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Tuesday, November 12, 2013

Congressional Briefing Attempts to Discredit Vaccine Injury Compensation

From Shot of Prevention

By Christine Vara
November 8, 2013

On November 7th, a Congressional briefing, entitled “The Injustice of the Vaccine Injury Compensation Program (VICP),” was sponsored by “The Canary Party” and billed as a precursor to a hearing scheduled on December 4th in the Committee of Government Oversight and Reform.

Dorit Rubinstein Reiss, a passionate vaccine advocate with intimate knowledge of the legal system and Professor at University of California Hastings College of the Law, attended the briefing and provided the following post as her response to comments she heard there.

Doing Away With NVICP: Bad For Plaintiffs, Bad For Society

By Dorit Rubinstein Reiss

At a briefing in Congress about the National Vaccine Injury Compensation Program (NVICP), Ms. Mary Holland and Mr. Rolf Hazelhurst criticized the program’s operation. Ms. Holland, addressing several possible reform options, rejected improving the program (what she called “tinkering at the edges”) as a way to fix the problems she identified.

Her solution was to have claims of vaccine injuries litigated in the regular courts, either through making NVICP optional, limiting it to the original 7 vaccines it covered in 1986, or repealing the act completely.

Doing so would be an error. From plaintiffs’ perspective, adjudication through NVICP is either equivalent to the courts or better. For society, too, vaccine injuries are better handled by NVICP than by the regular courts.

What is NVICP?

In 1986, Congress passed the National Childhood Vaccine Injury Compensation Act, creating NVICP as a no-fault alternative to the tort system. NVICP provides an administrative scheme to compensate those who claimed they were injured by a vaccine. Parallel schemes exist in other countries.


The initial determination is made by a special master, but petitioners can appeal to a judge of the U.S. Court of Federal Claims, which also appoints the special master. A decision of that judge can then be appealed to the relevant Federal Circuit. The program was established to allow plaintiffs to sue the federal government rather than individual vaccine manufacturers in order to ensure the continued supply and development of new vaccines.

Since its creation the program has compensated 3412 claims to the tune of $2,777,620,433.90 (these numbers were accurate as of November 7, 2013). If those numbers look large to you, a reality check is in order: whether compared to the number of vaccine doses administered or to injuries from other sources, 3412 claims in 25 years is a tiny number. And while close to $2.8 billion sounds like a lot, the costs of motor vehicle accidents in 2009 alone – one year v. NVICP’s 25 – was $244.7 billion.

The Plaintiffs’ Perspective

Ms. Holland’s case focuses on the claim that NVICP is unjust and painful for plaintiffs. There is probably room for improving the program (or any other administrative program). But Ms. Holland is not interested in improving the program: she wants to abolish it and send plaintiffs to the courts.


As pointed out by Neil Komesar in his book “Imperfect Alternatives”, when choosing between institutions, the question is not whether one of the choices is good or bad in abstract, but which one is better at handling the problem at hand. And on every aspect she raised, NVICP is equivalent to or better than the civil courts for any plaintiff with a valid claim.

Ms. Holland highlights that most petitioners lose. She said 80% of cases lose, which means only 20% of plaintiffs win. My calculations were slightly different – I calculated the rate of winning to be 26% (3412 claims compensated out of 13077 adjudicated). While that might seem low, again a comparison is in order: In 2005, the last year for which we have data,plaintiffs won only 20% of non-asbestos product liability claims. Product liability claims are simply hard to win. In whatever forum. Sending plaintiffs to the regular courts would not make proving the claims easier for plaintiffs.


One reason for that was mentioned by Ms. Holland herself: showing causation for product liability can be hard. NVICP actually gives plaintiffs a break on that: if they have a table injury (a table listing conditions likely to be caused by vaccines, if occurring within a set time) within the defined time, causation is assumed.

While many plaintiffs bring injuries that are not on the table, requiring them to prove causation does not disadvantage them compared to the regular courts: there, too, plaintiffs would have to show that more likely than not the defect in question caused their injuries.

The real problem Ms. Holland and her colleagues face – a problem glossed over in the Canary Party video and her presentation, (as addressed in detail here, here and here) is that for the main injury they want to address, the claim that vaccines cause autism, they have no credible evidence for causation , and there is abundant evidence on the other side.

Many, many studies examined that question finding no link. Claims that vaccines cause autism were also rejected in several lengthy decisions by NVICP as part of the Autism Omnibus Proceeding. Mr. Hazlehurst argued that the rejection was because of government corruption; but the lengthy, detailed, thoughtful decisions of the special masters show differently. The special masters carefully examined plaintiffs’ evidence. It simply did not support the alleged causal link. In fact in one opinion, Special Master George Hastings wrote,

“This case, however, is not a close case. The overall weight of the evidence is overwhelmingly contrary to the petitioners’ causation theories…In short, this is a case in which the evidence is so one-sided that any nuances in the interpretation of the causation case law would make no difference to the outcome of the case.”

Similarly, the other conditions Ms. Holland wants to connect to vaccines – a large array of chronic conditions – lack evidence of a causal connection.

A causation problem also exists for the HPV cases in the video Ms. Holland ended her presentation with. In the video, multiple girls suffering from various conditions – or parents of deceased young girls – say to the camera that it is not a coincidence. Sincere as their belief in the causal connection to the HPV is, and painful as their conditions are, belief is not enough, and none of these cases has objective evidence of such a connection.


Studies examining the HPV vaccine did not find that it caused the harms claimed – for example, a large study from the United States and an even larger study from Sweden. With no credible evidence, these claims too face very high hurdles in the civil courts. In NVICP, the government – following Congress’ mandate to compensate even cases in doubt – settled a small number of HPV cases. A private litigant would not be operating under such a mandate.

Moving to the civil courts will not solve this problem. The same requirement of showing that the vaccine more likely than not caused the harm will apply. The same outcome should result.

Other problems raised by Ms. Holland are procedural. She says that the program forecloses access to other forums. That’s only partly accurate – while after Brusewitz v. Wyeth suits for design defect cannot be brought in state courts, a plaintiff can reject the special master’s determination and sue in state courts if her claim is based on a manufacturing defect or warning defect. And at any rate, by itself, the lack of an alternative forum is not a problem if the proposed forum is good enough.

She complains the NVICP has become adversarial in a way that Congress did not intend. First, a quick glance at the cases published online shows that most cases – as with the civil courts – settle; and second, if a plaintiff is interested in a non-adversarial process, sending them to the civil courts is hardly the solution: our trial system is an adversarial one.

Ms. Holland complains about the length of the trials. Ideally, victims would be compensated swiftly, but product liability trials are complicated, and can easily take a long time in the courts: of the trials lasting more than 3 years in the federal courts in 2009-2011, about half are product liability cases. (See examples here and here.) We just cannot assume trials will be quick in the civil courts.


In one example, Mr. Tenuto contracted paralytic polio from his daughter’s Oral Polio Vaccine. He had the choice of suing through NVICP but chose to go through the regular federal courts. Mr. Tenuto was injured in 1979. The case ended thirty years later in 2010. The NVICP has the infrastructure to more rapidly adjudicate cases – as Ms. Holland points out, the rules of procedure are relaxed, making the process easier on plaintiffs, and there is no discovery or jury trial, again streamlining the process. If even under those conditions the process takes a long time, imagine the length in the civil courts for these complicated cases.

Ms. Holland attacks the lack of judicial independence of the special masters; it’s true that neither the special masters nor the judges of the Court of Federal Claims are appointed for life, as federal judges are. But the judges who appoint the special masters are appointed by the President and confirmed by the Senate for 15 years; and the judges of the Circuit Courts to which the decision can be appealed do enjoy life tenure. In contrast, the state civil courts have judges who may be elected or appointed politically subject to retention election.

She complains about lawyer fees being slashed and delayed and expert fees delayed and reduced as well. I would like to see some evidence that fees are lower at NVICP than elsewhere. If they are, and it affects the ability of families to find representation, a modest reform might be in order – but Ms. Holland had not made that case.


At any rate, this criticism ignores an important aspect of the process: NVICP covers lawyer fees and costs, even if you lose. This means that lawyers appearing before NVICP have guaranteed income, which may compensate for a lower return (it may also provide an incentive to lawyers to bring cases with lower chances of success to the program, thus increasing the number of unjustified claims. A reform addressing lawyer fees should probably examine the entire framework and its effect on cases). It also means plaintiffs receive the full award directly instead of paying the lawyer 30-50% as a contingency fee.

Ms. Holland also highlights the statute of limitations, with a period of three years (which Mr. Hazelhurst erroneously suggested starts on the date of vaccination. Actually, the clock of limitations starts “after the first symptom of the vaccine injury”. But statutes of limitation exist in civil courts too, and may even be shorter. One example is in California where the statute of limitations for personal injuries is “Two years from the injury. If the injury was not discovered right away, then it is 1 year from the date the injury was discovered.”

Finally, plaintiffs going through the civil courts would have to prove a design defect. Proving a design defect is done under principles of negligence, and is not easy. This would be an additional burden facing plaintiffs before they can recover.

In short, NVICP offers plaintiffs substantial advantages over the regular courts. Is the process perfect? Certainly not. But neither would a court process be, and it would impose substantial burdens on plaintiffs.


The Social Perspective

From a social perspective, NVICP offers substantial advantages. The most obvious is that by protecting manufacturers from liability, NVICP reduces the risk of manufacturers leaving the market and of vaccine shortages. This is not a theoretical risk: vaccine shortages – and resultant diseases outbreaks, harming children – were behind the original act.

In addition, handling such cases by a specialized court allows for more expert determination, and the simplified procedures can guarantee quicker, more efficient compensation (the process may need reforming, and it is worth examining; but the potential for a more streamlined and efficient process than a regular court proceeding is there).

Ms. Holland suggests that an advantage of going through the courts will be to incentivize manufacturers to make vaccines safer. But vaccine safety is already regulated in other ways, with important safeguards in place to assure safety: vaccines have to go through three stages of clinical trials before they go on the market, the last stage involving tens of thousands of people and they are carefully monitored after market . A vaccine can be pulled off the market (as has happened in the past) if a serious safety problem arises. Ms. Holland does not explain why that’s not enough of a safeguard.

Two groups would benefit from abolishing NVICP: plaintiffs who cannot prove causation and lawyers who would like more control of the fee structure.

Plaintiffs who cannot prove causation may, in the regular court system, come across a judge who will let the claim go forward in spite of the lack of evidence. Judges should not: if plaintiff does not bring credible evidence that more likely than not defendants caused their harm, a claim should be dismissed.

But even judges can make mistakes, so it is possible for a judge to wrongly accept flawed studies or let a case go forth with insufficient evidence, and a judge unfamiliar with the subject matter is more likely to do so than a judge in a forum that specializes in vaccine injury cases. And a jury may accept a claim with insufficient evidence, especially when faced with a child suffering a severe disability.

It’s easy to feel sympathy for a child with serious disabilities, and for the family having to support and help that child. And it may be appropriate for society to provide for such children, regardless of the cause of their problem. That’s a discussion worth having.

But that’s not what the United States’ torts system is set up to do: the torts system is not a government insurance or assistance problem. It would, in fact, be very bad at it. It’s adversarial, it’s formalized and technical (leading to delays and costs), and because decisions are made by individual decision makers and not subject to any close centralized control, it’s inconsistent. It would be an expensive, inefficient, and probably unjust way to administer social assistance.

What the tort system is supposed to do is compensate plaintiffs who can show that a tort by the defendant caused their harm. As sad as their plight might be, plaintiffs who cannot show causation should not be compensated through the tort system. And the possibility that the system might err and compensate them anyway is not a reason to replace NVICP with a civil trial. If anything, it’s a reason not to.

The other group that may benefit from replacing NVICP with a court trial is lawyers. who will be willing to take these cases on contingency fees and absent the program’s regulation will be have freedom to set costs (e.g. for expert reports). They will also collect 30-50% of whatever is awarded at trial.

I teach at a law school. I have friends, colleagues, and students who are lawyers. Most of the people I know in the legal field are highly ethical, bright, well-intentioned and professional. I would be the last person to attack lawyers’ desire to make a living. But the ability of lawyers to be able to get more money at the expense of the plaintiffs is not a good policy reason to want to move away from NVICP.

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