LOREN A. SMITH, Senior Judge.
Petitioner, Mark Miles, on behalf of and as the legal representative of a minor child, J.M., seeks review of a decision issued by Special Master Laura D. Millman denying his petition for vaccine injury compensation. Petitioner brought this action pursuant to the National Childhood Vaccine Injury Act, 42 U.S.C. §§ 300aa-10 to -34 (2012), alleging that the influenza ("flu") vaccine administered to his son, J.M. on October 1, 2009, caused J.M. to have a second relapse of his preexisting nephrotic syndrome. The Special Master denied compensation, finding that petitioner failed to provide a persuasive scientific or medical theory proving that the flu vaccine caused J.M.'s second relapse of minimal change nephrotic syndrome. Miles v. Sec'y of Health & Human Servs., 2019 WL 3990987 (Fed. Cl. Spec. Mstr. June 28, 2018) (Miles). Petitioner now moves for review of this decision. For the reasons that follow, the Court
A brief recitation of the facts provides necessary context.
J.M. was born on February 23, 2001, and he has an extensive medical history. On April 19, 2001, when J.M. was two months old, his mother took him to Willow Bend Pediatrics to be treated for head congestion, sneezing, and loss of appetite. On April 24, 2001, J.M. received his first DTaP, Hib, hepatitis B, and IVP vaccines. On June 12, 2001, J.M. was diagnosed with bronchiolitis
On September 6, 2007, J.M. went to Children's Medical Center in Dallas, Texas, where his medical history indicates he had a new onset of edema,
On December 19, 2007, J.M. was in remission and his steroid was slowly tapered. By February 6, 2008, J.M. was in full remission and completely tapered off prednisone. On March 26, 2008, J.M. was still in remission and off prednisone, but he was taking Norvasc,
On June 15, 2009, Becky Nolde-Hurlbert, Dr. Seikaly's nurse practitioner, noted that J.M. had had proteinuria since June 10, 2009, swelling in his face and abdomen, and elevated blood pressure. J.M. did not report any illness that could have triggered his first relapse of his nephrotic syndrome. On June 22, 2009, J.M.'s parents reported to Willow Bend Pediatrics that J.M. had a relapse of his nephrotic syndrome and was back on high-dose steroids. By June 29, 2009, J.M. was back in remission while taking another course of prednisone. J.M. was weaned off prednisone by September 7, 2009.
On October 1, 2009, J.M. received a flu vaccine. On October 9, 2009, J.M. saw Dr. Seikaly, who noted J.M. had done well since his last visit in August 2009 until the past two weeks when he had an increase in his urine protein and developed edema. According to the timeline of J.M.'s medical records, the relapse must have occurred prior to his October 1, 2009 flu vaccination. J.M. reported vomiting several times on October 13, 2009. He was hungry but unable to tolerate fluid or food. He did not have fever and had normal stools. On November 4, 2009, J.M.'s urine protein stayed mildly elevated. He was again prescribed prednisone and weaned slowly. When J.M. was weaned to 10 mg of prednisone every 48 hours in December 2009, J.M. had his third relapse.
On February 24, 2010, RN Nolde-Hurlbert noted that "anything that affects the immune system [] could be a contributing factor [to relapse]," but that "no cause and effect relationship [between the flu vaccine and nephrotic syndrome relapse] has been directly documented in the literature[;] there is only speculation." J.M. had a fourth relapse in March of 2010 and his fifth relapse in May of 2010.
J.M. saw his second pediatric nephrologist, Dr. Albert Quan, on May 13, 2010. Shortly thereafter, a renal biopsy was performed, which showed no evidence of focal segmental glomerulosclerosis
On January 28, 2011, Dr. Quan noted that J.M. had not had a relapse since his last office visit, and J.M. was weaned off Prograf.
On August 18, 2011, J.M. had a cardiovascular attack
In October 2011, J.M.'s hematologist noted that he had made a remarkable post-stroke recovery, and recommended anticoagulation therapy
As of March 2012, J.M.'s neurologist recorded that J.M. was off steroids and continued taking anti-epileptic medicine. Dr. Quan noted that J.M. was receiving Prograf, which would help prevent future strokes. Based on a neuropsychological evaluation performed in June 2012, J.M. continued to have cognitive deficits secondary to his CVAs.
On October 20, 2015, J.M. saw Dr. Kazi Majeed, a pediatric neurologist. J.M. had residual spastic hemiparesis. J.M. had a right cerebral infarct
Petitioner filed his Petition on behalf of J.M. with the Office of Special Masters on April 18, 2012. See generally Petition. On June 30, 2012, petitioner filed the expert report of pediatric nephrologist, Dr. Albert H. Quan.
Under the Vaccine Act, this Court may review a special master's decision upon the timely request of either party. See 42 U.S.C. § 300aa-12(e)(1)-(2). In that instance, the Court may:
Id. at § 300aa-12(e)(2)(A)-(C). Findings of fact and discretionary rulings are reviewed under an "arbitrary and capricious" standard, while legal conclusions are reviewed de novo. Munn v. Sec'y of Health & Human Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992).
This Court cannot "substitute its judgment for that of the special master merely because it might have reached a different conclusion." Snyder ex rel. Snyder v. Sec'y of Dep't of Health & Human Servs., 88 Fed. Cl. 706, 718 (2009). "Reversal is appropriate only when the special master's decision is arbitrary, capricious, an abuse of discretion, or not in accordance with the law." Id. Under this standard, a special master's decision "must articulate a rational connection between the facts found and the choice made." Cucuras v. Sec'y of Dep't of Health & Human Servs., 26 Cl. Ct. 537, 541-42 (1992), aff'd, 993 F.2d 1525 (Fed. Cir. 1993) (citing Burlington Truck Lines, Inc. v. United States, 371 U.S. 156, 168 (1962)). This standard is "highly deferential." Hines v. Sec'y of Dep't of Health & Human Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991). "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." Id.
Althen v. Secretary of Health & Human Services provides the evidentiary burden for petitioners attempting to succeed in a vaccine petition based on causation. See generally Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005). In order to prove causation-in-fact, a petitioner must
Id. at 1278. In order to succeed, petitioners must provide a "reputable medical or scientific explanation" for their claim. Id. Loving v. Secretary of Health and Human Services provides the "correct framework for evaluating off-table significant aggravation claims." W.C. v. Sec'y of Health and Human Servs., 704 F.3d 1352, 1357 (Fed. Cir. 2013) (citing Loving v. Sec'y of Health and Human Servs., 86 Fed. Cl. 135, 144 (Fed. Cl. 2009)). The Loving test is comprised of the following six parts:
Loving, 86 Fed. Cl. at 144.
Within this framework, petitioner makes five numbered objections to the June 28, 2018 decision. See MFR at 3-5. First, petitioner asserts that the Special Master rejected the well-supported and generally-recognized theory that nephrotic syndrome is caused by an adverse immune reaction, significantly raising petitioner's burden of proof in violation of limitations set by Althen. Id. at 3. Second, petitioner argues that the Special Master further rejected the petitioner's plausible theory of causation by adopting an idiopathic or unknown cause for the injury in violation of 42 U.S.C. § 300aa-13(a)(2)(A). Id. at 3-4. Third, petitioner argues that the Special Master rejected the well-accepted theory of causation based upon the credibility of the treating physician which was arbitrary and capricious, as well as in violation of the instructions in Andreu ex rel. Andreu v. Sec'y of Health and Human Servs. Id. at 4 (citing Andreu, 569 F.3d 1367, 1375 (Fed Cir. 2009)). Fourth, petitioner contends that the Special Master arbitrarily and capriciously misconstrued petitioner's claim to be that the vaccine injury took place on the first through the second of October 2009, when petitioner actually claimed that the injury was the exacerbation of the syndrome from steroid-sensitive to steroid-dependent following the vaccine, an aggravation that was not discovered until December of 2009, well within the three-day to eight-week period consistent with an immune reaction. Id. at 4. Finally, petitioner alleges that the Special Master arbitrarily and capriciously ignored the testimony of all the experts in finding that the vaccine did not cause J.M.'s strokes. Id. at 5.
In his Motion for Review, petitioner alleges that "by rejecting a well[-]accepted theory of causation based upon inconclusive new research, the Special Master impermissibly increased the petitioner's burden of proof." MFR at 34. In making this assertion, petitioner posits that he has satisfied the three-prong test set forth in Althen, and is, therefore, "entitled to recover unless the respondent shows, also by a preponderance of the evidence, that the injury was in fact caused by factors unrelated to the vaccine." Id. at 35 (quoting Knudsen v. Sec'y of Health and Human Servs., 35 F.3d 543, 547 (Fed. Cir. 1994)). Petitioner goes on to argue that "those factors cannot include any idiopathic, unexplained, unknown, hypothetical, or undocumentable cause, factor, injury, illness, or condition." Id. (citing 42 U.S.C. § 300aa-13(a)(2)(a)).
In her decision, Special Master Millman accurately articulates petitioner's burden of proof in vaccine compensation cases. A petitioner must provide a persuasive medical theory. "A persuasive medical theory is demonstrated by `proof of a logical sequence of cause and effect showing that the vaccination was the reason for the injury.'" Dec. at 57 (citing Althen, 418 F.3d at 1278 (quoting Grant v. Sec'y of Health and Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992))). The Special Master then goes on to point out that "[w]ithout more, `evidence showing an absence of other causes does not meet petitioner's affirmative duty to show actual or legal causation.'" Id. (citing Grant, 956 F.2d at 1149). Finally, a "[m]ere temporal association is not sufficient to prove causation in fact." Id. (citing Grant, 956 F.2d at 1148).
Petitioner clearly misapplies the law in his Motion for Review. Petitioner argues that "[t]he respondent has not proven by a preponderance of any evidence that there is an alternate cause of nephrotic syndrome or how an alternate cause, if discovered, can lead to the aggravation of the nephrotic state." MFR at 37. Petitioner alone bears the burden of proving his theory of causation. "[T]he statutory standard of preponderance of the evidence requires a petitioner to demonstrate that the vaccine more likely than not caused the condition alleged." LaLonde v. Sec'y of Health and Human Servs., 746 F.3d 1334, 1339 (Fed. Cir. 2014). If the petitioner is unsuccessful in meeting this burden, that burden does not then shift to the respondent to prove an alternative persuasive medical theory for the petitioner's injury. Bradley v. Sec'y of Health and Human Servs., 991 F.2d 1507, 1575 (Fed. Cir. 1993); see also Doe 11 v. Sec'y of Health and Human Servs., 601 F.3d 1349, 1358 (Fed. Cir. 2010); Deribeaux v. Sec'y of Health and Human Servs., 105 Fed. Cl. 583, 587 (2012), aff'd, 717 F.3d 1363 (Fed. Cir. 2013). Respondent need only "offer evidence to demonstrate the inadequacy of the petitioner's evidence on a requisite element of the petitioner's case in chief." De Bazan v. Sec'y of Health and Human Servs., 593 F.3d 1347, 1353 (Fed. Cir. 2008).
Petitioner undercuts his argument by pointing out that his theory of causation is not well documented among medical literature and remains unproven. MFR at 36. Undeterred, petitioner then attempts to shift the burden of proof to respondent by stating that "[t]he respondent has not proven by a preponderance of any evidence that there is an alternate cause of nephrotic syndrome or how an alternate cause, if discovered, can lead to the aggravation of the nephrotic state." Id. at 37. Here, it is again important to note that "evidence showing an absence of other causes does not meet petitioner's affirmative duty to show actual or legal causation." Grant, 956 F.2d at 1149. As the burden rests solely on the petitioner to prove his medical theory, and as the Special Master reasonably determined that petitioner did not meet that burden, the Court finds that petitioner's burden was not unreasonably elevated.
Petitioner's second numbered objection alleges that the Special Master rejected the petitioner's plausible theory of causation by adopting an idiopathic or unknown cause for the injury in violation of 42 U.S.C. § 300aa-13(a)(2)(A). MFR at 3-4. In making this assertion, petitioner once again misapplies the law. Althen requires that petitioners must provide a "reputable medical or scientific explanation" for their claim." Althen, 418 F.3d at 1278. "The determination of whether a proffered theory of causation is `reputable' may `involve an assessment of the relevant scientific data.'" Hazlehurst ex rel. Hazlehurst v. Sec'y of Health & Human Servs., 88 Fed. Cl. 473, 479 (2009) (quoting Andreu, 569 F.3d at 1379). The Special Master clearly engaged in such an analysis.
In her decision, Special Master Millman narrows down petitioner's case to the following two main issues:
Dec. at 58. After careful review of the record, Special Master Millman determined that "minimal change nephrotic syndrome is not immune-mediated, contrary to [petitioner's expert,] Dr. Bellanti's[,] entire presentation." Id. She goes on to point out that:
Id. at 58-59. Having deemed the petitioner's medical theory unpersuasive, the Special Master need go no further. The Special Master determined that "Greenbaum's article supports Dr. Kaplan's thesis that viewing minimal change nephrotic syndrome as immune-mediated is no longer the current medical view." Id. at 61. It seems clear to the Court that Special Master Millman determined that the flu vaccine was not the cause of J.M.'s nephrotic syndrome relapse because the petitioner's theory of causation was unpersuasive and insufficient.
In his second numbered objection, petitioner clearly misconstrues the law. Section 300aa-13(a)(1)(B) of United States Code Title 42 requires that the petitioner has demonstrated by a preponderance of the evidence that it has met the requirements of 42 U.S.C. § 300aa-11(c)(1). Only once the petitioner has met that burden, does the Special Master need to analyze whether "there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition." Id. Section 300aa-13(a)(2)(a) of United States Code Title 42 requires that those "factors unrelated to the administration of the vaccine" not include any "idiopathic, unexplained, unknown, hypothetical, or undocumentable cause, factor, injury, illness, or condition." Id. However, those rules, when read together, clearly place the burden on the petitioner to establish his case, before the respondent is required to refute it. Once the Special Master determines that petitioner fails to meet the standard set forth in 42 U.S.C. § 300aa-11(c)(1), the analysis need go no further. Respondent is not required to disprove a theory of causation that the Special Master has already determined to be insufficient. Therefore, the Special Master did not err in finding that petitioner failed to demonstrate his theory of causation by a preponderance of the evidence.
In his third numbered objection, petitioner argues that the Special Master was arbitrary and capricious in finding that Dr. Quan was less credible than respondent's expert, thereby rejecting a well-founded theory of causation in favor of new research. MFR at 39. In making this argument, petitioner contends that "[r]ejection of a generally accepted theory of causation based upon credibility raises the petitioners burden of proof and is an error of law," which, petitioner believes violates the standard set forth in Andreu. MFR at 42.
In her decision, Special Master Millman acknowledged the following:
Dec. at 59 (citing Capizzano, 440 F.3d at 1326; Broekelschen v. Sec'y of Health and Human Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010); Andreu, 569 F.3d at 1375). She then goes on to state that "[t]he undersigned considers seriously the opinion of Dr. Quan, J.M.'s second pediatric nephrologist." Id.
In its response, respondent correctly points out that "`there is nothing in Andreu that mandates that the testimony of a treating physician is sacrosanct—that it must be accepted in its entirety and cannot be rebutted.'" Respondent's Response to Petitioner's Motion for Review (hereinafter "Resp.") at 16 (citing Snyder, 88 Fed. Cl. at 745 n.67; 42 U.S.C. § 300aa-13(b)(1) (statements of treating physicians are not binding on special masters)). Respondent goes on to argue that "[a] treating physician's opinion on vaccine causation is only as strong as its underlying basis." Id. (citing Perreira v. Sec'y of Health and Human Servs., 33 F.3d 1375, 1377 n.6 (Fed. Cir. 1994); See also Dobrydnev v. Sec'y of Health and Human Servs., 566 Fed. Appx. 976, 982-983 (Fed. Cir. 2014) (holding that the Special Master was correct in noting that "when an expert assumes facts that are not supported by preponderance of the evidence, a finder of fact may properly reject the expert's opinion").
Special Master Millman repeatedly cited to both the expert reports and testimony of Dr. Quan, but ultimately determined that petitioner's theory of relapse was inadequate. The Special Master found that "[Dr. Quan] succinctly described the problem with understanding minimal change nephrotic syndrome in his expert report." Dec. at 59. She further found that "Dr. Quan also made some other important admissions," including that "it was impossible to say if a flu shot would make a relapse already in progress worse," and that "one does not really know if there is a natural course of minimal change nephrotic syndrome." Id. at 61 (citing Transcript of Proceedings (hereinafter "Tr.") at 66, 225). Ultimately, Special Master Millman found that these admissions, as well as respondent's evidence disputing the petitioner's theory of causation, tipped the scale firmly in respondent's direction.
Petitioner may not like the outcome of Special Master Millman's analysis, but "it is important to recognize that Special Masters may use their discretion in weighing expert testimony." Cunningham v. Sec'y of Health and Human Servs., 2017 WL 1174448 at 5(Fed. Cl. Jan. 25, 2017). "`[R]eversible error will be extremely difficult to demonstrate' where the special master `has considered the relevant evidence of record, drawn plausible inferences and articulated a rational basis for the decision.'" Porter, 663 F.3d at 1253-54 (quoting Hines, 940 F.2d at 1528); see also Lombardi v. Sec'y of Health & Human Servs., 656 F.3d at 1343, 1353 (Fed. Cir. 2010). The Court does not believe the Special Master's decision runs afoul of this deferential standard, and, as such, her findings as to Dr. Quan's expert opinions are neither arbitrary nor capricious.
In his fourth numbered objection, petitioner argues that the Special Master was arbitrary and capricious in finding that the onset of J.M.'s nephrotic syndrome relapse occurred too soon after administration of the flu vaccine. MFR at 4. In order to prevail under both Althen and Loving, petitioner must show by a preponderance of the evidence a proximate temporal relationship between vaccination and injury or significant aggravation. Althen, 418 F.3d at 1278; see also Loving, 86 Fed. Cl. at 144. The Court does not believe that the Special Master erred in determining that petitioner has not met the requisite burden.
Medical literature seems to support the Special Master's findings that vaccination could not trigger a relapse that began less that twenty-four hours after administration of the vaccine. The Special Master cites to a number of case studies with a causal connection between vaccine administration and nephrotic syndrome, but those case studies document relapses occurring, five days,
In determining whether a special master's finding of fact is arbitrary and capricious, this Court must look to plausibility, not to whether it is supported by a preponderance of the evidence. As long as the finding of fact is "based on evidence in the record that [is] not wholly implausible, [this Court is] compelled to uphold the finding as not being arbitrary or capricious." Porter v. Sec'y of Health & Human Servs., 663F.3d 1242, 1249 (Fed. Cir. 2012) (quoting Cedillo v. Sec'y of Health & Human Servs., 617 F.3d 1328, 1338 (Fed. Cir. 2010)). Ultimately, Special Master Millman determined the following:
Dec. at 60. It seems wholly plausible to this Court that the weight gain, which signaled edema, and the proteinuria began prior to and unrelated to the vaccination. As such, the Court must uphold Special Master Millman's findings as neither arbitrary nor capricious.
In his final numbered objection, petitioner argues that the Special Master arbitrarily and capriciously ignored the testimony of all the experts in finding that the vaccine did not cause J.M.'s strokes. MFR at 5. In making this assertion, petitioner points to "Dr. Quan's conclusion that J.M.'s strokes were caused by thrombosis resulting from his prolonged poorly controlled nephrotic state." Id. at 47. That conclusion alone is not enough to link J.M.'s second relapse of minimal change nephrotic syndrome to the flu vaccine.
Petitioner's argument is a bit of a misnomer. He asks the Court to determine that the Special Master erred in not finding that J.M.'s strokes were a direct result of his October 2009 flu vaccine, despite the fact that none of the experts ever attempted to find such a direct causal link. In his testimony, Dr. Quan testified that he believed that "flu vaccine led to J.M.'s new onset of his latest relapse that finally led to his stroke." Tr. at 64. Yet, petitioner's argument omits the important intermediate step between the vaccine and the strokes—nephrotic syndrome.
Special Master Millman noted Dr. Quan's testimony that "[a] poorly controlled nephrotic syndrome has a higher risk of stroke or any other type of clotting complication." Dec. at 37 (citing Tr. at 64). She also highlights the testimony of Dr. Kaplan, who could not "ascribe J.M.'s strokes to the flu vaccine or to his nephrotic syndrome." Dec. at 52 (citing Tr. at 370). Ultimately, Special Master Millman found that "the issue of J.M.'s strokes is an enigma that neither Dr. Quan nor Dr. Kaplan could explain in terms of sequelae." Id. at 59.
Even if the Special Master had accepted Dr. Quan's testimony and found that J.M.'s nephrotic syndrome caused his strokes, petitioner's theory still fails. The important causal link remains absent. Special Master Millman determined that "petitioner has failed to provide a persuasive scientific or medical theory proving that flu vaccine caused J.M.'s second relapse of minimal change nephrotic syndrome." Dec. at 62. Having arrived at that conclusion, it logically follows that the strokes resulting from the nephrotic syndrome relapse cannot be causally linked to that same vaccination. As such, Special Master Millman did not err in her determination that flu vaccine did not cause J.M.'s strokes.
The Court finds that petitioner has not met his burden of proof in alleging that his October 2009 influenza vaccine resulted in J.M.'s nephrotic syndrome relapse or significantly worsened his nephrotic syndrome. For the foregoing reasons, the Court
Dorland's at 539. Nephrotic syndrome is defined as the "general name for any of a large group of diseases involving defective renal glomeruli, characterized by massive proteinuria and lipiduria with varying degrees of edema, hypoalbuminemia, and hyperlipidemia." Dorland's at 1840.
Dorland's at 787.
Dorland's at 674.
