Senate Bill No. 768
(By Senators Kessler and Oliverio)
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[Originating in the Committee on the Judiciary; reported April 1,
2009.]
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A BILL to amend the Code of West Virginia, 1931, as amended, by
adding thereto a new section, designated §55-7-23a, relating
to products liability claims that are based upon prescription
drug manufacturer's alleged failure to warn.
Be it enacted by the Legislature of West Virginia:
That the Code of West Virginia, 1931, as amended, be amended
by adding thereto a new section, designated §55-7-23a, to read as
follows:
ARTICLE 7. ACTIONS FOR INJURIES.
§55-7-23a. Prescription drugs; claims based on inadequate
warnings.
No manufacturer of a prescription drug shall be liable in a
products liability action for failing to provide a warning or other
instruction directly to a consumer if an adequate warning or
instruction has been provided to the physician or other legally
authorized person who prescribes that prescription drug for the claimant and if the manufacturer has not done direct to consumer
advertising regarding the prescription drug:
Provided, That the
provisions of this section shall not apply if the United States
Food and Drug Administration requires that such direct consumer
warnings or instructions accompany the product.
If the warning or instruction given in connection with a
prescription drug has been approved by the United States Food and
Drug Administration under the Federal Food, Drug and Cosmetic Act,
21 U. S. C. §301,
et seq. or the Public Health Service Act, 42 U.
S. C. §201,
et seq., the warning or instruction shall be presumed
adequate.
For purposes of the section, the term "drug" has the meaning
defined in the Federal Food, Drug and Cosmetic Act.
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(NOTE: The purpose of this bill is to codify the learned
intermediary doctrine, which recognizes: (1) That prescribing
physicians are in a superior position to impart drug warnings to
patients and provide independent medical decisions as to whether
use of the drug is appropriate for treatment of a particular
patient; (2) that drug manufacturers lack effective means to
communicate directly with each patient; and (3) that imposing a
duty to warn upon drug manufacturers would unduly interfere with
the physician-patient relationship.)