1994: Bjork-Shiley Heart Valve Defect 105
intended to provide claimants with funds to provide medical and
psychologic consultation as they deemed best. It was to be divided
equally among claimants after paying or providing for fees paid out of
this fund. The settlement also provided $12.5 million for a Patient
Benefit Fund, in order to conduct research on the diagnosis of strut
fracture risk and to establish guidelines for diagnosis and valve replace-
ment (Special Masters/Trustees, 1995). As of 2004, there had been 93
(71 foreign) qualified outlet strut fracture claims and 137 (55 foreign)
qualified valve replacement surgery claims. The qualified valve replace-
ment surgery claims included 38 qualified single leg fracture claims
(Special Masters/Trustees, 2004).
APPLICABLE REGULATIONS
As a direct result of the Bjork-Shiley valve lawsuits, Congress enacted
the Safe Medical Devices Act of 1990. This Act provides specific rules for
medical device post-market surveillance. It appears in Title 21, Chapter 9,
of the United States Code (U.S.C.). The General Rule under Section 360i
(21U.S.C.§360i) is given below:
Title 21 Chapter 9 – Federal Food, Drug, and Cosmetic Act
Sec. 360i.—Records and reports on devices
(a) General rule
Every person who is a manufacturer or importer of a device
intended for human use shall establish and maintain such records,
make such reports, and provide such information, as the Secretary
may by regulation reasonably require to assure that such device is
not adulterated or misbranded and to otherwise assure its safety
and effectiveness. Regulations prescribed under the preceding
sentence—
(1) shall require a device manufacturer or importer to report to
the Secretary whenever the manufacturer or importer receives
or otherwise becomes aware of information that reasonably
suggests that one of its marketed devices—
(A) may have caused or contributed to a death or serious
injury, or
(B) has malfunctioned and that such device or a similar
device marketed by the manufacturer or importer would
be likely to cause or contribute to a death or serious
injury if the malfunction were to recur;
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106 Engineering Ethics: An Industrial Perspective
(2) shall define the term “serious injury” to mean an injury that—
(A) is life threatening,
(B) results in permanent impairment of a body function or
permanent damage to a body structure, or
(C) necessitates medical or surgical intervention to preclude
permanent impairment of a body function or permanent
damage to a body structure;
(3) shall require reporting of other significant adverse device
experiences as determined by the Secretary to be necessary to
be reported;
(4) shall not impose requirements unduly burdensome to a device
manufacturer or importer taking into account his cost of
complying with such requirements and the need for the
protection of the public health and the implementation of this
chapter;
(5) which prescribe the procedure for making requests for reports
or information shall require that each request made under such
regulations for submission of a report or information to the
Secretary state the reason or purpose for such request and
identify to the fullest extent practicable such report or
information;
(6) which require submission of a report or information to the
Secretary shall state the reason or purpose for the submission
of such report or information and identify to the fullest extent
practicable such report or information;
(7) may not require that the identity of any patient be disclosed in
records, reports, or information required under this subsection
unless required for the medical welfare of an individual, to
determine the safety or effectiveness of a device, or to verify a
record, report, or information submitted under this chapter; and
(8) may not require a manufacturer or importer of a class I
device to—
(A) maintain for such a device records respecting information
not in the possession of the manufacturer or importer, or
(B) to submit for such a device to the Secretary any report or
information—
(i) not in the possession of the manufacturer or
importer, or
(ii) on a periodic basis,
unless such report or information is necessary to
determine if the device should be reclassified or if
the device is adulterated or misbranded.
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