Amicus Curiae Brief — Williamson v. Mazda Motor of America, Inc. (No. 08-1314)

Supftewnea Coun, US

FILED

; AUG 5 - 2010

Mo. OB-1314 OFFICE OF THE Cie hx

In The

SUPREME COURT OF THE UNEPED STATES

«

Delbert WILLIAMSON, et al.,

OLTLOMOTS.

MAZDA MOTOR OF AMERICA, INCG., etal

Respondents.

On Petition fora Writ of Certioran to the Court of

Appeal of California, Fourth Appellate District,

Division ‘Three

BRIEF OF THE ATTORNEYS INFORMATION

KXCHANGE GROUP AS AMICUS CURTIAE

IN SUPPORT OF THE PETITIONERS

.

Larry Ik. Coben

Coben & Associates

710K. Vista Bonita Drive

Scottsdale, Arizona S525

(460) 515-4745

LCobentcobonlaw.com

Counsel for Amicus Curtae

Attorneys Information Exchange Group

Peal Porat the. Waste D0 @ 202-747 2400 @ bepalprinters com

1H, CI}

TABLE OF CONTENTS

TABLE OF AUTHORITIES 90.0000... a |

STATEMENT OF INTEREST 0.0.00... .. ae

SUMMARY OF THE ARGUMENT 000000000... 3

ARGUMENT —~_. —. ee eee ee. 10

A. Baékground ..... 07>. a re 0)

bb. Pederal Statutory Framework. ©..... 10

( Review of The Evolving Applreation of

Principles of Federal Preemption 12

Dy. Lower Court's Have Misapplied The

Supreme Court's Preemption

re 21

ly. The Court Should Reconsider Its

Conclusion of The Savings Clause . 22

What Did Congress Say in The Safety

| ng ORE Se a 26

Gi. NHTSA’s Regulatory Approach To Rear

Seat Belts and Executive Order

a | yAL)

CONCLUSION .....)......022..-.-2..2.... 33

i

TABLE OF AUTHORITIES

Page(s)

Cases

Bates v. Dow Aprosciences, LLC, 544 US. 481,

5S Ct. 1788, 161 Lhd. 2d 687 (2005)... 12, 17

breightliner Corp.v. Myrick, 514 US, 280, 115

S.Ct. 14838, 131 L.kd.2d 885 (1995) ..) 11, 18, 34

Geter vo American Honda Motor Co., Ine.,

5SYV4 US. &61, 10S Ct. 1918S, 146 Ld 2d

914 (2ZOOO) . on 6. eee eee eee passim

Haywood v. Drown, 129 S.Ct. 2108, 173 Lbed.2d

SIZU) CUD) wn ck cc hhc wo wee ee ee 22

Larsen v. General Motors Corporation, 897 Fo2d 495

(Sth Car. 19GB)... 2.0... ie eee 4

Medtronic, Inc. vo. Lohr, 518 US. 470, 116 S.Ct.

2240, 13h L.Ed.2d 700 (1996) ...2. 2. 13

Riegel vo. Medtronic, 552 US. 312, 128 S-Ct. 999,

169 L.Ed.2¢d 892 (2008)... ....23 12, 31

Sprietsma v. Mercury Marine, a Div. of Brunswick

Corp., 5387 US. 54, 123. S.Ct. 518, 154 Led. 2d

466 (ZODZ) ... 2.2 awe as oe eee 12, 1H, 24, 25

Wyeth v. Levine, --- USS. ---, 229 S.Ct. 1487, 178

| . v2, 38; 20, 2S

Statutes

15 U.S.C. § 1391 (2) (1966, 1988 & Supp. I

MT ol Se os 5 es ot ee ae _.. passim

Se 10

| a 0, ¢, 11, 26

In U.S.C. § 1892(d) (98K ed.) 20. 7

ee 61987) .......... ae 5, 6

SS ee 11, 15

meeemee © ees) ................... .. 26

49 U.S.C. § 30103(d) 2.22... PE oe og a 26

POMPEO, ww ee eee. 26

a 26-27

RE re YG

meee as, @ eosin) adh) ................. 26

iV

Federal Regulations

32 Fed. Reg. 2415 ......... ee Pe a ae 28

52 Fed. Reg. 22818 (June 16, 1987) ........... 30

54 Ped. Reg. 25275 (June 14, 1989)... . Rea

Cl Wee; Ga I gc oe eke ee eee 3]

68 Fed. Reg. 46546 (August 6, 2003) .......... 32

GS Fed. Reg. 46546 (December 4, 2002) .. 2... .. 32

69 Fed. Reg. 70904 (December &, 2004) | . Reeth

FMVSS 208 ...... eecat al Lier

Other Authorities

DOT 808 945, “Effectiveness of Lap/Shoulder Belts

in the Back Outboard Seating Positions’ 2.2. 32

myecutive Ordor 126132 ........ciccce a.

H.R. Rep. No. 1776, 89th Cong. 2d Sess. 24

RUE 6 sc 00 ea bebe oe OL ree a

Hearings Before the Committee on Interstate and

Foreign Commerce of the House of

Representatives, (Safety Act Hearing), 89th

Cony. 2d Sess. Part 2, 1249 (1966)... . . 6, 28

y

Hoening, Resolution of “Crashworthiness” Design

t !

Claims, 55 St. John's L. Rev. 633 (1981)... |. 4

Ralph Nader, Unsafe at Any Speed (1965) 00... 10

S. Rep. No. 1301, 89th Cong., 2d Sess. 12

SED We ib as oobi ar ko orale ea ke 5 ae ee ae

Safety Study—Performance of Lap/ Shoulder Belts in

167 Motor Vehicle Crashes, NTSB/SS-88/O02 . 29

Special Study, The Roles of General Services

Administration and Department of

Transportation in Motor Vehicle Safety

Standards, Report No. NPSB ISS 70 1 (dane 3.

ae et Set > cae eA Mee

STATEMENT OF INTEREST’

The Attorneys Information Exchange Group

(AIEG) ts an organization of over GOO attorneys who

practice civil ditigation throughout these Umited

States ALEG was founded in the mid-1970's by

attorneys who were then representing burn victims

who were motorists in cars and trucks that were

burning up oan collisions. Its founding members

dedicated themselves, and this organization, to the

creation of a private cooperative entity, which would

serve to educate and coordimate the acquisition of

technical information germane to the fair and honest

representation of Americans who have suffered serious

or catastrophic mjury as a result of defective designs

ino motor velucles. Over the years, ALEKG members

have represented the vietuems of such infamous

products as the Ford Pinto, General Motors cars and

pick-up trucks with poorly desizned fuel systems (e.g.

side saddle fuel tanks), Audt and Toyota vehicles with

sudden, uncontrollable acceleration, and thousands of

Ford Explorers with Firestone tires that have left

untold numbers of Americans maimed. Members of

AIEBG on a daily basis are involved ino pursuing

products labihty clams typically stemming from the

faulty design or manufacture of motor vehicles. Our

chents are those Americans who have suflfered

This Amicus Curiae brief is filed pursuant to Rute 37 and

consent to file it has been granted by written consent of the

parties Further, this Brief was not authored nor was any

monetary contribution to the preparation or submission of this

Brief provided by any party to this action

catastrophic injury or the families of deceased loved

ones. In the prosecution of these common law claims,

we are called upon to study and address the

relationship between vehicular design, injury

causation and any relevaney of compliance with

federal standards promulgated pursuant to the Safety

Act. Most often, tt has been found that there ts very

little relationship between a vehicle's compliance torth

these standards and the safety performance of these

products in real world accidents. ALEG' s members

have a vital interest in the effect of the decision of the

Cahforma Court of Appeals (and other similarly

decided cases) may have on its members and the

chents they represent because motor vehicle

manufacturers continue to produce vehicles which ouly

meet the bare minimum federal safety standards,

thereby resulting in the sale of vehicles which may not

be reasonably safe. The decision reached by the Court

of Appeals potentially allows product manufacturers to

argue that comphance with any federal vehicle

regulation that allows for alternative methods to

satisfy these minimum regulations mnmunizes them

from common law responsibility to build and sell aon

defective/safe vehicles. Likewise, the decision of the

Court of Appeals sat odds with the balance intended

by the United States Constitution, the United States

Congress and the Executive Branch (in the issuance of

Executive Order 12612) which has a continuime,

interest in limiting Federal Agenctes from imposing

their wall upon States without a clear Congressional

statement of the importance of taking such action and

then only after careful study and consultation with

~~

State representatives to minimize this excursion into

the tume-honored rote of the Common Law,

SUMMARY OF THE ARGUMENT

In 1966, the United States Congress pissed the

National Traffie Safety Act (referenced as the Safety

Act), on an effort to establish regulations for vehicle

and vehicle equipment performance which would

provide basic and minimum safety of vehicles sold in

thiscountry. Simultaneously, Congress authorized the

establishment of a government agency to develop and

promulgate these regulations, which became Known as

the National Highway ‘Traffic Safety Administration

(NHTSA). The legislators who passed the Safety Actin

1966 were quite aware of then existing regulations and

standards which many of the states had promulgated,

and which required automobile manufacturers to only

sell cars in these respective states if these vehicles

were equipped with certain devices, such as front seat

seatbelts,

Congress was asked by some facets of the motor

vehicle industry and the safety community to pass

legislation which would have the cftect of elyninating

diverse state regulations, so that only one

governmental agency would contro! the development

and promulgation of standards which velnele

compamies would be obliged to meet in order to market

their products in this country. These standards were

defined by Congress as “minimum standard[s] for

motor vehicle performance’ As the National

Transportation Safety Board reported in 1970":

The imposition of Federal Motor Vehicle

Satety Standards for certain

characteristics of vehicle safety insures

that a particular level of safety wall be

universally apphed, butit does not insure

thatthe highest level of safety will be the

standard, nor does it imsure that the

highest practical level of safety wall be

avallable to purchasers in the market.

As a result of Congress’ awareness of personal

myjury litigation and the appleation of the common liw

to question motor vehicle design safety ") as well as

the promulgation of some non-uniform state safety

standards, the Safety Act addressed both issues. The

Satety Act and its legaslative history establish that

Congress did not want conflicting safety regulations

promulgated by state, local and federal regulators

This was made clear by the inclusion of the

“1h USC. 8 1891 (2) (1966, 1958 & Supp HE 1991)

* Special Study, The Roles of General Service:

Admimstration and Department of Transportation in Motor

Vehicle Safety Standards, Report No NTSH HSS 70 1 Clune 3

1970), (see page dd)

‘ ee as -

larrsent Caene ral Motors ¢ orporati Ue I ~d 49 rosth

Cir, 1968). See peneraliy, Hoenmy, Resolution of

“Crashworthiness’ lesien Clarms, 55 St dohn's L Rev. G35 (1981)

preemption clause in 15 USC. & 13y2(d). Likewise,

the Conpress did not want the federal agency

interfering with the citrzenries’ right to faa

compensation under the common law, which was made

erystal clear by enacting the Savings Clause im 15

USC & W390) Phe federal regulations do not

exempl any person from any habilty under the

common Law,

Whatas evident upon a review of the legislative

history of the Safety Actas that the Savings Clause as

much more than amere expression of Congress’ belief

that “some tort clamns remam viable despite the

promulpation of vehicle reyulations. The legislative

history of this provision establishes that comphance

with a motor vehicle safety standard should not even

be permitted as a defense in product lability suits

agaist an automobile manufacturer, The Senate

Report noted that:

[t}he Pederal minimum safety standards

necd not be interpreted as restricting

State common law standards of care

Comphance with such standards would

thas not necessarily shield any person

from product hability at common law. 5

Kep. No 1401, 89th Conp., Zd Sess. 12

(1G)

The House of Representatives considered the

Senates draft) degashation and ansisted upon the

language of the enacted “Savings Clause’, providing

Congress express intent to preserve all comamon law

(,

Claims ‘The House Committee Report provided:

Common law hability - §108(c) of the

reported bill [15 USC. &1397(c)]

provides that) comphance with any

hederal motor vehicles safety standard

docs not exempt a person from any

habibty under comiunon law. It os

intended, and this subsection specifically

establishes, that comphance with safety

standards as not to be a defense or

otherwise to affeet the rights of parties

under common law particularly those

relating to warranty, contract, and tort

habalty. HR. Rep. Noo 1776, 69th Cony.

2d Sess. 24 (1966)

Conpressional sentiment explaining why the House of

Representatives imserted &§1S97(c) was explained by

Conpressman ‘Tim ‘Priplett, when he stated:

We need a traffic safety ayency and we

need to research our problem from end to

end, but we don't need to relieve the

manufacturer of his natural

responsibility for the performance of his

product. Heannps Before the Committee

on Interstate and Foreign Commerce of

the House of Representatives, (Safety

4

Act Hearing’), 49th Cong. 2d Sess. Part 2,

1249 (1966).

Unbke the language used by Congress im other

legaslation, here Conpress expressed its intent Gn

section 149 2(d)) to preempt only the conduct of states

and political subdivisions:

Whenever a Federal motor vehicle safety

standard established under this sub-

chapter is in effect, no State or political

cubdivisionw of a State shall have any

authority either to establish, or to

continue in effect, with respect to any

motor vehicle or item of motor vehicle

equipment, any safety standard

appheable to the same aspect of

performanee of such vehicle or item of

equipment which is not identical to the

Kederal standard. if U.S.C. & 1392(d)

(19988 ed).

In this instance, aoas not just that Congress’

Statement of preemption does not mention Common

law, but rather that Congress specifically identified

the state and poltical subdivision actavity which at

mitended to preempt, ce., the establishment by a State

or political subdivision of standards with respect to

vehicles or equipment that are not identical to the

federal standard. And, Congress also expressed tts

mitent to preserve all aspects of the common law by

Stating that comphanee with federal safety standards

a

docs not exempt any person from any liability under

common Law.

It was, we respectfully submit, a mistake of honest

but fallitte proportions when this Court concluded in

Cewrthat the Savings Clause was simply promulgated

to allow for some common law claims shown not to be

me conflict wath regulations issued by the NHTSA.

Congress antended by its language to establish

minimum standards which all compamies are required

toaeect before they can market their products in the

United States. On the other hand, since Congress

expected the federal agency to promulgate only

mindndm standards, ao likewise preserved for all

consumers the right to fair compensation vis-a-vis the

jury system, and at expected that the “threat” of

common law hability would spur manufacturers to do

much more, or suffer lability for inyury caused, then

simply mecting these standards.

When Congress passed the Safety Act it did not

establish any sort of administrative remedy for

Ameneans aojured by defectively designed and

manufactured products, because at expected that

common law remedies would address this harm. Over

the past thirty years, the motor vehicle federal

ctandards have, with few exceptions, not changed. A

prime example of the stagnant nature of these

standards is FMVSS 208 and what has been the course

of that regulation regarding the type of seat belt

equipment that may be installed in the second or third

row of passenger vehicles. Suffice it to state, at the

outset, that the NHTSA has never adopted a

7

regulation reyceting the safety efficacy of lap and

shoulder belts in the rear seats of passenger vehicles

In fact, the opposite is the history of how NIPTSA has

viewed the safety value to be added by installing Type

2 dap and shoulder belt) rather than Type 1 (ap belts)

inthe rear seats. tas, therefore, no wonder that the

United States in its Amicus Brief has informed the

Supreme Court that there is no grounds for finding

pniphed preemption in the mstant case.

We ask the Court to establish for all litigants the

clear proposition that because Congress expressly

preserved all common law remedies in promulgating

the Safety Act, at must follow that there is no statutory

authority to apply impled-conflict preemption here.

And, therefore, courts should not be given license to

impose therr will upon injured consumers and preempt

these clauns, despite a manufacturer's satisfaction of

the minnnum safety regulations.

There is nothing unique about a federal minimum

safety standard providing manufacturers with

alternative means to mect a very basic level of crash

safety, and allowing injured victims — of

non-crashworthy vehicles an opportunity to prove to

yunes that them anjuries are attributable to a

manufacturer's failure to go beyond the bear minimum

in safety design. Certainly following this approach

does not evidence nor facially establish a need for

mipled-conflict preemption. And, in faet, such

lawsuits can only serve to promote tmprovements in

design protection. In the event, however, that the

Court Should decide to analyze the issue here pursuant

10

toconflict-impled-precmption principles, we submat.as

has the United States in its Amicus Brief, that there rs

no yastification to find impled preemption.

ARGUMENT

A. Background

Over forty years apo, the publication of Ralph

Nader's Unsafe at Any Speed (1965) helped spur two

mayor developments in the law. First, it prompted

attorneys and the courts to pive increased attention

and recognition to what was then a relatively recent

engincermyg development--the design of vehicles to be

crashworthy. Second, it prompted Congress to pive

increased attention to the need for federal motor

vehicle safety legislation and, ultimately, the passage

of the Safety Act of L9GG. In the intervening years, the

appheation of the common law to the field) of

automotive safety has allowed actions for the deaths

and angurnies that the motor vehicle industry knew

would result from their longstanding refusal to install

safety device,

B. kederal Statutory Framework

Conpress passed the National Traffic Safety Act in

1966 to reduce motor vehicle mjunes and deaths. See

S. Rep. No. 89-1301, 89th Cong., 2d Sess., 1-2 (1966).

To this end, Congress empowered the NHTSA to

prescribe “motor vehicle safety standards.” 15 US.

& 1592(a). The Act defined “safety standards" as

“mintmoum standards] for motor vehicle performance

or motor vehicle equipment performance . " 15

USC. § 189102) [Emphasis added], The Safety Act

contains a preemption section providing thatonce a

standard is adopted, neither a State nor Pohtical

Subdivision may issue a Standard that is not identical

to a federal safety standard applicable to the same

aspect of performance. 15 US. C.§ 1392(d). Further,

the Safety Act includes a Savings Clause which

lepaslates that “[clomplance with any federal motor

vehicle safety standard issued under this subchapter

does not exempt any person from any lability under

common law.” 15 USC. § 1397(k)

More than 30 years after the passage of the Safety

Act, this Honorable Court was called upon to deeide, in

relatively short succession, two cases that analyzed

Congressional and Federal Agency preemptive intent

in twe common law clams, with very different

regulatory history. freightliner Corp. oo Myrick, 514

US. 280, 115 S.Ct. 1488, 131 L.Ed. 2d 385 (1995) and

Geter v. American Honda Motor Co., Ine., 520.05. 861,

870, 120 S.Ct. 1918, 1920, 146 L.Ed.2d 914 (2000).

This precedent has spawned, in the past decade,

literally hundreds of lower court decisions and several

subsequent decisions of this Court as at has been called

upon to decide the preemptive effect of other federal

lepastation and regulations appled to pleasure boat

LZ

propellers’, medical devices,” over the counter

medications’, pesticides” | ete.

’

» Review of The Evolving Application of

Principles of Federal Preemption.

This Honorable Court's construction of federal

legaslation, federal reyulations and common law causes

of achon and the application of ordinary principles of

federal preemption has, with all due respect, been

somewhat less than precise, Perhaps the evolution of

the Court's preemption methodology is the product of

the variability of the statutes and regulations that at

has been called upon to study. lt as difficult not te

notice the evolving sentiment of the Court's Majority

in several pertinent decisions.

* Sprietamau Mercury Marine, a Div. of Brunsiwtek ( loess

O47 US. SE, 125 5 Ct 518, 154 Led 2d 466 (2002) (propeller

guard issue)

* Reegel vo. Medtronic, 552 US 312. 128 S.Ct 999. 169

Ld 2d so (2008) (FDA regulations preempted tort cloum for

neghpent marketing of medical device approved by the Agency

Wyeth uv. hevine, US ,1295-Ct. 1187, 173 Lhd 2d

Sf) (2009) (failure to warn cha was not preempted by the BDA

regulation /standards). Reeped supra

* Bates vo Dow Aproserences, LLG, dALULS 431, 1255 Cr

1788, 1Ob LL kd 2d GS7 (2005)

13

Myrick, :

Absent an appheable standard, there is no

occasion under the apphlieable statutory

scheme to consider federal preemption of this

common law claym.

Because no federal standard exists, we

need not reach respondents’ argument

that the term ‘standard’... pre-empts

only state statues and repulations, but

not common law. We also need not

address respondents’ claim that the

suving Clause 2. . does not permit a

manufacturer to use a federalsafety

standard to immunize itself from state

common-law lability. STA US. 2380, 28a,

na

Because the States are independent soveremns

in our federal system, the Court noted that if

has long presumed that Congress does not

cavaherly preempt state-law causes of action.

As a result, any understanding of the scope of

aprecmmption statute must rest primarily ona

fair understanding of congressional purpose.

" ‘ ‘

Phe dudgment of the Court was Unanimous in

Myrick decided in 199OS

" Medtronic, Inc v. Lokr, 518 US. 470, 1168S Ce. 2240

Mob kd Yd FOU CLG)

14

Congress’ intent, of course, primarily ts

discerned from the Language ofthe preemption

statute and the ‘statutory framework

surrounding it... Also relevant, however, 1s

the ‘structure and purpose of the statute as a

whole, oo... as revealed not only in the text,

but through the reviewing court's reasoned

understanding of the way in which Congress

intended the statute and its surrounding

regulatory scheme to affeet | business,

consumers, and the law. 518 U.S. at 485

ee i

Creer, '

The saving clause assumes that there are

some significant number of common-law

liability cases to save. And a reading of the

express pre-emption provision that excludes

common-law tort actions gives actual meanme

to the saving clause's literal language, while

leaving adequate room for state tort law to

operate-for example, where federal law creates

only a floor, ne, a minimum safety standard

~The languayve of the pre-emption provision

permits a narrow reading that) excludes

common-law actions... . [Emphasis added |

Gh es ss oD ‘ . ' .

POLLS at kos 0S Ce at LOIS

i

_.. We now conclude that the saving clause

(like the express pre-emption provision) docs

not bar the ordinary working of conthet

pre-emption principles.

Nothing ip the language of the saving clause

suggests an antent to save state-law tort

actions that conflict with federal reyulations

The words [clompliance’ and ‘docs not exempt,

IS USC. 8 1897(K) (1988 ed), sound as if they

simply bara special kind of defense, namely, a

defense that) comphance with a tederal

standard automatically exempts a defendant

from state haw, whether the Pederal

Government meant that standard to be an

absolute requirement or only aq minimum one,

—. leas difficult to understand why Congress

would have asisted on a compliance with

federal) regulation precondition to the

provision's apphicabiblty had it wished the Act

to‘save allstate- law tort actions, regardless of

their potential threat to the objectives of

federal safety standards promulgated under

that Act. S29 US. at 860.

‘ > py

Sprvels ma,

Spreisma, supra, S87 US. at 64, LSS Ceo at

joating Gerer} (Unanimous decision)

7 “tt ’

It

_.. [The express pre-emption clause in § 10

apples to ‘a [state or local] law) or

regulation... .. We think that this language

Is most naturally read as not encompassing

common-law claims for (wo reasons. First,

the article ‘a’ before ‘law or regulation

mmiples a discreteness- whichis embodied im

statutes and regulations that ts not present

in the common law. Second, because ‘a

word is known by the company it keeps’,

the terms ‘law and ‘regulation’ used

together in the pre-emption clause indicate

that Congress pre-empted only positive

enactments. If law were read broadly so as

torclude the common law, tt might also be

interpreted to include regulations, which

would render the express reference to

‘regulation ino the pre-emption clause

superfluous

The Aet's saving clause buttresses this

conclusion... ito states that ‘Lejompliance

with this chapter or standards, regulations,

or orders prescribed under this chapter does

not relieve ao person from trabilitw at

common lLiw or under State law.

Bates!

—. We consider whether petitroners’ claims

are pre-empted by § 186v(b) 0. 0 Such State

shall not impose or continue in effect any

requirements for labeling or packaging in

addition to or different from those required

under this subchapter.

The prohibitions inp §bo6v(b) apply only to

‘requirements. An occurrence that merely

motivates an optional decision does not quality

asa requirement. The Court of Appeals was

therefore quite wrong when it assumed that

any event, such as a jury verdict, that might

induce’ a pesticide manufacturer to change its

labelshould be viewed as a requirement .

That §136v(b) may preempt judge made rules,

as well as statutes and regulations. says

nothing about the scope of that pre-emption

Rates that require manufacturers to design

reasonably safe products, to use due care in

conducting appropriate testing of their

products, to market) products tree of

manufacturing defects, and to honor their

express Warranties or other contractual

= Bates tg th id Agrescte ices ce4: one | l S 131. 4345-44

1225S .Cr. 1788, 161 1. Ed 2d 687 (2005)

Is

commiuments plunly do not) quality as

requirements for labelbng or packaging. None

of these common-law rules requires that

manufacturers labelor package their products

moanv particular wav. Thus. petitioners’

Claums for detecttwe design, defective

manufacture, neghygent testing, and breach of

express Warranty are not pre-empted

Wyeth ti

Employing principles of imphed preemption via the

regulatory scheme of the FDA. the Court observed

Wyeth contends that the FFDCA establishes

both a Moor and a ceiling for drug regulation

Once the FDA has approved a drug's libel, a

state-law verdict may not deem the label

madequate, regardless of Whether there is any

evidence that the FDA has considered the

stronger warning at issue) The most glaring

problem with this argument as that all

evidence of Congress’ purposes is to the

contrary. 2. 0 Congress did not provide a

federal remedy for consumers harmed by

unsafe or ineffective drugs in the [93S statute

or in any subsequent amendment. Evidently.

* Wreth. supra los 29S Ce at 120%

i

(ode termaned= that) wadely available state

hight: ofaetion provided appropriate relief for

injured = ocomsumers It may also have

recognized that) state-law remedies further

Consumer protection by miotivatiny

manufacturers. to produce safe and effective

drags and te pive adequate warnings. . PAL

A. at FT BCU.

loo Conecurmnagy Oponion Mer Justice Phomas

stated

Pohave become inercasunge tly} reluctan|t} te

expand federal statutes beyond thear terms

(hrouweh doctrines of ampled prc-emplion

i295. Ot att

Vhe Court’: decision om Gretrer to upply

oupooos and objectives) pre caption based on

apeney comments, regulatory hustory, and

apfeney litigating posutiens was especially

flawed piven that at conflicted wath the plain

statutory text of the saving clause within the

Safety Act. which expheithy proscrved state

common-law actions by providing — that

J jommphoanee with any Pederal motor vehicle

cafety standard assucd under thas subehapter

does notexcmpt any person from any hability

Hider common law feitations omatted). Tn

addition, the Courts rehanee on ats divined

purpooe of the federal law -to pradually phase

20)

bi at max of passive restramt systema, in order

tounvalidate a State's imposition of a greater

calety standard was contrary to the more

voneral express statutory goal of the Safety

Act to reduce traffic accidents and deaths and

injuries to persons resulting from traffie

acedents This Court has repeatedly

toted that when statutory Language i plan,

Houst be enforced according to ats terms

The textan Gerer directly addressed the precise

question at issue before the Court, so that

should have been ‘the ond of the matter: for

the court, as well as the agveney, must pive

effecttothe unambiyugusly expressed intent of

Congress) feitation oautted|, Wath text that

allowed state acthons ike the one at msue om

Giese, the Court had no authority to comb

through apeney commentanes to find a basis

for an alternative conelusion, 129 US. at

—

244-120.

} ‘2 5 oe dD

The Dhesentiagy Opinion an Wyeth observed that the

federal apeney es view of the scope of ite statutory authority and

ryulatory appbeatvon aoa valuable aidieator of the seope of

biaapedae dq preemption Keflectiny upon the decision wna Geren, the

Wyeth Diet etited

ot woathes teapedany tha etataate savenpy Clause and

pobwothetagmdiag the fact that Conpre: pave thie

feerctary cuthorty te set ouly “manwnum’ safety

tandoad= we held Gaener’s state torts uit pre-empted

[Where bred Pieavaly onthe view of the Seenetanryol

Transportation eapresced an an anaces brick that!

Stomdard 20s embodies the Secretary's poli )

yuo recut Chaat siafety would be 1 bn promoted il

a

oe

Db. lower Court's Have Misapplied The Supreme

Court's Preemption Decisions

The Brief in support of the Petition for

Cortiorari filed by the United States aptly points out

that many courts, dike the one below, have

misappled the Gerer rationale to a host of common

law claames that do not warrant dismissal based on

federal preemption

Manufaeturcrs always have the option’ of

cxeeeding @ minimum safety standard

when NHPSA has decided not to

mandate a more stringent alternative

because of considerations of cost) or

fr asability, as NHPSA did in this case,

and gndeed, offen does in considernny

ropulatory alternatives tut oaf such an

option) alone were enough to tripper

federal preemption under Geter, the

Safety Act's savings clause would be

vresatly undermined Gaever does not

mandate that result, beeause = at

determined that under the Safety Aet,

jpanuboetaurces laStalked allernatioce protection

femsoan thear fleets rather than one parte ular

lonmaunevery car. (quoting Bred for United States

Amicus Carnie, O'V. 1999, No 9s-15T1 po 2)

fi the an tant case, the Secretary of Tran portation has written

thatthe Wiallamson's lawsuit does mot confliet with the relevant

repulation

common law tort actions may proceed

unless they conflict with a FMVSS, and

here there as ono conthet US

Government Amicus Brief, ZO1lO WH,

1655014 *15

i. The Court Should Reconsider lis Conclusion

of The Savings Clause

Before we analyze the appleation of inplied-

confliet preemption, we ask that the Court

reconsider the precise languape Congress uscd when

ioncladed a state/political sub-division s standards

preemption clause” and a state common jaw

“savings clause.” Tt as, we respectfully submit,

unfortunate that the sweepmge approach to

preemption based on perceived congressional

purpose an Geter has ded to an unconstitutional!

invalidation of state common laws. Flaywood ov

Drown, 1295 Ct. 2108, 21385, 175 1. kd 2d 920 (2009)

(Dissent by Thomas, do and jorned by the Chief

Justice and dustices Alito and Sealy)

In Geer, [629 U.S. at 871, 1208. Ct. at 1920],

the Majority explamed why at studied implied

preemption, stating:

the saving clause reflects a

congressional determination that

occasional nonuniformaty is a small price

to pay for a system in which puries not

only \ereate, but also enforce, safety

standards, whale samultanmeously

proveeding Necessary COoblpensation to

victims ‘That poley by itself disfavor:

°

.~

—

preemption at least some of the time

Mat we can fiad nothing many natural

reading of the two provisions that would

favor one set of poles over the other

where a jurvamposed safety standard

actually conflicts with a federal safety

ctandard,

We do not claim that Congress lacks

the constitutional power tovortte a statute

that mandates such a complex type of

state/federal relationship Cl. post, at

1935, mo WG. Pat there ts no reason to

belive Congress has done so here.

[ianpahsis added

The predicate emploved by the Geter Court to

reyect the conclusion that Congress intended to

preserve adf common law actions, even af seme might

conflict with a NEPSA repulation, was capsalized by

this query. “[wihy, an any event, would Congress not

have wanted ordinary pre-emption principles to apply

where an aetual conflict with a federal objective is at

stake?” dd But, wath all due respeet, that query

should not have been raised piven Congress’ clear

statements. And even more perplexing was the fact

that after raring this inquiry, the Court did not read

the Congressional Reeord for an aaswer, but instead at

discerned the answer based upon general principles of

federalism. Why make that inquiry when Congress

made a clear distinction between state and political

standards atone endofthe spectrum and common law

Claams at (he other? The language chosen by Congres:

2A

in the Safety Aet was very sumolar to the statutory

scheme studied in Spreetsma, supra, 537 US. at 62-64

The saviany clause as also relevant for an

mdependent reason The contrast

between its woneral refercace to lability

ateommon law and the more speciic and

detatled deseription oof what as

preempted by & 10) including the

exeeption for state regulations

addressing Cumiquely hazardous

conditions’, andicates that §& TO) was

dratted to preempt performance

standards and equipment requirements

Imposed by statute or regulation.

Gur interpretation of the statute's

language does not produce anomalous

results. Tt would have been pertectly

rational for Congress mot to pre-empe

common-law clams, Which anhke most

administrative and levoslative

revulations-necessarily perform an

nniportant remedial role an compensating

acerdent | victims — Dicheed,

compensation os the manifest object: of

thi: SAV DEAS! clause, which foo tuses hot on

state authority to regulate, but) on

preserving ‘hability of common law or

under State law) Tn context, this phrase

surely orefers to private damages

remedies

>,

oo

’

These observations in Sprietsma harken back to

the view expressed in the Dissenting Opinion in Gerer:

lhoas perfectly clear, however, that the

term ‘safety standard’ as used in these

two sections refers to an objective rile

preseribed by il legnslature or an

administrative ageney and does not

encompass case specific decisions by

judges and jurtes that resolve

common-law elas When the

preemption provision refers to a safety

standard estabhshed by a ‘State or

political subdivision ofa State, therefore,

ios most naturally read to convey a

Stlar meaning. Pn addition, when the

Iwo sections are read together, they

provide compelling evidence ofan mtent

to distinguish between legislative and

adpiunistrative rulemaking, on the one

hand, and common-law lability, on the

other. ‘Chis distinction was certamly a

rationalone for Congress to draw in the

Safety Act piven that) common-law

habilitveuntikhe most lepushative or

administrative rulemaking necessarily

performs an important remedial role in

compensating accident vietims (/

Silkiwwood vo Kerr MeGee Corp... 2 O29

US. at 896

See also Wyeth vo. Levin, supra, 129 St. at W214

(Concurmnag Opmon of Mr. dustice Thomas)

‘3(,

What Did Congress Say in The Satety Act?

The statutory provision labeled “Preemption”

states: (MYLES. § SOLO8C |:

Whenevera Federal motor vehicle satety

standard established under this

subchapter is ain effeet, no State or

pohtticalsubdierston ofa State shallhave

vny authority either to establish, or to

continue im effect, with respect to any

motor vehicle or item of motor vehicle

equipment{,} any safety standard

appheable to the same aspect of

performance of such velnele or item of

equipment whieh as not identieal to the

Federal standard. (Previously found at b5

USC. § bead).

The statutory provision reparding “Warrants

Obligations and additional legal rights and remedtes |

states [HOTELS IO. § SOOKE]

Sections SOLE Ab) | Proeemption}, GOELS

BOPP T, SOT6GOD and 80167 (a) and (bd of

this tithe do aot establish or affect a

warranty obligation ander a law of the

Lmted States ora State. A remedy under

those Sectious . of thas: tithe as an

addition te other rights and remedies

under other lLiws of a State

{Manphasis added |

Minally. Congress provided in Seetron GUT LT e) that

zi

Common law lability. Compliance with

uw omotor vehicle safety standard

presembed under this chapter does not

cvemptaperson from lability at common

law. [Eimphasis added |

Read together, these statutes prove that the

preemption section was rot camed at alterme any

aspect of the American consumers states rights

because (Da manufacturer remains hable for breach

of warranties and (2) comphance wath theses

standards. issued by NIPPSA, does not exempt a

manufacturer from lability at common law

In Geer, the Court posited that while Congress

Can ereate a statutory scheme that eliminates the

appheoation of ordinary preempton principles, why

would they do so? ‘The answer ts found here

We necd a trative satety agency and we

need to research our problem fromrend to

end, but ive don ‘t need {wo relieve the

manufacturer of his natural

responsibility for Che performance of his

product.

You may think that the manufacturer is

afraid of Government regulations buat the

ery you are hearing may be “Briar box,

plense don't throw mean the brica patel

Itoothe opowernment assumes the

responsibility of safety design in our

velneles. the manufacturers wall youn

flopether for another GO-vear snoos

_

238

under the verl of Government sanction

and in thousands of courtrooms across

the Nation wronged individuals wall

encounter the stone wallbot Our product

meets the Government standards’, and

an already compounded problem will be

recompounded ""

The decision in Gerer to not follow the hteral words

of the Safetw Act has led hundreds of courts to simply

ignore what Congress imtended We, therefore,

respectfully submiut, that its tume to address this issue

and rule that Congress expressly saved all common

law claims despite the promulgation and compliance

with any federal motor vebicle satety standard

Gi. NHTSA’s Regulatory Approach Lo Rear Seat

Belts and Executive Order 12612

The 1968 Rule FMVSS 20S first took ettect im

Koos) ‘Then, and through boo this regulation

provided for compliince by the installation of lap belts

or lap/shoulder belts at desipmated seating position

bevond the first row 32 Fed. Reg. 2415. This

regulation contamed no explanation or statement ot

poltey with respeet to the decision to list lap andor kup

shoulder belts as the restraimt systems of chotee in

rear seating positions = fd

an an brig: Bbetore the Committee on [naterstate and

bore rt ON merce oh Clve tla t* uit hoprescnt fives CSatlets Vel

Hearing’), Sth Cong 2adsS Part 2. 249 (190)

eS |

i. The 1982 Petitton

In Os’. NIPPSA was petitioned to chiinge PMVSS

20S Co require only lap/shoulder belts mn the rear secats

of passenger cars. After the NHTSA studied this

petition, itt decided Chat because most Americans were

not buckhng up, there was no ‘cost-benetie’

necessitating a change to FMVSS 20S

2, 1981 Amendments to PMVSS 208

In LOS4, NEPESA amended FMVSS 2US to require

that manufacturers advise consumers in the Owners

Manual that > rear seat) bap/shoulder belts were

avatiable for retrofitting. and to specify: how these

additions could be made.”

3. 1986 NTSB Rear Seat Lap Belt Study

In 1986, the National Transportation Satety Boord

(he "NTSB") published a study describing the havards

assoctated wath wearmg a lap belt only ino frontal

collisions. {Safety Study Performance ef

Lap/Shoulder Belts in 1607 Motor Vehtele Crashes,

N'TUSBISS-SS/02 | Based upon this detailed

Investigation, the NTSB otssued Suatety

Recommendations. which, stated that

By LYSh some Furepesan car manufecturers Mad

iweady mmstalled bap'shoulder belts im the rear scats of thea

Bu)

lxjiven the Known deficiencies of Lip-only

belt systems and the superior crash

protection offered by belt systems they

Incorporate an upper Corso restramel, th

Satety Board beheves that government

and industry should take a number ot

steps to reduce reliance on hip belts sid

increase the availablity of hep shoulder

belt systems

With respect to new cars, the N USB recommended that

all designated positions im the rear seat should be

equipped with Lip shoulder belts

4. 1986 Petition To Amend EMVSS 208

In August 1986. NEEPSA was again petitioned to

require Che imstallationot rear lap shoulder belts in all

new passenger cars See OL Ped. Reg 2YS1TS-19 Chine

16,7987) The Agency granted the petition and began

recxamiming Whether to change FMVSS YOS and

require the installation of reat seat lap shoulder belts

In 19S7, NHPSA issued an Advance Notice of Proposed

Rulemaking requesting comments on a proposal to

amend FMVSS 20S to require lap shoulder belts un

rears cats ofpassenger cars 52 Pod Reg VLSIS (dune

lo. PYs7) In this publication, the NHVSA estimated

Chat replacing lap belts with lap/shoulder belts would

ruse effecteveness un reducing fatalities Co O38 percent

and reduce serious uyjurtes to 50 percent. dd) at 22820

The NHTSA estimated that mstalling a lap’shoulder

belt at the rear-center seat pesition would cost omy

|

S20 per velnele. dd at 2Z28ho. In lose the Agenes

published its final rule requiring lap shoulder belts in

allrear- outboard seating positions 54 Ped Rep 2205

(June 14, 19s

The NHTSA) concluded that the greater

effectiveness of rear seat lap/shoulder belts had

become asigniticant factor because of Che increased

use of seat belts dad at Zo276 This requirement

was not extended to the center rear seat position

nor to outboard seats in multipurpose passenger

vehicles. Jd. at 25278. See also, 54 Fed Reg. at

40258. NHTSA did, however, comment that if

manufacturers were able to design and install

lap/shoulder belts in these positions, it “ts

encouraged to doso”™. Ot course. NILESA did no:

state any objection to mstalling a lap/shoulder belt

rnstead of a lap belt in these other seat position

Finally, am assuming this amended Rule.

NHTSA stated that wt had analvzed these

amendments in accordance with Executive Order

1Ol2 and determined that this Amendment did not

warrant thes preparation of a Pederalism

Assessment because at did mot have anv derisive

affect on state law. Ju

5b. The Sune 1999 Study

While the reclevanev of the remulatorv event

Cragspiting after th of the le an gi

tr i } t ‘ head a | " We fit 1 .

a

In dune 19% NHTSA published a study on the

relative satety advantages of hup belts and iap shoulder

belts in the rear seats of cars (DOT SUS 45

"Effectiveness of (Lap/Shoulder- Belts im the Back

Outboard Seating Positions) NEHPSA’s pronoipal

conclusion was that "[t}he change from lap. te

lap shoulder belts has siguifieanth enhanced oceupiant

protection, especrally mm frontalerashes” fd

ln frontal crashes. lap/shoulder belts are

YS percent more effective than lap belts

alone...) Lap’shoulder belts reduce the

risk of both head and abdominal inmurics

In potentially fatal tromt crashes relative

to lap belts onlw: head injuries by 4;

percent and abdominal myeries by

percent lid

6. Lhe 2003 Proposed Amendment

In December 2002, President Bush signed Anton s

Law" which provided tor improvements in child satets

devices. See tS Ped Reg. 40540 (Docember 4. 2000)

One provision of Anton's Law required that NEPSA

amend FMVSS 20S to require the installation of

lap/shoulder belts im rear-center seating positions by

no later than December 2004 ln August 20dS

pursuant tothis statutory directive, NH ESA published

a proposal toe require lap’shoulder belts ima

rear-center seats OS Fed Reg. deodoe (August 6

ZOOS). NHPSA stated that Anton's Law as’ fal.s

consistent with the agenevs precAisting plan to

initiate rulemaking’ to require Lip shoulder belts om

rear-center seats Jd at 40547. In its Notice of

proposed rulemaking, the Agency emphasized that

requiring lap/shoulder belts in rear-center seats would

not just benefit children, [but] "ijt would also benefit

older occupants.” fd. On this point, the Agency cited

the conclusions of its 1999 study, which found that

requiring lap/shoulder belts im all rear seats would

provide significant safety benefits for both adults and

Children. lad

Ss The 2004 Final Rule Requiring

Lap/Shoulder Belts In Rear Center Seats

ln 2004, NH'PSA published a final rule requiring

the installation of lap/shoulder belts in all rear seats.

In (his announcement, NHTSA speciheally stated that

“lthhe final rule is not intended to preempt state tort

croactions.” 69 Fed. Reg. 70904, 70912 (December &,

200A)

CONCLUSION

The core teaching of Geter is that regulatory

options, standing alone, do not possess any preemptive

force. Ifthe mere existence of regulatory options were

sufficient to preempt tort claims, then the Majority in

Geer would not have needed to address the complex

policy reasons underlying the air bag phase-in of

EMVSS 208; it would have been sufficient to point out

that the car maker had chosen to install one of several

permitted regulatory options. Geter, however, never

purported to rely on such an observation. To the

contrary, the Court's decision included and is based on

a detailed and exhaustive examination of the highly

unusual history and framework of the air bag standard

of FMVSS 208. Gerer thus makes clear that regulatory

options do not exert any preemption force under the

Safety Act unless they are based on special safety

concerns that would be directly undermined by a

common-law chum. As we now explaim, no such

concerns exist in this case.

lor over thirty years, NHTSA has remained a

major proponent of lap and shoulder belts. The

regulatory history of FMVSS 208 shows at least two

things: (1) a lap and = shoulder belt) system = 1s

significantly superior to a lap belt only, and (2) the

government continuously expressed its hopes and

voals to have lap and shoulder belts in every seated

position in every motor vehicle as early as possible.

And, conversely, NHTSA has never rejected as a safety

imperative the inclusion of lap and shoulder belts at

each seating designation.

The government's decision to defer making lap and

shoulder belts a requirement was certainly not the

, or tantamount to, a policy statement

encouraging the continuing installation of lap belts

only. ‘The regulatory history in this instance is very

much the same as what the Court considered in both

Myrick and Spriestma. And, therefore, at the very

least the same decision rejecting implied preemption

should be found.

same as

Respectfully submitted, this 20 day of duly, 2010

Larry lk. Coben

COBEN & ASSOCIATES

S710. Vista Bonita Drive

Scottsdale, AZ 85255

(480) 515-4745

LCoben@ecobenlaw.com

Counsel for Amicus Curtae

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