LAURA D. MILLMAN, Special Master.
On October 28, 2016, petitioner filed a petition under the National Childhood Vaccine Injury Act, 42 U.S.C. § 300aa-10-34 (2012), alleging that, within a month of receiving influenza ("flu") vaccine on November 4, 2013, she had peripheral neuropathy. Pet. Preamble and at ¶¶ 6, 9, and 17.
Around Thanksgiving 2013, petitioner's primary care physician prescribed Avelox
On March 3, 2017, during the third telephonic status conference the undersigned held in this case, petitioner's counsel stated that the undersigned's suggestion that petitioner had a reaction to Avalox was valid. Petitioner's counsel also stated she could not obtain an expert in support of petitioner's allegations. Petitioner moved to dismiss.
The undersigned
Petitioner was born on November 7, 1939, making her 77 years old. On July 9, 2012, petitioner saw Dr. Robert Elgar. Med. recs. Ex. 3, at 662. She had a history of non-insulin-dependent diabetes mellitus, human immunodeficiency virus ("HIV") since 1989, colorectal cancer for which she had surgery in 1996, polyarthritis, neurogenic bowel and bladder, L4-L5 spinal stenosis, anemia, depression, gastroesophageal reflux disease ("GERD"), carpal tunnel syndrome, hiatal hernia, osteoporosis, left hip revision in 2011, right hip replacement, left hip replacement, right knee arthroscopy, Morton's neuroma in her left foot, bilateral cataract surgery, syncope, hyperlipidemia, and thoracic aneurysm.
In November 2012, petitioner had her right fractured ankle repaired.
On November 4, 2013, petitioner received flu vaccine. Med. recs. Ex. 1, at 3.
On November 26, 2013, petitioner saw Dr. Michael G. Gartlan, an ENT specialist, complaining of hoarseness and other difficulty breathing, and facial swelling of one month's duration. Med. recs. Ex. 4, at 2. Since Thanksgiving, she had been on the antibiotic Cefdinir for a supposed bladder infection and sore throat, which petitioner said did not help at all. Her doctor switched petitioner to Avelox and, two days afterward, her face swelled. She was put on Prednisone, and the swelling and hoarseness persisted. She had a history of chronic sinusitis, sudden hearing loss, smell and taste disorder, nose bleed (epistaxia), chronic serous otitis media, hoarseness, and environmental allergies.
On December 5, 2013, petitioner went to Presence St. Joseph Medical Center Emergency Room ("ER"), complaining of facial swelling, possible allergic reaction, sore throat, myalgias, right ankle arthralgia, diarrhea, and oral thrush. Med. recs. Ex, 3, at 5.
On December 7, 2013, petitioner returned to the same ER, complaining of bilateral leg pain.
The discharge summary issued on December 8, 2013.
Also, on December 8, 2013, Dr. Daniel Magdziarz of Provena St. Joseph Medical Center ER wrote that petitioner had complained of bilateral leg pain. Med. recs. Ex. 8, at 13. She had a "flight of ideas."
On December 12, 2013, petitioner saw Dr. Miguel G. Camara, an allergist.
On December 19, 2013, petitioner saw Dr. Rajeev H. Mehta, an ENT specialist, complaining of hoarseness which had been gradual and occurring in a persistent pattern for two months (which would put onset before the November 4, 2013 flu vaccination). Med. recs. Ex. 4, at 4. She was breathy and raspy. She had neck swelling and occasional sore throat. Her personal care physician prescribed Cefdinir, Avelox, and prednisone, none of which relieved her symptoms. Petitioner said she could feel sores in her throat when swallowing and complained of a poor sense of smell and taste for two to three months (also putting onset before the November 4, 2013 flu vaccination).
On January 4, 2014, petitioner went back to St. Joseph, complaining of swelling of her face, neck, and back for the past month. Med. recs. Ex. 3, at 108. She saw Dr. Garganera, an infectious disease specialist, who opined that she seemed to have "accelerated HIV related lipodystrophy," which her HIV medications could cause, plus she had been on multiple other medications related to her HIV that could cause this condition.
Also on January 4, 2014, petitioner saw Dr. Mary E. Monaco, a neurologist. Med. recs. Ex. 3, at 266. On Friday, November 29, 2013, petitioner said she was able to walk without difficulty and shop at multiple stores. But the Sunday after Thanksgiving, she started to have a raspy voice, swelling of her face and extremities. The leg swelling lasted about 14 hours and then resolved. She saw her personal care physician and an ENT and started on antibiotics and a steroid pack. She started to have atrophy of her legs and had numbness of her arms and legs. She had weakness and had difficulty rising from a seated position. She had a gait abnormality and had been using a walker. She stated she had cramps in her lower extremities, low back pain, and a history of right and left peroneal and sural neuropathy. On physical examination, she had weakness of the proximal muscles of her upper extremities.
On January 6, 2014, an MRI of petitioner's thoracic spine showed mild to moderate degenerative changes.
Also, on January 6, 2014, Dr. Monaco did an EMG and nerve conduction study on petitioner.
On January 8, 2014, Dr. Nitin V. Nadkami, a neurologist, noted petitioner had a subacute onset of neuromyopathy. Med. recs. Ex. 12, at 19. On the same date, Dr. Tamir Y. Hersonskey noted petitioner had a longstanding neuropathy of the lower extremities.
On January 9, 2014, in an addendum diagnosis by Dr. Carrie Y. Inwards of the Mayo Clinic, she stated these findings were nonspecific. Med. recs. Ex. 3, at 132.
On January 11, 2014, Dr. Subhash K. Patel performed an EMG on petitioner. Med. recs. Ex. 12, at 32. Petitioner had bilateral median neuropathy, bilateral peroneal neuropathy, right greater than the left tibial neuropathy, and bilateral sural neuropathy. The protein in her cerebrospinal fluid was 43, which was normal. Her cortisol level was low at 0.3.
On January 13, 2014, Dr. Harry G. Brown reported that the muscle biopsy of the right quadriceps was negative for inflammatory infiltrates. Med. recs. Ex. 3, at 112. The type 2 fiber atrophy was significant. The findings suggested a neuropathic cause although drug effect and disuse were also possibilities.
On February 26, 2014, petitioner sought a second opinion from Dr. Thomas J. Kelly, a neurologist at the University of Chicago Medical Center. Med. recs. Ex. 7, at 286. She wanted to know the cause of her weakness. She had severe atrophy in her right quadriceps with lesser atrophy in both calves and left quadriceps.
On March 20, 2014, petitioner had an EMG done at the University of Chicago Medical Center.
On April 2, 2014, petitioner saw Dr. Shwetha Manjunath. Med. recs. Ex. 9, at 7. The results of petitioner's ACTH stimulation test were abnormal.
On April 4, 2014, petitioner saw Dr. Jose T. Bolanos, an infectious disease expert. Med. recs. Ex. 13, at 22. Petitioner had right ankle pain for which she was seeing her podiatrist Dr. George. She continued physical therapy for her right leg due to weakness. She had ongoing easy bruisability. She reported a lot of stress due to family issues. Dr. Bolanos's assessment was neuropathy with unclear etiology, possibly due to HIV infection, antiretroviral therapy, diabetes mellitus, and spinal stenosis. EMG/NCV studies done January 6, 2014 showed bilateral median neuropathy, and peroneal, tibial, and sural neuropathy without evidence of radiculopathy. She also had bruising of unclear etiology.
On March 3, 2015, Dr. Vincent Benig, petitioner's personal care physician, filled out a VAERS report stating petitioner had face edema, right leg atrophy, and weakness starting November 22, 2013 after flu vaccine. Med. recs. Ex. 2, at 5. This was 16 months after she received flu vaccine on November 4, 2013.
On May 26, 2015, petitioner saw Dr. Benig complaining of back pain and suprapubic pain radiating to her low back one hour after eating, lasting several hours. Med. recs. Ex. 7, at 15. Petitioner had a history of chronic diarrhea after her colon was resected in 1994 due to cancer. She normally had baseline diarrhea after every meal. She had daily calf cramps each morning for one minute which then went away completely. Her gait was normal.
To satisfy her burden of proving causation in fact, petitioner must prove 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 showing of a proximate temporal relationship between vaccination and injury."
418 F.3d at 1278.
Without more, "evidence showing an absence of other causes does not meet petitioner's affirmative duty to show actual or legal causation."
Petitioner must show not only that but for flu vaccine, she would not have had the multiple complaints recorded in her medical records, but also that flu vaccine was a substantial factor in causing the multiple complaints recorded in her medical records.
The Vaccine Act, § 300aa-13(a)(1), prohibits the undersigned from ruling for petitioner based solely on her allegations unsubstantiated by medical records or medical opinion. Although petitioner's personal care physician Dr. Vincent Benig filled out a VAERS form on March 3, 2015 to report petitioner had a reaction to flu vaccination, the medical records do not support that petitioner did have such a reaction. They support that she reacted to Avelox and that she has longstanding issues with muscle weakness and various neuropathies, none of which is demyelinating. The undersigned notes that Dr. Benig's VAERS report is also contrary to his earlier medical records noting petitioner's swollen face was due to steroid injections or, according to Dr. Camara, fat redistribution from steroids in general.
In addition, petitioner has not filed a medical expert report in support of her allegations and her counsel admits that she cannot find an expert to support petitioner's allegations.
The undersigned
This petition is