Vaccine injury compensation and autoimmune syndromes

Vaccine injury compensation and autoimmune syndromes

This post examines the treatment by the National Vaccine Injury Compensation Program (NVICP) of the second of two claims (see first one here) heard from those claiming vaccines cause more injuries than acknowledged in recent days. This article will focus on vaccine injury compensation and autoimmune syndromes.

The Special Master’s decisions – as many decisions in NVICP are – are long, complex, and examine the evidence closely and in detail. They address factual debates, expert disagreements specific to the case and expert disagreements on the science.

This post won’t cover them – that’s not my goal. All I will address are the Special Master’s conclusion about two hypotheses raised by those who believe vaccines injured their child (and also promoted by anti-vaccine organizations).

The NVICP (commonly called the Vaccine Court) is a no-fault program created by Congress to serve two goals: to protect the vaccine supply by offering limited liability protections to vaccine manufacturers and providers and to help those injured by vaccines – or even those who may have been so injured – be compensated more easily than in the regular courts.

As I addressed in the past, NVICP provides petitioners – as claimants are called – with substantial breaks compared to the regular courts. Petitioners do not have to prove a product defect or any kind of fault; the requirements for proving causation are relaxed; evidentiary rules are relaxed, allowing the introduction of evidence and experts that would not be allowed in a regular court.

NVICP is not, however, a benefits program. Its goal is not providing any parent with a child with a problem support. The United States certainly needs to offer more support to families of children with disabilities, but NVICP’s aim is different: it focuses on compensating injuries that may, at least, have been caused by vaccines.

To be compensated by an NVICP decision a petitioner does need to meet minimal standards suggesting a possible connection between a vaccine and an injury (a settlement does not require similar proof; parties settle for all kinds of reasons, including a view that the case isn’t worth litigating). At the very least a petitioner needs to show an injury, and provide expert testimony (expert testimony is generally needed when someone claims medical causation in the courts as well – that a medical act, device, drug etc. caused harm – with very narrow exceptions).

Continue reading “Vaccine injury compensation and autoimmune syndromes”

Rachael Ross gets Vaxxed – that’s never good for a real doctor

Rachael Ross gets Vaxxed

Recently,  Dr. Rachael Ross, who gained fame when she was on the medical talk show, The Doctors has written a letter that suggests she now subscribes to a large number of anti-vaccine tropes. While there really isn’t anything new in the letter – the claims in it are far from original, and have been repeatedly shown untrue – as a doctor, her words carry weight. So Rachael Ross gets Vaxxed – it’s worth responding to her.

I don’t know what drove Dr. Ross to promote anti-vaccine misinformation. It may have been misplaced trust, believing in Del Bigtree, Vaxxed producer, who has been promoting quite a bit of misinformation recently, some of it incredibly harmful. She may have already been susceptible. Maybe all of the above. It doesn’t matter.

She chose to speak up, and whatever her intent, the result is that she provided ammunition to anti-vaccine activists and anti-vaccine parents that can be used to sway others away from protecting children from disease. Dr. Ross includes in her letter the mantra of “do no harm.” But a letter promoting this kind of misinformation – by a doctor, with the authority the profession confers – is very likely to do harm. It’s unfair to the children denied vaccines because of it.  Continue reading “Rachael Ross gets Vaxxed – that’s never good for a real doctor”

Merck vaccine lawsuit – implausible narrative, bad law and facts

Merck vaccine lawsuit

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.  Continue reading “Merck vaccine lawsuit – implausible narrative, bad law and facts”

Brian Hooker’s vaccine injury claim denied by NVICP

Brian Hooker holds a Ph.D. in chemical engineering and has a background that involves researching and teaching in related areas. He is also the father of a boy – now almost young man, at 16 and a half – with autism. Brian Hooker believes his son’s autism was caused by vaccines, and he has been vocal about it.

He is the one who initiated the most recent claims that the CDC conspired to hide a link between vaccines and autism because of calls he had with a CDC scientist (the so called CDC whistleblower)– claims shown, on examination of the data, to be incorrect. He has also, in recent years, published (problematic) research articles claiming a link between vaccines and autism. One of his articles has been retracted because of undeclared conflicts of interests and methodological flaws.

In 2002 Brian Hooker filed a claim with the National Vaccine Injury Compensation Program (NVICP), the special administrative program created in 1986 to compensate vaccine injuries. On 19 May 2016, the court rejected his claim in a detailed, comprehensive decision. The Special Master explained that “this is not a close case.”

This post explains the decision, explaining the legal framework and the application of it. In short, the claim was rejected because:

  1. The evidence suggested that SRH – the initials by which Hooker’s son was known – had symptoms of Autism Spectrum Disorder (ASD) from early on. In fact, these symptoms appeared long before receiving the vaccines alleged to cause his harm. Moreover, there was no evidence of regression or other severe reaction to the vaccines.
  2. The evidence does not support, and in fact, contradicts, Hooker’s contention that thimerosal-containing vaccines cause autism. This evidence consisted of scientific studies and expert reports. Hooker’s experts’ had questionable credibility and qualifications, and were, at least, far surpassed by the Respondent’s, the Secretary of Health and Human Services, experts.
  3. This decision follows the thorough and detailed Omnibus Autism Proceedings, along with many other decisions that found the same.

Continue reading “Brian Hooker’s vaccine injury claim denied by NVICP”

Gardasil DNA and aluminum – myth debunking time

Gardasil DNA and aluminum

Here we go again. Anti-Gardasil activists and other vaccine deniers are attempting, once again, to make specious claims about the HPV anti-cancer vaccine. This time claiming that Gardasil DNA and aluminum somehow interacted to kill a young child.

This time, it’s a claim filed in United States Court of Federal Claims Office of Special Masters, as a part of the National Vaccine Injury Compensation Program (NVICP), that an injection of the Gardasil vaccine lead to the death of a young male the next day.

As tragic as that death is, and all children’s deaths are tragic, let’s take a look at the evidence being used here. Of course, I’m not a Special Master in the Federal Court System (admittedly, I want that title), I’m not an attorney (nor do I pretend to be one on the internet), and the NVICP has some complex rules and decisions processes. It’s never simple, and remember, the NVICP, or any court for that matter,  lacks the privilege of deciding what is good science.  Continue reading “Gardasil DNA and aluminum – myth debunking time”

Maine Coalition for Vaccine Choice legislation–bad premises, bad law

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.

In the United States, the Centers for Disease Control (CDC) recommend certain vaccines. CDC cannot, and do not, mandate vaccines. However, states can and do require their residents to have received certain vaccines on the CDC recommended schedule in order, most notably, for children to enroll in school. All states, however, also offer exemptions from school immunization requirements, and some – like Maine – offer very easy-to-get ones.

A bill was proposed by Maine legislator Richard Farnsworth adopting an informed refusal requirement before a parent can make use of Maine’s philosophical exemption to send their child to school without the required immunizations. In response, the Maine Coalition for Vaccine Choice (MCVC), an antivaccine advocacy group, proposed its own law, the “Maine Vaccine Consumer Protection Act.” Proposing an alternative law is not inappropriate.

There are, however, two significant problems of the Maine Coalition for Vaccine Choice legislation – the premises underlying the alternative law, and the content of the proposal. The proposal is based on premises that are either simply untrue or inaccurate and misleading. And it’s extremely bad law. Continue reading “Maine Coalition for Vaccine Choice legislation–bad premises, bad law”