Amicus Curiae Brief — Riegel v. Medtronic, Inc.

Supreme Court brief2008

Ask Donna

What actually matters in this document.

Text

(p Dov 1B FILED

‘

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.

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

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

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

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

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.

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

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

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).

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

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.

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

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

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

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.

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.

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

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).

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

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,

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).

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.

CONCLUSION

The judgment of the court of appeals should be reversed.

Respectfully submitted,