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Judge in Gardasil lawsuit throws out most claims

Dorit Rubinstein Reiss, a law professor and vaccination policy expert, discusses a federal judge’s recent decision in the Gardasil lawsuit, which barred several claims against Merck as preempted by the National Childhood Vaccine Injury Act but permitted discovery to proceed on claims involving failure to warn the plaintiffs’ doctors and fraudulent concealment. This pivotal ruling reduced the scope of the plaintiffs’ cases, originally marked by broad allegations, to more specific claims of deficient warnings to healthcare providers and concealed risks, despite substantial evidence against the alleged harms of the HPV vaccine.

COVID-19 vaccine liability

Vaccine court myths – instead, here are facts about the NVICP

The anti-vaccine world loves its myths, because, lacking any real scientific evidence supporting their outlandish claims, fairy tales are all they have. Not that I like picking and choosing the worst of the anti-vaccine urban legends, but the vaccine court myths are among the most egregious and ridiculous.

Although there are a lot of vaccine court myths, I wanted this article will focus on just three critical points:

  1. The vaccine court vs. civil courts for plaintiffs.
  2. Vaccine manufacturers are immune to lawsuits.
  3. Billions of dollars have been paid out to “victims.”
  4. The vaccine court said that vaccines cause autism.

Let’s get to the article.

Read More »Vaccine court myths – instead, here are facts about the NVICP
brown wooden gavel on brown wooden table

NVICP compensation and autoimmune syndromes – vaccine court review

This article about NVICP compensation and autoimmune syndromes was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who 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 a 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. She is also a member of the Vaccines Working Group on Ethics and Policy.

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 NVICP 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).

Read More »NVICP compensation and autoimmune syndromes – vaccine court review
SIRVA vaccine court

A review of how the vaccine court deals with SIRVA claims

This article about the vaccine court and SIRVA claims was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who 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 a 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. She is also a member of the Vaccines Working Group on Ethics and Policy.

In this article, we are going to take a look at how “shoulder injury related to vaccine administration” (SIRVA) relates to the National Vaccine Injury Compensation Program (NVICP), often called the Vaccine Court, claims. In 1986, the United States Congress passed the National Childhood Vaccine Injury Act, which among other things created the  NVICP. The act’s main goal was to protect vaccine manufacturers from vaccine injury claims and liability–but not for the reasons you might think. 

Congress was rightly concerned that the costs for these legal actions were going to drive most, if not all, manufacturers from the USA market. That would have been a horrific problem for the country, with no ability to protect children from deadly and dangerous diseases.

The NVICP provides a no-fault program to resolve vaccine injury claims – “quickly, easily, with certainty and generosity.” The program was (and continues to be) funded by a tax on all vaccines sold in the country. Moreover, using a system of expert administrative “judges” (called Special Masters), a petitioner seeking to establish causation-in-fact must show, by a preponderance of the evidence, that but for the vaccination, they would not have been injured, and that the vaccination was a substantial factor in bringing about their injury.

Read More »A review of how the vaccine court deals with SIRVA claims
SIRVA vaccine court

How does the vaccine court deal with SIRVA claims? A review

This article about the vaccine court and SIRVA claims was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who 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 a 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. She is also a member of the Vaccines Working Group on Ethics and Policy.

In this article, we are going to take a look at how “shoulder injury related to vaccine administration” (SIRVA) relates to the National Vaccine Injury Compensation Program (NVICP) claims. In 1986, the United States Congress passed the National Childhood Vaccine Injury Act, which among other things created the  NVICP, sometimes called the Vaccine Court. The act’s main goal was to protect vaccine manufacturers from vaccine injury claims and liability–but not for the reasons you might think. 

Congress was rightly concerned that the costs for these legal actions were going to drive most, if not all, manufacturers from the USA market. That would have been a horrific problem for the country, with no ability to protect children from deadly and dangerous diseases.

The NVICP provides a no-fault program to resolve vaccine injury claims – “quickly, easily, with certainty and generosity.” The program was (and continues to be) funded by a tax on all vaccines sold in the country. Moreover, using a system of expert administrative “judges” (called Special Masters), a petitioner seeking to establish causation-in-fact must show, by a preponderance of the evidence, that but for the vaccination, they would not have been injured, and that the vaccination was a substantial factor in bringing about their injury.

Read More »How does the vaccine court deal with SIRVA claims? A review
COVID-19 vaccine liability

COVID-19 vaccine liability – what are the legal facts and limits

This article about COVID-19 vaccine liability was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who 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 a 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. She is also a member of the Vaccines Working Group on Ethics and Policy.

I have been getting many questions about vaccine manufacturers and liability. Here is a short answer. There are limits to the ability to sue manufacturers for injuries from routine vaccines given to children or pregnant women. They are not absolute and are accompanied by a compensation program that is easier to win in than the regular courts.

There are very strong limits on the ability to sue manufacturers of emergency products – not just vaccines. Those are accompanied by a very hard to use compensation program, that provides limited compensation.

Ideally, I would like to see COVID-19 vaccine liability moved to the routine compensation program.

Read More »COVID-19 vaccine liability – what are the legal facts and limits

national vaccine injury compensation program

National Vaccine Injury Compensation Program facts

This article about the National Vaccine Injury Compensation Program was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who 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 a 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 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.

Read More »National Vaccine Injury Compensation Program facts

Del Bigtree Andrew Wakefield

Del Bigtree vaccine safety complaints – HHS Vaccine Program responds

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.Read More »Del Bigtree vaccine safety complaints – HHS Vaccine Program responds

vaccine testing

Debunking myths about vaccine testing and safety

The goal of this article is to respond to a number of recurring myths raised by anti-vaccine activists regarding vaccine testing and safety – a common trope used against vaccines.

The bottom line is that vaccines are extensively and carefully tested for safety, and that vaccine safety is shown by many, many studies from a variety of sources, reinforcing each other and all pointing to the same result – serious problems from vaccines are possible, but extremely rare. And those small, rare risks are far outweighed by the benefits vaccines provide by protecting us against much larger risks.

Read More »Debunking myths about vaccine testing and safety