Products Liability Medical Devices Federal Preemption

Product Liability Prof. George Conk Ford am La! "c ool "pring #$1%
Preemption - Medical Devices 1

/ e Medical Device 0mendments

#1 &"C '$1( et se) *1+,-.

Preemption - Medical Devices

Classification of devices #1 &"C '-$c

Class 1 2 bandaids( tongue depressors Class 11 2 acupuncture needles( infusion pumps Class 111 - intended to be implanted in t e uman body or is 3 represented to be for a use in supporting or sustaining uman life Class 111 is sub4ect to premarket approval Mfr. must s o! 5reasonable assurance6 of safety and effectiveness *'-$e.
Preemption - Medical Devices '

*f. 1nitial classification and reclassification of certain devices (1) 0ny device3 not introduced 3 before May #7( 1+,-( is classified in class 111 unless- (A) t e device--3 (ii) is substantially e)uivalent to anot er device 8distributed before May #7( 1+,-$96

Determined by a classification panel

Preemption - Medical Devices %

#1 &"C '-$k "tate and local re)uirements respecting devices *a. General rule :;cept as provided in subsection *b. of t is section( no "tate or political subdivision of a "tate may establis or continue 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 t is c apter to t e device( and
Preemption - Medical Devices <

#1 &"C '-$k "tate and local re)uirements respecting devices (2) ! ic relates to t e safety or effectiveness of t e device or to any ot er matter included in a re)uirement applicable to t e device under t is c apter.

Preemption - Medical Devices

#1 &"C '-$k *b. e;emptions *1+,-.

3t e "ecretary may3e;empt a re)uirement of suc "tate3 if-(1) t e re)uirement is more stringent t an a re)uirement under t is c apter ! ic !ould be applicable to t e device if an e;emption !ere not in effect under t is subsection= or (2) t e re)uirement-(A) is re)uired by compelling local conditions( and
Preemption - Medical Devices ,

#1 &"C '-$k *b. e;emptions *1+,-.

(B) compliance !it t e re)uirement !ould not cause t e device to be in violation of any applicable re)uirement under t is c apter.

*>une #<( 1+'7( c. -,<( ? <#1( as added May #7( 1+,-( Pub.L. +%-#+<( ? #( +$ "tat. <,%..
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@iegel v. Medtronic
<<# &.". '1# *#$$7.

Preemption - Medical Devices

Design defect

Is the statutory standard of reasonable assurance of safety and effectiveness more or less demanding than the Ne !or" ris"#utility test hich uses the $ade factors% Does the &DA a''rove a design% Does it com'are the chosen design to available alternatives%

Preemption - Medical Devices

1$

A at is a 5re)uirement6B

$hat does a liability verdict re(uire% Is an incentive or a duty to com'ensate a re(uirement%

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11

)tate la s of general a''lication not directly a''licable to a device are not 'reem'ted* #1 C.F.@. ? 7$7.1

)calia+ ,eneral tort duties of careunli"e fire codes or restrictions on trade 'ractices- directly regulate the device itself- including its design* Isn.t a fire code re(uirement /ust as direct%
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C anges permitted #1 CF@ ?71%.'+*d.*1.

Labeling c anges t at add or strengt en a contraindication( !arning( precaution( or information about an adverse reaction= Labeling c anges t at add or strengt en an instruction t at is intended to en ance t e safe use of t e device= Labeling c anges t at delete misleading( false( or unsupported indications
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Post approval information

1s t e product liability la! duty of 5reasonable safety6 t e same as t e FD0Cs post approval duty to report results of furt er studies( and information reported to t e manufacturerB

Preemption - Medical Devices

1%

Post approval information

Do claims of failure to

arn of ne

'ost#a''roval safety information survive as 'arallel claims under 0iegel%

$hat is a 'arallel claim%

Preemption - Medical Devices

1<

@iegel v. Medtronic( 1nc.( <<# &.". '1#

1t is not our 4ob to speculate upon congressional motives. 8/9 e te;t of t e statuteDsuggests t at t e solicitude for t ose in4ured by FD0approved devices( ! ic t e dissent finds controlling( !as overcome in CongressEs estimation by solicitude for t ose ! o !ould suffer !it out ne! medical devices if 4uries !ere allo!ed to apply t e tort la! of <$ "tates to all innovations.
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Fvercoming t e presumption against preemption

A at kind of presumption is t atB >ustice "calia as been a defender of state sovereignty. 1s e consistent ereB A at !eig t s ould be given to t e FD0Cs amicus briefB A at !eig t s ould be given to "en. Gennedy and @ep. Aa;manCs briefB

Preemption - Medical Devices

1,