MARGARET M. SWEENEY, Judge.
Petitioner seeks compensation under the National Childhood Vaccine Injury Act of 1986 ("Vaccine Act"), 42 U.S.C. §§ 300aa-1 to -34 (2006), alleging that she sustained a spinal cord stroke caused by a human papillomavirus ("HPV") vaccination. In a September 28, 2013 decision, the special master denied petitioner's request for compensation. Before the court is petitioner's motion for review of the special master's decision. For the reasons set forth below, the court denies petitioner's motion for review and sustains the decision of the special master.
Petitioner's medical history is not in dispute, and can be briefly summarized.
At Rush, petitioner underwent an extensive medical workup and was given a working diagnosis of transverse myelitis. That diagnosis changed after two neurologists, Drs. Tilwalli and Stefofski, examined petitioner on August 6, 2008. As described by the special master:
On August 7, 2008, petitioner was transferred from Rush to the Rehabilitation Institute of Chicago. Her physical condition did not improve; she continued to require total assistance for mobility and all activities of daily living. In addition, she had been on continuous ventilation during her stay at Rush and remained on the ventilator during her rehabilitation. Petitioner was discharged from inpatient rehabilitation on December 16, 2008. Since that time, she has shown some improvement-she has begun to feel some sensation in her extremities and exhibited voluntary movement in two fingers. However, she remains dependent on a ventilator.
Petitioner's father filed a petition for compensation under the Vaccine Act on July 29, 2010, claiming that the HPV vaccine caused his daughter's spinal cord stroke. Upon reaching the age of majority, Ms. Flores was substituted as petitioner. After the submission of medical records and expert reports, the special master convened an evidentiary hearing, during which he heard the testimony of three expert witnesses. Petitioner offered the testimony of neurologist Douglas A. Kerr, M.D., Ph.D., and respondent offered the testimony of pediatric neurologist Peter M. Bingham, M.D., and pediatric hematologist Joan Cox Gill, M.D. Posthearing briefs were filed, and the special master issued a decision on September 12, 2013.
In his decision, the special master noted that all three experts agreed that petitioner had suffered a spinal cord stroke, which was caused by a blood clot that had become lodged in a spinal cord vessel, depriving petitioner's spinal cord of oxygen and causing permanent injury. Where the experts disagreed, the special master explained, was on the cause of the blood clot. Dr. Kerr opined that the blood clot was caused by the HPV vaccine. Specifically, he asserted that petitioner had a genetic predisposition to blood clotting involving multiple genes; that petitioner's first HPV vaccination sensitized her immune system; that the second HPV vaccination elicited an exuberant, rapid immune response; and that the immune response resulted in petitioner's blood clot, either through inflammation or platelet aggregation. Drs. Bingham and Gill, on the other hand, found it improbable that the HPV vaccine could be connected to petitioner's blood clot. Dr. Bingham explained that there was neither clinical evidence of inflammation, nor a noted connection between the HPV vaccine and spinal cord strokes or blood clots. Dr. Gill asserted that there was no clinical evidence of inflammation or platelet aggregation, and that a clotting response via inflammation would have taken at least four days to develop.
The special master initially found that petitioner was unable to establish that she had a genetic predisposition to blood clotting. Because this genetic predisposition was a critical factor of the theory of causation advanced by Dr. Kerr, the special master concluded that petitioner could not establish that Dr. Kerr's theory was probable. Although this conclusion, on its own, was sufficient to deny petitioner's request for compensation under the Vaccine Act, the special master addressed other aspects of Dr. Kerr's theory. First, he noted that Dr. Kerr's theory was premised on petitioner's spinal cord stroke originating from a blood clot in a vein (venous thrombosis), but that the evidence supported a finding that the blood clot originated in an artery (arterial thrombosis). Second, the special master held that petitioner failed to demonstrate that the HPV vaccine can contribute to the type of inflammation that causes blood clots and strokes or that petitioner's second HPV vaccination did contribute to her blood clot or stroke. Similarly, the special master concluded that petitioner had not shown that she had experienced platelet aggregation or that any platelet aggregation contributed to her blood clot or stroke.
In addition to addressing specific elements of Dr. Kerr's theory of causation, the special master discussed some of the medical literature submitted by the parties. He held that the Slade article, relied upon heavily by Dr. Kerr, did not offer "significant support" for the proposition that the HPV vaccine can contribute to strokes. The special master also concluded that other medical literature added "slightly" to the reasons to reject Dr. Kerr's theories of causation.
At the close of his decision, after concluding that the lack of an identifiable cause of petitioner's spinal cord stroke did not offer "significant support" for her theory that the HPV vaccine caused the stroke, the special master analyzed petitioner's case under the test for causation set forth in
The United States Court of Federal Claims has jurisdiction to review the record of the proceedings before a special master, and upon such review, may:
42 U.S.C. § 300aa-12(e)(2). In the instant case, petitioner enumerates, pursuant to Vaccine Rule 24, three objections to the special master's decision. First, petitioner asserts that the special master impermissibly required her to identify the specific genes or cluster of genes that could have caused her susceptibility to blood clotting. Second, petitioner contends that the special master abused his discretion by rejecting several aspects of Dr. Kerr's testimony regarding the logical sequence of cause and effect that connected her second HPV vaccination to her spinal cord stroke. Third, petitioner avers that the special master held her to an elevated burden of proof that was rejected in
Pursuant to 42 U.S.C. § 300aa-13(a)(1), the court shall award compensation if a petitioner proves, by a preponderance of evidence, all of the elements set forth in 42 U.S.C. § 300aa-11(c)(1),
To establish a prima facie case when proceeding on a causation-in-fact theory, as petitioner attempted to do in this case, a petitioner must "prove, by a preponderance of the evidence, that the vaccine was not only a but-for cause of the injury but also a substantial factor in bringing about the injury."
As noted above, the Federal Circuit, in
Once a petitioner has established a prima facie case, the burden shifts to the respondent to show, by a preponderance of the evidence, that the injury was caused by a factor unrelated to the vaccine. 42 U.S.C. § 300aa-13(a)(1)(B);
Within her enumerated objections to the special master's decision, petitioner contends that several of the special master's conclusions were not in accordance with the law. Specifically, she argues that the special master, in various portions of his decision, required her to provide "objective confirmation in the medical community" linking her second HPV vaccination to her spinal cord stroke, impermissibly elevating her burden beyond what is permitted by the Vaccine Act. Mot. 16.
Petitioner first asserts that the special master improperly elevated her burden of proof by requiring her to identify the specific genes or cluster of genes that made her susceptible to a vaccine injury. In his decision, the special master noted that Dr. Kerr's theory of causation depended on petitioner being genetically susceptible to blood clotting, and that Dr. Kerr testified that such a genetic predisposition would involve a combination of several genes. However, Dr. Kerr was unable to identify what genes or gene combination would be involved. In addition, Dr. Kerr acknowledged that a gene mutation discovered during petitioner's workup at Rush-a MTHFRA1298C heterozygous mutation-could not, by itself, cause susceptibility to blood clotting or stroke, and that the MTHFR gene might not have been part of the gene cluster at all. Indeed, remarked the special master, Dr. Gill, a hematologist, explained that petitioner's MTHFR gene mutation does not cause blood clotting, and that there was no clinical evidence of petitioner having other MTHFR gene mutations that might increase the risk of blood clots. Based on all of this testimony, the special master concluded that Dr. Kerr's assertion that petitioner must have had a cluster of genes causing a predisposition to blood clotting was no more than mere speculation, and was therefore insufficient to meet petitioner's burden of establishing a probable theory of causation.
A close examination of the special master's analysis reveals that he did require petitioner to offer proof of the specific genes or gene cluster that contributed to petitioner's predisposition to blood clotting.
Under the second prong of the
Another portion of the special emaster's decision that was contrary to law, asserts petitioner, is the special master's review of and reliance on medical literature. Specifically, she contends that although the special master stated that he was not requiring her to submit medical literature, he improperly used the submitted medical literature showing that there was no association between the HPV vaccine and her injury to "bolster the weight of evidence" against her. Mot. 15. According to petitioner, this practice was rejected by the Federal Circuit in
In
569 F.3d 1367, 1379-80 (Fed. Cir. 2009) (citations omitted). In his decision, the special master thoroughly evaluated the Slade article, which was submitted by both parties in support of their respective positions, and concluded that it did not provide "significant support for Dr. Kerr's general proposition that the HPV vaccine [could] contribute to causing strokes."
The third portion of the special master's decision challenged by petitioner as contrary to law is the special master's discussion of the lack of evidence supporting an alternative cause for her injury. Petitioner contends that this lack of evidence is only relevant to respondent's burden of establishing an alternative cause, and not to Dr. Kerr's theory of causation. Petitioner is mistaken.
As noted above, a special master may consider the existence of alternative causes of injury in determining whether the petitioner has established a prima facie case of causation.
In addition to arguing that parts of the special master's decision were contrary to law, petitioner contends that the special master abused his discretion in rejecting Dr. Kerr's testimony regarding certain elements of the logical sequence of cause and effect that allegedly connected her second HPV vaccination to her spinal cord stroke; namely, the origin of her blood clot and the existence of inflammation and platelet aggregation. An abuse of discretion occurs when a "decision is based on clearly erroneous findings of fact, is based on erroneous interpretations of the law, or is clearly unreasonable, arbitrary or fanciful."
Petitioner first contends that the special master abused his discretion by rejecting Dr. Kerr's testimony that her spinal cord stroke originated from a venous thrombosis in favor of Dr. Gill's testimony that her stroke originated from an arterial thrombosis. In support of this contention, petitioner notes that Dr. Kerr has more experience than Dr. Gill with spinal cord strokes and avers that Dr. Gill relied on the results of a test-the D-dimer test-that do not support her position. Accordingly, petitioner argues, the special master's conclusion that Dr. Gill was more persuasive on the origin of the blood clot was improper.
While petitioner's first point-that Dr. Kerr was more experienced than Dr. Gill regarding spinal cord strokes-may be true, it is only one aspect of what the special master could have considered in analyzing the origins of petitioner's blood clot. Indeed, the special master's decision reflects that he considered the testimony of all three experts regarding the bases for their respective positions, as well as a medical article that supported Dr. Gill's position. That the special master assigned different weights to this evidence than the weights preferred by petitioner is not an abuse of discretion.
Petitioner's second point concerns the results of three D-dimer tests she underwent at Rush on July 5 and 6, 2008. According to the undisputed testimony of Dr. Gill, the D-dimer test shows whether there is ongoing coagulation, and a negative result suggests that a venous thrombosis is highly unlikely. The reference range for petitioner's D-dimer tests was "0.00 - 0.60 ug/mL," and appended to the results of each test was the following comment: "D-Dimer results of less than 0.5 ug/mL have been shown to contribute to the exclusion of venous thromboembolism with a negative predictive value of approximately 98% when results are used as part of the total clinical evaluation of the patient." Pet'r's Ex. 20 at 928-32. The results of petitioner's three D-dimer tests were 0.51 ug/mL, 0.46 ug/mL, and 0.49 ug/mL.
Petitioner advances two arguments related to the D-dimer test results: (1) Dr. Gill's testimony was contradicted by the comment in the test results, and (2) Dr. Gill acknowledged that petitioner was taking medication that could lower the test results. Petitioner's first argument suffers from an error in logic. Petitioner contends that the 0.51 ug/mL test result contradicts Dr. Gill's testimony because it does not meet the "less than 0.5 ug/mL" threshold described in the test result comment.
Petitioner's second argument fares no better. While Dr. Gill acknowledged that one of petitioner's medications could lower the D-dimer test results, she did not retract her conclusion that the test results made a venous thrombosis unlikely. As a result, the record contains evidence that supports the special master's reliance on Dr. Gill's analysis of the D-dimer test results. Petitioner therefore has not demonstrated that the special master's acceptance of Dr. Gill's testimony was an abuse of discretion. Instead, all that she has established is that she would weigh the evidence regarding the effect of petitioner's medication on the D-dimer test results differently.
In sum, the special master's conclusion that Dr. Gill was more persuasive than Dr. Kerr regarding the origin of petitioner's blood clot was not improper.
In addition to arguing that the special master should not have rejected Dr. Kerr's testimony that she experienced a venous thrombosis, petitioner contends that the special master abused his discretion in rejecting Dr. Kerr's testimony regarding how the immune response triggered by her second HPV vaccination led to a blood clot, and instead accepting the testimony of Dr. Gill.
Dr. Kerr proposed two mechanisms that might link petitioner's immune response to her blood clot: inflammation and platelet aggregation. With respect to inflammation, petitioner asserts that Dr. Kerr's theory relied upon the presence of localized inflammation, i.e., inflammation in her central nervous system, and that Dr. Gill rejected Dr. Kerr's theory because (1) there was no evidence of systemic inflammation in her test results and (2) her spinal cord stroke occurred too soon after her second HPV vaccination. Petitioner contends that the special master's acceptance of Dr. Gill's testimony over the testimony of Dr. Kerr was improper because Dr. Gill was looking for systemic inflammation based on an incorrect diagnosis of her neurological injury, and because the timing of her stroke was appropriate because her immune system was primed by her first HPV vaccination. She further contends, with respect to platelet aggregation, that the special master improperly required her to prove a specific biological mechanism of injury.
Ultimately, Dr. Gill's characterization of petitioner's injury and the possible priming effect of petitioner's first HPV vaccination were not material to the special master's decision to reject Dr. Kerr's testimony. Not only did Dr. Gill and Dr. Bingham testify that none of petitioner's test results reflected systemic inflammation, Dr. Bingham further testified that the results of tests of petitioner's spinal cord fluid did not show inflammation, i.e., there was no evidence of localized inflammation. Moreover, Dr. Gill testified that there was no evidence of platelet aggregation in petitioner's test results. The special master was therefore entitled to conclude that if the logical sequence of cause and effect posited by Dr. Kerr included the existence of inflammation or platelet aggregation, but there was no evidence of inflammation or platelet aggregation in any of petitioner's test results, then petitioner could not establish an essential element of causation linking her second HPV vaccination to her spinal cord stroke.
The court's conclusion finds ample support in Federal Circuit precedent.
The theory of causation advanced by Dr. Kerr was that petitioner had a genetic predisposition to blood clotting involving multiple genes; that petitioner's first HPV vaccination sensitized her immune system; that the second HPV vaccination elicited an exuberant, rapid immune response; that the immune response resulted in the blood clot, either through the creation of inflammation or platelet aggregation; and that the blood clot caused petitioner's spinal cord stroke. To establish the second prong of the
For the reasons stated above, the court
(1) that the vaccine in question is set forth in the Vaccine Injury Table ("Table"); (2) that the vaccine was received in the United States or in its trust territories; (3) that the injured person either sustained an injury as a result of the administration of a Table-designated vaccine for a period of more than six months after the administration of the vaccine, suffered illness, disability, injury, or condition from the vaccine that resulted in inpatient hospitalization and surgical intervention, or died from the administration of the vaccine; and (4) that the petitioner has not previously collected an award or settlement of a civil action for damages arising from the alleged vaccine-related injury or death. 42 U.S.C. § 300aa-11(c)(1).