"Compensating Vaccine Injuries: Are Reforms Needed?"

My name is Marcel Kinsbourne. I am a pediatric neurologist; my curriculum vitae has been provided. I have served as an expert witness for Petitioner in many actions under the terms of the 1986 National Vaccine Injury Compensation Act, from when these proceedings began in 1988. Before that, I lectured on neurological aspects of vaccine injury at the two-day training workshop for prospective Special Masters, that was held at the U.S. Court of Claims. I have also testified both for plaintiff and defendant in civil litigation. I am therefore in a position to compare the prevailing practice in vaccine injury litigation at the U.S. Court of Claims with practice in civil litigation. On August 3, 1999, I testified before the Committee on Government Reform on the issue of vaccine safety. My current testimony addresses the three issues that the Subcommittee has chosen for its deliberations.

The adversarial nature of Vaccine Act litigation

The Vaccine Act was introduced in 1986, in the context of a mounting volume of litigation against vaccine manufacturers, especially with respect to the DPT vaccine. It had come to the point that vaccine manufacturers threatened to abandon making this product. The Vaccine Act sought to provide claimants with an alternative to lawsuits, which was intended to proceed "quickly, easily, and with certainty and generosity". Initially, petitions were indeed dealt with in a non-adversarial manner, with the benefit of the doubt given to the Petitioner. This soon changed, and Respondent’s defense against petitions on behalf of allegedly vaccine-injured people, mostly children, has become increasingly stubborn and aggressive, to the point that in its spirit, it is now indistinguishable from the adversarial manner in which some civil lawsuits are conducted.

The Department of Justice (DOJ) attorneys make full use of the apparently limitless resources available to them, in order to defeat petitions. They increasingly often substitute one expert for another if the opinion rendered by the first is unfavorable or seems not to impress the Court (or one theory for another), or recruit multiple experts for a single case, as against Petitioner’s usually single expert. Multiple Entitlement Hearings result. The DOJ has retained and paid a group of professional investigators to perform a scientific study for litigation purposes, to reopen and defeat claims (Hanlon v. Sec HHS, Plavin v. Sec HHS) for which entitlement had previously been found. This was a considerable expense that Petitioner’s attorneys could not remotely emulate under present rules. If the Court’s decision in a particular case is unwelcome to the Justice Department attorney, he or she increasingly often reopens issues at the Damages Hearing that automatically follows, that are similar in nature to the arguments that failed at the stage of Entitlement. As a result, Damages Hearings threaten to become as burdensome to Petitioners as Entitlement Hearings. If after all this the outcome remains unfavorable to Respondent, the DOJ attorneys increasingly often resort to the multistage appeals process. The process is adversarial at every step.

Another tactic that is increasing in frequency is an attempt to discredit Petitioner’s expert in the eyes of the Court by means of accusations of bias. A striking instance occurred in the most recent Hearing in which I testified (Flanagan v. Sec HHS). The DOJ attorney filed the statement that I had submitted to the Committee on Government Reform ahead of my testimony on August 3, 1999, as an Impeachment Exhibit. Her point was not that my testimony was flawed; when she cross-examined me she challenged none of it. She was content to have me acknowledge that this did represent a submission that I had made at the invitation of a Congressional Committee. Her point was that the fact that I had testified at all before the Committee impeaches my credibility as an objective medical expert (Closing argument, Transcript page 164, lines 21-25):

"The fact that he recently testified before Congress about a number of issues, but in particular, about his views on the problems with this program I think also shows that, to some degree, he is an advocate on behalf of the Petitioners, and Dr. Holmes is not."

I am confining my testimony to matters of which I have direct knowledge. But I do not believe that my experience is unique. I believe that the other medical experts, as well as Life Care Planners, retained by Petitioners, have had similar experiences.

The Special Masters continue to do their best to maintain objectivity, although they appear to be very conscious of the threat of appeals by Respondent. They also maintain a courteous and compassionate attitude toward the families that petition for compensation. They implement relaxed rules of procedure at the Hearings. Finally, they do their best to move the cases along in a timely fashion. This, however, becomes increasingly difficult as the defense stiffens, and families who are ultimately compensated often have waited for many years for this to happen. The Flanagan matter in which I testified last month was filed in 1991.

At the Committee’s previous Hearing, I heard mention of two years as typical for the resolution of a claim under the Act. Even two years without interim funding for fees and expenses is burdensome. But in my experience, cases that are contested and finally resolved in favor of Petitioner often take much longer, four or five years, and even nine or ten. This contrasts with the initial expectation of Congress, in 1986, that the proceedings would last nine months at the outside.

I recognize from my experience of testifying in civil cases that the aggressive approach that I have outlined is not unusual in adversarial proceedings. I question whether it is consistent with the intent of Congress, at the time when the National Vaccine Injury Compensation Act was first formulated. By no stretch of the imagination can it be presented as nonadversarial or generous to Petitioner.

Changes in the criteria for a presumption of causation

The scientific basis for establishing causation in vaccine injury is complicated by the lack of disorders that are known only to be caused by a particular vaccine, and the unavailability of specific laboratory tests that identify vaccine injury. Neurological diseases of children, such as cerebral palsy, epilepsy, mental retardation and autism, are caused by many different factors, and one usually cannot determine simply from what currently ails the child what in his case was the cause. Even after all pertinent tests have been done, the cause often still remains uncertain. So it is with neurological vaccine injuries. The inference that a vaccine injury has occurred can often be neither confirmed nor disconfirmed based on peer-reviewed scientific studies alone, since in many cases the relevant studies have simply not been performed. The argument that the onset of a disorder for which compensation has been claimed was coincidental with, and not caused by, the vaccination, can be adjudicated by epidemiological studies, but these are usually found not to have been performed. Several reports of the Institute of Medicine have pointed to the absence of studies based on which the Committee could determine whether certain complaints can be caused by particular vaccines or not. As new vaccines are now being introduced at an increasing rate, this absence of studies is becoming an even more serious problem.

The Act in its initial form introduced criteria for a presumption of causation that eased the burden on Petitioner to present scientific studies that simply have not been performed. Where there was uncertainty, Petitioner was given the benefit of the doubt. This was particularly important with respect to claims dealing with the pertussis vaccine, which have constituted the great majority of claims filed up to now. Starting in 1995, the Secretary of HHS has made the criteria for presumption of causation so much more stringent and demanding that the presumption is now unavailable to almost all claimants. The Secretary has effectively changed the guidelines for entitlement from a "mighty very well be due to" to a "no question that" criterion. These additional restrictions on entitlement were implemented in the absence of any new or recent scientific findings that might justify such changes. To the contrary, successive findings of the Institute of Medicine (1990, 1994) have increasingly confirmed the reality of pertussis vaccine brain injury.

An instance of a severe rollback of the presumption of causation is the redefined criterion for encephalopathy, a major subject of pertussis vaccine injury claims. Encephalopathy was redefined so that the diagnosis requires as a sine qua non in excess of 24 hours of a diminished level of consciousness, a criterion which is far more restrictive than that of the leading epidemiological study of pertussis vaccine injury, the British National Childhood Encephalopathy Study (NCES). Moreover, seizures have been removed from the Table, although that the pertussis vaccine can cause seizures is uncontested (and warned in the manufacturer’s package insert), and although the NCES found a significant association between a severe seizure and DPT administration in the preceding three days (a finding that was endorsed by the Institute of Medicine). Essentially, the presumption of causation has been restricted to the point that it has become tantamount to causation-in-fact. It therefore no longer renders "the benefit of the doubt" to Petitioner, let along any "generosity". Almost all claims for injury by the pertussis vaccine must now meet causation-in-fact criteria, initiating a lengthy and arduous process, that is often unproductive because the relevant science is unavailable. Given the great expense and difficulty of prevailing with a Vaccine Act claim as to pertussis vaccine injury, there has been a resurgence of lawsuits against vaccine manufacturers, a development that the Act was intended to render unnecessary. Indeed, a plaintiff may well now find it easier and quicker to prevail in civil litigation than in the U.S. Court of Claims.

The dearth of relevant science on which to base a causation-in-fact Petition becomes an even more serious problem when the claim is for an injury inflicted by a newly marketed vaccine, not listed in the Table of qualifications for a presumption of causation. If Petitioner has to produce nonexistent studies to prevail, he or she essentially remains without a remedy. To avoid this undesirable outcome, it is necessary to establish a Table of presumptive causation for the newer vaccines, that lists Table injuries on a "might very well be due to" basis. An example might be the causation of autoimmune diseases by Hepatitis B vaccine.

In sum, the initial intention of Congress, that a relatively informal, generous and friendly process, concluded in a timely fashion, would offer claimants an attractive alternative to launching lawsuits against drug manufacturers, has been undermined. Among the Legislative changes recently proposed by HHS are ones that would undermine it still more. I believe that the current criteria for a presumption of vaccine injury need review and revision. Some revised criteria should be revised back to their original formulations.

Funding for future needs

Up to recently, the great majority of claims were filed with respect to injuries caused by the whole cell pertussis vaccine. Now that an acellular vaccine is available, I expect a greatly diminished rate of injury from vaccination against whooping cough. But this will only occur if the continuing use by some pediatricians of the less safe whole cell vaccine is halted.

The prospect of fewer claims with respect to pertussis vaccine is offset by the continuing introduction of new vaccines, with ill-researched and ill-understood adverse side effects. It is also offset by the increasing practice of combining the administration of multiple vaccines, a practice the safety of which has barely been investigated. Finally, if less adversarial procedures are introduced, more petitions will be recognized to have merit.

Obviously, significant funding will be required for the foreseeable future. However, I learned at the previous hearing that there is a "surplus" of 1.4 billion dollars in the Trust Fund (though how this sum is a surplus, given pending and anticipated petitions, escapes me). The monies in the Trust Fund contributed by citizens as a compulsory surcharge on vaccines should continue to be used only for the purpose for which they were intended, namely, to compensate victims of vaccine injury.