Covered products, no COVID-19 products liability, when

537.1015. Covered products, no COVID-19 products liability, when — evidence required for liability — inapplicability, when. — 1. Notwithstanding any other provision of law to the contrary, and except as otherwise provided in this section, no individual or entity who designs, manufactures, imports, distributes, labels, packages, leases, sells, or donates a covered product shall be liable in a COVID-19 products liability action if the individual or entity:

(1) Does not make the covered product in the ordinary course of business;

(2) Does make the covered product in the ordinary course of business, however the emergency due to COVID-19 requires the covered product to be made in a modified manufacturing process that is outside the ordinary course of business; or

(3) Does make the covered product in the ordinary course of business and use of the covered product is different than its recommended purpose and used in response to the emergency due to COVID-19.

2. For a plaintiff to prevail in a COVID-19 products liability action over the use or misuse of a covered product, the plaintiff shall prove by clear and convincing evidence:

(1) Recklessness or willful misconduct by the individual or entity; and

(2) That the alleged harm, damage, breach, or tort resulting in the personal injury was caused by the alleged recklessness or willful misconduct.

3. The provisions of this section shall not apply to any fraud in connection with the advertisement of any covered product.

4. The provisions of this section shall apply to any claim for damages that has a causal relationship with the administration to or use by an individual of a covered product, including a causal relationship with the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, lease, donation, dispensing, prescribing, administration, licensing, or use of such covered product.

5. The provisions of this section shall apply only if the covered product was administered or used for the treatment of or protection against COVID-19.

6. The provisions of this section shall apply to a covered product regardless of whether such covered product is obtained by donation, commercial sale, or any other means of distribution by or in partnership with federal, state, or local public health officials or the private sector.