# Appendix — CareToLive v. von von Eschenenbach (No. 08-584)

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385015_0364%3A2

## Record

- **Collection:** Supreme Court brief
- **Document type:** Appendix
- **Published:** January 1, 2009

## Text

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APPENDIX A

NOT RECOMMENDED FOR FULL-TEXT
PUBLICATION

UNITED STATES COURT OF APPEALS
FOR THE SIXTH CIRCUIT

Case No. 07-4465

[Filed August 28, 2008]

CARETOLIVE,
Plaintiff-Appellant,
Vv.

ANDREW VON ESCHENBACH,
Commissioner, Food and Drug
Administration, et al.,

Defendants-Appellees.

ee ee ee ee ee ee ee ee ee

ON APPEAL FROM THE UNITED STATES
DISTRICT COURT FOR THE SOUTHERN
DISTRICT OF OHIO

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BEFORE: BATCHELDER and GILMAN, Circuit
Judges; ZOUHARY '’, District Judge.

ALICE M. BATCHELDER, Circuit Judge.
Plaintiff—Appellant CareToLive (“CTL”), appeals the
judgment of the district court dismissing CTL’s action
for lack of subject matter jurisdiction. CTL, which
characterizes itself as an association of cancer
patients, patient families, doctors, investors, and
advocates, filed suit in the district court to challenge
the Food and Drug Administration’s (“FDA”) decision
not to immediately approve a Biologics License
Application (“BLA”) for the vaccine Provenge. The
FDA neither approved nor denied the application, but
instead issued a Complete Response Letter to the
vaccine’s sponsor, Dendreon Corp., requesting more
information. CTL’s lawsuit named as defendants the
Commissioner ofthe FDA, Andrew von Eschenbach,
M.D., and the Secretary of the United States
Department of Health and Human Services, Michael
Leavitt, in their official capacities; the complaint also
named two FDA officials, Richard Pazdur, M.D., and
Howard Scher, M.D., in both their official and
individual capacities.

On November 21, 2007, the district court dismissed
CTL’s official-capacity claims for lack of subject matter
jurisdiction, citing ripeness, finality, and sovercign
immunity. CTL filed an immediate notice of appeal.
On December 4, 2007, the district court dismissed
CTL’s individual-capacity claims. CTL filed no notice

' The Honorable Jack Zouhary, U.S. District Judge for the
Northern District of Ohio, sitting by designation.

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of appeal from the latter order, and appeals only the
dismissal of its official-capacity claims.

After carefully reviewing the record, the applicable
law, the parties’ briefs and counsels’ arguments, we
conclude that the district court did not err in its
conclusion that it lacked subject matter jurisdiction
because, at the very least, CTL’s action is unripe. As
the district court’s opinion carefully and correctly sets
out the law governing the issues raised, and clearly
articulates the reasons underlying its decision,
issuance of a full written opinion by this court would
serve no useful purpose. Accordingly, for the reasons
stated in the district court’s opinion dismissing CTL’s
official-capacity claims, we AFFIRM.

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APPENDIX B

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF OHIO
EASTERN DIVISION
Case No. 2:07-cv-729

[Filed November 21, 2007;

CARETOLIVE,
Plaintiff,
v.
ANDREW von ESCHENBACH, et al.,

Defendants.

ee ee a ee ee ee

JUDGE GREGORY L. FROST
Magistrate Judge Norah McCann King

OPINION AND ORDER

This action involves a biologics license application
(“BLA”) that ‘was submitted to the Food and Drug
Administration (“FDA”) for Provenge, a biological
product which is intended to treat a particular type of
metastatic prostate cancer and is manufactured by
Dendreon Corporation. Plaintiff CareToLive

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challenges the decision of the FDA “not to approve
Provenge for immediate use and instead [to] issue[] a
Complete Response Letter requesting more data.”
(Doc. # 22.) This matter is before the Court on
Defendants’ Motion to Dismiss Plaintiffs Official
Capacity Claims (Doc. # 38) and on Defendants’
Motion to Strike Improper Supplemental
Memorandum (Doc. # 59). For the reasons that follow,
the Court GRANTS both of Defendants’ motions.

I. BACKGROUND
A. The Parties

Plaintiff characteriz :s itself as an association of
“cancer patients, patient families, doctors, investors,
and advocates.” (Doc. # 22 at 2.) Plaintiff brought this
action against the Commissioner of the FDA Andrew
von Eschenbach, M.D., and the Secretary of the United
States Department of Health and Human Services
Michael Leavitt, in their official capacities and against
Richard Pazdur, M.D. and Howard Scher, M.D., in
both their official and individual capacities.’ Id. ]] 4,
5, 6, 7. Pazdur is the Director of the Office of
Oncologic Drug Products in the FDA’s Center for Drug
Evaluation and Research. Id. { 6. Scher is a special
government employee who served on the FDA
Advisory Committee that considered the Provenge
BLA. Id. ¥ 7.

' Defendants filed a separate motion to dismiss the claims against
Pazdur and Scher (Doc. # 37). The Court addresses arguments for
dismissal of the personal capacity claims set forth in that motion
by separate Opinion and Order.

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B. Statutory and Regulatory Scheme

Biological products are defined under the Public
Health Service Act (“PHSA”) as any “virus, therapeutic
serum, toxin, antitoxin, vaccine . . . or analogous
product .. . applicable to the prevention, treatment, or
cure of a disease or condition of human beings.” 42
U.S.C. § 262(i). Biological products can also be drugs,
and are generally subject to the same statutory and
regulatory requirements that apply to drugs. See 42
U.S.C. § 262(j) (the Food, Drug, and Cosmetic Act
(“FDCA”), 21 U.S.C. § 321, applies to biological
products subject to regulation under the PHSA, 42
U.S.C. § 262).

The FDCA defines “drug” to include, inter alia,
“articles intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in man
....” 21U.S.C. § 321(g)(1)(B). A “new drug” is defined
as either (1) a drug that is “not generally recognized,
among experts qualified by scientific training and
experience to evaluate the safety and effectiveness of
drugs, as safe and effective for use under the
conditions prescribed, recommended, or suggested in
the labeling thereof,” or (2) a drug that, “as a result of
investigations to determine its safety and effectiveness
for use under such conditions, has become _ so
recognized, but which has not, otherwise than in such
investigations, been used to a material extent or for a
material time under such conditions.” 21 U.S.C.
§ 321(p).

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1. Biological Product Approval Process

For unapproved biological products, the sponsor
seeks FDA approval by submitting a BLA pursuant to
the PHSA. 42 U.S.C. § 262(a). The FDA will approve
a BLA for an unapproved biological product if the BLA
demonstrates that the product is safe, pure, and
potent, id. § 262(a)(2)(C)(G)(1), and that the facility in
which the product is manufactured “meets standards
designed to assure that the biological product
continues to be safe, pure, and potent,” id.

§ 262(aM2 CIID.

Generally, when the sponsor of a biological product
has completed the clinical trial process, it can submit
a BLA in accordance with 21 C.F.R. § 601.2(a). The
required documentation in a BLA provides information
for the FDA evaluation of the biological product,
including the results of clinical trials, the composition
of the drug, manufacturing information, and sample
labeling. Jd. The FDA will not consider a BLA to be
filed until all pertinent data have been received by the
agency. See id.

2. FDA Responses to a BLA

In response to a BLA, the FDA may refuse to file it
if it is incomplete. See FDA, “Refusal to File Procedure
for Biologics License Applications,” SOPP 8404,
available at http://www.fda.gov/cber/regsopp/
8404.htm. Further, under certain circumstances the
FDA will approve a BLA, 21 C.F.R. § 601.4(a), or deny
it and provide the applicant the opportunity for a
hearing, id. § 601.4(b). Finally, if there are
deficiencies in the BLA, the FDA may send a Complete

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Response Letter declining to approve the BLA as it
was presented and requesting additional information
from the sponsor. Applications for Approval to Market
a New Drug, 69 Fed. Reg. 43351, 43352 (July 20, 2004)
(to be codified at 21 C.F.R. §§ 314.110, 314.120).

C. Statement of Facts

Provenge is a biological product intended to treat a
particular type of metastatic prostate cancer. (Doc. #
22 4 15.) Provenge uses a patient’s own cells to
prepare a final product designed for infusion back into
the patient’s bloodstream to activate his or her
immune system against the cancer cells. Jd. {J 14, 16.
Provenge is referred to as an active cellular
immunotherapy, designed to elicit a patient’s specific |
immune response to a target antigen expressed in
prostate cancer tissue, i.e., to train a patient’s immune
system to recognize cancer cells and to fight them. Id.
4% 14-16, 19. Because it is designed to act in this
manner, Provenge is a vaccine and thus a “biological
product” subject to FDA regulation under the PHSA.
42 U.S.C. § 262(i).

Dendreon has been studying Provenge’s safety and
effectiveness in clinical trials pursuant to an
investigational new drug application it submitted to
the FDA in 1996. See Transcript of March 29, 2007
Cellular, Tissue, and Gene Therapies Advisory
Committee Meeting at 20; (Doc. # 23, Ex. C.)
Dendreon submitted its BLA for Provenge in late 2006,
and the FDA considered it to be filed in January 2007.
(Doc. # 22 Y 27.) Because Provenge is an
immunotherapy vaccine, regulatory responsibility for
reviewing and, ultimately, approving or denying

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approval of the BLA rests with the Office of Cellular,
Tissue, and Gene Therapies in the FDA Center for
Biologics Research and Evaluation (“CBER”). Id. 4 29;
68 Fed. Reg. 38067, 38068 (June 26, 2003).

In the Amended Complaint, Plaintiff claims that
Pazdur intentionally violated “Federal Regulations
and US Law by improperly controlling the makeup of
the FDA [Office of Cellular, Tissue, and Gene
Therapies] Advisory Committee, and applying
improper pressure on Committee members” in an
effort to deny due process for the BLA for Provenge;
purposely placed on the Advisory Committee two
oncologists who had conflicts of interest and who
Pazdur was sure would be opposed to the approval of
Provenge; prior to the vote, changed the question
posed to the Advisory Committee members to get them
to recommend against approval of Provenge; and
“recruited and illegally used [the] FDA employees” at
and after the Advisory Committee meeting to assist
Pazdur in “wrecking” the Provenge BLA by requesting
anti-Provenge letters and “design[ing] a method for
‘leaking’ them to the press.” (Doc. # 22 79 6, 50, 62,
63, 67, 70, 71, 72, 73, 77, 79.)

Further, Plaintiff alleges that Scher “failled] to
disclose conflicts of interest that would have placed the
FDA on notice that his own personal interests
provided him additional reasons” to be opposed to the
immediate approval of the Provenge BLA; wrote a
letter attacking Provenge that contained false
information and that was later “leaked to the press”;

and failed to exercise care in the responsibility he
undertook to aid patients. Jd. J{ 7,60, 70, 72, 77, 79.

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Plaintiff also alleges Leavitt, who controls that
agency with FDA oversight duties, “ignored and
continues to ignore the agency’s dysfunction.” Id. 4 5.
Finally, Plaintiff claims that von Eschenbach “decided
not to approve Provenge for immediate use and instead
issued a Complete Response Letter requesting more
data which might not be available until 2010.” Zd.
q 43.

On May 8, 2007, CBER issued a Complete
Response Letter to Dendreon, Provenge’s sponsor,
declining to approve the BLA in its current form
because of various deficiencies. See Dendreon Corp.,
“Dendreon Receives Complete Response Letter from
FDA for Provenge Biologics License Application,” May
9, 2007, available at http://investor.dendreon.com/
Release Detail.cfm?ReleaseID=241649&Header=News
(“Dendreon Receives Complete Response Letter”). The
FDA requested that Dendreon submit additional
information with respect to the chemistry,
manufacturing, and controls section of the BLA, id.;
such information is required to demonstrate that the
facility in which the product would be manufactured
“meets standards designed to assure that the biological
product continues to be safe, pure, and potent.” 42
U.S.C. § 262(aK2KCXiXID. The FDA also requested
that Dendreon submit additional clinical data in
support of its effectiveness claim. Dendreon Receives
Complete Response Letter. Dendreon has since met
with the FDA to discuss the additional data required
to support licensure and indicated that it intends to
proceed with its new Phase 3 study designed to
measure survival and to submit such data to the FDA
when it becomes available. See Dendreon Corp.,
“Dendreon Announces FDA Confirms Data Required

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for Provenge Licensure,” May 31, 2007, available at
http:/Anvestor.dendreon.com/ReleaseDetail.cfm?Rele
aseID=246500 &Header=News.

Plaintiff submitted a citizen petition to the FDA
dated July 26, 2007. (Doc. # 2 Ex. B.) The FDA’s
Docket Branch received the citizen petition on July 27,
2007 and assigned it docket number 2007P-0297. Jd.
Under FDA regulations, a citizen petition is the
mechanism for formally asking the agency to take a
particular action, and is a prerequisite to filing suit on
the subject. See 21 C.F.R. §§ 10.25, 10.30, 10.45. In its
citizen petition, Plaintiff urges the Commissioner of
Food and Drugs to “reverse [the FDA’s] decision to
deny immediate approval to Provenge.” (Doc. # 2 Ex.
B.) FDA regulations require the Commissioner, within
180 days of receipt of a citizen petition, to either
approve the petition, deny the petition, or, if more time
is required, issue a tentative response. 21 C.F.R.
§ 10.30(e)(2). On July 30, 2007, the FDA
acknowledged receipt of the citizen petition, but
otherwise has not yet responded. See 7/30/07 Letter.,
Jaffe to Kearney, available at
http://www. fda.gov/ohrms/dockets/dockets/07 p0297/
07p-0297-ack000 1-vol1.pdf.

On July 30, 2007, Plaintiff filed this action and on
September 5, 2007, Plaintiff filed an amended
complaint (Doc. # 22).

On October 5, 2007, Defendants Pazdur and Scher
filed their motion to dismiss (Doc. # 37) and on October
24, 2007, Plaintiff filed its memorandum in opposition
to that motion (Doc. # 46). Defendants filed their reply

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in support of their motion to dismiss on October 31,
2007. (Doc. # 51.)

On October 5, 2007, Defendants filed their motion
to dismiss the claims brought against them in their
official capacity. (Doc. # 38.) On October 19, 2007,
Plaintiff filed its memorandum in opposition to
Defendants’ motion (Doc. # 43) and on October 26,
2007, Defendants filed their reply in support of their
motion.

On November 11, 2007, Plaintiff filed Plaintiffs
Supplemental Memorandum in Support of
Memorandum in Opposition to Defendant’s Motion to
Dismiss and as Supplement to Motion for Injunctive
Relief. (Doc. #58.) Defendants filed a motion to strike
the supplemental memorandum on November 13,
2007. (Doc. # 59.)

II. MOTION TO STRIKE

Plaintiff filed a supplemental memorandum in
support of its memorandum in opposition to
Defendants’ motions to dismiss. (Doc. #58.) Plaintiff
contends that it has new evidence that this Court
should view in its consideration of Defendants’ motions
to dismiss.

Defendants move to strike Plaintiff's supplemental
memorandum pursuant to Rule 7.2 of the Southern
District of Ohio Civil Rules, which allows the party
opposing a motion to file an opposition brief; and the
party filing a motion to support it with an opening
brief and a reply brief. S.D. Ohio Civ. R. 7.2(a)(2). “No
additional memoranda beyond those enumerated will

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be permitted except upon leave of court for good-cause
shown.” Id. Plaintiff has neither requested leave of
Court to file its supplemental memorandum nor has it
shown the good cause necessary to comply with Rule
7.2. Moreover, Plaintiff failed to consult with
Defendants or to bring its allegedly new evidence to
the attention of the Court, both as required by
subsection (d) of Local Rule 7.2.

Consequently, the Court GRANTS Defendants’
Motion to Strike Improper Supplemental
Memorandum. (Doc. # 59.) However, the Court notes
that there is nothing in Plaintiffs supplemental
memorandum that would have changed this Court’s
analysis of Defendants’ motions to dismiss.

Ill, STANDARD FOR MOTION TO DISMISS

Defendants move to dismiss under, inter alia,
Rule12(b)(1) of the Federal Rules of Civil Procedure,
which provides for dismissal for “lack of subject matter
jurisdiction[.] Fed. R. Civ. P. 12(b)(1). “A Rule 12(b)(1)
motion can either attack the claim of jurisdiction on its
face, in which case all allegations of the plaintiff must
be considered as true, or it can attack the factual basis
for jurisdiction, in which case the trial court must
weigh the evidence and the plaintiff bears the burden
of proving that jurisdiction exists.” DLX, Inc. v.
Kentucky, 381 F.3d 511, 516 (6th Cir. 2004) (citing
RMI Titanium Co. v. Westinghouse Elec. Corp.,78 F.3d
1125, 1133-35 (6th Cir. 1996)). In this action, all
parties have submitted evidence in support of their
positions on dismissal and all parties point to disputed
facts that they have called upon the Court to resolve.
(Doc. ## 37, 38, 43, 46, 47, 51.) Thus, Defendants

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mount a factual attack on the jurisdiction of this
Court. The United States Court of Appeals for the
Sixth Circuit instructs that,

when a court reviews a complaint under a
factual attack, as here, no presumptive
truthfulness applies to the factual allegations.
Such a factual attack on subject matter
jurisdiction commonly has been referred to as a
“speaking motion.” See generally C. Wright &
A. Miller, Federal Practice and Procedure
§ 1364, at 662-64 (West 1969). When facts
presented to the district court give rise to a
factual controversy, the district court must
therefore weigh the conflicting evidence to
arrive at the factual predicate that subject
matter jurisdiction exists or does not exist. In
reviewing these speaking motions, a trial court
has wide discretion to allow affidavits,
documents and even a limited evidentiary
hearing to resolve disputed jurisdictional facts.
(citations omitted.)

Ohio Nat'l Life Ins. Co. v. United States, 922 F.2d 320,
325 (6th Cir. 1990); see also Nat'l Assoc. of Minority
Contractors v. Martinez, 248 F. Supp.2d 679, 681 (S.D.
Ohio 2002) (applying foregoing standard).

IV. MOTION TO DISMISS OFFICIAL
CAPACITY CLAIMS

Plaintiff claims that Defendants von Eschenbach,
Leavitt, Pazdur, and Scher in their official capacities
violated his rights under the Administrative Procedure
Act (“APA”), 5 U.S.C. §§ 702, 704. In an official

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capacity lawsuit, the official’s employing agency is the
real partyin interest, and the suit “is, in all respects
other than name, to be treated as a suit against the
entity” that employs him. Kentucky v. Graham, 473
U.S. 159, 166 (1985). Though an official is named as
a defendant, an official capacity suit “is not a suit
against the official but rather is a suit against the
official’s office.” Will v. Mich. Dep’t of State Police, 491
U.S. 58, 71 (1989). Plaintiffs official capacity claims
are accordingly analyzed as brought against the
United States.

In their motion to dismiss, Defendants argue that
this Court lacks subject matter jurisdiction over this
action based on the doctrines of ripeness, finality, and
sovereign immunity. This Court agrees.

A. Ripeness

“The ripeness doctrine ‘is drawn both from Article
III limitations on judicial power and from prudential
reasons for refusing to exercise jurisdiction.’ “ Airline
Prof Ass’n of the Int'l Bhd. of Teamsters, Local Union
No. 1224, AFL-CIO v. Airborne, Inc. , 332 F.3d 983, 987
(6 Cir. 2003) (quoting Reno v. Catholic Soc. Servs.,
Inc., 509 U.S. 43, 57 n.18 (1993)). Ifa claim is unripe,
a federal court lacks subject matter jurisdiction and
the claim must be dismissed. Nationwide Mut. Ins.
Co. v. Cisneros, 52 F.3d 1351, 1361 (6th Cir. 1995).
The United States Supreme Court outlined the
ripeness doctrine in Abbott Labs. v. Gardner, 387 U.S.
136 (1967), and two companion cases, Toilet Goods
Ass’n, Inc. v. Gardner, 387 U.S. 158 (1967) and

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Gardner v. Toilet Goods Ass’n, Inc., 387 US. 167
(1967). Id. at 1361-62. The Court explained:

Without undertaking to survey the intricacies of
the ripeness doctrine it is fair to say that its
basic rationale is to prevent t’xe courts, through
avoidance of premature adjudication, from
entangling themselves in abstract
disagreements over administrative policies, and
also to protect the agencies from judicial
interference until an administrative decision
has been formalized and its effects felt in a
concrete way by the challenging parties.

The problem is best seen in a twofold aspect,
requiring us to evaluate both the fitness of the
issues for judicial decision and the hardship to
the parties of withholding court consideration.

Abbot Labs., 387 U.S. at 148-49. Further, to be ripe for
review, claims must satisfy both the fitness and the
hardship components of the inquiry. Cisneros, 52 F.3d
at 1361 (citing Franklin Fed. Sav. Bank v. Dir., Office
of Thrift Supervision, 927 F.2d 1332, 1336 (6th Cir.
1991)).

1. Fitness for Judicial Decision

The parties agree that, whether Plaintiffs official
capacity claims are fit for judicial resolution turns
upon (a) whether the claims raise purely legal
questions, and (b) whether the decisions they challenge
constitute final agency action. Toilet Goods Ass’n, 387
U.S. at 163-64; Abbot Labs., 387 U.S. at 149.

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a. Purely legal questions

In considering an issue’s fitness for judicial
decision, the Court’s analysis begins with determining
whether the issue is purely legal. Franklin Fed. Sav.
Bank, 927 F.2d at 1336 (“The Supreme Court began
with the fact that the issue before it in that case was
purely legal.” citing Abbot Labs, 387 U.S. at 149).
Although Plaintiff has raised many issues in its
Amended Complaint, Plaintiff submits that only one of
those issues is purely legal, i.e., “whether the FDA’s
prohibition to the access of Provenge to terminally ill
patients violates the Constitution.” (Doc. # 43 at 28.)
Defendants do not disagree with Plaintiffs contention;
however, Defendants correctly point out that Plaintiff
raises many issues in its official capacity claims that
are not purely legal and instead are fact-intensive.

Consequently, Plaintiff raises one purely legal
issue.

b. Final agency action

“Final agency action” is both a critical prerequisite
to Article II] justiciability, namely ripeness, and a
riecessary element of a cause of action under the APA.
5 U.S.C. § 704; Dalton v. Specter, 511 U.S. 462, 469
(1994). As this Court explains in detail infra, the
Complete Response Letter does not constitute final
agency action. Because the Provenge BLA
administrative process is ongoing, the FDA may
ultimately approve the application, which would
render Plaintiffs claims moot.

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Thus, this element of the test for fitness for judicial
decision is not met. Consequently, even though
Plaintiff raised one purely legal issue, that issue is not
fit for judicial decision. |

2. Hardship to the Parties of Withholding
Court Consideration

The final element considered under ripeness is
hardship to the parties in deferring consideration by
the courts. Abbott Labs. , 387 U.S. at 149. Defendants
correctly contend that Plaintiff faces no greater
hardship from waiting for a final agency decision
before bringing suit than the patients who might
potentially benefit from many other biologics or drugs
intended to treat life-threatening conditions that are
under review by the FDA at any given time. (Doc. # 38
at 18.) Indeed, Congress balanced such hardships
against the risks and dangers of using unsafe and
ineffective drugs when it set the statutory standards
for approval of drugs and biologics. See, e.g., United
States v. Rutherford, 442 U.S. 544, 552-53 & n.9, 556
(1979) (discussing Congressional intent and legislative
history, especially in context of risks borne by
terminally ill cancer patients).

The FDA’s issuance of the Complete Response
Letter, at most, potentially prevents access to an
unproven and speculative future benefit. Moreover,
immediate consideration of the administrative record
by this Court could not speed patients’ access to
Provenge, because the only remedy that this Court
could issue is a remand to the FDA to continue its
review of Dendreon’s BLA. Fla. Power & Light Co. v.
Lorion, 470 U.S. 729, 744 (1985); (Doc. # 33 at 35-36.)

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3. Conclusion Ripeness Test

Plaintiff failed to satisfy either prong of the
ripeness test — fitness for judicial resolution and
hardship from delaying judicial consideration. Under
these circumstances, it is without question that
Plaintiffs claims are manifestly unripe leaving this
Court with no subject matter jurisdiction to hear
Plaintiffs official capacity claims.

B. Finality

Even this Court did not lack subject matter
jurisdiction over the official capacity claims because
they are unripe, the claims would still be dismissed
under the doctrine of finality. The APA permits
judicial review of “final agency action for which there
is no other adequate remedy in a court.” 5 U.S.C.
§ 704. “Final agency action” is a necessary element of
a cause of action under the APA. Id.; Dalton uv.
Specter, 511 U.S. 462, 469 (1994). Indeed, if an action
does “not constitute ‘final agency action’ as used under
the APA, the district court lacks subject matter
jurisdiction to evaluate the complaint...” Invention
Submission Corp. v. Rogan, 357 F.3d 452, 460 (4th Cir.
2004) Gif the action did “not constitute ‘final agency
action’ as used under the APA, the district court did
not have subject matter jurisdiction to evaluate the
complaint under Rule 12(b)\(6) and should have
dismissed this case under Rule 12(b)(1)”).

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As the United States Supreme Court has explained,
two conditions must be satisfied for agency action to be
final:

First, the action must mark the ‘consummation’
of the agency’s decisionmaking process—it must
not be of a merely tentative or interlocutory
nature. And second, the action must be one by
which “rights or obligations have been
determined” or from which “legal consequences
will flow.”

Bennett v. Spear, 520 U.S. 154, 177-78 (1997) (citations
omitted). See also Franklin v. Massachusetts, 505 U.S.
788, 797 (1992) (“The core question is whether the
agency has completed its decisionmaking process, and
whether the result of that process is one that will
directly affect the parties.”). In addition, the action
must not be that of a subordinate official. Franklin,
505 U.S. at 797 (internal quotation marks omitted;
quoting Abbott Labs. v. Gardner, 387 U.S. 136, 151
(1967)); Air Brake Sys. v. Mineta, 357 F.3d 632, 640
(6th Cir. 2004) (quoting same passage from Abbott
Labs.). None of these conditions is satisfied in the
instant action.

The agency action at issue here is the issuance of
the Complete Response Letter. Although Plaintiff
acknowledges that it must show that the agency action
is final, Plaintiff sets forth an entire two pages of
factual assertions—including direct quotes—without so
much as one citation to the evidentiary source of the
assertions. (Doc. # 43 at 15-17.) However, even if this
Court were to accept Plaintiffs factual assertions,
Plaintiff has utterly failed to apply the applicable law

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to those facts. Indeed, as Defendants correctly state:
“The total of [Plaintiffs] analysis on final agency
action is the conclusory assertion that any ‘argument’
that ‘there has been not final decision made . . . lacks

-any merit what so ever and is close to laughable.”

(Doc. # 47 at 4-5 citing Doc. # 43 at 17.) Plaintiffs
conclusory statement falls far short of supporting
Plaintiffs claim that the issuance of the Complete
Response Letter constitutes final agency action.

In glaring contrast, Defendants have convincingly
shown that issuance of a Complete Response Letter
does not constitute final agency action. (Doc. # 38 at
12-19; Doc. # 47 at 1-7.) A Complete Response Letter
is an established mechanism for the FDA to request
additional information from the sponsor of a BLA.

_ FDA, Applications for Approval to Market a New Drug,

69 Fed. Reg. 43351, 43352 (July 20, 2004). A Complete
Response Letter is meant to “ensure a consistent
approach to informing sponsors of needed changes
before [the FDA] can approve an application, with no
implication as to the ultimate approvability of the
application.” Id. AComplete Response Letter does not
signal the end for a product; rather, it is a step the
FDA takes to assure that it has sufficient data to
establish safety and effectiveness prior to licensure.
The FDA continues to work with sponsors to resolve
any outstanding issues. See id.

Indeed, the Complete Response Letter made clear
that it was not “the consummation of the agency’s
decisionmaking process” and instead was an
interlocutory step in the agency’s administrative
process. See Dendreon Receives Complete Response
Letter. The letter affirmatively requests Dendreon to

22a

submit additional evidence to support its BLA. See id.
(“The FDA has requested additional clinical data in
support of the efficacy claim contained in the BLA.”).
In its press release, Dendreon explained that “[w]Je are
committed to working closely with the FDA to resolve
these questions in a timely and efficient manner.” Id.
Thus, Dendreon clearly understood the letter to be “of
a merely ... interlocutory nature.” Bennett, 520 U.S.
at 178. Because the Provenge BLA administrative
process is ongoing, the FDA may ultimately approve
the application, which would render Plaintiffs claims
moot. Under these circumstances, the challenged FDA
action is clearly not a “final agency action” as that
phrase is interpreted under the APA. 5 U.S.C. § 704.
See also Telespectrum, Inc. v. Pub. Serv. Comm’n of
Ky., 227 F.3d 414, 423 (6th Cir. 2000) (the agency’s
order “contain[led] no language which indicates that
PSC will hear further evidence”).

In addition, the Complete Response Letter did not
determine any legal rights or obligations, or trigger a
process “from which legal consequences will flow.”
Bennett, 520 U.S. at178 (internal quotation marks and
citations omitted). To be sure, makers of biologic
products cannot market them without an approved
BLA. 42 U.S.C. § 262(a). But the Complete Response
Letter neither approved, nor denied, Dendreon’s BLA.
It thus did not “alter the legal regime” and “in no way
affected the legal rights of the relevant actors.”
Bennett, 520 U.S. at 178.

Finally, the Complete Response Letter was the
ruling of a subordinate official. It was signed by Dr.
Ashok Batra, who is the Director of the Division of
Clinical Evaluation and Pharmacology/Toxicology

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within the Office of Cellular, Tissue, and Gene
Therapies, which is in turn within CBER. CBER has
delegated to officials at Dr. Batra’s level the authority
to issue Complete Response Letters, but not the
authority to approve BLAs. CBER, “Signature
Authority for Action Letters,” Sept. 20, 2004, in Manual
of Standard Operating Procedures and Policies, SOPP
8405, ver. 4, App. 1, available at http://www.fda.gov/
cber/regsopp/8405sign.htm. In Air Brake Systems, the
Sixth Circuit found that actions taken by subordinate
officials did not constitute “final agency action”:
“While [the agency]’s Chief Counsel has considerable
authority over purely legal interpretations of pertinent
statutes and regulations, the Secretary has not
delegated authority to the Chief Counsel to make final
fact-bound determinations of compliance with [the
agency]’s safety standards.” Air Brake Sys., 357 F.3d
at 640. Because the FDA’s Complete Response Letter
was “only the ruling of a_ subordinate official,”
Franklin v. Massachusetts, 505 U.S. 788, 797 (1992), to
whom the Commissioner has not delegated authority

to approve BLAs, it was not a final agency action. See
also Air Brake Sys., 357 F.3d at 640.

Accordingly, because the Complete Response Letter
does not constitute final agency action under the APA,
this Court lacks subject matter jurisdiction over this
action and must dismiss it.

C. Sovereign Immunity

Even if the official capacity claims did not lack
subject matter jurisdiction based upon the doctrines of
finality and ripeness, it would still be dismissed based
upon the doctrine of sovereign immunity. “Jurisdiction

24a

over any suit against the [United States] Government?
requires a clear statement from the United States
waiving sovereign immunity . . . together with a claim
falling within the terms of the waiver.” United States
v. White Mountain Apache Tribe, 537 U.S. 465; 472
(2003). Indeed, it is “axiomatic that the United States
may not be sued without its consent and that the
existence of consent is a prerequisite for jurisdiction.”
United States v. Mitchell, 463 U.S. 206, 212 (1983); see
also Reed v. Reno, 146 F.3d 392, 398 (6th Cir. 1998)
(“The United States can be sued only when it has
expressly given its consent to be sued.”) (internal
quotation marks and citation omitted).

Waivers of sovereign immunity “cannot be implied
but must be unequivocally expressed.” Mitchell, 463
U.S. at 239; Reed, 146 F.3d at 398 (waiver must be
“express, clear and unequivocal”). Thus, absent an
express waiver of sovereign immunity, a district court
lacks jurisdiction over claims against the United
States. See, e.g., Mitchell, 463 U.S. at 212. It is
Plaintiffs burden to “identify a waiver of sovereign
immunity in order to proceed against the United
States. If [it] cannot identify a waiver, the claim must

* The FDA is part of the Department of Health and Human
Services, 21 U.S.C. § 393(a), which Congress has established as
one of the fourteen Executive Branch departments, 5 U.S.C. § 101.
Sovereign immunity is thus fully applicable to actions brought
against the FDA andor its officials. See, e.g., NVE Inc. v. HHS,
436 F.3d 182, 189 (3d Cir. 2006) (holding that challenge to FDA
regulation banning dietary supplements containing ephedra must
proceed under APA because Dietary Supplement Health and
Education Act did not provide a private cause of action or “contain
a waiver of sovereign immunity that would permit [plaintiff] to
sue a federal agency”).

25a

be dismissed on jurisdictional grounds.” Reetz v.
United States, 224 F.3d 794, 795 (6th Cir. 2000).

In the case sub judice, Plaintiff argues that “[t]here
is no immunity for intentional conduct done with
malice that rises to the level of a constitutional tort”
and thus asserts that “[nJeither the government itself
nor the government officials Dr. von Eschenbach, Dr.
Scher, and Dr. Pazdur have immunity from being
sued.” (Doc. # 43 at 80.) This argument, however, as
Defendants correctly note, confuses sovereign
immunity with the concept of qualified immunity that
is applicable only to Plaintiffs claims against Pazdur
and Scher in their individual capacity. Plaintiffs
reliance on caselaw concerning the standards for
imposing individual liability on government officials is
thus misplaced. Jd. at 80-82. |

Plaintiffs next argument centers on a series of
United States Supreme Court decisions from the 1930s
and 1940s that dealt with government-chartered
corporations authorized to conduct financial business
transactions and to “sue and be sued” in their own
name. Id. at 81 (citing Keifer & Keifer v.
Reconstruction Fin. Corp., 306 U.S. 381 (1939)
(Reconstruction Finance Corp.); FHA v. Burr, 309 U.S.
242 (1940) (Federal Housing Administration);
Reconstruction Fin. Corp. v. Menihan Corp., 312 U.S.
81 (1941) (Reconstruction Finance Corp); and
Standard Oil Div. v. Starks, 528 F.2d 201 (7th Cir.
1975) (United States Postal Service)). The rulings in
those cases were based on findings that Congress had
not meant to endow such entities with sovereign
immunity. Plaintiff here appears to rely on these
cases for support of its contention that the FDA

26a

likewise lacks immunity from suit. Plaintiff's reliance,
however, is misplaced.

Even assuming these decisions are still good law,
the FDA is not a quasi-governmental business entity
or private corporation like the Reconstruction Finance
Corporation or the Postal Service, nor can it sue and
be sued in its own name. See Parrett v. Se. Boll Weevil
Eradication Found., Inc., 155 Fed. Appx. 188, 191 (6th
Cir. 2005) (questioning continued authority of Keifer
and its progeny); Galvan v. Fed. Prison Indus., Inc.,
199 F.3d 461, 467 (D.C. Cir. 1999) (same). Rather, the
agency is part of the Department of Health and
Human Services, 21 U.S.C. § 393(a), which Congress
has established as one of the fourteen Executive
Branch departments, 5 U.S.C. § 101. Sovereign
immunity is thus fully applicable to actions brought
against the FDA and/or its officials. See, e.g., NVE Inc.
v. HHS, 436 F.3d 182, 189 (3d Cir. 2006) (holding that
challenge to FDA regulation banning dietary
supplements containing ephedra must proceed under
APA because Dietary Supplement Health and
Education Act did not provide a private cause of action
or “contain a waiver of sovereign immunity that would
permit [plaintiff] to sue a federal agency”).

Plaintiff next argues that this Court should
“exercise its power of equity jurisdiction,” by which
Plaintiff presumably means the Court’s power to enter
injunctive or other equitable relief where a plaintiff
has no adequate legal remedy. (Doc. # 43 at 82-83.)
Although it is unclear whether Plaintiff asserts this
argument as a means to avoid the bar of sovereign
immunity or for some other purpose, it goes without
saying that a court’s exercise of equitable authority

27a

depends in the first instance on the existence of subject
matter jurisdiction. See Mickler v. Nimishillen &
Tuscarawas Ry. Co., 13 F.3d 184, 189 (6th Cir. 1993);
see also Wooten v. United States, 825 F.2d 1039, 1045
(6th Cir. 1987) (“Since federal courts are courts of
limited jurisdiction, jurisdiction that is otherwise
lacking cannot be conferred by [equitable doctrines
such as] consent, collusion, laches, waiver, or
estoppel.”).

For the same reason, i.e., lack of subject matter
jurisdiction, Plaintiffs reference to declaratory relief
under Rule 57 of the Federal Rules of Civil Procedure
is equally unavailing. (Doc. # 43 at 85.) The
Declaratory Judgment Act, 28 U.S.C. § 2201, does not
waive sovereign immunity or create an independent
basis for jurisdiction, but merely provides courts with
the discretion to fashion a remedy. See Heydon uv.
MediaOne of Se. Mich., Inc., 327 F.3d 466, 470 (6th
Cir. 2003). Thus, declaratory relief, like injunctive
relief, is only available if the court otherwise has
subject matter jurisdiction over the action.

Finally, Plaintiff turns to the APA,’ observing
correctly that, although the APA does not itself confer
subject matter jurisdiction, it does waive sovereign
immunity for certain nonmonetary claims against the

United States. (Doc. # 43 at 84); 5 U.S.C. §§ 702, 704.

* In the Amended Complaint, Plaintiff relies on a number of other
sources for subject matter jurisdiction. In Defendants’ Motion to
Dismiss, however, Defendants correctly explain that none of the
named sources waives the sovereign immunity to which
Defendants are entitled. (Doc. # 38 at 30-34.) Plaintiff,
appropriately, does not dispute Defendants’ conclusions.

28a

However, by its terms, the APA authorizes challenges
only to “final agency action for which there is no other
adequate remedy in court.” Beamon v. Brown, 125
F.3d 965, 967 (6th Cir. 1997) (“Although the APA
provides a broad waiver of sovereign immunity,
codified at 5 U.S.C. § 702, the waiver is limited... .
{[U]nder the APA, a federal district court may only
review ‘[a]gency action made reviewable by statute and
final agency action for which there is no other
adequate remedy in a court.’ “). Such statutory
waivers of sovereign immunity are “strictly construed
in favor of the United States.” Reed, 146 F.3d at 398.

In the instant action, this Court has already
concluded that a Complete Response Letter is in no
sense a “final agency action.” Consequently, Plaintiff
has not stated a claim under the APA, which prevents
it from availing itself to the APA’s waiver of sovereign
immunity. Because Plaintiff has failed to identify any
waiver of sovereign immunity applicable to its claims,
its complaint must be dismissed for lack of subject
matter jurisdiction.

V. CONCLUSION

This Court lacks subject matter jurisdiction over
the official capacity claims brought against Defendants
based on the doctrines of ripeness, finality, and
sovereign immunity. Therefore, the Court GRANTS
Defendants’ Motion to Dismiss Plaintiffs Official
Capacity Claims (Doc. #38) and GRANTS Defendants’
Motion to Strike Improper Supplemental
Memorandum (Doc. # 59).

IT IS SO ORDERED.

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30a

APPENDIX C

5 U.S.C. § 702

United States Code Annotated Currentness
Title 5. Government Organization and
Employees (Refs & Annos)

Part I. The Agencies Generally
Chapter 7. Judicial Review (Refs & Annos)

5 U.S.C. § 702. Right of review

A person suffering legal wrong because of agency
action, or adversely affected or aggrieved by agency
action within the meaning of a relevant statute, is
entitled to judicial review thereof. An action in a court
of the United States seeking relief other than money
damages and stating a claim that an agency or an
officer or employee thereof acted or failed to act in an
official capacity or under color of legal authority shall
not be dismissed nor relief therein be denied on the
ground that it is against the United States or that the
United States is an indispensable party. The United
States may be named as a defendant in any such
action, and a judgment or decree may be entered
against the United States: Provided, That any
mandatory or injunctive decree shall specify the
Federal officer or officers (by name or by title), and
their successors in office, personally responsible for
compliance. Nothing herein (1) affects other
limitations on judicial review or the power or duty of
the court to dismiss any action or deny relief on any

3la

other appropriate legal or equitable ground; or (2)
confers authority to grant relief if any other statute
that grants consent to suit expressly or impliedly
forbids the relief which is sought.

CREDIT(S)

(Pub.L. 89-554, Sept. 6, 1966, 80 Stat. 392; Pub.L. 94-
574, § 1, Oct. 21, 1976, 90 Stat. 2721.)

5 U.S.C. § 704

United States Code Annotated Currentness
Title 5. Government Organization and
Employees (Refs & Annos)

Part I. The Agencies Generally
Chapter 7. Judicial Review (Refs & Annos)

5 U.S.C. § 704. Actions reviewable

Agency action made reviewable by statute and final
agency action for which there is no other adequate
remedy in a court are subject to judicial review. A
preliminary, procedural, or intermediate agency action
or ruling not directly reviewable is subject to review on
the review of the final agency action. Except as
otherwise expressly required by statute, agency action
otherwise final is final for the purposes of this section
whether or not there has been presented or
determined an application for a declaratory order, for
any form of reconsideration, or, unless the agency
otherwise requires by rule and provides that the action
meanwhile is inoperative, for an appeal to superior
agency authority.

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385015_0364%3A2. Public record. Not legal advice.