VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_12-vv-00442 Package ID: USCOURTS-cofc-1_12-vv-00442 Petitioner: Zohreh Gerami Filed: 2012-07-13 Decided: 2014-07-30 Vaccine: DPT Vaccination date: 2011-11-27 Condition: skin irritation, rash, insomnia, cellulitis, and anxiety Outcome: denied Award amount USD: AI-assisted case summary: Zohreh Gerami, a 61-year-old woman, received a DPT vaccine on November 27, 2011. She alleged that the vaccine caused skin irritation, a rash, insomnia, cellulitis, and anxiety. Three days after vaccination, she presented to the emergency room with right arm pain and redness, diagnosed as cellulitis. Her medical records also noted anxiety both before and after the vaccination. Ms. Gerami filed a petition for compensation under the National Childhood Vaccine Injury Act, alleging an off-table injury. The primary issue was whether her alleged injuries persisted for more than six months, a requirement for compensation. The Special Master dismissed her petition, finding insufficient evidence that the residual effects of her injuries lasted longer than six months. Contemporaneous medical records showed symptoms up to February 15, 2012 (less than three months post-vaccination), and later medical notes did not mention lingering vaccine-related symptoms. A letter from her treating physician, Dr. Naimi, stated the symptoms persisted for over six months, but the Special Master found this letter unpersuasive as it lacked citation to medical records and contradicted contemporaneous documentation. Ms. Gerami's petition for review of this decision was denied by the Court of Federal Claims, which affirmed the Special Master's ruling. The court found that Ms. Gerami failed to demonstrate by a preponderance of the evidence that her alleged vaccine-related injuries persisted for more than six months, and that new evidence submitted with the motion for review could not be considered. Therefore, her petition was denied on the merits. Separately, a decision on attorneys' fees and costs awarded $9,150.00 in fees and $661.02 in costs, as respondent did not object, even though compensation was denied. Theory of causation field: Off-Table Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_12-vv-00442-cl-extra-2642077 Date issued/filed: 2013-10-11 Pages: 1 Docket text: Supplementary opinion from CourtListener cluster 2642077 -------------------------------------------------------------------------------- In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS ********************* ZOHREH GERAMI, * A Married Woman, * * No. 12-442V Petitioner, * Special Master Christian J. Moran * v. * Filed: October 11, 2013 * SECRETARY OF HEALTH * Decision dismissing case; AND HUMAN SERVICES, * six-month requirement; * insufficient proof. Respondent. * ********************* Cyrus Meshki, Law Offices of Cyrus Meshki, APC, Los Angeles, CA, for petitioner. Darryl R. Wishard, United States Dep’t of Justice, Washington, DC, for respondent. UNPUBLISHED DECISION DENYING COMPENSATION1 Zohreh Gerami filed a petition under the National Childhood Vaccine Injury Act, 42 U.S.C. §300aa—10 et seq. (the “Vaccine Act” or “Program”), on July 13, 2012. Ms. Gerami alleged that she suffered an adverse reaction, including skin irritation, severe rash, cellulitis, insomnia, depression, and lingering skin scars, resulting from the receipt of a diphtheria-pertussis-tetanus (“DPT”) vaccine she received on November 27, 2011. The information in the record, however, does not show entitlement to an award under the Program. 1 The E-Government Act of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17, 2002), requires that the Court post this ruling on its website. Pursuant to Vaccine Rule 18(b), the parties have 14 days to file a motion proposing redaction of medical information or other information described in 42 U.S.C. § 300aa—12(d)(4). Any redactions ordered by the special master will appear in the document posted on the website. I. Procedural History On November 1, 2012, petitioner filed a restated claim for damages as well as exhibits 1-7.2 On November 2, 2012, respondent filed a status report in which she stated that petitioner had not filed the supporting documentation required under the Act. Respondent requested that petitioner file several sets of medical records. Specifically, respondent requested “[p]roof that petitioner’s alleged vaccine injury lasted for more than 6 months.” On November 15, 2012, petitioner filed exhibits 8 and 9 (petitioner’s affidavit). In her affidavit, petitioner asserted that her vaccine-caused injuries persisted for more than six months. Exhibit 9 at ¶ 7. On November 27, 2012, petitioner filed exhibit 10, a two page letter from Dr. Houshang Naimi dated November 27, 2012 and containing a summary of petitioner’s post-vaccination medical history. A status conference was held on November 28, 2012. During the status conference, respondent requested that petitioner file complete post- vaccination records and not merely a summary of her medical history since the date of her vaccination. On November 29, 2012, petitioner was ordered to file those records requested by respondent in her November 2, 2012 status report. Petitioner filed exhibits 11-13 on January 8, 2013. On January 9, 2013, respondent filed another status report. In her report, respondent again asserted that petitioner had “not met the requirements under the Vaccine Act for filing supporting documentation for her petition.” Respondent noted that exhibit 13 was an exact duplicate of exhibit 10 (Dr. Naimi’s summary of Ms. Gerami’s medical history), and thus was insufficient proof that petitioner’s alleged vaccine-caused condition persisted for more than six months after her vaccination. Another status conference was held on February 1, 2013. During the status conference, petitioner was strongly encouraged to file a motion for authorization to 2 The principal difference between the petition and petitioner’s restated claim for damages concerns attorney fees and costs. Compare Petition, with [Restated] Claim for Damages under Statutory Vaccination Program. The injuries alleged and the allegedly causal vaccine are identical in both pleadings. Id. 2 serve a subpoena on Dr. Naimi to obtain records related to his treatment of Ms. Gerami.3 See order, issued Feb. 2, 2013. On March 4, 2013, petitioner filed exhibit 14. A status conference was held on April 12, 2013. During the status conference, respondent stated that the record was sufficiently complete for her to file a Rule 4(c) report. See order, issued Apr. 12, 2013. Respondent filed her Rule 4 report on May 10, 2013. In her report, respondent asserted that petitioner had failed to meet “the six-month residual effects requirement for a vaccine-related injury under the Act.” Resp’t Rep’t at 6 (citing 42 U.S.C. § 300aa—11(c)(1)(D)). Respondent noted that Ms. Gerami apparently suffered from cellulitis at the injection site, but that the “last recorded complaints regarding her arm were on February 15, 2012 – less than three months after vaccination.” Resp’t Rep’t at 7-8. Respondent added that petitioner’s claims of anxiety and/or depression lasting for more than six months were not supported by the records filed. Id. at 7. Further, respondent noted Ms. Gerami’s apparent “periodic nervousness and anxiety before vaccination.” Id. at 8. On May 30, 2013, during a status conference, petitioner agreed to file a response to respondent’s Rule 4 report, identifying the medical records that support satisfaction of the Act’s six-month requirement. See order, issued May 31, 2013. On June 25, 2013, petitioner filed a letter from Dr. Naimi (exhibit 15). Dr. Naimi stated that Ms. Gerami’s injection-site symptoms “persisted over 6 months, and started fading away over 6 months,” and that “her psychological problems (anxiety disorder) lasted almost a year.” Another status conference was held on July 16, 2013. During the status conference, respondent stated that Dr. Naimi’s letter did not satisfy her concerns. Specifically, respondent noted that Dr. Naimi did not refer to any medical records to support his statements. See order, issued July 18, 2013. Noting that she had no additional documents to file, petitioner requested a ruling on the record. See id. On July 18, 2013, respondent filed a status report in which she concurred with petitioner regarding the appropriateness of a ruling on the record. Although respondent discussed causation in her Rule 4 report, she requested that a ruling be 3 To date, petitioner has not requested authorization to serve a subpoena on Dr. Naimi. 3 limited to the issue of whether petitioner has demonstrated that she suffered an injury lasting more than six months. Resp’t Status Rep’t, filed July 18, 2013. Also on July 18, 2013, in anticipation of a ruling on the record, the parties were ordered to file any additional materials or information they wished to be considered by August 16, 2013. Neither party filed any additional material. This case is now ready for disposition. II. Ms. Gerami’s Relevant Medical History On November 27, 2011, Ms. Gerami received a DPT vaccination at a Rite Aid in San Rafael, California. Exhibit 11; exhibit 12 at 2. On November 30, 2011, Ms. Gerami presented to Marin General Hospital’s Emergency Department complaining of right arm pain. Exhibit 12 at 2.4 The attending physician, Dr. Tami Gash-Kim, assessed Ms. Gerami as having “[r]ight upper extremity cellulitis,” which the doctor attributed to Ms. Gerami’s DPT immunization. Id. at 3. Dr. Gash-Kim added that the infection did “not appear to be allergic in nature.” Id. A blood culture was negative. Id. at 1, 4-5. Ms. Gerami was discharged from the hospital on December 1, 2011. Id. at 3. She was instructed to return in 24 hours for a repeat evaluation. Id. On December 2, 2011, Ms. Gerami returned to the hospital, complaining of local itching. Id. at 1. The doctor’s impression was “[l]ocal reaction to vaccine versus cellulitis.” Id. Less than an hour after her admittance, Ms. Gerami was discharged “in satisfactory stable condition” and instructed to seek reexamination “if high fever, shaking chills, vomiting or other systemic symptoms” manifested. Id. On February 15, 2012, Ms. Gerami was seen by her primary care physician, Dr. Naimi. Exhibit 14.1 at 40-41. Dr. Naimi noted Ms. Gerami’s restlessness, anxiety, muscular tension, tachycardia, and fatigue. Id. He also noted Ms. Gerami’s arm redness. Id. at 41. In a progress note from April 19, 2012, it was noted that Ms. Gerami had stopped smoking, but no mention was made of the persistence of symptoms of the alleged injury. Id. at 32. 4 Some of petitioner’s exhibits, including exhibit 12, were not paginated. Citations to exhibits without page numbers are made to the page number of the PDF filed. 4 On November 21, 2012, Ms. Gerami was seen for a physical. Id. at 42. At that time, she had no complaints. Id. A recording of her past medical history included herpes zoster (May 10, 2012), post-vaccination cellulitis (November 30, 2011), and a breast nodule excision (May 12, 2012). Id. Although questions of hypertension and hyperthyroidism were raised, no mention was made of symptoms of the alleged injury. Id. at 42-43. A letter from Dr. Naimi, dated November 27, 2012, summarized Ms. Gerami’s 2011-2012 medical history. Exhibit 10 at 1-2. Dr. Naimi mentioned Ms. Gerami’s 2012 treatments for herpes zoster and a benign nodule in her left breast. Id. at 1. Additionally, he noted petitioner’s February 15, 2012 complaint of “anxiety due to a vaccination in California.” Id. Dr. Naimi added that Ms. Gerami “had been suffering from insomnia, restlessness, and irritability” since her vaccination. Id. Finally, concerning Ms. Gerami’s November 21, 2012 “complete major physical examination,” Dr. Naimi noted Ms. Gerami’s blood pressure of 130/70 and her normal blood chemistry and urine analysis. Id. at 2. He added, “[n]o other findings.” Id. A progress note from January 7, 2013, includes the notation that Ms. Gerami “does not take meds.” Exhibit 14.1 at 34. No mention was made of symptoms of the alleged injury. Id. III. Analysis Under the Vaccine Act, a petition for compensation must contain “supporting documentation, demonstrating that the person who suffered [a vaccine related injury] . . . suffered the residual effects or complications of such illness, disability, injury, or condition for more than 6 months after the administration of the vaccine.” 42 U.S.C. § 300aa—11(c)(1)(D)(i). The burden of establishing, by a preponderance of the evidence, the persistence of a vaccine-caused injury for longer than six months is borne by petitioners. Song v. Sec’y of Health & Human Servs., 31 Fed. Cl. 61, 65-66, aff’d, 41 F.3d 1520 (Fed. Cir. 1994). Petitioner asserted that she experienced “severe skin irritation, rash, insomnia, and depression,” as well as scars due to her November 27, 2011 DTP vaccination, and that these symptoms persisted for “nearly seven (7) months.” Exhibit 9 at ¶¶ 2-3, 7. She added that she continues to “suffer from the residual lingering effects of skin anomaly.” Id. at ¶ 7. Respondent contended, however, that “[t]here are no records or medical opinions to support this allegation.” Resp’t Rep’t at 5. 5 A review of petitioner’s medical records reveals no support for her claim that her allegedly vaccine-caused injuries persisted for longer than six months. Under the Vaccine Act, the residual effects of such injuries must have persisted beyond May 27, 2012, six months after Ms. Gerami’s November 27, 2011 vaccination. Ms. Gerami suffered cellulitis at the injection site shortly after receiving the DTP vaccination. Exhibit 12 at 2. The last recorded symptom related to this condition (redness of the arm), however, was noted by Dr. Naimi on February 15, 2012, less than three months after Ms. Gerami’s vaccination. Exhibit 14.1 at 41. Petitioner has offered no persuasive medical opinion to support her claim. In his letter of November 27, 2012, Dr. Naimi noted Ms. Gerami’s February 15, 2012 complaint of anxiety due to her vaccination. 5 Exhibit 10 at 1. Dr. Naimi, however, did not cite any medical record evidencing the persistence of petitioner’s alleged vaccine injuries beyond the required six-month period. When ordered to file a status report identifying the medical records supporting the satisfaction of the Act’s six-month requirement, petitioner filed another letter from Dr. Naimi. Although Dr. Naimi stated that Ms. Gerami’s vaccine-related injuries persisted for over six months, the letter is significant for its absence of citations to petitioner’s medical records.6 See exhibit 15. In a status conference held on July 16, 2013, respondent noted the absence of citations and stated that Dr. Naimi’s letter did not satisfy her concerns. See order, issued July 18, 2013. Thereafter, petitioner was afforded the opportunity to file any additional materials or information she wished to be considered in anticipation of a ruling 5 Ms. Gerami’s records indicate that she suffered from anxiety prior to her vaccination. See, e.g., Exhibit 14.1 at 31 (“Presents with [a]nxiety disorder” on May 12, 2008). She has not claimed that her vaccination significantly aggravated her anxiety. 6 Although statements from treating physicians can be probative, Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006) (citing Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005)), such statements are not binding on special masters. See 42 U.S.C. § 300aa—13(b)(1); see also Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1346-49 (Fed. Cir. 2010) (affirming the special master’s finding that the petitioner suffered from one disease even though the petitioner’s treating doctor had diagnosed the petitioner with a different disease). 6 concerning the Act’s six-month requirement. Petitioner filed no additional documentation. IV. Conclusion Based on the record as a whole, petitioner has failed to prove by preponderant evidence that her allegedly vaccine-caused injuries persisted for longer than six months, as required by the Vaccine Act. Thus, this case is dismissed for insufficient proof. The Clerk shall enter judgment accordingly. IT IS SO ORDERED. s/Christian J. Moran Christian J. Moran Special Master 7 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_12-vv-00442-0 Date issued/filed: 2014-05-12 Pages: 2 Docket text: PUBLIC DECISION (Originally filed: 04/16/2014) regarding 41 DECISION Fees Stipulation/Proffer. Signed by Special Master Christian J. Moran. (tpj) Copy to parties. -------------------------------------------------------------------------------- Case 1:12-vv-00442-MCW Document 42 Filed 05/12/14 Page 1 of 2 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS * * * * * * * * * * * * * * * * * * * * * ZOHREH GERAMI, * A Married Woman, * * No. 12-442V Petitioner, * Special Master Christian J. Moran * v. * Filed: April 16, 2014 * SECRETARY OF HEALTH * Attorneys’ fees and costs; award AND HUMAN SERVICES, * in the amount to which * respondent does not object * Respondent. * * * * * * * * * * * * * * * * * * * * * * UNPUBLISHED DECISION ON FEES AND COSTS1 Cyrus Meshki, Law Offices of Cyrus Meshki, APC, Los Angeles, CA, for petitioner. Darryl R. Wishard, United States Dep’t of Justice, Washington, DC, for respondent. Petitioner Zohreh Gerami filed an application for attorneys’ fees and costs on April 8, 2010. The Court awards the amount to which respondent does not object. Petitioners claimed that the diphtheria-pertussis-tetanus (“DPT”) vaccine caused Ms. Gerami’s skin irritation, a rash, insomnia, cellulitis, and anxiety. See Petition, filed July 13, 2012. The information in the record failed to demonstrate 1 The E-Government Act of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17, 2002), requires that the Court post this decision on its website. Pursuant to Vaccine Rule 18(b), the parties have 14 days to file a motion proposing redaction of medical information or other information described in 42 U.S.C. § 300aa-12(d)(4). Any redactions ordered by the special master will appear in the document posted on the website. Case 1:12-vv-00442-MCW Document 42 Filed 05/12/14 Page 2 of 2 entitlement to an award under the Program and compensation was denied. Decision, dated October 11, 2013. The United States Court of Federal Claims denied a motion for review of the October 11, 2013 decision on March 31, 2014. Even though compensation was denied, a petitioner who brings her petition in good faith and who has a reasonable basis for the petition may be awarded attorneys’ fees and costs. See 42 U.S.C. § 300aa–15(e)(1). Respondent does not contend that petitioners failed to satisfy these criteria. Petitioner seeks a total of $9,150.00 for attorneys’ fees. Additionally, Ms. Gerami filed a statement of costs in compliance with General Order No. 9, stating that she incurred $661.02 while pursuing this claim. Respondent stated that she had no objection to this application for attorneys’ fees and costs. After reviewing the request, the court awards the following: 1. A lump sum of $9,150.00 in the form of a check payable to petitioner’s attorney, Cyrus Meshki, Law Offices of Cyrus Meshki, APC and petitioner, Zohreh Gerami, for attorney’s fees and costs available under 42 U.S.C. § 300aa-15(e). 2. A lump sum of $661.02 in the form of a check payable to petitioner, Zohreh Gerami. The court thanks the parties for their cooperative efforts in resolving this matter. The Clerk shall enter judgment accordingly.2 IT IS SO ORDERED. s/Christian J. Moran Christian J. Moran Special Master 2 Pursuant to Vaccine Rule 11(a), the parties can expedite entry of judgment by each party filing a notice renouncing the right to seek review by a United States Court of Federal Claims judge. 2 ================================================================================ DOCUMENT 3: USCOURTS-cofc-1_12-vv-00442-1 Date issued/filed: 2014-07-30 Pages: 11 Docket text: PUBLIC DECISION (Originally filed: 03/31/2014) re: 37 Order on Motion for Review, Judge Vaccine Order/Opinion. Signed by Judge Mary Ellen Coster Williams. (ee) Copy to parties. (Main Document 44 replaced on 6/30/2016) (jt1). -------------------------------------------------------------------------------- Case 1:12-vv-00442-MCW Document 44 Filed 07/30/14 Page 1 of 11 In the United States Court of Federal Claims No. 12-442V (Filed Under Seal: March 31, 2014)1 (Filed for Publication: July 30, 2014) * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ZOHREH GERAMI, a Married Woman, * National Childhood Vaccine * Injury Act, 42 U.S.C. § 300aa-10 Petitioner, * et seq.; Diphtheria-Pertussis- * Tetanus Vaccine; Off-Table v. * Injury; Six-Month Residual * Effects Requirement; Insufficient SECRETARY OF HEALTH AND * Evidence; Unpersuasive Medical HUMAN SERVICES, * Evidence. * Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * Cyrus Meshki, Law Office of Cyrus Meshki, APC, 10866 Wilshire Boulevard, Suite 400, Los Angeles, California, 90024, for Petitioner. Darryl R. Wishard, United States Department of Justice, Civil Division, Torts Branch, P.O. Box 146, Benjamin Franklin Station, Washington, District of Columbia 20044, for Respondent. ______________________________________________________________ OPINION ______________________________________________________________ This case comes before the Court on Zohreh Gerami’s motion for review of the Special Master’s decision dismissing her petition for compensation under the National Childhood Vaccine Injury Act (“Vaccine Act”), 42 U.S.C. § 300aa-10 et seq. (2006), for insufficient proof. After receiving the diphtheria-pertussis-tetanus (“DPT”) vaccine, Ms. Gerami suffered skin irritation, a rash, insomnia, cellulitis, and anxiety, and filed suit under the Vaccine Act seeking compensation for an off-table injury. Because Petitioner failed to demonstrate that her injuries persisted for six months after her vaccination, the Court affirms the ruling of the Special Master. 1 Pursuant to Vaccine Rule 18 of the Rules of the United States Court of Federal Claims, the Court issued its opinion under seal to provide the parties an opportunity to submit redactions. Neither party filed proposed redactions. Accordingly, the Court publishes this opinion. Case 1:12-vv-00442-MCW Document 44 Filed 07/30/14 Page 2 of 11 Background Ms. Gerami’s Medical History On November 27, 2011, Ms. Gerami, then age 61, received a DPT vaccine at a clinic in a Rite-Aid store in San Rafael, California. Three days later, on November 30, 2011, at 9:42 p.m., Ms. Gerami was admitted to the Emergency Room (“ER”) of Marin General Hospital in California with the “chief complaint” of right arm pain. Pet’r’s Notice of Filing Docs. (“Pet’r’s Add’l Docs. #4”) Ex. 11, Jan. 8, 2013. The physician who saw Ms. Gerami, Dr. Gash-Kim, noted that she had a temperature of 100.3 degrees Fahrenheit and “increasing redness” that had “spread distally” from the DTP injection site on her right arm. Id. Ex. 12. The doctor referred to Ms. Gerami’s injury as “right upper extremity cellulitis,” noted its size as 15 centimeters, prescribed her medications, and instructed her to return to the ER in 24 hours or sooner “for repeat evaluation.” Id. Ms. Gerami was discharged at 2:42 a.m. on December 1, 2011. On December 2, 2011, Ms. Gerami returned to the ER where Dr. Neill evaluated her. He noted that she “complain[ed] of local itching” but did not report “fever, shaking chills, vomiting or other systemic symptoms.” Id. Dr. Neill’s charts list “local reaction to vaccine versus cellulitis” as the “impression,” and reflect that Ms. Gerami was discharged in “satisfactory stable condition.” Id. Ms. Gerami, a resident of the United States and Canada, returned to Quebec, Canada, and visited Dr. Naimi who had been her primary care physician since 1988. The first entry in Dr. Naimi’s records is dated May 12, 2008—more than three years before the vaccine—and states that she “present[ed] with anxiety disorder due to [illegible].”2 Pet’r’s Notice of Filing Docs. (“Pet’r’s Add’l Docs. #5”) Ex. 14 at 31, Mar. 4, 2013. On May 1, 2011, almost seven months before her vaccination, Ms. Gerami received a complete physical, and Dr. Naimi’s charts listed her “problems” as periodic anxiety, menopause, Raynaud’s disease, and a fungal infection of the toes. Within Dr. Naimi’s medical records, separate from the charts, is a form dated February 15, 2012—almost three months after the vaccine. Entitled “psychiatric evaluation,” the form indicates that Ms. Gerami exhibited anxiety and mentions redness on the right arm, but does not reference the vaccine. Id. at 40-41. The first post-vaccine entry in Dr. Naimi’s medical charts is dated April 19, 2012, and reflects blood pressure measurements and other metrics and states that “she stopped smoking.” Id. at 32. No reference is made to either the vaccine or her ER visits. On May 22, 2012, Ms. Gerami again visited Dr. Naimi, and his notes reflect that she was worried about why she was taking certain medications. Again, Dr. Naimi makes no mention of the ER visits, vaccine, or 2 Though Dr. Naimi, in his letter dated October 10, 2012, relates that he has been Ms. Gerami’s doctor since 1988, the medical records in this case only date back to 2008. 2 Case 1:12-vv-00442-MCW Document 44 Filed 07/30/14 Page 3 of 11 alleged vaccine effects. On October 2, 2012, Ms. Gerami “present[ed] for [follow-up],” and the charts indicate “high anxiety.” Id. at 33. Dr. Naimi’s medical chart entries for Ms. Gerami on October 23, 2012, November 21, 2012, and January 7, 2013, do not reference anxiety, the ER visits, or the vaccine effects. The other records, however, contain a form entitled “COMPLETE MAJOR PHYSICAL” dated November 21, 2012, listing “Medical – HERPES ZOSTER May 10, 2012; – cellulitis post vaccination Rt Upper Ext. Nov. 30, 2011” under the category “Past Medical History.” Id. at 42. Under the “Problems” section, the form lists only: “1. Hypertension.?! 2. Multinodular Thyroid 3. R/o Hyperthyroidism.” Id. at 43. In addition to medical charts and forms, the record before the Special Master contained three letters from Dr. Naimi and Ms. Gerami’s affidavit. In her affidavit, dated November 12, 2012, Petitioner related that “immediately after vaccination, [she] experienced symptoms such as severe skin irritation, rash, insomnia, and depression. The scars on [her] skin persisted for several months thereafter . . . [and other] symptoms persisted for nearly seven (7) months. To date, [she] still suffers from the residual effects of [the] skin anomaly.” Pet’r’s Notice of Filing Docs. (“Pet’r’s Add’l Docs. #2”) Ex. 9, Nov. 15, 2013. In his first letter, dated October 10, 2012, Dr. Naimi outlines Ms. Gerami’s medical conditions since 2008 and prior to the vaccination, listing fibrocystic breast disease, varicose veins and varicosity, duodenitis “with a positive result for H. Pylori,” vulvitis, and perianal fungal infection. Restated Claim Ex. 4, at 2. In his second letter, dated November 27, 2012, with the subject designated as “[m]edical report from January 2011 to November 25, 2012,” Dr. Naimi states that on February 15, 2012: [T]he patient complained of having anxiety due to a vaccination in California. Soon after vaccination, her right arm (site of vaccination) developed swelling, redness, pain . . . ‘cellulitis’?. . . . Since that time she had been suffering from insomnia, restlessness, and irritability. She was tense and fatigued. *** Her somatic symptoms: BP 149/90 (this was high for the first time, due to stress), and had Trachycardia and mild tremors. *** Her blood chemistry and urine analysis were normal. Slight sensitivity and redness were observable on her right arm. Pet’r’s Notice of Filing Docs. (“Pet’r’s Add’l Docs. #3”) Ex. 10, Nov. 27, 2012. Dr. Naimi’s second letter also notes that “[o]n May 10, 2012, the patient developed a Herpes Zoster and was treated for it” and that on November 21, 2012, a complete physical evaluation revealed normal lab results and “[n]o other findings.” Id. 3 Case 1:12-vv-00442-MCW Document 44 Filed 07/30/14 Page 4 of 11 The third letter from Dr. Naimi, dated June 20, 2013, states in full: In response to [Petitioner’s counsel’s] request, this is to state that following Ms. Gerami’s injection (vaccination) in California, she developed, at the site of injestion [sic], certain symptoms which persisted over 6 months, and started fading away over 6 months. But her psychological problems (anxiety disorder) lasted almost a year. Pet’r’s Notice of Filing Docs. (“Pet’r’s Add’l Docs. #6”) Ex. 15, June 25, 2013. Procedural History The Record before the Special Master On July 13, 2012, Ms. Gerami filed a petition for compensation under the Vaccine Act. On September 6, 2012, the Special Master held a status conference and entered an Order the following day instructing Petitioner to “file all outstanding records.” Gerami v. Sec’y of Health & Human Servs., No. 12-442V, Slip Op. at 2 (Fed. Cl. Spec. Mstr. Oct. 11, 2013) (“Opinion”). On November 1, 2012, Petitioner filed a “Restated Claim for Damages” and, concurrently, proof of vaccination, hospital records, medical bills, and a letter from Dr. Naimi. Respondent filed, on November 2, 2012, a status report noting that Petitioner had not filed the supporting documents required by the Vaccine Act and sought “[p]roof that petitioner’s alleged vaccine injury lasted for more than 6 months.” Resp’t Status Report 1-2, Nov. 2, 2012. On November 27, 2012, Petitioner filed Dr. Naimi’s second letter summarizing Ms. Gerami’s medical history from 2011 to 2012. Pet’r’s Add’l Docs. #3. On November 28, 2012, the Special Master held a status conference and entered an Order directing Petitioner to file “all outstanding records identified by respondent as soon as reasonably possible” and encouraging Petitioner’s counsel “to file a motion for subpoena authority.” Order, Nov. 29, 2012. On January 8, 2013, Petitioner filed proof of vaccination, the hospital’s transcription of its records, and the previously filed second letter from Dr. Naimi. The next day, Respondent filed another status report seeking “[p]roof that petitioner’s alleged vaccine injury lasted for more than 6 months” and “treatment records for petitioner’s . . . ‘lingering skin anomaly’.” Resp’t. Status Report 2, Jan. 9, 2013. On February 1, 2013, the Special Master held a third status conference and entered an Order stating that “Petitioner shall file the medical records identified by respondent as soon as reasonably possible. Petitioner’s attorney is strongly encouraged to file a motion for subpoena authority.” Order, Feb. 1, 2013 (emphasis in original). On March 4, 2013, Petitioner filed hospital records from the two visits to the ER she made following her vaccination. 4 Case 1:12-vv-00442-MCW Document 44 Filed 07/30/14 Page 5 of 11 On April 12, 2013, the Special Master held a fourth status conference “to discuss the completeness of the medical records . . . .” Order, Apr. 12, 2013. On May 10, 2013, Respondent filed her position statement known as a “Rule 4 Report” positing that Petitioner had not submitted sufficient medical records to demonstrate that she met “the six-month residual effects requirement for a vaccine-related injury under the Act.” Opinion at 3; Resp’t’s Vaccine Rule 4 Report 6, May 10, 2013. On May 30, 2013, the Special Master held a fifth status conference. As reflected in the Order memorializing his rulings, “petitioner agreed to submit a status report identifying medical records that show petitioner met [the six month] requirement. . . . by Monday, July 1, 2013.” Opinion at 3; Order, May 31, 2013. In response to this Order, on June 25, 2013, Petitioner filed a single document—the third letter from Dr. Naimi concluding that Ms. Gerami’s injuries lasted longer than six months. On July 16, 2013, the Special Master held the sixth and final status conference. Respondent contended that, despite Dr. Naimi’s third letter, there was still no evidence that Petitioner suffered residual vaccine effects longer than six months. The Special Master entered an Order on July 18, 2013, memorializing: “At the conclusion of the status conference, petitioner requested that her case be submitted to the [Special Master] for adjudication.” Order, July 18, 2013. Though Petitioner requested an adjudication, the Special Master kept the record open to permit additional submissions and ordered the following: 1. By Friday, August 16, 2013, respondent may file any additional materials or information she wishes the undersigned to consider. 2. Petitioner shall consider whether she would like to file any additional materials (for example, photographs) or information. Additionally, petitioner will be afforded the opportunity to respond to any materials or information filed by respondent. Id. (emphasis omitted). On July 18, 2013, Respondent filed a status report stating: “Respondent concurs that the Special Master proceed to rule on the record as requested by petitioner, but asks that this ruling be limited to the issue of whether petitioner has demonstrated that she suffered her alleged injury for the six month period required by the Vaccine Act.” Resp’t’s Status Report, July 18, 2013. Though the Special Master’s Order permitted Petitioner to respond to this status report, Petitioner did not do so. Neither Petitioner nor Respondent filed any additional evidence.3 The Special Master’s Opinion On October 11, 2013, the Special Master issued a decision denying compensation and 3 From the record, it appears that Petitioner did not request an evidentiary hearing, never sought to put forth testimony from a doctor, and never sought authority to subpoena additional medical evidence. Opinion at 3 n.3. 5 Case 1:12-vv-00442-MCW Document 44 Filed 07/30/14 Page 6 of 11 dismissing the case for insufficient proof, concluding that Petitioner “failed to prove by preponderant evidence that her allegedly vaccine-caused injuries persisted for longer than six months, as required by the Vaccine Act.” Opinion at 1, 7. Since Ms. Gerami received the DTP vaccine on November 27, 2011, the Special Master concluded that Ms. Gerami needed to show vaccine-induced effects past May 27, 2012. The Special Master observed that the last symptoms of cellulitis and anxiety were recorded on February 15, 2012, and that Ms. Gerami’s medical charts reveal that she suffered from anxiety prior to the DTP vaccine. The Special Master stated that Dr. Naimi’s April 19, 2012 progress note and November 21, 2012 medical physical report did not mention any lingering vaccine-related symptoms and that the November 21, 2012 report included “post vaccine cellulitis” in the “past medical history” category. Id. at 4-5. The Special Master ultimately concluded that a “review of petitioner’s medical records reveals no support for her claim that her allegedly vaccine-caused injuries persisted for longer than six months.” Id. at 6. The Special Master also addressed Dr. Naimi’s second and third letters. The Special Master noted that Dr. Naimi’s second letter listed the February 15, 2012 complaint of post- vaccination anxiety and cellulitis, but that the reports of the subsequent visits did not mention any of the alleged post-vaccine symptoms. The Special Master related that, in response to the Order directing Petitioner to file a status report identifying medical records to support the contention that Ms. Gerami’s injuries persisted for longer than six months, Petitioner submitted Dr. Naimi’s third letter. Though the third letter asserts that Ms. Gerami’s symptoms lasted for longer than six months, the Special Master did not find the letter persuasive, instead noting that “the letter is significant for its absence of citations to petitioner’s medical records.” Id. Explaining that statements from treating physicians are probative but not binding, the Special Master found the contemporaneously documented medical evidence more persuasive than the letter prepared for litigation purposes. Opinion at 6, n.6 (citing 42 U.S.C. § 300aa—13(b)(1)); see also Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1346-49 (Fed. Cir. 2010). As such, the Special Master dismissed the case for insufficient proof. Petitioner’s Motion for Review On November 12, 2013, Petitioner filed a motion for review of the Special Master’s decision and attached additional evidence never previously filed. Pet’r’s Mot. Review of Special Master’s Decision (“Pet’r’s Mot.”), Nov. 12, 2013. The first attachment is a declaration of Ms. Gerami dated the same day as the motion for review, listing dates she experienced symptoms “as a direct consequence of the faulty vaccination.” Id. at 6-7. The second attachment is a prescription for “Valacyclovir 500mg” dated May 10, 2012, directing Ms. Gerami to take the medication for seven days, with a handwritten note beside it stating “prescription for treatment of shingles.” Id. Ex. 1. The third attachment contains several untranslated pages of notes in French dated May 10, 2012. This Court held a telephonic oral argument on January 27, 2014. During argument Petitioner confirmed that she sought to overturn the Special Master’s decision on the merits, was “not claiming any procedural infirmity in the process utilized by the Special Master,” and was satisfied she “had an ample opportunity to present [her] case.” Oral Arg. Tr. at 5, 12. The 6 Case 1:12-vv-00442-MCW Document 44 Filed 07/30/14 Page 7 of 11 parties represented that the only issue before this Court is “whether there was sufficient evidence in the record below on the merits to demonstrate that the Plaintiff had suffered this injury lasting more than six months.” Id. at 7. Discussion Jurisdiction and Standard of Review This Court has jurisdiction under the Vaccine Act to review the decision of a Special Master upon a party’s timely filed motion. 42 U.S.C. § 300aa-12(e)(2). After a party so moves, the Court “undertake[s] a review of the record of the proceedings” and may sustain, set aside, or remand the Special Master’s decision. Id. The Court reviews a Special Master’s findings of fact under the arbitrary and capricious standard, legal conclusions under the not in accordance with law standard, and discretionary rulings under the abuse of discretion standard. Id.; Turner v. Sec’y of Health & Human Servs., 268 F.3d 1334, 1337 (Fed. Cir. 2001); Cedillo v. Sec’y of Health & Human Servs., 89 Fed. Cl. 158, 167-68 (2009). The Vaccine Act’s Requirement that Petitioner Prove the Residual Effects of Her Injuries Lasted More Than Six Months The Vaccine Act creates a Program authorizing individuals to seek compensation for injuries alleged to have been caused by a vaccine. 42 U.S.C. § 300aa-11(b); see Figueroa v. Sec’y of Health & Human Servs., 715 F.3d 1314, 1317 (Fed. Cir. 2013). The Act contains a “Vaccine Injury Table” listing certain vaccines, their corollary injuries, and time periods for the first symptom. 42 U.S.C. § 300aa-14. If a petitioner’s alleged injury falls into one of these categories, then he or she is entitled to a presumption that the vaccine caused the injury. Id.; Turner, 268 F.3d at 1337. If an injury does not fall within the Vaccine Act’s Injury Table, then a petitioner may still seek compensation for this “off-table” injury, but must prove causation in fact by a preponderance of the evidence. 42 U.S.C. § 300aa-13(a)(1)(A); Deribeaux v. Sec’y of Health & Human Servs., 717 F.3d 1363, 1367 (Fed. Cir. 2013); Turner, 268 F.3d at 1337. Ms. Gerami alleges an “off-table” injury. The Vaccine Act limits eligibility for compensation, stating: “any person who has sustained a vaccine-related injury . . . may, if the person meets the requirements of subsection (c)(1), file a petition for compensation under the Program.” 42 U.S.C. § 300aa-11(b)(1)(A). Subsection (c)(1) requires: (c) Petition content. A petition for compensation under the Program for a vaccine- related injury or death shall contain— (1) except as provided in paragraph (3), an affidavit, and supporting documentation, demonstrating that the person who suffered such injury or who died-- *** 7 Case 1:12-vv-00442-MCW Document 44 Filed 07/30/14 Page 8 of 11 (D) (i) suffered the residual effects or complications of such illness, disability, injury, or condition for more than 6 months after the administration of the vaccine, or (ii) died from the administration of the vaccine, or (iii) suffered such illness, disability, injury, or condition from the vaccine which resulted in inpatient hospitalization and surgical intervention. 42 U.S.C. § 300aa-11. In § 300aa-13, “Determination of Eligibility and Compensation,” the Vaccine Act reemphasizes that proving the elements of § 300aa-11(c), including vaccine-related residual effects lasting longer than six months, are mandatory prerequisites for compensation, stating that: (1) Compensation shall be awarded under the Program to a petitioner if the special master or court finds on the record as a whole-- (A) that the petitioner has demonstrated by a preponderance of the evidence the matters required in the petition by [§ 300aa-11(c)(1)] . . . 42 U.S.C. § 300aa-13(a). The Act, therefore, requires that the petitioner demonstrate by a preponderance of the evidence that she suffered the “residual effects” of her injury for “more than 6 months after the administration of the vaccine.” See § 300aa-11(c)(1)(D)(i). The Federal Circuit has explained that the eligibility requirements in § 300aa-11(c) are not mere pleading requirements or matters of proof at trial, but instead are “threshold criteri[a] for seeking entry into the compensation program.” Black v. Sec’y of Health & Human Servs., 93 F.3d 781, 785-87 (Fed. Cir. 1996). In Black, the Federal Circuit affirmed a dismissal of a petition where the Court of Federal Claims stated: [T]his Court holds that the requirements of subsection 11(c) are indeed jurisdictional and that a potential petitioner must do something more than merely submit a petition and an affidavit parroting the words of the statute. He or she must submit supporting documentation which reasonably demonstrates that a special master has jurisdiction to hear the merits of the case. Black v. Sec’y of Health & Human Servs., 33 Fed. Cl. 546, 550 (1995), aff’d., 93 F.3d 781 (Fed. Cir. 1996) (internal citations omitted). Furthermore, the Federal Circuit has characterized the requirement that residual effects persist for more than six months after vaccination as “a condition precedent to filing a petition for compensation.” Cloer v. Sec’y of Health & Human Servs., 654 F.3d 1322, 1335 (Fed. Cir. 2011), cert. denied, 2012 U.S. LEXIS 3093 (U.S. Apr. 16, 2012). The Circuit explained that “Congress included the 6 month petition requirement ‘to limit the availability of the compensation system to those individuals who are seriously injured from taking a vaccine.’ Thus, this provision, along with the other petition requirements, is intended to restrict eligibility to the compensation program.” Id. (quoting H.R. Rep. No. 100-391(I), at 699 (1987), reprinted in 1987 U.S.C.C.A.N. 2313-1, -373). As directed by § 300aa-13 and precedent, the Special 8 Case 1:12-vv-00442-MCW Document 44 Filed 07/30/14 Page 9 of 11 Master determined Petitioner’s eligibility by looking to the requirements in § 300aa-11(c)(1), specifically the six-month residual effects requirement. Petitioner bears the burden of proving by a preponderance of the evidence that she meets the six-month residual effect requirement. Song v. Sec’y of Health & Human Servs., 31 Fed. Cl. 61, 65-66, aff’d, 41 F.3d 1520 (Fed. Cir. 1994). Petitioner contends that the evidence establishes that her vaccine-related injuries endured for longer than six months. It is telling, however, that the evidence upon which Petitioner relies was not submitted to the Special Master and therefore cannot be considered by this Court. Rather, Petitioner filed that evidence, her November 13, 2013 declaration and a prescription for medication for shingles, for the first time in this Court as exhibits to her motion to review. This new declaration lists dates of claimed vaccine symptoms. Pet’r’s Mot. at 6-7. Petitioner further states that six months after her vaccination, in May 2012, she had an outbreak of shingles “as a direct consequence of the faulty vaccination performed nearly six months prior.” Id. at 3, 7.4 It would be error for the Court to consider new evidence presented for the first time in this Court. Vaccine Rule 8(f) makes clear that facts not raised before the Special Master are waived. See Vaccine Rule 8(f); Weddel ex rel. Weddel v. Sec’y of Health & Human Servs., 23 F.3d 388, 390 n.2 (Fed. Cir. 1994) (citing Vaccine Rule 8(f) in holding “The government correctly observes that the Weddels failed to raise before the Special Master the . . . arguments they now press. Congress has expressly forbidden us to consider such arguments.”); see also 42 U.S.C. § 300aa-12(d)(3)(B) (empowering only Special Masters to take evidence); Oral Arg. Tr. at 26 (denying Petitioner’s counsel’s request to submit additional medical records). Casting aside this new evidence, as the Court must, it is clear that on the record before him, the Special Master properly concluded that Petitioner failed to establish that the residual effects of her alleged vaccine-related injuries lasted for more than six months. Ms. Gerami’s contemporaneous medical records—the ER documents, and Dr. Naimi’s charts and forms— record symptoms of upper right arm pain, cellulitis, swelling, and redness immediately following the vaccine and lingering into her February 15, 2012 visit to Dr. Naimi, but this was less than three months after administration of the vaccine. No other contemporaneously recorded 4 Though the medical records note that Petitioner had an outbreak of herpes zoster, i.e. shingles, Petitioner never alleged that shingles were a residual effect of the vaccine in her case before the Special Master. See Pet’r’s Restated Claim; Resp’t Resp. to Mot. for Review at 3, Dec. 4, 2013. Petitioner first articulated this allegation before this Court in her motion for review and its attachments. At oral argument, counsel for Petitioner admitted that the shingles prescription was not before the Special Master and that Petitioner never submitted photographs of this injury or her scars. Counsel for Respondent stated that the Government never disputed that Ms. Gerami suffered shingles, but objected because it was never alleged to be a vaccine-induced injury. Oral Arg. Tr. at 18-19. In any event, the prescription dated May 10, 2012, for shingles, falls short of demonstrating that Petitioner suffered residual vaccine effects beyond six months—May 27, 2012—since the prescription’s last dosage was May 17, 2012. 9 Case 1:12-vv-00442-MCW Document 44 Filed 07/30/14 Page 10 of 11 documents note symptoms of upper right arm pain, cellulitis, swelling, and redness, beyond February 15, 2012. See Pet’r’s Add’l Docs. #5, Ex. 15 (showing post-vaccination visit dates of February 15, 2012, April 19, 2012, May 22, 2012, October 2, 2012, October 23, 2012, November 21, 2012, and January 7, 2013). In fact, all later visits state “no complaint.” As the Special Master’s opinion states, and as Petitioner recognizes, the only evidence before the Special Master that Ms. Gerami’s alleged injuries persisted beyond six months is Dr. Naimi’s third letter. Oral Arg. Tr. 8. In this letter, dated June 20, 2013—after commencement of this litigation before the Special Master—Dr. Naimi asserts that Ms. Gerami’s symptoms persisted beyond six months, but does not explain his conclusion or account for the fact that his contemporaneously recorded medical records do not bear out this determination. In finding this letter unpersuasive, the Special Master noted that it lacked any citation to the medical records. As the Special Master observed, Dr. Naimi’s contemporaneous medical records covering the same time period fail to mention any lingering vaccine effects. In assessing the relative persuasiveness of the evidence, the Special Master afforded the contemporaneous medical records more weight than a physician’s letter that responded to an attorney’s request and made conclusory assertions without any citation to medical records. This is a sound exercise of the Special Master’s discretion and comports with precedent. Broekelschen, 618 F.3d at 1346-49 (affirming the Special Master’s holding in which he found a discharge summary more persuasive than post-hospitalization notes where the doctor who wrote the discharge summary “was able to consider all of [petitioner’s] medical records” and the doctors who wrote the post-hospitalization notes “did not provide any reasoning for their statements.”)); see also, Song, 31 Fed. Cl. at 67-68 (affirming a Special Master’s decision to accord little weight to a doctor’s conclusion that the vaccine caused the alleged injuries where the doctor only made conclusory statements without explanation). Petitioner also contends that the Special Master’s decision is arbitrary and capricious because the record demonstrated that Petitioner suffered anxiety beyond six months. The contemporaneous records mention Ms. Gerami’s anxiety symptoms on May 12, 2008, May 1, 2011, February 15, 2012, and October 2, 2012. The Special Master noted that Petitioner’s medical charts reflected her anxiety on several occasions before she received the vaccine— indicating that the anxiety was not a residual effect of the vaccine and thus not a vaccine-related injury persisting for more than six months. Because the Special Master considered the contemporaneous medical records to be more persuasive than Dr. Naimi’s third letter, he found that Petitioner did not offer a persuasive medical opinion to support her claims of vaccine-caused anxiety. Opinion at 6. The Special Master gave Petitioner multiple opportunities to submit such proof, but Petitioner opted not to avail herself of these opportunities.5 5 Respondent consistently maintained that Petitioner failed to prove that her injuries persisted for longer than six months. The Special Master held six status conferences in which he pointedly raised these concerns, received all evidence Petitioner filed, and encouraged Petitioner to seek subpoena authority. Even after Petitioner requested adjudication on the existing record, the Special Master kept the record open for Petitioner to file additional documents. Petitioner declined to do so. 10 Case 1:12-vv-00442-MCW Document 44 Filed 07/30/14 Page 11 of 11 Petitioner has not demonstrated that the Special Master erred. The Federal Circuit has explained that if the Special Master “has considered the relevant evidence of record, drawn plausible inferences and articulated a rational basis for the decision, reversible error will be extremely difficult to demonstrate.” Hines ex rel. Sevier v. Sec’y of Health & Human Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991). Conclusion Because Petitioner has not demonstrated that the Special Master’s decision was arbitrary and capricious, not in accordance with law, or an abuse of discretion, this Court sustains his decision dismissing Ms. Gerami’s petition for compensation under the Vaccine Act. s/Mary Ellen Coster Williams MARY ELLEN COSTER WILLIAMS Judge 11