The Vaccine Injury Compensation Program: What Does the AP Report Really Show?
Nov 25, 2014

This guest post has been written by Dr. Dorit Reiss, Professor of Law at the University of California Hastings College of  the Law in San Francisco, CA.   Dr. Reiss contributes to various articles, blogs and law journals, utilizing her legal expertise to examine the social policies of immunization.

This post responds to two articles. First, it addresses claims made in an article about the Vaccine Injury Compensation Program (VICP) which was created in 1986 by Congress through the National Childhood Vaccine Injury Compensation Act.  The VICP is a no-fault alternative to the tort system designed to compensate those who claim they were injured by a vaccine.  The article draws on an Associated Press report which claims that the program is causing harm to Americans:  “[a] system intended to speed help to vaccine-injured Americans has instead heaped additional suffering on thousands of families.” This article itself highlights some important problems with the program, though its framing undervalues some of the program’s most important and claimant-friendly benefits – coverage of lawyer fees and lax evidentiary standards.

Worse, however, in an article dated November 18, 2014, The Northwestern used the story of Jeffrey McCord, a young man compensated by the National Vaccine Injury Compensation Program (VICP) to suggest that petitioners to the program are abused by government lawyers. This latter story is much more misleading due to its inherent inaccuracies and lack of evidence-based support to the claim that the system is problematic.  Although there may certainly be things to improve about the program, they are not necessarily the issues highlighted in the article. The title claims that the court “keeps claimants waiting,” however, the reason for the program’s delays are not necessarily the fault of the defendants. In addition, Jeffrey McCord’s case is a poor example of a problem with the system.

I do not have the AP report (though I have recently received, and will address, a report about VICP from the Government Accountability Office, GAO; but AP claims to have their own report). I can therefore only respond to the stories’ depiction of it. I will address each of the criticisms in the report, and then rebut the inaccuracies from the Northwestern story: the problems with the McCord case, and the misuse of cases not compensated for autism.

The AP Reports Points, One By One

Payment of lawyer fees, even for losing cases:

The articles highlights several problems this, allegedly, creates:

1. Filing of meritless claims.
2. Filing of cases without having medical records available (the Northwestern article only).
3. Lawyers taking too many cases, clogging the court

Coverage of lawyer fees and costs is an important part of helping those who suffer  rare cases of vaccine injuries who seek  compensation from the VICP. It’s not something that heaps suffering on families – it’s a benefit offered to petitioners to alleviate costs as a factor when filing suit.   The coverage does extend to claims that lose, as long as they are filed in good faith, which is a benefit to the petitioners. The fact that a petitioner’s belief that it was the vaccine that caused the injury may be denied at the end does not mean the case was inappropriately brought. Congress bars the petitioners from suing manufacturers directly.  Under Bruesewitz v. Wyeth, 131 S.Ct. 1068, 1072 (2011), they cannot sue manufacturers for design defects at all. In exchange, petitioners get a number of breaks – and this is one. Moving away from covering lawyer fees will make things harder for petitioners. If the article’s goal is to improve their lot, that’s not a good way to go.

The article does, however, highlight misuse of the availability of lawyer fees by petitioners’ lawyers. That merits some thinking. One way to handle this is to tighten the criteria and, for example, not award lawyer fees for a case filed with no medical records, which never results in the provision of those records. Or for other clearly meritless cases. I In a sense, this penalizes the families, not the lawyer –  a family with a disabled child should not incur the financial costs for a lawyer simply because their case should not have been filed, something a lawyer should disclose from the outset. On the other hand, professional malpractice suits against lawyers are available to such families. Those are not easy to win, but can offer some remedy.

Similarly, the article mentions that the court does not discipline abusing lawyers. Perhaps it should.

Every time a system is put in place, it can be abused. But doing away with lawyer fees would have serious costs for petitioners and go against the program’s goal of generous compensation.

The article highlights quality problems in the petitioners’ experts and ends with a line that “doctors hired by the government to defend vaccine safety in court have ties to the pharmaceutical industry.”

NVICP is an administrative program, and is not subject to the federal rules of evidence, or to state rules of evidence. One example of this is not holding scientific evidence or expert testimony to the standards set in the Daubert trilogy (Daubert v. Merrel Dow Pharmaceuticals, Inc., 509 U.S. 579, 593 (1993); The special masters may use Daubert standards for experts, but are not required to do so Terran v. Secretary of Health and Human Services, 195 F.3d 1302, 1316 (1999), which requires judges to assess scientific evidence – including expert testimony – for reliability and validity and exclude such evidence if unreliable). That may have encouraged petitioner lawyers to be less careful in their choice of experts. Some of the experts, over the years, were justifiably criticized by the court for their lack of expertise. For example, Mark Geier was criticized by the court multiple times, as summarized in King v. Secretary of Health and Human Service, 2010 WL 5470787 (2010) (and see also Masias v. Sec’y of Health and Human Services, 2009 WL 1838979 (2013), 39). But raising the standard on allowing expert witnesses also comes with a cost. It may make it harder and more expensive for petitioners to bring their case at all. To prove medical causation in the regular courts, plaintiffs have to provide expert testimony. VICP is no different, and to prove causation, an expert witness is generally necessary. Making it harder for petitioners to find an expert may result in reduced access.

Of course, the other side of this is that the use of an unreliable expert is problematic, too. From the petitioners’ point of view, a clearly unreliable expert can lose their case, unless the program is really willing to relax its standards (and some NVICP decisions suggest such a relaxation). As pointed out by the special master, for example for the Geiers, “There appears to be little dispute that a petitioner should not retain Dr. Geier now. His qualifications and his opinions have been questioned so often that a reasonable petitioner would be better served by seeking the opinion of someone else.” Masias, id, p. 39. In that case the VICP denied covering Dr. Geier’s expert fees.

From society’s point of view, discredited experts can lead to erroneous decisions if their claims are accepted and wasted resources if their claims cannot support a case. Inquisitorial systems may handle this by having a court-appointed expert, rather than have the parties present their own expert, but that is foreign to our adjudicatory system (though to some degree, agency experts are used, for example, in social security – however that, too, has been criticized).

The writers claim that the government’s experts have “ties to the pharmaceutical industry.” That is an extremely vague and unhelpful statement, and its relevance here is even less certain. Many serious researchers in an area that has to do with pharmaceutical products – if not all – will have some such ties: they would have published an article that used a grant from a pharmaceutical company at some point, consulted on a product or clinical trial, and so forth. That’s not a good indication of a problem if the expert does not have a conflict of interest that is relevant to the case. Furthermore, NVICP cases are not against the manufacturers, they are brought against the Department of Health and Human Services. The manufacturers are in fact protected from liability, at least in relation to design defects.  Compensation is awarded through the VICP trust fund to winning claimants.  What, then, is the relevance of these vaguely defined ties to manufacturers?

Government Fights Legitimate Claims: 

This is a place where seeing the report would make a big difference. The fact that a claim won does not mean it was illegitimate for the government to contest it. The program is an adjudicatory program aimed at compensating injuries caused by vaccines. If the government thinks an injury was not caused by the vaccine, it’s probably its job to say so. The fact that a Special Master – or a Court of Appeals – sees it differently does not mean the government was wrong to contest the case. That requires evidence.

Delays: 

The AP articles highlight that most cases do not meet the 240 days deadline. A recent GAO report confirmed this (GAO, Report to the Chairman, Committee on Oversight and Government Reform, House of Representatives “Vaccine Injury Compensation Most Claims Took Multiple Years and Many Were Settled through Negotiation, November 2014, GAO-15-142). The report highlights that a main reason many cases are delayed is due to the time it takes petitioners to gather evidence to support their claims. The Northwestern article suggests – rightly or wrongly – that part of the problem lies with petitioners’ lawyers: if they file cases without complete medical records, delays while the details of the case are put together are almost inevitable.

The McCord case cited in the article reaffirms that (Toomey v. Sec’y of Health and Human Services, No. 98-643V). The case, while carefully avoiding directly accusing the lawyer or the petitioner in that case, says that

In many cases, the primary delay in resolving the damages issue is petitioner’s failure to file its Life Care Plan in a timely manner. Aggravating the delay is the discovery that petitioner failed to file the information required by this Order, infra, in support of the compensation requested, such as medical and school records, medical insurance information, and provider information.

There can be many legitimate reasons for petitioners taking time to get the information. But accusing the system for delays caused by the petitioners’ delay in finding evidence or by their lawyers’ failure to act in timely manner is problematic. Describing delays caused by petitioners or their lawyers as part of what is heaping “additional suffering on thousands of families” is unfair. The program’s willingness to give the petitioners time to gather evidence and develop their case is an attempt to help petitioners, not hinder them. It would hardly be in petitioners’ interests if the program simply dismissed incomplete cases, or cases not completed within a reasonable time, for lack of evidence. And without evidence of causation, an adjudicative system should not compensate cases.

As mentioned above, if the issue is abuse by the lawyers, perhaps the program should be more proactive in filing disciplinary complaints against abusing lawyers.

Causation:

The Northwestern article states that “In 2005, a higher court ruled it had become too hard to show that a vaccine “more likely than not” caused the injury. Winning compensation became easier.” The article is most likely referring to the Althen case: Althen v. Secretary of Health and Human Services, 418 F.3d 1274, 1278 (2005). But that is not a good depiction of what Althen did.   Althen interpreted the National Childhood Vaccine Injury Act to apply a more lax standard of causation to vaccine injury cases than to regular cases – in a way that would allow more claims with no scientific evidence behind them to win. In regular cases where the question is whether a product or drug (or other substance – for example, in a toxic tort case, where the claim is that some kind of pollution caused, for example, cancer), proving causation has two parts. The plaintiff has to prove that the substance or product in question can cause the injury in question, using scientific evidence, usually studies of some sort – that is known as “general causation”. The plaintiff also needs to prove that the substance or product caused their own injury – what is known as “scientific causation.” In Althen, the court interpreted the statute to allow a finding of causation if three things are provided: (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 (p. 1278).” Basically, the court removed the requirement of general causation: petitioners no longer have to show that there is scientific evidence supporting a causal connection. If there is a theory that sounds probable to the Special Masters – lawyers, not scientists – and a temporal connection, a case may win even absent scientific support. Of course, defendants can bring countering scientific evidence, as was done in the Omnibus Autism Proceeding, that will lead to a rejection of the petitioner’s claim . But it is a very real relaxation of the petitioners’ burden to prove their case, allowing them to win, on occasion, with just a theory supported by one expert. This would not happen in civil court. It may fit Congress’ intent that doubts should be resolved in favor of the petitioner. It does, however, mean that cases where its unlikely it was the vaccine that caused the harm are compensated or settled.

Jeffrey McCord’s Case:

The Northwestern article opens its discussion with a discussion of Jeffrey McCord’s case, presenting it as an example of excessive delay and the government fighting cases. But the McCord’s case is anything but a clear cut case, for a number of reasons. The case itself was a battle of experts on several issues. Let me highlight two of them:

1. What was the injury? The government expert suggested it was a seizure disorder – which is not, according to the evidence, caused by the DPT vaccine. The petitioners’ expert described it as an encephalopathy, which the experts agreed can be caused by the vaccine (and since an encephalopathy is still a table injury, it was natural for the court to accept that; though the evidence for an association between the DTP vaccine and encephalopathy is weak at best, and there is evidence to the contrary).
2. When did the seizures start? The government expert suggested, based on the records, that they started four days before the vaccine. The petitioner’s expert suggested they started immediately after.

The court gave extra weight to the petitioner’s experts, since he was also the physician treating the child. But the court pointed out: “This is a close case involving a complex medical picture. However, in the final analysis and based upon Dr. Shafrir’s convincing testimony, the undersigned finds that petitioner has thus met her burden by meeting all three prongs of Althen and successfully rebutting respondent’s arguments.”  In other words, this was anything but a clear-cut case. When there is evidence on both sides, as here, it is appropriate for the government to contest the claim. As for the length of time, as quoted above, at least part was due to delays on the part of the petitioner – or her lawyer – in getting together the life care plan. It’s unclear what happened earlier, but if the government had serious doubts about causation, it’s not surprising that they resisted the petitioner’s case.

In other words, as an example of abuse, this complex, problematic case is not a good one.

In short, the AP report and the Northwestern report make claims about systematic problems with NVICP, but their claims are problematic in many ways, and go against the evidence.

A different and more careful analysis is the Government Accountability Office’s new report titled “Vaccine Injury Compensation” from November 2014. That report covered some of the same ground, but addressed other issues as well, and more in depth. For example, the length of time it takes for a complaint to be resolved, but did so in a more nuanced way, highlighting that the time for process has improved since 2009, and highlighting some of the causes, including the time it takes petitioners to prepare their case, the statutory limit on the number of special masters, and the increase in off table cases. It also addressed other issues, like the changes to the Table of Injuries and the program’s lack of visibility.

Unlike the AP articles, the report did not conclude that the program is causing additional suffering to families. Instead, it highlighted areas that may be seen as needing improvement, highlighted what the Department of Health and Human Services is doing to improve those areas, and provided extensive data about the program – a much more objective and accurate analysis. It is unfortunate the Associated Press did not follow this more careful approach.

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