Dr. Jack Wolfson examined Claimant's medical records, spoke to Claimant by phone on April 24, 2014, and testified on behalf of Claimant. Dr. Wolfson is board certified in internal medicine and cardiology, and is licensed to practice medicine in the state of Arizona. He did not know which specific medical records he reviewed. He testified Claimant's medical history was mostly a "verbal history". He testified he reviewed records from an office visit with Dr. Brown on January 13, 2011, Dr. Janosik on May 10, 2012, Dr. Serota's record of November 13, 2012, and cardiac rehabilitation records from 2010 and 2011. He did not review Claimant's deposition. He reviewed all the medical records sent to him, but Dr. Wolfson testified he does not know if he viewed all of Claimant's records.
Dr. Wolfson testified that the H1N1 vaccine is a live attenuated or weakened strain of the H1N1 virus that caused her cardiomyopathy.
Dr. Wolfson testified the December 12, 2009 vaccine administered to Sylvia Johnson was the proximate cause of her congestive heart failure and cardiomyopathy. He later testified he believed the H1N1 shot Sylvia Johnson received on December 7, 2009 was the prevailing cause of her cardiomyopathy and resultant disability. This led to her disability from October 2010 to July 2011. Her symptoms clearly started after the vaccination in December 2009. She was a woman that was working her full-time job. She had no cardiovascular symptoms whatsoever. She got a vaccination and abruptly developed symptoms that were ultimately diagnosed as congestive heart failure. When determining cause and effect, Dr. Wolfson believes it was very clear that one thing led to another.
Dr. Wolfson stated that given the nature of her job as a respiratory therapist, 50 % PPD is advised since she cannot perform activities requiring prolonged standing, walking, or lifting above 15 pounds.
This is Dr. Wolfson's first independent medical examination. He never rated a workers' compensation claimant in the state of Missouri. He testified he did not know how permanent partial disability is defined or determined in the state of Missouri.
Dr. Wolfson reviewed the Vaccine Adverse Event Reporting System (VAERS) in which there were several cases reported of cardiomyopathy after the H1N1 vaccine. The VAERS data base was established to allow patients and physicians to report on suspected vaccine associated adverse events or vaccine injury. Dr. Wolfson testified he is familiar with literature that links vaccinations to cardiomyopathy. There is a report from the South Medical Journal in 2004 called "Rare Association: Possible myocarditis secondary to influenza vaccination". He testified there is a trail in the literature linking vaccinations to cardiomyopathy. He opined these instances are underreported because physicians are not taking proper histories from their patients.
Dr. Wolfson testified he relied on the following studies in formulating his opinions: "Myopericarditis Following Smallpox Vaccination;" "Acute Myocarditis Associated with the Tetanus Vaccination;" "Smallpox Vaccination and Myopericarditis: A Clinical Reviw;" and "Myocarditis after Triple Immunization." Two of the reports deal with smallpox vaccination. One deals with the tetanus vaccination. The last one deals with the diphtheria, tetanus, and pertussis vaccination. In developing his report, Dr. Wolfson was unable to find any articles or studies that definitively linked the H1N1 influenza vaccination with the development of myocarditis, cardiomyopathy, and/or congestive heart failure.
Dr. Wolfson testified the articles he cited relied upon a cut-off date between the timing of the vaccination, and the onset of symptoms, in establishing a causal relation between the vaccination and the myocarditis. The myocarditis following the Smallpox vaccination required presentation for medical care within 30 days. The acute myocarditis associated with tentanus vaccination developed chest pain within three days of receiving the vaccination. With the case of the myocarditis after triple immunization, the patient sought treatment within 12 hours after the vaccination.
Dr. Wolfson testified although he believes you can always find a cause, most doctors find a significant amount of idiopathic instances of cardiomyopathy. Dr. Wolfson testified within a reasonable degree of medical certainty that Claimant had myocarditis that led to cardiomyopathy and congestive heart failure that was diagnosed in October 2010. He believes this, despite the fact Claimant was not diagnosed for 10 months post vaccination, and the sources he cited required medical treatment to be sought within 30 days for purposes of establishing causation. Dr. Wolfson believes this despite the fact that his causation opinion does not cite a source that specifically links the H1N1 influenza vaccination to the development of myocarditis, cardiomyopathy, or congestive heart failure.
Dr. Stephen Schuman examined Claimant on June 8, 2015, prepared a report, and testified on behalf of Employer. Dr. Schuman is board certified in internal medicine and cardiology. He is licensed to practice medicine in the state of Missouri. Dr. Schuman testified he reviewed medical records from Christian Hospital, Barnes-Jewish West County, Missouri Baptist Medical Center, Mercy Clinic Heart and Vascular, St. Louis Heart and Vascular, Dr. Howell, Dr. Tables, Dr. Siddiqui, and Dr. Wolfson. Dr. Schuman also reviewed Claimant's deposition testimony.
At the time of her examination, Claimant reported ongoing complaints of exertional dyspnea and weakness, shortness of breath in the supine position, and paroxysmal nocturnal dyspnea, which is awakening from one's sleep short of breath. She reported ongoing exertional dyspnea and weakness if she tries to walk up one flight of stairs. She cannot walk one full block on level ground without being short of breath and fatigued. She also reported intolerance to heat. She continues to take carvedilol, isosorbide mononitrate, hydrochlorothiazide, Micardis, CoQ10. Claimant had a normal electrocardiogram during her exam.
The first records Dr. Schuman reviewed were for an ER visit on June 7, 2010. He testified this was a significant time lapse if Claimant's cardiomyopathy possibly due to myocarditis was going to be related to getting the H1N1 flu shot.
Dr. Schuman diagnosed Claimant with nonischemic cardiomyopathy that led to congestive heart failure in October 2010. "Nonischemic" means that the cardiomyopathy was not caused by cardio blockages or coronary artery disease. Nonischemic cardiomyopathy is a weakening of the heart muscles and defined as depressed ejection fraction below 40 % without obstructive coronary artery disease. This can be caused by toxins and alcohol. There is some genetic predisposition to cardiomyopathy. The condition can also be caused by viruses, including myocarditis. Dr. Schuman testified Claimant may have had myocarditis, but this cannot be proven without an endomyocardial biopsy. Myocarditis cannot be diagnosed through blood work. In Claimant's case, with normal coronary arteries and assuming normal valve structure, it is referred to as idiopathic dilated cardiomyopathy.
Dr. Schuman testified Claimant did not sustain an injury as a result of the December 7, 2009 H1N1 flu vaccination. He explained there is no correlation between the H1N1 influenza vaccine and the development of myocarditis dilated cardiomyopathy.
According to Dr. Schuman, the December 7, 2009 H1N1 flu vaccination was not the prevailing factor in causing Claimant's congestive heart failure or cardiomyopathy. He stressed there is no known correlation between the influenza vaccine and myocarditis. Furthermore, patients with cardiomyopathy are groups of people who are strongly recommended to get the flu vaccine. He explained that individuals with heart failure are at a high risk of dying from influenza. If there was a concern among cardiologists that the influenza vaccine was causing cardiomyopathy or myocarditis, they would not be recommended to get the shot.
From a biological plausibility standpoint, Dr. Schuman stated that the H1N1 vaccine causing myocarditis or cardiomyopathy would be difficult to explain. The H1N1 flu vaccine is a killed virus. It is not a live attenuated weakened strain of the virus. Dr. Schuman testified Claimant's medical treatment for congestive heart failure and cardiomyopathy did not flow from the December 7, 2009 flu vaccination, and she does not require any additional medical treatment that would flow from it. She may have some disability as a result of her congestive heart failure and cardiomyopathy, but the December 7, 2009 flu vaccination is not the prevailing cause in causing the disability. Dr. Schuman testified Claimant did not sustain any PPD as a result of the December 7, 2009 flu vaccination.
Dr. Schuman testified the flu vaccination was not the prevailing factor in causing Claimant to miss work from October 2010 until July 2011. He testified it would not be uncommon for a person to experience some flu-like symptoms for two days up until a week after a flu vaccination, but that reaction is due to the nonspecific antigen nature of the vaccine that is stimulating the immune system.
Dr. Schuman did not review the Vaccine Adverse Events Reporting System (VAERS) in preparation of his report. Dr. Schuman testified that the manufacturer's insert clearly states that the H1N1 vaccine is an inactivated virus, which means it is a killed virus. The H1N1 vaccine is not a live, weakened virus.
In defending his opinion that there was no link between the influenza vaccine and myocarditis, cardiomyopathy, and heart failure, Dr. Schuman cited his knowledge from medical school, 29 years of practice and cardiology training, conferences, and review of medical journals.
Claimant's Deposition Exhibit D was handed to Dr. Schuman for review. He reviewed the article, "Rare association: Possible myocarditis secondary to influenza vaccine" from the Southern Medical Journal on October 1, 2004. The article suggests there could be a possible connection between myocarditis and the influenza vaccine. Dr. Schuman said the title of the article is misleading and that any connection would be purely coincidental. The word "association" is misleading because it does not establish a definitive link. He continued that if there was any relation of heart disease to any type of influenza vaccine, the internal medical and cardiology community would be aware of it. Furthermore, the patient in the article had an onset of symptoms and sought treatment within two weeks of vaccination.
He reviewed the articles cited by Dr. Wolfson in his IME, none of which dealt with the influenza vaccine. The articles cited by Dr. Wolfson dealt with smallpox and tetanus vaccines. All four articles cited the importance of temporal association between the vaccines and onset of symptoms. Dr. Schuman testified the criteria for establishing and confirming probable cases of vaccine-related myocarditis required presentation for medical care within 30 days of vaccination. Dr. Schuman testified Claimant did not present for medical treatment within 30 days of vaccination. The first medical treatment she sought after her vaccination was six months later. If Claimant had presented to an internist within a week of an influenza vaccine complaining of aches, dry cough and fever, he would have believed it was a reaction to the flu vaccine. Dr. Schuman conceded Claimant probably had flu-like symptoms about a week after her December 7, 2009 flu vaccine, even though she did not present for medical treatment with her primary physician. However, it appears she had a common reaction to the flu vaccination. He believes an internist would have been able to identify symptoms of heart failure if she had been displaying those symptoms.