S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   1964
 
                        2017-2018 Regular Sessions
 
                           I N  A S S E M B L Y
 
                             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:
 
   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.
   §  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.
   § 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.
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD02505-01-7
              

 A. 1964                             2
 
   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.
   § 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.
   § 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.
   § 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.
   §  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.
   § 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.