tetanus toxoid is a compensable injury; and second, that he was entitled to compensation because the Td vaccine actually caused his brachial neuritis.

The special master held a fact hearing in March 2015 to determine the onset date of petitioner's symptoms. In a July 31, 2015 decision, the special master remarked that petitioner's symptoms satisfied the then-operative definition of brachial neuritis in the Vaccine Injury Table's "qualifications and aids to interpretation." Under that definition, brachial neuritis is

dysfunction limited to the upper extremity nerve plexus (i.e., its trunks, divisions, or cords) without involvement of other peripheral (e.g., nerve roots or a single peripheral nerve) or central (e.g., spinal cord) nervous system structures. A deep, steady, often severe aching pain in the shoulder and upper arm usually heralds onset of the condition. The pain is followed in days or weeks by weakness and atrophy in upper extremity muscle groups. Sensory loss may accompany the motor deficits, but is generally a less notable clinical feature. The neuritis, or plexopathy, may be present on the same side as or the opposite side of the injection; it is sometimes bilateral, affecting both upper extremities.

42 C.F.R. § 100.3(b)(7)(i) (2014). The special master then found that petitioner's symptoms began no earlier than September 1, 2009—forty-one days after the Td vaccination. Because petitioner's symptoms arose after the time period prescribed in the Vaccine Injury Table, the special master dismissed petitioner's Table claim.

Over the next two years, in an effort to resolve petitioner's remaining claim of actual causation, petitioner filed two expert reports from Thomas W. Wright, M.D., an orthopedist, and the parties engaged in settlement discussions. In September 2016, the special master learned that the settlement discussions had not been successful because respondent rejected as inadequate petitioner's showing that forty-one days was a medically acceptable time frame for the Td vaccine to cause brachial neuritis. Thus, the special master directed petitioner to file a supplemental expert report. In early 2017, petitioner filed an expert report from Marcel Kinsbourne, M.D., a neurologist.

In March 2017, respondent filed a motion for a ruling on the record, to which petitioner responded the following month. In a May 26, 2017 decision, the special master found that the record did not support petitioner's claim that the Td vaccine caused his brachial neuritis because petitioner could not establish, more probably than not, that a forty-one-day period between the vaccination and the first symptoms of the injury was medically acceptable.

On June 16, 2017, petitioner filed a motion for reconsideration pursuant to Vaccine Rule 10(e), as well as a supplemental expert report from Dr. Kinsbourne and supporting documentation (including eighteen medical and scientific articles and a letter/report from Vera S. Byers, M.D., Ph.D., an immunologist). In his motion, petitioner argued that he had provided sufficient evidence to establish that a forty-one-day onset period was medically acceptable, but that if the special master continued to deem the existing evidence insufficient, Dr. Kinsbourne's supplemental expert report and supporting documentation would establish the medical acceptability of the onset period.

The special master granted petitioner's motion for reconsideration and then, in a September 26, 2017 "Decision on Reconsideration Denying Entitlement," concluded that "[t]he record [did] not support Petitioner's allegation that his Td vaccine more likely than not caused his brachial neuritis 41 days following the vaccination." Greene v. Sec'y of HHS, No. 11-631V, 2017 WL 5382856, at *7 (Fed. Cl. Spec. Mstr. Sept. 26, 2017). He therefore dismissed petitioner's actual causation claim.

Petitioner filed a motion for review of the special master's decision denying entitlement. Because the special master applied the incorrect legal standard when evaluating the evidence offered by petitioner, the court, in a February 27, 2018 Opinion and Order, granted petitioner's motion, vacated the special master's decision, and remanded the case to the special master to issue a new entitlement decision. On May 17, 2018, the special master issued a remand decision in which he denied respondent's motion for a ruling on the record, determined that respondent should be provided the opportunity to submit an expert report, and indicated that an entitlement hearing would likely be necessary.

Respondent filed an expert report from Eric Lancaster, M.D., Ph.D., a neurologist, on June 14, 2018. On November 13, 2018, petitioner filed an expert report from Lawrence Steinman, M.D., a neurologist and immunologist, and a response to Dr. Lancaster's expert report from Dr. Kinsbourne. On April 9, 2019, respondent filed Dr. Lancaster's response to Dr. Steinman's and Dr. Kinsbourne's submissions. Then, on April 29, 2019, petitioner filed a supplemental expert report from Dr. Kinsbourne. Shortly thereafter, on May 9, 2019, the special master held an entitlement hearing during which he heard testimony from Dr. Kinsbourne, Dr. Steinman, Dr. Lancaster, and petitioner.

The special master issued his entitlement decision on August 2, 2019. After summarizing the case's factual and procedural history, he provided an extensive description of the credentials, reports, and testimony of Dr. Kinsbourne, Dr. Steinman, and Dr. Lancaster, along with the medical and scientific literature relied upon by the experts. He also set forth the legal standards for his review of the experts' opinions, for his review of the medical and scientific literature, andfor petitioner to establish causation. Then, the special master analyzed petitioner's case under the test for causation set forth in Althen v. Secretary of HHS, 418 F.3d 1274 (Fed. Cir. 2005).

In Althen, the United States Court of Appeals for the Federal Circuit ("Federal Circuit") articulated a three-part test, based on prior precedent, explaining what a petitioner must show to prove causation under the Vaccine Act:

[Petitioner]'s burden is to show by preponderant evidence that the vaccination brought about [the] injury by providing: (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.

Id. at 1278. The special master noted that he had previously concluded that petitioner had established the first prong of the test, and therefore focused his analysis on the second and third prongs.

With respect to the third prong, the special master concluded that petitioner did not establish, by a preponderance of the evidence, that forty-one days was a medically acceptable length of time between petitioner's Td vaccination and the onset of petitioner's brachial neuritis. Specifically, he concluded that petitioner's direct proof was insufficient and that petitioner's arguments based on circumstantial evidence—evidence concerning risk intervals and evidence pertaining to the similarities between brachial neuritis and Guillain-Barré syndrome ("GBS")—were unpersuasive.⁴ He further noted that respondent successfully rebutted the evidence and arguments presented by petitioner, finding that respondent's evidence was persuasive and that the opinions of petitioner's experts were not as persuasive as Dr. Lancaster's opinions. Thelatter conclusion was based, in part, on petitioner's experts' purported lack of experience in treating patients with brachial neuritis.

With respect to the second prong (which the special master was not required to address having concluded that petitioner had not satisfied the mandatory third prong), the special master determined that petitioner had not satisfied his burden of establishing that the Td vaccine did cause his brachial neuritis. This conclusion was based, in part, on his assessment that the record lacked any evidence that petitioner was experiencing an autoimmune reaction to the vaccine.

In accordance with his analysis, the special master concluded that petitioner failed to establish that the Td vaccine caused his brachial neuritis and therefore dismissed petitioner's actual causation claim. Petitioner timely filed a motion for review on September 3, 2019, and respondent filed a response on October 3, 2019. The court heard argument on January 23, 2019, and is now prepared to rule.

II. DISCUSSION

A. Standard of Review

The United States Court of Federal Claims has jurisdiction...