WASHINGTON (Legal Newsline) - Protection from liability claims is all but certain in the fight against COVID-19 for the vaccine manufacturers, distributors of the new drugs and pharmacists immunizing the public who follow government-mandated protocols, according to attorneys on a recent conference call sponsored by Lawyers for Civil Justice that discussed the Pfizer/BioNTech vaccine.
There is less certainty about liability protection for protective equipment (PPE) manufacturers, retail outlets selling PPE, restaurants and other businesses and institutions open to the public during the pandemic.
The lawyers cited a 2005 federal law, the Public Readiness and Emergency Preparedness Act (PREP), approved in the wake of avian flu outbreak, to protect manufacturers and distributors when a public emergency is declared by the U.S. Department of Health and Human Services (HHS). Pharmacists were added this past September under an HHS order. (No group is protected in instances of willful misconduct.)
“It was enacted so that manufacturers wouldn’t have to be looking over their shoulders in fear of lawsuits when developing a vaccine,” Paul Taylor, Senior Counsel for the U.S. House Republican Caucus, said during the call.
The PREP Act may cover other business and institutions from COVID claims in certain instances, but protection is not guaranteed, according to Cary Silverman, partner at Shook, Hardy & Bacon, one of the country’s leading business defense firms.
For the act to apply “the lawsuit needs to be tied to a product covered by the Act, not just alleged exposure due to negligence,” Silverman told Legal Newsline.
“Coverage also depends on whether the product is used pursuant to the instructions of an ‘authority having jurisdiction’ under the law,” he added.
In its most recent advisory, Office of General Counsel for HHS included illustrations of how the PREP Act may offer a defense when a business or institution is blamed for an infection.
The examples include:
-A claim that a university should have tested more frequently than required by local guidance;
-A claim against a grocery store by a customer saying the store did not follow local guidance on cloth mask use; and
-A claim against a pharmacy denying a vaccine when the pharmacy was following CDC prioritization guidance.
“The examples provide HHS’s opinion that in some circumstances the PREP Act’s liability protection may apply, but not in others,” Silverman said.
Sixteen states have thus far approved legislation offering liability protections from COVID exposure claims. Silverman said that additional states and Congress need to approve liability protection legislation as well.
“Businesses, schools, religious institutions and others need more assurance than the PREP Act offers,” he said. “That is why there is strong interest in a straight-forward legislative solution at the federal or state level that removes the threat of liability when they do their best to follow public health guidance, which is continually evolving with science and conditions.”