Bill Text: MI SB0936 | 2011-2012 | 96th Legislature | Introduced
Bill Title: Torts; product liability; limitation on liability for drugs that have been approved by federal food and drug administration; rescind. Amends sec. 2946 of 1961 PA 236 (MCL 600.2946).
Spectrum: Partisan Bill (Democrat 12-0)
Status: (Introduced - Dead) 2012-02-08 - Referred To Committee On Government Operations [SB0936 Detail]
Download: Michigan-2011-SB0936-Introduced.html
SENATE BILL No. 936
February 8, 2012, Introduced by Senators BIEDA, WHITMER, HUNTER, GLEASON, SMITH, YOUNG, ANDERSON, GREGORY, JOHNSON, HOOD, WARREN and HOPGOOD and referred to the Committee on Government Operations.
A bill to amend 1961 PA 236, entitled
"Revised judicature act of 1961,"
by amending section 2946 (MCL 600.2946), as amended by 1995 PA 249.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
Sec.
2946. (1) It shall be is admissible as evidence in a
product liability action that the production of the product was in
accordance with the generally recognized and prevailing
nongovernmental standards in existence at the time the specific
unit of the product was sold or delivered by the defendant to the
initial purchaser or user.
(2) In a product liability action brought against a
manufacturer or seller for harm allegedly caused by a production
defect, the manufacturer or seller is not liable unless the
plaintiff establishes that the product was not reasonably safe at
the time the specific unit of the product left the control of the
manufacturer or seller and that, according to generally accepted
production practices at the time the specific unit of the product
left the control of the manufacturer or seller, a practical and
technically feasible alternative production practice was available
that would have prevented the harm without significantly impairing
the usefulness or desirability of the product to users and without
creating equal or greater risk of harm to others. An alternative
production practice is practical and feasible only if the
technical, medical, or scientific knowledge relating to production
of the product, at the time the specific unit of the product left
the control of the manufacturer or seller, was developed,
available, and capable of use in the production of the product and
was economically feasible for use by the manufacturer. Technical,
medical, or scientific knowledge is not economically feasible for
use by the manufacturer if use of that knowledge in production of
the product would significantly compromise the product's usefulness
or desirability.
(3) With regard to the production of a product that is the
subject of a product liability action, evidence of a philosophy,
theory, knowledge, technique, or procedure that is learned, placed
in use, or discontinued after the event resulting in the death of
the person or injury to the person or property, which if learned,
placed in use, or discontinued before the event would have made the
event less likely to occur, is admissible only for the purpose of
proving the feasibility of precautions, if controverted, or for
impeachment.
(4) In a product liability action brought against a
manufacturer or seller for harm allegedly caused by a product,
there is a rebuttable presumption that the manufacturer or seller
is not liable if, at the time the specific unit of the product was
sold or delivered to the initial purchaser or user, the aspect of
the product that allegedly caused the harm was in compliance with
standards relevant to the event causing the death or injury set
forth in a federal or state statute or was approved by, or was in
compliance with regulations or standards relevant to the event
causing the death or injury promulgated by, a federal or state
agency responsible for reviewing the safety of the product.
Noncompliance with a standard relevant to the event causing the
death or injury set forth in a federal or state statute or lack of
approval by, or noncompliance with regulations or standards
relevant to the event causing the death or injury promulgated by, a
federal or state agency does not raise a presumption of negligence
on the part of a manufacturer or seller. Evidence of compliance or
noncompliance with a regulation or standard not relevant to the
event causing the death or injury is not admissible.
(5)
In a product liability action against a manufacturer or
seller,
a product that is a drug is not defective or unreasonably
dangerous,
and the manufacturer or seller is not liable, if the
drug
was approved for safety and efficacy by the United States food
and
drug administration, and the drug and its labeling were in
compliance
with the United States food and drug administration's
approval
at the time the drug left the control of the manufacturer
or
seller. However, this subsection does not apply to a drug that
is
sold in the United States after the effective date of an order
of
the United States food and drug administration to remove the
drug
from the market or to withdraw its approval. This subsection
does
not apply if the defendant at any time before the event that
allegedly
caused the injury does any of the following:
(a)
Intentionally withholds from or misrepresents to the
United
States food and drug administration information concerning
the
drug that is required to be submitted under the federal food,
drug,
and cosmetic act, chapter 675, 52 Stat. 1040, 21 U.S.C. 301
to
321, 331 to 343-2, 344 to 346a, 347, 348 to 353, 355 to 360,
360b
to 376, and 378 to 395, and the drug would not have been
approved,
or the United States food and drug administration would
have
withdrawn approval for the drug if the information were
accurately
submitted.
(b)
Makes an illegal payment to an official or employee of the
United
States food and drug administration for the purpose of
securing
or maintaining approval of the drug.
