Richard H. Hughes, IV, Kala Shankle, and Chloe Hillard, attorneys in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, co-authored an article in Health Affairs, titled “COVID-19 PREP Act Litigation: The Tip of the Liability Iceberg.”

Following is an excerpt:

While the Public Readiness and Emergency Preparedness Act (PREP Act) is presumed to authorize the Secretary of the Department of Health and Human Services (HHS) to limit the liability of those tasked with responding to the COVID-19 pandemic, several hundred cases have already been filed against health care providers. Most notably, these include owners and operators of senior care and other long-term care facilities involving allegations of negligence in failing to protect patients from COVID-19.

The litigation is likely to reach beyond the long-term care sector. Biopharmaceutical manufacturers, distributors, pharmacies, and providers along the COVID-19 supply chain may face the risk of suits. These suits could test the liability protections of the PREP Act, as multiple courts of appeal have already called into question the presumption that it preempts state tort law.

The PREP Act Provides Broad Liability Protection

In 2005, President George W. Bush announced a national strategy to prepare for an influenza outbreak. Following the SARS and avian influenza outbreaks, he warned that a similar pandemic could reach an unprepared United States. Stockpiling vaccines and encouraging vaccine innovation was an important aspect of Bush’s strategy. However, at the time there was only one US manufacturer that could produce the influenza vaccine, rendering the stockpile strategy incomplete. Because vaccine-related litigation had previously driven vaccine manufacturers out of the market, President Bush called upon Congress to pass liability protection to spur innovation. He also asked Congress to extend liability protection to manufacturers and distributors of critical supplies, as well as the providers who would care for patients during a pandemic. The intent was to insulate the entire medical countermeasures enterprise and health care system from liability concerns during the uncertain circumstances of emergency responses.

The result was the PREP Act, passed in December 2005, which limits legal liability for losses relating to the manufacture, testing, development, distribution, administration, and use of medical countermeasures against chemical, biological, radiological, and nuclear agents of terrorism, epidemics, and pandemics.

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