VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_08-vv-00786 Package ID: USCOURTS-cofc-1_08-vv-00786 Petitioner: John Gerard Filed: 2008-11-03 Decided: 2015-09-04 Vaccine: influenza Vaccination date: 2005-11-11 Condition: Guillain-Barré Syndrome Outcome: compensated Award amount USD: 175000 AI-assisted case summary: John Gerard filed a petition on November 3, 2008, alleging that an influenza vaccine had caused him to develop Guillain-Barré syndrome and that he experienced residual effects for more than six months. He did not file a vaccination record. On August 8, 2014, Special Master Dorsey issued Findings of Fact and Conclusions of Law determining, based on a preponderance of the evidence in the record, that Mr. Gerard had received a flu vaccination on or about November 11, 2005. The parties filed a joint stipulation on August 13, 2015. Respondent denied that Mr. Gerard received a flu vaccine in November 2005, denied that a flu vaccine caused his Guillain-Barré syndrome or any other injury, and denied that his current disabilities result from a vaccine-related injury. Nevertheless, the parties agreed to resolve the case through stipulation. Special Master Dorsey found the stipulation reasonable and adopted it as the decision of the Court. Mr. Gerard received a lump sum payment of $175,000.00 representing compensation for all damages available under 42 U.S.C. § 300aa-15(a). On August 17, 2015, the parties stipulated to an award of $82,460.65 in attorneys' fees and costs. Mr. Gerard's counsel represented that he had not personally incurred any costs in pursuit of his claim. Special Master Dorsey awarded $82,460.65 payable jointly to Mr. Gerard and his attorney, F. John Caldwell, Jr., of Maglio Christopher & Toale. Theory of causation field: Flu vaccine ~Nov 11, 2005 (date determined by Findings of Fact Aug 8, 2014; no vaccination record filed) → GBS (alleged; residual effects >6 months). Resolved by joint stipulation Aug 13, 2015. Respondent denied vaccination and causation. Lump sum $175,000 awarded. Fees $82,460.65 (SM Dorsey, Aug 18, 2015). Dates correct. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_08-vv-00786-cl-extra-2648203 Date issued/filed: 2013-12-16 Pages: 1 Docket text: Supplementary opinion from CourtListener cluster 2648203 -------------------------------------------------------------------------------- In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS (Filed: December 16, 2013) * * * * * * * * * * * * * * * PUBLISHED JOHN GERARD, * * No. 08-786V Petitioner, * * Special Master Dorsey v. * * Fact Ruling; Sufficiency of Evidence; SECRETARY OF HEALTH * Receipt of Vaccination; Influenza (“flu”) AND HUMAN SERVICES, * Vaccine; Guillain-Barré Syndrome (“GBS”) * Respondent. * * * * * * * * * * * * * * * * Franklin John Caldwell, Jr., Maglio, Christopher & Toale, Sarasota, FL, for petitioner. Michael Patrick Milmoe, U.S. Department of Justice, Washington, DC, for respondent. RULING REGARDING FINDINGS OF FACT1 I. Introduction On November 3, 2008, John Gerard (“petitioner”) filed a petition for compensation under the National Vaccine Injury Compensation Program2 (“the Program”) in which he alleges that a trivalent influenza (“flu”) vaccination that he received in October or November 2005 caused him 1 Because this ruling contains a reasoned explanation for the special master’s action in this case, the special master intends to post it on the website of the United States Court of Federal Claims, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17, 2002). All decisions and substantive rulings of the special masters will be made available to the public unless they contain trade secret or commercial or financial information that is privileged and confidential, or medical or similar information whose disclosure would clearly be an unwarranted invasion of privacy. When such a decision or designated substantive order is filed, a party has 14 days to identify and to move to redact such information before the document’s disclosure. Absent a timely motion, the decision shall be made available to the public in its entirety. Upon the filing of a timely motion to redact, along with a proposed redacted version of the decision, if the special master, upon review, agrees that the identified material fits within the categories listed above, the special master shall redact such material from the ruling made available to the public. 42 U.S.C. § 300aa-12(d)(4); Vaccine Rule 18(b). 2 The Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-10 et seq. (hereinafter “Vaccine Act” or “the Act”). Hereafter, individual section references will be to 42 U.S.C. § 300aa of the Act. to develop Guillain-Barré Syndrome (“GBS”) on November 14, 2005. See Petition (“Pet.”) at 1. In her report filed pursuant to Vaccine Rule 4(c), respondent noted that “no record of . . . vaccination ha[d] been submitted,” and that petitioner was “unable to locate any documentation to substantiate the claim” that he received a flu vaccine in October or November 2005. Respondent’s Rule 4 Report (“Resp’t’s Rep’t”), filed June 10, 2010, at 2. Because nothing in the record documents the administration of a flu vaccine to petitioner in October or November 2005, petitioner filed a motion for a finding that he received the vaccine. Petitioner’s Renewed Motion for a Finding that Petitioner Received the Influenza Vaccine on November 11, 2005, and Memorandum of Law Regarding Evidence of Vaccine Receipt (“Pet’r’s Mot.”), filed Sept. 22, 2011. Petitioner argues that “[t]he evidence… is sufficient to conclude that it is more likely than not that [he] . . . received the flu vaccine on or about November 11, 2005.” Id. at 10. Upon consideration of the record as a whole, the undersigned finds that a preponderance of the evidence does not support a finding that petitioner received an influenza vaccination prior to the onset of his GBS on November 14, 2005. II. Procedural Background Petitioner was an employee at Eagle Ottawa Leather Company, LLC (“Eagle Ottawa”) in Grand Haven, Michigan, for thirty years. Petitioner’s Exhibit (“Pet’r’s Ex.”) 8 at 1 (petitioner’s affidavit). He alleges that he received a flu vaccine at Eagle Ottawa on or about November 11, 2005, and developed GBS approximately three days later. Id. Petitioner filed his petition on November 3, 2008. Pet. at 1. In addition to medical records and his own affidavit, petitioner filed an affidavit from his co-worker and friend, Mr. Scott Perley. Pet’r’s Exs. 8 and 9. Respondent filed her Report pursuant to Vaccine Rule 4(c) on June 10, 2010. Resp’t’s Report at 1. Respondent asserted that petitioner did not provide sufficient evidence to support a finding that he had received the flu vaccine in November 2005 that allegedly caused his GBS. See id. at 13, 17. On September 22, 2011, petitioner filed a motion for a finding on whether he received the flu vaccine. Pet’r’s Renewed Motion for a Finding that Petitioner Received the Influenza Vaccine on November 11, 2005, and Memorandum of Law Regarding Evidence of Vaccine Receipt (“Pet’r’s Mot.”). Petitioner asserted that the record was supported by his filing an affidavit from Mr. Scott Landis, Vice President of Human Resources at Eagle Ottawa (Pet’r’s Ex. 14 at 1). Id. at 1. Respondent opposed petitioner’s motion on the ground that the record was insufficient to support a finding that petitioner received the flu vaccine, regardless of Mr. Landis’s affidavit. Resp’t’s Opp’n to Pet’r’s Renewed Mot. for a Factual Finding (“Resp’t’s Opp’n”), filed Oct. 24, 2011, at 2. After discussing the parties’ respective briefs during a status conference, the special master previously assigned to the case determined that the record remained insufficient to rule on 2 petitioner’s motion. See Order, filed Jan. 13, 2012, at 2. Accordingly, the special master “concluded that it [wa]s reasonable and necessary to inquire further into the nature of . . . [Eagle Ottawa] records and potential information that [Eagle Ottawa] . . . may possess.” Id. (citing § 300aa-12(d)(3)(B)). Pursuant to the previous special master’s ensuing orders, petitioner submitted additional records from Eagle Ottawa. See Court Ex. 1000. Petitioner also submitted responses to questions the previous special master posed to Mr. Robert “Bob” Tovey, the person who administered flu vaccines to Eagle Ottawa employees in 2005, see Court Ex. 1002 at 1, and Ms. Debra Parrish, a customer service representative for the company that “provided support for Mr. Tovey in obtaining influenza vaccinations” in 2005. Court Ex. 1004 at 1. A fact hearing was held on May 21, 2013, before the previous special master. Transcript (“Tr.”) 1. Petitioner and Mr. Perley testified at the hearing. See Tr. 2. The matter is now ripe for adjudication. The pertinent evidence concerning whether the record supports a finding, by a preponderance of the evidence, that petitioner received a flu vaccine before his GBS manifested on November 14, 2005, is set forth and discussed in sections III and V below. III. Summary of the Evidence The undersigned has considered the entirety of the record. § 300aa-13(a)(1). See Paterek v. Sec’y of Health & Human Servs., 527 Fed. App’x 875, 884 (Fed. Cir. 2013) (stating that “[f]inding certain information not relevant does not lead to—and likely undermines—the conclusion that it was not considered”); see also Veryzer v. Sec’y of Health & Human Servs., 98 Fed. Cl. 214, 223 (2011) (noting that special masters are bound by both § 300aa-13(b)(1) and Vaccine Rule 8(b)(1) to consider only evidence that is both “relevant” and “reliable”). The evidence includes (1) petitioner’s medical records; (2) petitioner’s affidavit and testimony; (3) Mr. Tovey’s affidavit3; (4) Eagle Ottawa records; and (5) Mr. Perley’s affidavit and testimony. These sources of evidence are discussed in turn. A. Petitioner’s medical records On the afternoon of November 14, 2005, petitioner “began experiencing tingling in his legs and upper chest which then spread to his arms.” Pet. at 1. These symptoms progressed up petitioner’s left and right sides, and he began experiencing problems with walking and balance. Pet’r’s Ex. 1 at 182. He presented to the Ludington emergency room and was transferred to Mercy Health Partners (“Mercy”) in Muskegon, Michigan, on November 15, 2005. Id. 3 Mr. Tovey submitted sworn responses to the previous special master’s questions. Court Ex. 1002. As the previous special master indicated, Mr. Tovey’s responses would be considered sworn testimony provided under oath. See Questions for Mr. Bob Tovey, filed Dec. 19, 2012, at 2. Accordingly, the undersigned considers Mr. Tovey’s responses to constitute an affidavit and will refer to them as such. 3 In petitioner’s admission profile at Mercy on November 15, 2005, Jacklyn Burr, R.N., recorded, among other things, that petitioner’s seasonal flu vaccine was not current. Nurse Burr’s documentation is copied below: Pet’r’s Ex. 11 at 801. Nurse Burr then documented that she performed an assessment as to whether petitioner was eligible to receive the flu vaccine. Id. She charted that the flu vaccine was contraindicated for petitioner because he had an acute febrile illness. Id. Nurse Burr documented that petitioner “may be vaccinated after symptoms have abated.” Id. Nurse Burr instructed petitioner “to talk with [his] physician after discharge to obtain the vaccine if not administered during hospitalization.” Id. Pet’r’s Ex. 11 at 801. Nurse Burr also recorded the influenza virus vaccine under “allergies,” which were reviewed with petitioner. Pet’r’s Ex. 11 at 866. She documented GBS as a “reaction” to the influenza virus vaccine. Id.; see also Pet’r’s Ex. 11 at 49.4 On November 15, 2005, Dr. Joan Nagelkirk, petitioner’s admitting physician, recorded that petitioner “has not had flue [sic] or pneumococcal vaccinations.” Dr. Nagelkirk’s documentation of November 15, 2005, is copied below: Pet’r’s Ex. 11 at 707. 4 Nurse Burr’s documentation that petitioner had not received the flu vaccine and then her subsequent entry that petitioner had a reaction to the vaccine appears self-contradictory. The contradiction may be explained by Nurse Burr’s entry stating that the flu vaccine was contraindicated. Nurse Burr may have documented that petitioner had a “reaction” and an “allergy” to the flu vaccine because the vaccine was contraindicated due to petitioner’s GBS. See Pet’r’s Ex. 11 at 143 (flu vaccine absolutely contraindicated in November 2006 because of petitioner’s history of GBS). 4 Dr. Nagelkirk subsequently ordered a flu vaccine for petitioner “[i]f appropriate per protocol.” Pet’r’s Ex. 11 at 719.5 Petitioner was transferred to Mercy’s acute rehabilitation facility on November 21, 2005, for continued treatment. Pet’r’s Ex. 11 at 165-67. An admission profile was performed by Connie Katafias, R.N., on November 21, 2005. Id. at 386. The assessment form indicates that Nurse Katafias asked petitioner if his seasonal flu vaccine was current. Id. Nurse Katafias documented “No,” indicating that petitioner had not received the seasonal flu vaccine in November 2005. Nurse Katafias’s documentation is copied below: Pet’r’s Ex. 11 at 387. On November 21, 2005, Dr. Anthony Wilson recorded that petitioner “meets criteria and has agreed to [flu] vaccination.” Pet’r’s Ex. 11 at 239. Dr. Wilson then ordered a flu vaccine for petitioner. Dr. Wilson’s order is set forth below: Pet’r’s Ex. 11 at 239. Mr. Joseph Graftema, Pharm.D., verified Dr. Wilson’s order for the influenza vaccine on November 21, 2005. Pet’r’s Ex. 11 at 240. However, the order was later voided.6 Pet’r’s Ex. 11 at 240; see also Pet’r’s Ex. 11 at 702 (“Reaction status: Active; Reactions: guillian barre syndrome”). On January 4, 2006, petitioner presented to his primary care physician, Dr. Koryn Van Ittersum, for follow-up of his GBS. Dr. Ittersum’s note from that visit states “no etiology was identified for the Guillain-Barre Syndrome, which has been quite frustrating to the patient.” Pet’r’s Ex. 1 at 65. In a letter dated January 8, 2006, Dr. Ittersum wrote that “[petitioner] has questions about the cause of his illness.” Id. at 162. Dr. Ittersum’s records do not contain any reference to any flu vaccine received by petitioner in the fall of 2005. 5 The order, however, was later voided by Donna Eppler, Pharm.D. Id.; see also Pet’r’s Ex. 11 at 876. Presumably, Dr. Nagelkirk’s order was voided because petitioner did not fit within the vaccine protocol or the vaccination was contraindicated due to petitioner’s GBS. See supra, page 4. 6 Mr. Joseph Graftema, Pharm.D., voided Dr. Wilson’s order on November 22, 2005. Pet’r’s Ex. 11 at 240. Presumably, Wilson’s order was voided because petitioner did not fit within the vaccine protocol or the vaccination was contraindicated due to petitioner’s GBS. See supra, page 4. 5 On April 28, 2006, petitioner presented to the emergency department at Mercy with complaints of lower back pain. Pet’r’s Ex. 11 at 211. Dr. Thomas J. Zyniewicz confirmed petitioner’s past history of GBS. Pet’r’s Ex. 11 at 215. Dr. Zyniewicz also documented that petitioner was allergic to insulin and the “flu virus vaccine.” Id. The nursing assessment form completed by Nancy L. O’Brien, R.N., also documented that petitioner was allergic to the influenza virus vaccine, noting “Reaction, gullian barre syndrome.” Pet’r’s Ex. 11 at 211; but see Pet’r’s Ex. 2 at 49 (Dr. Ivan Landan noting on January 23, 2006, that petitioner had no allergies). Petitioner was admitted to Mercy Health on November 4, 2006, for a lumbar discectomy. Pet’r’s Ex. 11 at 130. The adult admission profile was performed by Michelle M. Perk, R.N. Id. at 143. Nurse Perk performed an assessment for the influenza immunization. Id. at 143. She documented that the flu vaccine was contraindicated for petitioner due to his history of GBS. Nurse Perk’s documentation is as follows: Pet’r’s Ex. 11 at 143. B. Petitioner’s affidavit and testimony In his affidavit, petitioner stated that Mr. Tovey administered a flu vaccine to him on November 11, 2005. Pet’r’s Ex. 8 at 1. Petitioner stated that he paid $5.00 for the vaccination and that Mr. Tovey handled the payment. Pet’r’s Ex. 8; Tr. 7.7 Petitioner testified that he declined a receipt for the payment. Tr. 7. Petitioner testified that he had received a flu vaccine at Eagle Ottawa every year (except for 2004, when they were unavailable) for approximately 15-20 years. Pet’r’s Ex. 8 at 1; Tr. 9. He testified that he had never signed a consent form to receive a flu vaccine, Tr. 9, and that Eagle Ottawa had “no record that [he] . . . ever received a flu shot.” Pet’r’s Ex. 8 at 1. According to petitioner, “there was never any waiver for G.B.S. until after [he] . . . was hospitalized with [GBS].” Id.; Tr. 39. Thereafter, petitioner claims that Eagle Ottawa “[m]anagement posted . . . a notice that any employees wishing to get a flu shot will have to sign a waiver for G.B.S.” Id. C. Mr. Tovey’s affidavit Mr. Tovey was responsible for administering flu vaccines to Eagle Ottawa employees in November 2005. Court Ex. 1002 at 1. Mr. Tovey was unable to verify that he had administered a flu vaccine to petitioner in November 2005. See Court Ex. 1002 at 6. Mr. Tovey stated that “flu shots were available at Eagle Ottawa beginning Monday, November 21, 2005.” Court Ex. 1002 at 1. Mr. Tovey stated that “[t]he [flu] vaccine was made 7 The transcript spells Mr. Tovey’s name as “Tovi.” See, e.g., Tr. 6. 6 available to the [Eagle Ottawa] employees [on] November 21, 2005”). Id. at 4.8 “Eagle Ottawa employees who requested the [flu] vaccination were asked to complete a consent form.” Id. at 3; see also id. at 2 (“The influenza vaccination consent form would have been filed in the non- workers compensation employee file”); id. at 5 (“all employees, as a standard procedure, complete a consent form.”). Mr. Tovey stated that he “did not handle any payment for the [flu] vaccines,” Court Ex. 1002 at 4, because “[human resources] managed the collection of the fee [for the vaccine].” Id. at 6. D. Eagle Ottawa Records A number of records from Eagle Ottawa speak to whether petitioner received a flu vaccine on November 11, 2005. Although petitioner testified that he never signed a consent form or “waiver” to receive a flu vaccination, consent forms bearing his name and signature were produced for the years 2002 and 2003. See Pet’r’s Ex. 3 at 39-40. Among other things, these forms provided that petitioner “voluntarily request[ed] the [flu] vaccine be provided to [him] at Eagle Ottawa” and “release[d] Eagle Ottawa . . . from any and all claims or liability in any way related to this voluntary flu vaccination program.” Id. at 39, 40. Eagle Ottawa purchased the flu vaccines that Mr. Tovey administered in November 2005 from a company named MED-1. See Court Ex. 1002 at 1. MED-1 generated an invoice for the purchase dated November 17, 2005. See Court Ex. 1004 at 8. Mr. Tovey explained that the invoice memorialized the purchase of 40 flu vaccines, Court Ex. 1002 at 5, which became available on November 21, 2005. Id. at 1; see also id. at 8 (MED-1 invoice dated November 17, 2005). An Eagle Ottawa posting9 that stated 40 “flu shots” were available beginning November 21, 2005, corroborates this aspect of Mr. Tovey’s testimony. Court Ex. 1001 at 31. E. Mr. Perley’s affidavit and testimony Mr. Perley, a friend and co-worker of petitioner, submitted an affidavit and testified on petitioner’s behalf at the hearing. Pet’r’s Ex. 9 at 1; Tr. 24. Mr. Perley stated that Eagle Ottawa had provided annual flu shots for all employees “for the past 15 years.” Pet’r’s Ex. 9 at 1; see also Tr. 25, 28. He stated that Eagle Ottawa previously provided flu vaccines free of charge, but the company began charging $5.00 for the vaccines in 2005. Pet’r’s Ex. 9 at 1; Tr. 25. Mr. Perley stated that he “was present when [petitioner] . . . received his flu shot given by Bob Tovey who was the Eagle Ottawa Nurse.” Pet’r’s Ex. 9 at 1; see also Tr. 25. According to Mr. Perley, petitioner paid Mr. Tovey the $5.00 fee in cash, Tr. 28, and petitioner declined a receipt when Mr. Tovey offered to produce one. Tr. 25-26. 8 November 21, 2005, is one week after the onset of petitioner’s GBS on November 14, 2005. Petitioner was in Mercy’s acute rehabilitation facility on November 21, 2005. He was not at Eagle Ottawa on November 21, 2005. 9 Mr. Tovey circulated the posting to various Eagle Ottawa employees via email on November 21, 2005, and asked them to “post in [their] . . . department[s].” Court Ex. 1000 at 12. The posting stated “FLU SHOTS ARE AVAILABLE . . . $10.00.” Id. at 13. 7 Mr. Perley did not, however, know the date on which petitioner allegedly received the flu vaccine. See Pet’r’s Ex. 9 at 1; Tr. 36. He suggested that he learned the date when discussing it with petitioner the day before the hearing, but otherwise he only had “an idea of when it was.” Tr. 36. Mr. Perley testified that he did not recall whether petitioner signed a consent form prior to receiving the flu vaccine. Tr. 28. Mr. Perley testified that he did not sign a consent form for the flu vaccine that he received in 2005, and that Eagle Ottawa employees had never been required to sign anything prior to receiving a flu vaccine at Eagle Ottawa. Tr. 28, Tr. 39. Further, Mr. Perley stated that “[a]fter [petitioner] was diagnosed with [GBS] . . . Eagle Ottawa posted a waiver for each employee to sign who was going to get the flu shot because of Guillain- Barre Syndrome.” Pet’r’s Ex. 9 at 1. IV. Applicable Legal Standards Under the Vaccine Act, petitioner must first prove by a preponderance of the evidence that he “received a vaccine set forth in the Vaccine Injury Table.” § 300aa-11(c)(1)(A). The preponderance of the evidence standard means a fact is more likely than not. Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010). Although contemporaneous documentation of vaccination from a health care provider is the best evidence, its production is not an absolute requirement. See Centmehaiey v. Sec’y of Health & Human Servs., 32 Fed. Cl. 612, 621 (1995) (“The lack of contemporaneous, documentary proof of a vaccination . . . does not necessarily bar recovery.”). Thus, special masters have found in favor of vaccine administration where contemporaneous documentation of vaccination is unavailable when other forms of evidence have provided preponderant evidence of vaccination administration. For example, corroborative, though retrospective, medical notations have been found to provide preponderant evidence of vaccine administration. See Lamberti v. Sec’y of Health & Human Servs., No. 99-507V, 2007 WL 1772058, at *7 (Fed. Cl. Spec. Mstr. May, 31, 2007) (finding multiple medical record references to vaccine receipt constituted preponderant evidence of administration); Groht v. Sec’y of Health & Human Servs., No. 00- 287V, 2006 WL 3342222, at *2 (Fed. Cl. Spec. Mstr. Oct. 30, 2006) (finding a treating physician’s note “4/30/97-Hep B. inj. # 1 (not given here) ([patient] wanted this to be charted)” to be sufficient proof of vaccination); Wonish v. Sec’y of Health & Human Servs., No. 90-667V, 1991 WL 83959, at *4 (Cl. Ct. Spec. Mstr. May 6, 1991) (finding parental testimony “corroborated strongly by medical records [referring] back to the [vaccination]” to be sufficient to establish vaccine administration). Testimony alone has also been found to provide preponderant evidence of vaccine administration. Alger v. Sec’y of Health & Human Servs., No. 89-31V, 1990 WL 293408, at *7 (Cl. Ct. Spec. Mstr. Mar. 14, 1990). In Alger, the special master found the oral testimony alone “more than adequate to support a finding that the vaccine was administered to [petitioner].” Id. at *7. Medical records “warrant consideration as trustworthy evidence.” Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). Accordingly, where later-given 8 testimony conflicts with medical records created closer in time to the events in question, special masters frequently accord more weight to the medical records. See, e.g., Reusser v. Sec’y of Health & Human Servs., 28 Fed. Cl. 516, 523 (1993) (“[W]ritten documentation recorded by a disinterested person at or soon after the event at issue is generally more reliable than the recollection of a party to a lawsuit many years later.”). V. Determination The undersigned has considered the entire record. § 300aa-13(a)(1). Petitioner has failed to provide preponderant evidence that he received a flu vaccine before the onset of his GBS on November 14, 2005. An evaluation of the evidence that informs this conclusion follows. A. Medical records Petitioner’s medical records provide the most persuasive evidence that he did not receive a flu vaccination prior to the onset of his GBS on November 14, 2005. None of petitioner’s medical records documents that he received a flu vaccination at any time in November 2005. From November 15, 2005 through November 21, 2005, four different health care providers documented that petitioner had not received a flu vaccine prior to his emergency room admission on November 14, 2005. On the admission profile dated November 15, 2005, Nurse Burr documented that petitioner had not received the flu vaccine. Pet’r’s Ex. 11 at 801. Likewise, Dr. Nagelkirk recorded on November 15, 2005, that petitioner had not received the seasonal flu vaccine. Pet’r’s Ex. 11 at 707. Because petitioner had not received the vaccine, Dr. Nagelkirk subsequently ordered that petitioner be given the vaccine if appropriate per the hospital’s protocol. Pet’r’s Ex. 11 at 719. Common sense dictates that Dr. Nagelkirk would not have ordered the flu vaccine on November 15, 2005, if petitioner had already received it earlier. Likewise, it is reasonable to infer that petitioner did not receive the flu vaccine during his hospitalization in November 2005 because it was contraindicated due to his GBS. See Pet’r’s Ex. 11 at 801 (flu vaccine contraindicated for petitioner on November 15, 2005 due to his “acute febrile illness”); see also Pet’r’s Ex. 11 at 143 (flu vaccine contraindicated for petitioner in November 2006 due to his history of GBS). On the admission profile dated November 21, 2005, Nurse Katafias documented that petitioner had not received the seasonal flu vaccine, Pet’r’s Ex. 11 at 387, but that he was eligible and agreed to receive one. Id. at 388. Dr. Wilson ordered that petitioner receive the flu vaccine after obtaining petitioner’s consent. Pet’r’s Ex. 11 at 239-40. Again, it is unlikely that Dr. Wilson would have ordered the flu vaccine if petitioner had already received it. In summary, two registered nurses and two physicians made consistent entries in the medical records establishing that petitioner had not received the flu vaccine prior to his November 14, 2005 hospitalization for GBS. B. Inconsistent Testimony Petitioner’s testimony was not consistent with what else is known about Eagle Ottawa’s flu vaccination program. Mr. Perley’s testimony was similarly inconsistent. These weaknesses diminish the weight of petitioner’s and Mr. Perley’s testimony. Examples include (1) the 9 payment and cost of the flu vaccine; (2) the date on which flu vaccines were available at Eagle Ottawa in November 2005; and (3) Eagle Ottawa’s consent forms. 1. Payment and cost of the flu vaccine Petitioner testified that he paid Mr. Tovey $5.00 in cash for a flu vaccine that Mr. Tovey administered on November 11, 2005. Mr. Perley also testified that he (and all Eagle Ottawa employees) paid $5.00 for a the flu vaccine in November 2005. Mr. Tovey did not testify as to the cost of the vaccines, but the posting he circulated on November 21, 2005, established that each flu vaccine cost $10.00. Petitioner and Mr. Perley testified that Mr. Tovey handled the payment for petitioner’s flu vaccine in November 2005. Mr. Tovey, however, stated that he never handled any payments for the vaccines. According to Mr. Tovey, Eagle Ottawa human resources handled the payments. 2. Date on which flu vaccines were available at Eagle Ottawa in November 2005 Petitioner alleges he received a flu vaccine at Eagle Ottawa on November 11, 2005. The weight of the evidence, however, indicates that flu vaccines were not available at Eagle Ottawa until November 21, 2005. Mr. Tovey unequivocally stated that the flu vaccines were not available until November 21, 2005. The invoice generated by MED-1 dated November 17, 2005, and the Eagle Ottawa posting Mr. Tovey circulated on November 21, 2005, which stated that flu vaccines were available, corroborate Mr. Tovey’s testimony. 3. Eagle Ottawa’s consent forms Petitioner and Mr. Perley testified that Eagle Ottawa employees were never required to sign a consent form prior to receiving a flu vaccine at Eagle Ottawa. Eagle Ottawa, however, produced consent forms for flu vaccines from 2002 and 2003 bearing petitioner’s name and signature. Although none was found for 2005, Mr. Tovey testified that it was standard procedure for all Eagle Ottawa employees to sign a consent form to receive a flu vaccine. Moreover, the fact that petitioner testified that he had never signed a consent form, when such forms with his name and signature were produced for 2002 and 2003, calls into question the accuracy of petitioner’s testimony. 4. Mr. Perley’s testimony Mr. Perley testified that he was present when petitioner received his alleged flu vaccine. Mr. Perley could not, however, recall the date on which this occurred. He testified that he was unsure of the date, and suggested at the hearing that he only knew the approximate date because he discussed it with petitioner the day before the hearing. As mentioned, Mr. Perley testified that Eagle Ottawa employees were not required to sign a consent form to receive a flu vaccine, that the vaccines cost $5.00 each, and that Mr. 10 Tovey collected the payment. As discussed, other evidence indicates that this information is incorrect, which calls into question the accuracy of Mr. Perley’s recollection and testimony. VI. Conclusion The undersigned finds that petitioner has not provided preponderant evidence that he received a flu vaccine prior to the onset of his GBS on November 14, 2005. A status conference will be scheduled to discuss further proceedings. IT IS SO ORDERED. s/Nora Beth Dorsey Nora Beth Dorsey Special Master 11 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_08-vv-00786-0 Date issued/filed: 2014-09-02 Pages: 4 Docket text: PUBLIC DECISION (Originally filed: 08/08/2014) regarding 97 Findings of Fact & Conclusions of Law Signed by Special Master Nora Beth Dorsey. (tlj) Copy to parties. -------------------------------------------------------------------------------- Case 1:08-vv-00786-UNJ Document 98 Filed 09/02/14 Page 1 of 4 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 08-786V Filed: August 8, 2014 * * * * * * * * * * * * * * * * * * * * * * * * * JOHN GERARD, * UNPUBLISHED * Petitioner, * * Special Master Dorsey v. * * Motion for Reconsideration SECRETARY OF HEALTH * of Ruling Regarding AND HUMAN SERVICES, * Findings of Fact; Influenza * Vaccine (Flu); Guillain-Barre Respondent. * Syndrome (GBS) * * * * * * * * * * * * * * * * * * * * * * * * * * Franklin John Caldwell, Jr., Maglio, Christopher & Toale, Sarasota, FL, for Petitioner. Michael Patrick Milmoe, United States Department of Justice, Washington, DC, for Respondent. ORDER GRANTING MOTION FOR RECONSIDERATION AND RULING REGARDING FINDING OF FACT1 On November 3, 2008, John Gerard (“petitioner”) filed a petition pursuant to the National Vaccine Injury Compensation Program2 (the “Program”). Petitioner alleged that, as a result of receiving an influenza (“flu”) vaccination in October or November of 2005, he developed Guillain-Barré Syndrome (“GBS”) on November 14, 2005. See Petition (Pet.) at 1. Respondent’s report filed pursuant to Vaccine Rule 4(c) noted that a vaccination record was not 1 Because this ruling contains a reasoned explanation for the action in this case, the undersigned intends to post this order on the United States Court of Federal Claims’ website, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, § 205, 116 Stat. 2899, 2913 (codified as amended at 44 U.S.C. § 3501 and note (2006)). In accordance with Vaccine Rule 18(b), a party has 14 days to identify and move to delete medical or other information that satisfies the criteria in § 300aa-12(d)(4)(B). Further, consistent with the rule requirement, a motion for redaction must include a proposed redacted decision. If, upon review, the undersigned agrees that the identified material fits within the requirements of that provision, such material will be deleted from public access. 2 The Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-10 et seq. (hereinafter Vaccine Act or the Act). Hereafter, individual section references will be to 42 U.S.C. § 300aa of the Act. 1 Case 1:08-vv-00786-UNJ Document 98 Filed 09/02/14 Page 2 of 4 filed and petitioner had not submitted sufficient documentation to substantiate his claim that he received a flu vaccination as alleged. Respondent’s Rule 4 Report (“Resp’t’s Rep’t”) at 2. Petitioner filed a motion requesting a ruling that he received the flu vaccine as alleged in his petition. See Petitioner’s Renewed Motion for a Finding that Petitioner Received the Influenza Vaccine on November 11, 2005, and Memorandum of Law Regarding Evidence of Vaccine Receipt (“Pet’r’s Motion”), filed September 22, 2011. Petitioner argued that the evidence presented was sufficient to conclude that it was more likely than not he received the flu vaccine on or about November 11, 2005. Id. at 10. Respondent filed a response to petitioner’s motion on October 24, 2011. Respondent’s Opposition to Petitioner’s Renewed Motion for a Factual Finding (“Resp’t’s Opposition”). Respondent maintained that petitioner’s claim was unsubstantiated by any medical records or opinions. Id. at 3. The special master previously assigned to this case held a fact hearing on May 21, 2013. Transcript (“Tr.”) at 1. On September 23, 2013, the case was reassigned to the undersigned. See Order, dated September 23, 2013. On December 16, 2013, the undersigned issued a fact ruling stating that based on a review of the record as a whole, “a preponderance of the evidence d[id] not support a finding that petitioner received an influenza vaccine prior to the onset of his GBS on November 14, 2005.” Ruling Regarding Fact Finding (“Ruling”) at 2. On May 5, 2014, petitioner filed a Motion for Reconsideration3 of the Ruling (“Motion for Reconsideration”) in which he conceded that it was doubtful that the undersigned ignored evidence, but instead alleged that the undersigned erred in interpreting multiple medical chart notes. Motion for Reconsideration at 1-2. Petitioner also contended that the undersigned ignored testimony given by petitioner’s coworker, Scott Perley, who was allegedly present at the time petitioner received the flu vaccination at issue. Id. Petitioner requested and was granted the opportunity to file additional medical records in support of the Motion for Reconsideration. See Order, dated April 15, 2014. Petitioner filed four additional exhibits of medical records, as petitioner’s exhibits 16 through 19. Respondent filed a response to the Motion for Reconsideration on June 16, 2014, arguing that petitioner did not meet any of the necessary criteria for reconsideration. Respondent’s Response to Petitioner’s Motion for Reconsideration (Resp’t’s Response) at 3. The matter is now ripe for adjudication. 3 Vaccine Rule 10(e) governs motions for reconsideration and provides that a motion for reconsideration must be filed “within 21 days after the issuance of a decision, if judgment has not been entered…” Procedurally, the ruling, which is the subject of this motion, is not a “decision” and thus, judgment has not been entered. The undersigned conducted a status conference with the parties and issued an order on February 4, 2014, granting petitioner’s request to file a motion for reconsideration and setting a specific deadline of March 6, 2013, for the motion to be filed. Several enlargements of time were requested by petitioner and granted. Petitioner filed the motion for reconsideration on May 15, 2014. 2 Case 1:08-vv-00786-UNJ Document 98 Filed 09/02/14 Page 3 of 4 I. The Applicable Legal Standards Under the Vaccine Act, petitioner must first prove by a preponderance of the evidence that he “received a vaccine set forth in the Vaccine Injury Table.” § 300aa-11(c)(1)(A). The preponderance of the evidence standard means a fact is more likely than not. Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010). Although contemporaneous documentation of vaccination from a health care provider is the best evidence, its production is not an absolute requirement. See Centmehaiey v. Sec’y of Health & Human Servs., 32 Fed. Cl. 612, 621 (1995) (“The lack of contemporaneous, documentary proof of a vaccination . . . does not necessarily bar recovery.”) Thus, special masters have found in favor of vaccine administration where contemporaneous documentation of vaccination is unavailable as long as other forms of evidence have provided preponderant evidence of vaccination administration. For example, corroborative, though retrospective, medical notations have been found to provide preponderant evidence of vaccine administration. See Wonish v. Sec’y of Health & Human Servs., No. 90-667V, 1991 WL 83959, at *4 (Cl. Ct. Spec. Mstr. May 6, 1991) (finding parental testimony “corroborated strongly by medical records [referring] back to the [vaccination]” to be sufficient to establish vaccine administration); Groht v. Sec’y of Health & Human Servs., No. 00-287V, 2006 WL 3342222, at *2 (Fed. Cl. Spec. Mstr. Oct. 30, 2006) (finding a treating physician’s note “4/30/97-Hep B. inj. # 1 (not given here) ([patient] wanted this to be charted)” to be sufficient proof of vaccination); Lamberti v. Sec’y of Health & Human Servs., No. 99-507V, 2007 WL 1772058, at *7 (Fed. Cl. Spec. Mstr. May, 31, 2007) (finding multiple medical record references to vaccine receipt to constitute preponderant evidence of administration). A party seeking reconsideration “must support the motion by a showing of extraordinary circumstances which justify relief.” Fru-Con Constr. Corp. v. United States, 44 Fed. Cl. 298, 300 (1999). The motion for reconsideration “must be based ‘upon manifest error of law, or mistake of fact, and is not intended to give an unhappy litigant an additional chance to sway the court.’” Prati v. United States, 82 Fed. Cl. 373, 376 (2008) (quoting Fru-Con Constr. Corp., 44 Fed. Cl. at 300). “Specifically, the moving party must show: (1) the occurrence of an intervening change in the controlling law; (2) the availability of previously unavailable evidence; or (3) the necessity of allowing the motion to prevent manifest injustice.” Matthews v. United States, 73 Fed. Cl. 524, 526 (2006) (citing Griswold v. United States, 61 Fed. Cl. 458, 460-61 (2004)). II. Evaluating the Evidence In the Motion for Reconsideration, petitioner admitted that it was “doubtful that the Court ignored evidence” but argues that there are “two key pieces of evidence…which…suggests the Court erred in finding that the vaccination was not administered as alleged on November 11, 2005.” Motion for Reconsideration at 1. These two key pieces of evidence include multiple medical records indicating that petitioner had an “allergic reaction to the flu shot in the form of GBS” and “the testimony of Scott Perley.” Id. at 1-2. Petitioner further argues that any inconsistencies in the medical record notes should be disregarded in favor of other records that 3 Case 1:08-vv-00786-UNJ Document 98 Filed 09/02/14 Page 4 of 4 do mention his allergy to the influenza vaccine. Motion for Reconsideration at 14. In his motion for reconsideration, petitioner also states that the testimony of his coworker, Scott Perley, who was allegedly present when petitioner received the influenza vaccine, should have been credited. Id. Having reviewed petitioner’s arguments and the newly submitted evidence, the undersigned finds that petitioner has made the requisite showing under Matthews, supra. Accordingly, in order to prevent a potential “manifest injustice,” the undersigned has evaluated petitioner’s reconsideration motion on its merits and GRANTS it. The undersigned agrees with petitioner and concludes that the numerous entries in the medical records, while inconsistent, could be interpreted as suggested by petitioner. That conclusion, in addition to the testimony by Mr. Perley, tips the scale in favor of a finding for petitioner. III. Conclusion The undersigned has carefully reviewed the Motion for Reconsideration, Resp’t’s Response, and petitioner’s additional exhibits. Based on the record as a whole, the undersigned finds that petitioner has shown by a preponderance of the evidence that petitioner received an influenza vaccine on or about November 11, 2005. Accordingly, the undersigned finds that the influenza vaccine was administered to petitioner on or about November 11, 2005. Respondent is hereby ORDERED to file a status report by September 12, 2014, stating whether she wishes to engage in settlement negotiations, and, if she does not, that she propose a scheduling order for expert reports. Any questions regarding this Ruling may be directed to my law clerk, Francina Segbefia, at (202)357-6358 or Francina_Segbefia@ao.uscourts.gov. IT IS SO ORDERED. /s/ Nora Beth Dorsey Nora Beth Dorsey Special Master 4 ================================================================================ DOCUMENT 3: USCOURTS-cofc-1_08-vv-00786-1 Date issued/filed: 2015-09-04 Pages: 7 Docket text: PUBLIC DECISION (Originally filed: 08/14/2015) regarding 116 DECISION Stipulation/Proffer Signed by Chief Special Master Nora Beth Dorsey. (tlf) Copy to parties. -------------------------------------------------------------------------------- Case 1:08-vv-00786-UNJ Document 124 Filed 09/04/15 Page 1 of 7 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 08-786V Filed: August 14, 2015 * * * * * * * * * * * * * * * * UNPUBLISHED JOHN GERARD, * * * Special Master Dorsey Petitioner, * * v. * * Joint Stipulation on Damages; SECRETARY OF HEALTH * Flu vaccine; Guillian-Barré AND HUMAN SERVICES, * Syndrome. * Respondent. * * * * * * * * * * * * * * * * * * Altom M. Maglio, Maglio Christopher & Toale, Sarasota, FL, for petitioner. Michael P. Milmoe, United States Department of Justice, Washington, DC, for respondent. DECISION1 On November 3, 2008, John Gerard (“petitioner”) filed a petition pursuant to the National Vaccine Injury Compensation Program.2 42 U.S.C. §§ 300aa-1 to -34 (2006). Petitioner did not file a vaccination record, however, the undersigned determined on August 8, 2014 that, based on a preponderance of the evidence in the record, petitioner received an influenza (“flu”) vaccine on or about November 11, 2005. See Findings of Fact and Conclusions of Law, docket no. 97, filed Aug. 8, 2014. In his petition, petitioner alleged that as a result of receiving the flu vaccination he 1 Because this decision contains a reasoned explanation for the undersigned’s action in this case, the undersigned intends to post this ruling on the website of the United States Court of Federal Claims, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, § 205, 116 Stat. 2899, 2913 (codified as amended at 44 U.S.C. § 3501 note (2006)). As provided by Vaccine Rule 18(b), each party has 14 days within which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). 2 The National Vaccine Injury Compensation Program is set forth in Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended, 42 U.S.C. §§ 300aa-1 to -34 (2006) (Vaccine Act or the Act). All citations in this decision to individual sections of the Vaccine Act are to 42 U.S.C.A. § 300aa. 1 Case 1:08-vv-00786-UNJ Document 124 Filed 09/04/15 Page 2 of 7 suffered from Guillain-Barré Syndrome (“GBS”). See Petition at ¶ 1, 4, docket no. 1, filed Nov. 3, 2008. Further, petitioner alleged that he experienced residual effects of his injury for more than six months. Id. at ¶ 4. On August 13, 2015, the parties filed a stipulation in which they state that a decision should be entered awarding compensation. Respondent denies that petitioner received a flu vaccine in November 2005, and denies that the flu vaccine caused petitioner’s GBS, or any other injury, and further denies that petitioner’s current disabilities are the result of a vaccine-related injury. See Stipulation for Award at ¶ 6, docket no. 115, filed Aug. 13, 2015. Nevertheless, the parties agree to the joint stipulation, attached hereto as Appendix A. The undersigned finds the stipulation reasonable and adopts it as the decision of the Court in awarding damages, on the terms set forth therein. The parties stipulate that petitioner shall receive the following compensation: A lump sum of $175,000.00, in the form of a check payable to petitioner, John Gerard. This amount represents compensation for all damages that would be available under 42 U.S.C. § 300aa-15(a). Id. at ¶ 8. The undersigned approves the requested amount for petitioner’s compensation. Accordingly, an award should be made consistent with the stipulation. In the absence of a motion for review filed pursuant to RCFC Appendix B, the clerk of the court SHALL ENTER JUDGMENT in accordance with the terms of the parties’ stipulation.3 IT IS SO ORDERED. s/ Nora Beth Dorsey Nora Beth Dorsey Special Master 3 Pursuant to Vaccine Rule 11(a), entry of judgment is expedited by the parties’ joint filing of notice renouncing the right to seek review. 2 Case 1:08-vv-00786-UNJ Document 124 Filed 09/04/15 Page 3 of 7 Case 1:08-vv-00786-UNJ Document 124 Filed 09/04/15 Page 4 of 7 Case 1:08-vv-00786-UNJ Document 124 Filed 09/04/15 Page 5 of 7 Case 1:08-vv-00786-UNJ Document 124 Filed 09/04/15 Page 6 of 7 Case 1:08-vv-00786-UNJ Document 124 Filed 09/04/15 Page 7 of 7 ================================================================================ DOCUMENT 4: USCOURTS-cofc-1_08-vv-00786-2 Date issued/filed: 2015-09-08 Pages: 2 Docket text: PUBLIC DECISION (Originally filed: 08/18/2015) regarding 119 DECISION Fees Stipulation/Proffer Signed by Chief Special Master Nora Beth Dorsey. (tlf) Copy to parties. -------------------------------------------------------------------------------- Case 1:08-vv-00786-UNJ Document 125 Filed 09/08/15 Page 1 of 2 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS Case No. 08-786V Filed: August 18, 2015 * * * * * * * * * * * * * * JOHN GERARD, * UNPUBLISHED * Petitioner, * * v. * Special Master Dorsey * SECRETARY OF HEALTH * Attorneys’ Fees and Costs; AND HUMAN SERVICES, * Reasonable Amount Requested to which * Respondent Does not Object. Respondent. * * * * * * * * * * * * * * * F. John Caldwell, Jr., Maglio Christopher & Toale, Sarasota, FL, for petitioner. Michael P. Milmoe, United States Department of Justice, Washington, DC, for respondent. ATTORNEYS’ FEES AND COSTS DECISION1 On November 3, 2008, John Gerard (“petitioner”) filed a petition pursuant to the National Vaccine Injury Compensation Program.2 42 U.S.C. §§ 300aa-1 to -34 (2006). Petitioner alleged that he developed Guillain-Barré Syndrome (“GBS”) as a result of an influenza (“flu”) vaccination he received on November 11, 2005. See Petition at 1. On August 14, 2015, the undersigned 1 Because this decision contains a reasoned explanation for the undersigned’s action in this case, the undersigned intends to post this decision on the website of the United States Court of Federal Claims, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17, 2002). As provided by Vaccine Rule 18(b), each party has 14 days within which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the entire decision will be available to the public. Id. 2 The National Vaccine Injury Compensation Program is set forth in Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended, 42 U.S.C. §§ 300aa-1 to -34 (2006) (Vaccine Act or the Act). All citations in this decision to individual sections of the Vaccine Act are to 42 U.S.C.A. § 300aa. 1 Case 1:08-vv-00786-UNJ Document 125 Filed 09/08/15 Page 2 of 2 entered a decision awarding compensation to petitioner based on a joint stipulation filed by the parties. On August 17, 2015, the parties filed a stipulation concerning attorneys’ fees and costs. The parties stipulate to a total award of attorneys’ fees and costs in the amount of $82,460.65. In accordance with General Order #9, petitioner’s counsel represents that petitioner did not personally incur any costs in pursuit of his claim. The Vaccine Act permits an award of reasonable attorneys’ fees and costs. 42 U.S.C. § 300 aa-15(e). Based on the reasonableness of petitioner’s request and the lack of any objection by respondent, the undersigned GRANTS the request for approval and payment of attorneys’ fees and costs. Accordingly, an award should be made as follows: in the form of a check jointly payable to petitioner and to petitioner’s attorney, F. John Caldwell, Jr., of the law firm Maglio Christopher & Toale, in the amount of $82,460.65. In the absence of a motion for review filed pursuant to RCFC Appendix B, the clerk of the court SHALL ENTER JUDGMENT in accordance with the terms of the parties’ stipulation.3 IT IS SO ORDERED. s/Nora Beth Dorsey Nora Beth Dorsey Special Master 3 Pursuant to Vaccine Rule 11(a), entry of judgment is expedited by the parties’ joint filing of notice renouncing the right to seek review. 2