December 30, 2003, Introduced by Rep. Drolet and referred to the Committee on Judiciary.
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:
1 Sec. 2946. (1) It shall
be is admissible as evidence in a
2 product liability action that the production of the product was
3 in accordance with the generally recognized and prevailing
4 nongovernmental standards in existence at the time the specific
5 unit of the product was sold or delivered by the defendant to the
6 initial purchaser or user.
7 (2) In a product liability action brought against a
8 manufacturer or seller for harm allegedly caused by a production
9 defect, the manufacturer or seller is not liable unless the
10 plaintiff establishes that the product was not reasonably safe at
1 the time the specific unit of the product left the control of the
2 manufacturer or seller and that, according to generally accepted
3 production practices at the time the specific unit of the product
4 left the control of the manufacturer or seller, a practical and
5 technically feasible alternative production practice was
6 available that would have prevented the harm without
7 significantly impairing the usefulness or desirability of the
8 product to users and without creating equal or greater risk of
9 harm to others. An alternative production practice is practical
10 and feasible only if the technical, medical, or scientific
11 knowledge relating to production of the product, at the time the
12 specific unit of the product left the control of the manufacturer
13 or seller, was developed, available, and capable of use in the
14 production of the product and was economically feasible for use
15 by the manufacturer. Technical, medical, or scientific knowledge
16 is not economically feasible for use by the manufacturer if use
17 of that knowledge in production of the product would
18 significantly compromise the product's usefulness or
19 desirability.
20 (3) With regard to the production of a product that is the
21 subject of a product liability action, evidence of a philosophy,
22 theory, knowledge, technique, or procedure that is learned,
23 placed in use, or discontinued after the event resulting in the
24 death of the person or injury to the person or property, which if
25 learned, placed in use, or discontinued before the event would
26 have made the event less likely to occur, is admissible only for
27 the purpose of proving the feasibility of precautions, if
1 controverted, or for impeachment.
2 (4) In a product liability action brought against a
3 manufacturer or seller for harm allegedly caused by a product,
4 there is a rebuttable presumption that the manufacturer or seller
5 is not liable if, at the time the specific unit of the product
6 was sold or delivered to the initial purchaser or user, the
7 aspect of the product that allegedly caused the harm was in
8 compliance with standards relevant to the event causing the death
9 or injury set forth contained
in a federal or state statute or
10 was approved by, or was in compliance with regulations or
11 standards relevant to the event causing the death or injury
12 promulgated by, a federal or state agency responsible for
13 reviewing the safety of the product. Noncompliance with a
14 standard relevant to the
event causing the death or injury set
15 forth contained in a federal or state statute or
lack of
16 approval by, or noncompliance with regulations or standards
17 relevant to the event causing the death or injury promulgated by,
18 a federal or state agency does not raise a presumption of
19 negligence on the part of a manufacturer or seller. Evidence of
20 compliance or noncompliance with a regulation or standard not
21 relevant to the event causing the death or injury is not
22 admissible.
23 (5) In a product
liability action against a manufacturer or
24 seller, a product that
is a drug is not defective or unreasonably
25 dangerous, and the
manufacturer or seller is not liable, if the
26 drug was approved for
safety and efficacy by the United States
27 food and drug
administration, and the drug and its labeling were
1 in compliance with the
United States food and drug
2 administration's
approval at the time the drug left the control
3 of the manufacturer or
seller. However, this subsection does not
4 apply to a drug that
is sold in the United States after the
5 effective date of an
order of the United States food and drug
6 administration to
remove the drug from the market or to withdraw
7 its approval. This
subsection does not apply if the defendant at
8 any time before the
event that allegedly caused the injury does
9 any of the following:
10 (a) Intentionally
withholds from or misrepresents to the
11 United States food and
drug administration information concerning
12 the drug that is
required to be submitted under the federal food,
13 drug, and cosmetic
act, chapter 675, 52 Stat. 1040, 21 U.S.C. 301
14 to 321, 331 to 343-2,
344 to 346a, 347, 348 to 353, 355 to 360,
15 360b to 376, and 378
to 395, and the drug would not have been
16 approved, or the
United States food and drug administration would
17 have withdrawn
approval for the drug if the information were
18 accurately submitted.
19 (b) Makes an
illegal payment to an official or employee of
20 the United States food
and drug administration for the purpose of
21 securing or
maintaining approval of the drug.