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September 2011 Special Session
2011 - 2012 LEGISLATURE
October 11, 2011 - Introduced by Committee on Assembly Organization, by request
of Governor Scott Walker, Representative Kooyenga, and Senator Zipperer.
Referred to Committee on Judiciary and Ethics.
AB13,1,3 1An Act to amend 895.047 (1) (intro.); and to create 895.0475 of the statutes;
2relating to: providing immunity from liability to drug and device
3manufacturers and sellers under certain circumstances.
Analysis by the Legislative Reference Bureau
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.
The people of the state of Wisconsin, represented in senate and assembly, do
enact as follows:
AB13, s. 1 1Section 1. 895.047 (1) (intro.) of the statutes, as created by 2011 Wisconsin Act
22
, is amended to read:
AB13,2,63 895.047 (1) Liability of manufacturer. (intro.) In Except as provided in s.
4895.0475, in
an action for damages caused by a manufactured product based on a
5claim of strict liability, a manufacturer is liable to a claimant if the claimant
6establishes all of the following by a preponderance of the evidence:
AB13, s. 2 7Section 2. 895.0475 of the statutes is created to read:
AB13,2,9 8895.0475 Product liability; drugs and devices. (1) Definitions. In this
9section:
AB13,2,1010 (a) "Device" has the meaning given in s. 450.01 (6).
AB13,2,1111 (b) "Drug" has the meaning given in s. 450.01 (10).
AB13,2,1212 (c) "Entity" means a corporation, partnership, or association.
AB13,3,313 (d) "Manufacturer" means an entity licensed or approved by the federal food
14and drug administration to engage in the manufacture of drugs or devices, consistent

1with the definition of "manufacturer" under the federal food and drug
2administration's regulations and interpreted guidances implementing the federal
3Prescription Drug Marketing Act.
AB13,3,12 4(2) Liability of manufacturer or seller; strict liability. Except as provided
5in sub. (4), a manufacturer or a seller of a drug or device is immune from civil liability
6for any claim based on strict liability for a defect in the design of a drug or device if
7the drug or device was approved for safety and efficacy by the federal food and drug
8administration at the time the drug or device left the control of the manufacturer or
9seller. A drug or device approved pursuant to the procedures under section 510 (k)
10of the federal Food, Drug and Cosmetic Act, 21 USC 360, shall not be considered
11approved for safety and efficacy by the federal food and drug administration for the
12purposes of this subsection.
AB13,3,19 13(3) Liability of manufacturer or seller; failure to warn. Except as provided
14in sub. (4), a manufacturer or a seller of a drug or device is immune from civil liability
15for any claim based on the failure to adequately warn of risk of a drug or device if
16labeling for the drug or device was made available to the consumer or to the person
17who prescribed the drug or device to the consumer and the labeling was in
18compliance with the federal food and drug administration's applicable standards for
19labeling at the time the drug or device left the control of the manufacturer or seller.
AB13,3,24 20(4) Exception; fraud. Immunity under subs. (2) and (3) shall not extend to a
21claim brought against a manufacturer or a seller of a drug or device if the federal food
22and drug administration determines that the manufacturer or seller committed a
23fraud against the federal food and drug administration with regard to the product
24at issue in the claim.
AB13, s. 3 25Section 3. Initial applicability.
AB13,4,2
1(1) The treatment of section 895.0475 (2) of the statutes first applies to a claim
2based on strict liability commenced on the effective date of this subsection.
AB13,4,43 (2) The treatment of section 895.0475 (3) of the statutes first applies to a claim
4based on failure to warn of risk commenced on the effective date of this subsection.
AB13,4,55 (End)
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