Merck vaccine lawsuit – implausible narrative, bad law and facts

On 19 July 2016, New York Attorney Patricia Finn filed a complaint in a federal district court against the pharmaceutical firm Merck, officials in the Department of Health and Human Services, and Julie Gerberding (formerly director of the CDC, and currently Merck’s Executive Vice President for Strategic Communications, Global Public Policy and Population Health). This Merck vaccine lawsuit, called Doe v Merck,  is an amended complaint that was filed on 20 July, and will be the one examined in this article.

While the complaint was filed in the name of a Jane Doe and Baby Doe, the text of the complaint made it very clear that Jane Doe is in fact Maria Dwyer, and Baby Doe is her son Colin Dwyer.  Colin Dwyer’s case was one of the test cases in the Omnibus Autism Proceedings (OAP) for the National Vaccine Injury Compensation Program (NVICP). The Dwyer case, like the other five test cases in the OAP, was rejected.

The Doe v Merck complaint makes two demands. First, that Merck’s license to produce the measles, mumps, rubella vaccine (M-M-R®II ) be revoked.

Second, it asks for damages for Colin’s alleged vaccine injuries. The complaint is problematic from three aspects:

  1. The story it tries to tell is full of holes;
  2. as a legal matter, it makes no case; and
  3. it includes many factual inaccuracies.

In short, the Merck vaccine lawsuit is bad work.  However, the complaint is being shared widely, and a discussion of its shortcomings might be of value to many readers. 

Merck vaccine lawsuit – key players

 

This is not Ms. Finn’s first vaccine case. She was the lawyer in both Workman v. Mingo County Board of Education (pdf) and Phillips v. New York. Both cases challenged school immunization requirements, and both cases were rejected by the courts.

Ms. Finn’s hostility to school immunization requirements leaks over into this case, with some of her arguments focused on the necessity of a mandate – even though that’s not part of the case at hand.

While the plaintiffs are described as “JANE DOE, Individually and as Parent/Guardian of BABY DOE,” their identity is very clear. The complaint explains BABY DOE is one of the three test cases presented to the Omnibus Autism Proceedings (OAP) for the second theory – the claim that thimerosal containing vaccines cause autism – and on p. 21-22 the complaint quotes from the case relating to the plaintiffs, with the initials CD. The only CD among the test cases is young Colin Dwyer, and the quotes are from that decision (pdf). That makes Jane Doe Ms. Maria Dwyer, who is on the board of the anti-vaccine organization Safeminds:

Maria is the mother of four boys, Colin, age 13 was diagnosed with autism at 2.5 years old. Colin’s vaccine injury was one of nine test cases tried in the United States Court of Federal Claims Omnibus Autism Proceedings. All nine families subsequently lost their cases in 2009.

This is going to become important later.

A holey narrative

 

One principle of law is that to make a case, a complaint needs to weave facts into a narrative that supports a legal claim. In other words, it’s the lawyer’s job to make a connection between the various factual claims they make and some legal entitlement.

This complaint hardly has a coherent narrative, and it’s hard to see it as supporting anything. As far as a narrative can be teased out, it’s that young Colin received several different vaccines on July 10, 2000, and then began to regress into autism.  This came after a CDC conference held on June 8 at the Simpsonwood Retreat Center that the complaint describes as a conspiracy between Merck scientists and government scientists to hide evidence that thimerosal-containing vaccines cause autism.

This, according to the complaint, is a first step in a sequence of scientific frauds committed by Julie Gerberding and Merck. These alleged frauds include a 2004 Pediatrics paper about MMR written by authors who were CDC members (where Gerberding was, at the time, director) and a 2002 paper from Denmark that was manipulated, says the complaint, by Poul Thorsen, indicted for embezzling from the CDC. This, apparently, led to harm to young Colin and is still causing harm to him and his family, though the complaint is a little fuzzy about what, exactly, is this ongoing harm.

Readers familiar with the anti-vaccine scene already recognize the elements of the narrative as a concatenation of anti-vaccine talking points . These points, all of which have been addressed in detail by many others in the past, have time and again been shown not to hold water. But even if we put that aside, the complaint narrative suffers from serious problems in consistency and credibility on its face.

The Simpsonwood Conference

 

The first step in the narrative is, apparently, the Simpsonwood conference, a meeting held in June 2000 to discuss initial findings of a project looking at the link between thimerosal in vaccines and neurodevelopmental problems. Ms. Flinn goes out of her way to present the conference as an attempt to conceal data showing a link between vaccines and autism.

In the 16 years since the Simpsonwood conference, it has been pointed out by others that the way anti-vaccine activists present Simpsonwood is misleading.  In particular, the skeptical blogger Skeptico did a great job of going through that, and showing there was no coverup – there was a meeting to discuss and examine what the data showed and examine the methodology, with most present finding little evidence of a causal connection between thimerosal and autism.

The point I want to emphasize here is one made by Skeptico but worth repeating. In the complaint, Attorney Finn writes ““they all then agreed to conceal the credible evidence of failed vaccine safety uncovered by Verstraeten to avoid “litigation”, (Complaint, page 3). The claim of agreement to coverup was repeated elsewhere in the complaint.

But on p. 256 of the Simpsonwood transcript  – a page Ms. Finn herself references, so it’s unconvincing to say she did not read it – Dr. Bernier (then the Associate Director for Science in the National Immunization Program) says:

You may have given a copy, but I think if we will all just consider this embargoed information, if I can use that term, and very highly protected information, I think that was the best I can offer. If anyone else wants to make a suggestion, but I would say consider it embargoed and protected until it is made public on June 21 and 22 at the ACIP. There is a plan to do that.

The ACIP – the Advisory Committee on Immunization Practices – is the CDC committee that makes recommendations regarding the schedule. It’s a federal advisory committee and by law, its meetings are public, open to the public and press, with meetings slides posted online after the fact.

In other words, during the Simpsonwood meeting it was clear that the data in question will be presented to a public committee. Dr. Paul Offit, a vaccine expert and educator, was on the committee at the time and confirms that the material was, in fact, presented, describing the presentation as “lively.” As is obvious, presenting data publicly to a federal advisory committee demonstrates transparency and not a conspiracy to cover it up.

The “CDC Whistblower” manufactroversy 

 

Ms. Finn spends a long time in the complaint addressing the so-called CDC whistleblower conspiracy theory (or see this more reverent review). The claim, based on recorded phone calls with an actual CDC researcher, is that authors of a relatively small MMR study from 2004 omitted a statistically significant sub result linking MMR and autism in African American children. I will address some of the factual problems in the claims in the last section. But ignoring those for the moment, it’s completely unclear how that particular conspiracy theory helps Ms. Finn’s narrative.

First, Ms. Finn claims that:

On July 10, 2000, about a month after the Simpsonwood Agreement was formed, in Queens, New York, BABY DOE’s medical records show he received a series of vaccines mandated under §2164 to attend school, and began to regress into autism.

However, as noted in the NVICP decision about him, “Colin received his only measles, mumps, and rubella [“MMR”] vaccination on November 22, 1999, when he was 12 months old.” In other words, he received it long before the alleged beginning of the regression.  It’s not clear, then, what role MMR was supposed to play in the story that tries to draw a link between his July 2000 vaccines and his autism.

Ms. Finn never connects MMR to Colin’s autism. The NVICP decision shows no link. Why, then, is this lengthy discussion here, and what is the connection between Colin’s alleged harm and the demand to withdraw the license for MMR?

The complaint spends many pages on discussing the claim that there was a link hidden between MMR and autism in African American boys. But the complaint nowhere alleges that Colin is African American. That is probably because he likely isn’t, given the pictures of his mother and himself available on Safeminds (though I’m happy to be corrected on this point). At any rate, not claiming that Colin is African American is a big disconnect between the story of his harm and the lengthy discussion of the CDC whistleblower manufactroversy in the complaint.

Poul Thorsen and the “Danish Studies

In the complaint, the story of the Danish studies is very, very garbled. The complaint claims, without linking or a full citation that:  “In 1999, CDC hired a foreign scientist from Denmark Poul Thorsen who produced at least five different vaccine autism research studies published in the 2002 Danish Autism Studies in Pediatrics.”

Poul Thorsen is a Danish citizen who was a visiting researcher at the CDC in the late 1990s.  While he was one of the authors on a number of studies, there aren’t five studies on vaccines and autism in Pediatrics on which Thorsen is an author, as far as I have seen.

There is one, from 2003, and Thorsen is neither lead author (the one who usually does most of the work and is most responsible) nor last author (the senior scientist in the group, responsible for supervision: he is just one of a crowd, and it’s unclear how he was supposed to manipulate data over the other authors. There is also a 2002 study in the New England Journal of Medicine. Thorsen is neither lead nor last on this one either.

Generally, as Emily Willingham has pointed out, Thorsen’s potential embezzlement from the CDC is a different matter than any alleged research misconduct. There is no evidence of research misconduct. If the complaint wants to use Thorsen to try and claim a link between vaccines and autism, it needs more than a confused and hard to track reference to studies on which he was not first author.

Poling Case and mitochondrial disorders

 

Ms. Finn spends a long time discussing the Poling concession, another favorite of the anti-vaccine movement. The anti-vaccine position is that vaccines, when given to children with mitochondrial disorders, cause autism.   This is an unsupported claim.

Further, recent decisions by NVICP made it clear that claim would not be grounds for compensation today. She makes a vague and general claim that some of children in the test cases before the vaccines court had mitochondrial disorders. But she never claims Colin did, nor did she provide any support for such a claim. Again, a lengthy part of the complaint isn’t coherently linked to any legal claim made.

Stephen Bustin’s OAP Testimony

Polymerase chain reaction (PCR) is a laboratory technique used to amplify DNA samples.  Stephen Bustin is one of the world experts in the use of this technique. In the complaint, Ms. Finn complains about the role of Dr. Bustin, who testified in the Cedillo case, in resolving that claim against petitioner. Ms. Finn is wrong about the role of Dr. Bustin in Cedillo as well. In the federal circuit’s examination of the Cedillo decision, the court said (pdf):

We agree with petitioners that the government’s failure to produce or even to request the documentation underlying Dr. Bustin’s reports is troubling, but we think that in the circumstances of this case, that failure does not justify reversal.

In our recent decision in Hazlehurst, we specifically addressed this question and held that the failure to exclude the testimony and reports of Dr. Bustin did not constitute reversible error. See Hazlehurst, 604 F.3d at 1348-52. In particular, we concluded that the Special Master’s decision to admit and consider Dr. Bustin’s testimony was “in full accord with the principle of fundamental fairness” under Vaccine Rule 8(b)(1) and did not “contravene[] the purpose[] of the Vaccine Act” to avoid proceedings resembling tort litigation. Id. at 1351.

We also concluded that even if the admission of the Bustin evidence was improper, the Special Master would have reached the same conclusions regarding the unreliability of the Unigenetics testing in the absence of the Bustin evidence.

In other words, the Cedillo decision would be the same without Bustin’s evidence, and there was plenty of opportunity for plaintiffs to respond to Bustin or ask for more data.

With respect to this case, Bustin’s testimony is beside the point. Dr. Bustin’s testimony addressed MMR. As pointed out above, if the claim is that Colin regressed because of his July 2000 vaccines, which did not include MMR, and there is nowhere a claim that there was any testing of the presence of MMR in Colin’s gut, nor blaming of his autism on MMR, the issues brought up by Bustin’s testimony are irrelevant.

 
 

Legal problems

 

Legally, too, this complaint suffers from a number of problems. Ms. Finn opens by basing her claim in the National Childhood Vaccine Injury Act’s provision that allows citizens to sue the Secretary of Health and Human Services for violating the act. But she nowhere explains exactly how the Secretary violated the act. She also refers to 42 U.S.C. §1983, which allows tort suits against people violating federal constitutional or statutory rights by people acting under color of state law.

Most of her complaint is an attack of Merck. Merck is not the Secretary. What is the basis of suing Merck? And in federal court? What is the legal basis?

The suit also demands the FDA revoke the license for MMR – but provides no legal basis for doing so. But a tort claim is not the right vehicle for demanding licence revocation. Those need to be challenged in administrative law. Ms. Finn has not really made a good administrative law claim against the Secretary that would justify revoking the license for MMR. Nor does she point to any current harm to her plaintiffs from MMR being license that would justify it.

Finally, the complaint repeatedly refers to anti-vaccine sources rather than primary sources, for example, referring to a blog post a now defunct website formerly operated by an anti-vaccine group (vaccinationcouncil) to support a claim about the effectiveness of the measles vaccines.

The most strange reference, in my eyes, was directing the court to “Vaxxed the Documentary” a reference made no less than three times in the complaint. A movie, especially one directed by a disgraced scientist with a history of misrepresentations, is not appropriate evidence to support a claim in a court of law.

Factual inaccuracies

 

The complaint includes many anti-vaccine claims that, for the most part, are incorrect. Some have been addressed already. Here are some others:

  1. The Complaint claims that MMR is not effective. The support in the complaint is the fact that most students in a 2016 mumps outbreak at Harvard are vaccinated. But that’s not good evidence. With most students vaccinated, most cases will be in the vaccinated. On the other hand, 50 students out of Harvard’s population of 21,000 is a small number.  Even if only 10% of the students – or 2100 – were exposed, that’s a rate of less than 2% that got the disease. Hardly dramatic vaccine failure. And mumps is the least effective part of MMR. The complaint then claims that most people in measles outbreaks – “in some cases more than 95%” – were vaccinated. It’s unclear what the source for that claim is. It’s certainly not reflected, for example, in the CDC reporting on measles:  “The majority of people who got measles were unvaccinated.” Or in a recent article that reviewed vaccination rates in measles outbreaks between 2000-2015 and found that the majority were unvaccinated. In short, the evidence goes against this claim.
  2. The Complaint says that “there are very real risks associated with the shedding of the live viruses from the MMR, and possibility of transmissions to others,” – apparently, that’s the basis of the claim that MMR is still a risk to the plaintiffs, though the complaint never actually says that. But People inoculated with MMR do not shed virus in large enough quantities to cause those with whom they come in contact to either develop an immune response to the vaccine viruses or symptoms from those strains. With respect to measles, the most contagious of the three diseases, a systematic review in 2016 confirmed that no evidence for secondary disease from shedding has been found.
  3. The complaint completely ignores the many, many other studies of MMR and thimerosal containing vaccines – studies from all over the world – that found no link to autism. Frankly, even if the complaint was right about the 2004 study and the Danish studies the evidence would still show no link between vaccines and autism.
  4. The complaint claims that the data related to the 2004 Pediatrics article discussed in it was trashed – thrown in the garbage can. But that was neither the claim made by the Dr. William Thompson, her source, nor is it true. The data in question was stored on government servers, is still available, and was used by anti-vaccine activist Dr. Brian Hooker in a now-retracted and horribly flawed paper to claim MMR causes autism in African American boys. The claim made by Thompson was that documents related to the analysis were destroyed. This was discussed by Matt Carey, who pointed out some preliminary documents should, appropriately, be thrown out. Thompson also claimed he kept the documents. While Ms. Finn claimed not to have access to them, scientist Matt Carey and I made those documents public back in January 2016. Ms. Finn would do well to examine them. They do not support claims of wrongdoing.
  5. The complaint suggests – with no evidence – that Brian Deer’s investigation of Andrew Wakefield was financed by Merck.
  6. The complaint suggests that it was Merck’s fault that Andrew Wakefield lost his medical license. Andrew Wakefield lost his license after serious ethical violations he committed came to light.  He was given a chance to defend himself during a lengthy quasi-judicial proceeding, and there is abundant documentary evidence of his actions.  Wakefield brought his troubles upon himself.
  7. The complaint suggests that was Merck’s fault Mark Geier lost his medical license. Mark Geier lost his license for misdiagnosing autistic children with precocious puberty in order to prescribe a chemical castration drug to them – with dubious to no justification.  Geier brought his troubles upon himself.
  8. The complaint suggests that Merck had something to do with Dr. Jeff Bradstreet’s suicide. The facts are that  Dr. Bradstreet was under FDA investigation for his involvement with a specific drug he sold under claims that it was a treatment for autism and cancer.  There’s no clear link between his death and MMR, or Merck in any way.
  9. The Complaint states that “Many vaccines children receive in the United States are made overseas in China and Japan that are purportedly shipped refrigerated to New York for children to inject, drink and snort in order to attend school.” This is a flatly false claim. The vaccines used in the United States are not made in China or Japan.

Merck vaccine lawsuit – TL;DR summary

 

There is a lot more that can be said, but I hope this demonstrates how bad this complaint is. Honestly, as much as I disagree with Ms. Dwyer’s views on vaccines and her efforts to promote the untrue claim that vaccines cause autism, she deserved better professional representation than is reflected in this complaint. I hope the court does the right thing and disposes of this quickly.

Complaint – Doe v Merck

Dorit Rubinstein Reiss
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.