Two conservative Republican senators are attempting to do away with the liability shield for vaccine manufacturers, as a measure to provide justice for patients who have adverse side effects from vaccines.
Public health experts, though, warn that doing so could severely curtail production and distribution of a variety of vaccines.
Sens. Rand Paul (R-KY) and Mike Lee (R-UT) on Tuesday introduced legislation to remove civil liability protections for pharmaceutical companies if their product allegedly causes an injury or death.
The bill, titled the End the Vaccine Carveout Act, would amend the Vaccine Injury Compensation Program, a federal panel created by Congress in the 1980s that reviews vaccine injury or wrongful death claims and uses funds collected through excise taxes on vaccines to compensate injury victims.
Paul and Lee aim to remove the stipulation that patients must have their case reviewed by the VICP before seeking remedy in civil court, opening manufacturers up for litigation.
The bill would also exclude COVID-19 vaccines from the designation “covered countermeasures” under the Public Readiness and Emergency Preparedness Act, removing immunity for manufacturers, distributors, and administrators from COVID-19 vaccine injury claims.
Paul called the federal vaccine compensation system “cronyism” that prevents patients from going “through the normal legal process.”
“When it comes to vaccines, and in many cases the COVID vaccine, the rules are rigged: you’re funneled into a federal no-fault program that limits damages, restricts your options, and — in many cases — leaves people without real justice,” Paul wrote in a statement.
Health and Human Services Secretary Robert F. Kennedy Jr. has signaled his desire to reform the VICP.
Last month, Kennedy removed two panelists from the Advisory Commission on Childhood Vaccines, which advises HHS on problems relating to the VICP.
The advisory commission recommends to HHS which vaccines should be included in the injury compensation program as well as which injuries are eligible for compensation under the federal program.
Kennedy has floated adding autism to the list of vaccine injuries to the program, as well as expanding the definitions of two serious brain conditions, encephalopathy and encephalitis, to allow certain autism cases to qualify.
Public health experts have warned that opening liability for vaccine manufacturers will crumble the existing immunization infrastructure in the U.S.
Experts say that the VICP was created as a reaction to a slew of lawsuits against vaccine manufacturers in the early 1980s, which cost companies upwards of $3.2 billion in the first few years.
Andrew Powaleny, a spokesman for the trade group PhRMA that represents drugmakers, told the Washington Examiner that his organization is “very concerned” about any legislation that would change VICP and “threaten continued patient access to FDA-approved vaccines.”
Congress created the VICP in 1986 to ensure pharmaceutical companies would still have the financial incentive to continue producing vaccines while ensuring injury victims were compensated.
Powaleny said that VICP offers a no-fault alternative to traditional litigation by not requiring proof of negligence from the drug companies. He also said that plaintiffs who take their case to VICP may file in civil court if they disagree with the federal panel’s verdict.
“The National Vaccine Injury Compensation Program (VICP) provides fair and timely compensation to the small number of individuals who experience side effects from vaccines that are recommended for routine administration to children or pregnant women,” Powaleny said. “It remains a vital safeguard for public health and importantly doesn’t shield manufacturers from liability.”
But Lee called the legal protections for pharmaceutical companies “unconstitutional vaccine carveouts,” saying that the VICP unjustly prevents vaccine injury victims from exercising their Seventh Amendment right to a trial by jury.
“Americans have a constitutional right to a trial by jury, but current laws allow Big Pharma players to dodge accountability and bar victims from pursuing their cases,” Lee wrote in a statement. “Many of these patients were forced to get vaccinated or lose their jobs during the pandemic and are now dealing with permanent and very serious complications.
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Rep. Paul Gosar (R-AZ) introduced the House version of the bill. He said in a press release that the bill “restores fairness, strengthens trust, and puts patients—not special interests—first.”
“No product should be shielded from accountability simply because it is labeled a vaccine,” Gosar wrote. “Americans deserve equal protection under the law, full transparency, and the right to seek justice when harmed.”
