NORA BETH DORSEY, Chief Special Master.
On August 19, 2014, Nicole Solomon ("petitioner") filed a petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10,
Under the Vaccine Act, compensation may not be awarded "based on the claims of a petitioner alone, unsubstantiated by medical records or by medical opinion." § 13(a)(1). Petitioner has failed to file the report of a medical expert, and the medical records do not support petitioner's claims. For the reasons discussed below, petitioner has failed to demonstrate that she is entitled to compensation. The petition is dismissed for insufficient proof.
Petitioner indicated she filed her petition on August 19, 2014, without all relevant medical records due to the impending expiration of the Vaccine Act's statute of limitations. Petition, ¶ 2. The next day, she filed some medical records.
During the following month, petitioner continued to file medical records.
On December 21, 2014, respondent filed a status report indicating her belief that "settlement discussions [were] not appropriate." Status Report at 1 (ECF No. 19). Respondent argued that "petitioner's correct diagnosis is fibromyalgia syndrome and not Guillain-Barre Syndrome."
On January 29, 2015, respondent filed her Rule 4(c) report asserting that petitioner's claim should not be compensated. Rule 4(c) Report at 1 (ECF No. 21). Respondent again argued that petitioner has not established that she suffered from Guillain-Barré Syndrome ("GBS") adding that she had not proven her vaccinations caused her alleged injury, whether categorized as "GBS, fibromyalgia or any other condition."
Over the next five months, petitioner filed three motions for additional time to file an expert report. Shortly after the first and second motions, petitioner filed updated medical records and a letter from one of her treating physicians.
Instead, on July 21, 2015, petitioner filed a motion for a decision on the record pursuant to Vaccine Rule 8(d).
Respondent filed her response approximately one month later (on August 24, 2015). Respondent argued that petitioner's claim should not be compensated and instead, should be dismissed. Response at 6 (ECF No. 32).
The matter is now ripe for adjudication.
The medical records from petitioner's primary care physician, Dr. Karen Wendowski, consist mainly of Dr. Wendowski's copy of records from other providers.
The medical records from petitioner's allergist, Dr. Wise, show petitioner suffered frequent upper respiratory infections ("URIs") since childhood.
On May 4, 2010, approximately 18 months prior to the alleged causal vaccinations (in May 2010), petitioner was seen by her gynecologist for excessive and frequent menstruation. Exhibit 6 at 22. Around that same time, allergy testing revealed petitioner suffered from a "significant mold allergy," and she began receiving injections for allergen immunotherapy. Exhibit 7 at 15. Approximately one year later (on April 18, 2011), petitioner was described as improving and "tolerating the immunotherapy" with no intervening sinusitis. Exhibit 7 at 12.
On July 7, 2011, petitioner was treated by her ophthalmologist for a bump and morning "goop" in her left eye. Exhibit 5 at 3. Although she suffered from itchy eyes due to her allergies, she reported that the bump did not itch. She also reported that she treated the same problem in May 2011 with warm compresses and eye drops.
Medical records from petitioner's allergist, Dr. Wise, indicate she suffered a sinus infection in early September 2011 but was feeling better after ten days of an antibiotic. Exhibit 7 at 11. Petitioner received the influenza vaccination on September 20, 2011 and the TDP vaccination on October 6, 2011.
On October 30, 2011, petitioner visited the emergency room at St. Vincent's Indianapolis Hospital with complaints of right side numbness and frequent urination. Exhibit 13 at 97. She indicated her symptoms began on Wednesday, October 26, 2011 after she returned from vacation.
Petitioner saw Dr. Vogel on October 31, 2011. According to Dr. Vogel's records, petitioner described a "vague sense of dizziness" after returning from her trip. Exhibit 10 at 4. A few days after that she felt heaviness, numbness, and tingling in her right foot and calf but no pain. As this sensation continued, she "began to note a cold sensation like an ice pack running up and down the leg [and] . . . felt as though she [was] a little off balance"
During the visit with Dr. Vogel, petitioner mentioned her recent injections (Botox, influenza, and TDP) and reported some cognitive impairment and greater frequency in urination over the last several months. Exhibit 10 at 4. Dr. Vogel reassured petitioner that her "neurologic evaluation [was] normal but . . . agree[d] we need to rule out secondary causes such as a demyelinating disease or less likely [a] mass or stroke."
Petitioner visited Dr. Vogel again on November 14, 2011. At that visit, petitioner reported that her symptoms were worsening with the numbness moving to all four extremities, her face, and her head and the addition of twitching and "waves of fatigue." Exhibit 10 at 6. She also reported a reoccurring sinus infection. Noting that all tests to date had been normal, Dr. Vogel ordered an EMG,
On January 6, 2012, petitioner visited her allergist, Dr. Wise, for a follow-up visit regarding her reoccurring sinusitis, specifically mentioning an episode in early October 2011. Exhibit 7 at 10;
Petitioner saw Dr. Vogel in March 12, 2012. At that visit, petitioner described her symptoms as improving after she began taking Cymbalta but "not totally gone." Exhibit 10 at 10. She indicated that she sometimes feels a random twitch and tingling all over, that she sleeps poorly and fatigues easily, and that "her muscle pain is worse when the weather is about to change."
Petitioner saw Dr. Vogel again six months later on September 10, 2012. Previously, Dr. Vogel had described petitioner's symptoms as diffuse myalgia and paresthesia and chronic dizziness.
Petitioner returned to Dr. Vogel approximately two months later on November 12, 2012. Indicating petitioner suffered from fibromyalgia, Dr. Vogel described her symptoms as improving but "exacerbated by stress (and her menstrual cycle), sleep deprivation, and weather changes." Exhibit 10 at 13. Noting that petitioner regularly exercised and practiced yoga, Dr. Vogel attributed petitioner's improvement to her medication, Cymbalta and Savella.
Over the next six months, petitioner visited Dr. Vogel two more times regarding her symptoms. On February 11, 2013, Dr. Vogel noted that petitioner was taking melatonin to help her sleep and had experienced a definite improvement on the higher dosage of Savella. Exhibit 10 at 15-16. Because of concerns regarding weight gain, Dr. Vogel instructed petitioner to discontinue the Cymbalta. When petitioner returned on May 20, 2013, Dr. Vogel indicated there was no change in her weight but a definite improvement in her level of fatigue which petitioner attributed to an intensive vitamin therapy she had begun.
On July 24, 2013, petitioner began seeing a chiropractor. On her intake form, she listed numbness and twitching as her primary complaint and fibromyalgia as her secondary complaint. Exhibit 4 at 10. She attributed her condition to her flu and tetanus vaccinations and Botox injections.
Petitioner sought treatment from a new neurologist, Dr. McGarvey, during the fall of 2013, approximately two years after her symptoms began. At her first visit (on November 4, 2013), petitioner listed her chief complaint as fibromyalgia and indicated debilitating pain was her biggest concern. Exhibit 12 at 32. She reported that her pain was triggered by her menstrual cycle and the weather.
When providing her history, petitioner reported that she received a flu and tetanus vaccination on the same day, a Botox injection to treat her right eye Bell's palsy, weakness and numbness in the left calf and neck, and dizziness and difficulty with her vision. "These symptoms slowly dissapated [sic] and she was left with diffuse muscle pain in arms and legs, which has gotten better [but she still had] pain in [her] neck and jaw."
Based on this history, Dr. McGarvey concluded petitioner "[l]ikely had GB, now with residual symptoms." Exhibit 12 at 35. She ordered a second EMG and referred petitioner to an ophthalmologist for her eye issues.
When petitioner visited the ophthalmologist on November 20, 2013, she reported a history of GBS and fibromyalgia. Exhibit 3 at 5. Her examination was normal with no edema observed.
The results of the second EMG performed on November 22, 2013 were normal but Dr. McGarvey discounted this finding since the EMG was performed "far out" from when her symptoms occurred. Exhibit 12 at 29;
Petitioner underwent a sleep study on December 19, 2013. The study indicated she suffered from moderate sleep apnea but concluded not all of petitioner's symptoms could be explained by this finding. Exhibit 12 at 27. When Dr. McGarvey saw her the next day, she noted petitioner was sleeping better due to her medication.
In February 2014, petitioner visited her allergist, Dr. Wise. He reported that she was doing well with no sinusitis since her last visit and would continue her immunotherapy. Exhibit 7 at 6. Reporting that petitioner suffered an episode of GBS after receiving the flu vaccine in 2009, he indicated "the influenza vaccine is contraindicated in her case."
In December 2013, petitioner saw her gynecologist for abnormal bleeding between periods.
Petitioner saw Dr. McGarvey again in May and July 2014. At both visits, petitioner reported improving pain but continued fatigue and some dizziness. Exhibit 12 at 5, 12. For the first time, she also reported an inability to sing.
Updated medical records from petitioner's allergist, Dr. Wise, show she continued to receive immunotherapy injections in 2014 and early 2015.
On June 30, 2015, petitioner filed a letter from Dr. McGarvey to petitioner's counsel (dated June 22, 2015). Citing the instance of GBS related to vaccinations reported in medical literature, Dr. McGarvey opined "it sounds as if [petitioner] had a neurologic complications secondary to [one] or more of the combination of vaccines that she had." Exhibit 17 at 1. She qualified her opinion by noting that she "was not involved in [petitioner's] initial care" and thus, her opinion was "based on [petitioner's] history and symptoms."
Under the Vaccine Act, petitioner may prevail on her claim if she has "sustained, or endured the significant aggravation of any illness, disability, injury, or condition" set forth in the Vaccine Injury Table (the Table). § 11(c)(1)(C)(i). The most recent version of the Table, which can be found at 42 C.F.R. § 100.3, identifies the vaccines covered under the Program, the corresponding injuries, and the time period in which the particular injuries must occur after vaccination. § 14(a). If petitioner establishes that she has suffered a "Table Injury," causation is presumed.
If, however, petitioner suffered an injury that either is not listed in the Table or did not occur within the prescribed time frame, she must prove that the administered vaccine caused injury to receive Program compensation. § 11(c)(1)(C)(ii) and (iii). In such circumstances, petitioner asserts a "non-Table or [an] off-Table" claim and to prevail, petitioner must prove her claim by preponderant evidence. § 13(a)(1)(A). This standard is "one of . . . simple preponderance, or `more probable than not' causation."
The Circuit Court has indicated that petitioner "must show `a medical theory causally connecting the vaccination and the injury'" to establish that the vaccine was a substantial factor in bringing about the injury.
Petitioner is not required to eliminate alternative causes when establishing his prima facie case.
Once petitioner has established a prima facie case, the burden shifts to respondent to show by preponderant evidence that petitioner's injury was "due to factors unrelated to the administration of the vaccine." § 13(a)(1);
Petitioner maintains that she suffered GBS causally related to the influenza vaccination she received on September 20, 2011 and the TDP vaccination she received on October 6, 2011. Motion for a Decision on the Record at 1. To support her claim, petitioner relies solely on the medical records filed and the June 22, 2015 letter from Dr. McGarvey.
Respondent opposes compensation in this case and maintains that the petition should be dismissed. Response at 1. She argues that petitioner's correct diagnosis is fibromyalgia and that petitioner has not established that she suffered from GBS. Response at 5. She further argues that petitioner has failed to prove "that her alleged injury, whether it is GBS, fibromyalgia, or any other condition, was caused in fact by either her flu or DTP vaccines."
The Federal Circuit has held that, when the injury itself is in dispute, "it was appropriate . . . for the special master to first determine which injury was best supported by the evidence presented in the record before applying the Althen test so that the special master could subsequently determine causation relative to injury."
In this case, the record does not support petitioner's allegation that she suffered from GBS. GBS is mentioned in only a few places in the medical records filed. Petitioner's allergist, Dr. Wise, first suggested that petitioner's symptoms may be due to GBS or some viral illness in early January 2012. Exhibit 7 at 10. He did not opine further and did not mention the possibility again until more than two years later on February 17, 2014 after petitioner began seeing Dr. McGarvey.
On November 20, 2013, one of petitioner's ophthalmologists, Dr. Brazus, also recorded a history of GBS as well as fibromyalgia. Exhibit 3 at 5. Like Dr. Wise, Dr. Brazus appears to be reciting a history provided to him by petitioner. It is important to note that neither Dr. Wise nor Dr. Brazus are neurologists and likely would not diagnosis a condition such as GBS but would refer petitioner to a neurologist to determine if such a diagnosis was appropriate.
Dr. McGarvey is the only physician who actually opined that it is likely petitioner suffered from GBS, and she did not begin treating petitioner until two years after her symptoms began.
Furthermore, Dr. McGarvey based her opinion on the medical history provided to her by petitioner.
On the other hand, petitioner's initial neurologist, Dr. Vogel (who treated petitioner at the time of her initial symptoms and for the following two years and ordered the December 5, 2011 EMG) never mentioned the possibility that petitioner suffered from GBS. In fact, she consistently noted that petitioner's neurological work-up was negative and there was no indication petitioner suffered from any neuropathy.
The opinion of a treating physician is favored because "treating physicians are likely to be in the best position to determine whether a logical sequence of cause and effect shows that the vaccination was the reason for the injury."
In forming her opinion, Dr. McGarvey relied upon information provided to her two years later by petitioner which conflicts with the information found in the contemporaneously created medical records. "It has generally been held that oral testimony which is in conflict with contemporaneous documents is entitled to little evidentiary weight."
In light of Dr. Vogel's contemporaneous diagnosis, Dr. McGarvey's opinion two years after the fact is not sufficient to establish petitioner suffered from GBS. And Drs. Wise and Brazus relied on representations by petitioner shortly after Dr. McGarvey opined petitioner had suffered from GBS. As the neurologist treating petitioner during onset and the following two years, Dr. Vogel provides the more trustworthy diagnosis.
In
Even if she had established that she had GBS, petitioner would still have to prove that her injury was vaccine caused by satisfying the three pronged
Petitioner has provided no expert report with a medical theory causally connecting her injury to the vaccinations she received. Similarly, she has provided no evidence of a proximate temporal relationship between the vaccinations she received and the symptoms she suffered. She has failed to satisfy the first and third prongs of the
The only evidence petitioner has provided to show a logical sequence of cause and effect connecting the vaccinations she received to the symptoms she suffered is predicated on the assertion that she suffered from GBS. Thus, petitioner has failed to satisfy the second
Petitioner has not provided preponderant evidence that her symptoms were caused by the vaccinations she received. Therefore, she has failed to satisfy all three
Petitioner has failed to offer the opinion of a medical expert, and the medical records filed do not support her allegations. She has failed to demonstrate that she suffered from GBS and that her condition was caused the vaccination she received.
Petitioner has failed to establish that she is entitled to compensation under the Vaccine Act.
The clerk of the court is directed to enter judgment in accordance with this decision.
