# Amicus Curiae Brief — Riegel v. Medtronic, Inc.

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URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385016_0289%3A16

## Record

- **Collection:** Supreme Court brief
- **Document type:** Amicus Curiae Brief
- **Published:** January 1, 2008
- **Citation:** 552 U.S. 312

## Text

(p Dov 1B FILED

i
‘

IN THE

Supreme Court of the Gnited States

CHARLES R. RIEGEL AND DONNA S. RIEGEL, Petitioners
Vv.

MEDTRONIC, INC., Respondent

ON WRIT OF CERTIORARI TO
THE UNITED STATES COURT OF APPEALS
FOR THE SECOND CIRCUIT

BRIEF OF CONSUMERS UNION
OF UNITED STATES, INC.,
AS AMICUS CURIAE
IN SUPPORT OF PETITIONERS

LISA HEINZERLING

Counsel of Record

600 New Jersey Ave., N.W.
Washington, D.C. 20001
(202) 662-9115

MARK SAVAGE
Consumers Union
of United States, Inc.
1535 Mission Street
San Francisco, CA 94103-2512

Counsel for Amicus Consumers Union of United States, Inc.

aS
WALSON-EPES PRINTING Co., INC. — (202) 789-0096 -— WASHINGTON, D. C. 20002

oS

QUESTION PRESENTED

Whether the express preemption provision of the
Medical Device Amendments to the Food, Drug, and
Cosmetic Act, 21 U.S.C. § 360k(a), preempts state-law claims
seeking damages for injuries caused by medical devices that
received premarket approval from the Food and Drug
Administration.

TABLE OF CONTENTS

Page
GEE 5 6 oc cscccevene seccesesecessen 1
SUID, ov cccccccceccmeesosecessoeucs 2

Argument:

I. The Food, Drug, And Cosmetic Act Sets Minimum
Standards, Designed To Continually Improve The Safety Of
Regulated Products, And Thus The Statute Fits Comfortably
With State-Based Common Law Remedies ............. 4

Il. This Court’s Recent Rulings On Preemption Must Be
Understood With Reference To The Specific Regulatory
Settings In Which They Arose................-02000 005 11

III. The Medical Device Amendments Do Not Preempt The
PY DORE occ ccessvocectenccesverceses 16

Il

TABLE OF AUTHORITIES

Cases: Page
62 Cases, More or Less, Each Containing Six Jars of Jam v. ULS.,
ENS 0 6 Sov cteedndvetesiviccsesnsenas 5
Abbott Labs. v. Lapp, 78 F.2d 170 (7th Cir. 1935)......... 7

Bates v. Dow Agroscience LLC, 544 U.S. 431 (2005) . .14-16, 17
Berry v. Am. Cyanamid Co., 341 F.2d 14 (6th Cir. 1965).. 8
Bine v. Sterling Drug, Inc., 422 S.W.2d 623 (Mo. 1968).... 8
Cinocca v. Baxter Lab., Inc., 400 F. Supp. 527 (E.D. Okla.

GOED < oncsetenesedss0ccceeseadnsnndsehenseadsans 9
Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992)... 12,15
Coca Cola Bottling Works v. Selvidge, 4 Tenn. App. 558

SR, GH Se os k vesccenchescenssreebbaenuees 7
Crocker v. Winthrop Labs., Div. of Sterling Drug, Inc., 514
EU PR eas ee cceucteds coscscedaceeas 8
Croft v. York, 244 So.2d 161 (Fla. App. 1971)........... 8

Davis v. Wyeth Labs., Inc., 399 F.2d 121 (9th Cir. 1968)... 8
Dreiling v. Gen. Elec. Co., 511 F.2d 768 (Sth Cir. 1975).... 9
E.R. Squibb & Sons, Inc. v. Jordan, 254 So.2d 17 (Fla. App.

GEFs voc adeusesbsvdcusnseeveensesnquaeee nse 9
Friedman v. Medtronic, Inc., 345 N.Y.S.2d 637 (NY App. Div.
TTT TTC re err 9
Fritz v. Parke Davis & Co., 277 Minn. 210 (Minn. 1967)... 8
Geier v. Am. Honda Motor Co., 529 U.S. 861 (2000)....... 4
Grinnell v. Charles Pfizer & Co., 79 Cal. Rptr. 369 (Cal. Ct.
OM Tiere eee 8
Henry v. Richardson-Merrell, Inc., 508 F.2d 28 (3d Cir. 1975) .
cvebeavpesedseenssens +0 eseh keke sone been aneene 8
Hoffman v. Sterling Drug, Inc., 374 F. Supp. 850 (M.D. Pa.
GPE Knedcdcvieciveechenseve su eunnheeneneeeenee 8
Hornung v. Richardson-Mermill, Inc., 317 F. Supp. 183 (D.
PPP ee 8

Hruska v. Parke, Davis & Co., 6 F.2d 536 (8th Cir. 1925).. 7

IT]

Cases — Continued: Page

In re A. H. Robbins Co., Inc. “Dalkon Shield” IUD Prod.s Liab.

Litig., 406 F. Supp. 540 (J.P.M.L. 1975) .........-.44.. 10
Kershaw v. Sterling Drug, Inc., 415 F.2d 1009 (5th Cir. 1969)

ACURA RACESUDSRUREOECR OREO OA RNS Cd eoneccescess 8
Kordel v. United States, 335 U.S. 345 (1948) ............. 7
Krug v. Sterling Drug, Inc., 416 S.W.2d 143 (Mo. 1967)... 8
Love v. Wolf, 58 Cal. Rptr. 42 (Cal. Ct. App. 1967)...... 8
Machlitt v. Myers, 23 Ohio App. 160 (Ohio App. 1926)... 7
Mazetti v. Armour & Co., 75 Wash. 622 (Wash. 1913) ..... 7

McEwen v. Ortho Pharm. Corp., 270 Or. 375 (Or. 1974) .... 8
Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996). 2, 4, 10, 13-15, 17
Moehlenbrock v. Parke, Davis & Co., 141 Minn. 154 (Minn.

EEE E I try rere errr eT Tre trey TTT Tee 7
Oresman v. G. D. Searle & Co., 388 F. Supp. 1175 (D. R.1.
il eeee iced 6bednkecedacesedesecenses 8
Orthopedic Equip. Co. v. Eutsler, 276 F.2d 455 (4th Cir. 1960) .
PPUPUAURENAneReee Ses eRe Wereodsecuceoeesseseoes 9
Parke-Davis & Co. v. Stromsodt, 411 F.2d 1390 (8th Cir. 1969)
SGM CedkeheNateteedeeeedeserctooecceccoces 8
Redfield v. Mead, Johnson & Co., 264 Or. 273 (Or. 1973)... 8
Keyes v. Wyeth Labs., 498 F.2d 1264 (5th Cir. 1974)...... 8
Rice v. Santa Fe Elevator Corp., 331 U.S. 218 (1947)...... 11
Riegel v. Medtronic, Inc., 451 F.3d 104 (2d Cir. 2006).... 16
Ritchie v. Sheffield Farms Co., 222 N.Y.S. 724 (N.Y. Mun. Ct.
Mist AicheaGanues bad sedebesbeceecéceses 7
Salmon v. Parke, Davis & Co., 520 F.2d 1359 (4th Cir. 1975) . .
SE MOcsE hb nedberenededesebsebedceecececes 8
Schenebeck v. Sterling Drug, Inc., 423 F.2d 919 (8th Cir. 1970)
Ue SPESCCSEDEED ESRD ESR eee eeeeecoe cece: 8
Silkwood v. Kerr-McGee Corp., 464 U.S. 238 (1984) ....... 11
Singer v. Sterling Drug, Inc., 461 F.2d 288 (7th Cir. 1972). . 8
Sprietsma v. Mercury Marine, 537 U.S. 51 (2002)........ 13

Sterling Drug, Inc. v. Cornish, 370 F.2d 82 (8th Cir. 1966). 8

IV

Cases — Continued: Page

Sterling Drug, Inc. v. Yarrow, 408 F.2d 978 (8th Cir. 1969) . 8
Stevens v. Parke, Davis & Co., 507 P.2d 653 (Cal. 1973)... 8
Tinnerholm v. Parke, Davis & Co., 411 F.2d 48 (2d Cir. 1969) .

chcbcndtedieiwerses+sccesesindeaeelateeneneeens 7
Toole v. Richardson-Merrell Inc., 60 Cal.Rpir. 398 (Cal. Ct.
RE TED soc cccdecctsscctesesesvessencevenessse 8
United States v. Article of Drug . . . Bacto-Unidisk, 394 U.S.
ots nedavdvadinanandennsebaasnessahes 6,7
United States v. Dotterweich, 320 U.S. 277 (1943) ..... 5, 10
United States v. Park, 421 U.S. 658 (1975) .............. 10

Vergott v. Deseret Pharm. Co., 463 F.2d 12 (5th Cir. 1972). 9
Wechsler v. Hoffman-La Roche, Inc., 99 N.Y.S.2d 588 (N.Y.

SE Si ndcdsces sevecaccendudscenaenesaebaenes 8
Wennerholm v. Stanford Univ. Sch. of Med., 128 P.2d 522,
CRIS ROI i aS F 7-8

Whitley v. Cubberly, 210 S.E.2d 289, (N.C. Ct. App. 1974) . 8
Williams v. Vick Chemical “o., 279 F. Supp. 833 (S.D. lowa

Pn deccccnsedebeutsusbidedeteugewensneeneeens 8
Statutes:

Drug Amendments of 1962, Pub. L. No. 87-781, 76 Stat. 780

pee iukdeb cdebcnehousudeusseeduséane Genaudanent 5

Federal Food and Drugs Act of 1906, ch. 3915, 34 Stat. 768 .

(nbeedeusneostpcconbanraactqnerenncsspenveneeees 4

Federal Food, Drug, and Cosmetic Act of 1938, Pub. L. No.

FTG EL HEE voc cvcccveveccceviseseusees 3, 6
(codified as amended at 21 U.S.C. §§ 301 et seq. (2006)):

Nh ada wesecoccoscstnenvssenaneniees 5

Pe cnr ess cbedvencsececeensteses 5

21 U.S.C. § 360e(d)(2)(A), (B).... 6. eee eee eee 17

Be Es bccn cccectcdescscdcsccecess 17

yp fi a PPPTTETITETITIT TTT 6

BE UEA.. BOI «ccc cc ccccvescecccccees 6

Statutes — Continued: Page

in ccc enereséenkonseeanad 16
I a a 6
Medical Device Amendments of 1976, Pub. L. 94-295, 90
ee at at te LE ete ee ee 5
Miscellaneous: Page

S. Rep. 94-33 (1975), 94 Cong. 2d Sess., as reprinted in 1976
NI . dikesépneddansaneccdscdcursans 9
David Owen, Federal Preemption of Products Liability Claims,
SOSA. L. TRV. GAL, GES GOED. 0 onc cceeccccccccsne 12
David C. Vladeck, Preemption and Regulatory Failure, 33
Pes Ea ENS SE PE s co cecccsccecessccesees 12

VI

BRIEF OF AMICUS CURIAE
CONSUMERS UNION OF UNITED STATES, INC.,
IN SUPPORT OF PETITIONERS

STATEMENT OF INTEREST OF AMICUS CURIAE!

Consumers Union of United States, Inc., the publisher of
Consumer Reports, is a non-profit membership organization
chartered in 1936 to provide consumers with information,
education, and counsel about goods, services, health, and
personal finance. Consumers Union's publications have a
combined paid circulation of approximately 8 million. These
publications regularly carry articles reporting on Consumer
Union’s own product testing; health, product safety, and
marketplace economics; and legislative, judicial, and
regulatory actions that affect consumer welfare. Consumers
Union's income is solely derived from the sale of Consumer
Reports, its other publications and services, and from
noncommercial contributions, grants, and fees. Consumers
Union's publications and services carry no _ outside
advertising and receive no commercial support.

Consumers Union's mission is to work for a fair, just,
and safe marketplace for all consumers and to empower
consumers to protect themselves. In line with that mission

! The parties have lodged letters with the Court consenting
generally to the filing of briefs amicus curiae, and
accordingly, the parties have consented to the filing of this
brief. See Sup. Ct. R. 37.3(a). No counsel for a party to this
case authored this brief in whole or in part, and no person or
entity other than Amicus Curiae Consumers Union, its
members, or its counsel, made a monetary contribution to
the preparation or submission of the brief. See Sup. Ct. R.
37.6.

2

and our assessment of priorities, Consumers Union has
actively worked for a fair and just marketplace for
consumers in critical areas implicated by this case, including
health care and prescription drugs. From its beginnings, on
through the present time, Consumers Union has filed actions
in both state and federal courts to protect consumers, and
has participated in a variety of proceedings before both state
and federal regulatory agencies. Consumers Union played
an active role in securing the passage of the Food, Drug, and
Cosmetic Act of 1938 and the 1958 amendments to the Act.
Consumers Union also filed an amicus brief in Medtronic,
Inc. v. Lohr, 518 U.S. 470 (1996), a decision of central
importance to this case.

SUMMARY OF ARGUMENT

In 1996, Charles Riegel had an angioplasty performed on
his right coronary artery. During the procedure, Mr. Riegel’s
surgeon used respondent Medtronic’s Evergreen Balloon
Catheter. The catheter burst inside Mr. Riegel’s artery,
causing Mr. Riegel severe and permanent injuries and
disabilities. In addition, his wife, Donna Riegel, suffered a
loss of companionship with her husband. The Riegels sued
Medtronic, alleging common-law claims for, among other
things, defective design and inadequate warning.

Nothing in the Food, Drug, and Cosmetic Act required
Medtronic to manufacture and distribute a negligently and
defectively designed catheter with negligently chosen
labeling. The law aims higher than that, toward a state of
affairs in which the manufacturers of medical devices and
other products covered by the statute are under a continuing
obligation to ensure the safety of their products.

_ Nevertheless, the court below held that the Riegels’ state-
law claims were preempted by the Medical Device

3

Amendments of 1976 to the Food, Drug, and Cosmetic Act.
The court's sweeping ruling reflects a misunderstanding of
the federal statute at issue, a misapplication of this Court's
precedents, and a misreading of the specific provision on
preemption in play in this case.

1. The Food, Drug, and Cosmetic Act aims to protect the
health of American consumers by regulating foods, drugs,
cosmetics, medical devices, and other products and
technologies associated with health and health care. A
careful reading of the statute reveals a regulatory system
designed to set minimum standards for covered products
and to press regulated entities to continually improve the
safety of their goods. The Act, in its overall substance and
structure, fits comfortably with state-created common law
aimed at protecting the health and safety of American
consumers and providing recompense to those injured
through no fault of their own.

2. This Court's precedents on preemption dictate a close
analysis of both the purportedly preemptive federal law and
Ue purportedly preempted state rule. Indeed, the Court's
recent cases in this area can only be understood by reference
to the very specific legal settings from which they arose.
These cases reflect the Court's traditional wariness about
preempting state laws protecting health and safety. The care
with which the Court in recent cases has examined the
specific legal setting at issue reaffirms the Court's
longstanding acknowledgment that federal preemption of
state health and safety laws is strong medicine, not to be
taken lightly.

3. This case falls within the line of decisions from this
Court narrowly construing the scope of statutory
preemption. The premarket approval of Medtronic’s catheter
by the Food and Drug Administration is not a “requirement”

~

» 4

absolving Medtronic of liability for negligence and other
torts; preserving the Riegels’ tort claims creates no tension
with that approval; the standard for approving medical
devices implies the existence of post-market remedies; and
the history of tort litigation preceding the Medical Device
Amendments of 1976 strongly reinforces the conclusion that
these amendments do not preempt the claims at issue here.

ARGUMENT

I. The Food, Drug, And Cosmetic Act Sets Minimum
Standards, Designed To Continually Improve The Safety
Of Regulated Products, And Thus The Statute Fits
Comfortably With State-Based Common Law Remedies.

In determining whether a federal statute preempts state
law, this Court has repeatedly stressed the importance of
close examination of the statute’s text, history, and structure.
See, e.g., Medtronic, Inc. v. Lohr, 518 U.S. 470, 485-486 (1996).
In undertaking this inquiry, the Court has found it necessary
to look beyond specific provisions on preemption to the
broader context of a regulatory scheme in order to
responsibly decide the question of preemption. See, e.g.,
Geier v. Am. Honda Motor Co., 529 U.S. 861, 869-874 (2000).
Thus, before studying the preemption provision at issue
here, a careful look at the broader context of the Federal
Food, Drug, and Cosmetic Act is in order.

The Food, Drug, and Cosmetic Act is perhaps the
premier consumer protection law in this country. Its basic
structure dates back over 100 years, to the Federal Food and
Drugs Act of 1906, ch. 3915, 34 Stat. 768. That early
enactment created a regulatory framework which, despite
many intervening amendments, still exists (albeit in
modified form) today. The Medical Device Amendments of
1976 comprise but one piece of this venerable and complex
statute. For this reason as well, the preemption provision of

5

these amendments cannot be well understood without an
appreciation of the larger statutory framework of which it is

a part.

Careful review of the statutory framework as it has
evolved over time reveals several important features
relevant to this case. First, in adding new requirements to
the statute, Congress tended to keep in place the basic
framework that had preceded them. The statute as originally
developed in 1906 regulated foods and drugs. United States
v. Dotterweich, 320 U.S. 277, 280 (1943). It protected American
consumers against the twin evils of dangerousness and
deception through prohibitions on “adulteration” and
“misbranding.” 62 Cases, More or Less, Each Containing Six
Jars of Jam v. United States, 340 U.S. 593, 596 (1951). When
Congress stiffened the requirements for drugs - in 1938, by
providing for premarket review to assess safety, Federal
Food, Drug, and Cosmetic Act of 1938, Pub. L. No. 75-717, §
505, 52 Stat. 1040, 1052, and in 1962, by requiring review to
assess effectiveness, Drug Amendments of 1962, Pub. L. No.
87-781, § 102(a), 76 Stat. 780, 781 - it left the prohibitions
against adulteration and misbrandiny in place. 21 U.S.C. §§
331, 351. Congress did the same when it added premarket
approval requirements for medical devices to the statute in
1976. Medical Device Amendments of 1976, Pub. L. No. 94-
295, § 515(a), 90 Stat. 539, 552-553; 21 U.S.C. §§ 331, 351.
Thus, drugs and devices approved by the FDA are still
subject to the law’s prohibitions on adulteration and
misbranding. The Food, Drug, and Cosmetic Act is, in short,
a palimpsest, a tablet on which the newest layers of writing
dom. _.se earlier ones. The Court should be exceptionally
chary of an interpretation of the statute that would use a
new regulatory layer (the Medical Device Amendments) to
sweep away an old one (state-based remedies of the
common law).

6

Second, while Congress often responded to emerging
problems with broader or more stringent premarket review
of consumer products, it also retained and strengthened
statutory provisions creating a continuing obligation on the
part of regulated entities to improve safety. Not only did
Congress keep in place the prohibitions against adulteration
and misbranding, even for products that had received
premarket approval, but it also added provisions designed
to ensure post-market vigilance in matters of safety. See, e.g.,
21 U.S.C. § 360h(e) (authorizing FDA to recall devices); 21
U.S.C. § 360h(e)(1)(B) (requiring notification to doctors and
hospitals of dangerous devices); 21 USC. § 360
(establishing requirements for post-market surveillance).
These provisions demonstrate Congress’s understanding
that the premarket approval process sets a minimum
standard for regulated products, one that sometimes proves
inadequate in light of subsequent consumer and market
experience. Preservation of state-based tort claims is a
complement, not an affront, to this statutory scheme.

Third, the Food, Drug, and Cosmetic Act regulated
medical devices long before the Medical Device
Amendments of 1976. The 1938 enactment added the
category of “device” to the products regulated under the
Act. See United States v. Article of Drug . . . Bacto-Unidisk, 394
U.S. 784, 796-797 (1969). Under this statute, the prohibitions
against adulteration and misbranding were applied to
medical devices. Id. at 797; Federal Food, Drug, and
Cosmetic Act of 1938, Pub. L. No 75-71, § 301(a), 52 Stat.
1040, 1042. Thus medical devices became subject to the same
protections against dangerousness and deception that had
long been applied to foods and drugs.

The 1938 statute did not, however, apply the process of
premarket safety review to devices. The absence of a
requirement of premarket safety approval, combined with

7

the recognition of the strong public health purposes of the
Act, persuaded this Court to extend the premarket approval
requirements applicable to drugs to items that, in truth,
looked a lot more like devices than drugs. In Bacto-Unidisk,
the Court held that devices used in the laboratory to test the
sensitivity of certain microorganisms to certain antibiotics
(aptly called “antibiotic sensitivity discs”) were “drugs” and
thus were subject to the Act’s requirements for premarket
safety review. 394 U.S. at 793-798. Although the discs never
touched a patient's body, the Court thought that the Act’s
“overriding purpose to protect the public health” counseled
in favor of broad construction of the Act. Id. at 798. The
practical effect of the Court's ruling was to subject the
antibiotic sensitivity discs to the same premarket approval
process applied to drugs. The decision in Bacto-Unidisk is of a
piece with other decisions from this Court recognizing “the
high purpose of the Act” in protecting consumers. Kordel v.
United States, 335 U.S. 345, 349 (1948).

Fourth, state-based tort claims have peacefully co-existed
with the federal regulatory framework for many decades.
Foods and drugs regulated by the Food, Drug, and Cosmetic
Act remained subject to state-based common law claims not
only in the period between 1906 and 1938, when the federal
requirements applicable to them were the prohibitions on
adulteration and misbranding. See, e.g., Mazetti v. Armour &
Co., 75 Wash. 622 (Wash. 1913); Moehlenbrock v. Parke, Davis
& Co., 141 Minn. 154 (Minn. 1918); Hruska v. Parke, Davis &
Co., 6 F.2d 536 (8th Cir. 1925); Machlitt v. Myers, 23 Ohio
App. 160 (Ohio App. 1926); Coca Cola Bottling Works v.
Selvidge, 4 Tenn. App. 558 (Tenn. App. 1927); Ritchie v.
Sheffield Farms Co., 222 N.Y.S. 724 (N.Y. Mun. Ct. 1927);
Abbott Labs. v. Lapp, 78 F.2d 170 (7th Cir. 1935). Drugs also
remained subject to tort claims even after 1938, when
Congress added the provisions creating a premarket review
process for drugs. See, e.g., Wennerholm v. Stanford Univ. Sch.

8

of Med., 128 P.2d 522 (Cal. 1942); Wechsler v. Hoffman-La
Roche, Inc., 99 N.Y.S.2d 588 (N.Y. Sup. 1950); Berry v. Am.
Cyanamid Co., 341 F.2d 14 (6th Cir. 1965); Sterling Drug, Inc. v.
Cornish, 370 F.2d 82 (8th Cir. 1966); Love v. Wolf, 58 Cal. Rptr.
42 (Cal. Ct. App. 1967); Krug v. Sterling Drug, Inc., 416S.W.2d
143 (Mo. 1967); Toole v. Richardson-Merrell Inc., 60 Cal.Rptr.
398 (Cal. Ct. App. 1967); Fritz v. Parke Davis & Co., 277 Minn.
210 (Minn. 1967); Williams v. Vick Chemical! Co., 279 F. Supp.
833 (S.D. lowa 1967); Bine v. Sterling Drug, Inc., 422 S.W.2d
623 (Mo. 1968); Davis v. Wyeth Labs., Inc., 399 F.2d 121 (9th
Cir. 1968); Sterling Drug, Inc. v. Yarrow, 408 F.2d 978 (8th Cir.
1969); Tinnerholm v. Parke, Davis & Co., 411 F.2d 48 (2d Cir.
1969); Parke-Davis & Co. v. Stromsodt, 411 F.2d 1390 (8th Cir.
1969); Grinnell v. Charles Pfizer & Co., 79 Cal.Rptr. 369 (Cal.
Ct. App. 1969); Kershaw v. Sterling Drug, Inc., 415 F.2d 1009
(5th Cir. 1969); Schenebeck v. Sterling Drug, Inc., 423 F.2d 919
(8th Cir. 1970); Hornung v. Richardson-Merrill, Inc., 317 F.
Supp. 183 (D. Mont. 1970); Croft v. York, 244 So.2d 161 (Fla.
App. 1971); Singer v. Sterling Drug, Inc., 461 F.2d 288 (7th Cir.
1972); Stevens v. Parke, Davis & Co., 507 P.2d 653 (Cal. 1973);
Redfield v. Mead, Johnson & Co., 266 Or. 273 (Or. 1973);
Hoffman v. Sterling Drug, Inc., 374 F. Supp. 850 (M.D. Pa.
1974); Reyes v. Wyeth Labs., 498 F.2d 1264 (5th Cir. 1974);
Crocker v. Winthrop Labs., Div. of Sterling Drug, Inc., 514
S.W.2d 429 (Tx. 1974); McEwen v. Ortho Pharm. Corp., 270 Or.
375 (Or. 1974); Whitley v. Cubberly, 210 S.E.2d 289, (N.C. Ct.
App. 1974); Oresman v. G. D. Searle & Co., 388 F. Supp. 1175
(D. R.I. 1975); Henry v. Richardson-Merrell, Inc., 508 F.2d 28
(3d Cir. 1975); Salmon v. Parke, Davis & Co., 520 F.2d 1359 (4th
Cir. 1975). Of course, this is only a partial list of the actual
cases; in particular, the list stops at 1975. This end date has a
substantive objective: the listed cases were all on the books
when Congress enacted the Medical Device Amendments of
1976. If Congress wanted to avoid the history of tort
litigation that had accompanied drugs even after the creation
of the premarket review process in 1938, one would have

9

expected a different statement than the one provided in the
preemption provision Congress chose.

When medical devices were added to the statutory mix
in 1938, they, too, remained subject to state-based tort
claims. In fact, in the ensuing decades, courts entertained
many tort suits relating to medical devices. See, e.g.,
Orthopedic Equip. Co. v. Eutsler, 276 F.2d 455 (4th Cir. 1960)
(upholding jury ruling in favor of plaintiff in action against
manufacturer of surgical nail); Vergott v. Deseret Pharm. Co.,
463 F.2d 12 (5th Cir. 1972) (upholding tort-based jury verdict
against manufacturer of needle used for catheter, which
broke off in plaintiff's vein); Dreiling v. Gen. Elec. Co., 511
F.2d 768 (5th Cir. 1975) (upholding jury ve dict for
defendant in case involving allegedly defective pacemaker);
Cinocca v. Baxter Lab., 400 F. Supp. 527 (E.D. Okla. 1975)
(denying summary judgment to corporate successor of firm
that manufactured allegedly defective heart valve); E.R.
Squibb & Sons., Inc. v. Jordan, 254 So.2d 17 (Fla. App. 1971)
(remanding for new trial on question whether beef bone
processed and marketed by defendant and used in spinal
operation was defective); Friedman v. Medtronic, Inc., 345
N.Y.S.2d 637 (NY App. Div. 1973) (jury verdict for plaintiff,
alleging breach of implied warranty with respect to
pacemaker, overturned on appeal).

Indeed, the tort system itself played no small part in
galvanizing support for the very 1976 amendments alleged
to preempt relief in this case. In the early 1970s, reports
emerged about serious safety problems associated with
medical devices. Most famously, thousands of women who
used the Dalkon Shield were injured by it, and some died. S.
Rep. 94-33, at 6 (1975), 94 Cong. 2d Sess., as reprinted in 1976
U.S.C.C.A.N. 1070. Lawsuits sprang up all over the country,
to such an extent that eventually a multidistrict panel on
litigation was convened to deal with the numerous claims. In

10

re A. H. Robbins Co., Inc. “Dalkon Shield” IUD Prod. Liab. Litig.,
406 F. Supp. 540 (J.P.M.L. 1975). In 1976, in the midst of this
episode, Congress passed the Medical Device Amendments
- without so much as a whisper suggesting that the Dalkon
Shield lawsuits (or the many other lawsuits that had been
brought relating to medical devices) might be undone by the
statute it had passed. Lohr, 518 US. at 490-491 & n. 13.

Fifth, this Court’s decisions construing the Act have
respected, even celebrated, the protective purposes of the
statute. The Act, Justice Frankfurter wrote in 1943, touches
“phases of the lives and health of people which, in the
circumstances of modern industrialism, are largely beyond
self-protection. Regard for these purposes should infuse
construction of the legislation if it is to be treated as a
working instrument of government and not merely as a
collection of English words.” Dotterweich, 320 U.S. at 280. At
the same time, the Court has underscored the Act’s goal of
encouraging continuous efforts to improve safety by holding
corporate officials responsible for dangers within their reach:
“[I]n providing sanctions which reach and touch the
individuals who execute the corporate mission . . . the Act
imposes not only a positive duty to seek out and remedy
violations when they occur but also, and primarily, a duty to
implement measures that will insure that violations will not
occur.” United States v. Park, 421 U.S. 658, 672 (1975).
Acknowledging that “[h]ardship there doubtless may be”
under such a system, the Court has recognized that
Congress chose to place the hardship “upon those who have
at least the opportunity of informing themselves of the
existence of conditions imposed for the protection of
consumers before sharing in illicit commerce, rather than to
throw the hazard on the innocent public who are totally
helpless.” Dotterweich, 320 U.S. at 284-285. The application of
tort law to matters embraced by the Act is fully consistent
with the Act’s large purpose of promoting responsible

11

commerce. In truth, it would be a deep irony if this same
statute were held to displace one of the few avenues
consumers have to engage in self-help against irresponsible
commerce - state-based common law.

In sum, a finding that tort law remains as a complement
to the regulatory framework of the Food, Drug, and
Cosmetic Act is perfectly consistent with - and indeed,
congenial to - the history and structure of the statute as a
whole.

II. This Court’s Recent Rulings On Preemption Must Be
Understood With Reference To The Specific Regulatory
Settings In Which They Arose.

This Court has long recognized that federal preemption
of state laws related to health and safety is a delicate matter.
Indeed, the Court has frequently invoked “the assumption
that the historic police powers of the States were not to be
superseded by [federal statute] unless that was the clear and
manifest purpose of Congress.” Rice v. Santa Fe Elevator
Corp., 331 U.S. 218, 230 (1947).

This solicitousness toward state protections of health and
safety is evident in the modern regulatory era. In Silkwood v.
Kerr-McGee Corp., the Court held that a claim for punitive
damages relating to the operation of a facility that made
plutonium fuel pins was not preempted by the Atomic
Energy Act. 464 U.S. 238, 258 (1984). Based on a painstaking
analysis of the text and history of the relevant federal
statutes, the Court found that Congress had all along
assumed that state tort law would remain viable even in the
midst of the massive federal regulatory regime applicable to
nuclear facilities. [d. at 248-258.

12

Likewise, in Cipollone v. Liggett Group, Inc., the Court
meticulously scrutinized the textual differences between the
Federal Cigarette Labeling and Advertising Act of 1965 and
the Public Health Cigarette Smoking Act of 1969 in coming
to its conclusion that the latter statute, but not the former,
preempted some common law claims. 505 U.S. 504, 518-524
(1992). The Court further scrutinized the 1969 statute in
order to figure out precisely which common law claims had
been preempted. Id. at 524-531. Based on a close reading of
the statutory text, the Court found that failure-to-warn
claims were preempted, but claims based on breach of
express warranty and fraudulent misrepresentation were
not. [bid.

The Court’s decision in Cipollone has been regarded by
some observers as a watershed moment in preemption
history, insofar as it appears to be the first case in whicn this
Court held that a federal statute preempted a state products
liability claim even where the federal law provided no
individual remedy of its own. See David Owen, Federal
Preemption of Products Liability Claims, 55 S.C. L. REV. 411, 423
(2003). In addition, the Court's reading of the 1969 statute's
language of “requirements” to include state common law
claims inspired fear that the decision presaged a large-scale
turn away from the Court's traditional reluctance to set aside
state laws protecting health and safety. And indeed, this
concern appeared well founded when Cipollone spurred a
whole new wave of preemption litigation. See David C.
Vladeck, Preemption and Regulatory Fa’.ure, 33 PEPP. L. REV.
95, 106 (2005). Nevertheless, a close reading of the decision
reveals the Court doing the work it has always done in
preemption cases: assiduously comparing the allegedly
preemptive federal statute with the specific state-law claims
being pressed.

13

This narrower understanding of the implications of
Cipollone has been validated by subsequent decisions of this
Court. The Court's next major pronouncement on the
relationship between an allegedly preemptive federa] law
and a state tort claim came in the context of the same statute
at issue here. In Medtronic, Inc. v. Lohr, 518 U.S. 470, the
Court held that the Medical Device Amendments did not -
despite their use of the term “requirements,” the
interpretation of which had led to such a ruckus following
Cipollone - preempt state common-law claims based on
negligent design, manufacturing, and labeling. 518 U.S. 470,
501-503 (1996).

In Lohr, the plurality came within a whisker of holding
that the Medical Device Amendments simply did not
preempt tort claims at all, but refrained from deciding the
question conclusively because it was not necessary to
dispose of the case. 518 U.S. at 502-503. In preserving the tort
claims at issue there, the Court found that “generic concerns
about device regulation generally” were not the sorts of
federal “requirements” that would lead to preemption under
the stalule, id. at 501, and that general state common-law
claims likewise were “not the kinds of requirements that
Congress and the FDA feared would impede the ability of
federal regulators to implement and enforce specific federal
requirements.” Ibid. The Court in Lohr was, above all else,
concerned with actual inconsistencies between federal and
state requirements, not with an abstract potential for tension.

The same preference for the specific statutory language
and intent over abstract possibilities carried the day in the
Court's unanimous decision in Sprietsma v. Mercury Marine,
537 US. 51 (2002). In construing the express preemption
provision in the Federal Boat Safety Act, the Court found it
“perfectly rational for Congress not to pre-empt common-
law claims, which - unlike most administrative and

14

legislative regulations - necessarily perform an important
remedial role in compensating accident victims.” Id. at 64.
The Court also found that the Coast Guard’s general
declination to set propeller guard standards for boats was
perfectly consistent “with a tort verdict premised on a jury’s
finding that some type of propeller guard should have been
installed on this particular kind of boat equipped with
respondent's particular type of motor.” Id. at 67.

Even more telling is the Court's recent decision in Bates
v. Dow Agroscience LLC, 544 U.S. 431 (2005). While holding
that the word “requirements” in the preemption provision of
the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) referred to at least some state-based common law
claims, the Court also held that the fact that the provision
preempted “judge-made rules, as well as statutes and
regulations, says nothing about the scope of that
preemption.” Id. at 443-444. The Court narrowed the class of
common-law claims that might be preempted by FIFRA by
focusing on the statutory phrases qualifying the word
“requirements.” Id. at 444. In addition, the Court narrowed
even the scope of what might be regarded as “requirements”
by excluding tort principles that merely induced particular
action on the part of pesticide manufacturers:

A requirement is a rule of law that must be obeyed; an
event, such as a jury verdict, that merely motivates an
optional decision is not a requirement. The proper
inquiry calls for an examination of the elements of the
common-law duty at issue; it does not call for
speculation as to whether a jury verdict will prompt the
manufacturer to take any particular action (a question, in
any event, that will depend on a variety of cost/benefit
calculations best left to the manufacturer's accountants).

Id. at 445 (citation omitted).

15

Even where the Court found that the common-law
claims at issue in Bates fell within the statutory definition of
“requirements,” the Court found that they were not
preempted if they “were equivalent to, and fully consistent
with,” the federal provisions. Id. at 447. Here, the Court
called upon statutory language strikingly similar to that
contained in the Medical Device Amendments, and found
that it preserved state-law claims so long as they were
parallel to federal requirements. Id. at 447-448 (relying on
Lohr, 518 U.S. at 495).

Significantly, the Court in Bates found support for its
ruling in “the long history of tort litigation against
manufacturers of poisonous substances.” Id. at 449. The
Court thought that this history not only “emphasizes the
importance of providing an incentive to manufacturers to
use the utmost care in the business of distributing inherently
dangerous items,” id. at 450, but that it also made it
“unlikely” that Congress used a “relatively obscure
provision” to erase this traditional liability. Id. at 450. The
Court also thought that tort liability could “aid, rather than
hinder,” the operation of the federal statute, particularly
since the statute contemplated that the pesticide labels
governed by the statute “will evolve over time.” /d. at 451.

The cases relevant here are, in short, both complex and
pragmatic. The cases are complex as a result of the Court's
salutary insistence on digging deep into the details of the
putatively preemptive federal scheme and comparing them
to the details of the putatively preempted state laws. The
cases are pragmatic insofar as they are alert to the way in
which Congress is likely to express an intent to displace state
law. The Court's decision in Bates is especially instructive on
the latter point, as the Court thought it improbable that

16

Congress would subtly undo a long history of state-based
tort litigation.

The appeals court's decision in this case shows none of
the subtlety and pragmatism that characterize this Court's
preemption cases. In place of complex and concrete analysis
of exactly how the federal law on medical devices relates to
the tort claims at issue here, the court offered generalized
anxiety about the abstract potential for conflict between the
federal and state schemes. Riegel v. Medtronic, Inc., 451 F.3d
104, 121-123 (2d Cir. 2006). And in place of a realistic
appraisal of how Congress is likely to express an intent to
displace longstanding tort principles, the court vaguely
opined that “it is much less clear” that these principles
survived creation of the premarket review process for the
most dangerous medical devices. Id. at 123.

III. The Medical Device Amendments Do Not Preempt The
Petitioners’ Tort Claims.

Petitioners’ brief explains in detail why petitioners’ tort
claims survive the narrow preemption provision of the
Medical Device Amendments, 21 U.S.C. § 360k(a). We adopt
these arguments. In this closing section, we highlight several
points that might not stand out in_ petitioners’
comprehensive discussion of the relevant issues.

First, this case is very different from Cipollone. There, the
federal statute dictated the contents of the labels on cigarette
packages. Cigarette makers were not allowed to deviate
from those mandates. Here, in contrast, the FDA simply
approved an application developed and submitted by
Medtronic. Approval without specific, prescriptive
conditions is not a “requirement”; it is more a dispensation
than a dictate. Nothing in the FDA’s approval required
Medtronic to manufacture or distribute a defective device,

17

inadequately labeled. Even if the FDA had listed some
conditions of approval, generic common-law duties and
remedies such as the duty of care and the duty to warn
would not conflict with those device-specific conditions.

Second, the preceding point highlights the lack of
conflict here between the federal and state frameworks.
Medtronic was not required, to borrow Justice Breyer’s
formulation from his partial concurrence in Lohr, to use the
catheter-equivalent of a two-inch wire, 518 U.S. at 503-508,
and petitioners’ prayer for tort relief asks for nothing
inconsistent with the FDA’s approval of Medtronic’s
catheter. If petitioners prevailed on their tort claims,
Medtronic would not be caught in a bind between federal
and state compliance. This case thus does not present the
potential for conflict that concerned Justice Breyer in Lohr.
Indeed, it bears noting that Medtronic no longer even makes
the Evergreen Balloon Catheter. In this case, even a potential
for tension between federal law and state remedies is
nonexistent.

Third, the criterion tor premarket approval of medical
devices itself points to the contingent and preliminary
nature of the FDA’s decision, reinforcing our earlier point
that the premarket approval process is complemented by
post-market controls, including tort law. The standard for
approval of medical devices is “reasonable assurance” of
safety. 21 U.S.C. § 360e(d)(2)(A), (B). The hopeful but
tentative nature of this standard appears to assume the
availability of the kind of post-market discipline embodied
in tort-based remedies. See also 21 U.S.C. 306h(d) (offset
provision regarding economic damages recovered under
federal or state law, embodying background assumption of
tort liability).

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Fourth, the abundant tort actions relating to medical
devices entertained by the courts prior to 1976 parallel the
long history of tort litigation relating to poisonous
substances, emphasized by this Court in Bates. 544 U.S. at
449-450. Here, as there, it is improbable that Congress would
undo these longstanding remedies with a provision that
does not even mention the common law. Equally telling is
the rich history of litigation relating to drugs, discussed in
Part I above, following the creation of the premarket review
process for drugs. If Congress had wanted, in creating the
premarket review process for medical devices, to avoid the
tort litigation that had for decades complemented the
premarket review process for drugs, it is reasonable to
expect that it would have said so in plain terms.

Every day in this country, consumers must trust
strangers to provide them with uncontaminated food, good
medicine, honest financial services, safe cars, and the whole
host of other products and services associated with modern
life. Congress has passed a wide variety of laws aimed at
promoting a fair and safe marketplace. Longstanding
principles of tort, such as the duty of care and the duty to
warn, are fixed on the same goal, albeit with the added aim
of compensating victims of wrongful conduct. It has been,
and should continue to be, the most unusual case when this
Court upends the friendly collaboration between federal
laws and state tort remedies. This is not that case.

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CONCLUSION

The judgment of the court of appeals should be reversed.
Respectfully submitted,

LISA HEINZERLING

Counsel of Record

600 New Jersey Ave., N.W.
Washington, D.C. 20001
(202) 662-9115

MARK SAVAGE
Consumers Union
of United States, Inc.
1535 Mission Street
San Francisco, CA 94103-2512

August 27, 2007

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385016_0289%3A16. Public record. Not legal advice.