CHRISTIAN J. MORAN, Special Master.
Before receiving a tetanus-diphtheria-acellular pertussis ("Tdap") vaccine in 2013, David Landis, the petitioner, suffered from many health problems, including osteoarthritis. Osteoarthritis is a noninflammatory degenerative disease of the joints. Mr. Landis alleges that the Tdap vaccine significantly aggravated his osteoarthritis, and the Secretary of Health and Human Services, the respondent, disputes this allegation.
The development of this case took a relatively long time, culminating in a series of reports from experts. Mr. Landis retained Dr. Anna Nowak-Wegrzyn, a pediatrician and allergist/immunologist, whose reports are exhibits 21 and 42. The Secretary retained Dr. Arnold I. Levinson, an internist and allergist/immunologist, whose reports are exhibits A, C, and D.
Mr. Landis has requested a ruling on the record in his favor. Although a resolution based on the papers is appropriate, the record does not support Mr. Landis's claim for entitlement.
Mr. Landis began this case by filing a petition on December 21, 2015, which alleged that the Tdap vaccine significantly aggravated his osteoarthritis.
The Secretary filed his report, pursuant to Vaccine Rule 4, on July 29, 2016. Resp't's Rep. The Secretary reviewed Mr. Landis's medical history in considerable detail.
In the ensuing status conference, Mr. Bolton agreed to seek the missing medical records.
The parties discussed the state of the record in a January 13, 2017 status conference. Order, issued Jan. 19, 2017. The Secretary continued to request more medical records.
In the January 13, 2017 status conference, the undersigned also directed Mr. Landis to provide evidence supporting his claim that the worsened osteoarthritis caused him to lose income from his job as a chiropractor.
Mr. Landis filed more medical records on February 5, 2017. Exhibits 16-19. The parties again discussed the status of the record in a status conference on February 15, 2017. Order, issued Feb. 16, 2017. Mr. Bolton relayed that he was having difficulty communicating with Mr. Landis.
With respect to the question of lost earnings, Mr. Bolton had filed Mr. Landis's tax return from 2010 as exhibit 20. Mr. Bolton represented that Mr. Landis had become ill with asthma between 2010 and 2013, a time in which he did not see many patients. Mr. Bolton further stated that Mr. Landis's sister closed his office in August 2014 and destroyed his office records.
To facilitate the process of obtaining useful reports from experts, the undersigned proposed a set of instructions in his February 16, 2017 order. After not receiving any comments, the undersigned made those proposed instructions final.
On behalf of Mr. Landis, Mr. Bolton filed a status report on April 7, 2017, discussing many issues. In response to the plan to obtain reports from experts, Mr. Bolton relayed that he was retaining an expert. As to the information regarding Mr. Landis's lost earnings, Mr. Bolton stated that 2010 was the most recent year that Mr. Landis submitted a tax return. Finally, Mr. Bolton also reported that he had requested information on the Tdap vaccine and arthritis, together with pre- and post-marketing findings and reports, from GlaxoSmithKline but had not received any response.
Mr. Landis filed a report from Dr. Nowak-Wegrzyn on May 4, 2017. Exhibit 21. As discussed below, Dr. Nowak-Wegrzyn generally opined that the Tdap vaccination significantly aggravated Mr. Landis's osteoarthritis.
The Secretary responded with a report from Dr. Levinson, filed on August 21, 2017. Exhibit A. Dr. Levinson agreed with Dr. Nowak-Wegrzyn that Mr. Landis suffered from osteoarthritis before the Tdap vaccination.
Mr. Bolton filed a motion for discovery on September 26, 2017. Mr. Bolton sought further information about Dr. Levinson. Specifically, Mr. Bolton wanted to know how many times Dr. Levinson had testified in medico-legal matters in the previous five years and what percentage of his income was derived from such activity. Mr. Bolton also wanted to ascertain whether Dr. Levinson had any affiliations with GlaxoSmithKline or with any of its affiliates. The September 26, 2017 motion for discovery did not request any information from GlaxoSmithKline. The undersigned eventually ordered Dr. Levinson to provide a limited amount of additional information (
Meanwhile, Dr. Nowak-Wegrzyn wrote a rebuttal report, which was filed as exhibit 42 on October 29, 2017. With Dr. Nowak-Wegrzyn's rebuttal report on file, Mr. Bolton filed a motion for a ruling on the record on January 6, 2018. The Secretary responded on January 23, 2018.
The undersigned denied the motion for a ruling on the record without prejudice. Order, issued May 1, 2018. The undersigned found that the motion was not adequately developed.
The Secretary filed the final expert report from Dr. Levinson on July 13, 2018. Exhibit D. The parties discussed the experts' presentations in an August 20, 2018 status conference.
Mr. Bolton did file such a motion on October 26, 2018. In a February 5, 2019 decision, the undersigned awarded Mr. Landis all the attorney's fees and costs that the October 26, 2018 motion requested. 2019 WL 1061516.
On December 11, 2018, Mr. Landis filed the pending motion for a ruling on the record. The Secretary filed his response on March 28, 2019, and Mr. Landis replied on May 28, 2019. With the filing of Mr. Landis's reply, the case is ready for adjudication.
Petitioners are required to establish their cases by a preponderance of the evidence. 42 U.S.C. § 300aa-13(1)(a). The preponderance of the evidence standard requires a "trier of fact to believe that the existence of a fact is more probable than its nonexistence before [he] may find in favor of the party who has the burden to persuade the judge of the fact's existence."
The process for finding facts in the Vaccine Program begins with analyzing the medical records, which are required to be filed with the petition. 42 U.S.C. § 300aa-11(c)(2). Medical records that are created contemporaneously with the events they describe are presumed to be accurate.
Not only are medical records presumed to be accurate, they are also presumed to be complete, in the sense that the medical records present all the patient's medical issues. Completeness is presumed due to a series of propositions. First, when people are ill, they see a medical professional. Second, when ill people see a doctor, they report all of their problems to the doctor. Third, having heard about the symptoms, the doctor records what he or she was told.
Appellate authorities have accepted the reasoning supporting a presumption that medical records created contemporaneously with the events being described are accurate and complete. A notable example is
Judges of the Court of Federal Claims have followed
The presumption that contemporaneously created medical records are accurate and complete is rebuttable, however. For cases alleging a condition found in the Vaccine Injury Table, special masters may find when a first symptom appeared, despite the lack of a notation in a contemporaneous medical record. 42 U.S.C. § 300aa-13(b)(2). By extension, special masters may engage in similar fact-finding for cases alleging an off-Table injury. In such cases, special masters are expected to consider whether medical records are accurate and complete. To overcome the presumption that written records are accurate, testimony is required to be "consistent, clear, cogent, and compelling."
In determining the accuracy and completeness of medical records, special masters will consider various explanations for inconsistencies between contemporaneously created medical records and later given testimony. The Court of Federal Claims has identified four such explanations for explaining inconsistencies: (1) a person's failure to recount to the medical professional everything that happened during the relevant time period; (2) the medical professional's failure to document everything reported to her or him; (3) a person's faulty recollection of the events when presenting testimony; or (4) a person's purposeful recounting of symptoms that did not exist.
When weighing divergent pieces of evidence, special masters usually find contemporaneously written medical records to be more significant than oral testimony.
The participants differ on events in Mr. Landis's life, particularly before the Tdap vaccination. The Secretary and his expert, Dr. Levinson, sing with one voice—they treat the medical records created contemporaneously with the events being described in the medical records as accurate. Dr. Nowak-Wegrzyn, Mr. Landis's expert, seems to share this view as she states that before the vaccination Mr. Landis suffered from:
Exhibit 21 at 9. However, Mr. Landis and Mr. Bolton take a different view. Before this vaccination, Mr. Landis's "health was excellent." Pet'r's Mot. at 2, citing exhibit 3 (Mr. Landis's affidavit) at 1;
Crediting Mr. Landis's version is difficult for several reasons. Most fundamentally, Mr. Landis's account is contrary to the medical records created in the years before he was vaccinated. In addition, in the briefing on the motion for ruling on the record, Mr. Landis generally failed to rebut the Secretary's assertions of fact. Finally, Mr. Landis's accounts have been inconsistent.
An example of erratic recounting concerns Mr. Landis's employment status. Some inconsistencies appear within medical records. On May 19, 2012, Mr. Landis's primary care physician recorded that "Mr. Landis used to work as a chiropractor." Exhibit 14 at 38. On the other hand, medical records from 2013 refer to him as still working.
Other inconsistencies come from Mr. Bolton. In the petition, Mr. Landis asserted that he was actively employed. Pet., filed Dec. 21, 2015, at ¶ 3. Yet, two years later, Mr. Bolton wrote, "Petitioner closed his chiropractic office about Aug[.] 2014 because of his disabilities related to the Tdap vaccine." Pet'r's Rebuttal, filed Dec. 28, 2016, at 4 (referencing footnote 1). In the February 15, 2017 status conference, Mr. Bolton stated that Mr. Landis's sister closed his practice in August 2014.
Another level of confusion comes from records government agencies kept from information Mr. Landis supplied. After being directed to submit his tax returns (
Collectively, this evidence suggests that Mr. Landis (as well as Mr. Bolton as Mr. Landis's agent) cannot provide a consistent and accurate information in response to a basic inquiry—was Mr. Landis working? Although Mr. Landis's employment status sheds indirect light on his health, the more general point is that Mr. Landis has not presented consistent and credible accounts about his employment. Thus, he seems unlikely to provide accurate assertions on more difficult questions such as the state of his health years earlier. For these reasons, in finding the following facts, the undersigned relies upon information contained in medical records created contemporaneously with the events being described in the medical records.
The earliest medical record appears to come from an internist, Jennifer P. Goldstein, in 2009, approximately 3 ½ years before the relevant Tdap vaccination.
Three features that Dr. Goldstein noted in 2009 appear frequently in the medical records before the vaccination. Mr. Landis required assistance for COPD or asthma. Mr. Landis suffered skin problems. And, Mr. Landis's appearance was unkempt. Details can be found in the Secretary's response to the petitioner's motion for a ruling on the record.
In 2012, which was the year before the relevant vaccination, Mr. Landis saw medical personnel at least 11 times. Some of these visits were for asthma and/or a skin problem and seem not directly relevant to Mr. Landis's osteoarthritis. However, a few medical records from 2012 stand out:
Medical personnel recorded similar comments in records created during the first four months of 2013, during which Mr. Landis had at least five encounters with medical personnel. Significant notations include:
These records are the background for Mr. Landis's appointment with Dr. Henock M. Ayalew, an internist, on May 2, 2013. Dr. Ayalew described Mr. Landis as "a disheveled male, frail-appearing, he has poor hygiene and he is wearing clothing that appears to be of poor hygiene as well, he is in mild discomfort from pruritus and he is itching all over his body." Exhibit 14 at 71. Dr. Ayalew encouraged Mr. Landis to follow up with his dermatologists and to take the medicines that the doctors were prescribing.
Following the May 2, 2013 vaccination, Mr. Landis next saw a medical practitioner on June 3, 2013. Nurse Practitioner Stephanie A. Mnich evaluated Mr. Landis's right ankle and calf, which had open ulcerations. Exhibit 15 at 149, 151. Ms. Mnich stated: "Secondary to his disheveled appearance as well as overgrowth of his toenails, I did send a consultation note over to our foot and ankle department for podiatry consult for nails."
According to an affidavit that Mr. Landis submitted in this litigation, within two weeks of his vaccination, he started to experience pain in his lower back and hip. Exhibit 3 at ¶ 4;
The undersigned declines to credit this assertion. As discussed in the recitation of events before vaccination, Mr. Landis often sought treatment from allopathic doctors. In addition, if Mr. Landis were truly experiencing hip and back pain by May 17, 2013, he could have easily told Nurse Practitioner Mnich when he saw her on June 3, 2013.
The omission of any complaint about hip or back pain in the record from June 3, 2013, is consistent with the omission of any similar complaint in the next medical appointment, which occurred on July 11, 2013. Then, Mr. Landis saw Dr. Ayalew for his dermatitis. Dr. Ayalew described Mr. Landis as a "disheveled male, [with] very poor hygiene [and] hunched over when walking." Exhibit 14 at 78-79. Although Mr. Landis was requesting IV antibiotics to relieve a perceived systemic infection, Dr. Ayalew recommended that Mr. Landis bathe himself daily and take the prescribed medications.
Mr. Landis argues that the July 11, 2013 visit with Dr. Ayalew supports his claim that he was experiencing hip and back pain shortly after the vaccination.
About two months later (or slightly more than four months after the vaccination), the evidence that Mr. Landis's condition had deteriorated is more persuasive. On September 16, 2013, Mr. Landis returned to see Dr. Ayalew in a follow-up visit. Mr. Landis's sister from California accompanied Mr. Landis on this visit. Dr. Ayalew recorded that Mr. Landis's sister was "very concerned about his functional status" because, in part, he seemed to be "hoarding a lot of material at home." Exhibit 14 at 76. Dr. Ayalew also wrote that Mr. Landis was working, but he was "unable to provide adequate care as a therapist."
In 2014, Mr. Landis continued to see doctors for asthma and skin problems. Some records include complaints potentially related to Mr. Landis's (undiagnosed) osteoarthritis. For example, on January 15, 2014, Mr. Landis told Bret A. Daniels, a family medicine doctor, that he has been having "ongoing back and upper thigh discomfort and gait disturbance for 1 year."
Dr. Daniels made other referrals to an orthopedist as well, most of which Mr. Landis declined.
Eventually, on referral from Dr. Daniels, an orthopedic surgeon, David Hughes, saw Mr. Landis on October 3, 2014.
Dr. Hughes's October 3, 2014 report carries significance in this case because both Dr. Nowak-Wegrzyn and Dr. Levinson see it as presenting objective signs of Mr. Landis's osteoarthritis.
Among the more recent medical records, the most relevant reflects a discussion between Mr. Landis and Charles Prezzia, an internist, on November 6, 2014. Mr. Landis sought medical attention because he had "watched an internet video of a doctor who warned of the risk of immunization and he [Mr. Landis] believe[d] that the Tdap shot caused the leg weakness and back pain since 2013." Exhibit 14 at 82. Dr. Prezzia also wrote that Mr. Landis was "only [t]here to address the fact that he felt that the adverse reaction to the vaccination should be reported."
Mr. Landis is claiming that the Tdap vaccination significantly aggravated his pre-existing osteoarthritis. As such, the elements of his case are set forth in
Before the Tdap vaccination, X-rays revealed degenerative changes in Mr. Landis's spine.
In addition to this radiographic evidence, Mr. Landis displayed some impaired movements.
Besides osteoarthritis, Mr. Landis suffered from other problems before the vaccination. These pre-existing problems included asthma and various skin problems, although the extent to which they contributed (if at all) to Mr. Landis's joint problems after vaccination is not entirely clear.
As noted in the fact section above, by September 16, 2013, Mr. Landis was using a walker. (The medical record does not state when he began using a walker.) Mr. Landis's use of a walker constitutes a change in his condition.
The extent and duration of this decreased mobility is not clear. On January 15, 2014, Mr. Landis saw Dr. Daniels, who commented that Mr. Landis walked in a "flexed forward" position. Exhibit 18 at 30. Dr. Daniels, however, did not explicitly note that Mr. Landis was using a walker.
Evidence that Mr. Landis was still using a walker comes from a March 15, 2014 medical record. Exhibit 17 at 15. But, whether Mr. Landis continued to use a walker remains uncertain as Dr. Hughes on October 3, 2014, also did not document the use of a walker.
Congress defined significant aggravation as "any change for the worse in a preexisting condition which results in markedly greater disability, pain, or illness accompanied by substantial deterioration of health." 42 U.S.C. § 300aa-33(4). The parties' briefs on this point are relatively conclusory.
Due to the sparseness of information, a factual finding on this point is difficult to make. As discussed above, the evidence about Mr. Landis's employment varied. He also suffered from other problems and this multiplicity of diseases makes an analysis of his osteoarthritis more challenging. Ultimately, the undersigned will assume, for the sake of argument, that Mr. Landis established preponderant evidence that his osteoarthritis was markedly worse sometime after the vaccination.
Here, through Dr. Nowak-Wegrzyn, Mr. Landis advances the theory that the adjuvant in the Tdap vaccination induced an activation of his innate immune system.
Mr. Landis recognizes that no studies have affirmatively linked the Tdap vaccination and osteoarthritis. Pet'r's Mot. at 10.
In lieu of studies on Tdap vaccine and osteoarthritis, Dr. Nowak-Wegrzyn relies upon articles about different conditions, such as ASIA or rheumatoid arthritis.
Fundamentally, Dr. Nowak-Wegrzyn is positing that the Tdap vaccination causes an increase in cytokines and an increase in cytokines causes disease. Special masters have found cytokine-based theories not persuasive.
For these reasons, Mr. Landis has not met his burden of presenting a persuasive medical theory causally connecting the Tdap vaccination and the worsening of his osteoarthritis.
The timing prong actually contains two parts. A petitioner must show the "timeframe for which it is medically acceptable to infer causation" and that the onset of the disease occurred in this period.
As to the interval between the vaccination and the worsening of osteoarthritis, Mr. Landis does not really propose any expected duration.
As to when Mr. Landis experienced a worsening of his osteoarthritis, Mr. Landis and Dr. Nowak-Wegrzyn appear to disagree. Mr. Landis asserts that his "osteoarthritis became severe within two weeks of vaccination." Pet'r's Mot. at 23. In contrast, Dr. Nowak-Wegrzyn opined that the first evidence of a worsened osteoarthritis was on July 11, 2013, 2 ½ months after the vaccination. Exhibit 21 at 10.
Neither of these attributions is persuasive. As explained above, the better and more persuasive evidence from the medical records supports a finding that Mr. Landis's osteoarthritis became worse between July 11, 2013 and September 16, 2013. Because Dr. Nowak-Wegrzyn has relied upon assertions that are not supported by preponderant evidence, her opinion may be discounted.
Furthermore, special masters have found that if cytokines were to harm the recipient of a vaccine, then the damage would be apparent in a matter of a few days. This relatively short interval follows from the fact that cytokines exist for a matter of hours or days.
Thus, Mr. Landis has not established the timing prong.
Given that Mr. Landis has established neither a theory nor appropriate timing, it follows as a matter of logic that he cannot establish a logical sequence of cause and effect, linking the Tdap vaccination to his osteoarthritis.
With respect to this prong, the Federal Circuit has instructed special masters to consider carefully the views of a treating doctor.
On the other hand, the Secretary identified one doctor who proposed an alternative explanation. Resp't's Resp. at 32. Dr. Prezzia stated:
Exhibit 14 at 83 (record from November 6, 2014). In this context, Dr. Prezzia also explicitly addressed and rejected Mr. Landis's suggestion that the Tdap vaccination was causing his problem. Dr. Prezzia wrote, "the likelihood of a Tdap shot causing muscle weakness or pain for as long as 18 months after receiving a shot would be highly unlikely."
Thus, the records from Mr. Landis's treating doctors do not weigh in favor of a finding that the Tdap vaccination affected Mr. Landis adversely.
Mr. Landis may genuinely believe that the Tdap vaccination harmed him. However, preponderant evidence in the form of medical records or medical opinions do not support his claim. The Clerk's Office is instructed to enter judgment in accord with this decision unless a motion for review is filed.
The difference between Dr. Nowak-Wegrzyn's theory here and ASIA is not readily apparent. Nevertheless, the undersigned assumes that there is some distinction. However, if Dr. Nowak-Wegrzyn were simply asserting ASIA, then her opinion would not be persuasive due to a strong line of cases declining to credit ASIA.
