Court Opinion

ID: 4535033
Source: CourtListenerOpinion
Date Created: 2020-05-18 16:00:58.993506+00
Date Added: 2024-06-11T09:27:28.738599
License: Public Domain

Case: 19-2138    Document: 37     Page: 1   Filed: 05/18/2020

   United States Court of Appeals
       for the Federal Circuit
                  ______________________

             CARMEN MORENO LOZANO,
                 Petitioner-Appellee

                             v.

       SECRETARY OF HEALTH AND HUMAN
                   SERVICES,
               Respondent-Appellant
              ______________________

                        2019-2138
                  ______________________

     Appeal from the United States Court of Federal Claims
 in No. 1:15-vv-00369-LAS, Senior Judge Loren A. Smith.
                  ______________________

                  Decided: May 18, 2020
                  ______________________

     RONALD C. HOMER, Conway Homer, PC, Boston, MA,
 for petitioner-appellee. Also represented by CHRISTINA
 CIAMPOLILLO.

     LOWELL STURGILL, JR., Appellate Staff, Civil Division,
 United States Department of Justice, Washington, DC, for
 respondent-appellant.     Also represented by ABBY
 CHRISTINE WRIGHT, ROBERT PAUL COLEMAN, III, JOSEPH H.
 HUNT.
                 ______________________

  Before MOORE, O’MALLEY, and TARANTO, Circuit Judges.
Case: 19-2138    Document: 37     Page: 2    Filed: 05/18/2020

2                                              LOZANO   v. HHS

 O’MALLEY, Circuit Judge.
     The Secretary of Health and Human Services (“the gov-
 ernment”) appeals from a final judgment of the United
 States Court of Federal Claims, which denied the govern-
 ment’s motion for review and affirmed the special master’s
 decision granting entitlement to compensation under the
 National Childhood Vaccine Injury Act of 1986, 42 U.S.C.
 §§ 300aa–1 and –34 (“Vaccine Act”). See Lozano v. Sec’y of
 Health & Human Servs., 143 Fed. Cl. 763 (2019); Lozano v.
 Sec’y of Health & Human Servs., No. 15-369V, 2017 WL
3811124 (Fed. Cl. Spec. Mstr. Aug. 4, 2017). We affirm.
                        BACKGROUND
     On July 14, 2012, Carmen Lozano (“Lozano”) gave
 birth to a baby girl at Community Memorial Hospital
 (“CMH”) in Ventura, California. The next day, while she
 was still hospitalized, Lozano received a tetanus-diphthe-
 ria-acellular-pertussis (“Tdap”) vaccination. Two weeks
 later, on July 30, 2012, Lozano reported to Ventura County
 Obstetrics and Gynecology, complaining of a low-grade fe-
 ver, body aches, and breast tenderness. The nurse practi-
 tioner suspected that Lozano had early mastitis, and
 prescribed medication. Lozano’s symptoms persisted and
 she began to experience fatigue.
     On August 9, 2012, Lozano went to the emergency
 room with complaints of abdominal pain and difficulty uri-
 nating. After the laboratory tests showed no signs of infec-
 tion, she was discharged, but returned later that same day,
 reporting fever, weakness, loss of balance, vision changes,
 neck pain, headache, vomiting, and dizziness. A brain MRI
 revealed “numerous focal and patchy high signal intensity
 lesions involving the brainstem, cerebellopontine angles,
 right cerebellum, basal ganglia, corpus callosum and sub-
 cortical white matter,” which suggested to the radiologist
 that Lozano possibly had multiple sclerosis (“MS”), acute
 disseminated encephalomyelitis (“ADEM”), or vasculitis.
 Lozano, 2017 WL 3811124, at *1.
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 LOZANO   v. HHS                                          3

     Lozano was admitted to the hospital for further evalu-
 ation, including a consultation with a neurologist, Dr.
 Francisco Torres. Dr. Torres opined that Lozano had pos-
 sibly experienced an MS attack, and began treating her
 with steroids. Lozano’s symptoms improved after three
 days of treatment and she was discharged with a working
 diagnosis of MS. Lozano was instructed to follow up with
 Dr. Timothy Sheehy, who determined that a second opinion
 was necessary to ensure that her diagnosis was accurate.
 Before she could obtain that second opinion, however,
 Lozano returned to the emergency room with burning in
 her chest, slurred speech, hearing changes, and numbness
 in her tongue. She was diagnosed with an MS flare and
 discharged the same day. Lozano was instructed to see her
 primary care physician for an MRI of the spine. That MRI
 showed “[p]atchy areas of altered signal intensity within
 the thoracic spinal cord . . . worrisome for foci of demye-
 lination.” Id. at *2.
     In September 2012, Lozano sought a second opinion
 from Dr. Barbara Giesser, a neurologist at the University
 of California Los Angeles Neurology Outpatient Clinic. Dr.
 Giesser provided a detailed medical history of Lozano since
 the onset of her symptoms in July 2012. Dr. Giesser’s dif-
 ferential diagnosis included post-viral encephalitis/myeli-
 tis, with a working diagnosis of “Clinically Isolated
 Syndrome,” a condition similar to MS. Id.
     Throughout the fall of 2012, Lozano continued to see
 Dr. Sheehy, with complaints of a burning sensation from
 her back to chest and decreased memory, cognition, and de-
 pression. In February 2013, however, a repeat MRI
 “showed dramatic improvement, suggesting that ADEM
 was a more likely etiology, which was confirmed through
 later serological findings.” Id. at *3. Since that time,
 Lozano’s doctors have continued to opine that ADEM is the
 likely explanation for her symptoms. Id.
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4                                              LOZANO   v. HHS

     In April 2015, Lozano filed a petition for compensation
 under the Vaccine Act, alleging that she suffered ADEM as
 a result of the Tdap vaccine. Both parties submitted expert
 reports from neurologists as well as medical literature and
 prehearing briefing. In June 2017, the special master held
 an entitlement hearing, where both sides’ experts testi-
 fied—Dr. Norman Latov on behalf of Lozano and Dr.
 Thomas Leist for the government.
     Dr. Latov opined that Lozano’s ADEM was the result
 of her receipt of the Tdap vaccine. Id. He described ADEM
 “as an autoimmune demyelinating disease of the central
 nervous system that attacks the white matter of the brain
 and spinal cord of its patients.” Id. Dr. Latov noted that
 ADEM can be confirmed through lesions on an MRI, and
 that “a hallmark of ADEM is its subsequent resolution—
 something that can be confirmed by later MRIs.” Id. He
 also cited several pieces of medical literature observing an
 association between tetanus-containing vaccines and
 ADEM. Dr. Latov proposed that the Tdap vaccine trig-
 gered Lozano’s autoimmune response, and noted that her
 treating physicians changed their diagnosis to ADEM after
 Lozano’s “MRIs cleared and she had experienced no subse-
 quent neurological episodes.” Id. at *4.
     Dr. Latov disputed the government’s theory that
 Lozano was suffering from posterior reversible encephalo-
 pathy syndrome (“PRES”), rather than ADEM. In doing so,
 he explained that “PRES is a condition marked by the pres-
 ence of edema in the posterior part of the brain as revealed
 on MRIs,” and that the majority of patients with PRES
 have a “decreased level of consciousness and have sei-
 zures.” Id. at *5. But Lozano’s MRIs “showed lesions
 throughout the spinal cord and brain—not just in the pos-
 terior region—and detected no edema.” Id. Nor had she
 experienced seizures or decreased consciousness. Given
 these factors, and because none of Lozano’s treating physi-
 cians found that PRES was a reasonable explanation of her
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 LOZANO   v. HHS                                            5

 condition, Dr. Latov opined that PRES was an improper di-
 agnosis.
     The government’s expert—Dr. Leist—testified that
 Lozano had PRES and that it was not caused by the Tdap
 vaccine. Given the rapid onset of symptoms after she gave
 birth, Dr. Leist opined that PRES, a known vascular com-
 plication following pregnancy, was likely the correct diag-
 nosis. Although he recognized that none of Lozano’s
 treating physicians considered PRES the proper diagnosis,
 Dr. Leist “opined that this was because her physicians had
 not given sufficient weight to the fact that she was post-
 partum” when the symptoms began. Id. at *6.
      Following the hearing, the special master granted
 Lozano’s petition, finding that she was entitled to compen-
 sation. At the outset, the special master found that Dr. La-
 tov’s testimony and the supporting medical literature
 demonstrated that the Tdap vaccine can cause autoim-
 mune diseases such as ADEM. Id. at *11. The special mas-
 ter then turned to the government’s primary challenges—
 that ADEM was not the correct diagnosis and that her
 symptoms began pre-vaccination. As to the first issue, the
 special master found that, although Lozano’s treating phy-
 sicians initially included MS as part of the differential di-
 agnosis, “her subsequent clinical progression ultimately
 led them away from MS and toward ADEM.” Id. at *12.
 The special master expressly rejected the government’s
 suggestion that Lozano’s proper diagnosis was PRES, on
 grounds that “the overall record does not support it.” Id.
 As to the second issue, the special master found that the
 government was unsuccessful in establishing that Lozano
 had symptoms potentially related to her ADEM pre-vac-
 cination. Finally, because Lozano experienced her symp-
 toms roughly 21 days after receiving the vaccine, the
 special master found that Lozano offered preponderant ev-
 idence of a proximate temporal relationship between the
 vaccine and her injury. Because Lozano carried her burden
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6                                               LOZANO   v. HHS

 to show causation, the special master found that she was
 entitled to compensation under the Vaccine Act.
     The government filed a motion for review of the special
 master’s decision with the Court of Federal Claims. In rel-
 evant part, the government argued that the special master
 erred “by failing to require evidence of a logical sequence of
 cause and effect showing that the vaccination was the rea-
 son for the injury.” Lozano, 143 Fed. Cl. at 768. The Court
 of Federal Claims denied the motion, finding that the spe-
 cial master’s decision was neither an abuse of discretion
 nor contrary to law, and that his fact findings were neither
 arbitrary nor capricious. Id. at 770. The Court of Federal
 Claims subsequently entered judgment, awarding dam-
 ages to Lozano in the form of a lump sum payment of
 $1,199,216.86.
     The government timely appealed the Court of Federal
 Claims’ final judgment to this court. We have jurisdiction
 under 42 U.S.C. § 300aa-12(f).
                         DISCUSSION
      In Vaccine Act cases, we review the Court of Federal
 Claims’ decision de novo, “applying the same standard of
 review as the Court of Federal Claims applied to its review
 of the special master’s decision.” Griglock v. Sec’y of Health
 & Human Servs., 687 F.3d 1371, 1374 (Fed. Cir. 2012) (ci-
 tation omitted); see also Paluck v. Sec’y of Health & Human
 Servs., 786 F.3d 1373, 1378 (Fed. Cir. 2015). We owe no
 deference to the trial court or the special master on ques-
 tions of law, but we uphold the special master’s findings of
 fact unless they are arbitrary or capricious. Griglock, 687
F.3d at 1374 (citation omitted). “We ‘do not sit to reweigh
 the evidence. [If] the Special Master’s conclusion [is] based
 on evidence in the record that [is] not wholly implausible,
 we are compelled to uphold that finding as not being arbi-
 trary or capricious.’” Cedillo v. Sec’y of Health & Human
 Servs., 617 F.3d 1328, 1338 (Fed. Cir. 2010) (quoting
 Lampe v. Sec’y of Health & Human Servs., 219 F.3d 1357,
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 LOZANO   v. HHS                                             7

 1363 (Fed. Cir. 2000)). Our role is not to “second guess the
 Special Master[’]s fact-intensive conclusions,” particularly
 in cases where “the medical evidence of causation is in dis-
 pute.” Id. (quoting Hodges v. Sec’y of Health & Human
 Servs., 9 F.3d 958, 961 (Fed. Cir. 1993)).
     The Vaccine Act distinguishes between two types of in-
 juries: “Table” and “off-Table.” 42 U.S.C. §§ 300aa–
 11(c)(1)(C)(i), 300aa–11(c)(1)(C)(ii). “Causation is pre-
 sumed for Table injuries when a specified condition follows
 the administration of a specified vaccine within a specified
 period of time.” Moriarty v. Sec’y of Health & Human
 Servs., 844 F.3d 1322, 1327 (Fed. Cir. 2016) (citation omit-
 ted). All other injuries alleged to be caused by a vaccine
 are “off-Table injuries,” where the petitioner has to prove
 causation by a preponderance of the evidence. Althen v.
 Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed.
 Cir. 2005). It is undisputed that Lozano’s injury is in the
 off-Table category, meaning that she must prove “actual
 causation” or “causation in fact” by preponderant evidence.
     To prove causation, a petitioner must show 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, 1352
 (Fed. Cir. 1999). In doing so, the petitioner’s burden:
     is to show by preponderant evidence that the vac-
     cination brought about her injury by providing:
     (1) a medical theory causally connecting the vac-
     cination and the injury; (2) a logical sequence of
     cause and effect showing that the vaccination was
     the reason for the injury; and (3) a showing of a
     proximate temporal relationship between vaccina-
     tion and injury.
 Althen, 418 F.3d at 1278. Because the special master
 found, and the parties do not dispute, that Lozano satisfied
 the first and third prongs of the Althen test, only the second
 prong of Althen is at issue in this appeal.
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8                                              LOZANO   v. HHS

     The government’s primary argument is that the special
 master and the Court of Federal Claims erred in finding
 that proof of a diagnosis, standing alone, suffices to prove
 causation in a non-Table case. According to the govern-
 ment, the special master ignored “the government’s argu-
 ments regarding causation, and reliev[ed] petitioner of her
 burden to demonstrate not only that she suffers from
 ADEM, but also that the vaccine actually caused her
 ADEM.” Appellant Br. 15. We disagree. As explained be-
 low, the special master fully addressed the parties’ argu-
 ments and considered all of the record evidence in finding
 that Lozano established causation by preponderant evi-
 dence.
      At the outset, although the government submits that
 the special master ignored its arguments, review of the rec-
 ord reveals that the special master specifically addressed
 the arguments the government raised in connection with
 Althen prong two. In its prehearing briefing to the special
 master, the government argued that Lozano failed to sat-
 isfy the second prong of Althen for two reasons: “the timing
 of petitioner’s symptoms pre-date[d] the vaccine admin-
 istration; and the alternative diagnoses of petitioner’s con-
 dition provide[d] an alternative explanation for why [she]
 experienced so many symptoms after vaccination.” J.A.
 111.
     The special master began by addressing the govern-
 ment’s arguments regarding diagnosis, finding that the
 medical evidence supported a diagnosis of ADEM and that
 none of Lozano’s treating physicians had questioned that
 diagnosis since the winter of 2013. Lozano, 2017 WL
3811124, at *12. The special master next turned to the
 government’s arguments regarding pre-vaccination symp-
 toms, finding that the government was “unsuccessful in es-
 tablishing that Mrs. Lozano had symptoms potentially
 related to her ADEM that began pre-vaccination.” Id. Fi-
 nally, the special master considered and rejected the
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 LOZANO   v. HHS                                             9

 government’s argument that Lozano’s proper diagnosis
 was PRES. Id.
     In reaching these conclusions, the special master noted
 that he was addressing the government’s PRES argument
 within his Althen prong two discussion “since it relates di-
 rectly to the accuracy of the ADEM diagnosis, and was in
 fact offered to contradict it,” but that he would reach the
 same conclusion if he had “more rigidly determined that
 [Lozano] had carried her initial burden, and then consid-
 ered (under the burden-shifting test applied) whether [the
 government] had carried [its] burden of establishing an al-
 ternative, unrelated cause for Mrs. Lozano’s condition.” Id.
 at *12, n.11. Accordingly, although he recognized that he
 was addressing issues in an unconventional order, the spe-
 cial master focused his analysis on the issues as the gov-
 ernment framed them, and expressly noted that his
 conclusion would have been the same had he structured his
 analysis differently.
      In any event, the government’s argument that the spe-
 cial master relied solely on Lozano’s diagnosis to satisfy Al-
 then prong two is unfounded. Indeed, review of the special
 master’s decision reveals that he considered the record as
 a whole in finding that Lozano “established a logical se-
 quence of cause and effect from vaccine to injury that is
 supported by the evidentiary record.” Id. at *12–*13.
     It is well established that petitioners need not present
 “epidemiologic studies, rechallenge, the presence of patho-
 logical markers or genetic disposition, or general ac-
 ceptance in the scientific or medical communities to
 establish a logical sequence of cause and effect.” Capizzano
 v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1325
 (Fed. Cir. 2006). Instead, we have explained that medical
 records and medical opinion testimony can satisfy Althen
 prong two, and that evidence used to satisfy one of the Al-
 then prongs can overlap to satisfy another prong. Id. at
 1326.
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 10                                              LOZANO   v. HHS

     We have also recognized that expert testimony is often
 very important in off-Table cases like this one, which re-
 quire proof of actual causation. Lampe v. Sec’y of Health &
 Human Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000) (“As is
 often true in Vaccine Act cases based on a theory of actual
 causation, the expert medical testimony was important in
 this case.”). Where both sides offer expert testimony, a spe-
 cial master’s decision may be “based on the credibility of
 the experts and the relative persuasiveness of their com-
 peting theories.” Broekelschen v. Sec’y of Health & Human
 Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing Lampe,
219 F.3d at 1362). As such, the special master’s credibility
 findings “are virtually unchallengeable on appeal.” Id.
     Here, the special master examined the medical records,
 medical literature, and both parties’ expert reports and tes-
 timony. The record demonstrates that the special master
 was persuaded by Lozano’s expert, Dr. Latov, who offered
 both written and oral testimony opining that Lozano’s
 “ADEM was the product of her receipt of the Tdap vaccine.”
 Lozano, 2017 WL 3811124, at *3. Based on the clinical
 signs and symptoms set forth in Lozano’s medical records,
 Dr. Latov agreed with Lozano’s treating neurologist, Dr.
 Sheehy, that she suffered from ADEM. Id. Dr. Latov ex-
 plained that ADEM typically develops days to weeks fol-
 lowing a triggering event, such as an infection or
 vaccination. See id. And he testified that it is well accepted
 in the medical community that tetanus-containing vaccina-
 tions, such as Tdap, can cause ADEM. Id. at *4. Given the
 record evidence that Lozano began to experience symptoms
 of ADEM roughly three weeks after her vaccination, cou-
 pled with the fact that no treating physician identified any
 alternative cause for her ADEM, Dr. Latov testified at the
 entitlement hearing that it was “highly likely that [Lozano]
 had vaccine-induced ADEM.” J.A. 226–28.
      The government argues that Dr. Latov’s expert analy-
 sis is insufficient to prove causation in light of our decision
 in Moberly v. Sec’y of Health & Human Servs., 592 F.3d
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 LOZANO   v. HHS                                           11

 1315 (Fed. Cir. 2010). Specifically, the government main-
 tains that, in both Moberly and this case, experts found
 causation based solely on: (1) evidence that a vaccine can
 cause an injury; (2) proof that the petitioner developed an
 injury within the expected onset time after receiving that
 vaccination; and (3) a conclusion that there was no likely
 alternative cause. Appellant Br. 21 (citing Moberly, 592
F.3d at 1320–21, 1323). According to the government, we
 rejected this evidence in Moberly on grounds that the peti-
 tioner failed to demonstrate actual causation, and we
 should do the same here. But in Moberly, the special mas-
 ter found the petitioner’s expert’s testimony “contradictory
 and confusing,” and thus discredited his testimony on those
 grounds. 592 F.3d at 1320. Setting aside the expert testi-
 mony, the special master found, and we agreed, that the
 remaining evidence merely showed a temporal association
 between vaccine and injury, which was insufficient to
 demonstrate actual causation. Id. at 1323.
     Here, however, Lozano’s expert neurologist—Dr. La-
 tov—proffered testimony that was supported by peer-re-
 viewed, published medical literature, as well as Lozano’s
 own medical records. Lozano, 2017 WL 3811124, at *11–
 12. Unlike Moberly, where the expert testimony was dis-
 credited, the special master here found Dr. Latov’s testi-
 mony reliable and persuasive. Id. We see no reason to
 disturb that credibility determination on appeal. See
 Lampe, 219 F.3d at 1361–62. Because the evidence of rec-
 ord in Moberly was significantly different from the record
 in this case, the result in Moberly does not compel the same
 result here.
     To the extent the government suggests that Lozano
 cannot satisfy Althen prong two because no treating physi-
 cian expressly opined that the Tdap vaccination caused her
 ADEM, we have made clear that “testimony from treating
 physicians is not required in Vaccine Act cases.” Moberly,
592 F.3d at 1325. Given the testimony from Dr. Latov, cou-
 pled with the evidentiary record, the special master found
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 12                                            LOZANO   v. HHS

 that Lozano “provided sufficient preponderant evidence to
 meet her Althen Two burden. She established a logical se-
 quence of cause and effect from vaccine to injury that is
 supported by the evidentiary record.” Lozano, 2017 WL
3811124, at *13. Because it is clear that he considered the
 record as a whole in reaching this conclusion, we agree with
 the Court of Federal Claims that the special master did not
 violate the bounds of his discretion and that his findings
 were neither arbitrary nor capricious. See Lozano, 143
Fed. Cl. at 769.
     We likewise agree with the Court of Federal Claims
 that, despite the government’s suggestion to the contrary,
 this case neither creates a “new ‘Table’-type presumption
 for non-Table conditions,” nor compromises “the scientific
 integrity of the Vaccine Program.” Appellant Br. 22–23; see
 Lozano, 143 Fed. Cl. at 770 (rejecting the government’s ar-
 guments that “a de facto Table claim was created” and that
 the special master’s “opinion has put the integrity of the
 Vaccine Program at risk”). On this record, there was suffi-
 cient evidence to support the special master’s causation
 analysis, including his conclusion with respect to Althen
 prong two. We therefore decline the government’s request
 to remand for reapplication of the Althen test.
                        CONCLUSION
      We have considered the government’s remaining argu-
 ments and find them unpersuasive. For the foregoing rea-
 sons, we conclude that the special master applied the
 correct legal standard and considered the entire record in
 finding that Lozano proved causation by a preponderance
 of the evidence. Accordingly, we affirm the judgment of the
 Court of Federal Claims, which affirmed the special mas-
 ter’s decision granting Lozano entitlement to compensa-
 tion.
                        AFFIRMED