S T A T E   O F   N E W   Y O R K
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                                 8142--A

                       2015-2016 Regular Sessions

                          I N  A S S E M B L Y

                              June 10, 2015
                               ___________

Introduced  by M. of A. MAYER -- read once and referred to the Committee
  on Consumer Affairs and Protection -- recommitted to the Committee  on
  Consumer  Affairs  and  Protection in accordance with Assembly Rule 3,
  sec. 2 -- committee discharged, bill  amended,  ordered  reprinted  as
  amended and recommitted to said committee

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:

  Section  1. Section 2803 of the public health law is amended by adding
a new subdivision 8-b to read as follows:
  8-B. THE COMMISSIONER SHALL ESTABLISH PROCEDURES  TO  BE  FOLLOWED  BY
HOSPITALS  FOR  NOTIFICATION  TO PATIENTS WHO RECEIVE ELECTRONIC MEDICAL
DEVICES OR IMPLANTABLE HIP OR KNEE MEDICAL DEVICES, AS DEFINED IN  ARTI-
CLE  THIRTY-B  OF  THE  GENERAL BUSINESS LAW, DURING THE COURSE OF THEIR
TREATMENT, THAT SUCH DEVICES ARE WARRANTED FOR A PERIOD OF AT LEAST FIVE
YEARS.
  S 2. The general business law is amended by adding a new article  30-B
to read as follows:

                              ARTICLE 30-B
                         MEDICAL DEVICE WARRANTY
SECTION 645. DEFINITIONS.
        646. EXPRESS WARRANTY REQUIRED.
        647. ADDITIONAL REMEDIES OF CONSUMERS.
        648. PROHIBITION AGAINST WAIVER OF RIGHTS.
        649. EXCLUSION.
  S  645. DEFINITIONS. WHENEVER USED IN THIS ARTICLE, UNLESS THE CONTEXT
CLEARLY REQUIRES OTHERWISE, THE FOLLOWING WORDS OR TERMS SHALL HAVE  THE
FOLLOWING MEANINGS:

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD00303-05-6

              

A. 8142--A                          2

  1.  "CONSUMER"  MEANS THE PERSON UPON WHICH A MEDICAL DEVICE WAS USED,
ATTACHED OR APPLIED,  REGARDLESS  OF  WHO  PURCHASED  OR  ACQUIRED  SUCH
DEVICE.
  2.  "ELECTRONIC  MEDICAL  DEVICE"  MEANS AN IMPLANTABLE MEDICAL DEVICE
THAT REQUIRES A BATTERY OR SIMILAR POWER SOURCE TO FUNCTION.
  3. "IMPLANTABLE HIP OR  KNEE  MEDICAL  DEVICE"  MEANS  A  DEVICE  THAT
REPLACES THE COMPONENTS OF A HIP OR KNEE.
  4.  "INITIAL  SELLER"  MEANS  THE  SELLER  WHO MANUFACTURED, MODIFIED,
REBUILT, IMPROVED OR RECONDITIONED AN IMPLANTABLE ELECTRONIC OR  HIP  OR
KNEE MEDICAL DEVICE.
  S 646. EXPRESS WARRANTY REQUIRED.  1. EVERY INITIAL SELLER OF AN ELEC-
TRONIC  MEDICAL  DEVICE  OR IMPLANTABLE HIP OR KNEE MEDICAL DEVICE SHALL
PROVIDE EACH CONSUMER OF SUCH DEVICE WITH A WARRANTY  THAT  THE  MEDICAL
DEVICE  IS  FIT FOR THE ORDINARY PURPOSES FOR WHICH SUCH DEVICE IS USED,
AND IS FREE FROM DEFECTS FOR A PERIOD OF AT LEAST FIVE YEARS  AFTER  THE
MEDICAL DEVICE IS FIRST USED BY, ATTACHED TO OR APPLIED TO THE CONSUMER.
  2.  IF  A  MEDICAL DEVICE FAILS TO CONFORM TO THE WARRANTY REQUIRED BY
SUBDIVISION ONE OF THIS SECTION, AND THE CONSUMER, OR HIS OR HER AUTHOR-
IZED REPRESENTATIVE REPORTS SUCH NONCONFORMITY OR DEFECT TO THE  INITIAL
SELLER OR ITS AGENTS DURING THE TERM OF THE WARRANTY, THE INITIAL SELLER
SHALL  BE  LIABLE  FOR  ALL COSTS INCURRED BY THE CONSUMER OR HIS OR HER
INSURER TO MAKE SUCH  REPAIRS  AND  REPLACEMENTS  AS  ARE  NECESSARY  TO
CORRECT  SUCH CONFORMITY OR DEFECT, AND ANY ADDITIONAL MEDICAL AND REHA-
BILITATION CARE NECESSARY AFTER SUCH REPAIR OR REPLACEMENT.
  S 647. ADDITIONAL REMEDIES OF CONSUMERS. NOTHING IN THIS ARTICLE SHALL
IN ANY WAY LIMIT THE RIGHTS, REMEDIES OR PRIVILEGES WHICH ARE  OTHERWISE
AVAILABLE TO A CONSUMER AT LAW OR EQUITY.
  S  648.  PROHIBITION AGAINST WAIVER OF RIGHTS. WAIVER OF ANY RIGHTS BY
THE CONSUMER UNDER THIS ARTICLE SHALL BE DEEMED CONTRARY TO PUBLIC POLI-
CY AND SHALL BE UNENFORCEABLE AND VOID.
  S 649. EXCLUSION. THE PROVISIONS OF THIS ARTICLE SHALL  NOT  APPLY  TO
DEVICES  APPROVED THROUGH THE UNITED STATES FOOD AND DRUG ADMINISTRATION
PRE-MARKET APPROVAL PROCESS WHERE 21 USC 360(K) WOULD  PROHIBIT  IMPOSI-
TION OF THE WARRANTY ESTABLISHED UNDER THIS ARTICLE.
  S  3. This act shall take effect on the first of January next succeed-
ing the date on which it shall have become a law,  and  shall  apply  to
medical devices initially used by, attached to or applied to a person on
or after such date.