On October 19, 2016 a press release appeared in several outlets claiming – naming Mr. Robert F. Kennedy, Jr. as a primary source – that the CDC “blocked” (his term) the appearance of Dr. William Thompson, the so-called CDC whistleblower, in a medical malpractice case. This was done, apparently, in a letter Dr. Tom Frieden, CDC Director, sent in response to attorneys asking that Dr. Thompson testify in a malpractice case. Several articles, based on the press release, troubled me because of numerous clear inaccuracies. I therefore asked for, and obtained, the CDC’s letter (pdf) and read it to understand the CDC’s decision.
This post proceeds in three parts:
- I will explain some of the warning signs – the clearly inaccurate claims – in these articles, using the longest article, in Ecowatch, as the main source.
- I’ll explain what the CDC letter actually said, and why the decision was well-reasoned and not unusual.
- I’ll explain what the standard would be on appeal, if Kennedy and his colleage, Mr. Bryan chose to appeal to federal court, and why they’re unlikely to meet this standard.
There is one more part to this puzzle. This article will examine a lawsuit was filed for Yates Hazelhurst, whose claim – that vaccines caused his autism – was rejected in detailed decisions by the National Vaccine Injury Compensation Program, by a Court of Federal Claims judge on appeal, and by the federal circuit on further appeal (Hazelhurst v. Secretary of Health and Human Services, 604 F.3d 1343). I would like to be able to address that suit, but have not yet been able to obtain the complaint, and would rather look at the primary materials than rely on press release with the kind of warning signs these have.
Warning signs in the press release
- The Ecowatch article claims that “Destefano called his four co-authors into a room and ordered them to dump the damning datasets into a giant garbage can.” But the datasets have not been dumped, and Dr. William Thompson never claimed they were. In fact, Dr. Brian Hooker used the same datasets in a now retracted, deeply flawed, analysis.
- The articles claimed that “Dr. Thompson revealed that the data underlying CDC’s principal vaccine safety studies demonstrated a causal link between vaccines and autism or autism symptoms.” But in a statement given to Congressman Posey (pdf), Dr. Thompson actually said: “the fact that we found a strong statistically significant finding among black males does not mean that there was a true association between the MMR vaccine and autism-like features in this subpopulation. This result would have probably have [sic] led to designing additional better studies..” The closest Dr. Thompson came to claiming the link was in conversation with Dr. Brian Hooker, after being pushed to make such a claim, when he suggested that his thimerosal studies showed an association between tics and thimerosal containing vaccines. Tics are not autism, and even that claim has been challenged by other scientists – there is no scientific consensus that thimerosal causes tics. Nothing in what was provided so far suggests that Dr. Thompson claims vaccines cause autism. That also raises questions about his ability to “rebut defense experts’ testimony that Yates was not damaged because vaccines do not cause autism.” Even if we ignore the fact that studies from all over the world asked whether vaccines cause autism and the answer was a clear and consistent ‘no’, there is no real support to that claim.
- The articles claim that “Hazlehurst v. The Jackson Clinic is the only vaccine injury case that has gone to any U.S. court in 30 years.” That, too, is not actually true. First, appeals against the decisions of vaccine court go first to a judge of the Court of Federal Claims and then to the federal circuit courts, and many have been heard over the years (as the Hazelhurst claim itself was). Some even reached the Supreme Court. And second, attempts have been made in the past to get around the preemption imposed by the National Vaccine Injury Compensation Act – and the courts have mostly rejected those attempts. That was the basis for the famous Bruesewitz case (pdf). I addressed another such case not that long ago. This case is somewhat unusual in that it is a medical malpractice suit rather than a product defect one. But it’s not nearly the first to reach the courts. That claim is simply incorrect.
- Less importantly, the Ecowatch article claimed there are four problematic studies, but only mentioned and linked to three. But that might just be a typo.
- The articles also repeated other problematic anti-vaccine claims.
What did the CDC letter say about testimony from Dr. William Thompson?
It proceeds in three parts. First, it explains to the lawyers the legal framework for requiring the testimony of officials of the Department of Health and Human Services in a civil case in which the United States government is not a party. The general rule- applied in all cases – is that usually officials don’t testify in their official capacity. The way the rules phrase it is that records and information are provided to private litigants in the same way they are given to the general public – and no more. This is codified in chapter 45 of the Code of Federal regulations, part 2, and it is based on two rationales: government impartiality – not treating litigants differently – and not disrupting the other duties these officials have to carry out.
“The availability of Department employees to testify in litigation not involving federal parties is governed by the Department’s policy to maintain strict impartiality with respect to private litigants and to minimize the disruption of official duties.”
As the letter explained, the Supreme Court upheld the authority of agencies to limit testimony by officials (United States ex rel. Touhy v. Ragen 340 U.S. 462 (1951)) and the CDC’s authority to refuse subpoenas specifically in Moore v. Armour Pharmaceuticals, 927 F.2d 1194 (11th circuit, 1991).
To make a long story short, the courts acknowledge that agency officials have important duties, and civil litigation can disrupt them. The government’s disinclination to be part of such suit out of concern of appearing not to treat parties impartially is also reasonable.
That said, a complete ban could prevent justice and even harm public policy. In consideration of that, the regulations contain a way to get officials to testify in appropriate cases. To do that, lawyers need to meet three conditions:
- Ask the agency head in writing.
- Explain why the information is not available by other means.
- Explain why the testimony is in the interest of the DHHS or the federal government.
“2.4 (a) All requests for testimony by an employee or former employee of the DHHS in his or her official capacity and not subject to the exceptions set forth in § 2.1(d) of this part must be addressed to the Agency head in writing and must state the nature of the requested testimony, why the information sought is unavailable by any other means, and the reasons why the testimony would be in the interest of the DHHS or the federal government.”
In his letter, applying these rules, Director Frieden explains that the request from Yates Hazelhurst’s attorneys only fills the first requirement. That’s because the suit – from the letter and the articles – claims that “the vaccines were improperly administered in 2001.” The studies in question were published in 2004, 2007, and 2010 – so they would not have made the vaccines “improperly administered” in 2001: medical malpractice is assessed based on what is known at the time, not in hindsight, and at the time of administering the vaccines to Yates, the studies were not yet done. So even if the claims were true (and the evidence at present does not support a claim of fraud, or support a real link between vaccines and autism that anyone would have to hide, it would not be relevant to a claim of malpractice in giving Yates Hazelhurst the vaccines. Doctors are not required to consider evidence that does not yet exist when they decide if to vaccinate. Given that, the letter describes Dr. Thompson’s testimony as “superfluous” and explains that “it does not appear to promote the objectives of CDC of HHS”.
Though the CDC didn’t say this, even if there was fraud that the CDC covered up, it wouldn’t be known to the doctors, and they wouldn’t be committing malpractice. So even if the articles were before Yates’ vaccines – as they were not – the testimony would not be relevant.
- Contrary to the claims in the article and, apparently, the datasets for the 2004 study (the ones the articles allege, incorrectly, were destroyed) “are available for analysis by others.” The letter provides a link to instructions on how to access that data. These can be found here. Therefore, the request fails requirement B, that the information not be available by other means.
- The letter also pointed out that the CDC considers the studies valid, and that they are part of a large body of literature from all around the world that shows, strongly, that vaccines don’t cause autism.
- The goal of ensuring scientific integrity in publications is better addressed through scientific process and other processes, and is not promoted by giving testimony in an individual case.
- The CDC receives a lot of requests for testimony, and if it accepted all of them, it could not do its other important work.
The first three reasons, at least, are extremely robust, and each of these reasons has at least some merit. You can argue that litigation can have some value in providing additional oversight to assure scientific integrity, and that internal scientific processes aren’t always enough to assure integrity – though even there, it’s not clear testifying in a civil trial is an appropriate complement. Disciplinary or criminal proceedings after an investigation (like the one the CDC is conducting into the CDCwhistleblower allegations) are probably a better tool. You can argue that not all requests are alike, but in this case, you do have to make a case why this request should be treated differently. So the last two reasons can be challenged, but are still reasonable ones.
What will an appeal do?
The decision not to allow Dr. William Thompson to testify is an agency decision, an exercise of administrative discretion, applying the regulation to a specific situation. It can be challenged in federal court under the Administrative Procedures Act’s arbitrary and capricious standard, encoded in 5 U.S.C §706 (2)(A). Under this standard, to simplify, the lawyers would have to convince the court that the agency’s decision was unreasonable or badly explained. But the agency provided a detailed explanation of its reasons, and the explanation is careful and reasonable.
The lawyers are going to find it hard, especially, to get around the first point – that the articles were after the point of injury, and therefore the testimony is not relevant. I’m sure they’ll try. They will have to offer a challenge to many of the facts at the basis of the letter, and there might be some factual questions. And you never know, when you go into court, what will happen. But their chances of winning this are not very good. They’re simply up against a very, very well reasoned administrative decision, with multiple strong arguments supporting it.
The content of this decision also makes the strongly-worded headlines suggesting coverup just as problematic as the other inaccuracies in the article. Simply put, the lawyers’ claims are not well founded.
This article is by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy and the law.
Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease.
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