Americans who experience side effects from COVID-19 vaccines will not be able to sue the drug companies that made the vaccines.
Pfizer and Moderna are exempted from the usual rules that allow lawsuits for damaging side-effects because the federal government invoked a 2005 rule protecting companies making essential medical supplies from lawsuits, according to CNBC.
In March, the federal government said that “countermeasures” against COVID-19 would be covered under the Public Readiness and Emergency Preparedness Act.
“During the pandemic, the Trump Administration has made broader use of the PREP Act to expand access to potentially life-saving countermeasures than we’ve ever done before in a public health emergency,” said HHS Secretary Alex Azar, according to a statement on the HHS website.
The step reflected the unique circumstances of the pandemic.
“It is very rare for a blanket immunity law to be passed,” Rogge Dunn, a Dallas labor and employment attorney, told CNBC. “Pharmaceutical companies typically aren’t offered much liability protection under the law.”
Dunn said that the Trump administration’s push to put a vaccine in play in record time was linked to the action, which only allows liability suits for side effects when willful misconduct can be proven.
“When the government said, ‘We want you to develop this four or five times faster than you normally do,’ most likely the manufacturers said to the government, ‘We want you, the government, to protect us from multimillion-dollar lawsuits,'” said Dunn.
The deal also cut the drug price, he told the network.
“The government doesn’t want people suing the companies making the COVID vaccine. Because then, the manufacturers would probably charge the government a higher price per person per dose,” Dunn said.
The Food and Drug Administration, which approved an emergency authorization for the drug to be used, is also immune from lawsuits.
“You can’t sue the FDA for approving or disapproving a drug,” Dorit Reiss, a professor at the University of California Hastings College of Law, told CNBC. “That’s part of its sovereign immunity.”
Employers can also mandate that workers get the vaccine, Reiss said.
“Requiring a vaccine is a health and safety work rule, and employers can do that,” said Reiss.
That means that side effects would be dealt with under workers’ compensation programs.
“But there are significant limits or caps on the damages an employee can recover,” Dunn told CNBC.
The federal government created the Countermeasures Injury Compensation Program to assist anyone who is impacted by a protected company. However, CNBC reported, the fund “typically only deals with vaccines you probably would never get, like the H1N1 and anthrax vaccines.”
It would provide no more than $50,000 a year and a death benefit cannot top $370,376.
And the program, which started a decade ago, long before the arrival of the coronavirus, is not easy to access.
“This government compensation program is very hard to use,” Reiss told CNBC. “The bar for compensation is very high.”
Out of 499 claims filed in CICP’s 10-year history, only 29 were ever paid, CNBC reported.
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