RETRIEVE BILL
 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                          4476
 
                               2003-2004 Regular Sessions
 
                   IN ASSEMBLY
 
                                    February 19, 2003
                                       ___________
 
        Introduced by M. of A. REILICH, WIRTH, FINCH -- Multi-Sponsored by -- M.
          of A. KOLB -- read once and referred to the Committee on Judiciary
 
        AN ACT to amend the civil practice law and rules, in relation to prohib-
          iting punitive damages in certain product liability actions
 
          The  People of the State of New York, represented in Senate and Assem-
        bly, do enact as follows:
 
     1    Section 1. The civil practice law and rules is amended by adding a new
     2  article 14-B to read as follows:
     3                                ARTICLE 14-B
     4                          PRODUCT LIABILITY ACTIONS
     5          1414. Definitions.
     6          1415. Drugs regulated or approved by the food and drug  adminis-
     7                 tration.
     8    § 1414. Definitions. In this chapter:
     9    (a)  "Product  liability  action"  means  an  action brought for or on
    10  account of personal injury or injury to  property  caused  or  resulting
    11  from the manufacture, sale, use, construction, design, formula, develop-
    12  ment  of standards, preparation, processing, assembly, testing, listing,
    13  certifying, warning, instructing, marketing, advertising,  packaging  or
    14  labeling  of any product; whether such action is based on: (1) strict or
    15  absolute liability in tort; (2)  negligence  or  gross  negligence;  (3)
    16  breach  of  express or implied warranty; (4) failure to discharge a duty
    17  to warn or instruct; or (5) any other theory that is the  basis  for  an
    18  award  for damages for personal injury or injury to property caused by a
    19  product.
    20    (b) "Product" means any object possessing  intrinsic  value  which  is
    21  capable  of delivery either as an assembled whole or as a component part
    22  and is produced for introduction into trade or commerce; but  such  term
    23  does not include human tissue, blood and blood products, or organs.
    24    (c) "Drug" and "medical device" shall have the meanings defined in the
    25  federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq.
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD08827-01-3

        A. 4476                             2
 
     1    (d)  "Labeling" means the written, printed, or graphic matter upon the
     2  immediate product or any of its containers or wrappers, or  other  writ-
     3  ten, printed, or graphic matter accompanying such product, including any
     4  warnings or instructions.
     5    (e)  "Manufacturer"  means  any person who is engaged in a business to
     6  design, produce, make, fabricate, construct, or remanufacture any  prod-
     7  uct (or component part of a product). Any product seller who acts prima-
     8  rily  as  a  wholesaler,  distributor,  or retailer of products may be a
     9  manufacturer with respect to a given product to  the  extent  that  such
    10  seller  designs,  produces, makes, fabricates, constructs, or remanufac-
    11  tures the product before its sale.
    12    § 1415. Drugs regulated or approved by  the  food  and  drug  adminis-
    13  tration.  (a)  In any product liability action, a manufacturer or seller
    14  of a drug or medical device shall not be subject to punitive damages  if
    15  the  drug or medical device that caused the plaintiff's harm was subject
    16  to pre-market approval or licensure by the federal food and drug  admin-
    17  istration  under  the  federal  food,  drug,  and  cosmetic  act and was
    18  approved or licensed, or is generally recognized as safe  and  effective
    19  pursuant  to  conditions and applicable regulations, including packaging
    20  and labeling regulations, established by  the  food  and  drug  adminis-
    21  tration.
    22    (b)  The  prohibition  on  the  award  of punitive damages provided in
    23  subdivision (a) of this section shall not apply where  the  manufacturer
    24  or  seller  knowingly withheld or misrepresented information required to
    25  be submitted to the food and drug administration  and  such  information
    26  was material and relevant to the harm in question.
    27    §  2.    This act shall take effect immediately and shall apply to all
    28  claims filed on or after its effective date.