Preemption of Medical Devices under Riegel v. Medtronic
-
Upload
george-conk -
Category
Documents
-
view
220 -
download
0
Transcript of Preemption of Medical Devices under Riegel v. Medtronic
-
8/12/2019 Preemption of Medical Devices under Riegel v. Medtronic
1/17
Preemption - Medical Devices 1
Products LiabilityProducts LiabilityMedical DevicesMedical Devices
Federal PreemptionFederal PreemptionProduct LiabilityProduct Liability
Prof. George ConkProf. George ConkFordam La! "coolFordam La! "cool
"pring #$1%"pring #$1%
-
8/12/2019 Preemption of Medical Devices under Riegel v. Medtronic
2/17
-
8/12/2019 Preemption of Medical Devices under Riegel v. Medtronic
3/17
Classification of devices #1 &"C '$cClassification of devices #1 &"C '$c
Class 2 bandaids( tongue depressorsClass 2 bandaids( tongue depressors
Class 2 acupuncture needles( infusionClass 2 acupuncture needles( infusionpumpspumps
Class - intended to be implanted in teClass - intended to be implanted in te
uman body or is 3 represented to be foruman body or is 3 represented to be fora use in supporting or sustaining umana use in supporting or sustaining uman
lifelife
Class is sub4ect to premarket approvalClass is sub4ect to premarket approval Mfr. must so! 5reasonable assurance6 ofMfr. must so! 5reasonable assurance6 of
safety and effectiveness *'$esafety and effectiveness *'$e
Preemption - Medical Devices '
-
8/12/2019 Preemption of Medical Devices under Riegel v. Medtronic
4/17
*f nitial classification and reclassification of
certain devices
(1)0ny device3 not introduced 3 beforeMay #7( 1+,( is classified in class
unless--
(A)te device--3 (ii)is substantiallye)uivalent to anoter device 8distributed
before May #7( 1+,$96
Determined by a classification panel
Preemption - Medical Devices %
-
8/12/2019 Preemption of Medical Devices under Riegel v. Medtronic
5/17
#1 &"C '$k#1 &"C '$k "tate and local re)uirements
respecting devices
*a General rule :;cept as provided in subsection *b of
tis section( no "tate or political
subdivision of a "tate may establis orcontinue in effect !it respect to a device
intended for uman use any re)uirement--
(1)!ic is different from( or in addition to(any re)uirement applicable under tis
capter to te device( and
Preemption - Medical Devices
-
8/12/2019 Preemption of Medical Devices under Riegel v. Medtronic
6/17
#1 &"C '$k#1 &"C '$k "tate and local re)uirements
respecting devices
(2)!ic relates to te safety oreffectiveness of te device or to any oter
matter included in a re)uirement
applicable to te device under tiscapter.
Preemption - Medical Devices
-
8/12/2019 Preemption of Medical Devices under Riegel v. Medtronic
7/17
#1 &"C '$k *b e;emptions *1+,#1 &"C '$k *b e;emptions *1+,
3te "ecretary may3e;empt a
re)uirement of suc "tate3 if-- (1)te re)uirement is more stringent tan
a re)uirement under tis capter !ic
!ould be applicable to te device if ane;emption !ere not in effect under tis
subsection= or
(2)te re)uirement-- (A)is re)uired by compelling local
conditions( and
Preemption - Medical Devices ,
-
8/12/2019 Preemption of Medical Devices under Riegel v. Medtronic
8/17
#1 &"C '$k *b e;emptions *1+,#1 &"C '$k *b e;emptions *1+,
(B)compliance !it te re)uirement!ould not cause te device to be in
violation of any applicable re)uirement
under tis capter.
*>une #
-
8/12/2019 Preemption of Medical Devices under Riegel v. Medtronic
9/17
-
8/12/2019 Preemption of Medical Devices under Riegel v. Medtronic
10/17
Design defectDesign defect
Is the statutory standard ofIs the statutory standard ofreasonable assurance of safety andreasonable assurance of safety and
effectiveness more or less demandingeffectiveness more or less demanding
than the Ne !or" ris"#utility testthan the Ne !or" ris"#utility test
hich uses the $ade factors%hich uses the $ade factors%
Does the &DA a''rove a design%Does the &DA a''rove a design%
Does it com'are the chosen design toDoes it com'are the chosen design toavailable alternatives%available alternatives%
Preemption - Medical Devices 1$
-
8/12/2019 Preemption of Medical Devices under Riegel v. Medtronic
11/17
Aat is a 5re)uirement6BAat is a 5re)uirement6B
$hat does a liability verdict reuire%$hat does a liability verdict reuire%
Is an incentive or a duty to com'ensateIs an incentive or a duty to com'ensate
a reuirement%a reuirement%
Preemption - Medical Devices 11
-
8/12/2019 Preemption of Medical Devices under Riegel v. Medtronic
12/17
tate las of general a''lication nottate las of general a''lication not
directly a''licable to a device are notdirectly a''licable to a device are not
'reem'ted*'reem'ted* #1 C.F.@. ? 7$7.1
calia+ ,eneral tort duties of care-calia+ ,eneral tort duties of care-
unli"e fire codesunli"e fire codesor restrictions onor restrictions on
trade 'ractices- trade 'ractices- directly regulatedirectly regulate the the
device itself- including its design*device itself- including its design*
Isn.t a fire code reuirement /ust asIsn.t a fire code reuirement /ust asdirect%direct%
Preemption - Medical Devices 1#
-
8/12/2019 Preemption of Medical Devices under Riegel v. Medtronic
13/17
Canges permitted #1 CF@ ?71%.'+*d*1
Labeling canges tat add or strengten a
contraindication( !arning( precaution( or
information about an adverse reaction=
Labeling canges tat add or strengten
an instruction tat is intended to enance
te safe use of te device=
Labeling canges tat delete misleading(
false( or unsupported indications
Preemption - Medical Devices 1'
-
8/12/2019 Preemption of Medical Devices under Riegel v. Medtronic
14/17
Post approval informationPost approval information
s te product liability la! duty ofs te product liability la! duty of
5reasonable safety6 te same as te5reasonable safety6 te same as te
FD0s post approval duty to report resultsFD0s post approval duty to report results
of furter studies( and informationof furter studies( and information
reported to te manufacturerBreported to te manufacturerB
Preemption - Medical Devices 1%
-
8/12/2019 Preemption of Medical Devices under Riegel v. Medtronic
15/17
Post approval informationPost approval information
Do claims of failure to arn of neDo claims of failure to arn of ne
'ost#a''roval safety information'ost#a''roval safety information
survive as 'arallel claims undersurvive as 'arallel claims under
0iegel%0iegel%
$hat is a 'arallel claim%$hat is a 'arallel claim%
Preemption - Medical Devices 1ustice "calia as been a defender of>ustice "calia as been a defender of
state sovereignty. s e consistent ereBstate sovereignty. s e consistent ereB
Aat !eigt sould be given to te FD0sAat !eigt sould be given to te FD0s
amicus briefBamicus briefB
Aat !eigt sould be given to "en.Aat !eigt sould be given to "en.ennedy and @ep. Aa;mans briefBennedy and @ep. Aa;mans briefB
Preemption - Medical Devices 1,