S T A T E   O F   N E W   Y O R K
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                                  9781

                          I N  A S S E M B L Y

                              May 22, 2014
                               ___________

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 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  MEDICAL  DEVICES
DURING  THE  COURSE  OF THEIR TREATMENT, THAT SUCH DEVICES ARE WARRANTED
FOR A PERIOD OF SEVEN YEARS FOR ELECTRONIC MEDICAL  DEVICES  AND  FOR  A
PERIOD  OF  TEN YEARS FOR ALL OTHER MEDICAL DEVICES, PURSUANT TO ARTICLE
THIRTY-B OF THE GENERAL BUSINESS LAW.
  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.
  S  645. DEFINITIONS. WHENEVER USED IN THIS ARTICLE, UNLESS THE CONTEXT
CLEARLY REQUIRES OTHERWISE, THE FOLLOWING WORDS OR TERMS SHALL HAVE  THE
FOLLOWING MEANINGS:
  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 A MEDICAL DEVICE THAT REQUIRES A
BATTERY OR SIMILAR POWER SOURCE TO FUNCTION.
  3. "MEDICAL DEVICE" MEANS  INSTRUMENTS,  APPARATUS  AND  CONTRIVANCES,
INCLUDING THEIR PARTS, COMPONENTS AND ACCESSORIES INTENDED FOR THE CURE,

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD13114-03-4
              

A. 9781                             2

MITIGATION,  TREATMENT OR PREVENTION OF ANY DISEASE, CONDITION OR INJURY
IN HUMANS.
  4.  "INITIAL  SELLER"  MEANS  THE  SELLER  WHO MANUFACTURED, MODIFIED,
REBUILT, IMPROVED OR RECONDITIONED A MEDICAL DEVICE.
  S 646. EXPRESS WARRANTY REQUIRED. 1. EVERY INITIAL SELLER OF A MEDICAL
DEVICE, OTHER THAN AN ELECTRONIC  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 TEN YEARS AFTER THE MEDICAL DEVICE IS FIRST
USED BY, ATTACHED TO OR APPLIED TO THE CONSUMER.
  2.  EVERY INITIAL SELLER OF AN ELECTRONIC MEDICAL DEVICE SHALL PROVIDE
EACH CONSUMER OF SUCH DEVICE WITH A WARRANTY THAT THE ELECTRONIC MEDICAL
DEVICE IS FIT FOR THE ORDINARY PURPOSES FOR WHICH SUCH DEVICE  IS  USED,
AND IS FREE FROM DEFECTS FOR A PERIOD OF SEVEN YEARS AFTER THE ELECTRON-
IC  MEDICAL  DEVICE  IS  FIRST  USED  BY,  ATTACHED TO OR APPLIED TO THE
CONSUMER.
  3. IF A MEDICAL DEVICE FAILS TO CONFORM TO THE  WARRANTY  REQUIRED  BY
SUBDIVISION  ONE OR TWO OF THIS SECTION, AND THE CONSUMER, OR HIS OR HER
AUTHORIZED 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  NECES-
SARY  TO  CORRECT  SUCH CONFORMITY OR DEFECT, AND ANY ADDITIONAL MEDICAL
AND REHABILITATION 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 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.