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. LBD02505-01-7A. 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.