In this post I explain how one goes about proving a case in the National Vaccine Injury Compensation Program (NVICP), and how that differs from proving a case in the civil courts, focusing on what it means to have a no-fault program and proving causation. I will use a case that started with the tragic death of a young child after a vaccine to illustrate the complexity and operation of the program, and also to address the idea of federal preemption, and how it limits the ability of those claiming vaccine injuries to use state courts for their claims.
- Holmes v. Merck: The Rules and Limits of NVICP
- The National Vaccine Injury Compensation Program and its Requirements:
- National Vaccine Injury Compensation Program legal standards
- Constitutionality of the NVICP court
- Preemption: the heart of Holmes v. Merck
- Summary or TL;DR version
Holmes v. Merck: The Rules and Limits of NVICP
Holmes v. Merck & Co., Inc., 697 F.3d 1080 (2012) tells the sad story of young Jacob Holmes and his family. At a year old, Jacob received the measles, mumps and rubella vaccine (MMR), according to the CDC’s recommendations. According to the claim filed by Jacob’s parents, he started having seizures and “encephalopathies” nine days after the vaccine and died within six months.
I can’t think of a pain worse than losing a child, and Jacob was very, very young. His parents believed his death was because of the vaccine, and filing a claim under the table of injuries received compensation from the NVICP – the maximum amount the law allows the program to pay for a death, $250,000, an amount not updated since the law was passed in 1986.
Still hurting and angry, they also brought suit for their own damages from Jacob’s injury against Merck, manufacturer of the vaccine, in Nevada state court for “strict product liability, negligent design, failure to warn, misrepresentation, express warranty, implied warranty of merchantability, implied warranty of fitness for a particular purpose, and punitive damages.” (pp. 1181-1182). Merck removed the case to federal district court on the basis of diversity jurisdiction. In our legal system, cases between parties from two different states can be heard by the federal courts. That is why Merck was able to remove to federal court.
After three years of discovery, the district granted Merck’s motion for summary judgment: the case was not allowed to proceed. In relation to the design defect and failure to warn claims, both in negligence and in strict liability, the court ruled that they were preempted by the vaccine act. This will be discussed further in part II of this post. For the other claims the court found, for a variety of reasons that are beyond this post, that plaintiffs have not provided enough evidence for their claims to allow them to continue litigating on those issues.
The National Vaccine Injury Compensation Program and its Requirements:
In 1986 Congress passed the National Childhood Vaccine Injury Act, which among other things created the National Vaccine Injury Compensation Program (NVICP). While a main impetus for the passage of the act was protecting manufacturers from liability – manufacturers were leaving the market because of lawsuits, many of them unjustified, and Congress was concerned about the vaccine supply – it was not the only goal and not the only value reflected in the act. In addition to protecting the vaccine supply, the program also addressed the shortcomings of the tort system in this area with a no-fault program designed to resolve vaccine injury claims “quickly, easily, with certainty and generosity.”
Civil court standards
This is not the best place for a comprehensive discussion of NVICP’s process. But let me highlight some of the things a petitioner going through NVICP has to prove, and how they differ from the courts. In a civil court, a petitioner claiming a vaccine injury is likely to claim a product defect, using either a negligence-like standard or a strict liability standard, depending on the claim. The plaintiff would have to show the following:
- That the product was defective in the relevant way – either a manufacturing defect (handled under strict liability), or a design defect or warning defect, both handled under what amounts to negligence principles. A plaintiff can also show negligence in relation to any of those defects.
- That the defect in the product actually caused the harm. With a pharmaceutical product leading to a medical injury, this will usually require (expensive) expert testimony.
- That the connection between the defect and the harm was not too remote, too unusual, or for other reasons, should be exempt from liability – this requirement is referred to, in technical legal term, as proximate cause, though a recent rend has been to try and move to calling it “being within the scope of liability”, to prevent confusion with the requirement of cause in fact.
- That there was legally cognizable harm.
The defendant would be able, in turn, to argue defenses against these claims, including, for example, a statute of limitations defense – in most states tort statutes of limitations run to two to three years. If suing the government, governmental immunity can limit a claim. Some jurisdictions apply the defenses of comparative negligence or assumption of risk to product liability claims as well, though not all do. Some jurisdictions cap certain kinds of damages.
Rules of evidence govern which types of evidence can be used. As I mentioned, some things require expert witnesses, for example, medical causation, and there are some limits on who qualifies as an expert. The standard of proof is the “more likely than not”, or the “preponderance of evidence” standard –the party with the burden of proof needs to show that for each of these requirements, it’s more than 50% likely that its claims are true.
Note that both expert witnesses and the process of discovery available to the party are very, very expensive, providing an advantage to wealthy parties (like pharmaceutical companies).
Most civil cases settle. Of those that do not, that proceed to trial, the initial claim will need to be proved to the appropriate standard in a trial court. The trial could be before a judge sitting alone, if the parties both agree to that – a so-called “bench” trial. The judge will be either a state judge, often appointed politically or elected, or with parties from more than one state, before a federal judge appointed for life. Or the case can be heard before a jury. Then there would be an appeal to an appeal court on matters of law only, and possibly, but not always, an appeal to the highest instance – a state supreme court or the United States Supreme Court.
National Vaccine Injury Compensation Program legal standards
With a few exceptions, on every one of those points the process in NVICP is as easy or easier as the process in regular courts. In other words, it is a much better option for those with provable claims of vaccine injuries (though for a family with a suffering child it may not feel friendly – especially if family members are not familiar with the regular courts, or have a weak case). Let’s go through these one by one, and address their application to Holmes, as far as we can from the facts presented.
In NVICP, a petitioner does not have a to show a product defect. This is why the program is referred to as a no-fault program. In some circumstances showing a product defect might be easy; for example, in some manufacturing defect cases the product may be clearly in deviation from the standards of production. But often, it won’t be.
For example, most vaccine injury claims are design defects. The claim is not that the vaccine was manufacturered badly, but that its inherent risks are too high, that its design is unsafe. Proving a design defect is done under one of two tests: the consumer expectations test or the risk/utility test.
For a product as carefully tested as vaccines, that is only licensed if it meets very high safety standards and if its benefits far outweigh its risks, and that is accompanied by a Vaccine Information Statement detailing the risks, proving either can be very, very hard. In fact, it is likely to be impossible in many circumstances. The fact that NVICP waives this requirement allows many petitioners who would have no chance in the regular courts to go forward. In the Holmes’ case, as far as I saw, they made no manufacturing defect claims, but they made design defect and warning defect claims.
Nevada uses the risk/utility test – they would have to show that the risks of the product outweigh its utility, and often would be expected to show a safer alternative design.The problem in showing this would be that MMR is a very, very safe vaccine, and serious problems from it are extremely rare – and much smaller than the risks of the diseases it prevents.
And the MMR used in the United States is actually safer than alternatives that have been used elsewhere – for example, the Urabe strain of mumps used in the past in Canada, U.K. and other places was associated with a higher rate of adverse events. In other words, proving a design defect would be problematic.
A warning defect would also be problematic: federal law requires that parents be provided with the Vaccine Information Statement – which contains the known risks from the vaccine, and even risks that are not necessarily connected with it, like seizure disorder and brain damage (neither of which shown connected). In other words, the parents were probably given warning of the relevant risks. The act aside, in the regular courts they would have to show the warning was not good enough – not an easy thing to do, given this section:
The program still requires that the petitioner meet the causation requirements it set. This is a separate requirement; in cases in the regular courts plaintiffs would usually have to show both fault and causation. In NVICP they do not have to show fault. But NVICP is a compensation program, not a welfare benefit one. It’s designed to compensate for injuries that at least potentially were caused by vaccines. So it is very, very reasonable for the program to require showing some level of causal connection to the vaccine – and the program’s requirements are substantially less demanding than those of the civil courts. There are two ways of showing causation in the program:
a. Showing a table injury: The Table of Injuries sets out injuries that there is a basis of thinking vaccines cause (pdf). If a petitioner shows that an injury included on the table happened within the timeframe in the table, causation is presumed.This seems to be the case for Jacob Holmes: if the parents claimed an encephalopathy nine days after the MMR vaccine, there would be a presumption of causation. In a civil court, the family would have to prove that more likely than not the vaccine caused the injury.There is also a question of whether encephalopathy should still be on the table – and reason to think that no – but as this post is already getting very long, I’ll save that for another day.
b. Off-Table injuries: today, most claims are not on the table of injuries. For those, petitioners need to show that more likely than not the vaccine caused their harm. The standard they have to meet, however, is still less demanding than in the regular courts. In the regular courts, a plaintiff claiming something causing a medical problem – pointing the finger at a drug, a substance, or a procedure – will have to show that the claimed instrument can cause the alleged harm.
This is often referred to as general causation, and is usually established by expert testimony that needs to meet the standard set in Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993). Under Daubert, a judge assesses the scientific reliability of the evidence using a multi-factor, flexible test. Daubert is generally considered to make proving a case harder for plaintiffs. In addition to showing that the instrument can cause the harm in question generally, the plaintiff also has to show specific causation: that the instrument caused her specific harm.
In NVICP proceedings, special masters (a type of judicial officer that are used in technical cases) may use the Daubert precedence, but don’t have to, and frequently don’t, allowing expert testimony and other types of evidence that would not be allowed in civil courts. Furthermore, the general causation requirement is relaxed, even done away with completely. The standard required in NVICP is, instead, the Althen standard. Althen requires that petitioner:
show by preponderant evidence that the vaccination brought about her injury by providing: (1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury.
In other words, if the petitioner can find an expert willing to testify and argue a theory that is logical and there is a temporal connection, a petitioner may win a case in which there is no scientific evidence supporting the claim that the vaccine can caused this harm. This is a very, very big break for petitioners.
The reason for this interpretation is the clear desire of Congress for the compensation scheme to be generous and compensate even cases in doubt. It means that cases where the causal connection is dubious can win. It’s certainly not guaranteed that you will win a case if the evidence for causation is bad. And having clear scientific evidence against causation can lose you a case. But still, it’s a substantial break.
Let me reemphasize that since the program compensates for vaccine injuries, not for every bad thing under the sun, that’s the correct result – the program is supposed to reject things clearly not caused by vaccines. But it is possible to be compensated even in the face of some causation evidence to the contrary under NVICP’s standards.
Further, while a plaintiff in a civil trial would have to foot the costs of experts (though potentially only after the case is done), NVICP covers reasonable expert fees. Since expert witnesses can be very, very expensive, this is a big deal.
There are several other important considerations:
- Proximate Cause/scope of liability: This is not often an issue in vaccine injury cases.
- Damages: The National Vaccine Injury Compensation Program covers most of the damages you could get in the regular courts for the actual vaccine injury. Two heads of damages are capped: non-economic damages, also referred to as pain and suffering. Caps on pain and suffering are increasingly common in some contexts in torts, but the cap here was set in 1986, and it’s probably time to adjust it. And the damages for death are also capped, again at an amount set in 1986, and again, should probably be adjusted.As highlighted in Holmes, while in a state court case relatives could sue for their own damages in addition to the damages of the person directly injured, they cannot sue for those damages in NVICP. 42 U.S.C §300aa–15(d)(2).
- Statute of limitations: as in the civil courts, NVICP has a statute of limitation, using the pretty common period of three years. However, in the regular civil courts the clock of limitations stops for a minor – in other words, the period in which you’re a child doesn’t count against you, and the statute of limitations’ period only starts running when you hit majority, at 18 year old. Like other government programs, NVICP doesn’t do that: it runs the clock of limitations from the first symptom of injury. As I’ve said before, for a program designed to be generous, this isn’t the best choice. Allowing tolling for children or lengthening the period of limitations would be a better choice.
- The Department of Health can choose to concede and settle the case, a decision that is then confirmed by a special master. As with the regular courts, most cases settle – without a need to show causation. If the case is not settled or conceded, the first decision in NVICP is made by a Special Master, a lawyer appointed by the judges of the United States Court of Federal Claims. There is then an appeal to the Judges of the Court of Federal Claims, who are appointed by the President and confirmed by the Senate for a period of fifteen years, with the ability to continue hearing cases for longer.Note that both facts and law can be appealed.The decisions of the Court of Federal Claims can, in turn, be appealed to the federal circuit courts, and from there to the Supreme Court, if the Supreme Court agrees to take the case (to remind readers, the Supreme Court has the discretion to agree or refuse to hear cases). In other words, saying that the existence of NVICP denies petitioners access to regular courts, or saying there is no appeal to our courts of justice, is simply incorrect.
- Length: petitioners complain that the program takes a long time. Three points are important. First, a civil trial in the regular courts can take a very long time, too. Second, in two sources – an AP report and the recent Government Accountability Office (GAO) report – it was highlighted delays are often the result of petitioners not having all the evidence, and the program generously giving them time to get it rather than rejecting an incomplete claim. And third, as highlighted, again, in the GAO report, the program has been working on overcoming a backlog and deciding cases more quickly, with substantial improvements made since 2009.
Constitutionality of the NVICP court
A plaintiff in the United States does not have a right to be compensated in torts for whatever the plaintiff wants. Judicially, courts limit the type of claims that can be compensated in torts through the device of duty of care: some claims do not give rise to liability even if the defendant was negligent. For example, normally you do not have a right to sue if your only harm was emotional; normally, you cannot sue someone for not rescuing you.
There are exceptions to these rules, but the basic principle is clear–it’s legitimate and normal to limit what people can sue for in torts for policy reasons. Just as the courts can do so, so can the democratically elected legislature – state or federal. In California, to give one example among many, liability of landlords to trespassers committing a felony was limited by the legislature (Cal. Civil Code, §847). There’s nothing unconstitutional – or even unusual – in limiting causes of liability. It’s a policy decision.
The National Childhood Vaccine Injury Act does exactly that. It limits the ability to sue in torts for some types of claims for policy reasons. But it does not leave claimants without a remedy, as other limits on liability do–instead, it offers them a no-fault government program where the government undertakes to compensate them with real benefits compared to the court (and with lawyer fees and costs covered even for losing cases).
It’s not only constitutional: it’s fair, even generous. Congress, in passing the act, turned what would have been tort claims against the manufacturer into administrative claims. In legal terms, it creates a public right to compensation against the government. Compensation is no longer provided under tort law, between individuals: it’s the government’s responsibility to pay those injured by vaccines out of the public purse. Public rights are not subject to constitutional guarantees like the right to an article III judge or a right to a jury (Granfinanciera, S.A. v. Nordberg, 492 U.S. 33 (1989) and Stern v. Marshall 564 U.S. ___ (2011)).
Preemption: the heart of Holmes v. Merck
The focus of Holmes v. Merck was on whether the National Vaccine Childhood Injury Act preempts the Holmes’ claims. Preemption means that a federal law prevents state legal action.
The court decided that the answer was yes, rejecting the Holmes’ arguments.
1. One of the Holmes’ main claims was that since the act did not allow them to collect compensation for their own damages through NVICP, it didn’t intend to deprive them from suing in the states courts. The court rejected that based on four arguments:
- The act was clearly designed to apply broadly to any harm caused by vaccine product defects: Congress clearly intended to remove regulating large parts of vaccine safety from the state, and take command of it.
- Allowing the plaintiff to sue for their own damages will undermine the liability protections the act provides and hence the goal of protecting the vaccine supply. To allow these protections to work, preventing disease and protecting adults and children alike, preemption can’t be limited to the child’s own injuries.
- Where a claim can be taken to the state courts after going through NVICP the act creates a special procedure for trying it – but that procedure wouldn’t apply to the parents’ claims, and that doesn’t make sense.
- No court which examined the issue so far distinguished between the child’s injuries and the parents’ claims of harms.
2. The court pointed out that the preemption clause, as interpreted by the Supreme Court in Bruesewitz v. Wyeth, 562 U.S. ___ (2011) (pdf), preempted design defects completely. For warning defects, manufacturers can’t be sued if they complied with regulatory requirements and have given the warning to the healthcare professional, the vaccine recipient, or the vaccine recipient’s legal representative.The court reminded us of the extensive regulatory scheme in place to protect vaccine safety and prevent harms as further support: this heavy regulation is the other side of liability protection. Vaccine safety is taken very seriously by the system; there are other protections to replace the tort liability that has been limited.
Summary or TL;DR version
- In short, National Vaccine Injury Compensation Program is a better forum for those with claims with any merit than the regular courts.
- It is easier to make a claim.
- It costs less to use than regular state or federal courts.
- It is constitutional.
- And yes, it does prevent claims about vaccine injuries in the state courts. But it gives much in return.
Acknowledgements: I am grateful to David Jung, David Levine and Richard Marcus for their comments on the accuracy of the descriptions of the legal process. I’m grateful to Kayla Colburn and Hannah Henry for their extremely useful comments on previous drafts.
Editor’s note – this article was first published in June 2015. This has been updated to include new links, fix broken links, and repair some formatting issues .