BILL NUMBER:  S5566A

 TITLE OF BILL :  An act to amend the public health law and the
general business law, in relation to the warranting of certain medical
devices

 PURPOSE :

To require sellers of certain medical devices to provide an express
warranty that their product is fit for the ordinary purpose for which
such device is used

 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 electronic medical devices or implantable hip or
knee medical devices, that such devices are warranted for a period of
at least five years.

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 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. 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 :

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.