MINDY MICHAELS ROTH, Special Master.
On October 13, 2015, Joni Marco ("petitioner") filed a petition pursuant to the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10 et seq.
Respondent postures "the records indicate that petitioner's symptoms started the day before or the day of her vaccination, which would not be consistent with vaccine causation." Resp. Rule 4 Report at 8, ECF No. 18. In response, petitioner requested an onset hearing. ECF No. 36.
An onset hearing was conducted on October 13, 2017. Petitioner, her husband, Dr. Corey Marco, and her daughter, Danielle Marco, testified. See Transcript ("Tr."), ECF No. 46. This ruling is intended to clarify the onset of petitioner's symptoms only, and in no way is intended to be interpreted as a finding on causation or entitlement.
Having carefully considered the medical records, affidavits, testimony of the witnesses, and other documentary evidence submitted, I find that petitioner's symptoms began in the late evening of October 11, 2013, the day she received the flu vaccine.
Petitioner filed her petition and supporting medical records on October 13, 2015. Petition, Pet. Exs. 1-9, ECF No. 1. This case was initially assigned to Special Master Hamilton-Fieldman.
On May 9, 2016, petitioner filed her affidavit as well as an affidavit from her husband. Pet. Exs. 12-13, ECF No. 20. On June 10, 2016, petitioner filed an expert report from Dr. Lawrence Steinman. Pet. Ex. 14, ECF No. 23. On November 7, 2016, respondent filed an expert report from Dr. Arnold Levinson. Resp. Ex. A, ECF No. 28-29. On April 13, 2017, petitioner filed a supplemental report from Dr. Steinman. Pet. Ex. 15, ECF No. 33.
A status conference was held on July 11, 2017. During the conference, petitioner's expert reports were discussed, particularly concerns that petitioner's expert did not address various inconsistencies in petitioner's medical records or the timing of onset of her alleged symptoms. I also noted that the contemporaneous medical records place the onset of petitioner's symptoms either prior to the date of vaccination or on the same day, as early as twelve hours after the vaccination. Petitioner was ordered to file a status report advising how she would like to proceed and whether testimony clarifying the issue of onset would be appropriate. ECF No. 35.
On July 19, 2017, petitioner filed a status report stating that she would like to proceed with testimony clarifying any factual issues regarding onset prior to submitting additional expert reports. ECF No. 36. An onset hearing was held on October 13, 2017. Following the hearing, a status conference was held on October 17, 2017 at which time I expressed concerns about the inconsistencies between petitioner's medical records, affidavits, and testimony at hearing. Petitioner was ordered to file a status report indicating how she would like to proceed. ECF No. 42.
On October 17, 2017, unbeknownst to her attorney or respondent's counsel, petitioner mailed a six page letter directly to me. Petitioner's letter included additional facts that petitioner wanted me to consider. She further stated that she was not permitted to properly prepare for her testimony nor was she afforded the opportunity to have her expert testify on causation. She requested another hearing. The letter was filed into the record. ECF No. 44.
A status conference was held on October 31, 2017, during which I discussed the October 17, 2017 letter. The status conference was recorded for the purposes of discussing with counsel the content of that letter. Counsel was advised that a written decision on onset would be issued based on all of the evidence filed in this matter including the medical records, the hearing testimony, the affidavits and the petitioner's letter of October 17, 2017. ECF No. 45. Additional medical records were filed on December 12, 2017. Pet. Exs. 17-18, ECF No. 48. These medical records were considered as well. This matter is now ripe.
In order to determine the onset of, or first manifestation of, petitioner's alleged injuries following the October 11, 2013 influenza vaccine, petitioner's longstanding chronic medical history must be included.
Petitioner was under the care of Dr. Sherry L. Braheny, a neurologist, since approximately 1987,
On September 9, 1992, petitioner presented to Dr. Braheny for evaluation post head injuries in 1975, 1979, and 1983, with continuing positional dizziness, headaches, scalp tenderness, whiplash, memory loss and insomnia. Pet. Ex. 8 at 39-41. She reported increased pain and tenderness over her right temple, as well as the left and right posterior areas of the head with continued dizziness. Id. at 38. Dr. Braheny's impression was possible right occipital neuralgia and continued dizziness with uncertain significance. Id. Petitioner received an injection of lidocaine and Dr. Braheny recommended a sedimentation rate and an MRI scan. Id.
On February 20, 1996, petitioner presented to Dr. Braheny with possible reflex sympathetic dystrophy ("RSD")
On March 7, 1997, petitioner presented to Dr. Braheny with complaints of overall inflammatory condition with heightened sensitivities, hyper anxiety, and menopause. Pet. Ex. 8 at 31. She complained of left foot pain that began in the summer of 1994. Id. at 30-34. She could not walk due to pain, had to wear a left foot brace, and had developed numbness in both hands and feet which had greatly increased over the past three weeks. She was noted to be quite frightened over the significance of the numbness. EMG testing a year before had confirmed RSD. Id. at 32. She was worried about memory lapses. Dr. Braheny's overall impression at that time was general inflammatory condition with heightened sensitivity resulting in multiple myalgias
The records further reflect that in 2002, petitioner underwent transvaginal repair of a grade 4 cystocele,
At a February 18, 2003 visit, Dr. Braheny documented sensations of nervousness, coldness, racing pulse consistent with dysautonomia,
Since approximately 2002, petitioner has suffered from diverticulitis as well as rectovaginal fistula,
Records were provided for the years between 2004 and 2009 showing treatment of diverticulitis and fistula. Pet. Ex. 11 at 103-20. A CT on September 9, 2009 of the abdomen and pelvis with intravenous contrast due to lower quadrant pain showed sigmoid diverticulitis without abscess. Id. at 115. On November 4, 2009, petitioner's labs showed heavy growth of klebsiella oxytoca
Petitioner was hospitalized between December 2 and December 8, 2009, for recurrent lower quadrant pain. Pet. Ex. 11 at 94-110. A discharge summary showed a 61 year old with a 9-year history of rectovaginal fistula. For two month prior to hospitalization she was treated with Augmentin and Flagyl for an episode of acute diverticulitis, which improved then output from the fistula increased. Id. at 94-95. CT of the abdomen showed acute diverticulitis with microabscesses. She had recurrent episodes of lower quadrant pain and was hospitalized for acute diverticulitis. Petitioner received two weeks of antibiotics. A CT scan thereafter revealed acute diverticulitis with a 2.5 cm diverticular abscess. Id. at 94-110. She had consults with multiple specialists, including infectious disease and colorectal surgery. Id. at 97-99, 103-05, 107-08. Petitioner was noted to have persistent, recurrent diverticulitis, with significant inflammation requiring surgical intervention. Id. at 98-100, 103-05. A surgical consult noted a need to wait for inflammation to calm down prior to surgery. Id. at 100-02. Petitioner was discharged, requiring home health care due to ongoing diverticulitis with abscess, colovaginal fistula, RSD, cervical spinal degenerative disc disease, and hypokalemia.
Due to increasing lower back pain, petitioner came under the care of Dr. Sanjay Ghosh at the Senta Clinic's Division of Neurological and Spinal Surgery ("Senta Clinic"). Pet. Ex. 6 at 62. On November 9, 2009, petitioner saw Dr. Ghosh for symptomatic lumbar radiculopathy
Petitioner began seeing Dr. Keith Kortman for epidural steroid injections ("ESIs") in December 2009, with her first injection on December 22, 2009, her second on April 20, 2010, and third on July 27, 2010.
On April 28, 2010, petitioner's gastroenterologist, Dr. Ali Banaie, wrote a letter on her behalf so that she could travel, stating that petitioner had been hospitalized for peritonitis and abdominal cavity abscess secondary to a rupture of a colon diverticulum in December of 2009.
On June 4, 2010, petitioner was noted to have an intestinal abscess and diverticular colon without hemorrhage. Pet. Ex. 11 at 12. She received home infusions from June 4, 2010 through August 2, 2010. Id. at 65-66. She was noted to have had chronic diverticulitis for years but was noncompliant with recommendations. She continued to have chronic rectovaginal fistula and sympathetic dystrophy and she was still having pain and nausea. A long discussion about her conditions was had. Id. at 62-63. Petitioner suffered a blood clot in her groin in August of 2010. Pet. Ex. 6 at 11.
On January 21, 2011, petitioner received an ESI. Pet. Ex. 6 at 7-8. Petitioner had a follow-up with Dr. Ghosh at the Senta Clinic on April 27, 2011 for her symptomatic lumbar radioculopathy-type symptoms with severe lumbar stenosis at L4-5. Her diverticulosis and diverticulitis were precluding her ability to move forward with spinal surgery. Motor examination at that time was 4/5 on the left foot, 5/5 on the right foot, 4+/5 on the left knee, and 5/5 on the right knee. She had profound loss of pinprick and vibration sense in the left great toe, but such senses were intact in the right and bilateral aspects of the feet. His impression was that petitioner had "significant neurogenic
Petitioner received an additional ESI on May 6, 2011 at which time it was noted that her pain was dependent on how well Tramadol worked on that particular day. Pet. Ex. 6 at 9, 104. She was diagnosed with carpal tunnel syndrome, degenerative disc disease, and chronic regional pain syndrome. Id. at 103.
On July 29, 2011, petitioner received an ESI. She was taking four to six Tramadol a day for the pain. Petitioner advised that she was moving her youngest daughter into a condo and had been lifting heavy boxes and bending in "unusual positions so [the] pain [was] extreme." Pet. Ex. 6 at 11, 94, 96.
On January 25, 2012, petitioner presented to Dr. Ghosh for "progressively worsening lumbar radiculopathy." She was noted to be "handicapped by severe diverticulosis." Pet. Ex. 5 at 2309.
On February 28, 2012, petitioner underwent ESI. She advised that she had been having back, neck, arm, or leg pain for "years and years" from "surgeries, [] child bearing, as well as [an] airplane crash, auto accidents, [and] ... compet[ing] in diving, swimming [in] high school, [and] university level." Petitioner was also noted to have started "extreme exercise" and was unsure of whether to continue. Pet. Ex. 6 at 82, 85.
On July 3, 2012, petitioner had an MRI of her lower spine. In comparing the results with her MRI of October 28, 2008, Dr. Ghosh noted that petitioner had a grade VII spondylotic spondylolisthesis at L4-5 with central canal and foraminal stenosis and degenerative discopathy and facet arthrosis at L5-S1 with left foraminal stenosis. Her degenerative discopathy at L1-2, L2-3, and L3-4 remained unchanged. Pet. Ex. 6 at 59-60, 67-68.
On September 14, 2012, petitioner presented to Dr. Ghosh for back pain radiating down the legs. He noted excellent response to the ESIs, but her stenosis had worsened. He would contemplate an L4-5 laminectomy and fusion. Pet. Ex. 5 at 2303-04.
On October 5, 2012, petitioner presented for another ESI and noted her pain was the "worst it ha[d] ever been." Pet. Ex. 6 at 15, 71.
Blood work performed on March 13, 2013 showed high cholesterol. Pet. Ex. 5 at 2291. Petitioner had a chest x-ray for left-sided chest pain in the upper chest on March 20, 2013. The results showed mild degeneration in the AC joint
On May 7, 2013, petitioner saw Dr. Tomiko Fukuda, an orthopedist, for bilateral foot pain. Pet. Ex. 5 at 2284. Dr. Fukuda noted a "very complex history regarding her feet" and reported that petitioner ambulated with a normal gait but slow cadence. Id. at 2284, 2287. Following an x-ray of petitioner's left foot, Dr. Fukuda's impression was that petitioner suffered from hallux rigidus,
On May 10, 2013, petitioner had an abdominal ultrasound at the direction of her primary care physician, Dr. Corey Marco for reported pelvic pain. There was no evidence of free fluid or pelvic mass. Pet. Ex. 5 at 2281-83.
Petitioner was admitted to Memorial Hermann Hospital on May 17, 2013, for chest pain. A stress ECG and chest x-ray were normal; she was discharged the following day. Pet. Ex. 5 at 2268-79.
In mid-September of 2013, petitioner had a fall through the floor with reported awkward positioning upon landing. Pet. Ex. 4 at 76.
On September 19, 2013, petitioner presented to Dr. Marco, with back pain radiating to her legs. Pet. Ex. 5 at 2208. She had degenerative disc disease of the lumbar spine with spinal stenosis. She required Tramadol on a regular basis to function; the pain radiated down both legs to the level of the knees or further. There was no bowel or bladder incontinence other than Stress Urinary Incontinence ("SUI")
On October 1, 2013, petitioner had another ESI and noted that she had pain with walking, standing, sitting, laying down, and lifting. Pet. Ex. 6 at 17, 56.
On October 11, 2013, petitioner presented to Rite Aid and received the allegedly causal flu vaccine.
On October 15, 2013, petitioner presented to Dr. Boris Khamishon at the Neurology and Epilepsy Center. Pet. Ex. 2 at 3. She was a 65 year old woman with a history of chronic lower back pain diagnosed as degenerative disc disease with central canal stenosis. She presented with new onset of weakness in the lower extremities with bowel and bladder incontinence "since four days ago."
The following day, October 16, 2013, petitioner presented to the emergency room at Sharp Memorial Hospital ("Sharp") complaining of loss of bowel and bladder control. She came under the care of Dr. Roth. She reported long standing back pain for which she received injections. She reported recent routine lab work that showed high cholesterol for which she took a single Crestor and a day or so later, noticed some band like pain in the upper and lower extremities; the upper extremity pain had gone away. She stated that she then had increasing lower extremity pain, weakness, and difficulty walking. She had no fever, cough, or congestion. She had an overall generalized headache. She stated that she needed a walker to walk which was new for her. She noted irritation of her diverticulitis but this was chronic for her and did not appear to be acute. Pet. Ex. 3 at 221-24. She was admitted to Sharp on that date where she remained until November 3, 2013. Id. at 105.
A neurology consult that day, noted acute onset of bilateral sensory motor deficits involving the lower extremities. According to the patient, the symptoms started seven hours after taking Crestor. The event started as numbness involving the right foot which rapidly progressed and involved the left lower extremity up to the entire pelvic area. The event was associated with bilateral lower extremity weakness to the point that she was using a walker for ambulation. She complained of saddle and perineal area numbness with urinary and bowel incontinence. The event was sudden, bilateral, with less severe radicular pain, more on the low back with numbness that was localized to the perianal area, and was symmetric. There was no sensory level involvement on the thoracic area and no spinal focal tenderness. She denied trauma. She had preserved but symmetric hyper-reflexic reflexes, and overall absent ankle jerk on the right side. She had distal paresis of the left lower extremity with foot drop which was less marked on the right. There were no fasciculations,
Petitioner was noted to be alert and oriented with normal recent and remote memory, fund of knowledge, and fluent and comprehensive speech. Dr. Roth's impression at that time was a constellation of symptoms, including a sudden onset of bilateral sensory motor deficits involving deep tendon reflexes in the lower extremities with associated urinary and bowel incontinency. There was a consideration of conus medullaris syndrome.
A neurosurgical consult by Dr. Richard Ostrup took place later that day on October 16, 2013. Pet. Ex. 3 at 124-26. Petitioner was noted to be a 65 year old with back problems dating back a few years with occasional right leg radicular complaints which prompted epidural steroid injections. Id. at 124. According to the patient, she had recently been in Texas helping her daughter and after her return developed pain around October 1, 2013 requiring further evaluation and treatment with an epidural steroid injection.
Id. She apparently saw a neurologist the day before and tests were ordered, but she developed significant leg pain prompting presentation to the emergency room. Id. An MRI did not show any acute change to account for her neurologic change of incontinence or bilateral lower extremity pain. Id. at 124-25. Her study looked similar to one several years ago. A thoracic study had not been done. Id. at 125. "On talking with her today, she does move her legs. She walks but she walks with a waddle, which she says is markedly different than her usual gait. She has had some pain in the legs." Id. A CT of the head did not show acute issues. Her upper extremity issues appeared to be more carpal tunnel related. Id.
Dr. Ostrup further noted that she was resting comfortably in bed and her affect was "quite reasonable." Pet. Ex. 3 at 125. Palpation of her back generated some discomfort in the thoracic and lower spine. Id. at 126. She had reasonable strength in her lower extremities. She complained of decreased sensation throughout her legs, beginning about the level of the umbilicus (belly button). There was no definite upper motor neuron findings. Reflexes seemed to be diminished throughout. Dr. Ostrup ordered an MRI of the thoracic spine. Id.
The MRI of the thoracic spine performed on October 17, 2013 was normal. Pet. Ex. 3 at 166. A repeat MRI three days later, on October 20, 2013, noted a slightly elongated T2 hyperintensive lesion on the spinal cord at the T10 level. On retrospective review, it was noted that the lesion may have been present on the October 17, 2013 thoracic spine MRI study, but was less apparent. Id. The impression was possible transverse myelitis ("TM")
A urological consult was conducted on October 18, 2013, due to incontinence, noting a history of hysterectomy and vaginal sling surgery in 2003 with post-operative rectovaginal fistula requiring three surgical repairs, including a flap. Pet. Ex. 3 at 121. Petitioner reported that the repairs were unsuccessful. Diverticular disease with recurrent inflammation on antibiotics was also noted. She advised that her last flare was two weeks ago, for which she was taking ciprofloxacin.
On October 21, 2013, Dr. Roth ordered a lumbar puncture performed by Drs. Kortman and Keyvani for suspected transverse myelitis. Pet. Ex. 3 at 186, 724. The cerebrospinal fluid was clear and colorless with a colorless supernatant, 4 red blood cells, 4 nucleated cells with 80% lymphocytes, 20% monocytes, 50 mg/dL of glucose, and 19 mg/dL of protein with testing negative for oligoclonal bands but showing increased myelin basic protein at 22.65 ng/mL. There was no measured IgG synthesis and a normal IgG index with negative HTLV I/II antibodies. Cardiolipin IgA, IgG, and IgM were normal and cultures of CSF were negative for growth.
A consult with gastroenterology on October 24, 2013, noted abdominal pain with complicated diverticulitis, long term colovaginal fistula, and long term antibiotic use with surgery discussed previously but refused. The assessment was a 65 year old woman with at least three to four previous episodes of complicated diverticulitis with micro perforation and abscesses. The plan was to calm it down with antibiotics, though surgical intervention would be required at some point. Pet. Ex. 3 at 115.
Examination conducted on October 30, 2013, documented presentation to the hospital due to acute onset of loss of bowel and bladder function, with a lot of chronic complaints including chronic neuropathy over the years but now more pain and discomfort after taking Crestor. Creatine phosphokinase ("CPK")
Petitioner was discharged on November 3, 2013 to Kindred Care with a PICC line for TPN (nutrition), IV antibiotics, and a plan for surgery for her diverticulitis and related issues in seven weeks after all had calmed down. The admission to nursing care noted leg discomfort, weakness, fatigue, incontinence of stool and bladder, and possible TM on MRI. Pet. Ex. 3 at 105-08.
Petitioner subsequently developed acute perforated diverticulitis and on November 10, 2013 was transferred to Grossmont Hospital. Pet. Ex. 8 at 9, 16. On November 11, 2013, she was examined by Dr. Braheny, who had treated petitioner since 1987 for multiple problems relating to various neurological complaints, including recurrent headaches, neuralgia, atypical left lower extremity RSD, dizzy spells, and chronic neck and back pain. Dr. Braheny noted that she had not seen petitioner since 2006, but kept up to date through petitioner's husband, who was also a doctor. Petitioner was transferred to Grossmont Hospital for increasing abdominal pain, fever, recent diverticular rupture, and abdominal abscess. Petitioner provided Dr. Braheny with a history of taking Crestor on October 17, 2013 for the first time
Dr. Braheny noted that petitioner was ill appearing, with mild memory deficits for historical details of uncertain significance. She had mild generalized weakness with superimposed paraparesis,
An MRI performed on November 13, 2013, was compared with MRI results from October 17 and October 20, 2013. Signal abnormality was again noted at T11-12.
On November 16, 2013, petitioner had a consult with gastroenterologist, Dr. Matthew Isho, for recurrent attacks of diverticulitis since 2008. Pet. Ex. 9 at 7. Dr. Isho noted that her last attack was in October at Sharp, where CT-guided drainage of an abscess was performed. She developed neurological symptoms at that time, could not walk or feel her legs, and was diagnosed with questionable TM. She was administered steroids and had been on TPN and antibiotics since. Id. Dr. Isho's impression was complex diverticulitis. CT scan revealed a possible fistula to the colon. Petitioner had questionable TM and spinal spondylosis.
On November 25, 2013, Dr. Isho performed a low anterior resection with primary anastomosis, small bowel resection, drainage of pelvic abscess, take down and repair of colovaginal fistula, and splenic fissure mobilization with colostomy placed. Pet. Ex. 4 at 55-64.
In a follow-up examination on December 5, 2013, Dr. Braheny added petitioner's surgery of November 25, 2013 to her history. Dr. Braheny noted that her workup included a hazy lesion of the spinal cord at T10. Pet. Ex. 8 at 4. According to Dr. Braheny, this was initially missed, then diagnosed as TM; however, she did not clinically fit a typical picture of TM as she never had sensory level involvement. The loss of bladder and bowel with weakness in the legs could be secondary to the lesion. Other possibilities included spinal cord injury from a fall a month prior, viral or immunological etiology. Id. at 6. She had mild memory impairment for some past historical details. Dr. Braheny's impression was continued paraparesis superimposed on generalized weakness of uncertain cause, rule out viral, traumatic or inflammatory cause of spinal lesion at T10-12, which was significantly improving. L4-5 spondylolisthesis with moderately severe central canal stenosis was also noted. Dr. Braheny noted that petitioner had chronic neck pain with C6-7 disc bulge of uncertain clinical significance. She had bilateral carpal tunnel syndrome, hypothyroidism, hypertension, dyslipidemia, past history of occipital neuralgia, anemia, nausea of uncertain etiology, myalgias, arthralgias, and situational anxiety. Id. at 7.
On December 10, 2013, Dr. Banaie examined petitioner for persistent nausea suspected to be medication related noting her chronic and recent medical history. Pet. Ex. 11 at 54-57. She continued to have neurological symptoms. An abdominal ultrasound on bowel rest showed elevated liver enzymes, a gallstone, and elevated bilirubin. Id. at 54-55. Dr. Banaie's impression was that her persistent nausea was secondary to medication, status post-abdominal surgery, deep vein thrombosis of calf, and questionable spinal cord lesion with paraparesis. Id. at 57.
An MRI performed on December 18, 2013 showed a resolution of the previously noted spinal cord abnormality in the lower thoracic spine at T10-12 and was thought to reflect resolving spinal cord edema. Pet. Ex. 8 at 46.
On her discharge summary on December 21, 2013, petitioner was noted to have atypical TM with resultant paraparesis, possible neurogenic bladder, L4-5 spondylolisthesis with moderately severe central canal stenosis, complex diverticulitis, ruptured diverticulum, pelvic abscess, partial small bowel obstruction, and colovaginal fistula requiring surgery with primary ileostomy creation. She had persistent nausea, multi drug resistant e. coli bacteria, left soleal deep venous thrombosis, status post-inferior vena cava filter placement on October 25, 2013, chronic rectovaginal fistula, persistent alkaline phosphatase elevation partially due to immobilization, anemia, chronic neck pain with mild disc bulge at C6-7, bladder incontinence, atypical RSD of the left lower extremity, chronic arthralgias, depression, anxiety, hyponatremia, mobility, and self-care deficits secondary to the above comorbidities. Petitioner was discharged home to her family. Pet. Ex. 11 at 48-51. An MRI of the thoracic spine performed on June 4, 2014 was normal. Pet. Ex. 3 at 8.
The remainder of the medical records relate to petitioner's ongoing treatment and current medical status and are not relevant for purposes of this onset decision. It is notable that petitioner showed up to hearing in a wheelchair. The reason for wheelchair use at the time of hearing was unclear.
The affidavit of Joni Marco was filed on May 9, 2016. Pet. Ex. 12.
Petitioner affirmed that she had a prior history of back pain, radicular symptoms, and diverticulitis. According to petitioner, the symptoms she suffered after the influenza vaccination differed from her prior health concerns in both type and severity. Id. at 1. Following receipt of the flu vaccine on October 11, 2013, she had some arm soreness and generalized achiness which she attributed to a normal reaction to the flu vaccination. Id.
According to petitioner, late in the evening of October 14, 2013, she experienced pain and weakness in her legs. Id. On October 15, 2013, she presented to the neurologist, Dr. Khamishon, with urinary incontinence, bowel incontinence, bilateral leg pain and weakness, and an abnormal gait. An MRI of the lumbar spine was ordered. Id. On October 16, 2013 she was admitted to Sharp Memorial Hospital with severe pain, leg discomfort, weakness, incontinence of stool and bladder, and "atony with a dilated bladder."
Petitioner is a certified licensed interior designer, set designer, attorney, and part-time manager of her daughter's 501(c)(3) charity. Tr. 8. At the time of her vaccine, October 11, 2013, petitioner represented indigent clients in finding the medical care they needed. Tr. 8.
At the beginning of the hearing, petitioner stated that she wore a Fentanyl patch, which is 10 to 100 times stronger than morphine and 5 to 10 times stronger than heroin and can "clog your mind at times." She was also taking Tramadol for pain, thyroid medication, anti-nausea medication, Robaxin,
Petitioner testified that, on October 11, 2013, she met her daughter at the Rite Aid later in the day and they both went to the back of the store to get their flu vaccines. She stated that she was asked her age, and it was suggested that she take the flu vaccine for those over the age of 65, so she did. Her husband was supposed to come in for his flu vaccine, but he was running late. Tr. 10-11.
Petitioner recalled that she and her daughter then met her husband at Chili's. She had a history of diverticulosis but had not had problems "for a long time" so she decided to have a "really spicy Mexican dish and it was so spicy when they served it, that I began to drink like crazy because my mouth was on fire." Tr. 11. That night, she was up urinating all night from drinking so much water and had diarrhea from eating food she was not used to. Tr. 11, 37. When asked on cross-examination to clarify whether she was just urinating a lot or wetting her pants, petitioner responded:
Tr. 39. She remembered being up until 2 or 3 a.m. going to the bathroom. She then awoke on October 12, 2013 around 10:30 a.m. and went to the airport to pick up her other daughter, who was coming home. Tr. 11-12. According to petitioner, her arm may have been sore from the vaccine and maybe her body hurt a little bit, but it was the usual from a flu vaccine. Tr. 13.
Petitioner recalled that on Sunday, October 13, 2013, she cleaned all day because she was expecting company that week. Tr. 13. Around dusk, she was going to the family room and saw something on the floor and thought one of the dogs had an accident. According to petitioner, she went to get her husband who looked at it and said it was human stool. She went to the bathroom and checked her underpants and there were "some more little tiny pebbles of stool" in her underpants. According to petitioner, she was shocked that she could pass stool without even knowing it. Tr. 13-14. According to petitioner, "[i]t was totally opposite from what [she] experienced only a couple days before" with the diarrhea from the Mexican food. Tr. 15.
According to petitioner, on Monday, October 14, 2013, she felt like she strained her back. She attributed it to everything she had done the day before, cleaning the house, the patio furniture, being "up on ladders," and felt it came from bending over the wrong way. Her legs "were just kind of pulling and felt funny." Tr. 15-16. According to petitioner, she could not really define the pain, it was like "pressure ... and kind of like a weakness almost at the same time," but she did not think much of it. Tr. 16.
Petitioner testified that on Tuesday, October 15, 2013, when she awoke, she had "some weird back pain and leg pain." She felt weak and was dragging her left leg. She felt some pain but felt like she had overextended herself. She called her husband in the office and described the symptoms. He said it sounded neurological and set up an appointment with a friend, Dr. Khamishon. Tr. 17.
Petitioner recalled seeing Dr. Khamishon that day. She explained to Dr. Khamishon that on Friday night, she couldn't stop going to the bathroom with diarrhea and urinating and could not control it, and that morning was the total opposite; she felt like she had to urinate but couldn't. They talked about her back and he suggested an MRI. Tr. 18. Petitioner explained that she now understands the meaning of incontinence: the night of the shot she couldn't stop urinating and maybe leaked a little in her pants, but when she saw Dr. Khamishon, she couldn't go at all, but "her panties were a little wet," which would be incontinence. Tr. 38.
Petitioner recalled that, after her appointment with Dr. Khamishon, she went home and laid down as he suggested. Her husband got her a walker because she couldn't walk. According to petitioner, she had a history of back issues and diverticulosis but this was different. It was a band like pain around her leg, with pressure in her back. She was dragging her leg, and the pain was higher than her usual pain. It felt like a lead ball in her back pulling up and pulling down. Tr. 19-21.
Petitioner remembered waking up at 3 a.m. on October 16, 2013, "screaming in pain." Tr. 21. She couldn't walk, couldn't bend her knees, it was the most intense pain she ever had. Her screaming woke everyone in the house. She wanted to go to the bathroom but couldn't. "And the whole thing was very alarming to me." Later that morning, her husband thought they should go to the emergency room. When she arrived at the emergency room, she tried to answer the doctor's questions. Tr. 21-22. According to petitioner, the emergency room doctor asked when she had pain, and she asked him, "pain of any kind, any type of pain, when did I first have pain?" Tr. 22. She told him it was when she had the flu vaccine that she had pain that she did not normally have, an "achy flu shot sensation." Tr. 22. She then asked the doctor what day it was, and was told it was the 16
According to petitioner, upon admission she was catheterized because she couldn't go to the bathroom, and while doing that, they saw stool in her pants, but she couldn't feel it. She was screaming from the pain, and was given "heavy duty pain medications, kept on "heavy duty pain medication" throughout her stay and her family told her she was out of her mind for most of the time. Tr. 23-24.
Petitioner stated that she mentioned the flu vaccine one more time during her admission, but the doctors said that it was irrelevant, so she never mentioned it again. She then stated, "No one knew I had taken the flu shot. And I thought it was irrelevant myself." Tr. 24.
Petitioner was asked about her references to taking Crestor. She stated that her husband brought it home and she thought it would be good for her, but she was afraid to take it unless he was home, so she took it around 6:30 or so Saturday night, October 12, 2013, seven or eight hours after she awoke that day. Tr. 26-27, 30-31. She was asked why the records repeatedly indicate that she had problems seven or eight hours after taking the Crestor. She responded that she never had problems before or after the Crestor and had no idea why her medical records would say that. Tr. 31-32.
Petitioner was then presented with a medical record from October 18, 2013, which stated, "[a]bout six days ago, she took a cholesterol pill, Crestor. She states that at that [sic] night she woke up with pain which was some sort of band like pain around her legs coupled with incontinence not only of bladder but also of stool." Pet. Ex. 3 at 124-26; Tr. 33. Petitioner responded, "I don't know what to say. I took Crestor Saturday night. I didn't wake up that night. I think he's confused. He's mixed up several different things in here." Tr. 33.
Petitioner again used the process of counting backward, stating that the record was written on the 16
Respondent's counsel asked petitioner how she remembered the events she was testifying to. Petitioner stated that she remembered the events because things stick out in your mind, like the stool on Sunday night, and the flu shot before the Mexican dinner, which was so spicy she "paid for it." Tr. 36.
I asked petitioner to again take me through the details from October 11, 2013, until her hospitalization. She stated that on Saturday, October 12, 2013, she picked up her daughter at the airport and was fine until the night of Sunday, October 13, 2013. Tr. 43. I asked her if she had any leg pain while she was cleaning the house on Sunday. She stated that she might have told someone she had pain on Sunday, but she could not remember it that clearly because it wasn't acute enough, but that changed on Monday. Tr. 44.
I asked her if she had been receiving pain injections in her lower back for chronic back pain prior to her flu shot. She stated that she did, once a year, maybe every six months. She testified that she had spinal stenosis at L4-5, but the pain she experienced after the flu vaccine was totally different. Tr. 44-45. Petitioner stated that at first, she thought the pain was from cleaning and just her L4-5 problem, adding:
Tr. 45. Petitioner submitted that her answers that "seem peculiar" or "not in line with the dates" was because of how the doctors framed their questions, and because she speaks fast, and because some of them had language difficulties. Tr. 46.
I asked petitioner to describe what was happening on Monday, October 14, 2013. She responded that it was not like Tuesday or Wednesday, and she couldn't really define it, but:
Tr. 46. Petitioner could not recall if it was her left leg or her right that was dragging, stating maybe she had sensations in both of them of pain, it was not definitive yet. Id.
I asked petitioner if she ever wore a brace on her left foot. She stated that she did years ago, in about 2001. She had ruptured her tendon and after it healed, she was told she had complex regional pain syndrome — RSD. She was so active that after it healed she never wore the brace. Tr. 47.
I asked petitioner to describe what she was experiencing on Tuesday, October 15, 2013. She stated that was when the sensations really started. She was dragging her leg, but thought she had overextended herself cleaning the house and doing things she had not done in a long time. Tr. 48.
Petitioner reiterated that everything started Sunday night with the stool on the floor, but no pain. There was nothing going on before the shot and nothing going on until Sunday night around 6:30. Tr. 48-49.
The petitioner added that she does not understand how everyone took a different perspective. "I was confused by this whole experience of what was happening to me and I pride myself in being accurate. But I probably was in a great amount of pain once I got into the hospital and maybe my answers were not totally accurate, and for that I apologize." Tr. 50.
Following the hearing, petitioner sent a letter directly to me without the knowledge of her attorney. The letter was filed into the record as ECF No. 44. The letter is being considered as an addendum to petitioner's affidavit.
In her letter, petitioner stated that she "was unable to give comprehensive and consistent testimony at my hearing that took place Friday. I understand in evidence that the record speaks for itself and that in the end one has to defer to the record." ECF No. 44 at 2. Petitioner wrote about the "discrepancy of the timeline I gave various doctors during the time that I was panicked, unwell, emotional, and concerned over the incidents that had happened to me." Id.
Petitioner wrote that the first question asked of her in the emergency room was "When did I feel any pain?" According to petitioner, she was not asked about "this particular pain" but "when and where did I feel any pain at all." She asked what day it was, and when told it was October 16, 2013, she counted backward on her fingers to the moment that she received the flu shot because her arm hurt afterward, so October 16 was day 1 and October 11 would be day 6. Id. at 3. The pain six days before was
Id. According to petitioner, the intense pain that brought her to the emergency room started on October 16 at 3 a.m. and continued onward through her illness. Id.
In explaining why the October 13, 2013 incident of Sunday was not contained anywhere in the record until the time of hearing, petitioner wrote that her husband explained to her what it meant when the doctors referred to her stool incident as incontinence.
Id.
Petitioner wrote that she would not have taken a flu vaccine if she had symptoms the day of or in the days prior to the vaccine. According to petitioner, the literature is clear that you don't receive a flu shot when you are sick and she has always been asked that when receiving the flu shot "over the last twenty or so years." Id. at 4.
Finally, petitioner wrote
Id. at 5-6.
I do not hold any negative impressions of the petitioner and recognize that this was a very trying and emotional time for her and her family. While I have considered the content of petitioner's letter as part of the evidence in this matter, I remind petitioner that ex parte communications with me outside the purview of her attorney is not appropriate. Her action, however, did not negatively affect my determination of the onset of her symptoms.
On May 9, 2016, the affidavit of petitioner's husband, Corey Marco, was filed. Pet. Ex. 13. According to Dr. Marco, petitioner received a flu vaccine on October 11, 2013, after which she complained of soreness and pain in her right arm. Pet. Ex. 13 at 1.
Dr. Marco stated that, he and petitioner went out for dinner the night of her vaccine. He stated that the meal was very spicy and petitioner complained of diarrhea afterwards. She also urinated during the night but he assumed this was due to the amount of water she drank to "quell the spiciness of her food." Id. at 2.
According to Dr. Marco, on the morning of October 15, 2013, petitioner awoke with bladder and bowel incontinence and unsteady gait. They went to Dr. Khamishon that day for bilateral leg weakness and urinary and bowel incontinence. Id.
Dr. Marco testified that on Wednesday October 16, 2013, petitioner was admitted to the hospital where she continued to receive treatment for symptoms of transverse myelitis, perforated diverticulum, and a myriad of complications through April 29, 2015.
Dr. Marco is both a doctor and an attorney. Tr. 53. As of the date of the hearing, he had retired from the practice of medicine after 50 years and was practicing law. Tr. 54. Dr. Marco and petitioner have been married for 46 years. He has also been her primary care provider for the past 46 years. Tr. 54.
Dr. Marco stated that October 11, 2013, was a very busy day in his office because it was flu season and he was running late. He was supposed to meet his wife and daughter at the pharmacy two blocks away for influenza vaccines and then proceed to their dinner reservation. Their youngest daughter was coming home the next day and the week had been busy at work and at home trying to straighten things up. He was tired and recalled only wanting to go to dinner. He remembered the pharmacy because "my wife tends to be very dramatic and bubbly and overflowing sort of, and she had discovered there was a new flu shot, a quadrivalent shot. And she was trying to entice me to get that." Dr. Marco stated that he just wanted to go to dinner, which was what they did. It was a very relaxing dinner in one of their favorite restaurants. Tr. 54-56.
According to Dr. Marco, prior to petitioner's October 11, 2013 vaccine, she had complaints but they were her usual complaints, nothing out of the ordinary. Tr. 56.
Dr. Marco did not recall much of October 12, 2013, because it was a Saturday and he worked six days a week. Saturday is his short day, in which he had office hours from 7 a.m. to noon. He would have left that morning before petitioner got up. Tr. 56. He did recall asking her why she was up during the night and he thinks she had stomach problems, diarrhea and was urinating a lot. Tr. 56-57. He recalled being a little happy and excited that his youngest child was coming home, but nothing unusual about that day. Tr. 57.
Dr. Marco was asked why in his affidavit he mentioned his wife's urination the night of October 11, 2013. He responded that it was not terribly significant, it was just not petitioner's habit to get up at night. Tr. 72-73.
According to Dr. Marco, Sunday was a "crisis." It was around dusk, and he was with his two daughters in the house when petitioner came in and said there's poop on the family room floor.
Tr. 57-58.
Dr. Marco stated that Monday, October 13, 2013, was a better day. Petitioner had been complaining about her back and her leg but they "chalked it up to the fact that she had done a lot of cleaning." Tr. 58. They did not have a lot of interaction during the day because Dr. Marco gets to his office by 6 a.m. Tr. 58. When he got home that night, petitioner had complaints but "my wife often had complaints." Tr. 58. According to Dr. Marco, as her primary care physician and her husband, he knew she had spinal stenosis and significant degenerative disease of the lumbar spine. When she did too much, she would have complaints. She complained a bit more on Monday and he was "scratching his head" because there was poop on the floor the night before and Monday she was complaining of a bit more back and leg pain but he did not make much of it. Tr. 58-59.
Dr. Marco testified that he will never forget Tuesday, October 15, 2013. In 50 years of practice, he never cancelled a patient until that Tuesday. He does not recall what time petitioner called him, but she stated that she could not walk, could not get out of bed, was dragging her feet, and was in way more pain than the day before. Tr. 59. He stated that he thought to himself, there's "poop on Sunday night in her pants without explanation, we've got pain that's more than she usually complains about, and now she's dragging her leg and she can't walk." Tr. 59. Dr. Marco stated that when he got home, his wife could walk but "[he] didn't recognize it as a walk. She looked like a duck. She walked like a duck. And it looked painful and she was crying in pain. So — I'll never forget that day. That was a very worrisome day and I, frankly, didn't know what to do." Tr. 60. According to Dr. Marco, he called Dr. Khamishon, the neurologist that he usually refers to, and begged him to see petitioner. Dr. Khamishon cancelled some patients to see her. Dr. Marco, with the help of his daughters, got petitioner into the car and drove her to Dr. Khamishon. Tr. 60-61.
Once at Dr. Khamishon's office, Dr. Marco provided petitioner's medical history, her back problems, and the Sunday night bowel incontinence incident, stating to Dr. Khamishon that "when we looked in her underwear on Sunday — Sunday night, her underwear was wet as well." Tr. 61. According to Dr. Marco, petitioner certainly had bowel incontinence and he "felt she had some urinary incontinence as well on October 13
Dr. Marco testified that Wednesday was the worst, "the day in infamy for us." Tr. 62. They went to bed Tuesday night and at about 3 a.m., petitioner awoke screaming in pain. He had never had anyone wake him up screaming in pain. Petitioner was in "dire straits," and could not walk. She woke everyone up "shrieking in pain, I can't — I can't get it out of my mind." Tr. 62-63. According to Dr. Marco, it was 3:00 or 4:00 in the morning, and "I'm a physician and I didn't know what to do for her." The family debated which emergency room to take petitioner and decided to drive to Sharp Memorial Hospital, 15 miles away, not the closest hospital near them. They arrived early morning, around 8 or 9.
Dr. Marco stated that petitioner was admitted to the hospital and they did an MRI that showed her usual back problems. Tr. 64. She was begging for pain medication and they gave it to her. Tr. 64. According to Dr. Marco, the admitting doctor was his friend, Dr. Roth, and he was arguing with him about the amount of pain medication that petitioner was given stating that pain medication constipates her and he could not tell whether she was screaming from pain in her back, leg, or from constipation. Tr. 65. Dr. Marco added that petitioner "gets looney" on medicines and her thinking was clouded and confused. "I kept saying to myself, I don't know if they're getting a clear picture here. But it wasn't my job. I was trying not to be a physician, but to be a husband. And so I'm sitting there listening to them taking her history and I'm not so sure she was a good historian." Tr. 65
When questioned about the references to Crestor in the record, Dr. Marco stated when petitioner took Lipitor she had "all kinds of pain, muscle pain, which is — you know, they're notorious for causing that as their side effect." Tr. 66. He had gotten samples of Crestor and brought it home Friday night. Petitioner wanted to try it and he had reminded her of the issues with Lipitor, but she wanted to try it anyway. They discussed it and she decided to take it Saturday night when he was home in case she had a reaction. Tr. 66-67.
Dr. Marco was shown Dr. Khamishon's record for October 15, 2013, which documented that petitioner took Crestor four days ago (on October 11, 2013). Pet. Ex. 2 at 3. Dr. Marco responded "I can guarantee you that she did not" take the Crestor on October 11, 2013. He then added that he recalled her telling Dr. Khamishon and the other doctors about the Crestor and "that I argued with her every time she said it because I said, that is ridiculous, it had nothing to do with the Crestor. Whatever's happening to you now, this pain, your inability to walk and drag your leg, that's ridiculous for you to — to associate that with Crestor." Tr. 69. According to Dr. Marco, he had conversations with every one of petitioner's consulting doctors. "I talked to Dr. Roth about it; I talked with Dr. — the ER doctor about it; I talked with Dr. Ostrup about it. They all agreed with me. I said this is irrelevant. I can recall several discussions about the Crestor." Tr. 69-70.
When asked how he remembered all of the details that he testified to, Dr. Marco stated
Tr. 70-71.
Respondent's counsel then asked Dr. Marco why the incident on Sunday night October 13, 2013, was not described in his affidavit. Dr. Marco responded, "I could have written this better. Had I written it better, I would have said, I was aware that she had had bowel incontinence on the 13
Dr. Marco confirmed that he reviewed the affidavit before he signed it and stated that it was true and accurate to the best of his recollection when he signed it in 2016. Tr. 76. His counsel tried to redirect him and get him to agree that there was a lot of discussion about the content of his affidavit prior to his signing it, but Dr. Marco would not agree, stating that he had no memory of that. Tr. 76.
Danielle Marco is the youngest daughter of petitioner and Dr. Marco. Tr. 79-80.
According to Ms. Marco, she had come home from medical school in Houston, Texas for the weekend to visit her family on Saturday (which would have been October 12, 2013). Tr. 79-80. She recalled petitioner picking her up at the airport. There were no specific plans for the weekend. Tr. 81.
According to Ms. Marco, nothing specific "jumps out to me during the day on Sunday." Tr. 81. They were cleaning the house. Petitioner was always cleaning so it was not anything out of the ordinary. Tr. 86. Ms. Marco did some homework and thinks they might have watched a movie, "really nothing was out of the ordinary until that night with the poop incident when my mom discovered her stool on the floor, which was pretty shocking. But other than that, it, you know, seemed natural." Tr. 81.
When asked to describe the Sunday night event, Ms. Marco stated that petitioner started getting very excited and yelled for them to come help her and see what was happening. Tr. 82. According to Ms. Marco, petitioner may have called for her dad first, but when they heard the commotion, they went to check it out. Tr. 86. "She seemed pretty embarrassed and ashamed when she figured out it was her own stool, but seemed alarmed, too, and you know, wanted to alert us to this thing that happened." Tr. 82, 87. Ms. Marco believes her dad pointed out that it came from petitioner. Petitioner said she did not feel it, so she was surprised. Tr. 87
According to Ms. Marco, Monday was ordinary; they tried to forget Sunday night and not make a big deal out of it. They were cleaning the house, nothing out of the ordinary. Tr. 82. Petitioner made her usual complaints of aches and pains, joking that she was getting old. According to Ms. Marco, petitioner complained of "some back pain that I think sometimes gave her some leg pain. But nothing—nothing really serious." Tr. 87-88.
According to Ms. Marco, on Tuesday, her mom's normal complaining of getting old was different. She seemed to have a little bit of difficulty walking, some leg stuff going on and seemed worried about the issues she was having. Tr. 83. According to Ms. Marco, her dad booked a neurology appointment. She did not think much of it, and planned to go back to school the next day. Tr. 83. Ms. Marco stated that the appointment was in the afternoon. Her dad is a doctor and had asked a friend who was a neurologist to see petitioner. Tr. 88. After being specifically asked, Ms. Marco added that her dad cancelled patients to come home to take her mom to the doctor which was "a little alarming. But I didn't want to think too much into it until we knew what was happening, I guess." Tr. 89.
According to Ms. Marco, on October 16, 2013, she recalled her mother woke everyone up screaming in pain at around 3 a.m. They decided to take her to the emergency room, but it took some time to get her up and moving, so they did not get her out of the house until around 9:00 a.m. Tr. 83-84.
According to Ms. Marco, they all went to the emergency room. She recalled that they catheterized petitioner and a lot of urine came out, even though she had been complaining that she could not go. They did a gait test because she "was walking very strangely, like a duck." Because of her pain, they started "pretty heavy-duty pain medication right away." Other than that, she does not remember anything else. Tr. 84.
According to Ms. Marco, she recalls these events, because she did not return to school after that. Tr. 85.
Petitioner bears the burden of establishing her claims by a preponderance of the evidence. § 13(a)(1). A petitioner must offer evidence that leads the "trier of fact to believe that the existence of a fact is more probable than its nonexistence before [he or she] may find in favor of the party who has the burden to persuade the judge of the fact's existence." Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations omitted).
The process for making determinations in Vaccine Program cases regarding factual issues, such as the timing of onset of petitioner's alleged injury, begins with analyzing the medical records, which are required to be filed with the petition. § 11(c)(2). Medical records created contemporaneously with the events they describe are presumed to be accurate and "complete" such that they present all relevant information on a patient's health problems. Cucuras v. Sec'y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). In making contemporaneous reports, "accuracy has an extra premium" given that the "proper treatment hang[s] in the balance." Id. A patient's motivation for providing an accurate recount of symptoms is more immediate, as opposed to testimony offered after the events in question, which is considered inherently less reliable. Reusser v. Sec'y of Health & Human Servs., 28 Fed. Cl. 516, 523 (1993); see Murphy v. Sec'y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), aff'd, 968 F.2d 1226 (Fed. Cir. 1992) (citing United States v. U.S. Gypsum Co., 333 U.S. 364, 396 (1948)). Contemporaneous medical records that are clear, consistent, and complete warrant substantial weight "as trustworthy evidence." Cucuras, 993 F.2d at 1528. Indeed, "where later testimony conflicts with earlier contemporaneous documents, courts generally give the contemporaneous documentation more weight." Id.
However, there are situations in which compelling oral testimony may be more persuasive than written records, such as in cases where records are deemed to be incomplete or inaccurate. See Campbell ex rel. Campbell v. Sec'y of Health & Human Servs., 69 Fed. Cl. 775, 779 (2006) ("[L]ike any norm based upon common sense and experience, this rule should not be treated as an absolute and must yield where the factual predicates for its application are weak or lacking."). The Court of Federal Claims has listed four possible explanations for inconsistencies between contemporaneously created medical records and later testimony: (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. La Londe v. Sec'y of Health & Human Servs., 110 Fed. Cl. 184, 203-04 (2013), aff'd, 746 F.3d 1334 (Fed. Cir. 2014). Ultimately, a determination regarding a witness's credibility is needed when determining the weight that such testimony should be afforded. Andreu v. Sec'y of Health & Human Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009); Bradley v. Sec'y of Health & Human Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).
When witness testimony is used to overcome the presumption of accuracy afforded to contemporaneous medical records, such testimony must be "consistent, clear, cogent and compelling." Sanchez v. Sec'y of Health & Human Servs., No. 11-685V, 2013 WL 1880825, at *3 (Fed. Cl. Spec. Mstr. Apr. 10, 2013) (quoting Blutstein v. Sec'y of Health & Human Servs., No. 90-2808V, 1998 WL 408611, at *85 (Fed. Cl. Spec. Mstr. June 30, 1998)); see, e.g., Stevenson ex rel. Stevenson v. Sec'y of Health & Human Servs., No. 90-2127V, 1994 WL 808592, at *7 (Fed. Cl. Spec. Mstr. June 27, 1994) (crediting the testimony of a fact witness whose "memory was sound" and "recollections were consistent with the other factual evidence"). Moreover, despite the weight afforded medical records, special masters are not bound rigidly by those records in determining onset of a petitioner's symptoms. Vallenzuela v. Sec'y of Health & Human Servs., No. 90-1002V, 1991 WL 182241, at *3 (Fed. Cl. Spec. Mstr. Aug. 30, 1991); see also Eng v. Sec'y of Health & Human Servs., No. 90-175V, 1994 WL 67704, at *3 (Fed. Cl. Spec. Mstr. Feb 18, 1994) (explaining that § 13(b)(2) "must be construed so as to give effect to § 13(b)(1) which directs the special master or court to consider the medical record ... but does not require the special master or court to be bound by them"). In short, "the record as a whole" must be considered. § 13(a).
The only issue to be addressed at this time is the onset of petitioner's symptoms.
Petitioner alleges that she developed TM, perforated bladder, hernia, small bowel obstruction, neurogenic bladder, and associated complications as a result of a flu vaccine she received on October 11, 2013. Pet. at 1. In general, TM is an autoimmune condition in which inflammation causes damage to the spinal cord. The clinical presentation often develops suddenly and is marked by bladder and bowel problems, a loss of movement in the legs, and numbness.
Petitioner's long standing health problems including chronic diverticulosis, diverticulitis, abscesses, colovaginal fistula, RSD, hypokalemia, cervical spinal degenerative disc disease, and severe symptomatic lumbar radiculopathy with pain radiating down her legs are well documented in the medical records. Pet. Ex. 6 at 98; Pet. Ex. 11 at 62-63, 77-78.
In the month prior to her vaccination, petitioner suffered a fall for which there were no medical records filed or description of injuries, if any, provided. Pet. Ex. 4 at 76. On September 19, 2013, she presented for medical care due to severe back pain radiating down both legs to the level of her knees or further requiring medical intervention. She needed Tramadol on a regular basis in order to function due to chronic pain. She had no bowel or bladder incontinence other than stress urinary incontinence from cystocele. She also had a sore throat and urinary tract infection for which 500 mg of Amoxicillin was prescribed. Pet. Ex. 5 at 2206, 2208. Upon examination, she had limited range of motion of her back and was referred for epidural injections. Id. at 2208-09. Blood work on that date showed positive CCP antibodies IgG/IgA, which indicate a likelihood of rheumatoid arthritis, and high cholesterol. Id. at 2580, 2582. Petitioner underwent CT guided L4-5 inter laminar epidural corticosteroid injection and bilateral sacroiliac intra-articular corticosteroid injections on October 1, 2013. Pet. Ex. 6 at 17.
In the late afternoon/early evening of October 11, 2013, petitioner presented to Rite Aid and received a flu vaccine. Pet. Ex. 1 at 6. She then went to dinner consuming a spicy Mexican dinner requiring a lot of water, causing her to be up all night with diarrhea and urinating. Tr. 11, 37. When asked to clarify whether she was just urinating a lot or wetting her pants, petitioner responded:
Tr. 39.
On Tuesday, October 15, 2013, petitioner reported to Dr. Khamishon with new onset of weakness in the lower extremities and bowel and bladder incontinence "since four days ago." Pet. Ex. 2 at 1-4. Petitioner explained to Dr. Khamishon that four days ago, Friday night she could not stop going with diarrhea and urinating "and could not control it", but that morning, October 15, 2013 was the opposite, she felt like she had to urinate but couldn't. Tr. 18.
Dr. Marco testified that he provided Dr. Khamishon with petitioner's medical history and the events of Sunday night in which she had a bowel movement but was unaware of it. "[w]hen we looked in her underwear on Sunday — Sunday night, her underwear was wet as well." Tr. 61. According to Dr. Marco, she certainly had bowel incontinence and he felt she had "some urinary incontinence as well on October 13
In the letter petitioner submitted after the hearing, she stated:
ECF No. 44 at 5-6.
Upon presentation to the emergency room at Sharp on Wednesday, October 16, 2013, petitioner reported to Dr. Roth the presence of chronic complaints and neuropathies over the years and a loss of bladder and bowel function since Thursday and walking more irregularly. Pet. Ex. 3 at 109.
On Friday, October 18, 2013, during a urological consult, petitioner reported that eight hours after Crestor, which she had taken one week ago,
At the time of her MRI on Friday, October 18, 2013, she reported that she had weakness in her hips and left foot and had been "very unsteady since last Thursday,"
By petitioner's own admission, the onset of her inability to control her bladder (and potentially her bowels) started on the evening of October 11, 2013 and into the morning hours of October 12, 2013. Petitioner described her development of diarrhea with frequent urination blaming that event on spicy food and water intake. Despite the amount of water petitioner drank, she admitted multiple times and in different contexts that she was unable to control her urination that night/early morning. Her loss of bladder control was followed by bowel, and potentially bladder incontinence, on the evening of Sunday, October 13, 2013, according to Dr. Marco. Tr. 61, 73-74. She then developed weakness and pain in her lower extremities on Monday, October 14, 2013, which became more profound with urinary incontinence on Tuesday, October 15, 2013. By Wednesday, October 16, 2013, she was hospitalized with further weakness and numbness that extended to her perineal area, extreme pain, and bowel and bladder incontinence requiring catheterization.
The petitioner and her family blame the inconsistencies between the affidavits, testimony, and medical records on petitioner being heavily medicated in the emergency room for her pain, resulting in her poor recollection and providing inaccurate facts. In her letter to me, she blamed the inaccuracies on her level of pain. ECF No. 44. However, the various doctors who saw her from the emergency room through the first several days of admission documented her as alert and oriented, with normal recent and remote memory, language, and fund of knowledge. Her speech was fluent and comprehensive. Pet. Ex. 3 at 128-29. She was resting comfortably in bed, and her affect was "quite reasonable." Pet. Ex. 2 at 126. The hospital record further documents that petitioner was given .05 mg. of Dilaudid
There are many discrepancies and inconsistencies in the record regarding other issues to be addressed at a later time. This ruling is on onset only and on that issue, one thing is for certain: petitioner's inability to hold urine and loss of bladder control, began the evening of October 11, 2013, and her symptomology then progressed, resulting in her hospitalization on October 16, 2013.
Upon careful review of the record, I find that the onset of petitioner's symptoms began with the loss of bladder control in the late evening of October 11, 2013, the same day as her influenza vaccine. Petitioner has already filed two expert reports from Dr. Lawrence Steinman; however, these reports were based on the facts as provided by petitioner. Petitioner is to file an expert report from Dr. Steinman which relies on the timing of onset as found in this Ruling. All experts in this case, are to rely on the timing of onset as found in this Ruling. Accordingly, the following is ORDERED:
