Lombardi v. Sec'y of Health & Human Servs.
| Decision Date | 06 September 2011 |
| Docket Number | 2011-5004 |
| Parties | CHERYL LOMBARDI, Petitioner-Appellant, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent-Appellee. |
| Court | U.S. Court of Appeals — Federal Circuit |
Appeal from the United States Court of Federal Claims in Case No. 99-VV-523, Judge Marion Blank Horn.
CLIFFORD J. SHOEMAKER, Shoemaker & Associates, of Vienna, Virginia, argued for the petitioner-appellant.
HEATHER L. PEARLMAN, Trial Attorney, Torts Branch, Civil Division, United States Department of Justice, of Washington, DC, argued for the respondent-appellee. With her on the brief were TONY WEST, Assistant Attorney General, TIMOTHY P. GARREN, Director, MARK W. ROGERS, Deputy Director, and CATHARINE E. REEVES, Assistant Director.Before RADER, Chief Judge, and LOURIE and O'MALLEY,
Circuit Judges.
Opinion for the court filed by Circuit Judge LOURIE.
Cheryl Lombardi appeals from the decision of the United States Court of Federal Claims ("Claims Court") affirming the decision of a special master denying compensation under the Vaccine Act for injuries that she alleged were a result of receiving hepatitis B vaccinations. Doe v. Sec'y of Dept. of Health & Human Servs., 94 Fed. Cl. 597 (2010) ("Claims Court Op."). Because we agree with the Claims Court that the special master did not err in concluding that Lombardi failed to prove by a preponderance of the evidence that she suffered the alleged injuries, we affirm.
The facts in this case are mostly undisputed. Lombardi was born on October 17, 1946. She received the first dose of the hepatitis B vaccine on April 1, 1997, and the second dose on May 6, 1997. She suffered no immediate adverse reactions to those first two doses. On October 28, 1997, she received a third dose of the vaccine. Then, on November 9, 1997, Lombardi visited a hospital emergency room, complaining of right flank pain radiating into her right chest. Various tests were performed, but the evaluation failed to find a cause of her symptoms. She was discharged the same day with a diagnosis of atypical chest pain. Lombardi returned to the emergency room on November 14, 1997, once again complaining of right flankpain. The various tests that were performed on her during that visit also failed to detect any identifiable problems.
On January 15, 1998, Lombardi sought treatment from an internal medicine specialist, Dr. Michael Conaway. Records from that visit document Lombardi's complaints of ongoing pain on her right side, as well as weakness and fatigue. Lombardi also informed Dr. Conaway that she had experienced a weight gain of 40 pounds in the past five years. Dr. Conaway reviewed the results of tests on blood drawn on January 13, 1998, which indicated that petitioner had a positive antinuclear antibody ("ANA") rate. Dr. Conaway's notes indicate that Lombardi had a chest X-ray that showed some pleural thickening and that he ordered additional tests to determine whether petitioner had systemic lupus erythematosus ("SLE"). Those notes also indicate that Lombardi had consulted Dr. Cordasco and was undergoing a work-up for possible SLE.
In February 1998, Dr. Teresa George, a rheumatologist, evaluated Lombardi for possible SLE, but found nothing based on that examination. Instead, the doctor noted that Lombardi had a history of joint pain which was not associated with swelling. Dr. George wrote that Lombardi denied having any skin rashes, hair loss, photosensitivity, or changes in memory or concentration. Dr. George also noted a higher ANA rate, but found all other laboratory tests, including other serologies for diagnosing SLE, were normal. She suspected that Lombardi "probably had a positive ANA in the past," and concluded that her right chest pain was of "unclear etiology" and that there was not "enough evidence for systemic lupus erythematosis [sic] or another autoimmune process at this time."
In February and March 1998, Lombardi returned to Dr. Conaway three times with complaints of right-sided pain, nausea, and fatigue. After conducting a thorough workup, Dr. Conaway wrote that he was "really at a loss to explain both her pain and her fatigue at this point." After Lombardi's third visit, Dr. Conaway referred her to the Cleveland Clinic to obtain a more comprehensive diagnostic evaluation.
On March 16, 1998, Lombardi saw Dr. John Campbell, a preventative medicine specialist at the Cleveland Clinic. Dr. Campbell ordered blood tests, which revealed that Lombardi had a vitamin B12 deficiency and an elevated level of methylmalonic acid. He directed her to have additional tests performed and to see a neurologist. A radiology report from that time indicates that Lombardi had decreased bone density, consistent with osteopenia of her lumbar spine, and osteoporosis in her left hip. On one of the physical evaluation forms entitled "impressions," Dr. Campbell's notes state "post hepatitis B—fatigue," followed by an illegible word. On April 9, 1998, Lombardi was examined by Dr. Patrick Sweeney, a neurologist at the Cleveland Clinic, and Dr. Ian Lavery in the colorectal surgery department. Dr. Lavery did not diagnose any problems and Dr. Sweeney was doubtful that Lombardi suffered from any neurologic problem, stating in his notes that he "doubt[ed] neuro disease." Following her return from the other Cleveland Clinic physicians, Dr. Campbell summarized his findings, based on their evaluations, as "post vaccine syndrome." Dr. Campbell's recommendation to Lombardi was that she take B12 and follow up with her local physician.
On April 23, 1998, Dr. Conaway assessed Lombardi with chronic fatigue, expressing uncertainty as to whether the mild vitamin B12 deficiency could explain her symptoms. Lombardi reported that she could walkonly for about ten minutes before becoming exhausted. Dr. Conaway also noted that Lombardi had "chronic right lateral rib cage pain," but was unable to determine a cause of the pain. At the visit, Dr. Conaway referred Lombardi to Dr. Elizabeth Hurst for a psychological evaluation to investigate whether underlying depression or trauma could account for her symptoms. There is no record of Lombardi's visit to Dr. Hurst.
On May 1, 1998, Lombardi returned to Dr. Conaway explaining that a friend had told her about a news report suggesting that hepatitis B vaccine could lead to chronic fatigue by causing rheumatologic problems. In his notes from that visit, Dr. Conaway was doubtful of that diagnosis, noting that the "fact that I have seen no objective signs of a rheumatologic condition and her [erythrocyte sedimentation] rate has always been normal combined with the fact that she has not responded in the past to [non-steroidal anti-inflammatory drugs] and/or steroids tend to push me away from that diagnosis." Dr. Conaway did however indicate that he was "unsure what to make of her positive ANA."
In July 1998, Lombardi saw Dr. Andrew Campbell, a specialist with experience evaluating chronic fatigue syndrome due to the hepatitis B vaccine. Dr. Campbell assessed her as having fatigue, chest pain, and polyneuropathy. On another visit a few weeks later, Dr. Campbell again diagnosed Lombardi as having fatigue and polyneuropathy. He added the diagnosis of an adverse reaction to a vaccine, and recommended a reassessment in 90 days. Dr. Campbell's notes from another visit three weeks later stated that the decline in Lombardi's health was a direct result of her hepatitis B vaccination. Later, in October 1998, Dr. Campbell indicated that she also suffered from high cholesterol and prescribed vitamins, including a vitamin B complex.
On October 6, 1998, Lombardi visited Dr. Albert Beraducci of Neurologic Associates, Inc., but there is no diagnosis from that visit in the record. On October 30, 1998, she saw Dr. Joseph Plouffe, an infectious disease specialist, who also found that specific antibodies to test for SLE were negative. Dr. Plouffe concluded that petitioner had a "[p]ossible immunologic process of questionable etiology Hep B vaccine certainly possible." Throughout 1999, Lombardi continued to see Dr. Andrew Campbell with little change in her condition. On September 24, 1999, petitioner again had a positive ANA test. In late 1999, following another positive ANA test, Dr. Campbell began intravenous immunoglobin treatment for chronic inflammatory demyelinating polyneuropathy and Lombardi remained on the treatment through at least May 2000.
In August and September 1999, Lombardi visited Dr. Sandra Stewart-Pinkham, a pediatrician who assessed that her problems were "best explained by an adverse reaction to hepatitis B vaccine which contains 25 mcg of mercury in each injection." Dr. Stewart-Pinkham noted that Lombardi's problems "are identical to individuals with chronic fatigue immune dysfunction, a disease of unknown etiology." Lombardi was evaluated by a dermatologist, Dr. Adam Hessel, in September 2001 for a recurrent episodic rash. A skin biopsy was performed on March 7, 2002, after which petitioner was diagnosed with Wells Syndrome. Dr. Hessel indicated that Wells Syndrome "could be seen in association with a vaccination reaction" but that the "relationship is uncertain." Dr. Hessel later concluded that the rash was likely caused by a reaction to toxic black mold found in her home.
On June 18, 2004, a CT scan of Lombardi's abdomen indicated a tiny, unobtrusive stone in the upper portion of the right kidney and an even smaller stone possibly in thelower portion of the right kidney. The study was otherwise normal. Urologist Dr. Bruce E. Woodworth stated that based on the CT scan results, "one wonders if the patient's episodes of right flank pain may be due to passage of tiny calculi." A radiographic examination of Lombardi's cervical spine taken on October 28, 2004, showed multilevel degenerative disk disease with spondylosis and compression of the spinal cord at levels C5-6 to the left and C6-7 to the right,...
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