§ 82.008.Compliance with Government Standards

The regulatory compliance presumption, in two parallel versions.

The first applies to mandatory standards. There is a rebuttable presumption that a manufacturer or seller is not liable for injury caused by an aspect of the formulation, labeling, or design of a product if it establishes that these complied with mandatory safety standards or regulations adopted by the federal government or a federal agency.

The second applies to pre-market approval. The same presumption arises where the product was subject to pre-market licensing or approval by the federal government and the manufacturer complied with the government's procedures.

Each is rebutted the same two ways. Either the standards or approval procedures were inadequate to protect the public from unreasonable risks, or the manufacturer withheld or misrepresented information material and relevant to the government's determination.

The first ground is significant. A claimant may attack the federal standard itself as insufficient, so compliance is a presumption rather than a defence — which is why this section is not federal preemption.

Subsection (d) is the important exclusion: the section does not extend to manufacturing flaws or defects even where the manufacturer complied with all federally mandated quality control and manufacturing practices.

Compliance addresses whether the design and labelling were adequate. A product that departed from its own approved specification is a different claim, and this section does not touch it.

Subsection (e): the section does not extend to products covered by the pharmaceutical warnings section, which has its own presumption.