NORA BETH DORSEY, Chief Special Master.
On December 20, 2016, Jennifer Reed ("petitioner") filed a petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.
Petitioner filed medical records in support of her December 20, 2016 petition. Pet's Exs. 1-5, ECF No. 6; Pet's EXs. 6 & 7, ECF No. 9. An initial status conference was held on February 17, 2017. Order, ECF No. 10. During that conference, a schedule was set for respondent to file initial feedback in the case and petitioner was directed to provide respondent with a settlement demand. Id.
Petitioner forwarded a settlement demand for respondent's review on March 31, 2017. See Pet's Status Report, ECF No. 14. On May 12, 2017, respondent filed a status report stating that his review of the case was complete and an indicating an interest in pursuing litigative risk settlement. Resp.'s Status Report, ECF No. 17. A schedule was set for the parties to report on the progress of settlement discussions. Order, ECF No. 18.
On May 16, 2017, respondent informed the court via email that the parties had reached a tentative settlement agreement and requested that the undersigned issue a 15-week stipulation order. Order, ECF No. 19 (withdrawn). An October 13, 2017 deadline was set for the filing of the parties' stipulation of settlement. Id.
Less than one month later, respondent reported that the authorized representative of the Attorney General had declined to grant settlement approval for the parties' proposed tentative settlement. Resp.'s Status Report, ECF No. 20. The undersigned ordered respondent to file a Rule 4(c) report, ECF No. 21, and withdrew the May 17, 2017 15-week stipulation order, ECF No. 23.
Respondent filed his Rule 4(c) report on June 28, 2017, ECF No. 22. In this report, respondent argued that petitioner failed to meet her burden of proof and was not entitled to compensation for her alleged vaccine injury. Resp.'s Rule 4(c) Report at 1 & 7.
Petitioner was afforded time to file additional evidence. Order, ECF No. 24. In August 2017, petitioner filed affidavits from herself (Ex. 8), her coworker, Jolynn LaChance (Ex. 9), and her daughter, Kiara Reed (Ex. 11). ECF Nos. 27 & 28. Petitioner also filed her payroll records. ECF No. 27 (Ex. 10).
A status conference was held on September 5, 2017. Order, ECF No. 30. Following that conference, respondent was directed to file a status report setting forth his position in the case in light of petitioner's newly filed evidence. Id.
Two days later, respondent filed a status report stating a position that the case could not be settled and requesting a ruling on the record regarding entitlement. ECF No. 31. The undersigned ordered the parties to file concurrent motions for ruling by October 10, 2017.
On September 14, 2017, petitioner filed updated medical records (Exs. 12 & 13). ECF No. 33. On October 6, 2017, Respondent filed a status report indicating that he would rely upon his June 28, 2017 Rule 4(c) report in lieu providing a motion for ruling. ECF No. 34.
Petitioner filed her motion for ruling on the record on October 10, 2017, ECF No. 35. No responses were ordered and the matter is now ripe for ruling. See Order, ECF No. 32.
Under Section 13(a)(1)(A) of the Act, a petitioner must demonstrate, by a preponderance of the evidence, that all requirements for a petition set forth in section 11(c)(1) have been satisfied. A petitioner may prevail on her claim if the vaccinee for whom she seeks compensation has "sustained, or endured the significant aggravation of any illness, disability, injury, or condition" set forth in the Vaccine Injury Table (the Table). § 11(c)(1)(C)(i). The most recent version of the Table, which can be found at 42 C.F.R. § 100.3, identifies the vaccines covered under the Program, the corresponding injuries, and the time period in which the particular injuries must occur after vaccination. § 14(a). If petitioner establishes that the vaccinee has suffered a "Table Injury," causation is presumed.
If, however, the vaccinee suffered an injury that either is not listed in the Table or did not occur within the prescribed time frame, petitioner must prove that the administered vaccine caused injury to receive Program compensation on behalf of the vaccinee. § 11(c)(1)(C)(ii) and (iii). In such circumstances, petitioner asserts a "non-Table or [an] off-Table" claim and to prevail, petitioner must prove her claim by preponderant evidence. § 13(a)(1)(A). This standard is "one of ... simple preponderance, or `more probable than not' causation." Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274, 1279-80 (Fed. Cir. 2005) (referencing Hellebrand v. Sec'y of Health & Human Servs., 999 F.2d 1565, 1572-73 (Fed. Cir. 1993). The Federal Circuit has held that to establish an off-Table injury, petitioners must "prove ... that the vaccine was not only a but-for cause of the injury but also a substantial factor in bringing about the injury." Shyface v. Sec'y of Health & Human Servs., 165 F.3d 1344, 1351 (Fed. Cir 1999). Id. at 1352. The received vaccine, however, need not be the predominant cause of the injury. Id. at 1351.
The Circuit Court has indicated that petitioners "must show `a medical theory causally connecting the vaccination and the injury'" to establish that the vaccine was a substantial factor in bringing about the injury. Shyface, 165 F.3d at 1352-53 (quoting Grant v. Sec'y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992)). The Circuit Court added that "[t]here must be a `logical sequence of cause and effect showing that the vaccination was the reason for the injury.'" Id. The Federal Circuit subsequently reiterated these requirements in its Althen decision. See 418 F.3d at 1278. Althen requires a petitioner
Id. All three prongs of Althen must be satisfied. Id.
Section 11(c)(1) also contains requirements concerning the type of vaccination received and where it was administered, the duration or significance of the injury, and the lack of any other award or settlement. See § 11(c)(1)(A),(B),(D) and (E). With regard to duration, a petitioner must establish she
§ 11(c)(1)(D) (emphasis added).
To satisfy the first Althen prong, the petitioner must show that the vaccination in question can cause the injury alleged. See Pafford v. Sec'y of Health & Human Servs., 2004 WL 1717359, at *4 (Fed. Cl. Spec. Mstr. July 16, 2004), aff'd, 64 Fed. Cl. 19 (2005), aff'd, 451 F.3d 1352 (Fed. Cir. 2006). The petitioner must offer a medical theory which is reputable and reliable. See, e.g., Pafford, 451 F.3d at 1355 (reputable); Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315, 1324 (Fed. Cir. 2010) (reliable). The petitioner must prove this prong by preponderant evidence. Broekelschen v. Sec'y of Health & Human Servs., 618 F.3d 1339, 1350 (Fed. Cir. 2010).
Effective for petitions filed beginning on March 21, 2017, SIRVA is an injury listed on the Vaccine Injury Table ("Table"). See Vaccine Injury Table: Qualifications and aids to interpretation. 42 C.F.R. § 100.3(c)(10). Although petitioner's claim was filed before SIRVA was added to the Table, and thus cannot be found to be a SIRVA Table injury, the undersigned's findings were informed by the Qualifications and Aids to Interpretation for SIRVA criteria used to evaluate such claims. The criteria are as follows:
A vaccine recipient shall be considered to have suffered SIRVA if such recipient manifests all of the following: (i) No history of pain, inflammation or dysfunction of the affected shoulder prior to intramuscular vaccine administration that would explain the alleged signs, symptoms, examination findings, and/or diagnostic studies occurring after vaccine injection; (ii) Pain occurs within the specified time-frame; (iii) Pain and reduced range of motion are limited to the shoulder in which the intramuscular vaccine was administered; and (iv) No other condition or abnormality is present that would explain the patient's symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy, brachial neuritis, mononeuropathies, or any other neuropathy). Id.; see also National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table, 80 Fed. Reg. 45132, Notice of Proposed Rulemaking, July 29, 2015 (citing Atanasoff S, Ryan T, Lightfoot R, and Johann-Liang R, 2010, Shoulder injury related to vaccine administration (SIRVA), Vaccine 28(51):8049-8052).
The undersigned's findings and conclusions are as follows:
The undersigned reviewed Ms. Reed's medical history prior to her Tdap vaccination. Petitioner did not have a history of pain, inflammation or dysfunction of her right shoulder prior to vaccination.
Respondent argues that petitioner has not established that her right shoulder pain began within 48 hours from her March 28, 2016 Tdap vaccination. Resp.'s Rule 4(c) Report at 6. In support of this assertion respondent refers to the call placed by petitioner to her gynecologist's office on April 8, 2016.
Likewise, respondent refers to a report provided by petitioner to her primary care physician on April 13, 2016 as a basis for finding that petitioner's pain began more than 48 hours after her March 28, 2016 Tdap vaccination. Resp.'s Rule 4(c) Report at 6. The records from that appointment include the following history: "right arm pain which started after a tetanus injection ... patient received a tetanus vaccination at her GYNs office approximately 2-1/2 weeks ago on March 28 and one week after the injection she started to notice intense pain involving her right upper arm." Pet.'s Ex. 3 at 42. As this record is somewhat ambiguous as to whether petitioner intended to report the intensity of her pain increasing after one week, or starting after one week, the undersigned will instead consider the evidence of onset as a whole taking into account petitioner's proffered affidavits and payroll records.
Relying on his Rule 4(c) report which was filed prior to petitioner's affidavits and payroll records (Pet.'s Exs. 8-11), respondent has not provided a brief on the issue of onset that evaluates all of petitioner's evidence.
Petitioner claims that she immediately began to have pain in her right shoulder following the vaccination at issue. Pet.'s Ex. 8 ¶ 3. Petitioner states that her pain was so severe she was unable to immediately return to work. Id. at ¶4. Petitioner's payroll records confirm that she did not clock-in for two days following her Tdap vaccination and was afforded two hours of sick leave on March 31, 2016. Pet.'s Ex. 10. Ms. Jolynn LaChance, petitioner's coworker, also recalls petitioner being unable to work on March 29, 2016 due to severe shoulder pain. Pet.'s Ex. 9. Petitioner's daughter, Kiara Reed, also averred that during a visit with her mother on March 28, 2016 after the vaccination petitioner reported being in extreme pain. Pet.'s Ex. 11.
Based upon the evidence set forth in the medical records, affidavits, and payroll records the undersigned finds that the onset of petitioner's shoulder pain was within 24 hours of the March 28, 2016 Tdap vaccination, and therefore, is within the specified time frame of ≤48 hours.
The evidence submitted by petitioner includes medical records detailing the treatment which she sought for pain in her right shoulder over nearly two years since her March 2016 Tdap vaccination. A summary of these records follows below.
Petitioner reported pain in her right arm to her gynecologist on April 8, 2018, and was prescribed a Lidoderm patch for the pain. Pet.'s Ex. 2 at 7. On April 13, 2016, petitioner was seen by Angela Karavasilis, D.O. for continued right arm pain. Pet.'s Ex. 3 at 42. Dr. Karavasilis noted that petitioner had "tenderness to palpation over the right bicep tendon and in the general area of her R humerus. She has significant weakness to isometric resistance on the right compared to the left upper extremity." Id. at 44. Petitioner was referred for an x-ray and evaluation by an orthopedist. Id. at 45. Petitioner's April 13, 2016 right shoulder x-ray revealed "no evidence for fracture, dislocation or arthritic joint disease." Pet.'s Ex. 3 at 135.
On April 15, 2016, petitioner was seen by an orthopedic surgeon
Petitioner began physical therapy on May 11, 2016, and was scheduled for continued therapy sessions twice a week for six to eight weeks. Pet.'s Ex. 5 at 157. By August 24, 2016, petitioner had completed 14 physical therapy sessions. Pet.'s Ex. 5 at 69. During that time, petitioner remained under the care of her orthopedist and received a cortisone injection in her right shoulder on June 30, 2016. Pet.'s Ex. 3 at 148-49; Pet.'s Ex. 7 at 3. Petitioner saw a second orthopedist, Dr. Anthony R. Marino, on August 24, 2016. Pet.'s Ex. 4 at 25.
Having not seen significant improvement in her pain after physical therapy and cortisone treatment, petitioner underwent right shoulder arthroscopic debridement and right shoulder arthroscopic acromioplasty on September 27, 2016. Pet.'s Ex. 5 at 15. Petitioner returned to Dr. Marino for a post-operative follow-ups on October 5, 2016 and November 2, 2016 and reported soreness and pain in her right shoulder. Pet.'s Ex. 4 at 2, 27. Dr. Marino's post-operative assessment was "right shoulder tendonitis and subacromial irritation." Id. at 28.
Petitioner began a long-term pain management program for her right shoulder in May 2017. Pet.'s Exs. 12 & 14 passim (pain management records from May 2017 — January 2018).
Petitioner returned to orthopedist, Dr. Marino, on June 7, 2017, for a follow up of her right shoulder. Pet.'s Ex. 13 at 2. On examination, petitioner had "some pain with resistive function." Id. Dr. Marino offered petitioner another cortisone shot and recommended that she try relieving her pain with ice and anti-inflammatories with a hope for improvement over the long term. Id. No further intervention was recommended. Id.
Based on the records of petitioner's ongoing treatment summarized above, the undersigned finds that the pain and decreased range of motion petitioner experienced are limited to her right shoulder in which she received the Tdap vaccine. Thus, petitioner has satisfied this criteria.
There is no evidence in the record that demonstrates any type of condition or abnormality that would explain petitioner's symptoms. See Pet.'s Ex. 3 at 135 (x-ray negative for fracture, dislocation, or arthritic disease).
Guided by the criteria for evaluating a Table SIRVA injury, the undersigned finds that petitioner has shown, by a preponderance of the evidence, a logical sequence of cause and effect showing that her March 28, 2016 Tdap vaccine was the reason for her shoulder injury. The SIRVA criteria provides a perfectly logical sequence of cause and effect including (1) no history of pain, inflammation or dysfunction of the affected shoulder prior to intramuscular vaccine administration that would explain the alleged signs, symptoms, examination findings, and/or diagnostic studies occurring after vaccine injection; (ii) Pain occurs within the specified time-frame; (iii) Pain and reduced range of motion are limited to the shoulder in which the intramuscular vaccine was administered; and (iv) No other condition or abnormality is present that would explain the patient's symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy, brachial neuritis, mononeuropathies, or any other neuropathy). The undersigned has found, infra, that petitioner has satisfied all these requirements and thus has satisfied Althen prong two.
"The proximate temporal relationship prong [under Althen] requires preponderant proof that the onset of symptoms occurred within a timeframe for which, given the medical understanding of the disorder's etiology, it is medically acceptable to infer causation-in-fact." De Bazan v. Sec'y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). This analysis involves two inquiries: (1) considering the medical basis of the proffered theory, how long after vaccination would onset or worsening of the disease occur; and (2) did onset or worsening of the disease actually occur in the expected timeframe. The first inquiry necessarily intersects with the prong one analysis. See Langland v. Sec'y of Health & Human Servs., 109 Fed. Cl. 421, 443 (2013); Veryzer v. HHS, 100 Fed. Cl. 344, 356 (2011).
As discussed above, under the SIRVA criteria, the onset of the symptoms of petitioner's shoulder injury must begin within 48 hour or less of the vaccination. The undersigned has found that the onset of petitioner's shoulder injury began within 24 hours of the vaccination, and thus, petitioner has satisfied Althen prong two.
A cause-in-fact injury is established when petitioner demonstrates by a preponderance of the evidence: (1) She received a vaccine set forth on the Vaccine Injury Table; (2) She received the vaccine in the United States; (3) She sustained or had significantly aggravated an illness, disease, disability, or condition caused by the vaccine; and (4) the condition has persisted for more than six months. § 13(a)(1)(A). To satisfy the burden of proving causation in fact, petitioner must establish each of three factors announced by the Federal Circuit in Althen v. Sec'y of Health & Human Servs. by preponderant evidence: (1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a proximate temporal relationship between vaccination and injury. 418 F.3d 1274, 1278 (Fed. Cir. 2005). Proof of medical certainty is not required. Bunting v. Sec'y of Health & Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991).
