Bill Text: NY A01964 | 2017-2018 | General Assembly | Introduced

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Bill Title: Requires the provision of at least a 5 year warranty on electronic medical devices and implantable hip and knee medical devices.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Introduced - Dead) 2018-04-30 - enacting clause stricken [A01964 Detail]

Download: New_York-2017-A01964-Introduced.html

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                STATE OF NEW YORK
        ________________________________________________________________________
                                          1964
                               2017-2018 Regular Sessions
                   IN ASSEMBLY
                                    January 17, 2017
                                       ___________
        Introduced  by M. of A. MAYER -- read once and referred to the Committee
          on Consumer Affairs and Protection
        AN ACT to amend the public health law and the general business  law,  in
          relation to the warranting of certain medical devices
          The  People of the State of New York, represented in Senate and Assem-
        bly, do enact as follows:
     1    Section 1. Section 2803 of the public health law is amended by  adding
     2  a new subdivision 8-b to read as follows:
     3    8-b.  The  commissioner  shall  establish procedures to be followed by
     4  hospitals for notification to patients who  receive  electronic  medical
     5  devices  or implantable hip or knee medical devices, as defined in arti-
     6  cle thirty-B of the general business law, during  the  course  of  their
     7  treatment, that such devices are warranted for a period of at least five
     8  years.
     9    §  2. The general business law is amended by adding a new article 30-B
    10  to read as follows:
    11                                ARTICLE 30-B
    12                           MEDICAL DEVICE WARRANTY
    13  Section 645. Definitions.
    14          646. Express warranty required.
    15          647. Additional remedies of consumers.
    16          648. Prohibition against waiver of rights.
    17          649. Exclusion.
    18    § 645. Definitions. Whenever used in this article, unless the  context
    19  clearly  requires otherwise, the following words or terms shall have the
    20  following meanings:
    21    1. "Consumer" means the person upon which a medical device  was  used,
    22  attached  or  applied,  regardless  of  who  purchased  or acquired such
    23  device.
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD02505-01-7
        A. 1964                             2
     1    2. "Electronic medical device" means  an  implantable  medical  device
     2  that requires a battery or similar power source to function.
     3    3.  "Implantable  hip  or  knee  medical  device"  means a device that
     4  replaces the components of a hip or knee.
     5    4. "Initial seller"  means  the  seller  who  manufactured,  modified,
     6  rebuilt,  improved  or reconditioned an implantable electronic or hip or
     7  knee medical device.
     8    § 646. Express warranty required.  1. Every initial seller of an elec-
     9  tronic medical device or implantable hip or knee  medical  device  shall
    10  provide  each  consumer  of such device with a warranty that the medical
    11  device is fit for the ordinary purposes for which such device  is  used,
    12  and  is  free from defects for a period of at least five years after the
    13  medical device is first used by, attached to or applied to the consumer.
    14    2. If a medical device fails to conform to the  warranty  required  by
    15  subdivision one of this section, and the consumer, or his or her author-
    16  ized  representative reports such nonconformity or defect to the initial
    17  seller or its agents during the term of the warranty, the initial seller
    18  shall be liable for all costs incurred by the consumer  or  his  or  her
    19  insurer  to  make  such  repairs  and  replacements  as are necessary to
    20  correct such conformity or defect, and any additional medical and  reha-
    21  bilitation care necessary after such repair or replacement.
    22    § 647. Additional remedies of consumers. Nothing in this article shall
    23  in  any way limit the rights, remedies or privileges which are otherwise
    24  available to a consumer at law or equity.
    25    § 648. Prohibition against waiver of rights. Waiver of any  rights  by
    26  the consumer under this article shall be deemed contrary to public poli-
    27  cy and shall be unenforceable and void.
    28    §  649.  Exclusion.  The provisions of this article shall not apply to
    29  devices approved through the United States Food and Drug  Administration
    30  pre-market  approval  process where 21 USC 360(k) would prohibit imposi-
    31  tion of the warranty established under this article.
    32    § 3. This act shall take effect on the first of January next  succeed-
    33  ing  the  date  on  which it shall have become a law, and shall apply to
    34  medical devices initially used by, attached to or applied to a person on
    35  or after such date.