NVICP Tarsell decision not proof of HPV vaccine-related mortality – just legal errors

NVICP Tarsell decision

On September 25, 2017, Special Master Christian Moran from the National Vaccine Injury Compensation Program (NVICP), acting under a Court of Federal Claims decision that changed the legal standard for compensation, awarded compensation to Ms. Emily Tarsell for the tragic death of her daughter, Christina Tarsell. The family had blamed the tragedy on Gardasil. the HPV vaccine. Let’s review the facts and legal issues of the NVICP Tarsell decision.

A reading of the decision shows that the Special Master himself had serious doubts that the HPV vaccine had actually caused the death (and could probably have more strongly stated his doubts); however, he felt bound by a flawed decision of the Court of Federal Claims and compensated because of that guidance. The claimant’s theory that was used to claim that the vaccine caused the young woman’s death is also extremely far-fetched. It should not have fulfilled the plausible theory requirement even under the watered-down version ordered by the Federal Claims judge. The timing (i.e., cause and effect) was likely wrong – the Special Master thought the disease symptoms started before the administration of the vaccine – but for procedural reasons, he did not dwell on that issue.

While anti-vaccine websites present the Special Master’s award as proof that the death was caused by the administration of the vaccine, that is a serious misreading of the NVICP Tarsell decision. Ms. Christina Tarsell’s death is extremely tragic. But there is no good basis to claim that the HPV vaccine caused it.

There are three legal errors in the decision of the Court of Federal Claims judge, a decision that was then legally binding on the Special Master it was returned to for reconsideration:

  1. Reversing the burden of proof in relation to the timing of the alleged harm;
  2. relaxing the standard under which a medical theory is evaluated; and
  3. applying a de novo standard instead of an arbitrary and capricious standard to the Special Master’s findings of facts (which I’ll explain).

Continue reading “NVICP Tarsell decision not proof of HPV vaccine-related mortality – just legal errors”

Merck whistleblowers – mumps vaccine lawsuit motions and updates

merck whistleblowers

In August 2010 Stephen A. Krahling and Joan A. Wlochowski (“the relators”), former Merck virologists and often called “Merck whistleblowers,” filed suit in the name of the United States – a so-called qui tam action, where the prosecution shares any fines or penalties with the two virologists  – against Merck.

They claimed that by faking effectiveness testing, Merck misled the United States government as to the effectiveness of the mumps component of its  MMRII vaccine (a vaccine which protects individuals against mumps, measles, and rubella). In 2012  a clinic and two MDs filed a class action against Merck claiming a violation of the Sherman Act – monopolistic, anti-competitive behavior resulting from the fraud – and violation of various state laws. (U.S. v. Merck and Chatom v. Merck). The suits were handled together. Continue reading “Merck whistleblowers – mumps vaccine lawsuit motions and updates”

Del Bigtree vaccine safety complaints – HHS Vaccine Program responds

Del Bigtree Andrew Wakefield

On January 18, 2018, Dr. Melinda Wharton, Acting Director of the National Vaccine Program Office in the Department of Health and Human Services, sent Mr. Del Bigtree, an anti-vaccine activist, and producer of the anti-vaccine film Vaxxed, a response to questions he raised about vaccine safety. The response is a very informative description of the substantial efforts regarding vaccine safety, and can and should reassure parents that there is abundant data – and many monitoring mechanisms in place – to examine and address vaccine safety, and that the expert consensus that vaccines are very safe is well grounded.

This post will shortly describe the background to the letter from Dr. Wharton, then provide some of the highlights. I do, however, encourage people to read the full letter, available here (pdf), for themselves, to understand many vaccine safety issues. Continue reading “Del Bigtree vaccine safety complaints – HHS Vaccine Program responds”

Healthcare worker flu vaccination – examining lawsuits about the vaccine

flu vaccination

On March 6, 2018, the Department of Justice filed a lawsuit in a federal district court against Ozaukee County, Wisconsin. The Department was suing on behalf of Barnell Williams, a certified nursing assistant in Lasata Care Center, a nursing home, who was claiming emotional distress from being forced to get a flu vaccination for work when getting one contradicted her religious beliefs.

This is not the first lawsuit brought under Title VII of the Civil Rights Act of 1964 on the issue of the flu vaccination for healthcare workers, the claims are not new, and the lawsuit seems well founded. I was not going to write about it because there really is nothing new there, but following several news articles on the topic (here and here), people had questions about it, so this is a short post addressing legal issues surrounding flu vaccination.

This article will list a few key points that are important considerations Continue reading “Healthcare worker flu vaccination – examining lawsuits about the vaccine”

NVICP Mini-Omnibus Autism decision – vaccines still do not cause autism

Mini-Omnibus Autism

On 7 February 2018, the National Vaccine Injury Compensation Program (NVICP) handed down a decision in a mini-omnibus autism proceeding asking whether petitioners established “by preponderant evidence, a medical theory connecting a vaccine and [the test case child]’s injury.”

The decision is important in two ways. First, it reminds us that NVICP has consistently and repeatedly rejected claims that vaccines cause autism. Second, it explains in detail why a theory (please see Note 1 at the end of the article) claiming human DNA fragments in vaccines cause autism – a claim whose main proponent is Dr. Theresa Deisher – is unconvincing and not supported by the evidence.

The detailed, thorough decision shows that the main study from Dr. Deisher to support the theory – a study attempting to draw a temporal connection between change points where vaccines containing such DNA were introduced and rise in rates of autism – is fundamentally flawed. It then also shows that the petitioners’ proposed mechanisms of causation – how the DNA fragments are supposed to cause autism – are untenable.

The Mini-Omnibus Autism decision is 94-pages, and this summary will just touch on the main points. I urge readers to wade into the full decision if they want to understand more.  Continue reading “NVICP Mini-Omnibus Autism decision – vaccines still do not cause autism”

Jessica Ericzon death blamed on HPV vaccine with no evidence

Jessica Ericzon

This post revisits another sad, sad tragedy, the death of Jessica Ericzon, was blamed on vaccines – this time, Gardasil, the vaccine that prevents infection with high-risk strains of HPV. Once again, the claim has no real evidence behind it. The concern, of course, is that these stories will lead to parents who are not already anti-vaccine refusing to protect their children against an infection that causes cancer.

Not protecting children against HPV infections that kill thousands and cause tens of thousands of cancer each year is putting them at unnecessary risk and setting the stage up for preventable tragedies. Doing it because of a painful death that no good evidence links to the vaccine, is doubly tragic. However painful, we owe it to future victims of preventable HPV cancers to set the facts straightContinue reading “Jessica Ericzon death blamed on HPV vaccine with no evidence”

Children’s book review – “Judah Maccabee Goes to the Doctor” for vaccine

children's book

Judah Maccabee Goes to the Doctor” is a recently published children’s book written by Ann D. Koffsky  and illustrated by Talitha Shipman.

It’s not aimed to introduce children to the science of vaccines, or to convince the heistant. It is, however, incredibly useful to parents who intend to vaccinate and want to help young children – maybe around the age of 2-6 – deal with fear of shots. And no, it’s not only for Jewish kids, though the Hanukkah theme may need explaining for others. It’s just a sweet, accessible story.

The story starts with an introduction to Judah and his family. Judah has a little sister called Hannah – a baby. He wants to be friends with her, and the scene describing his less-than-successful efforts to friend her will be relatable to many parents of multiple children. His Bubbe – grandma – helps him deal.

His grandmother also tells him the story of Judah Maccabee, who, along with his four brothers, led a rebellion against the Greek Empire when the Greek Empire occupied biblical Israel. Judah is naturally excited to hear about fighting, and imagines himself in the role. His grandmother gives him a toy shield as a Hannukah present.

The next part of the children’s book revolves around the children’s doctor visit. They are both deemed healthy, and then Judah is told he needs a shot. He – naturally – does not want one. Not even when his father explains a shot is like a shield. Then his father explains little Hannah is too young to get her own shots, and by getting his, Judah will protect her – by being protected himself, he won’t be able to get the sickness and that will keep him healthy, and prevent him from infecting Hannah.

This message helps Judah be brave and gets the shot. The book acknowledges it hurts, but that passes, and Judah is proud of helping to protect Hannah.

It’s a very sweet story. The pictures are fun and clear, the message positive. Children will enjoy the book, should be able to relate to it and it can help them approach being vaccinated in a more positive way. Most parents protect their children and vaccinate – but all of us want to make it easier, and many children understandably don’t like getting a shot. I’m glad this book exists to help.

Disclosure – I received the first copy from the author with a request to review it. After reading the book, I ordered two more copies. I look forward to reading them to my kids.






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Michigan vaccine regulations – Court decides on religious exemptions

Michigan vaccine regulations

On 7 November 2017, the 6th Circuit Court of Appeals mostly upheld a Federal District’s Court decision (pdf) to grant a motion to dismiss a lawsuit challenging Michigan vaccine regulations that require parents seeking an exemption from school immunization requirements have an interview with health department personnel first. The decision reinforced the strong support our courts have provided states’ efforts to increase vaccines rates.

Continue reading “Michigan vaccine regulations – Court decides on religious exemptions”

National Vaccine Injury Compensation Program facts

national vaccine injury compensation program

In this post I explain how one goes about proving a case in the  National Vaccine Injury Compensation Program (NVICP), and how that differs from proving a case in the civil courts, focusing on what it means to have a no-fault program and proving causation. I will use a case that started with the tragic death of a young child after a vaccine to illustrate the complexity and operation of the program, and also to address the idea of federal preemption, and how it limits the ability of those claiming vaccine injuries to use state courts for their claims.

Continue reading “National Vaccine Injury Compensation Program facts”

Nick Catone’s son dies tragically – blaming vaccines with no evidence

Nick Catone

On May 12, 2017, the son of retired UFC fighter Nick Catone, Nicholas Catone, by all accounts a healthy, sweet, happy, child, died in his sleep. It’s horrible to lose a child, and I want to start by extending my condolences to the family.

Sadly, I can’t stop there. His parents blame vaccines. The story is being spread in mom groups and understandably scares moms from vaccinating. But Nicholas’ tragic death is not a good reason to refuse vaccines. First, the alleged link to vaccines is extraordinarily weak. There is no good reason to blame vaccines for the boy’s tragic death. Second, even if this was linked to vaccines – and there’s no evidence of that – it’s still safer to vaccinate.  Continue reading “Nick Catone’s son dies tragically – blaming vaccines with no evidence”