THE UNITED STATES GOVERNMENT considers vaccines to be a primary prevention for many infectious diseases, including seasonal influenza (flu). For many years, federal government advisory committees have recommended annual vaccination for seasonal influenza in all healthcare personnel.1
Most nurses and patients don't miss a beat following seasonal influenza vaccination. However, a few people develop serious illnesses, such as Guillain-Barré syndrome (GBS) or transverse myelitis following vaccination. (See Comparing GBS with transverse myelitis.)
Using the cases of two nurses who believed they were injured by a seasonal flu vaccine, this article explains legal avenues for compensation for such an injury, including what the court requires to prove a claim. Some vaccine injury compensation claims are settled early and efficiently. Other claims are prepared for a formal hearing in court. The specific facts of each claim dictate the degree and extent of claim investigation, the need for legal discovery tools such as depositions, and the complexity of the hearing process before the court.
No-fault compensation program
In 1986, the National Childhood Vaccine Injury Act (the Vaccine Act) established a no-fault system for pursuing vaccine-related injury claims.2 The Vaccine Act's purpose was, in part, to “achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines.”3
The Vaccine Act creates a no-fault compensation program (the Vaccine Injury Compensation Program or VICP) to award compensation efficiently to people who can show, by a preponderance of the evidence, that they've been injured by specific vaccines.4 Cases are adjudicated in the so-called “vaccine court” administered by the Office of Special Masters in the U.S. Court of Federal Claims. The vaccine court is located in Washington, D.C., several blocks from the White House.
The Vaccine Act applies to anyone receiving specifically identified vaccines listed on the Vaccine Table. The seasonal trivalent influenza vaccine is one of the covered vaccines.5
Many vaccine-related injury claims are resolved between the parties without any need for the petitioner to testify or appear in court. Other vaccine-related injury claims are adjudicated by Special Masters. These specially appointed lawyers grapple with complex medical science when deciding whether or not an injured person has met the burden of showing that a vaccination was more likely than not a substantial cause of a specific illness.
Special Masters are required by law to make decisions based on a consideration of the “record as a whole.” They must consider all relevant and reliable evidence governed by principles of fundamental fairness to both parties.6
One nurse's day in court
Seeking compensation for an alleged vaccine-related injury, a nursing supervisor in a Midwestern hospital was my client in the vaccine court. At work one night, Ms. P developed ascending lower extremity weakness. She grabbed the handrails along the hospital corridor to avoid falling. She was admitted to the hospital, where she was diagnosed with GBS.
During the acute phase of her illness, Ms. P focused on her treatment and recovery. Soon, however, she started wondering if her seasonal flu vaccination was linked to her GBS.
In Ms. P's case, the admitting physician failed to document the administration of the seasonal flu vaccine 6 weeks before the onset of symptoms. Nonetheless, Ms. P sought an attorney (professional legal services are provided at no cost under the Vaccine Act for reasonable claims) and pursued a successful no-fault vaccine injury claim in the vaccine court. Ms. P was successful largely because the Vaccine Act doesn't require proof of a vaccine injury with medical certainty. Rather, the Vaccine Act requires the petitioner to show that the vaccination is more likely than not a substantial cause of her illness.7 (The Court may use other words to describe the standard of proof for a vaccine claim, such as proof of causation by a preponderance of the evidence, or proof of causation by 50% and a feather.) In a close call, the Court is expected to resolve the vaccine-related injury claim in favor of the petitioner. This outcome is reasonable in light of the current uncertainty about the effect of vaccines on the human body.8
Many patients believe that vaccines may cause specific illnesses even when their healthcare providers fail to raise the specter of a vaccine-related injury or question them about recent vaccinations. However, the belief or persuasion of the patient, standing alone, won't prove a vaccine injury claim to the court's satisfaction. Patients who believe that a vaccine injured them must prove their claim in court by a preponderance of the evidence. Their claims must be supported by either medical records or medical expert opinion.
Many practical threshold considerations must be taken into account when someone contemplates filing a claim under the Vaccine Act. These include the timeliness of the filing of the claim (filing must fall within the statute of limitations), and the residual effects of the illness (acute illness with hospitalization and surgical intervention or a chronic illness lasting at least 6 months or until death).
Another case in the vaccine court involved an OR circulating nurse who'd been in her usual state of good health when she suffered the sudden onset of cramping, pain, and weakness in her legs and back.9 The weakness and pain worsened over the course of 1 day and was relieved only somewhat by getting off her feet. By midafternoon, the nurse was completely unable to walk. She was taken by ambulance to the ED at the hospital where she'd been employed, complaining of numbness in her right leg up to her hip and, according to court documents, a sensation of touch (slightly) on her left leg. A computed tomography scan of her brain was negative, as was an X-ray of her spine. The ED record documented her receipt of an influenza vaccine 2 to 3 weeks prior to admission, but stopped short of specifically linking the vaccination to her neurologic signs and symptoms.
The following day, the nurse was transferred to a regional hospital and admitted with a differential diagnosis including GBS, transverse myelitis (idiopathic or autoimmune) or, less likely, a spinal vascular event. Due to the abrupt onset of her signs and symptoms, the presumptive diagnosis was transverse myelitis. She was treated with steroids with some success.
One month following vaccination, the nurse continued to experience significant lower extremity weakness, ongoing urinary retention, and fecal incontinence. The patient's urologist noted that her health history included a flu-like syndrome about 1 week prior to symptom onset, supporting the diagnosis of transverse myelitis. A gastroenterologist recommended a proton pump inhibitor, stool softener, and consideration of a gastrointestinal motility agent in light of the presumptive diagnosis of transverse myelitis at the level of L2.
Six weeks after the onset of her neurologic signs and symptoms, the nurse was discharged from physical therapy with a diagnosis of transverse myelitis, status post flu vaccine. Her attending physician marked off the box on the discharge forms indicating that he was “unable to determine” what caused the transverse myelitis.
The nurse continued to need help with grooming, eating, dressing, toileting, and ambulation. She received additional rehabilitation for another 41/2 weeks. At the time of discharge, she continued to require total assistance with ambulation. More than 1 year after illness onset, she still couldn't work as a nurse or care for her daughter.
The nurse filed a vaccine injury claim in the Vaccine Court and set forth to show that her influenza vaccination was more likely than not a substantial cause of her transverse myelitis.
Elements of a successful claim
To succeed, a petitioner, like these two nurses, must establish three prongs of a vaccine injury claim:10
1. a medical theory causally linking the vaccination to the injury
2. a logical sequence of cause and effect showing that the vaccination was the reason for the injury
3. a proximate temporal relationship existing between the vaccination and the injury.
The petitioner must establish all three prongs of his or her claim by a preponderance of the evidence. For example, showing the existence of a proximate temporal relationship (prong 3) between the vaccination and the onset of injury will not, standing alone, show that the vaccination was the legal cause of the injury.
In order to prove all three prongs of the claim, a petitioner usually retains a specialty-certified physician willing to review the medical records and offer expert opinions on the three prongs of the legal claim. The expert physician witness fees are paid by the VICP in reasonable claims. In some cases, proof of causation comes from the petitioner's treating physician or the medical records.
Under the three-prong vaccine case causation analysis, the physician witness must first present a medical theory that will causally connect the vaccination to the injury. The medical theory doesn't need to be scientifically certain or corroborated by epidemiologic evidence or medical literature. The medical theory does, however, need to have a scientific basis and present a reliable scientific explanation. The Special Master subsequently decides whether or not the medical theory is reliable, based on science, and persuasive.
One of the medical theories presented in vaccine injury claims involving demyelinating illnesses such as GBS and transverse myelitis is molecular mimicry. This medical theory suggests that the influenza vaccine is perceived as an invading pathogen that stimulates a patient's immune system. The vaccine's molecular structure resembles a molecular structure that already exists in the body. Because the vaccine resembles (mimics) the body's tissue, the body's immune system responds inadvertently to the natural host tissue as it mounts a response to the vaccine, resulting in damage to the host/patient.11
A successful vaccine claim also depends on the physician witness's ability to present preponderant evidence of a logical sequence of cause and effect showing that the vaccination was the reason for the illness (prong 2). The physician's testimony doesn't need to be scientifically or medically certain.
The court often prefers the testimony of the treating physician to establish prong 2 of the vaccine claim. The court has repeatedly held that the treating physician is in the best position to testify on the logical sequence of cause and effect between the vaccination and the onset of the patient's vaccine injury.
Occasionally, treating physicians document their unwillingness to administer the next dose of the same vaccine to their patient. A Special Master may consider a treating physician's unwillingness to administer a repeat vaccination as evidence of a link between the vaccine and the illness. The Special Master then determines whether the physician's testimony about the sequence of cause and effect is logical and probable.
The petitioner must identify a specific illness that was allegedly caused by the vaccine. In the case of the OR nurse, for example, transverse myelitis was the identified illness.
Physician expert witnesses may be called on to clarify and confirm the diagnosis. Much of the time the clarification is secured from a written report. For the most part, physician expert witnesses refer to and rely on peer-reviewed medical literature.
In addition, the Special Masters often refer to commonly accepted medical sources to improve their understanding of complex medical conditions. They often cite Dorland's Illustrated Medical Dictionary and Stedman's Medical Dictionary. In one recent vaccine injury claim, the Special Master considered the opinion of Drs. Michael Pender and Pamela McCombe from their textbook Autoimmune Neurological Disease, where they stated “a wide variety of vaccines have been reported to trigger...acute transverse myelitis, including influenza....”12
Case reports of vaccine-induced transverse myelitis are also commonly introduced into evidence and reviewed by the Special Masters. In one recent vaccine injury case, a journal article was introduced into evidence to show that “both myelitis and GBS-type polyneuropathy might occur after vaccination.13
Disappointing outcome for the OR nurse
Relying only on her medical records, the OR nurse attempted to show that documentation by her treating physicians demonstrated the logical sequence of cause and effect between the seasonal flu vaccine and her transverse myelitis (prong 2). She was unsuccessful. The Special Master decided that she'd failed to present preponderant evidence on prong 2 of the causation analysis. The Special Master stated that the attending physician's documentation that the patient's diagnosis, “transverse myelitis status post flu vaccine,” wasn't persuasive proof that the seasonal flu vaccine caused the transverse myelitis. Similarly the Special Master stated that the urologist's and gastroenterologist's mere documentation that their patient was diagnosed with transverse myelitis stopped short of showing that the flu vaccine caused the illness. The Special Master left the door open for the OR nurse to seek out the opinion of an expert physician witness willing to testify to the logical sequence of cause and effect that the Special Master found lacking in the treating physician's progress notes.
A petitioner who meets the first two prongs of a claim must also establish the third prong: that is, proving a proximate temporal relationship between the vaccination and the injury. Success depends on the physician witness's ability to present preponderant evidence that a medically acceptable proximate temporal relationship between the vaccination and the injury exists. For example, in the OR nurse's claim, her expert's testimony would have to persuade the Special Master that a delay of 2 weeks between influenza vaccine administration and her onset of pain, weakness, and bowel and bladder dysfunction is a medically acceptable time lapse to support her vaccine injury claim.
Making a case for the defense
If the petitioner presents sufficient evidence on prongs 1, 2, and 3 of the vaccine injury claim, then the Special Master turns to a consideration of the arguments made by the defense. In a vaccine injury claim, the defense is made by an attorney representing the Secretary of the U.S. Department of Health and Human Services. The burden is on the federal government to prove, by a preponderance of the evidence, that the illness claimed by the petitioner was due to something unrelated to the vaccination. In the OR nurse's claim, the government's most likely defense strategy would be to show that an alternative explanation is the more likely cause of the petitioner's transverse myelitis.
The defense hires its own expert physician witness, who's likely to delve into the petitioner's prevaccination illnesses in an attempt to show that preexisting neurologic problems were the more likely cause of her illness. Defense attorneys may offer proof of many alternative explanations for a petitioner's neurologic signs and symptoms, such as mixed connective tissue disease with rheumatoid arthritis overlap, osteoarthritis with spinal cord and nerve root compression, dietary vitamin B12 deficiency, mold allergy, cervical spine osteopenia and degenerative changes, or an evolving mixed collagen vascular disorder.
In situations where the petitioner and the respondent can't settle the claim, a hearing may be held where the petitioner and expert witnesses for both parties testify as to the facts and the experts testify as to their opinions about the case. The Special Master listens to the witnesses, weighs the complex medical and scientific evidence, and decides whether the petitioner has established that it's more likely than not that the vaccination was a substantial cause of the petitioner's injury.
Over the years, various petitioners following the three-prong analysis for vaccine injury causation have successfully shown in court that the influenza vaccine meets the criteria to be a substantial cause of transverse myelitis and GBS. In these cases, Special Masters have compensated petitioners for their pain, suffering, unreimbursed medical expenses, future medical costs, and unreimbursed wage loss. Death benefits may be awarded in appropriate cases.
As nurses become more aware of vaccine-related injuries, they may be more likely to query their patients about recent vaccinations and document their patients' history of seasonal influenza vaccination. The nurse's documentation of signs and symptoms of potential vaccine injuries should become a routine part of the nursing assessment.
None of the content of this article is intended to be formal legal advice or the formation of a lawyer-client relationship.
Comparing GBS with transverse myelitis
Rare and poorly understood, GBS and transverse myelitis are neurologic disorders characterized by varying degrees of paralysis. In GBS, which is considered an autoimmune disease, the body's immune system attacks the peripheral nervous system. Ascending muscle weakness, starting in the lower extremities, is common. In severe cases, patients become completely paralyzed and require mechanical ventilation to survive. With supportive care throughout the acute phase, however, most patients recover spontaneously, although residual weakness may persist for months or years.
Transverse myelitis is a segmental spinal cord injury caused by acute inflammation. For unknown reasons, inflammatory processes cause myelin sheath destruction and altered nerve impulse transmission. Signs and symptoms, which may include paralysis, urinary retention, and loss of bowel control, depend on the spinal cord segment involved. Some patients recover fully, but many develop permanent disabilities.
Underlying causes aren't well understood for either disorder, but both have been linked to gastrointestinal or respiratory viral infections, including influenza, among many other potential causes. According to the National Institute of Neurologic Disorders and Stroke (NINDS), “In rare instances, vaccinations may increase the risk of GBS.” The NINDS also notes that transverse myelitis “may occur as a complication of syphilis, measles, Lyme disease, and some vaccinations, including those for chickenpox and rabies.”
Sources: National Institutes of Neurological Disorders and Stroke. NINDS Guillain-Barré syndrome information page. http://http://www.ninds.nih.gov/disorders/gbs/gbs.htm. Transverse myelitis information page. http://http://www.ninds.nih.gov/disorders/transversemyelitis/.
1. Centers for Disease Control and Prevention. Recommendations and guidelines. http://http://www.cdc.gov
2. National Childhood Vaccine Injury Act, 42 U.S.C. §300aa-1 et seq.
3. National Childhood Vaccine Injury Act, 42 U.S.C. §300aa-1.
4. Health Resources and Services Administration. National vaccine injury compensation program. http://http://www.hrsa.gov
/vaccinecompensation/. Also see House Report 99–908, 99th Congress, 2d session 18, reprinted in 1986 U.S.C.C.A.N. 6344.
5. Health Resources and Services Administration. Vaccine Injury Table. http://http://www.hrsa.gov
6. National Childhood Vaccine Injury Act, 42 U.S.C. §300aa-13, Rules of the US Court of Federal Claims (RCFC), Appendix B, Vaccine Rule 8c.
7. Althen v Secretary of Health and Human Services, No. 00–170V, 9/30/03, 418 F. 3d 1274 (Fed. Cir. 2005).
8. Knudsen v Secretary of Health and Human Services, 35 F.3d 543 (Fed. Cir. 2005); Hennessey v Secretary of Health and Human Services, No. 01–190VC.
9. Joan Caves v Secretary of Health and Human Services, No. 07–443V (SM Moran, 2/25/08).
10. Althen v Secretary of Health and Human Services, 418 F.3d 1274 (Fed. Cir. 2005).
11. Hennessey v Secretary of Health and Human Services, No. 01–190VC (2010).
12. Pender MP, McCombe PA. Autoimmune Neurological Disease. Cambridge University Press; 1995:156.
13. Nakamura N, Nokura K, Zettsu T, et al. Neurologic complications associated with influenza vaccination: two adult cases. Intern Med. 2003;42(2):191–194.
Follows J. Vaccine adverse events. Workplace Health Saf. 2012;60(1):7–10.
© 2012 Lippincott Williams & Wilkins, Inc.