Home > Policy > The Vaccine Injury Compensation Program: What Does the AP Report Really Show?

The Vaccine Injury Compensation Program: What Does the AP Report Really Show?

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.

Side-Nav-one-third-VICPThis 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.

  1. November 25, 2014 at 2:46 pm

    Reblogged this on Jessica A Bruno (waybeyondfedup).

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  2. Lawrence
    November 25, 2014 at 3:23 pm

    The Vaccine Court is still a court, which requires the hearing of evidence. Those rules, as have been pointed out many times before & in the article above, are much more lax than what would be found in a Civil Court (in which just about any anti-vaccine “expert” would be invalidated by the rules governing expert witnesses) and the overall process is still significantly shorter than what would be experienced in any other Court.

    At the end of the day, while it may be an imperfect system, it is still a system that is substantially better than the alternative, both for the individuals involved and society in general.

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  3. November 25, 2014 at 4:32 pm

    Where is the original AP report? What expertise do the 3 AP writers have in legal matters, or background on the Vaccine court?

    Troy Thibodeaux is referred to as “AP’s top data guru”
    Justin Pritchard is now the transportation reporter for AP’s LA bureau (he previously was a national Investigative Reporter)
    Mitch Weiss is a correspondent with years of broad experience, but nothing specifically on vaccines or legal matters.

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  4. Brian Deer
    November 25, 2014 at 5:00 pm

    The recent case in the English court of protection, in which a vaccine litigant and campaigner was found to have lied over her son’s purported vaccine injury highlights the difficulty when lawyers are paid regardless of the merit of the case. In her case, her lawyers clearly had access to the incriminating records, but nevertheless filed in court.

    http://briandeer.com/solved/mother-lied-protection-news.htm

    Like the MMR omnibus case, the UK multiparty lawsuit which came before it suffered from the same blight of lawyers and experts take all.

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  5. December 11, 2014 at 7:21 pm

    Dorit Reiss has a history of glossing over vaccine safety issues so her approach taken here in commenting on a new GAO report [1,2] on the National Vaccine Injury Compensation program (NVICP) is not surprising. In the past she has used terms like “plaintiff-friendly”, “reduced causation standards” and “relaxed evidence rules” to characterize this program. [3] I would argue that no one who is actually familiar with this program, or has personally talked with anyone who has had the misfortune to endure it, would consider Dorit Reiss a credible source after reading these comments.

    I postulate here that Dorit’s conclusions regarding the NVICP are pre-ordained. I do not believe for a second that she had any intention of actually investigating the NVICP or reporting fairly on the GAO report. Why do I say that? Consider the following. She is commenting on a GAO report, and she includes the link to the report’s summary in her article, in which she claims:

    “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. […] 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.” [4]

    As is always the case with Dorit Reiss, it is not necessarily what she says that is most important, but what she leaves out. In this case, she neglects to mention the following (which comes from the SUMMARY PAGE OF THE REPORT SHE IS COMMENTING ON):

    “Since fiscal year 1999, HHS has added six vaccines to the vaccine injury table, but it has not added covered injuries associated with these vaccines to the table. This means that while individuals may file VICP claims for these vaccines, each petitioner must demonstrate that the vaccine that was administered caused the alleged injury. HHS is considering adding covered injuries associated with these vaccines; but as of September 2014, it had not published any final rules to do so.”

    Did you catch that?

    The NVICP has a list of “Table Injuries” which is essentially a list of injuries for which HHS will presume causation, for each vaccine recommended by the Advisory Committee for Immunization Practices (ACIP). Don’t you think it would be important to mention that HHS has neglected (I use that word very much on purpose) to add any new injuries to the table for ALL vaccines added since 1999? For the record, that is 15 years ago and in that time SIX new vaccines, most in multiple doses, have been added to the schedule.

    In our online conversation Dorit claims that for “regular” (off-table) injuries “the requirement of general causation is basically waived”. [3] But this is not consistent with the following from the very GAO report she is supposedly commenting on: “Individuals seeking compensation may submit claims for injuries not listed on the table (called off-table injuries) but they need to demonstrate by the preponderance of the evidence that the vaccine caused the alleged injury.”

    Did you catch that?

    Dorit portrays the NVICP as no-fault with relaxed standards of causation even for injuries not covered by the injury table, but this is not the case. For any injuries related to the last SIX vaccines added to the recommended list, plaintiffs are required to demonstrate causation.

    In addition, there are two glaring problems I see with the GAO’s report, and it does not surprise me one bit that Dorit fails to mention either of them. First, in the summary page under the heading “What GAO Found” [1], the text includes some quite flattering statements like: “In all but 1 year since fiscal year 2009, the program has met the target for the average time to adjudicate claims (about 3.5 years)”. Now doesn’t that sound like a tortured attempt to find something positive to say? And by the way, doesn’t 3.5 years seem like an awful long time to compensate families of children who have died or were permanently disabled and require lifelong medical care?. But please go to the link for the summary [1] and look at the pie chart…the first thing that jumps out at you is that over half of all claims filed since 1999 have taken LONGER THAN 5 YEARS to adjudicate. That would seem like it merits reporting, either in the text of the GAO report or by the likes of Dorit Reiss.

    My second problem with the GAO report involves the following two statements contained therein:

    “Since fiscal year 1999, HHS has added six vaccines to the vaccine injury table, but it has not added covered injuries associated with these vaccines to the table.” [1]

    “HHS has authority to promulgate rules to modify the vaccine injury table when certain criteria are met. HHS is also required to amend the table to include a vaccine within 2 years of the Centers for Disease Control and Prevention’s recommending it for routine administration to children.” [2]

    I mentioned earlier that six vaccines have been added to the Table since 1999, but no injuries associated with those vaccines have been added. I would argue that having a requirement that HHS add a new vaccine to the Table within 2 years of being recommended by ACIP, but not requiring that any associated injuries be added as well, is absolutely meaningless. It’s like a Speed Limit sign with no numbers on it. For all vaccines being recommended in the past 15 years, the NVICP no longer has reduced standards of causation, there is no presumed causation and the plaintiffs are instead required to prove causation. This requires expert testimony and can be very expensive.

    Dorit Reiss is critical of a report from the AP [5] which claims that claimants are kept waiting by the NVICP. Perhaps if she actually interviewed folks who have been through the program, or looked at case reports, she would have a different understanding of the problems inherent to this program. Instead, she relies on…well…honestly we can’t be sure what she relies on because as usual she does not reference the basis for any of her claims.

    For example, while discussing a specific NVICP case highlighted in a Northwestern article which also discusses the AP report [6], she claims very matter-of-factly that seizures are not caused by DPT vaccine, but she admits that encephalophy can be caused by the DPT vaccine. See this is the sort of tortured logic that one has to endure when reading anything from Dorit Reiss. Why? Because seizures are one of the symptoms of encephalophy: “Encephalitis generally begins with fever and headache. The symptoms rapidly worsen, and there may be seizures (fits), confusion, drowsiness and loss of consciousness, and even coma.” [7]

    This is sheer brilliance right! Because a vaccine can cause encephalophy, but the encephalophy itself is what caused the seizures, the vaccine is not what caused the seizures. HHS and the CDC uses the same ridiculous logic to deny that any claims have been awarded for cases of autism.

    I guess it would have been easier for me to refer to the NVICP Injury Table itself and simply point out that encephalophy is listed as a “table injury” for DPT vaccine, and note that MRI scans showed brain damage following the vaccine and this suggests some form of encephalophy when seizures are involved.

    In my online conversation with Dorit Reiss about the NVICP I had pointed out that the GAO report was critical of the NVICP in a number of ways. She denied this and asked me to please point out the criticisms. They are quite easy to find in the GAO report, as they are in fact the section sub-headings:

    – Most Claims Filed Since Fiscal Year 1999 Have Taken Multiple Years to Adjudicate [over half have taken more than 5 years]
    – Vaccines Have Been Added to the Vaccine Injury Table since Fiscal Year 1999 without Covered Injuries, Resulting in More Off-Table Claims
    – Changes in the Vaccine Injury Table Contributed to More Claims for Off-Table Injuries and for Injuries in Adults
    – Information on VICP Petitioner Experience Is Limited

    I would argue that this last criticism is perhaps the most significant. For their report on the NVICP the AP conducted over 100 interviews of petitioners to learn about their experiences with this program. Perhaps that is why their report was so critical of the program. Even the GAO report was critical of the NVICP, although it was limited to considering institutional problems rather than the experiences of the petitioners themselves.

    Perhaps it would be a good start if all of us, myself included, could stop calling these people “petitioners”, and remember that those entering the NVICP are families that have either lost or must now care for a loved one after possibly suffering a severe adverse vaccine reaction in service to the “Greater Good”.

    David Foster

    [1] GAO Report (summary): http://www.gao.gov/products/GAO-15-142
    [2] GAO Report (full): http://www.gao.gov/assets/670/667136.pdf
    [3] Comments section of Interlochen Public Radio article “Whooping cough outbreak sparks vaccination debate”
    http://interlochenpublicradio.org/post/whooping-cough-outbreak-sparks-vaccination-debate#comment-1732826133
    [4] The Vaccine Injury Compensation Program: What Does the AP Report Really Show? -Dorit Reiss
    https://shotofprevention.com/2014/11/25/the-vaccine-injury-compensation-program-what-does-the-ap-report-really-show/
    [5] AP IMPACT: ‘Vaccine court’ keeps claimants waiting
    http://news.yahoo.com/ap-impact-vaccine-court-keeps-claimants-waiting-183827288–finance.html
    [6] AP IMPACT: ‘Vaccine court’ keeps claimants waiting
    http://www.thenorthwestern.com/story/news/2014/11/17/vaccine-court/19146311/
    [7] What is encephalitis? What causes encephalitis?
    http://www.medicalnewstoday.com/articles/168997.php
    [8] NVICP Vaccine Injury Table
    http://www.hrsa.gov/vaccinecompensation/vaccinetable.html

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  6. December 13, 2014 at 2:24 am

    I posted a rather comprehensive comment on Dorit Reiss’ article, and pointed out some critical problems with the logic she uses on topics she covered, as well as pointing out some very important points she failed to address.

    Can someone please tell me why those were not allowed? What code of conduct did I break, besides possibly disagreeing with you?

    Like

  7. Lawrence
    December 13, 2014 at 10:04 am

    @DF – too many links will do it, as will certain language get you in automatic moderation…..

    Like

  8. Christine Vara
    December 13, 2014 at 11:21 am

    David, It appears that your comment had been moved to our “spam” folder, most likely because of the length and number of links. While we encourage dialogue on this forum, we ask that you keep your comments brief.

    Like

  9. reissd
    December 13, 2014 at 11:42 am

    @ David Foster:

    I think your comment is on the wrong post. I will, however, answer it here, as well.

    Like

  10. reissd
    December 13, 2014 at 11:43 am

    @ David Foster:
    I can completely see why someone whose main source of information about NVICP are parents in the anti-vaccine community – and especially parents claiming their children’s autism was caused by vaccines, and hence facing a frustrating process in which they simply cannot prove their case, since the evidence is against them – will see NVICP in such a bad light. Especially someone who lacks knowledge of our civil justice system or administrative adjudication system, which would allow a realistic assessment of what can be expected from an adjudicatory system – even one designed to be more friendly to the user, as NVICP – in spite of your views – was.
    However, you are incorrect. When I call NVICP plaintiff friendly, I base it on attributes that make it a lot easier to navigate than our civil justice courts – and that’s the simple truth.
    When I point out that its standards of causation are relaxed compared to our courts of justice, I am not referring to Table Injuries – although in relation to those, of course, petitioners get a very big break – but to off-table injuries, handled under the much more lenient Alten standard – not in the way regular civil cases will be handled.
    When I point out that the evidence standard are relaxed, it’s again correct: the usual rules limiting which evidence can be brought into a court are relaxed in the case of NVICP. Petitioners can use experts and make claims that will simply be kicked out of a court – for example, special masters are not required to apply the Daubert standard, which required that courts assess the scientific reliability of evidence before letting it in, and such a standard is routinely waived.
    The rest of your comments are just as problematic. Partly, of course, it’s because of lack of legal expertise. But not solely, and the nature of the comments, showing such a clear bias, make the claims of bias on my part more than a little ironic.
    For reader’s convenience, I will break this into several comments.

    A. Table Injuries and general causation:
    Mr. Foster complains about the fact that some of the vaccines added do not have table injuries. The Table of Injuries was created to simplify the process in relation to problems that we have scientific evidence that shows vaccines can cause them: for those, causation is presumed. When the program was formed, the vaccines on the market had a body of studies behind them. That could be used to create the Table. As new vaccines were added to the schedule, they were added to NVICP immediately – but for new vaccines, there was no such body of studies. It’s hardly surprising that no injuries were added to the Table when there was no evidence of specific problems associated with those vaccines: there was the experience of clinical trials, but since most serious problems with vaccines are extremely rare, and clinical trials are limited to thousands or tens of thousands of people, there were no known problems.
    For some of these vaccines, there still aren’t – for example, the Hepatitis A vaccine. For others, HRSA created a rule about intussusception for rotavirus and said it is looking at others.
    From my point of view, it’s natural and unsurprising that it took time.
    As for general causation, Mr. Foster seems to misunderstand the term, when he claim that by not addressing the reduction in claims that are off-table injuries I misrepresented the issue. The requirement of general causation would not be relevant to Table Injuries: it would be presumed. It’s off-table injuries where it matters. In the regular courts, a plaintiff claiming injury from a substance or drug or something of that kind would have to show with expert testimony and evidence that science shows this kind of problems is caused by the substance or drug. This is done by general studies. The courts prefer epidemiological studies, where possible, and usually you’d have to show the problem was twice as common in those exposed to the drug or substance.
    This requirement is waived for NVICP petitioners. They can just bring expert testimony hypothesizing about the connection. If credible – and absent evidence to the contrary – that would be enough. That is a tremendous break for petitioners in off-table injuries.
    B. Delays: actually, for a complex medical case, 3.5 years is not a long time. But Mr. Foster ignores what both the GAO report and the AP report mentioned about a primary reason for the delay: delays in submitting complete records and evidence from the petitioners. The NVICP could be stricter and kick out incomplete cases, where the petitioners did not submit full evidence. Instead, it seems willing to wait till the case is complete. That’s hardly against the petitioners.

    C. DTP and encephalopathy: Mr. Foster misunderstood my comment. I said: ” 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).”
    https://shotofprevention.com/20
    Encephalopathy may be associated with seizures, but seizure disorder is a separate claim, and that claim has been removed from the Table of Injuries as evidence mounted that it is not caused by the DTP vaccine. The evidence is that the vaccine does not cause encephalopathy, either, but that is still on the table. So, if the NVICP made a finding of encephalopathy, in spite of the fact that it’s not, according to the evidence the vaccine does not cause it, the program would compensate.

    D. Criticisms of the program in the GAO report: Mr. Foster seems to confuse highlighting facts and description with criticism. The report did not, for example, accuse NVICP of any wrongdoing in terms of the length of proceedings or suggest correction – in fact the report highlighted the improvements made. Similarly, the report pointed to limited data on petitioner experience – but did not accuse HRSA of wrongdoing in that. What it said was:

    “HRSA has taken some steps to undertake outreach activities, but the agency has not yet assessed the effect of these efforts.” [p. 29: http://www.gao.gov/assets/670/667136.pdf%5D Quite the opposite from criticism, the report is highlighting that the program is working on this and did things.

    For comparison, when GAO is actually critical of a program, it says so directly – and highlights recommendations from change. Both things are missing here. Here is an example: http://www.gao.gov/products/GAO-09-1014T

    “GAO has reviewed federal oil and gas management and revenue collection and found many material weaknesses. This testimony is based primarily on key findings from past GAO reports and some preliminary findings from ongoing work. These findings focus on Interior’s: (1) policies for oil and gas leasing, (2) oversight of oil and gas production, (3) royalty regime and policies to boost oil and gas development, (4) oil and gas information technology (IT) systems, and (5) royalty-in-kind program. GAO’s past reports provided recommendations that Interior officials report that they are working to implement.”

    GAO’s numerous evaluations of federal oil and gas management have identified five key areas where Interior could provide greater oversight..”

    Like

  11. Lawrence
    December 13, 2014 at 11:46 am

    @David – to address a couple of your points….table injuries shouldn’t just be added willy-nilly, without any sort of evidence (or biological plausibility) & while new vaccines have been added to the pediatric schedule, the “injuries” that people have claimed may have occurred hasn’t been backed up by even biological plausibility at this point.

    Add to that, your claim that the “time” is too long for compensation to occur – how does 3.5 years compare to what would be available via Civil Court proceedings? I know that those can take decades to decide, so in comparison, the NVICP is almost a blink of an eye compared to what most people who try to get compensation for something (even a car accident, for instance).

    Since anti-vax folks are now blaming anything and everything on vaccines, I can see how that would create an “off-table” issue and actually make the process that much harder on the Court (and extend lead times as well)…..but for actual table injuries, which are recognized and compensated for without the longer process, it does work well.

    Again, the muddying of the waters, because “vaccines are evil” isn’t helping anyone.

    Like

  12. reissd
    December 13, 2014 at 12:10 pm

    @David Foster: By saying it’s on the wrong post I meant that I think you intended to post it on the post about the GAO report. I may be wrong, of course, and at any rate, the comment is not intended as an insult.

    Like

  13. jgc56
    December 13, 2014 at 6:06 pm

    ” I would argue that no one who is actually familiar with this program, or has personally talked with anyone who has had the misfortune to endure it, would consider Dorit Reiss a credible source after reading these comments.”

    You would be wrong then, wouldn’t you?

    Like

  14. Lindsay
    December 13, 2014 at 9:07 pm

    I think one problem is that the table injuries that the Vaccine Court admits that vaccines may cause was compiled decades ago, before many people had ever heard of autism and at a time when even experts believed that all vaccine injuries would manifest almost immediately. No one wants to touch the question of what to do now that everyone recognizes that vaccines can cause autism, usually over an extended period of time, because admitting it would bankrupt the country and destroy public confidence in the vaccine program.

    Like

  15. reissd
    December 13, 2014 at 9:23 pm

    @Lindsay: The table of injuries is supposed to include injuries that the scientific evidence It’s reflects what was, at the time, known about what vaccines cause. Since the science does not support the claim that vaccines cause autism, and the scientific consensus is that there is no link, it’s pretty clear autism should not be included in it. Here is a list of studies on the topic: http://www.autismsciencefoundation.org/autismandvaccines.html

    The Table of Injuries should be updated periodically, of course. For example, since the evidence shows that the DTP vaccine does not cause encephalopathy, encephalopathy should not be a table injury for DTP. And when there’s new evidence that vaccines cause an injury, that should be added. But that is not a good reason to add injuries for which there is no such evidence – or where the evidence goes the other way, like for autism.

    Like

  16. Lindsay
    December 16, 2014 at 2:20 pm

    Thanks, David, superb comment (now published as an article on —)! This is what it is crucial that the public know!

    Like

  17. Lindsay
    December 16, 2014 at 2:34 pm

    And no, Dorit, the lack of the addition of any further “table injuries” for all the new vaccines added in the last twenty years is not for lack of new injuries, but terror at the idea of having to compensate all the parents whose children are injured or killed by them. The preponderance of the evidence has always shown, over the last seventy or eighty years, that the pertussis vaccine often causes encephalopathy, which can cause encephalitis, seizures, autism, ADHD, and leaning or behavioral disability. That’s what brain damage can do. The acellular pertussis vaccine may cause fewer mild reactions, but unfortunately causes just as many severe reactions as the old whole-cell version did (although it’s a lot less effective).

    Like

  18. reissd
    December 16, 2014 at 2:41 pm

    A. Please provide scientific evidence from more than 10 years ago that an new vaccine added to the table is associated with an injury that has not been added.

    B. No, actually. The increasing evidence has been that DTP is not associated with encephalopathy. Encephalopathy is actually still not he table – but it shouldn’t be.

    C. No vaccine is associate with ADHD, seizure disorder – several are associated with febrile seizures, which are generally harmless – or autism. If vaccines cause encephalitis, and there’s no good evidence on that, it’s extremely rare.

    D. Please provide credible evidence that DTaP does, in fact, cause encephalopathy or “many” severe reactions.

    Like

  19. reissd
    December 16, 2014 at 2:41 pm

    The evidence is, in fact, that serious problems from any of the modern vaccines are very rare (though not non-existent): http://pediatrics.aappublications.org/content/early/2014/06/26/peds.2014-1079.abstract

    Like

  20. Lindsay
    December 16, 2014 at 3:31 pm

    The interested reader can easily google the pertussis vaccine’s history in both its forms of causing the conditions I mentioned, and can also google you to ascertain your credibility, and I encourage him to do so, for the life of his children.

    Like

  21. reissd
    December 16, 2014 at 3:38 pm

    I note your lack of evidence.

    The interested reader can, of course, google anything, but I’ve no doubt most readers realize that google brings up non-credible articles as well as credible ones. They can also read the history in Dr. Offit’s Deadly Choices: One study, by Miller’s group, suggested a connection between DTP and brain injury very rarely – at the rate of 1:300,000. Large scale studies that followed were unable to replicate that link. In a judicial proceeding in England it turned out Miller and his group, worried about missing anything, conducted a study that was biased in a way that found a connection although the evidence – the many studies that followed – is that there is none.

    If there is any evidence about harms from DTaP – or my credibility – you are willing to post here and submit to scrutiny, do so. If not, readers probably realize that a call to google suggests that, knowing your sources cannot withstand scrutiny, you hope that sending them to google will lead to some of them falling for non-credible sources.

    Like

  22. Lawrence
    December 16, 2014 at 4:13 pm

    @Lindsay – I’d rather people actually do research, as opposed to attending the “University of Google.”

    Like

  23. novalox
    December 16, 2014 at 4:55 pm

    @lindsay

    [citation needed] within 3 posts, or we can assume that you are lying and admit that the pertussis vaccine is safe and effective.

    Like

  24. Lindsay
    December 16, 2014 at 5:41 pm

    The link to the Pediatrics article in Dorit’s comment above made at 2:41 today is, David observed, from authors all but one of whom are from RAND. Vested interests, anyone?

    Like

  25. Lawrence
    December 16, 2014 at 5:57 pm

    @lindsay – RAND is a consulting firm, what is their “vested interest?”

    Be specific, not just spinning some conspiracy.

    Like

  26. Lindsay
    December 16, 2014 at 6:13 pm

    One of many articles about the dangers of the pertussis vaccine. Dorit, you read this last week, do you not remember it?

    http://vran.org/about-vaccines/specific-vaccines/diphtheria-tetanus-pertussis-hib-vaccine/a-not-so-perfect-vaccine/

    One of many interesting things it says is that encephalopathy as a table injury after the pertussis vaccine is only allowed to happen within three days of the shot, when the CDC itself says that the vaccine encephalopathy can occur within seven days after the shot.

    Like

  27. December 16, 2014 at 6:30 pm

    @lindsay – how about not quoting from a notorious anti-vax website or from an author who believes vaccines cause “shaken baby syndrome…”

    Like

  28. Stewart
    December 16, 2014 at 7:01 pm

    Hello Lindsay, thanks for the article. I appreciate seeing both sides.

    Like

  29. Chris
    December 16, 2014 at 7:56 pm

    reissd: “If there is any evidence about harms from DTaP – or my credibility – you are willing to post here and submit to scrutiny, do so. If not, readers probably realize that a call to google suggests that, knowing your sources cannot withstand scrutiny, you hope that sending them to google will lead to some of them falling for non-credible sources.”

    What would be nice is if someone posted the PubMed indexed studies by reputable qualified researchers that the DTaP vaccine causes more harm than diphtheria, tetanus or pertussis.

    Like

  30. Lindsay
    December 16, 2014 at 9:12 pm

    Thanks, Stewart, here’s another one.
    http://vactruth.com/2013/07/24/brain-damage-death-vaccines/

    Like

  31. Gray Falcon
    December 16, 2014 at 9:32 pm

    Lindsay, anyone can make a website. The Flat Earth Society has a website. What we need its evidence.

    Like

  32. Chris
    December 16, 2014 at 10:04 pm

    Lindsay, that is not a PubMed indexed study by a reputable qualified researcher.

    Strike one, you have two to go.

    Like

  33. reissd
    December 17, 2014 at 12:11 am

    These two articles from anti-vaccine sites are excellent example why these kinds of sites are not reliable: they are simply full of gross inaccuracies. The need to use such bad sources is also evidence of the lack of credible scientific evidence behind the claims of harms from the pertussis-containing vaccines.

    A. Yazbak’s claims – yes, I have seen the article, and pointed out the blatant inaccuracies. Some include: ,
    1. Relying on Miller’s study and ignoring the many studies that could not replicate it afterwards;

    2. using articles focusing on temporal association for death, ignoring – to give one example – the dramatic decline in infant mortality since the introduction of the DTP vaccine. Mind you, I’m not saying the vaccine cause the decline – but that, and the fact that the vaccinated have less SIDS (http://www.ncbi.nlm.nih.gov/pubmed/17400342) is powerful evidence against a link to SIDS.

    3. Misrepresenting the Japanese experience: a. SIDS deaths did not stop after Japan withdrew the pertussis vaccine: they rose from 1975-1993: Funayama M., et al. “Autopsy cases of sudden unexpected infant deaths examined at the Tokyo medical examiner’s office, 1964-1993” Am J Forensic Med Pathol. 1996;17(1):32-7. Since SIDS refers to infants, it’s not surprising that, as Yazbak points out, there were no claims for infant deaths while they didn’t vaccinate under 2: deaths after 2 aren’t infant death. It certainly isn’t evidence infants didn’t die: as the article shows, they did.

    Like

  34. reissd
    December 17, 2014 at 12:22 am

    B. The VacTruth article is, again, grossly inaccurate. Some points:

    1. Getting pertussis naturally does not provide life long immunity.

    2. Their sources for harms include, again, the Miller study, completely ignoring the fact that many later studies couldn’t replicate it.

    3. The other sources are a number of reports by NVIC – not a scientific organization, and known for its inaccuracies: http://nvichonestly.wordpress.com; for example, they too ignore any studies that showed Miller wrong and makes claims the vaccine causes harm with no real evidence that it causes brain damage.

    4. The article uses VAERS reports as evidence of harms – ignoring the fact that VAERS reports don’t show causation: all they show is that someone submitted a report claiming something happened after a vaccine. http://www.harpocratesspeaks.com/2013/11/vaers-few-things-we-need-to-discuss.html

    5. The article uses the number of cases from NVICP as evidence of harm – but to remind you, at the point of creation of NVICP, when encephalopathy from DTP was added to the table of injuries, we did not yet have the many studies on the issue. While encephalopathy is still on the table, of course there will be compensation – there’s a presumption of causation. Since initially seizure disorder was on the table, since removed as the evidence against it mounted, there was compensation for that too.

    We really should update the Table of Injuries to reflect the evidence that DTP and DTaP do not cause encephalopathy. But that’s beyond the point.

    DTP had a bad rep in the 1980s – but the data now doesn’t support the claims against it, and there is no real evidence of serious harms from DTaP – which is why these articles had to rely on such problematic sources, without providing full information about them.

    And again, these inaccurate article are good examples why anti-vaccine sites are not a source of credible information.

    So, again, do you have any credible evidence of many harms from DTaP, as you claimed?

    Like

  35. Chris
    December 17, 2014 at 12:37 am

    Woot! I actually have a couple of PubMed links to support reissd’s comments!

    First: “Misrepresenting the Japanese experience”

    Expert Rev Vaccines. 2005 Apr;4(2):173-84.
    Acellular pertussis vaccines in Japan: past, present and future.

    After two infants died within 24 h of the vaccination from 1974 to 1975, the Japanese government temporarily suspended vaccinations. Subsequently, the public and the government witnessed the re-emergence of whooping cough, with 41 deaths in 1979.

    Then the “1. Getting pertussis naturally does not provide life long immunity.”

    This shows that even getting pertussis does confer permanent immunity, it can wane in just five years:
    Pediatr Infect Dis J. 2005 May;24(5 Suppl):S58-61.
    Duration of immunity against pertussis after natural infection or vaccination.

    Also there is not “natural immunity” to tetanus, and perhaps diphtheria. You can get them again even after you survive the disease.

    Like

  36. reissd
    December 17, 2014 at 12:57 am

    Thank you, Chris.

    Like

  37. dingo199
    December 17, 2014 at 5:01 am

    Thank you Dorit for explaining matters so well, and backing them up with facts and evidence with sources.

    @Lindsay…I hope people here do look at “both sides” – they will see your “side” is lacking in any credibility whatsoever.

    Like

  38. dingo199
    December 17, 2014 at 9:02 am

    The Yazbak paper on pertussis is interesting. Ignoring his misrepresentation of the Japanese IMR and SIDS experience, he does highlight one or two important points, such as the consequences of natural pertussis (usually denied by antivaxers):
    “Pertussis mortality in the US is 2-3/1000 cases. Seizures occur in 1.9% of cases, and encephalopathy in 0.3%.”
    [So one in 300 suffer brain damage, and one in 3-500 die. Not harmless, then]

    He says this of the old DPT vaccine:
    “From this study, the risk of permanent brain damage following DPT has been calculated as 1:310,000 doses.”
    [since 3 shots were given this equates to a risk of 1:100,000 of brain damage. Deaths are not mentioned, presumably there were too few to quantify as a rate]
    We know that many of the cases of post DPT encephalopathy were misattributed to vaccine from subsequent studies on the topic, so this 1 in 100,000 must represent the upper limit of vaccine related encephalopathy damage (if it even exists, which is doubtful based on recent evidence)

    As a pragmatist, I fail to see how Yazbak thinks the benefit-harm equation ever worked out in favor of NOT vaccinating with DPT, seeing as how the risk of brain damage would have been over 300 times LESS than if a child got the disease (and that’s assuming all vaccine “encephalopathy” cases were genuine in the first place.)

    Like

  39. jgc56
    December 17, 2014 at 1:06 pm

    “No one wants to touch the question of what to do now that everyone recognizes that vaccines can cause autism, usually over an extended period of time, because admitting it would bankrupt the country and destroy public confidence in the vaccine program.”

    But this is false, Lindsay: it is not recognized–much les by everyone–that vaccines can cause autism. In fact, all the evidence–including multiple very large retrospective epidemiologic studies conducted by multiple independent researchers and public health agencies in multiple antions–instead indicates no causal association between vaccines and ASD’s exists.

    Like

  40. jgc56
    December 17, 2014 at 1:18 pm

    Direct question, Lindsay:

    What, in your opinion, is the single most credible and compelling piece of evidence demonstrating a causal association between routine childhood vaccination and autism spectrum disorders? Be specific.

    I get that you believe one exists, but for the life of me I can’t imagine why.

    Like

  1. December 9, 2014 at 10:11 pm

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