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

• Decision Date: 18 June 2020
• Docket Number: No. 15-51V,15-51V
• Parties: DOUGLAS TULLIO, Petitioner, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent.
• Court: U.S. Claims Court

DOUGLAS TULLIO, Petitioner, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent.

No. 15-51V

United States Court of Federal Claims

June 18, 2020¹

Vaccine Act; Motion for Review; Preponderance of the Evidence; Expert Opinions; Influenza Vaccine; Rheumatoid Arthritis; Epidemiology; Application of Althen Test.

Jennifer Ann Gore Maglio, Maglio Christopher and Toale, P.A., Sarasota, FL, for petitioner.

Dhairya D. Jani, Trial Attorney, Torts Branch, Civil Division, United States Department of Justice, Washington, D.C., for respondent. With him were Heather L. Pearlman, Assistant Director, Torts Branch, Civil Division, Catherine E. Reeves, Deputy Director, Torts Branch, Civil Division, C. Salvatore D'Alessio, Acting Director, Torts Branch, Civil Division, and Ethan P. Davis, Assistant Attorney General, Civil Division.

OPINION

HORN, J.

On January 20, 2015, petitioner Douglas Tullio 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 (2012) (Vaccine Act), for an off-Table injury. See 42 U.S.C. § 300aa-11(c)(1)(C)(ii) (2012). Petitioner claimed that a September 29, 2012 fluzone high-dose influenza vaccination caused him to develop "rheumatoid arthritis." On December 19, 2019, Special Master Christian J. Moran of the United States Court of Federal Claims denied petitioner's claim for an award of compensation, finding that petitioner had not shown, by a preponderance of the evidence, that he is entitled to compensation under the Vaccine Act. See generally Tullio v. Sec'y of Health & Human Servs., No. 15-51V, 2019 WL 7580149 (Spec. Mstr. Fed. Cl. Dec. 19, 2019). On January 21, 2020, petitioner filed a motion for review in thiscourt of the Special Master's decision denying his claim pursuant to Rule 23 of the Vaccine Rules of the United States Court of Federal Claims (2019) (Vaccine Rules).

FINDINGS OF FACT

The following summary of the relevant facts regarding petitioner's medical history are established in the record before the court, many of which are not in dispute. On September 29, 2012, petitioner received a fluzone high-dose vaccination. According to the record before the court, at the time he received the vaccination, petitioner was working full-time with his wife, with whom he owned a business, and was sixty-nine years old. On October 12, 2012, petitioner saw an internist, Dr. John Samples, for the first time, at which time he complained that his legs "feel weaker." Thirteen days later, on October 25, 2012, petitioner once again visited Dr. Samples for an "[u]rgent overbooked visit," because petitioner complained of "diffuse body pain, worse since the last visit here 12 [sic] days ago." At that visit, petitioner had bloodwork done.

Throughout November and December of 2012, petitioner complained of pain and weakness in his legs to multiple medical providers. A diagnosis of possible Guillain-Barré syndrome (GBS) was considered, which led Dr. Mark Bouffard, a pain specialist, to refer petitioner to a neurologist, Dr. Catherine Brignoni, on November 28, 2012. On December 4, 2012, petitioner visited Dr. Brignoni with the chief complaint of "[p]ossible GBS, diffuse weakness and paresthesia after a flu vaccine." Dr. Brignoni conducted a neurological exam on petitioner, and based on the results, Dr. Brignoni began to treat petitioner for GBS. While Dr. Brignoni was treating petitioner for GBS, she stated "[h]e should not receive the flu vaccine any more [sic]." According to petitioner's medical records, the treatments to improve his pain from GBS "helped his bilateral shoulder pains and leg/thigh pains" initially, but "the weakness has not changed." This led petitioner to seek a second opinion from Dr. Perry Shieh at the University of California, Los Angeles, neurology department on January 18, 2013. Dr. Shieh recommended that petitioner see a rheumatologist.

Petitioner initially saw a rheumatologist, Dr. Sheri Hsu on January 30, 2013. At the first visit with Dr. Hsu, petitioner was not suffering from joint swelling, but was suffering from joint pain. At the January 30, 2013 visit, Dr. Hsu made a note in petitioner's medical records, "I am concerned about a pain syndrome associated with his flu vaccine." In February 2013, petitioner did complain of joint swelling. While treating petitioner, Dr. Hsu provided several different theories to explain petitioner's pain, including all of the following potential and distinct diagnoses: "seronegative RA [rheumatoid arthritis]," "Reactive arthritis," "Arthralgia," "DDD [degenerative disc disease] lumbar spine," and "Atrial fibrillation." (brackets added). By June 6, 2013, Dr. Hsu had diagnosed petitioner with "seronegative RA [rheumatoid arthritis]."² (capitalization in original) (brackets added).According to the most recent medical records dated December 11, 2018 from Dr. Hsu, as well as petitioner's testimony at the March 6 through 8, 2019 hearing, petitioner was still suffering from rheumatoid arthritis.

On January 20, 2015, petitioner filed a petition within the statutory time period for filing a petition for compensation with the Vaccine Program pursuant to the Vaccine Act. In his petition, Mr. Tullio alleged, in relevant part:

6. To the current date, Petitioner continues to suffer from his vaccine-induced injury.

7. Petitioner's injuries are causally related to an adverse reaction to a vaccination or vaccinations listed in 42 U.S.C. § 300aa-14.

8. Petitioner's vaccine related injuries have lasted more than six months. See,e.g., P Ex. 10 at 2-3.

Petitioner also stated in his petition that "his condition continued and subsequent evaluation identified Petitioner's condition as a rheumatological injury, most likely reactive arthritis caused by his influenza vaccination. See, e.g., P Ex. 4 at 11-15; P Ex 17 at 18-19."³

On January 21, 2015, petitioner's case was assigned to Special Master Christian J. Moran. On January 22, 2015, petitioner filed eighteen exhibits, which included 1,257pages of contemporaneous records from physicians' offices and hospitals Mr. Tullio had visited prior to filing his petition. On January 22, 2015, Special Master Moran issued an Order which required petitioner to file a statement of completion once any "outstanding medical records and affidavits" were filed. On April 7, 2015, petitioner filed his statement of completion, after filing an affidavit by petitioner and additional medical records. Throughout the proceedings before Special Master Moran, however, petitioner continued to file updated medical records, with the last filing submitted to the court on March 7, 2019 during the hearing.

On June 17, 2015, respondent filed a Vaccine Rule 4c Report in which respondent stated "[n]either RA [rheumatoid arthritis] nor reactive arthritis are presumptive injuries following flu vaccine. Therefore, petitioner necessarily pursues a cause-in-fact claim." (brackets added). Respondent also contended in the Rule 4c Report, "[o]n the existing record, petitioner has failed to provide preponderant evidence in support of the petition for compensation." Respondent further stated:

Without an expert opinion to support his claim, the sum total of petitioner's case is: that he received a flu vaccine on September 29, 2012; within three weeks developed a rheumatologic condition (either reactive arthritis or RA [rheumatoid arthritis]); and, no other cause for his condition has been identified. However, as the Federal Circuit has cautioned, "neither a mere showing of a proximate temporal relationship between vaccine and injury, nor a simplistic elimination of other potential causes of the injury suffices, without more, to meet the burden of showing actual causation." Moberly[ ex rel. Moberly v. Sec'y of Health & Human Servs.], 592 F.3d [1315,] 1323-24 [(Fed. Cir. 2010)]; citing Althen[ v. Sec'y of Health & Human Servs.], 418 F.3d [1274,] 1278 [(Fed. Cir. 2005)].

(brackets added).

During the proceedings before Special Master Moran, the parties in this case called four experts, two for the petitioner and two for the respondent, who filed, in total, ten expert reports. Petitioner's experts were Dr. Paul J. Utz and Dr. Lawrence Steinman. As of the most recent Curriculum Vitae filed on February 28, 2019, Dr. Utz is Board-certified in rheumatology and completed a residency in immunology and rheumatology. Dr. Utz also is the Director Emeritus of the Medical Scientist Training Program and Associate Director for Education of the Institute for Immunity, Transplantation, and Infection at Stanford University. In addition, Dr. Utz provides care at the Veterans Affairs Palo Alto Health Care Hospital and Clinics. Dr. Utz introduced and relied on the Bingham article and the Hennecke, Birnbaum, and Wooldridge papers. As of the most recent Curriculum Vitae filed on February 28, 2019, Dr. Steinman is a Board-certified neurologist and is a professor of neurology and neurological sciences at Stanford University. Dr. Steinman offered Blast search testimony. Respondent's experts were Dr. Mehrdad Matloubian and Dr. Neal Halsey. As of the most recent Curriculum Vitae filed on February 28, 2019, Dr. Matloubian is a Board-certified rheumatologist who practices rheumatology. Dr. Matloubian has a Ph.D. in virology. Dr. Matloubian is a Clinical Professor at Universityof California San Francisco. Dr. Matloubian introduced and relied on the Westra, Malmström, Svendsen, James, and Snir studies. As of his most recent Curriculum Vitae filed on February 28, 2019, Dr. Halsey is Board-certified in pediatrics and pediatric infectious diseases. Dr. Halsey is the Director Emeritus of the Institute for Vaccine Safety at the Johns Hopkins Bloomberg School of Public Health. Dr. Halsey introduced and relied on the Bardage and Ray studies. The various articles, studies, and papers introduced by the experts are discussed more fully below.

On January 4, 2019, petitioner submitted his pre-hearing...