As a pharmaceutical liability attorney, I know vaccines are somewhat out of fashion these days. Rates of vaccination of schoolchildren have gone down, causing certain diseases to make a reappearance and triggering debates about whether vaccinations should be optional. Into that fray went Lombardi v. Secretary of Health and Human Services, a claim before the United States Court of Appeals for the Federal Circuit for damages from a documented vaccine reaction. Cheryl Lombardi developed chest pain after the third of three shots that constitute the hepatitis B vaccine, but only a year later was she diagnosed with post-vaccine syndrome. In this case, the Federal Circuit upheld a decision by the U.S. Court of Federal Claims that Lombardi failed to prove the vaccine was responsible for her illness.
Lombardi, born in 1946, received the first two shots of the hepatitis B vaccine without incident in 1997. Eleven days after the third shot, however, she went to the emergency room complaining of chest pain, with no symptoms found. The hospital visit and non-diagnosis was repeated less than a week later. In January of 1998, she saw several doctors who considered but ruled out lupus as a cause for her right-side pain, nausea, fatigue and elevated levels of an autoimmune disease marker. Other problems were found, but none that led to a diagnosis until July of 1998, when Lombardi saw a doctor who diagnosed her with chronic fatigue syndrome caused by the hepatitis B vaccine. Various other aspects of Lombardi’s medical and personal history were discussed, including later diagnoses of small kidney stones and pressure on her spine. In 1999, Lombardi filed a claim for damages under the Vaccine Act, eventually claiming she suffered from transverse myelitis, chronic fatigue syndrome and systematic lupus. None of these are in the Vaccine Injury Table, which required Lombardi to prove her claim. At hearings, the government’s experts offered alternative diagnoses, and a special master ruled against her. The Claims Court upheld this decision.
Lombardi had no better results on appeal. She argued to the Federal Circuit that the lower court improperly focused on whether she had the claimed illnesses at all, rather than whether they were caused by the vaccine, and that she had shown causation. However, the Federal Circuit said, under recent caselaw, identifying the injury is a necessary first step toward proving causation. The experts at the original hearings, both for Lombardi and for the government, offered at least eight different diagnoses; the appeals court said this disagreement created a genuine question of what illness Lombardi may have. As for each individual claim, the Federal Circuit rejected the transverse myelitis diagnosis because Lombardi’s treating physicians had never diagnosed it, and her expert diagnosed it using an MRI whose results did not suggest it. The chronic fatigue syndrome may have been diagnosed by Lombardi’s previous treating physicians, the court said — but this is a diagnosis of exclusion, and the government’s experts offered plausible alternative theories of osteoarthritis and vitamin B12 deficiency. The court next rejected the lupus diagnosis, saying no doctor had diagnosed her with it before; indeed, two had ruled it out. Finally, it rejected as irrelevant Lombardi’s contention that the special master in her case is biased against petitioners. The court noted that Lombardi obviously has symptoms, but failed to connect them to the hepatitis B vaccine well enough.
As a dangerous drug lawyer, I’m interested in this case because vaccines have fallen so far out of favor recently. The Vaccine Act was enacted in 1986 to address concerns about vaccines hurting children and litigation over those concerns potentially hurting the supply of vaccines. It’s a no-fault system, similar to workers’ compensation, where petitioners don’t need to prove that the pharmaceutical company did something negligent — merely that they were hurt by the vaccine. However, as this case shows, petitioners still must connect the dots to the satisfaction of the special master. This is not the usual route for people who were injured by a prescription drug; in most cases, victims may file a lawsuit against the manufacturer. This is true only in limited circumstances for vaccines. Nonetheless, as a defective drug attorney, I offer free consultations to families suffering from adverse reactions to vaccines or any other medical product they thought would help them.
If you or someone you love suffered an injury or illness due to an adverse drug reaction, don’t wait to call Carey, Danis & Lowe to discuss how we can help. For a free case evaluation, call us today at 1-877-678-3400 or send us an email.
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