AB 13

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.