NORA BETH DORSEY, Chief Special Master.
On October 24, 2016, petitioner filed a petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10, et seq.,
After filing his petition, petitioner filed medical records marked as Exhibits "1" through "6" on November 4, 2016, along with a statement of completion. ECF Nos. 7-8. An initial status conference was held with the staff attorney managing this case on December 12, 2016, and respondent was ordered to indicate how he intended to proceed. ECF No. 9. Respondent indicated that he was amenable to settlement discussions on February 13, 2017, and the parties engaged in damages negotiations until petitioner requested formal proceedings to resolve the case on March 7, 2018.
Respondent filed his Rule 4 Report on April 30, 2018. ECF No. 41. Respondent recommended against compensation in this case, stressing in particular petitioner's three month delay in seeking treatment for his alleged vaccine-related injury. Id. at 3-4. Respondent indicated that "[i]n the opinion of medical personnel at the Department of Health and Human Services, Division of Injury Compensation Programs, the significant delay in seeking treatment does not support by preponderant evidence a finding that petitioner's shoulder injury began specifically within forty-eight hours of vaccination." Id. at 4.
Subsequently, petitioner filed further medical records marked as Exhibits "14" and "15" and an affidavit marked as Exhibit "16." ECF No. 43. However, respondent maintained the position stated in his Rule 4 Report. ECF No. 46.
Petitioner filed a motion for a ruling on the record on November 1, 2018. ECF No. 47. Petitioner requested that the undersigned find that petitioner's shoulder pain began within 48 hours of receiving his January 6, 2016 tetanus vaccination and that petitioner is entitled to compensation pursuant to the Vaccine Act. Id.at 9. Respondent filed a response on November 15, 2018, disputing that there is preponderant evidence that petitioner's shoulder pain began within forty-eight hours of vaccination. ECF No. 48. No reply was filed. Accordingly, this case is now ripe for the undersigned's ruling on entitlement.
After sustaining a dog bite to his leg on January 6, 2016, petitioner went to urgent care and was administered a tetanus vaccination in his left deltoid.
Petitioner further averred that his pain continued and became more severe. Id. He indicated that within 48 hours of vaccination "it was apparent that there was quite a bit of swelling high on my shoulder." Id. He explained that his pain did not abate and that it interfered with his normal activities, including lifting. Ex. 16, p. 1. He indicated that ibuprofen and acetaminophen did not provide relief for the pain, which he characterized as excruciating. Id.
Petitioner returned to the urgent care facility on January 14, 2016. Ex. 15. This visit is confirmed by a sign-in sheet; however, no medical record has been produced related to this visit.
Petitioner indicated that he continued to treat with over the counter medications as recommended for several weeks until he decided to seek a second opinion. Ex. 16, p. 2. On March 29, 2016, petitioner was seen by orthopedist Ricardo Colberg, M.D. Ex. 3, pp. 6-7.
Dr. Colberg recorded a history from petitioner indicating that his "left shoulder pain started on January 6, 2016, when he got a tetanus shot, he had a bruise afterwards. He had severe sharp pain when he was trying to move it. It has subsided to a mild sharp pain when he tries to lift his arm up overhead." Ex. 3, p. 6. Dr. Colberg also noted that "[i]t has failed to go away despite naproxen, ibuprofen, rest, and activity modification." Id.
On physical exam, Dr. Colberg found no atrophy or tenderness to palpation, but did report decreased range of motion and a positive empty can test. Id. X-ray and ultrasound imaging was performed and the diagnostic impression was "[l[eft shoulder pain with mild AC joint osteoarthritis and supraspinatus strain with residual tendinitis after a tetanus shot on January 6, 2016." Id. at 7. Conservative treatment, including physical therapy, was recommended. Id.
The next day, on March 30, 2016, petitioner had an initial physical therapy evaluation. Ex. 4, p. 21. Petitioner again reported that his pain began with his tetanus vaccination. The physical therapist noted that petitioner presented "with pain in his left shoulder since given a tetanus shot in his left arm in January. Pt. reports the pain has continued since then." Id. Additionally, on his physical therapy intake form, petitioner explicitly listed "1/6/16" as the "Date of Injury/Onset." Id. at 28. Petitioner was recommended four weeks of twice-weekly physical therapy. Id. at 23.
Petitioner returned to Dr. Colberg on April 28, 2016. Ex. 3, pp. 4-5. His symptoms were reported to be worsening. Id. at 4. Dr. Colberg indicated that petitioner "describes moderate-to-severe sharp, aching pain in the lateral aspect of his shoulder, worse with overhead activities, better at rest with associated weakness." Id. On physical exam, reduced range of motion was again noted as was a positive empty can test. Id. Petitioner also demonstrated positive signs of impingement. Id. At this time, petitioner received a cortisone injection into his bursa. Id. at 5. Petitioner's diagnosis changed to "left shoulder pain secondary to subacromial bursitis" following "interval development of subacromial bursitis"; however, Dr. Colberg still relied on January 6, 2016 as the date of onset. Id. at 4-5.
Petitioner again returned to Dr. Colberg on May 17, 2016. Ex. 3, pp. 2-3. At that time, due to petitioner's lack of improvement, Dr. Colberg became concerned petitioner may have a rotator cuff tear. Ex. 3, p. 2. He recommended a left shoulder MRI before determining further treatment. Id. The MRI was performed on May 18, 2016. Ex. 3, p. 15. It showed minimal AC joint hypertrophy and mild supraspinatus tendinosis, but "no MR evidence for rotator cuff tear, or other internal derangement of the left shoulder joint." Id. Petitioner returned to Dr. Colberg on June 20, 2016, for a plasma rich platelet injection. Ex. 3, p. 1. At that time his diagnosis was "left shoulder pain due to chronic rotator cuff tendinosis." Id.
About a year later, petitioner returned to Dr. Colberg and had a repeat MRI. Ex. 8, pp. 1-5. The MRI findings included a tear of the superior, posterior, and inferior labrum and "mild chondrosis in the glenohumeral joint with minimal humeral head marginal osteophyte formation." Ex. 8, p. 4. Petitioner's orthopedist additionally noted petitioner's subacromial bursitis and mild impingement. Ex. 8, p. 8.
Petitioner underwent arthroscopic surgery on June 30, 2017. Ex. 10, p. 3. His post-surgical diagnosis included a labral tear (type 1) as well as biceps tendinosis and shoulder impingement. Id.
Initially, petitioner was recovering well following his surgery; however, during recovery he tripped and fell on his arm, rupturing his bicep tendon and requiring a further surgery. Ex. 8, p. 6; Ex. 10, pp. 1-2. The remainder of petitioner's medical records focus on his recovery from his bicep rupture.
In this case, because petitioner's claim predates the inclusion of SIRVA on the Vaccine Injury Table, petitioner must prove his claim by showing that his injury was "caused-in-fact" by the vaccination in question. § 300aa-13(a)(1)(B); § 300aa-11(c)(1)(C)(ii). In such a situation, of course, the presumptions available under the Vaccine Injury Table are inoperative. The burden is on the petitioner to introduce evidence demonstrating that the vaccination actually caused the injury in question. Althen v. HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005); Hines v. HHS, 940 F.2d 1518, 1525 (Fed. Cir. 1991). The showing of "causation-in-fact" must satisfy the "preponderance of the evidence" standard, the same standard ordinarily used in tort litigation. § 300aa-13(a)(1)(A); see also Althen, 418 F.3d at 1279; Hines, 940 F.2d at 1525. Under that standard, the petitioner must show that it is "more probable than not" that the vaccination was the cause of the injury. Althen, 418 F.3d at 1279.
The petitioner need not show that the vaccination was the sole cause or even the predominant cause of the injury or condition, but must demonstrate that the vaccination was at least a "substantial factor" in causing the condition, and was a "but for" cause. Shyface v. HHS, 165 F.3d 1344, 1352 (Fed. Cir. 1999).
Under the leading Althen test, petitioner must satisfy three elements. The Althen court explained this "causation-in-fact" standard, as follows:
Althen, 418 F.3d at 1278 (citations omitted). The Althen court noted that a petitioner need not necessarily supply evidence from medical literature supporting petitioner's causation contention, so long as the petitioner supplies the medical opinion of an expert. Id. at 1279-80. The court also indicated that, in finding causation, a Program fact-finder may rely upon "circumstantial evidence," which the court found to be consistent with the "system created by Congress, in which close calls regarding causation are resolved in favor of injured claimants." Id. at 1280.
The undersigned finds that petitioner satisfies the three prongs of Althen as follows:
Under Althen Prong One, there must be preponderant evidence of a medical theory causally connecting petitioner's vaccination to his injury. In satisfaction of Althen Prong One, the undersigned takes notice of the fact that respondent has added SIRVA to the Vaccine Injury Table for tetanus-containing vaccines intended for intramuscular administration in the upper arm. See 42 C.F.R. § 100.3; 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); see also Doe 21 v. HHS, 88 Fed. Cl. 178 (July 30, 2009), rev'd on other grounds, 527 Fed. Appx. 875 (Fed. Cir. 2013)(holding that recognition of a link between vaccine and injury on the Vaccine Injury Table supports petitioner's burden under Althen Prong One.)
In any event, although respondent discussed petitioner's burden to establish a medical theory, he has not disputed that the tetanus vaccine can cause SIRVA. In that regard, it is worth noting that there is a well-established track record of awards of compensation for SIRVA being made on a cause-in-fact basis in this program. See, e.g. Loeding v. HHS, No. 15-740V, 2015 WL 7253760 (Fed. Cl. Spec. Mstr. Oct. 15, 2015)(noting that "respondent `has concluded that petitioner's injury is consistent with SIRVA; that a preponderance of evidence establishes that her SIRVA was caused in fact by the flu vaccination she received on October 14, 2014; and that no other causes for petitioner's SIRVA were identified."); see also Johnson v. HHS, No. 16-165V, 2016 WL 3092002 (Fed. Cl. Spec. Mstr. April 13, 2016)(awarding compensation for a SIRVA caused-in-fact by the influenza vaccine); Koenig v. HHS, No. 16-1496V, 2017 WL6206391 (Fed. Cl. Spec. Mstr. April 13, 2017)(same); Telonidis v. HHS, No. 15-450V, 2015 WL 5724746 (Fed. Cl. Spec. Mstr. Sept. 2, 2015); Salas v. HHS, No. 16-739V, 2016 WL 8459834 (Fed. Cl. Spec. Mstr. Nov. 7, 2016).
Under Althen Prong Two, petitioner must demonstrate a logical sequence of cause and effect showing that the vaccination was the reason for the injury. Although petitioner's claim does not constitute a Table Injury, the undersigned finds the Qualifications and Aids to Interpretation ("QAI") criteria for SIRVA to be persuasive regarding the factors necessary to demonstrate a logical sequence of cause and effect.
42 C.F.R. § 100.3(c)(10) (Qualifications and Aids to Interpretation for SIRVA).
In light of the factual history above, the undersigned finds that all four of the criteria listed in the QAI for SIRVA are satisfied by preponderant evidence. With regard to three of these criteria, there is little controversy.
As noted above, respondent concedes that there is no history of any medical condition contributing to petitioner's alleged SIRVA. The undersigned agrees. That is, the undersigned finds that there is no history of pain, inflammation or dysfunction of petitioner's left shoulder prior to his January 6, 2016 vaccination. Additionally, the undersigned finds that petitioner's pain and reduced range of motion were limited to the shoulder in which the intramuscular vaccine was administered and that no other condition or abnormality is present that would explain petitioner's symptoms. Respondent did not raise any argument suggesting a contrary finding.
The only SIRVA criteria meaningfully disputed in this case is whether petitioner's shoulder pain began within the specified timeframe (i.e. forty-eight hours). On that point, respondent argues that this case is based on petitioner's claim alone, unsubstantiated by independent evidence. ECF No. 48, pp. 1-2. The undersigned disagrees.
Petitioner's contemporaneous treatment records repeatedly and consistently record the fact that petitioner's shoulder pain began on January 6, 2016. See, e.g. Ex. 3, pp. 6-7; Ex. 4, p. 21, 28. Indeed, the medical records include petitioner's own hand-written intake form on which he explicitly indicated that the date of onset for his shoulder condition was January 6, 2016. Ex. 4, p. 28. None of petitioner's medical records indicate any other time of onset.
Nonetheless, respondent argues that "these records are also based on the representations of petitioner alone as reported histories. There is no independent evidence to support petitioner's assertions." ECF No. 48, p. 2. This argument is unavailing. Medical records generally "warrant consideration as trustworthy evidence." Cucuras v. HHS, 993 F.2d 1525, 1528 (Fed.Cir.1993). Greater weight is typically given to contemporaneous records. Vergara v. HHS, 08-882V, 2014 WL 2795491,*4 (Fed. Cl. Spec. Mstr. May 15, 2014) ("Special Masters frequently accord more weight to contemporaneously-recorded medical symptoms than those recorded in later medical histories, affidavits, or trial testimony.")
Respondent cites Lett v. HHS, 39 Fed. Cl. 259, 260 (1997), for the proposition that "[u]ltimately, the petitioner must substantiate the occurrence of a compensable, vaccine-related injury with independent evidence." ECF No. 48, p. 2. However, nothing in Lett suggests that a contemporaneously recorded patient history contained in petitioner's medical records is insufficient to corroborate a vaccine injury claim.
To the extent respondent would argue that the medical records in this case are not credible because they are not contemporaneous to the onset of petitioner's injury, the undersigned is not persuaded. Indeed, the undersigned has previously rejected this exact argument, noting that a delay of several months before seeking treatment does not necessarily defeat a SIRVA claim. See, e.g. Cooper v. HHS, 16-1387V, 2018 WL 1835179, *6 (Fed. Cl. Spec. Mstr. Jan. 18, 2018) (holding that "the undersigned does not find a delay in treatment of several months to be dispositive in and of itself regarding the question of onset in a SIRVA case such as this.")
The medical records at issue (beginning March 29, 2016) represent the first time petitioner was formally evaluated by a medical professional for his injury and his injury was still ongoing at that time with active treatment continuing for several months after. They are therefore contemporaneous treatment records and are entitled to significant weight as they "contain information supplied to or by health professionals to facilitate diagnosis and treatment of medical conditions." Cucuras, 993 F.2d at 1528. As the Federal Circuit has previously noted, treatment records are considered trustworthy at least in part because "[w]ith proper treatment hanging in the balance, accuracy has an extra premium." Id. This remains true regardless of whether there is some delay in seeking treatment.
Moreover, respondent is incorrect that petitioner's medical records are limited to petitioner's own representations. On multiple occasions, petitioner's orthopedist discussed his findings upon physical examination. Moreover, his diagnostic impression included interpretation of objective imaging results on X-ray, ultrasound, and MRI. Ex. 3, pp. 2-3, 7; Ex. 8, p. 4. Upon consideration of these findings as well as petitioner's history, Dr. Colberg opined that petitioner's shoulder injury was related to his January 6, 2016 tetanus vaccination.
For all these reasons the undersigned finds that there is preponderant evidence that petitioner's shoulder pain began within forty eight hours of receiving his tetanus vaccination. Therefore, the undersigned finds that petitioner has presented preponderant evidence pursuant to Althen Prong Two of a logical sequence of cause and effect supported by medical opinion showing that his injury was vaccine-caused.
Under Althen Prong Three, there must be a proximate temporal relationship between vaccination and injury. In this case, respondent agrees that the relevant, medically accepted, timeframe for onset of a SIRVA injury is within 48 hours of vaccination. ECF Nos. 41, pp. 3-4; 48, p. 2. Thus, in light of the above finding that petitioner's shoulder pain began on January 6, 2016 (i.e. within forty-eight hours of vaccination), petitioner has necessarily satisfied Althen Prong Three.
Respondent has not asserted, nor would the undersigned find, that there is any evidence in the record to support respondent's burden of establishing an alternative cause for petitioner's injury unrelated to vaccination.
