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By Dylan Sherman September 27, 2018
Andrew Withers
By Andrew Withers September 27, 2018

Missouri House candidate misses mark on vaccine protections for manufacturers

Steve West, the Republican challenger for Missouri’s 15th House District in North Kansas City, has made headlines recently for his incendiary claims regarding Jews, homosexuality and Muslims, among other things.

His platform includes the long-debunked claim of links between vaccines and autoimmune disorders. The medical establishment, including the Centers for Disease Control and Prevention, has found no link between vaccines and autism, but a vocal minority continues to push to make vaccines voluntary. (Generally, if you want to attend  school you must have proof you have been vaccinated.)

Under the subheading "Vaccines Should Be Voluntary" on his website, West says developments in plumbing and private transportation have eliminated the need for vaccinations.

West also states that the U.S. has an autoimmune epidemic and that it began after vaccines were introduced in the mid-1900s. According to the American Academy of Pediatrics, there have been cases where it was presumed that a vaccine caused a dormant autoimmune disease to show up; however, there is no conclusive data to prove that vaccines are a root cause of autoimmune disorders. The academy and other studies have said that vaccination is proven to be beneficial for children.

One part of his website that caught our eye is a statement that "PHARMACEUTICAL COMPANIES that manufacture vaccines have IMMUNITY FROM PROSECUTION!"

Given his past record of making controversial statements, we decided to take a look. While West is correct that manufacturers of vaccines have certain legal immunities, his use of the term ‘prosecution’ implies criminal activity, and civil protections carry caveats.

Legislation to protect drug companies

When we reached out to West for evidence of his claim, he referenced a Wikipedia entry on the National Childhood Vaccine Injury Act of 1986.

A reading of the act shows it was created to allow a compensation program for cases involving vaccine-related injuries or death to be settled. The goal was to stabilize the supply of vaccines in a time when lawsuits were numerous.

The law created a no-fault system, which means that a company isn’t legally responsible for what happens to those who take the vaccine. Victims of vaccine-related injuries or death can file a claim with the National Vaccine Injury Compensation program.

This program shields the vaccine manufacturing companies from liability while paying for vaccine related injuries or deaths. The Secretary of Health and Human Services is in charge of what constitutes a vaccine-related injury and can recommend changes to vaccines in place.

Looking deeper, there was also a Supreme Court ruling in 2011, Bruesewitz v. Wyeth LLC, that said pharmaceutical companies have federal shield laws to protect them from product-liability shield lawsuits.

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The Supreme Court’s decision left the legality of vaccines to federal agencies, notably the Food and Drug Administration, to determine if a vaccine is in fact harmful to children.

These laws do have exceptions.

Vaccine manufacturers have to properly manufacture the vaccines and could be found liable if they knowingly released a tainted vaccine. For example, under the Public Readiness Preparedness Act, a manufacturer of a vaccine may still be held liable, even after a PREP Act declaration, for "willful misconduct."

We should note that pharmaceutical companies produce many other drugs that are not protected from civil lawsuits. For example, Wyeth Pharmaceuticals was successfully sued in 2016 for "bundling" one of its drugs in sales to hospitals, thereby discouraging patients from switching to other, cheaper options.

What’s prosecution

However, neither the law nor the ruling address criminal action — the action suggested by West’s reference to "prosecution."

Usually, prosecution relates to criminal charges, rather than civil actions, according to Merriam-Webster. The 1986 law and the Supreme Court decision say nothing about what would happen if criminal charges were brought up.

A search through the the U.S. Health and Wellness code showed that no vaccine manufacturer shall be held civilly liable. Although manufacturers are shielded from civil damages, we could find no law that protects them from criminal prosecution.

We should note that the word "prosecute" does sometimes come up in civil actions. If a party in a lawsuit doesn’t show up, for instance, a judge can dismiss the suit for "failure to prosecute."

This definition of "prosecute" does add an element of confusion to interpreting West’s statement, but the more common usage of the term is for criminal law.

Our ruling

West said, "PHARMACEUTICAL COMPANIES that manufacture vaccines have IMMUNITY FROM PROSECUTION!"

Federal law and a Supreme Court ruling protects pharmaceutical companies from being held liable under civil law for damages due to their vaccines.

But West said vaccine-makers are safe from "prosecution," and we found no indication that a vaccine-maker or its employees were shielded from prosecution under the law if they faced a criminal charge.

We rate this statement Mostly False.

Our Sources

Email exchange, Steve West, Republican candidate for 15th House District, Sept. 1, 2018

Steve West for Missouri website

Bruesewitz v. Wyeth Inc., 09-152 U.S.(2010)

"National Childhood Vaccine Injury Act of 1986." H.R.5546 (enacted) 99th Congress (1986)

American Academy of Pediatrics, Addressing Parents’ Concerns: Do Vaccines Cause Allergic or Autoimmune Diseases?, 1 Mar. 2003

Reuters, Supreme Court rules for vaccine makers on lawsuits, Feb. 22, 2011

National Vaccine Information Center, No Pharma Liability? No Vaccine Mandates, 2 Mar. 2011

Centers for Disease Control and Prevention, State Vaccination Requirements, 29 Jan. 2016

The United States Department of Justice, Vaccine Injury Compensation Program,

The National Center for Biotechnology Information,Vaccination and autoimmune diseases: is prevention of adverse health effects on the horizon?, 20 July 2017

Clinical Infectious Diseases,Vaccination in Patients with Chronic Rheumatic or Autoimmune Diseases, 1 May 2008

The United States Department of Justice, Wyeth and Pfizer Agree to Pay $784.6 Million to Resolve Lawsuit Alleging That Wyeth Underpaid Drug Rebates to Medicaid, April 27, 2016

Wikipedia, National Childhood Vaccine Injury Act

Email exchange with Sandra Davidson, Professor, Curators' Teaching Professor

Adjunct Professor, School of Law at the University of Missouri,Sept. 19

Email exchange with Sam Halabi, Director of the Center for Intellectual Property & Entrepreneurship and Associate Professor of Law at the University of Missouri, Sept. 19-20

Merriam-Webster online dictionary, Prosecution

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More by Dylan Sherman

Missouri House candidate misses mark on vaccine protections for manufacturers

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