LEGAL OPINION - PREP ALLOWS FOR TWO DIFFERENT CAUSES OF ACTION

No case has ever alleged that wrongful death is permitted under the PREP Act

There have been over 600 cases filed around the country where a court has ruled on the protections and limitations of the PREP Act. Invariably, a line has been drawn between injuries involving the use of a covered countermeasure and those that didn’t.

In summary, if that injury was the result of a health care provider or other covered person’s use of a COVID-19 vaccine, Remdesivir, a ventilator, etc., then PREP precluded the recovery. If the injury resulted from some other tort (say negligence) that was not associated with the use or administration of a covered countermeasure (such as the roof caving in - even during the ‘pandemic’), then the case proceeded.

Contrary to a common misperception, PREP only provides conditional immunity from federal and state law: “[A] covered person shall be immune from suit and liability under Federal and State law,” “[s]ubject to the other provisions of this section [not ‘in accordance with’].” The wrongful death action is one such exception.

If a subsection of any statute is made ‘subject to’ some other provision, such provision shall yield to another provision to which it is made subject. This is opposite of a non-obstante clause that gives overriding effect to contrary provisions in the same statute.

A Court need look no further than the opening paragraphs of the PREP Act to recognize that the PREP Act doesn’t provide immunity, it conditions it.

However, no attorney has ever brought a case that pointed out that the PREP Act’s immunity is conditional. According to the language of statute itself, one exception permits state law claims for wrongful death or serious physical injury.

Exception to immunity of covered persons

42 U.S. Code § 247d–6d(d)(2) “An action under this subsection may be brought for wrongful death or serious physical injury by any person who suffers such injury or by any representative of such a person.”

The PREP Act provides two exceptions from the protections from suit and liability. One is Willful Misconduct (d)(1), the other is wrongful death and serious physical injury (d)(2). (d)(2) is not a subset of (d)(1), otherwise (d)(2) would be written as (d)(1)(A).

(d)(2) creates a permissible wrongful death action that overcomes liability protections. The General Exception (d)(1) – claims there is the sole exception. But there are two exceptions.

Wrongful Death and Willful Misconduct are not synonymous. Any interpretation that this is the sole exception is void for vagueness and contrary to the plain language of the statute.

Willful Misconduct is PREP’s made-up tort. The elements are:

42 U.S. Code § 247d–6d(c)Definition of willful misconduct

(1)Definition

(A)In general … the term “willful misconduct” shall, for purposes of subsection (d), denote an act or omission that is taken—

(i) intentionally to achieve a wrongful purpose; (ii) knowingly without legal or factual justification; and (iii) in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.

There are additional requirements such as a heightened pleading standard, a non-treating doctor’s verification, and a CICP prerequisite that is so impossible to satisfy that only one case has ever been filed in D.C (the only allowable venue)

Wrongful Death is essentially a negligence claim that resulted in death. It is infinitely easier to plead.

A statutorily authorized Wrongful Death cause of action obviates another one of PREP’s impossible hurdles — the enforcement action requirement.

Exclusion for regulated activity of manufacturer or distributor

42 U.S. Code § 247d–6d(c)(5)(A)

In general If an act or omission by a manufacturer or distributor with respect to a covered countermeasure, which act or omission is alleged under subsection (e)(3)(A) to constitute willful misconduct, is subject to regulation by this chapter or by the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], such act or omission shall not constitute “willful misconduct” for purposes of subsection (d) if—

(i) neither the Secretary nor the Attorney General has initiated an enforcement action with respect to such act or omission; or (ii) such an enforcement action has been initiated and the action has been terminated or finally resolved without a covered remedy.

It is my opinion that the PREP Act does not completely preempt a Plaintiff's state law Wrongful Death cause of action. No court has ruled on whether the PREP Act immunizes ‘covered persons’ for wrongful death under (d)(2).

Not intended as legal advice. Keep up the good fight!