8/12/2019 Preemption of Medical Devices under Riegel v. Medtronic

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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%

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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

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*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

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#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

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#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.

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#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

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#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 #

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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$

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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%

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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%

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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

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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

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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,