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Johnson & Johnson is essentially protected under a 2005 federal law from liability for any injuries or deaths arising from its COVID-19 vaccine, whose distribution was halted Tuesday, experts say.
Health care providers, including manufacturers, have immunity from tort liability under the 2005 Public Readiness and Emergency Preparedness Act’s countermeasures injury compensation program. The act became effective Feb.4, 2020, when then-Secretary of Health and Human Services Alex Azar declared COVID-19 a public health emergency.
The Centers for Disease Control and the Federal Drug Administration said Tuesday in a joint statement there have been six reported U.S. cases of a “rare and severe” type of blood clot in individuals who received the J&J vaccine, out of more than 6.8 million to whom it has been administered as of Monday.
All six cases occurred among women between the ages of 18 and 48, with symptoms appearing six to 13 days after vaccination.
The agency said it is pausing use of the vaccine “out of an abundance of caution” until their review processes are complete.
New Brunswick, New Jersey-based J&J said in a statement it is reviewing these cases with European health authorities and has decided to proactively delay the vaccine’s rollout in Europe.
The statement said, “We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public.”
The PREP Act, which has been invoked several times previously, confers immunity on manufacturers and authorizes a fund to provide compensation for physical injury or deaths caused by vaccines, drugs or medical devices.
Renée Gentry, director of the vaccine injury litigation clinic at George Washington University in Washington, said vaccine producers “don’t really have any” liability under the countermeasures program.
The program is limited and provides for out-of-pocket expenses and lost wages, she said. Claims are filed with the U.S. Department of Health and Human Services.
The clinic’s s former director, Peter Meyers, who is professor emeritus at George Washington University Law School, said the only narrow exception to the PREP Act is if there was intentional misconduct.
“It’s a very poor compensation program” whose intent was to have manufacturers’ assistance in dealing with health pandemics, he said. Prior to COVID, there have been a little over 400 claims filed under the program, of which more than 90% were rejected by the HHS, Mr. Meyers said.