House File 712, which advanced out of subcommittee would require vaccine manufacturers to waive liability protection for design defect claims.
Design defect claims occur when a problem with the vaccine’s design, rather than a flaw in the manufacturing process, makes it dangerous, even if it was produced properly and administered as intended.
State Rep. Charley Thomson, who introduced the bill, told The Defender that although the bill stalled in the judiciary committee, it isn’t dead. It can either be added to another bill this legislative term, or he can reintroduce it next term.
Thomson said he proposed the law because he didn’t think companies should be able to put products on the market if they don’t take responsibility for their potential to injure people.
Thomson said:
“We don’t allow it for toaster ovens, for paint, for any one of 10 million different items that people buy in the United States, and we shouldn’t allow it for vaccines.
“If anything, we should maybe be a little more strict with things that are very complicated and are being put into people’s bodies and represented as safe and not poisonous.
“If you are doing that, why would you object to being held to account?”
The bill comes amid growing public sentiment that vaccine makers should not have immunity from legal action and the public should be able to sue the manufacturer of a vaccine that caused them harm.
Vaccine makers won freedom from liability from design defects in a 2011 Supreme Court decision, Bruesewitz v. Wyeth, when the Court effectively reinterpreted the 1986 National Childhood Vaccine Injury Act to give Big Pharma blanket liability.
Until that point, the act had given Big Pharma partial liability protection for vaccines listed on the Centers for Disease Control and Prevention’s (CDC) childhood immunization schedule but continued to hold them responsible for product design defects.
Thomson said that in the subcommittee discussion, the support and opposition to the proposed bill didn’t simply break down along partisan lines — both Democrats and Republicans supported and opposed the bill.
Lindsay Mahar of Informed Choice Iowa said that people concerned with vaccine safety have been working for years to develop different legal mechanisms to protect the public from vaccine injuries. Part of the thinking behind the bill, she said, is that “if we could just restore accountability, the system would self-correct in a lot of ways.”
She said some people were concerned that passing the law on a state level might result in vaccine makers simply leaving the state. They said they hope the proposed bill will spark a state and national conversation about ending liability for vaccine makers.
Informed Choice Iowa saw a lot of public support for the bill, with opposition coming primarily from the pharmaceutical companies and medical associations, Mahar added.
She said public support for vaccine mandates and liability for Big Pharma has shifted since the COVID-19 pandemic period. Advocacy and education work by organizations like hers, along with “social media and the internet have just really helped educate people, get other sources of information besides just what they’re told in the doctor’s office.”
A 2022 Iowa poll found that only 34% of Iowans supported mandatory school vaccinations.
1986 Act set up ‘no-fault’ system to protect vaccine makers from lawsuits
The 1986 Act established the National Vaccine Injury Compensation Program (VICP), which adjudicates vaccine injury claims.
The act set up a “no-fault” system. Instead of suing the manufacturers, people injured by vaccines can file a claim against the U.S. Department of Health and Human Services through the VICP — also known as the “vaccine court” — which adjudicates the claims.
The VICP was meant to insulate vaccine makers from lawsuits that could bankrupt them while ensuring injury victims had a straightforward, non-adversarial and fair path to compensation.
Supporters say the program ensures access to vaccines for the broader public while compensating injury victims. However, critics say the program has devolved to protect government agencies and corporations rather than the health of vaccinated children.
Between 1988-2022, 28,292 petitions were filed with the VICP, according to the Health Resources & Services Administration, which houses the program.
Over that 30-year period, 24,602 petitions have been adjudicated, with 11,671 of those determined to be compensable, and 12,931 dismissed. Total compensation paid was approximately $5.3 billion.
Bruesewitz decision ‘devastating’ for vaccine-injured people and their families
When the 1986 law was first passed, it gave drug companies partial liability protection, but still allowed, in certain circumstances, an injured party who had gone through the vaccine court and wasn’t happy with the outcome to bring a case in court against the manufacturer, Children’s Health Defense General Counsel Kim Mack Rosenberg said.
This possibility was “severely curtailed” by the 2011 Supreme Court decision in Bruesewitz v. Wyeth, she said.
The case began as a Pennsylvania lawsuit brought by the parents of Hannah Bruesewitz, who suffered seizures and developmental issues after taking the DPT vaccine in 1992. The vaccine court didn’t compensate Hannah’s parents, so they sued the vaccine manufacturer, Wyeth (now Pfizer) in state court in Pennsylvania.
In its majority ruling in favor of Wyeth, the court interpreted the 1986 Act to shield Big Pharma with full immunity from liability for vaccine injuries by ruling that people could no longer sue vaccine makers for injuries caused by design defects.
In a scathing dissenting opinion, Justice Sonia Sotomayer, joined by Justice Ruth Bader Ginsburg, accused the court of imposing its own policy preferences, misconstruing the Act, and disturbing “the careful balance Congress struck between compensating vaccine-injured children and stabilizing the childhood vaccine market.”
Sotomayer noted that as Bruesewitz was argued, there were 5,000 petitions in the vaccine court alleging a causal link between some vaccines and autism spectrum disorder and that Wyeth/Pfizer argued that if the court did not find in its favor, it “could unleash a ‘crushing wave’ of tort litigation that would bankrupt vaccine manufacturers and deplete vaccine supply.”
Sotomayer wrote:
“This concern underlies many of the policy arguments in respondent’s brief and appears to underlie the majority and concurring opinions in this case. Manufacturers, given the lack of robust competition in the vaccine market, will often have little or no incentive to improve the designs of vaccines that are already generating significant profit margins.”
Mack Rosenberg said the decision, “was devastating to those who were injured or killed, and their families. Post-Bruesewitz, parties have very limited judicial remedies against the manufacturers, including manufacturing defect, failure to warn, and fraud-based claims, all of which are challenging claims for a plaintiff to bring.”
She said if the Iowa bill were enacted, she expects it would be subject to challenges due to its conflicts with Breusewitz.
However, Mack Rosenberg added, “This bill is important from an educational perspective as well. At a minimum, this bill focuses attention on the extraordinary liability protection enjoyed by vaccine manufacturers.”
She added:
“More and more people are waking up to the reality of vaccine injury, particularly as a result of COVID-19 vaccine injuries. People also need to know that vaccine manufacturers have no incentive to make safer vaccines due to the liability shield.”
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Brenda Baletti, Ph.D., is a senior reporter for The Defender. She wrote and taught about capitalism and politics for 10 years in the writing program at Duke University. She holds a Ph.D. in human geography from the University of North Carolina at Chapel Hill and a master’s from the University of Texas at Austin.
