Requires the provision of a warranty on medical devices

Summary of provisions

Section one adds a new Public Health Law § 2803(8-b) to require the Commissioner of Health to establish procedures for hospitals to notify patients receiving medical devices, that such devices are warranted for a period of seven years for electronic medical devices and ten years for all other medical devices.

Section two adds a new Article 30-B to the General Business Law establishing the medical device warranty. This section requires the initial seller of an electronic medical device, which is defined as a medical device that requires a battery or similar power source to function, to provide each consumer of such device with a warranty that the device is fit for its ordinary purpose and free from defect for a period of seven years after it is first used, attached or applied to the consumer. The section also requires every initial seller of medical devices, other than electronic medical devices, to provide the consumer with warranty that the device is fit for its ordinary purpose and free of defects for a period of ten years after it is first applied. The seller shall be liable for all costs incurred by the consumer or his or her insurer to make repairs and replacements for any device that fails to conform with these provisions upon the report of such nonconformity or defect.

This section also clarifies that nothing in this Article shall in any way limit the rights, remedies or privileges otherwise available in law or equity and prohibits the waiver of this warranty.

Section three provides that the act shall take effect on the first of January next succeeding the date on which it becomes law and applies to all devices used, attached or applied on or after such date.

Justification

Manufacturers and sellers of medical devices have an obligation to ensure their products are safe for use by consumers, especially when those devices are being implanted. Likewise, consumers should have confidence in the devices their surgeon is implanting. This legislation will hold manufacturers accountable by requiring medical devices be expressly warranted as fit for the purpose they are intended. Under this legislation, a medical device that relies on a battery to function is expressly warranted for seven years, all other medical devices are warranted for a period of ten years. Holding manufacturers accountable will enhance the safety of products and ultimately lead to a decrease in product recalls. This warranty will also provide consumers with an additional remedy to ensure they are

not financially responsible for any consequences resulting from a defective medical device.

Recent product recalls, and controversial lawsuits that followed, have highlighted the need for this legislation. In August 2010, DePuy Orthopaedics issued a recall of its ASRTM XL Acetabular Hip System and DePuy ASRTM Hip Resurfacing System. The New York Times reported that about 93,000 patients, about one-third of them in the United States, received an ASR. The ASR hip device utilized a metal ball and cup, which reportedly sheds metallic debris as it wears, this can result in tissue damage and even crippling injuries. The average artificial hip should last about 15 years or more before needing to be replaced, where as DePuy projections estimated that the ASR hip would fail in 40% of patients within five years. DePuy reportedly began phasing out the ASR when the FDA asked for more safety information about the implant in 2009, but continued to sell existing inventories. While DePuy claims they recalled the ASR after "receiving new, then-unpublished data from a joint replacement registry in the UK," documents disclosed at trial allegedly showed that officials were long aware that the flawed design resulted in premature failure at a high rate.

DePuy Orthopaedics is not alone. With regard to metal-on-metal hip implants alone, the FDA has recalled two other products, the Smith & Nephew R3 Metal Liners of the R3 Acetabular System and the Zimmer Duromù Acetabular Component. On May 30, 2013, the FDA issued a Class 1 recall of the Stryker Spine - OASYS Midline Occiput Plate used to promote fusion of the cervical spine and occipito-cervico-thoracic junction based on reports indicating post-operative fracture of the pin that connects the tulip head to the plate body. A Class 1 recall, the most serious type, means there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.

This legislation will help to ensure medical device manufacturers are diligent in guaranteeing the safety of their products and help to decrease recalls, meanwhile protecting the consumer when product defects do occur.

Legislative history

New bill.

Fiscal implications

None.

Effective date

Takes effect on the first of January next succeeding the date on which it becomes law and applies to all devices used, attached or applied on or after such date.