Require Warranties on Medical Implants

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, defined as an implantable medical device that requires a battery or similar power source to function, or an implantable hip or knee medical device, 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 at least five years after it is first used, attached or applied to the consumer. 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 finding 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. This section further clarifies that when federal law pre-empts, the provisions of this article do not apply.

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 certain medical devices be expressly warranted as fit for the purpose they are intended. Under this legislation, an electronic medical device that relies on a battery to function and implantable hip or knee devices are expressly warranted for a period of at least five years. These types of devices are reported to have the highest rates of failure, defect or recall. 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. 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

2015-2016: S.5566-A 2014: S.7092

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.