Amicus Curiae Brief — Mallinckrodt, Inc. v. Bennett

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No. 85-1710

IN THE

Supreme Court of the United States

OCTOBER TERM, 1985

MALLINCKRODT, INC.,

Petitioner,

Vv.

SAMUEL F. BENNETT, et al.,

Respondents.

On Petition for a Writ of Certiorari

to the Missouri Court of Appeals,

Eastern District

Motion for Leeve to File A Brief As Amicus Curiae

and Brief of the American College of Radiology As

Amicus Curiae In Support of the Petition

PAUL G. GEBHARD

Counsel of Record

KEVANN M. COOKE

VEDDER, PRICE, KAUFMAN

& KAMMHOLZ

115 S. LaSalle Street

Chicago, IL 60603

(312) 781-2200

Counsel for Amicus Curiae

CHAS. P. YOUNG COMPANY

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IN THE

Supreme Court of the United States

OCTOBER TERM, 1985

No. 85-1710

MALLINCKRODT, INC.,

Petitioner,

Ve

SAMUEL F. BENNETT, et al.,

Respondents.

On Petition for a Writ of Certiorari

to the Missouri Court of Appeals,

Eastern District

Motion of the American College of Radiology for

Leave to File A Brief As Amicus Curiae In

Support of the Petition

The American College of Radiology (“College”) hereby

requests, pursuant to Rule 36 of the Rules of this Court,

leave to file the accompanying brief as amicus curiae in

support of petitioner.' The amicus College is an organi-

zation of approximately 15,000 United States physicians

and radiological physicists who are specialists in radi-

olegy, the majority of whom practice nuclear radiology.

Low-level ionizing radiation from the types of radionu-

clides produced by petitioner is used by nuclear radiolo-

gists in the diagnosis and treatment of disease. Medical

use of radionuclides by a member of the College requires

the user to have a specific license from the Nuclear

‘Pursuant to Rule 36, amicus has obtained the written consent of

the petitioner, but was denied consent to file by respondents. Peti-

tioner’s letter of consent has been filed with the Clerk of the Court.

li

Regulatory Commission for human use of byproduct

material issued pursuant to 10 C.F.R. § 35.12. The regu-

latory scheme governing medical use of radionuclides is

uniquely extensive, detailed and prescriptive. Members

of the College practice nuclear radiology in all of the

states. They believe that the medical benefits of nuclear

radiology should be equally available to the citizens of all

of the states, without limitation resulting from differing

standards of safety imposed by varying formulations of

state tort liability law and federal regulation. The

American College of Radiology believes that its views as

amicus will assist the Court in deciding whether actions

under state tort law for alleged economic loss due to

radiation should be barred by adherence to federally-

mandated safety standards.

The amicus American College of Radiology therefore

prays that its motion for leave to file a brief in support of

the petitioner be granted.

Respectfully submitted,

PAUL G. GEBEARD

Counsel of Record

KEVANN M. COOKE

VEDDER, PRICE, KAUFMAN

& KAMMHOLZ

115 S. LaSalle Street

Chicago, Illinois 60603

(312) 781-2200

Counsel for Amicus Curiae

May 19, 1986

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QUESTION PRESENTED

Amicus Curiae will address the following question:

Is a state law tort action preempted by the Atomic

Energy Act, 42 U.S. § 2011 et seg., when the defendant

has operated in compliance with all relevant safety

standards established by the Nuclear Regulatory

Commission?

iv

TABLE OF CONTENTS

EN 9 Gast eles oa Dake RRR ee

QUESTION PRESENTED. ....................

INTEREST OF THE AMICUS CURIAE ......

Pare ee SO GUS 8 ie I a en

REASONS FOR GRANTING THE PETITION ....

io tole ey Pooh. tale unr cia, &

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TABLE OF AUTHORITIES

Cases: Page

Bennett v. Mallinckrodt, 698 S.W. 2d 854 (Mo.

Ge Is ra iene eal ce gece 3

Chicago and Northwestern Transportation

Company v. Kalo Brick and Tile Company,

eee Se Beer eee een 7

Cipollone v. Liggett Group, 593 F.Supp. 1146

(D.N.J. 1984) rev'd in part, slip op. Nos.

84-5073 and 84-5074 (8rd Cir. February 13,

ee oes Ss tes, Chee ee esi nee, 3

Fidelity Federal Sevings & Loan Association v.

De La Cuesta. 458 U.S. 141 (1982) ......... 7

San Diego Building Trades v. Garmon, 359 U.S.

MIN cs ons vk rca he ee Saat hie a 7

Silkwood v. Kerr-McGee, 464 U.S. 238 (1984) 4,8

Statutes:

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Miscellaneous:

S. Rep. No. 870 86th Cong., 1st Sess. reprinted

in 1959 U.S. Code Cong. & Ad News 2872... 6,7

Radiation Experience Data (RED), Docu-

mentation and Results of the 1980 Survey of

U.S. Hospitals, HHS Publication FDA

86-8253, September 1985.................. 2

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IN THE

Supreme Court of the United States

OCTOBER TERM, 1985

No. 85-1710

MALLINCKRODT, INC.,

Petitioner,

Vv.

SAMUEL F. BENNETT, et al.,

Respondents.

On Petition for a Writ of Certiorari

to the Missouri Court of Appeals,

Eastern District

BRIEF OF THE AMERICAN COLLEGE

OF RADIOLOGY AS AMICUS CURIAE

IN SUPPORT OF THE PETITION

INTEREST OF AMICUS CURIAE

The American College of Radiology (“College”) is a

non-profit, California curporation founded in 1924 to

advance the science of radiology, improve radiologic

service to the patient, study the socioeconomic aspects of

the practice of radiology, and encourage improved and

continuing education for radiologists and allied profes-

sional fields. The College has approximately 15,000 mem-

bers, a number of whom use radionuclides in the practice

of nuclear radiology or conduct research in that disci-

pline. Physicians who utilize radionuclides must obtain a

license from the Nuclear Regulatory Commission

2

(“NRC”) and comply with extensive prescriptive regula-

tions governing the use of radionuclides in the diagnosis

and treatment of disease. 10 C.F.R. parts 31 and 35 i

(1985).

In the decision for which certiorari is sought here, the

Missouri Court of Appeals held that a tort action alleg-

ing personal injuries to a class of plaintiffs who worked

near a radiopharmaceutical processing facility of peti-

tioner was not preempted, despite the fact that there was

no allegation that there had been any occurrence which

had violated NRC regulations. The members of the Col-

lege, who are currently faced with great difficulty and

expense in obtaining professional liability insurance

coverage under existing rules of law, are understandably

very apprehensive about the impact of the Missouri deci-

sion upon the continued availability of such insurance for

the millions of nuclear radiology procedures carried out

on patients in hospitals throughout the country in com-

pliance with federal regulations.’ A billion-dollar class

action against a manufacturer of radionuclides operating

within federal regulations can easily be followed by a

similar class action by patients against a hospital and its

physicians who employ radionuclides within {federal

regulatory standards. Insurers are well aware of this

possibility. If such insurance becomes unavailable or

prohibitively expensive, physicians will be forced to dis-

continue such procedures and patients will be the real

losers, a result which should not be ascribed to the intent

of Congress in enacting the Atomic Energy Act of 1954,

42 U.S.C. § 2011 et seg. or subsequent legislation.

'In 1980, the most recent year for which published data are availa-

ble, an estimated 6.4 million in-vivo nuclear medicine procedures

were performed in U.S. hospitais, a procedure rate of 2.8 per 100

persons. Radiation Experience Data (RED), Documentation and

Results of the 1980 Survey of U.S. Hospitals, HHS Publication FDA

86-8253, September 1985.

ee

3

Of even more immediate concern is the question of

whether the manufacturers of radionuclides, like the

manufacturers of certain types of vaccines, will be forced

by tort liability concerns to abandon production, a result

which would surely frustrate federal policy and purpose.

The probable impact of the decision of the Missouri

Court of Appeals upon the practice of nuclear radiology

and medicine and upon patients in all of the states ought

to be carefully considered by this Court in determining

whether to grant the petition. The American College of

Radiology, as amicus, respectfully requests this opportu-

nity to present its concerns on these issues to the Court.

THE FACTS OF THE CASE

Plaintiff-respondents allege that they represent a class

of persons who work adjacent to petitioner’s Missouri

plant which processes radionuclides for medical use.

They allege personal injuries under common law to: t

theories and claim damages to the members of the class

of one billion dollars. The Circuit Court of St. Louis

County dismissed on grounds of lack of subject matter

jurisdiction and failure to state a claim on which relief

could be granted.

The Missouri Court of Appeals reversed. The court

reasoned that there was no irreconcilable conflict

between federal regulation and “state standards,”

(apparently referring to state standards yet to be defined

on an ad hoc basis by juries in tort actions), because it

was theoretically possible to both operate within federal

regulatory standards and to pay tort damages under

state law. The court candidly admitted that “This

reasoning may appear to be disingenuous and smack of

sophistry ...” Bennett v. Mallinckrodt, 698 S.W. 2d at 860

(1985). In support of its conclusion the court twice cited

the District Court opinion in Cipollone v. Liggett Group,

493 F.Supp. 1146 (D.N.J. 1984), since reversed in part in

Cipollone v. Liggett Group, slip op. Nos. 84-5073 and

ee ee

4

84-5074 (February 13, 1986). It also considered that there

was no frustration of federai objectives in permitting ,

state tort actions, a conclusion it reached without ade-

quate analysis of the probable result of permitting such

actions against licensees who were in compliance with

federal standards. The court finally concluded that the

terms “nuclear incident” and “occurrence” in 42 U.S.C.

§ 2014(q) must be read to include any claimed cause and

effect relationship arising out of the existence of radio-

nuclides. Throughout, the Missouri Court relied upon its

reading of this Court’s opinion in Silkwood v. Kerr-

McGee Corp., 464 U.S. 238 (1984) relating to an award of

punitive damages. :

REASONS FOR GRANTING THE PETITION

The relevant Congressional purpose in enacting the

1959 amendments to the Atomic Energy Act is set forth

in 42 U.S.C. § 2021 as follows:

§ 2021. |

(a) It is the purpose of this section— |

* * *

(3) to promote an orderly regulatory pattern

between the Commission and State governments

with respect to nuclear development and use and

regulation of byproduct, source, and special nuclear

materials;

* * ”

(5) to provide for coordination of the development

of radiation standards for the guidance of Federal

agencies and cooperation with the States; and

* * %:

(b) Except as provided in subsection (c) of this sec-

tion, the Commission is authorized to enter into

5

agreements with the Governor of any State provid-

ing for discontinuance of the regulatory authority of

the Commission under subchapters V, VI, and VII of

this chapter, and seciion 2201 of this title, with

respect to any one or more of the following materials

within the State—

(1) byproduct materials;

(2) source materials;

(3) special nuclear materials in quantities not suf-

ficient to form a critical mass.

During the duration of such an agreement it is rec-

ognized that the State shall have authority to regu-

late the materials covered by the agreemert for the

protection of the public health and safety from

radiation hazards.

* * *

(d) The Commission shall enter into an agreement

under subsection (b) of this section with any State

if—

(1) The Governor of that State certifies that the

State has a program for the control of radiation

hazards adequate to protect the public health and

safety with respect to the materials within the State

covered by the proposed agreement, and that the

State desires to assume regulatory responsibility for

such materials; and

(2) the Commission finds that the State program

is compatible with the Commission’s program for

the regulation of such materials, and that the State

program is adequate to protect the public health and

safety with respect to the materials covered by the

proposed agreement.

Pursuant to the authority granted by Section 2021, the

NRC has entered into agreements with 26 states to

6

enforce state safety regulations which are consistent

with the NRC standards. Missouri is not such a state.

Public concern over the unique physical and biological

properties of radioactive materials, including radionu-

clides, and their concomitant promise of great public

benefit led to the unique regulatory system embodied in

the Atomic Energy Act, the subsequent amendatory leg-

islation, and the safety standards embedied in the regu-

lations issued by the NRC. These safety standards as

they apply to medical radionuclides are also unique,

among all bodies of federal regulation of medical activ-

ity, in their comprehensiveness, detail and prescriptive

effect. 10 C.F.R. parts 31 and 35 (1985). If the Congress

had intended the states to be able to impose inconsistent,

more stringent safety standards, it could certainly have

done so explicitly as it has in other statutes creating

regulatory schemes.’ In explaining what was intended

by the requirement of the Act for consistency, the Joint

Committee stated:

“5. The Joint Committee believes it important to

emphasize that the radiation standards adopted by

States under the agreements of this bill should

either be identical or compatible with those of the

Federal Government. For this reason the committee

removed the language ‘to the extent feasible’ in sub-

section g. of the original AEC bill considered at

hearings from May 19 to 22, 1959. The committee

recognizes the importance of the testimony before it

by numerous witnesses of the dangers of conflicting,

*In the Clean Air Act, 42 U.S.C. § 7401 et seq., as well as the

Federal We.ter Pollution Control Act, 33 U.S.C. § 1251 et seq.. states

were granted express authority to impose their own standards to

regulate the emission of air and water pollutants respectively. The

Federal Water Pollution Control Act provides: “nothing in this chap-

ter shall (1) preclude or deny the right of ary state or political

subdivision thereof or interstate agency to adopt or enforce (A) any

standard or limitation respecting discharges of pollutants,...”

(emphasis added). 33 U.S.C. § 1370. See also, 42 U.S.C. § 7416.

aot ee

nN a NT BA AN TAOS TRL TENTS AE MIE

7

overlapping and inconsistent standards in different

jurisdictions, to the hinderance of industry and jeop-

ardy of public safety.” (emphasis added). S.Rep. No.

870, 86th Cong., lst Sess. reprinted in 1959 U.S. Code

Cong. & Ad News 2872, 2979.

If the petition for certiorari is not granted and the pre-

emption issues are not thoroughly examined by this

Court, the practical effect of the Missouri decision wili be

exactly what the Congress wished to avoid, i.e. “... con-

flicting, overlapping and inconsistent standards in differ-

ent jurisdictions ...”, established by ad hoc jury verdicts.

This Court has held on several! occasions that state law

damage claims have a regulatory effect which potentially

frustrates congressional objectives and national policies.

Fidelity Federal Savings & Loan Association v. De la

Cuesta, 458 U.S. 141 (1982); Chicago and Northwestern

Transportation Company v. Kalo Brick and Tile Com-

pany, 450 U.S. 311, 326 (1981); San Diego Building Trades

Couneil v. Garmon, 359 U.S. 236, 246 (1959). The threat

of tort actions and jury verdicts as a mechanism for

establishing a “state standard” in each of the 50 states

for nuclear physicians, patients, hospitals and insurers,

with all of the uncertainty, expense and delay which

attends such extensive litigation, may well result in

curtailment of highly useful nuclear medical services

now available to the public.

The Congressional intent with respect to the availabil-

ity of nuclear medicine services is made explicit in 42

U.S.C. § 2134(a);

§ 2134.

(a) The Commission is authorized to issue licenses

to persons applying therefor for utilization facilities

for use in medicai therapy. In issuing such licenses

the Commission is directed to permit the widest

amount of effective medical therapy possible with the

amount of special nuclear material available for

8

such purpose and to impose the minimum amount of

regulation consistent with its obligations under this

chapter to promote the common defense and security

and to protect the health and safety of the public.

(emphasis supplied).

The present NRC standards, which in the absence of an

agreement with Missouri are applicable in that state,

permit “the widest amount of effective medical therapy

possible”. The carefully elaborated, highly specific fed-

eral regulatory system of the NRC has worked extremely

well for the public of medical patients. This fact, in

addition to the unique nature of the problems it

addresses, argues that it deserves special consideration

from this Court. The decision of the Missouri Court of

Appeals, based upon reasoning about which it candidly

expressed its own concern, is seriously deficient in failing

to consider the practical consequences of the rule it

prescribes. To ignore such consequences, which will

effectively frustrate the objectives of the federal law and

wholly subvert the federal regulatory scheme by permit-

ting the substitution of state-determined safety stand-

ards, is surely not a “regulatory consequence... that

Congress was quite willing to accept.” Szikwood, 464 U.S.

at 256.

If the analysis of the Missouri Court is correct, this

Court should grant certiorari and affirm that opinion so

that the medical community and patients can avoid .

expensive and protracted litigation on the same tort

issues in each of the other states, and can seek appropri-

ate Congressional clarification. It will ill serve the popu-

lation of medical patients to be required to await a

conflict among lower courts for a resolution of the perva-

sive preemption issues presented by this case.

This case presents this Court with an opportunity to

draw a distinction between the right of a state to assess

punitive damages in the event of violation of federai

ctandards, established in Silkwood, and the effect of the

ee ame NBA Ad OE, ON MONIT

9

federal legislation in preempting a private tort remedy

in the absence of violation of federal regulatory stand-

ards. Such a distinction would be consistent with

Silkwood, and would preserve both punitive damages and

the possibility of state law tort damages. It would have

the effect of permitting the “widest amount of effective

medical therapy” while reenforcing the desirability of

performance within the federal safety standards.

CONCLUSION

For the foregoing reasons, the petition for a writ of

certiorari should be granted.

Respectfully submitted,

PAUL G. GEBHARD

Counsel of Record

KEVANN M. COOKE

VEDDER, PRICE, KAUFMAN

& KAMMHOLZ

115 S. LaSalle Street

Chicago, Illinois 60603

(312) 781-2200

Counsel for Amicus Curiae