IN THE UNITED STATES COURT OF FEDERAL CLAIMS
OFFICE OF THE SPECIAL MASTERS
No. 12-285V
Filed: October 25, 2013
Not for Publication
****************************
MONTEZ PETRONELLI, *
*
Petitioner, *
* Decision on the Record; Influenza Vaccine;
v. * Guillain-Barré Syndrome; GBS
*
SECRETARY OF *
HEALTH AND HUMAN SERVICES, *
*
Respondent. *
****************************
Ronald Homer, Esq., Conway, Homer & Chin-Caplan, P.C., Boston, MA, for petitioner.
Michael P. Milmoe, Esq., U.S. Dept. of Justice, Washington, DC, for respondent.
RULING ON ENTITLMENT1
Vowell, Chief Special Master:
On May 4, 2012, Montez Petronelli [“Ms. Petronelli” or “petitioner”] timely filed a
petition for compensation under the National Vaccine Injury Compensation Program, 42
U.S.C. § 300aa-10, et seq.2 [the “Vaccine Act” or “Program”]. The petition alleged that,
as a result of her influenza vaccine on September 28, 2010, Ms. Petronelli suffers from
a neurological demyelinating injury. The amended petition, filed on December 10, 2012,
specified that petitioner suffers from Guillain-Barré syndrome [“GBS”].
The Vaccine Act provides that a special master may not make a finding awarding
compensation based on the claims of a petitioner alone, unsubstantiated by medical
1
Because this unpublished ruling contains a reasoned explanation for the action in this case, I intend to
post it on the United States Court of Federal Claims' website, in accordance with the E-Government Act
of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17, 2002). In accordance with Vaccine Rule
18(b), petitioner has 14 days to identify and move to delete medical or other information, the disclosure of
which would constitute an unwarranted invasion of privacy. If, upon review, I agree that the identified
material fits within this definition, I will delete such material from public access.
2
National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for
ease of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. §
300aa (2006).
records or medical opinion. See § 13(a)(1). Petitioner has proffered both medical
records and an expert medical opinion by Dr. Thomas Morgan causally linking her GBS
to her influenza vaccination.
For the reasons stated herein, I find that petitioner has established entitlement to
compensation.
I. Procedural History.
Between May 4, 2012 and September 4, 2012, when this case was reassigned to
me, Special Master Lord conducted the initial status conference and petitioner filed
exhibits 1-7 and her Statement of Completion. See Order, issued June 13, 2012; Notice
of Intent to file on CD, filed July 10, 2012; Statement of Completion, filed July 13, 2012.
On September 13, 2012, I held a status conference with the parties. During the
call, the parties expressed a desire to explore an informal resolution to this case. See
Order, issued Sept. 13, 2012. Petitioner was ordered to file (1) medical records
requested by respondent by October 15, 2012, (2) a status report when her demand
was conveyed to respondent, and (3) her expert report by March 13, 2013.
Petitioner filed exhibits 8 and 9 on October 9, 2012. She transmitted her demand
to respondent on November 20, 2012. Petitioner’s Status Report, filed Nov. 30, 2012.
Petitioner filed her affidavit and an amended petition on December 10, 2012. Although
the parties continued to discuss settlement, petitioner filed her expert report on March
13, 2013.
On April 8, 2013, the parties conveyed to the court that petitioner had received a
response from respondent regarding her life care plan assessment, but that she had not
yet received a comprehensive response to her settlement demand and therefore it was
unclear if a settlement agreement could be reached. Joint Status Report, filed Apr. 8,
2013, at 1. The parties requested a status conference to discuss future proceedings.
Id.
On April 17, 2013, following the parties’ requested status conference, I ordered
respondent to file her Rule 4(c) report, accompanied by any response to petitioner’s
expert report she may elect to file, by no later than June 17, 2013. Order, issued Apr.
17, 2013.
After receiving extensions to her original deadline, respondent filed her Rule 4(c)
report [“Res. Report”] on July 9, 2013. In the report, respondent stated that she would
“not offer an expert report in this case,” and that “other than [the] Rule 4(c) Report, and
the attached literature, respondent will not expend further resources to defend this
case.” Res. Report at 9. Respondent suggested I decide entitlement based on the
current case record. Id. Petitioner filed a responsive pleading to respondent’s Rule 4(c)
report on July 30, 2013.
2
II. Evidentiary Record.
Petitioner received an influenza vaccine on September 28, 2010. Petitioner’s
Exhibit [“Pet. Ex.”] 2, p. 1. No medical records prior to the immunization or from the day
of the immunization were filed by petitioner.
On October 21, 2010, petitioner was seen by her primary care physician, Dr.
Sraboni Banerjee. According Dr. Banerjee’s visit note, petitioner indicated she had
been sick for six weeks, starting with a chest cold with no fever, sore throat, or cough,
before progressing to a cough with nasal congestion and post nasal drainage.
Petitioner indicated that her cough had started to resolve after four weeks, but then
restarted during the past two weeks. Doctor Banerjee diagnosed her with sinusitis and
prescribed amoxicillin. Pet. Ex. 2, pp. 38-39. At this visit, petitioner also complained of
feeling very tired and numb, having tingling in her extremities, and muscle aches.
Doctor Banerjee attributed her tingling to her sinusitis and conveyed to petitioner that
her symptoms should improve within a couple of days. Id. at 39.
Petitioner had a follow-up visit for her sinusitis on October 25, 2010. Her cough
was mostly resolved, but she still complained of numbness and muscle pains and
indicated they had gotten worse. Pet. Ex. 2, p. 43. She expressed frustration that she
was feeling tired and was unable to read or cook. Id. Doctor Banerjee speculated that
her tiredness and general achiness were associated with the tension and stress brought
on by her upcoming GRE exam. Id.
In the evening of October 25, 2010, petitioner fainted and was brought to the
emergency room [“ER”] by her husband around midnight. She indicated she had a
cough for two weeks that was almost resolved and had been experiencing worsening
fatigue, numbness, and weakness. Pet. Ex. 1, p. 88. The ER physician ordered routine
blood and lab tests. Id., pp. 96-97. Because Dr. Banerjee had sent blood to the lab
following her appointment with him, there was confusion in the lab and testing of the
blood sample sent by the ER physician was delayed. Id., p. 95. Petitioner elected to
leave around 4:30 AM, prior to receiving her lab results, with the understanding that she
would return if abnormal results were found. Id.
Petitioner spoke with Dr. Banerjee on October 26, 2010. She reported that since
returning home from the ER she was doing worse with increased leg weakness,
difficulty walking and climbing stairs, and a loss of balance. She also indicated that she
was getting winded very easily and was unable to lift her arms above her head.
Concerned that she might be describing symptoms of GBS, Dr. Banerjee advised her to
return to the ER immediately for further evaluation. Pet. Ex. 6, p. 13.
She arrived at the Kaiser Permanente Santa Clara Medical Center [“SCMC”]
around 3:39 PM and was evaluated by emergency room physician Dr. Haydn Hok
Leung at 4:20 PM. Pet. Ex. 1, pp. 107-08. Ms. Petronelli relayed that she had a cough
and myalgias for a couple of weeks, and that October 19, 2010 she noticed numbness
in her toes which had progressively gotten worse and moved up her legs and also into
3
her arms. She also was experiencing shortness of breath. Pet. Ex. 1, p. 108.
Petitioner was admitted to the hospital with diagnosis of possible GBS. Id., p. 112.
A neurology resident at SCMC, Dr. Kelly Yeh, examined petitioner later that day.
Doctor Yeh recorded that Ms. Petronelli had received a flu vaccine on September 28,
2010, and thereafter developed a cold consisting of a cough with mucous and a sore
throat. Doctor Yeh also noted that during the previous week on October 19 th or 21st
petitioner started to develop numbness, pins and needles, and coldness in her toes.
The numbness then ascended up her feet, into her legs, and up to petitioner’s hands.
Doctor Yeh documented that petitioner had not had any recent medical changes except
for starting amoxicillin the previous week as treatment for her cold. Pet. Ex. 1, p. 120.
Upon examination, Dr. Yeh observed petitioner had decreased sensation to light touch
and pinprick which was worse in her toes bilaterally, but also present in her feet and
legs, normalizing around petitioner’s knees. Petitioner also demonstrated a decreased
sensation to touch and pinprick in her hands bilaterally to her mid-proximal forearm. Id.,
p. 121.
Doctor Yeh assessed petitioner as having “ascending numbness/paresthesisas
with absent reflexes, severe back pain and tenderness of face/extremities, also with
weakness primarily of hip flexors/hamstrings, suggestive of Guillain-Barre Syndrome.”
Pet. Ex. 1, p. 122. Doctor Yeh recommended frequent and serial pulmonary function
tests, a lumbar puncture, and IVIG3 treatment. Id. Doctor Jai Hee Cho, a physician at
SCMC, also briefly saw and examined petitioner. Doctor Cho “agree[d] with the findings
and the plan of care as documented in [Dr. Yeh’s] note.” However, in recounting
petitioner’s history of presenting illness in her consult note, Dr. Cho indicated that
petitioner had a mild upper respiratory infection [“uri”] prior to receiving her influenza
shot and that the symptoms worsened after the vaccination. Pet. Ex. 1, p. 123.
Petitioner’s lumbar puncture showed elevated protein levels and normal white
blood count and glucose, confirming the diagnosis of GBS. Pet. Ex. 1, p. 195. She
received five days of IVIG treatments at SCMC before being discharged to another
Kaiser Permanente facility for rehabilitation. Id., pp. 229-232, 236-37. Petitioner was
discharged from the rehabilitation facility on December 1, 2010. Pet. Ex. 5, pp. 6-7.
She received home health care, which included physical and occupational therapy until
January 24, 2011, when she was transitioned to out-patient therapy. See Pet. Ex. 7, pp.
7-18.
An EMG/NCV4 study was performed in May 2011. The study showed that
petitioner still had “evidence of a demyelinating sensorimotor polyneuropathy in the
3
“IVIG” stands for intravenous immunoglobulin. Neil M. Davis, MEDICAL ABBREVIATIONS, 15th Edition, at
178 (2011).
4
EMG (electromyography) studies look at the electrical activity within muscles and NCV (nerve
conduction or electroneurography) studies examine the integrity of the peripheral nerves. Kathleen D.
Pagona & Timothy J. Pagona, MOSBY’S MANUAL OF DIAGNOSTIC AND LABORATORY TESTS [“MOSBY’S LABS”]
at 571-77 (3d. ed. 2006). The two studies are commonly performed at the same time in patients
complaining of weakness.
4
upper and lower extremities.” Pet. Ex. 3, pp. 38-39. When compared with the study
conducted in December 2010, Pet. Ex. 1, pp. 256-57, the study showed significant
improvement. Pet. Ex. 3, pp. 38-39. In September 2011, petitioner was seen by
neurologist Dr. Cho and reported that she still required a cane to walk through large
stores, such as Costco, and could not go to parks without her wheelchair. Id., p. 64.
Doctor Cho noted that although the “lack of functional improvement is a concern, there
is no objective evidence that there has been a relapse,” and thus she was not
concerned about CIDP.5 Pet. Ex. 3, p. 65.
III. Discussion.
A. Legal Standards to Establish Entitlement to Compensation.
In order to prevail under the Program, a petitioner must prove either a “Table”
6
injury or that a vaccine listed on the Table was the cause in fact of an injury (an “off-
Table” injury). Because GBS is not a Table injury for any vaccine appearing on the
Vaccine Injury Table, petitioner must produce preponderant evidence that a covered
vaccine is responsible for her injury.
When a petitioner alleges an off-Table injury, eligibility for compensation–the
prima facie case–is established when the petitioner demonstrates, by a preponderance
of the evidence, that: (1) she received a vaccine set forth on the Vaccine Injury Table;
(2) that she received the vaccine in the United States; (3) that she sustained or had
significantly aggravated an illness, disease, disability, or condition caused by the
vaccine; and (4) that the condition has persisted for more than six months.7 To satisfy
her burden of proving causation in fact, petitioner must establish each of the three
Althen factors by preponderant evidence: (1) a medical theory causally connecting the
vaccination and the injury; (2) a logical sequence of cause and effect showing that the
vaccination was the reason for the injury; and (3) a proximate temporal relationship
between vaccination and injury. Althen v. Sec’y, HHS, 418 F.3d 1274, 1278 (Fed. Cir.
2005); see de Bazan v. Sec’y, HHS, 539 F.3d 1347, 1351-52 (Fed. Cir. 2008); Caves v.
Sec’y, HHS, 100 Fed. Cl. 119, 132 (2011), aff. per curiam, 463 Fed. Appx. 932, 2012
WL 858402 (Fed. Cir. 2012) (specifying that each Althen factor must be established by
preponderant evidence).
5
By definition, GBS is monophasic, meaning it occurs only once. In contrast, CIDP reoccurs. In initial
presentation, patients with CIDP are often difficult to distinguish from patients with GBS, as the initial
symptoms are very similar. However, GBS typically responds to either plasma exchange or IVIG; patients
with GBS who receive steroids typically do not improve or may get worse. Patients with CIDP generally
improve on steroids. A. Ropper & M. Samuels, ADAMS AND VICTOR’S PRINCIPLES OF NEUROLOGY, McGraw-
Hill Companies (9th ed. 2009) at 1292-93.
6
A “Table” injury is an injury listed on the Vaccine Injury Table, 42 C.F.R. § 100.3 (2011), corresponding
to the vaccine received within the time frame specified.
7
Section 13(a)(1)(A). This section provides that petitioner must demonstrate by a preponderance of the
evidence the matters required in the petition by section 300aa–11(c)(1)....” Section 11(c)(1) contains the
four factors listed above, along with others not relevant in this case.
5
Once petitioner establishes each of the Althen factors by preponderant evidence,
case, the burden of persuasion shifts and respondent must show that the alleged injury
was caused by a factor unrelated to the vaccination. See de Bazan, 539 F.3d at 1354
(citing Knudsen v. Sec’y, HHS, 35 F.3d 543, 548 (Fed. Cir. 1994)); § 13(a)(1)(B).
Respondent must demonstrate that “the factor unrelated to the vaccination is the more
likely or principal cause of the injury alleged. Such a showing establishes that the factor
unrelated, not the vaccination, was ‘principally responsible’ for the injury.” Deribeaux v.
Sec’y, HHS, 717 F.3d 1363, 1369 (Fed. Cir. 2013). Section 13(a)(2) specifies that
factors unrelated do “not include any idiopathic, unexplained, unknown, hypothetical, or
undocumented cause factor, injury, illness, or condition.” Close calls regarding
causation must be resolved in favor of the petitioner. Althen, 418 F.3d at 1280; but see
Knudsen, 35 F.3d at 550 (when evidence is in equipoise, the party with the burden of
proof fails to meet that burden).
By specifying petitioners’ burden of proof in off-Table cases as the
preponderance of the evidence, directing special masters to consider the evidence as a
whole, and stating that special masters are not bound by any “diagnosis, conclusion,
judgment, test result, report, or summary” contained in the record (§13(b)(1)), Congress
contemplated that special masters would weigh and evaluate expert opinions in
determining whether petitioners have met their burden of proof.
In weighing and evaluating expert opinions in Vaccine Act cases, the same
factors the Supreme Court has considered important in determining their admissibility
provide the weights and counterweights. See Kumho Tire Co. v. Carmichael, 526 U.S.
137, 149-50 (1999); Terran v. Sec’y, HHS, 195 F.3d 1302, 1316 (Fed. Cir. 1999). As
the Supreme Court has noted, a trial court is not required to accept the ipse dixit of any
expert’s medical or scientific opinion, because the “court may conclude that there is
simply too great an analytical gap between the data and the opinion proffered.” Gen.
Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997).
B. Parties’ Contentions Regarding Entitlement.
There is no dispute that petitioner received a covered vaccine administered in the
United States. It is also clear from the medical records that approximately four weeks
after receiving a flu vaccine, Ms. Petronelli was diagnosed with GBS and has
experienced sequelae of GBS for longer than six months. Therefore, the only issue left
to resolve is whether the influenza vaccine administered on September 28, 2010, was
the cause-in-fact of petitioner’s GBS.
1. Petitioner’s Expert Report.
In support of petitioner’s claim that her September 28, 2010 influenza vaccination
caused her GBS, petitioner filed an expert report from Dr. Thomas Morgan. Doctor
Morgan is a board certified neurologist who has been an assistant professor with the
Department of Clinical Neuroscience at Brown University’s School of Medicine since
1978. Pet. Ex. 13 at 1, 3. His report identifies a theory of causation, molecular mimicry,
6
and indicates that the timing of petitioner’s vaccination and onset of symptoms is
consistent with the immune mechanism he identified. Pet. Ex. 12 at 5 (explaining that
“the influenza immunization generated an immune response that cross reacted with
antigen targets shared by the normal elements of nerve fibers to cause” petitioner’s
GBS).
Acknowledging the discrepancy in the medical records regarding whether
petitioner had an infection prior to her vaccination, which could be the cause of her
GBS, Dr. Morgan asserts that the notation of a six week history of cold contained in Dr.
Banerjee’s October 21, 2010 consult note must be in error because petitioner would not
have been administered a nasal flu vaccine at a time when she was sick with
congestion and a cough. Pet. Ex. 12 at 5. He also notes that Dr. Banerjee’s consult
note contradicts the history provided to several physicians while petitioner was
hospitalized at SCMC and the timeline of events contained in petitioner’s affidavit.
Additionally, Dr. Morgan addresses petitioner’s sinusitis, diagnosed by Dr.
Banerjee at the October 21, 2012 visit. He remarked that if that diagnosis was proper, it
came after petitioner’s flu vaccine and was not the cause of her GBS. Pet. Ex. 12 at 5.
Doctor Morgan distinguished upper respiratory infections from sinusitis and noted that
sinusitis “is not causally associated with [GBS].” Id. at 6 (citing Duntz, M., Sinus
headache and nasal disease, HEADACHES IN CLINICAL PRACTICE, 2d. at 235).
2. Respondent’s Rule 4(c) Report.
Respondent declined the opportunity I afforded her to file an expert report. In
response to petitioner’s expert report, respondent only filed her Rule 4(c) report and
three medical journal articles. In her report, respondent criticizes Dr. Morgan’s report
because he did “not address a number of references in the record that refer to an
antecedent cold with no mucus or fever that was treated with amoxicillin connected to a
vaccination and resolved by October 26, 2010.” Res. Report at 7. Respondent also
complains that Dr. Morgan did not specifically address the October 26, 2010 note of Dr.
Cho and its reference to petitioner having an upper respiratory infection prior to her
influenza vaccination. Res. Report at 7.8
Because two-thirds of patients diagnosed with GBS suffer from an antecedent
infectious illness and some of petitioner’s records, particularly Dr. Cho’s, suggest that
Ms. Petronelli had an infection prior to her influenza vaccination, respondent argues that
“it is exceedingly unlikely that her GBS was caused by a flu vaccine.” Res. Report at 8
(citing Haber et al., Vaccines and Guillain-Barre Syndrome, DRUG SAFETY, 34(4): 309-
323 (2009) at 311). Respondent also questions the likelihood of vaccine causation
based on the findings contained in the 2011 IOM Report. After reviewing the available
epidemiologic and mechanistic evidence surrounding the influenza vaccine and GBS,
8
Respondent indicated that “Dr. Kelly Yeh, an internst [sic], related to Dr. Cho ‘that the patient had a mild
URI, then got flu shot on 9/28 . . . .’” I interpret the record (Pet. Ex. 1, p. 123) as attributing the comment
about Ms. Petronelli’s potential URI solely to Dr. Cho. Doctor Yeh’s own note concerning her evaluation
of petitioner states “flu vaccine on 9/28/10, thereafter developed a cold.” Pet. Ex. 1, p. 120.
7
the report concluded there was insufficient evidence to support a causal association
between the influenza vaccine and GBS. Res. Report at 8 (citing K. Stratton, et al.,
ADVERSE EVENTS ASSOCIATED WITH CHILDHOOD VACCINES: EVIDENCE BEARING ON
CAUSALITY (2011) at 321-34).
3. Petitioner’s Response to Respondent’s Rule 4(c) Report.
In her response to respondent’s Rule 4(c) report, petitioner highlights the
applicable evidence and discusses how she has satisfied the three Althen prongs. She
notes that her theory of causation (molecular mimicry) “has consistently been
recognized as a biologically plausible mechanism for the onset of neurologically
demyelinating disease, including GBS.” Response at 4. Petitioner also stresses that
her treating physicians linked her vaccination to her GBS, and that the timing of
approximately four weeks between her vaccination and onset of symptoms is consistent
with her causation theory. See Response at 4-7.
Petitioner argues that she has made a prima facie case, and that respondent has
failed to meet her burden of showing a factor unrelated to petitioner’s vaccination
caused her GBS. Petitioner counters respondent’s reliance on the 2011 IOM Report by
noting its conclusion of no causal relationship between influenza vaccines and GBS was
based on a requirement of scientific certainty and not the preponderant evidence
standard applied in the Vaccine Program. Response at 8. Additionally, petitioner notes
that the Haber article filed by respondent supports her theory of causation. Response
at 7-8. Because respondent did not file an expert report and indicated she would not
expend additional resources defending this case, petitioner posits that respondent will
be unable to meet her burden. Response at 9.
C. Analysis.
This case presents the issue of whether an expert report satisfying each of the
Althen prongs regarding vaccine causation of GBS can be countered successfully by
medical literature alone. Under the circumstances present here, I conclude that
literature alone, unexplained by an expert report, does not tip the balance back to
respondent.
Petitioner’s expert, Dr. Morgan is a board certified neurologist and an assistant
professor at Brown University’s School of Medicine. His curriculum vita (Pet. Ex. 13)
demonstrates that he is qualified to opine in this case. As petitioner noted in her
response, Dr. Morgan’s causation theory is supported by medical literature filed by
respondent. See e.g., Haber, Res. Ex. A, at 312 (discussing molecular mimicry as a
possible biological mechanism for GBS). Although other decisions involving this
vaccine and this injury do not constitute binding authority,9 Dr. Morgan’s opinion is also
buttressed by other decisions in the Vaccine Program awarding entitlement for GBS
associated with an influenza vaccine. See e.g., Figueroa v. Sec’y, HHS, 715 F.3d 1314,
9
See Hanlon v. Sec’y, HHS, 40 Fed. Cl. 625 (1998).
8
2013 WL 1811018 at *1 (Fed. Cir. May 1, 2013) (citing Torday v. Sec’y, HHS, No. 07-
372V, 2009 U.S. Claims LEXIS 745 (Fed. Cl. Spec. Mstr. Dec. 10, 2009; Griglock v.
Sec’y, HHS, 99 Fed. Cl. 373 (2011), aff’d, 687 F.3d 1371 (Fed. Cir. 2012); Stewart v.
Sec’y, HHS, No. 06-777, 2011 WL 3241585 (Fed. Cl. Spec. Mstr. July 8, 2011)).
Respondent argues that it was not the influenza vaccine but petitioner’s
infectious illness that caused her GBS.10 The onset of petitioner’s illness is not
concretely established. Some records place onset prior to her influenza vaccination and
others afterwards. Compare Pet. Ex. 1, p. 123; Pet. Ex. 2, pp. 38-39 with Pet. Ex. 1, pp.
88-89, 112, 126-27; Pet. Ex. 5, pp. 6-7. Additionally, the evidence in the case record
does not establish what infectious illness petitioner had. It is unclear whether petitioner
was suffering from an upper respiratory infection or sinusitis; the former being a viral
infection and the latter a bacterial infection and typically treated with antibiotics.11
Considering the facts contained in the medical records and petitioner’s affidavit,
the medical journal articles cited, and the sole medical expert opinion offered, I
conclude that the weight of the evidence in this case favors a finding that petitioner is
entitled to compensation.
IV. CONCLUSION
Based on the record before me, I find that there is preponderant evidence that
petitioner’s September 28, 2010 influenza vaccination was a substantial cause of her
GBS and that sequelae from petitioner’s GBS persisted for more than six months. I
further find that respondent did not meet her burden of establishing a factor unrelated
was responsible for petitioner’s injury. I therefore hold that petitioner has
established the statutory requirements for entitlement. A damages order will follow.
IT IS SO ORDERED.
s/ Denise K. Vowell
Denise K. Vowell
Chief Special Master
10
Respondent’s decision not to file an expert report prevents me from engaging in a comparison of expert
qualifications and the rationales behind competing causation theories.
11
Sinusitis Fact Sheet, National Institute of Allergy and Infectious Diseases [“NIAID”] (January 2012) at 3,
available at http://www.niaid.nih.gov/topics/sinusitis/Documents/sinusitis.pdf.
9