MARY ELLEN COSTER WILLIAMS, District Judge.
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
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.
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."
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]."
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.
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."
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."
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:
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."
The third letter from Dr. Naimi, dated June 20, 2013, states in full:
Pet'r's Notice of Filing Docs. ("Pet'r's Add'l Docs. #6") Ex. 15, June 25, 2013.
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."
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.
On March 4, 2013, Petitioner filed hospital records from the two visits to the ER she made following her vaccination.
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:
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.
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.
On October 11, 2013, the Special Master issued a decision denying compensation and 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.
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."
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."
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 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."
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.
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);
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:
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:
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."
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."
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."
Petitioner bears the burden of proving by a preponderance of the evidence that she meets the six-month residual effect requirement.
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. Niami, but this was less than three months after administration of the vaccine. No other contemporaneously recorded documents note symptoms of upper right arm pain, cellulitis, swelling, and redness, beyond February 15, 2012.
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.
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.
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."
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.
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.
