Bill Text: MI SB0019 | 2009-2010 | 95th Legislature | Introduced

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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 1-0)

Status: (Introduced - Dead) 2009-01-27 - Referred To Committee On Judiciary [SB0019 Detail]

Download: Michigan-2009-SB0019-Introduced.html

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SENATE BILL No. 19

 

 

January 27, 2009, Introduced by Senator GLEASON 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:

 

     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.