Providing immunity from liability to drug and device manufacturers and sellers under certain circumstances

What it would have done

Summary by the Legislative Reference Bureau, the Legislature's nonpartisan drafting office. It's their wording, not ours.

This bill provides immunity from liability to a manufacturer or a seller of a drug or device for any claim based on strict liability for a defect in the drug or device if the drug or device was approved by the federal Food and Drug Administration (FDA) at the time the drug or device left the control of the manufacturer or seller. The bill also provides immunity from liability to a manufacturer or seller of a drug or device for any claim based on the failure to warn of the risk of the drug or device if labeling for the drug or device was made available to the consumer or the person who prescribed the drug or device and the labeling was in compliance with applicable standards established by the FDA at the time the drug or device left the control of the manufacturer or seller.

The bill defines a "device" as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component, part, or accessory, which does not achieve any of its principal intended purposes through chemical action within or on the body of a person or other animal, is not dependent upon being metabolized for the achievement of any of its principal intended purposes, and is: (a) recognized by the U.S. pharmacopoeia and national formulary or official homeopathic pharmacopoeia of the United States, or any supplement to either of them; (b) intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or other conditions in persons or other animals; or (c) intended to affect the structure or any function of the body of persons or other animals. The bill defines a "drug" as: 1) any substance recognized as a drug in the official U.S. pharmacopoeia and national formulary or official homeopathic pharmacopoeia of the United States or any supplement to either of them; 2) any substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or other conditions in persons or other animals; 3) any substance other than a device or food intended to affect the structure or any function of the body of persons or other animals; or 4) any substance intended for use as a component of any article specified in items 1) to 3), above, but does not include gases or devices or articles intended for use or consumption in or for mechanical, industrial, manufacturing, or scientific applications or purposes. The bill defines a "manufacturer" as an entity licensed or approved by the FDA to engage in the manufacture of drugs or devices. The bill defines an "entity" as a corporation, partnership, or association.

Who's behind it

4 lawmakers are its authors⁠. 4 have no party on record.

2 more lawmakers signed on in support⁠.