US v Regen Sci - AAPS Lodged Amicus Br

8/6/2019 US v Regen Sci - AAPS Lodged Amicus Br

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IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF COLUMBIA

UNITED STATES OF AMERICA,

Plaintiff,

v.

REGENERATIVE SCIENCES LLC, CHRISTOPHERJ. CENTENO, M.D., JOHN R. SCHULTZ, M.D., andMICHELLE R. CHEEVER, Individuals,

Defendants;

ASSOCIATION OF AMERICAN PHYSICIANS &SURGEONS, INC.,

Amicus curiae.

))

)))))))))))

No. 1:10-cv-01327-RMC

AMICUS CURIAE BRIEF OF ASSOCIATION OF AMERICAN

PHYSICIANS & SURGEONS, INC., IN SUPPORT OF DEFENDANTS

OPPOSITIONS TO PLAINTIFFS MOTION FOR SUMMARY

JUDGMENT

Lawrence J. Joseph, D.C. Bar No. 4647771250 Connecticut Ave., NW, Suite 200Washington, DC 20036

Telephone: (202) 669-5135Telecopier: (202) 318-2254Email: [email protected]

Counsel for Amicus Curiae Association of American

Physicians & Surgeons, Inc.

Case 1:10-cv-01327-RMC Document 27-2 Filed 05/25/11 Page 1 of 23


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TABLE OF CONTENTS

Introduction ......................................................................................................................................1Summary of Argument ....................................................................................................................1Argument .........................................................................................................................................2I. This Court Has Jurisdiction for Counterclaims that Defeat the Entry of

Summary Judgment for the United States ...........................................................................2A. 1331 Provides Statutory Subject-Matter Jurisdiction ............................................2B. Sovereign Immunity Poses No Barrier to Counterclaims ........................................4

1. The APAs 1976 Amendment Waived Sovereign Immunity ......................42. This Court Has Equity Jurisdiction ..............................................................5

C. This Court Has Jurisdiction for Injunctive or Declaratory Relief ............................6D. A General Pleading Can State a Claim for Relief that a Party Did

Not Expressly Request in its Special Pleadings .......................................................6 II. The Presumption against Preemption Applies to Limit this Federal Foray

into a General Police Power over Medicine ........................................................................8III. Neither FDAs Rules Nor the United States Litigation Position Warrants

this Courts Deference .......................................................................................................11A. Substantively Ultra Vires Rules Do Not Warrant Deference ................................11B. General Statements of Policy Do Not Warrant Deference ....................................12C. Procedurally Invalid Rules Do Not Warrant Deference ........................................13

IV. Autologous Use of Bodily Fluids, Cells, or Tissue Is within the Practice ofMedicine and Outside FFDCAs Jurisdiction ....................................................................14Conclusion .....................................................................................................................................16



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INTRODUCTION

Amicus curiae Association of American Physicians & Surgeons, Inc. (AAPS) is a not-

for-profit membership organization incorporated under the laws of Indiana and headquartered in

Tucson, Arizona. AAPS members include thousands of physicians nationwide in all practices

and specialties. AAPS was founded in 1943 to preserve the practice of private medicine, ethical

medicine, and the patient-physician relationship.

AAPS and its members oppose this action by the United States acting on behalf of the

Food & Drug Administration (FDA) to use the Federal Food, Drug and Cosmetics Act, 21

U.S.C. 301-399a (FFDCA), to override Colorado law on the lawful practice of medicine by

Christopher J. Centeno, M.D., and John R. Schultz, M.D. (collectively with Regenerative

Sciences, LLC and the other co-defendant, the Regenerative group). COLO. REV. STAT. 12-

36-106(1). In the process, the United States would define the practice of medicine as the mere

use of FDA-approved drugs and devices to treat patients, making the entire practice of medicine

an outgrowth of the FFDCAs enactment in 1906. In light of this unprecedented attack on

medical practice, AAPS implores this Court not only to deny summary judgment to the United

States but also to enter judgment for the Regenerative group.

SUMMARY OF ARGUMENT

In this amicus brief, AAPS first demonstrates that the Court has jurisdiction to hear and

decide the Regenerative groups counterclaims, both the specific ones outlined in Defendants

First Amended Answer, Affirmative Defenses and Counterclaims (docket item #16) and any

other counterclaims within the general pleading for such other relief that the Court may deem

just and proper in that documents last line. These counterclaims preclude the entry of summary

judgment for the United States. See Section I, infra. Before reaching the merits, AAPS

demonstrates that the Santa Fe Elevator presumption against preemption applies and that



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neither the FDA rules nor the United States litigation position warrants this Courts deference.

See Sections II and III, infra. Finally, on the merits, AAPS demonstrates that the autologous use

of bodily fluids, cells, and tissue (i.e., the use of a patients body to support that patient) falls

within the practice of medicine and outside the FFDCAs jurisdiction. See Section IV, infra.

ARGUMENT

I. THIS COURT HAS JURISDICTION FOR COUNTERCLAIMS THAT DEFEAT

THE ENTRY OF SUMMARY JUDGMENT FOR THE UNITED STATES

As a general matter, notwithstanding that the United States initiated this litigation as a

plaintiff, the United States theoretically could oppose any counterclaims by the Regenerative

group on jurisdictional grounds. The following sections address the statutory, common law,

procedural, and constitutional bases on which the United States might oppose granting relief on

the Regenerative group counterclaims. Dismissing the Regenerative groups counterclaims is a

condition precedent to this Courts granting summary judgment to the United States.

A. 1331 Provides Statutory Subject-Matter Jurisdiction

Until 1976, federal-question jurisdiction included an amount-in-controversy threshold.

Since 1976, however, 1331 has provided statutory subject-matter jurisdiction for virtually all

challenges to federal agency action. Califano v. Sanders, 430 U.S. 99, 105 (1977) (cases

seeking nonstatutory review of Federal administrative action, absent the jurisdictional amount

in controversy arise under the Federal Constitution or Federal statutes, and the committee

believes they are appropriate matters for the exercise of Federal judicial power regardless of the

monetary amount involved) (quoting S. REP. NO. 94-996 at 12 (1976)). The obvious effect of

[eliminating 1331s amount-in-controversy requirement against federal agencies and officers],

subject only to preclusion-of-review statutes created or retained by Congress, is to confer

jurisdiction on federal courts to review agency action, regardless of whether the Administrative



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Procedure Act, 5 U.S.C. 551-706 (APA), of its own force may serve as a jurisdictional

predicate. Sanders, 430 U.S. at 107 (emphasis added); Andrus v. Charlestone Stone Prod. Co.,

436 U.S. 604, 608 n.6 (1978) (Nor does it matter that the complaint does not assert 1331(a)

as a basis of jurisdiction, since the facts alleged in it are sufficient to establish such

jurisdiction); Chrysler Corp. v. Brown, 441 U.S. 281, 317 n.46 (1979) (1331 provides subject-

matter jurisdiction to review agency action). Unless some statute expressly precludes review,

1331 plainly gives this Court statutory subject-matter jurisdiction over this type of challenge.

In addition, the Declaratory Judgment Act, 28 U.S.C. 2201-2202 (DJA), authorizes

declaratory relief whether or not further relief could be sought. 28 U.S.C. 2201(a); Duke

Power Co. v. Carolina Envtl. Study Group, Inc., 438 U.S. 59, 70-71 n.15 (1978) (While the

[DJA] does not expand our jurisdiction, it expands the scope of available remedies where

plaintiffs sought declaratory relief that a statute was invalid as an alternate remedy to seeking

compensation for a taking). Since 1976, 1331 has authorized DJA actions against federal

officers, regardless of the amount in controversy. Sanders, 430 U.S. at 105 (quoted supra).

Moreover, the availability of declaratory relief against federal officers predates the APA,

WILLIAM J. HUGHES, FEDERAL PRACTICE 25387 (1940 & Supp. 1945); EDWIN BORCHARD,

DECLARATORY JUDGMENTS, 787-88, 909-10 (1941), and the APA did not displace such relief,

either as enacted in 1946 or as amended in 1976. See ADMINISTRATIVE PROCEDURE ACT:

LEGISLATIVE HISTORY, S. DOC. NO. 248, 79th Cong., 2d Sess., at 37, 212, 276 (1946); 5 U.S.C.

559; Darby v. Cisneros, 509 U.S. 137, 153 (1993) (rejecting argument that 1976 APA

amendments expanded APAs preclusion of review) (citing 5 U.S.C. 559 and Dickinson v.

Zurko, 527 U.S. 150, 154-55 (1999)). Thus, even if the APA does not provide relief, the

Regenerative group nonetheless can obtain relief under the DJA and 1331.



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B. Sovereign Immunity Poses No Barrier to Counterclaims

As a general matter, notwithstanding that the United States initiated this litigation as a

plaintiff, the United States theoretically could enjoy sovereign immunity from any counterclaims

by the Regenerative group. U.S. v. U.S. Fidelity & Guar. Co., 309 U.S. 506, 513-14 (1940)

(suability of the United States, whether directly or by cross-action, depends upon affirmative

statutory authority). As explained in the following subsections, however, the United States has

consented to counterclaims in situations like this, and this Court has independent equity

jurisdiction in any event.

1. The APAs 1976 Amendment Waived Sovereign Immunity

As amended in 1976, 5 U.S.C. 702 of the APA waives sovereign immunity for equitable

and declaratory relief: [t]he United States may be named as a defendant in any such action, and

a judgment or decree may be entered against the United States. 5 U.S.C. 702. This waiver

eliminat[ed] the sovereign immunity defense in all equitable actions for specific relief against a

Federal agency or officer acting in an official capacity. Sea-Land Serv., Inc. v. Alaska R.R., 659

F.2d 243, 244 (D.C. Cir. 1982) (quoting S. Rep. No. 94-996, 8 (1976)) (emphasis added).

Significantly, APAs waiver of sovereign immunity applies to any suit whether under the APA

or not. Chamber of Commerce v. Reich, 74 F.3d 1322, 1328 (D.C. Cir. 1996) (emphasis added).

The APA also requires courts to decide all relevant questions of law, interpret

statutory provisions, and determine the meaning or applicability of the terms of an agency

action. 5 U.S.C. 706. In the absence or inadequacy of statutory review, the APA authorizes

declaratory as well as injunctive relief, 5 U.S.C. 703, unless a statute[] preclude[s] judicial

review. 5 U.S.C. 701(a)(1). Because no statuteprecludes counterclaims here, the Regenerative

group may bring counterclaims against the United States for any equitable or declaratory relief.



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2. This Court Has Equity Jurisdiction

This Court long has had equity jurisdiction over federal officers that exceeds the

jurisdiction of other district courts. Kendall v. Stokes, 37 U.S. (12 Pet.) 524, 580-81 (1838); Stark

v. Wickard, 321 U.S. 288, 290 n.1 (1944); Peoples v. Dept of Agric., 427 F.2d 561, 564 (D.C.

Cir. 1970); Gamen v. Heckler, 746 F.2d 844, 851 (D.C. Cir. 1984). Essentially, the Court has

common-law powers over such officers because its Maryland predecessor had common-law

powers over state officers, before Maryland ceded the district as a federal enclave. Kendall, 37

U.S. at 580-81; Peoples, 427 F.2d at 565; Gamen, 746 F.2d at 8. The current statute confers the

same jurisdiction as that on which the Peoples court relied. Compare D.C. Code 11-501 with

D.C. Code 11-521 (1967) (Ex. 1). Both versions grant this Court any other jurisdiction

conferred by law in addition to jurisdiction as a United States district court. The laws

expressly conferring this Court with general jurisdiction in law and equity dates back to 1801.

Act of March 3, 1863, 12 Stat. 762; Act of June 25, 1936, 49 Stat. 1921; Act of February 27,

1801, 2 Stat. 103.1 Significantly, declaratory relief is available under this Courts equity

jurisdiction, even to the extent that that relief is not available under federal-question jurisdiction.

Franchise Tax Bd. of State of Cal. v. Construction Laborers Vacation Trust for Southern

1 The District of Columbia Court Reorganization Act of 1970 did not repeal thisjurisdiction, but instead retained the jurisdiction granted to this Court by law, D.C. Code 11-501, which cannot impliedly repeal the prior jurisdiction. Schlesinger v. Councilman, 420 U.S.738, 752 (1975) (repeals by implication are disfavored, and this canon of construction applieswith particular force when the asserted repealer would remove a remedy otherwise available).

Indeed, the legislative history of the 1976 APA amendments to waive sovereign immunity notesthat, under the then-current law, plaintiffs could escape 1331s then-applicable $10,000amount-in-controversy requirement by seeking to enjoin federal officers in the District ofColumbia. H.R. REP. NO. 94-1656, at 15-16, reprinted in 1976 U.S.C.C.A.N. 6121, 6136. Inother words, Congress itself recognized in 1976 that its 1970 Reorganization Act had left intactthis Courts unique equity jurisdiction over federal actors.



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California, 463 U.S. 1, 17-18 (1983); FED. R. CIV. P. 57. Accordingly, this Courts equity

jurisdiction would provide another basis for the Regenerative groups counterclaims, even if the

APAs waiver of sovereign immunity did not.

C. This Court Has Jurisdiction for Injunctive or Declaratory Relief

Injunctive relief requires irreparable harm and inadequacy of legal remedies. Beacon

Theatres, Inc. v. Westover, 359 U.S. 500, 506-07 (1959). But those prerequisites do not apply to

requests for declaratory relief under the Declaratory Judgment Act, 28 U.S.C. 2201-2202. The

fact that another remedy would be equally effective affords no ground for declining declaratory

relief, 28 U.S.C. 2201; Hurley v. Reed, 288 F.2d 844, 848 (D.C. Cir. 1961); Tierney v.

Schweiker, 718 F.2d 449, 457 (D.C. Cir. 1983), and showing irreparable injury is not

necessary for the issuance of a declaratory judgment. Tierney, 718 F.2d at 457 (citing Steffel v.

Thompson, 415 U.S. 452, 471-72 (1974)); 10B WRIGHT & MILLER, FED. PRAC. & PROC. Civ.3d

2766 ([i]f the normal requirements of federal jurisdiction are present, the court has

jurisdiction for declaratory relief). Thus, even if not entitled to injunctive relief such as vacatur

of FDAs policies or rules, the Regenerative group is entitled to declaratory relief.

D. A General Pleading Can State a Claim for Relief that a Party Did Not

Expressly Request in its Special Pleadings

Like the counterclaims here, virtually every complaint in federal court ends with the

ubiquitous request for such other relief as the Court deems appropriate or words to similar

effect. Docket Item #16, at 32 (requesting such other relief that the Court may deem just and

proper). In equity pleading, this apparent boilerplate is known as a general pleading, and it

serves a critical role that warrants denying summary judgment to the United States.

The general pleading entitles the pleader usually the plaintiff, but here the defendant

and cross-complainant to relief on theories not contained in the specific pleadings. Scheduled



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Airlines Traffic Offices, Inc., v. Dept of Defense, 87 F.3d 1356, 1358-59 (D.C. Cir. 1996)

(finding jurisdiction based on general pleading for [s]uch other and further relief as the Court

deems appropriate notwithstanding absence of jurisdiction based only on specific pleadings)

(alteration in original) (SATO); People for the Ethical Treatment of Animals, Inc., v. Gittens,

396 F.3d 416, 421 (D.C. Cir. 2005) (the complaint requested such other and further relief as

the Court may deem just and proper[, which] permits a district court to award damages for

breach of contract even when the plaintiff has not pled a contract claim) (PETA); Bemis

Brothers Bag Co. v. U.S., 289 U.S. 28, 34, 53 S.Ct. 454, 456 (1933) ([t]he rule is now general

that at a trial upon the merits the suitor shall have the relief appropriate to the facts that he has

pleaded, whether he has prayed for it or not).

Indeed, it does not matter that the plaintiff [cannot] obtain the specific relief demanded

as long as the court can ascertain from the face of the complaint that some relief can be granted.

Doe v. U.S. Dept of Justice, 753 F.3d 1092, 1104 (D.C. Cir. 1985) (emphasis in original).

Instead, a party should experience little difficulty in securing a remedy other than that

demanded in the pleadings as long as the party shows he is entitled to it. Metro-North

Commuter R. Co. v. Buckley, 521 U.S. 424, 455, 117 S.Ct. 2113, 2129 (1997) (quoting 10

CHARLES A. WRIGHT, ARTHUR R. MILLER, & MARY KAY KANE, FEDERAL PRACTICE AND

PROCEDURE 2662, (2d ed.1983)).

There is nothing in the intricacy of equity pleading that prevents the plaintifffrom obtaining the relief under the general prayer, to which he may be entitledupon the facts plainly stated in the bill. There is no reason for denying his rightto relief, if the plaintiff is otherwise entitled to it, simply because it is askedunder the prayer for general relief, and upon a somewhat different theory fromthat which is advanced under one of the special prayers.

Lockhart v. Leeds, 195 U.S. 427, 436-37 (1904); id. at 437 (where all the facts are stated, it is

no reason for denying relief under a general prayer, because it may differ from the theory of the



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law upon which the special prayer for relief is based, where both prayers are based upon the

same facts, clearly set forth in the bill).

Under the circumstances here, even if the Regenerative groups procedural counterclaims

fail, for whatever reason, that failure would not prevent the Courts entering declaratory relief

along the same lines. For example, as explained in Section III.B, infra, if the Regenerative

groups counterclaim on procedural grounds falls short because the preamble statement is not

final agency action, that would not prevent this Courts entering declaratory relief on the

preambles not deserving deference and not setting any binding norm on which the public or the

agency can rely. Either form of relief ordering vacaturof the rule or essentially declaring it

void ab initio or of no effect leads to the same result: the Court ignores the agency action. In

sum, even if the United States succeeds in dismissing the Regenerative groups express

counterclaims, this Court still could rule for the Regenerative group on its general pleading and

therefore deny the United States summary judgment.

II. THE PRESUMPTION AGAINST PREEMPTION APPLIES TO LIMIT THIS

FEDERAL FORAY INTO A GENERAL POLICE POWER OVER MEDICINE

Echoing Louis XV, the United States claims that FFDCA created the practice of

medicine, which consists solely of physicians implementing FDA-approved drugs and devices:

avant moi, labysse. To the contrary, of course, the States had police power over the practice of

medicine, and regulated the practice of medicine, long before FFDCAs enactment in 1906.2

Indeed, physicians practiced their art long before the states ratified the Constitution or even

existed as political entities. The first vaccine (for smallpox) was developed in 1796, Hippocrates

2 In 1906, Congress enacted the Pure Food and Drugs Act, ch. 3915, 34 Stat. 768 (1906).In 1938, Congress amended and replaced that Act with FFDCA. PUB. L. NO. 75 -717, 52 Stat.1040 (1938).



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practiced medicine circa 430 B.C., and Imhotep practiced medicine circa 2980 B.C., all without

help from FFDCA. See generally Max Neuburger, HISTORY OF MEDICINE (Oxford Univ. Press

1910).

Even if the United States position were not factually preposterous, FFDAC could not

define the contours of the practice of medicine. See U.S. CONST. amend. IX (enumeration in the

Constitution, of certain rights, shall not be construed to deny or disparage others retained by the

people). Instead, the Constitution reserves to the States and the people all powers not expressly

provided to the federal government. U.S. CONST. amend. X. Moreover, Congress was rather clear

that FFDCA does not define the practice of medicine. See S. REP. NO. 74-361, at 3 (1935)

(FFDCA not intended as a medical practices act and [would] not interfere with the practice of

the healing art[s]). But the Regenerative group need not affirmatively establish that Congress

did not intendthe FFDCA to displace state regulation of the practice of medicine. Instead, under

the presumption against preemption that applies here, the United States must (but cannot)

establish that Congress clearly and manifestly intendedFFDCA to trump state law on that issue.

At the most basic level, of course, federal law preempts state law when they conflict. U.S.

CONST. art. VI, cl. 2. And State action may be foreclosed by express [statutory] language, by

implication from the depth and breadth of a [statute] that occupies the legislative field, or by

implication because of a conflict with a [statute].Lorillard Tobacco Co. v. Reilly, 533 U.S. 525,

541 (2001) (citations omitted). To determine a statutes preemptive scope, congressional intent

controls, Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516-17 (1992), and may be explicitly

stated in the statutes language or implicitly contained in its structure and purpose. Jones v.

Rath Packing Co., 430 U.S. 519, 525 (1977). If Congress states its preemptive intent explicitly, a

courts only task is to determine the statutes preemptive scope. Cipollone, 505 U.S. at 517. The



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statutory text is the best evidence of Congress pre-emptive intent, CSX Transp., Inc. v.

Easterwood, 507 U.S. 658, 664 (1993), and its plain meaning presumptively expresses that

intent.Morales v. Trans World Airlines, Inc., 504 U.S. 374, 383 (1992).

When reviewing the interplay between state and federal law for the latters possible

preemption of the former, courts apply a presumption against preemption for fields traditionally

occupied by state and local government. Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230

(1947). Even where a court finds that Congress expressly preempted some state action, the

presumption against preemption applies to determining the scope of that preemption.Medtronic,

Inc. v. Lohr, 518 U.S. 470, 485 (1996). Thus, [w]hen the text of an express pre-emption clause

is susceptible of more than one plausible reading, courts ordinarily accept the reading that

disfavors pre-emption.Altria Group, Inc. v. Good, 129 S.Ct. 538, 540 (2008) (quoting Bates v.

Dow Agrosciences LLC, 544 U.S. 431, 449 (2005)). When this presumption against

preemption applies, courts will not assume preemption unless that was the clear and manifest

purpose of Congress. Santa Fe Elevator, 331 U.S. at 230 (emphasis added). As explained in this

Section, the United States cannot overcome that presumption here.

Courts rely on the presumption because respect for the States as independent sovereigns

in our federal system leads [them] to assume that Congress does not cavalierly pre-empt [state

law]. Wyeth v. Levine, 129 S. Ct. 1187, 1195 n.3 (2009) (internal quotations omitted). For that

reason, [t]he presumption accounts for the historic presence of state law but does not rely on

the absence of federal regulation. Id. For example, Santa Fe Elevator, 331 U.S. at 230, cited a

1944 decision where 21 states (of 48) regulated warehouses. See Davies Warehouse Co. v.

Bowles, 321 U.S. 144, 148-49 (1944). Under those circumstances, the presumption applied to

prevent warehouses coming under federal regulation of public utilities without any apparent



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congressional consideration of whether warehouses should qualify as public utilities, even if

they fit the statutes literal definition. Id. Notwithstanding the literal application of the federal

statute, the presumption prevented the federal laws overstepping traditional state regulation in

the absence of something much more explicit from Congress.

Where, as here, the states have occupied the field historically, the presumption plainly

applies. Under the circumstances, the United States must cite clear and manifest congressional

intent to displace states historic police power over the practice of medicine before the United

States can ask this Court to have FFDCA displace that traditional state power.

III. NEITHER FDAS RULES NOR THE UNITED STATES LITIGATIONPOSITION WARRANTS THIS COURTS DEFERENCE

In any litigation that pits the public against governmental action by an administrative

agency like FDA, the reviewing court must determine whether the agencys views are entitled to

deference. Under the circumstances here, neither the FDA rules nor the United States litigation

position warrant deference.

A. Substantively Ultra Vires Rules Do Not Warrant Deference

As the Regenerative group explains, deference to administrative interpretations does not

apply when the rule under the agency interpretation exceeds the agencys authority. Instead,

Courts have an independent obligation whether at Chevron step one or Chevron step

zero to assess congressional intent using traditional tools of statutory construction. Chevron,

U.S.A., Inc. v. N.R.D.C., 467 U.S. 837, 482 n.9 (1984). For the substantive reasons set forth in

Section IV, infra, and by the Regenerative group, this Court should reject the United States

merits position, particularly given the presumption against preemption of state regulation of the

practice of medicine. See Section II, supra. Significantly, the United States argument that the

Regenerative groups procedural counterclaims are time barred has no application to the



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Regenerative groups merits arguments: plaintiffs can challenge rules apart from the original

rulemaking when [a] rule is brought before [a] court for review of [agency] action applying

it.Murphy Explorn & Prodn Co. v. DOI, 270 F.3d 957, 958-59 (D.C. Cir. 2001).

B. General Statements of Policy Do Not Warrant Deference

Even if FDA did not violate any APA procedures, the steps that FDA did take

nonetheless establish that FDAs interpretive gloss on autologous uses of bodily fluids, cells, or

tissue does not warrant this Courts deference. The Regenerative group argues that FDA crossed

the line between interpreting a rule and promulgating a substantive regulation. Viewed another

way, one could argue that the challenged language remains too open-ended to guide this Court.

The first theory argues that the agency position is cast in stone, whereas the second argues that

the agency position remains too ephemeral.

At the outset, amicus AAPS has no reason to doubt the Regenerative groups argument

that FDAs guidance here has crystallized into final agency action. Virtually any combination of

successive agency interpretations can crystallize into a binding rule, even if the Federal Register

preamble language did not do so by itself. See Barrick Goldstrike Mines v. Browner, 215 F.3d

45, 48 (D.C. Cir. 2000). Indeed, even a press release can push the agency over the edge into final

agency action. CropLife America v. E.P.A., 329 F.3d 876, 878 (D.C. Cir. 2003) (finding press

release to constitute an impermissibly legislative rule). Where that the agency position is

sufficiently set, through whatever combination of successive agency action, the Regenerative

group can challenge that final agency action, and the remedy is vacatur. By contrast, if indeed

the agency position is not set, that position also might not rise to the dignity required for this

Court to defer to the agency action at all.

Specifically, if (as appears to be the case here) the agency gloss is tentative and non-

definitive, the challenged action would be what the APA calls a general statement of policy, as



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distinct from an interpretive rule. General statements of policy have two defining characteristics:

(1) they operate only prospectively by announcing factors that the agency will consider in

resolving future substantive questions, and (2) they nonetheless leave the agency free to exercise

its discretion, without establishing a binding norm.Burroughs Wellcome Co. v. Schweiker, 649

F.2d 221, 224 (4th Cir. 1981). An agency cannot escape its responsibility to present evidence

and reasoning supporting its substantive rules by announcing binding precedent in the form of a

general statement of policy. Pacific Gas & Elec. Co. v. F.P.C., 506 F.2d 33, 38-39 (D.C. Cir.

1974). Accordingly, such statements are not entitled to deference when an agency relies on them

to resolve a future substantive question because, logically, the future action (not the initial

statement) is the final agency action. Pacific Gas & Elec. Co., 506 F.2d at 38-39; accord Texaco,

Inc. v. F.P.C., 412 F.2d 740, 744 (3d Cir. 1969); Amrep Corp. v. FTC, 768 F.2d 1171, 1178

(10th Cir. 1985);Mada-Luna v. Fitzpatrick, 813 F.2d 1006, 1013-14 (9th Cir. 1987). Thus, as an

alternative to the equitable remedy to vacaturof a procedurally invalid final agency action, this

Court could rely on its unquestionable jurisdiction here to provide a merely declaratory judgment

that the challenged rule is a mere general statement of policy not entitled to deference. Either

way, the agency action cannot control, either because it came into existence unlawfully or

because it has not sufficiently come into existence at all.

C. Procedurally Invalid Rules Do Not Warrant Deference

FDAs regulation of autologous uses of a patients own bodily fluids, cells, or tissue also

raises procedural concerns that undermine any deference that the Court otherwise might provide

to FDAs interpretations, particularly where those interpretations overstep state law in an area of

traditional state concern.

The Court of Appeals has held that the APA prohibits agencies from using a substantive

rules allowance for additional factors as the vehicle to add specific new regulatory factors to the



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existing enumeration of regulatory factors. United States v. Picciotto, 875 F.2d 345, 348-49

(D.C. Cir. 1989). In Picciotto, the U.S. Park Service attempted to impose a requirement on all

permits under its general authority to include additional reasonable conditions in permits. The

court first clarified that an interpretive rule explains an existing requirement; it does not impose

an additional one. The court expressly rejected the agencys attempt to circumvent the APAs

rulemaking procedures by creating new requirements under the guise of interpretation:

In essence, the Park Service is claiming that an agency can grant itself a validexemption to the APA for all future regulations, and be free of APAstroublesome rulemaking procedures forever after, simply by announcing itsindependence in a general rule. This is not the law.

Picciotto, 875 F.2d at 346-47. Under Picciotto, therefore, agencies cannot write themselves

blank checks to make regulations up as they go.

As indicated, the preemption context raises additional reasons to deny FDA any

deference. In Wyeth v. Levine, the Supreme Court emphasized that while federal regulations

may perhaps preempt state law a Federal Register preamble cannot claim that power, and

denied the agency deference for the procedural irregularity of providing a different view in a

final rules preamble than the agency announced in the proposals preamble. Wyeth v. Levine,

129 S.Ct. 1187, 1201-04 (2009); cf. Green v. Bock Laundry Mach. Co., 490 U.S. 504, 521-22

(1989) (party contending that legislative action changed settled law has the burden of showing

that the legislature intended such a change). Wyeth further warrants denying FDA any deference

until such time as FDA clearly and manifestly promulgates its position in legislative rules that

FDA both proposes as preemptive and promulgates as such.

IV. AUTOLOGOUS USE OF BODILY FLUIDS, CELLS, OR TISSUE IS WITHIN

THE PRACTICE OF MEDICINE AND OUTSIDE FFDCAS JURISDICTION

The United States enforcement efforts have no real or reasonable stopping point.

Although the United States focuses on the involvement of a limited liability company and a non-



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physician, the United States core theory would apply just as well if one physician

singlehandedly removed stem cells, manipulated them, and re-injected them all within a single

office visit. The Congress that enacted the relevant FFDCA provisions did not intend to reach the

practice of medicine, S. REP. NO. 74-361, at 3, which dooms FDAs latter-day attempts to do so.

While undoubtedly true that subsequent amendments expanded FFDCAs scope in other ways

and that subsequent Congresses took a wider view of federal authority, none of that changes the

original limitations of the original enactment. Fourco Glass Co. v. Transmirra, 353 U.S. 222,

227 (1957); Waterman S.S. Corp. v. U.S., 381 U.S. 252, 269 (1965). The United States could not

expand FFDCA without a new statute that expressly adopts the federal regime, and the United

States could not displace Colorado law without a new statute that clearly and manifestly

preempts state law.

To regulate the Regenerative groups activities, FDA and the United States seek to rely

on FFDCAs misbranding provisions and the Public Health Service Acts provision on

preventing the transmission of communicable diseases. See 21 U.S.C. 331; 42 U.S.C. 264. In

both cases, however, Congress regulated under the Commerce Clause, and FDAs attempts to

reach the purely intrastate practice of medicine far exceeds both the federal power under the

Commerce Clause and the terms that Congress enacted in those two statutes. Both reasons

independently doom FDAs and the United States overreach here.3

3 Even if the United States enforcement action here fell within the relevant statutes, thatenforcement nonetheless could not survive constitutional scrutiny because the claimed authoritywould undermine our constitutional structure by creating an unlimited power indistinguishablefrom a national police power. See U.S. v. Morrison, 529 U.S. 598, 618-19 (2000) (we alwayshave rejected readings of the Commerce Clause and the scope of federal power that wouldpermit Congress to exercise a police power).



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In pertinent part, FFDCAs misbranding provisions are limited to drugs in interstate

commerce, 21 U.S.C. 331, which FFDCA defines in pertinent part as commerce between any

State or Territory and any place outside thereof. 21 U.S.C. 321(b)(1) (emphasis added). Even

if the constitutional limits of the Commerce Power extended to the Regenerative groups actions

(and they do not), the United States would run afoul of FFDCAs statutory limitation of

regulated conduct to truly interstate commerce. The Regenerative groups actions here take place

exclusively within the State of Colorado.

As signaled above, however, even the outer constitutional limits of the Commerce Power

do not extend to the Regenerative groups wholly intrastate activity. The Commerce Power

encompasses three categories of regulation: (1) the channels of interstate commerce, (2) the

instrumentalities of interstate commerce, and persons or things in interstate commerce, and

(3) activities that substantially affect interstate commerce. Gonzales v. Raich, 545 U.S. 1, 16-

17 (2005) (emphasis added). None of these strands apply to the Regenerative groups minor

operations wholly within Colorado.4

CONCLUSION

For the foregoing reasons, amicus AAPS respectfully submits that this Court must deny

the United States motion for summary judgment and instead enter judgment for the

Regenerative group.

4 Under the three-part Raich tests second prong, the Public Health Service Act arguablywould give FDA authority to regulate persons who receive treatment from the Regenerativegroup from travelling in interstate commerce if they present risk of an interstate transmission ofcommunicable diseases. See 42 U.S.C. 264. The fanciful nature of that possibility demonstrateshow tenuous a reed the United States has chosen on which to base its overreach into regulatingthe practice of medicine.



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Dated: May 25, 2011 Respectfully submitted,

Lawrence J. Joseph, D.C. Bar No. 464777

1250 Connecticut Ave., NW, Suite 200Washington, DC 20036Telephone: (202) 669-5135Telecopier: (202) 318-2254Email: [email protected]



/s/ Lawrence J. Joseph



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IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF COLUMBIA

UNITED STATES OF AMERICA,

Plaintiff,

v.

REGENERATIVE SCIENCES LLC, CHRISTOPHERJ. CENTENO, M.D., JOHN R. SCHULTZ, M.D., andMICHELLE R. CHEEVER, Individuals,

Defendants;

ASSOCIATION OF AMERICAN PHYSICIANS &SURGEONS, INC.,

Amicus curiae.

)))))))))))))

No. 1:10-cv-01327-RMC

EXHIBIT 1 TOAMICUS CURIAE BRIEF OF ASSOCIATION OF

AMERICAN PHYSICIANS & SURGEONS, INC., IN SUPPORT OF

DEFENDANTS OPPOSITIONS TO PLAINTIFFS MOTION FOR

SUMMARY JUDGMENT

Lawrence J. Joseph, D.C. Bar No. 4647771250 Connecticut Ave., NW, Suite 200Washington, DC 20036

Telephone: (202) 669-5135Telecopier: (202) 318-2254Email: [email protected]





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US v Regen Sci - AAPS Lodged Amicus Br

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