Appellant Robert M. Davidson and Appellant Vanessa E.

Komar

(“Appellants”), representing themselves pro se, move this Court pursuant to 28

U.S.C. § 2201(a) to declare the Prescription Drug User Fee Act (“PDUFA”)

unconstitutional, as applied to Robert M. Davidson and Vanessa E. Komar. The

PDUFA is presently found in 21 U.S.C. Sections 379g-379h. Appellants incorporate

here by reference all of the allegations found at Count Five (¶s 22-36) of the

Amended Complaint (Document #19) at USCA5 546-548. This Court is referred to

the Schematic of RICO Conspiracy found attached to this Motion.

The constitutionality of the PDUFA is material to Appellants’ Article III

standing and the question of whether Appellants stated claims under the civil RICO

statute (18 U.S.C. 1964 ( c)) for violations of 18 U.S.C. 1962 (b), ( c), and (d) against

each of the defendants in this lawsuit.

Appellants’ incorporate here by reference all of the relevant arguments, points,

and authorities found in Document #16 captioned Plaintiffs’ Response to Albany

Medical College and Anthony P. Tartaglia’s Motion to Dismiss pursuant to FRCP

12(B) and Incorporated Brief in Support found at USCA5 305-315, Document #45

captioned Plaintiffs’ Answer to Motion of Defendants Jay Grossman, Eudice

Grossman, and Bruce R. Heurlin to Dismiss Amended Complaint pursuant to FRCP

Second M otion for Declaratory Judgment 07-20650 Davidson v. Grossman 1

12(B) found at USCA5 950-968, Document #47 captioned Plaintiffs’ Answer to

Sepracor Inc’s Motion to Dismiss for Failure to State a Claim found at USCA5 1059-

1067, Document #56 captioned Plaintiffs’ Consolidated Response found at USCA5

1498-1530, and Document #71 captioned Motion to Alter or Amend Judgment under

FRCP 59(E) and Memorandum in Support found at USCA5 1849-1873.

See U.S. Supreme Court Docket No. 04-537 found at Document #83-6, pages

39 and 40 of 40, in Case No. 4:07-cv-00471. See affidavit and Exhibits attached to

this Motion. On September 17, 2004, Davidsons filed Petition for Writ of Certiorari

before Judgment, (the “First Cert. Petition”) in Docket No. 04-537, a true and correct

copy of which is found attached as an Exhibit to this Motion. Certiorari was denied

on January 10, 2005. Appellants incorporate here by reference, all of the

arguments, points, and authorities found at Issues II and III of the First Cert.

Petition, which is attached as an Exhibit to this Motion.

Appellants’ challenge to the federal Constitutionality of the PDUFA rests on

5th Amendment equal protection grounds found in the U.S. Constitution. Appellants’

have stated an equal protection claim at Count Five of the Amended Complaint

(Document #19 Index of Record) under both the “selective enforcement” theory and

the “class of one” theory. See Village of Willowbrook v. Olech, 528 U.S. 562, 564

(2000). Davidsons were intentionally treated differently from others similarly situated

Second M otion for Declaratory Judgment 07-20650 Davidson v. Grossman 2

and there is no rational basis for the difference in treatment. See Sioux City Bridge

Co. v. Dakota County, 260 U.S. 441, 43 S.Ct. 190, 67 L.Ed 340 (1923); Allegheny

Pittsburgh Coal Co. v. Commission of Webster Cty, 488 U.S. 336, 109 S.Ct. 633,

1021 L.Ed.2d 688 (1989).

Appellants have alleged and provided evidence of wholly irrational,

retaliatory, and bribery-motivated FDA action against Davidson at Count Five, the

Exhibits attached to Document #16 at USCA5 401-402, 415-482, the Exhibits

attached to the Amended Complaint (Document #19) at USCA5 705-716, the Exhibits

attached to Document #45 at USCA5 1004-1023, and the Exhibits attached to

Document #47 at USCA5 1714-1803. See DeMuria v. Hawkes, 328 F.3d 704, 705 (2d

Cir. 2003); Esmail v. Macrane, 53 F.3d 176, 178-79 (7th Cir. 1995).

Davidson was “singled out” for selective enforcement of the PDUFA by the

FDA and Sepracor Inc, after Davidson “blew the whistle” on high-enroller [Jay

Grossman] in his Letter of April 14, 1999, to Dr Antoine El Hage of FDA, and the

Affidavit filed by Robert Davidson with FDA investigator, Armando Chavez, on May

21, 1999. See ¶ 5.3, 8.32, 8.63 of the Amended Complaint at USCA5 516, 529, and

534, respectively. While the principal target of the equal protection clause is

discrimination against members of vulnerable groups, the clause protects class-of-one

plaintiffs victimized by “the wholly arbitrary act”. The exercise of FDA discretion

Second M otion for Declaratory Judgment 07-20650 Davidson v. Grossman 3

was both intentionally discriminatory and arbitrary. Appellants have offered

evidence to suggest that Davidson was targeted by the FDA for an invidious reason

(a bribe from Sepracor Inc). See Mach v. County of Douglas, S-99-266, Neb. 787.

FDA was motivated by a ‘discriminatory purpose’ and FDA selected or reaffirmed

a particular course of action at least in part ‘because of’‘, not merely ‘in spite of’’, its

adverse effects upon an identifiable class-of-one (a “whistle-blower” physician

(Davidson)).

See Document #57, captioned Appendix of Exhibits in Support of Plaintiffs’

Consolidated Response at USCA5 1594-1600, 1605-1609, 1610-1623, 1624-1634,

and 1711-1713. The relationship between Appellants’ injuries and the defendants’

RICO violations are direct (not attenuated). See Document #71 at USCA5 1852-1853

where it states,

“Plaintiffs refer this Court to Justice Thomas’ dissenting opinion in

Anza v. Ideal Steel Supply Corp., 126 S.Ct. 1991, 1994 (2006). As the
lone dissent, Justice Thomas was able to reach the issue as to whether
reliance needs to be established as an element in a civil RICO action.
Based on Justice Thomas’ well-reasoned dissenting opinion, in the Anza
case, Appellants do not conclude that the holdings of the 5th Circuit U.S.
Court of Appeals in the cases referenced in Plaintiffs’ Consolidated
Response (filed Document #56) at pages 11-13 have been or will be
overturned by the Supreme Court. It may be too simplistic to conclude
at this time that the Supreme Court will further limit the class of
potential civil RICO plaintiffs, to only very obvious, non-subtle, direct
injuries which never involve 3rd party reliance See Summit Properties
Inc. v. Hoechst Celanese Corp., 214 F.3d 556 (5th Cir. 2000); Procter

Second M otion for Declaratory Judgment 07-20650 Davidson v. Grossman 4

 and Gamble Co. v. Amway Corp., 242 F.3d 539 (5th Cir. 2001);
Sandwich Chef of Texas, Inc. v. Reliance Natl. Indemnity, 202 F.R.D.
484 (5th Cir. 2001). Justice Thomas’ dissenting opinion in the Anza case
appears to lend considerable support for “target wing” types of injured
Plaintiffs, maintaining their standing to bring civil RICO complaints. It
should be apparent from the Amended Complaints in both the Northern
District of Texas (Dallas) and the Southern District of Texas (Houston),
that Plaintiffs sustained both “target wing” and “reliance wing” types
of injury to their business and property.”

Plaintiffs incorporate here by reference the arguments found in Document #56

at USCA5 1498-1511 under the heading Alleged Failure to State Claim: Proximate

Cause after the Anza Case. Plaintiffs incorporate here by reference the arguments

found in Document #56 at USCA5 1514-1515 under the heading Alleged Lack of

Article III Standing. The filing of Plaintiffs’ Original Complaint on

February 19, 2003, in the U.S. District Court for the district of Arizona (Case No. CV

03-110-TUC FRZ) tolled the limitations period as to Counts One, Two, and Three.

See Preveza Shipping Co. v. Sucrest Corp., 297 F.Supp. 954 (S.D.N.Y. 1969). (when

a federal statute of limitations is involved, the federal rule is applied to the effect that

the statute of limitations is tolled when the complaint is filed).

Selective Enforcement

Selective enforcement, if based upon improper motives, can violate equal

protection. See Little v. Streater, 452, 452 U.S. 1 (1981). See Gale v. North Dakota

Bd. Of Podiatric Medicine, 1997 ND 83 (1997). A statute may be held

Second M otion for Declaratory Judgment 07-20650 Davidson v. Grossman 5

constitutionally invalid as applied, when it operates to deprive an individual of a

protected right. See Snowden v. Hughes, 321 U.S. 1 (1944). Davidson has stated

claims that involve his fundamental right to equality of treatment before the law (fair

legal procedures) found in the Ninth Amendment of U.S. Constitution. Because

Davidson’s claims involve a fundamental right, his federal equal protection claims

are subject to de novo review. See Leonard W. Levy, Origins of the Bill of Rights,

1999, at page 254.

FDA retaliated against Davidson for an attempt to exercise one’s right to

equality of treatment before the law (fair legal procedures). FDA’s actions were

motivated by improper considerations. Davidson argues that he was denied equal

protection by FDA and that he was the victim of selective enforcement. Davidson

argues for certainly not the first time that his equal protection rights were violated by

selective enforcement of the PDUFA by FDA. See USCA5 1650 and USCA5 1584

for the Notification of Claim of Unconstitutionality in the First RICO Action (Case

# 03CV110TUCFRZ, captioned Davidson et al v. Vivra Inc et al) and page 25,

paragraphs 112 and 113 of Davidsons’ Amended Answer to First Amended

Complaint and Counterclaims in the State Action (Pima County Superior Court Case

No. 333954), respectively.

Davidson was singled-out by FDA for selective enforcement of the PDUFA.

Second M otion for Declaratory Judgment 07-20650 Davidson v. Grossman 6

Davidsons have alleged and provided proof that FDA’s act were motivated by

improper considerations to prevent Davidson’s exercise of his fundamental right to

equality of treatment before the law (fair legal procedures). See Beeler v. Rounsavall,

328 F.3d 813, 817 (5th Cir. 2003); Bryan v. City of Madison, 213 F.3d 267, 277 (5th

Cir. 2000). Appellants have alleged illegitimate animus, or ill will, on the part of the

Defendants/Appellees and FDA. Similarly situated individuals (clinical research

subinvestigators) were treated differently by FDA and Sepracor. See ¶ 28 of the

Amended Complaint at USCA5 546.

A finding of unlawful selective enforcement must be based upon an

unjustifiable standard such as an arbitrary classification. A discriminatory purpose

will not be presumed; there must be a showing of clear and intentional discrimination.

See State v. Long, 206 Neb. 446, 293 N.W.2d 391 (1980). Davidsons have offered

evidence to suggest that he was targeted by the FDA for invidious reasons. The

exercise of the FDA’s discretion in enforcing the PDUFA was both discriminatory

and arbitrary. See ¶s 8.99 and 8.100 of the Amended Complaint at USCA5 540.

Davidsons have alleged facts that would support a claim of invidious discrimination.

See ¶s 5.10, 5.14, 5.16, 8.64, 8.65, 8.67, 8.80, 8.82-8.84, 8.86, 8.89, 29-31, and 33-35,

of the Amended Complaint. See Count Five of the Amended Complaint at ¶ 31,

where it states,

Second M otion for Declaratory Judgment 07-20650 Davidson v. Grossman 7

 “Application of the PDUFA to the Plaintiffs was motivated by
invidiously discriminatory animus. Application of the PDUFA to the
Plaintiffs was intended to conceal the fraudulent clinical research of Jay
Grossman, Thomas B. Edwards, Albany Medical College, and Sepracor
Inc, in support of the NDA # 20-837 for Xopenex Inhalation Solution,
that gained FDA approval on 3/25/99 (review was posted on 6/20/01).”

Appellants have pleaded a strong equal protection case on the basis of selective

enforcement. Someone similarly situated to Davidson, but for the illegitimate

classification used by FDA, was treated differently. Illegitimate factors considered by

FDA in deciding when to enforce the PDUFA include whether the corporate research

sponsor had paid a “user fee” (paid a bribe to FDA), whether the principal

investigator is a “high-enroller” of study subjects, whether the principal investigator

is conducting multiple studies, and whether anyone at the site has “blown the whistle”

by raising concerns regarding patient safety, fraud, or both. See Stemler v. City of

Florence, 126 F.3d 856, 873 (6th Cir. 1997).

Personal animus is an element of a class-of-one case. FDA was bribed by

Sepracor Inc to selectively enforce the PDUFA in support of its New Drug

Application for Xopenex Inhalational Solution. Appellants have identified specific

actions of the FDA that were both wholly arbitrary and lacking in legitimate

justification and had a concrete effect on Davidsons’ rights. Appellants allege that

even if the PDUFA is facially valid, the method of enforcement is in derogation of

Second M otion for Declaratory Judgment 07-20650 Davidson v. Grossman 8

equal protection, if the decision to enforce is based upon illegitimate justifications

(bribery, high study subject enrollment, or whistle-blowing). Appellants’ “class of

one case” alleges a wholly irrational, retaliatory, and bribery-motivated FDA action

against a single person (Davidson).

The Supreme Court has recognized that the equal protection guarantee extends

to individuals who allege no specific class membership but are nonetheless subjected

to invidious discrimination at the hands of government officials. See Willowbrook v.

Olech, 528 U.S. 562, 564 (2000). In Olech, the Supreme Court “affirmed the validity

of such ‘class of one’ claims ‘where the plaintiff alleges that she has been

intentionally treated differently from others similarly situated and that there is no

rational basis for the difference in treatment.’” See Harlen Assocs. Inc. v. Village of

Mineola, 273 F.3d 494, 499 (2d Cir. 2001); Esmail v. Macrane, 53 F.3d 176, 178-79

(7th Cir. 1995); Ciechon v. City of Chicago, 686 F.2d 511, 522-24 (7th Cir. 1982).

FDA’s action at issue was motivated by personal animus. FDA had a malicious or bad

faith intent to injure the Davidsons.

Davidsons have provided evidence in the federal court proceeding of a

discriminatory design to favor one individual or class over another. See ¶s 8.63-8.89

and ¶s 22-36 of the Amended Complaint (Document #19) found at USCA5 546-548.

Davidson was treated differently from others similarly situated and that there was no

Second M otion for Declaratory Judgment 07-20650 Davidson v. Grossman 9

rational basis for the difference in treatment. FDA’s official acts were motivated by

improper considerations. Davidsons have alleged an improper (malevolent) motive

by FDA and Sepracor. In Willowbrook v. Olech, 120 S.Ct. 1073, 1074 (2000), the

Supreme Court explained that “[o]ur cases have recognized successful equal

protection claims brought by a “class of one.” As we read this part of the holding, it

merely stands for the proposition that single plaintiffs may bring equal protection

claims. They need not proceed on behalf of an entire group. Davidsons’ Count Five

is an example of selective enforcement. See Bryan v. City of Madison, 213 F.3d 267

(5th cir. 2000); Allred’s Produce v. U.S. Dep’t of Agric., 178 F.3d 743, 748 (5th Cir.

2000); Esmail v. Macrane, 53 F.3d 176, 178-79 (7th Cir. 1995); Stern v. Tarrant

county Hospital District, 778 F.2d 1052, 1058 (5th Cir. 1985). Davidsons allege that

FDA’s official acts were motivated by improper considerations, such as the desire to

prevent the exercise of a constitutional right. FDA selectively used their powers

against Davidson. Davidsons have shown that FDA’s acts were deliberately based

upon an unjustifiable standard, or other arbitrary classification. FDA retaliated

against Davidson for exercising his fundamental right to equality of treatment before

the law (fair legal procedures).

Discriminatory Animus

Davidsons have made a showing of clear and intentional discrimination in the

Second M otion for Declaratory Judgment 07-20650 Davidson v. Grossman 10

federal court proceeding. Strict scrutiny of a classification under the PDUFA

affecting a protected class is properly invoked only where the plaintiff can show

intentional discrimination by the government. See Wisconsin v. City of New York, 517

U.S. 1 (1996). Clinical research subjects, inappropriately screened specialty practice

patients, clinical research coordinators, and clinical research subinvestigators, are

groups which are particularly vulnerable to discriminatory treatment by officers of the

FDA (acting in their personal capacity for personal financial gain) under color of the

PDUFA. The PDUFA provides corporate pharmaceutical research sponsors with a

robust statutorily-sanctioned vehicle for bribery of FDA officials.

See Black’s Law Dictionary where bribery is defined as,

“the offering, giving, receiving, or soliciting of any item of value

to influence the actions as an official or other person in discharge of a
public or legal duty. The bribe is the gift bestowed to influence the
receiver’s conduct. It may be any money, good, right in action, property,
preferment, privilege, emolument, object of value, advantage, or
influence of a person in an official or public capacity.”

The application of the PDUFA to the Albany, NY FDA EIR of 10/22-12/23/97

by the FDA was improperly motivated. Officials of the FDA (acting in their personal

capacities) were bribed [into selectively applying the PDUFA] by Big Pharma

representatives (acting in their representative capacity), so as to facilitate “expedited”

review and market approval of their New Drug Applications (NDAs), while the for-

Second M otion for Declaratory Judgment 07-20650 Davidson v. Grossman 11

cause “investigations” of the clinical research misconduct languished indefinitely. See

Sanjour v. E.P.A., 56 F.3d 85 (1995). See ¶ 8.67 of the Amended Complaint at

USCA5 535.

The expedited market approval of Xopenex, based at least in part on

fraudulent clinical research of Thomas B. Edwards, M.D., Albany Medical College,

and Sepracor, in support of Sepracor’s New Drug Application, was the result of a

bribe (a “User Fee”) paid by Sepracor to FDA. See ¶s 5.5, 8.66, 8.67, 8.96-8.102,

10, 19, and 20, of the Amended Complaint presently before this Court.

“A refusal to enforce that stems from a conflict of interest, that is the

result of a bribe, vindictiveness, retaliation, or that traces to personal or other

corrupt motives ought to be judicially remediable”. See Heckler v. Chaney, 470 U.S.

821 (1985). “Traditional principles of rationality and fair process do offer

‘meaningful standards’ and ‘law to apply’ to an agencies’ decision not to act, and

no presumption of unreviewability should be allowed to trump these principles.” See

Marshall v. Jerrico Inc., 446 U.S. 238 (1980).

See ¶s 5.10, 5.14, 8.80-8.84, and 28-31, of the Amended Complaint (Document

#19). By delaying the publication of the FDA Tucson, AZ EIR of 5/5-6/28/99, the

PDUFA II substantially delayed the time at which Plaintiffs could begin to seek a

legal remedy against Defendants. This “delay” was intentional and directly targeted

Second M otion for Declaratory Judgment 07-20650 Davidson v. Grossman 12

at the Plaintiffs. It was readily foreseeable that this “delay” would result in wasted

legal expenses, loss of current employment, loss of prospective legitimate

employment opportunities, and damage to Davidsons’ reputation. Appellants were

deprived of their fundamental right to equality of treatment before the law under

the Ninth Amendment of the U.S. Constitution. Appellants have alleged and

provided evidence that the FDA’s acts were motivated by impermissible

considerations (bribery) and their desire to prevent Davidson’s exercise of his

fundamental right to equality of treatment before the law. The “delay” and

extraordinary process faced by Davidson in his interaction with FDA violated

Davidson’s equal protection rights. Appellants have alleged interference with a

fundamental right by FDA and Sepracor Inc, motivated by bribery.

Davidson was individually targeted for selective enforcement of the PDUFA.

There is no rational basis for the difference in treatment. Application of the PDUFA

to the Plaintiffs was motivated by invidiously discriminatory animus. Appellants have

alleged and provided evidence of improper motive (bribery), illegitimate animus, and

evidence of personal vindictiveness, by FDA and Sepracor towards the “whistle-

blower” Davidson. FDA and Sepracor Inc took affirmative steps to “silence the

messenger” (Davidson).

Application of the PDUFA to the Plaintiffs was intended to conceal the

Second M otion for Declaratory Judgment 07-20650 Davidson v. Grossman 13

fraudulent clinical research of Jay Grossman, Thomas B. Edwards, Albany Medical

College, and Sepracor Inc, in support of the NDA # 20-837 for Xopenex Inhalation

Solution, that gained FDA approval on 3/25/99 (review was posted on 6/20/01). Time

in the marketplace is literally worth “billions” to Big Pharma. The User Fees in the

PDUFA are bribes paid by Big Pharma to the FDA in order to gain expedited market

approvals. Bribery is a predicate act of racketeering under 18 U.S.C. §1961. The

PDUFA can be selectively enforced by FDA whenever the whistle is blown on high-

enrollers of clinical research subjects into studies sponsored by Big Pharma in

support of multiple New Drug Applications.

Appellants allege that they have been intentionally treated differently from

others (clinical research subinvestigators) similarly situated and that there is no

rational basis for the difference in treatment. Whether the complaint alleges a class

of one or of five is of no consequence because we conclude that the number of

individuals in a class is immaterial for equal protection analysis. Appellants have

provided evidence to show that the FDA’s motive in selectively enforcing the

PDUFA was to prevent or paralyze [the] exercise of [Davidson’s] fundamental

constitutional right to equality of treatment before the law. Davidson attempted to

exercise his constitutionally-protected right under the Ninth Amendment to equality

of treatment before the law.

Second M otion for Declaratory Judgment 07-20650 Davidson v. Grossman 14

 The FDA treated Davidson differently from other similarly situated clinical

research subinvestigators because Davidson exercised his right to equality of

treatment before the law by “blowing the whistle” on Grossman for patient safety

concerns. See ¶s 8.82 and 8.84 of the Amended Complaint at USCA5 536. The

selective treatment of Davidson by FDA and Sepracor was based on impermissible

considerations (bribery) and to inhibit and punish Davidson’s exercise of his Ninth

Amendment fundamental right to equality of treatment before the law. See Document

#45 at USCA5 1006 where it states,“This inspection report was delayed due to a

PDUFA report.” Underline, italics, and boldface have been added for emphasis. See

¶ 8.88 of the Amended Complaint at USCA5 537, which states,

“Paragraph 1, Page 1, of the FDA EIR Tucson facility on 7/6-

10/2000, a redacted copy of which was obtained through FOI by
Plaintiffs, states, “This was a High Priority CDER User Fee NDA Pre-
Approval Study-Oriented Clinical Investigator Data Validation
Inspection assigned by HFD-46 to audit...under CP 7348.811. Review
of the records found no deviations and no FD-483 was issued.”

Appellants’ have shown that they have suffered actual injury in both Arizona

and Texas. Appellants have demonstrated that the Appellees’ conduct caused the

injury. Granting the relief requested likely would redress Appellants’ injury. See the

affidavit and Exhibits attached to this Motion. As an example of immediate adverse

legal interests between the parties, warranting the issuance of a declaratory judgment,

Second M otion for Declaratory Judgment 07-20650 Davidson v. Grossman 15

this Court is referred to Sepracor’s motion to dismiss the Amended Complaint for

failure to state a claim in Case 4:07-cv-00471. See Document #38 at USCA5 775-

780.

Appellants are suffering continuing present adverse effects by reason of

serial concerted acts of concealment by the Defendants (Appellees) to this lawsuit,

targeted at the Davidsons. There exists a substantial controversy between the parties

having adverse legal interests of sufficient immediacy and reality to warrant the

issuance of a declaratory judgment. The interests of justice will be advanced and an

adequate and effective judgment may be rendered. There is an adequate and full-

bodied record. Appellants seek a holding by this Court that the PDUFA is

unconstitutional as applied to the Appellants. The Defendants/Appellees to this

lawsuit are estopped from asserting the statute of limitations as a defense to the

Amended Complaint under the doctrines of fraudulent concealment, continuing

violation, concerted action (conspiracy), equitable tolling, regulatory estoppel, and

constitutional regulatory estoppel.

As an example of immediate adverse legal interests between the parties,

warranting the issuance of a declaratory judgment, see USCA5 1650 and USCA5

1584 for the Notification of Claim of Unconstitutionality in the First RICO Action

(Case # 03CV110TUCFRZ, captioned Davidson et al v. Vivra Inc et al) and page 25,

Second M otion for Declaratory Judgment 07-20650 Davidson v. Grossman 16

paragraphs 112 and 113 of Davidsons’ Amended Answer to First Amended

Complaint and Counterclaims in the State Action (Pima County Superior Court Case

No. 333954), respectively. Davidson argues for certainly not the first time that his

equal protection rights were violated by selective enforcement of the PDUFA by

FDA. The First RICO Action (Case 4:03-cv-00110-FRZ) was filed on February 19,

2003. See Document #83-6 at pages 3-40 of 40, and Document #83-7 at pages 1-4 of

16, in Case 4:07-cv-00471, for unequivocal proof that Appellants have not at any

time “slept on their rights”. Appellants first raised their concern as to the

constitutionality of the PDUFA on February 19, 2003.

To date, no court (state or federal) has addressed the constitutionality of the

PDUFA. There is still a live and acute controversy. See Shell Oil Co. v. Noel, 608

F.2d 208, 1980-1 Trade Cas. (CCH) P 63118 (1st Cir. 1979). Appellants continue to

seek a legal remedy for significant injuries to their business and property, by reason

of the misconduct of the Defendants to this lawsuit. Those directly injured may

generally be counted on to serve as private attorneys general. See Holmes v.

Securities Investor Protection Corp., 503 U.S. 258 (1992), citing Associated Gen.

Contractors, 459 U.S. at 542. Plaintiffs have suffered direct injuries by reasons of the

Defendants’ misconduct.

Sepracor Inc alleged failure to state a claim and moved the District Court for

Second M otion for Declaratory Judgment 07-20650 Davidson v. Grossman 17

dismissal of the Amended Complaint under FRCP 12(b)(6) in Case 4:07-cv-00471.

See Document #38 at USCA5 775-780. Bribery is a predicate act of racketeering

under the RICO statute (18 U.S.C. 1961). The User Fees under the PDUFA are bribes.

See ¶s 6, 8.14, 8.28, 8.66, 8.67, 8.102, 10, 18, 19, 31, and 35, of the Amended

Complaint (Document #19). This Court is especially referred to ¶ 8.14 where it states,

“This assault and battery in the workplace on May 11, 1999, was
an unsuccessful attempt by Jay Grossman and others to provoke Robert
Davidson into defending himself physically. This unwitnessed assault
and battery was a carefully orchestrated attempt by Jay Grossman, and
others, acting by agreement and in concert, to shift blame for insurance
and research fraud from Jay Grossman to Robert Davidson. Their
contingency plan (should their attempt fail) called for Jay Grossman to
sue Robert Davidson (and his wife Vanessa Komar) for alleged
defamation after Davidson reported the incident to the Tucson Police
Department. Davidson was advised to make a police report on May 11,
1999, by Gayle F. Petrillo (the “Vivra” Tucson Office Manager). Their
contingency plan called for Grossman to use his stock ownership and
stock options in “Vivra” as a measure of alleged damages against the
Davidsons, should Grossman ultimately prevail in his defamation suit.
“Vivra” knew in advance of the assault and battery in the workplace on
May 11, 1999, that “Vivra” would terminate Jay Grossman’s
employment (“for cause”) under the terms of the Physician Employment
Agreement (the “Agreement”) of April 22, 1997. It is by means of the
“stock purchase and sale” that took place between Vivra Specialty
Partners of Arizona, P.C. (“VSP”) and Jay Grossman on or about April
22, 1997, and by means of the employee stock option plan of VSP, that
the “Vivra” enterprise gained control over Grossman while providing
Grossman with an interest in the “Vivra” enterprise. Jay Grossman is
known to have been involved in many lawsuits. See Albany county Case
#2960-91.”

This Court is especially referred to Document #57 at USCA5 1711-1713 for

Second M otion for Declaratory Judgment 07-20650 Davidson v. Grossman 18

a true and correct of the Minute Entry Order of November 24, 2004, where it states,

“Plaintiffs seek an award of damages for financial losses incurred

in connection with the sale of Dr Grossman’s medical practice and the
stock purchase and sale of Vivra stock,...” and “Plaintiffs are also
awarded the sum of $2,493,921.00 for the losses in connection with the
sale of Dr Grossman’s medical practice and the stock purchase and
sale,...”

The linkage of Grossmans’ violations of the substantive RICO statute 18 USC

Section 1962 (b), ( c), and (d), and the injury to Davidsons’ business and property,

is thus very direct. Appellants were directly in the headlights of Grossmans’ unlawful

acts, not the United States. See Document #71 “Motion to Alter or Amend Judgment”

at USCA5 1854, where it states,

“Plaintiffs seek for this court to avoid a manifest injustice by

altering or amending the “Final Order” and the “Memorandum and
Order” under FRCP 59(e). This court is referred to filed Document #45
at page 11 of 26, at lines 109, where it states, “Grossman’s stock
options and stock ownership in “Vivra” was used [as] a measure of
Grossmans’ alleged damages against Robert Davidson and Vanessa
Komar in the default Judgment in the State Action. Vanessa Komar was
a named Defendant in the Arizona State Action. How Vanessa Komar
was ever alleged to have defamed Jay Grossman and caused intentional
infliction of emotional distress to Jay Grossman and Eudice Grossman
is incomprehensible. Would not an attorney [of] even minimal
competence have moved for her dismissal for failure to state a claim
against Vanessa Komar? This goes to willful attorney misconduct by
MJM” Contrary to footnote 3 at page 5 of the “Memorandum and
Order”, Vanessa Komar was never employed by “Vivra” and Vanessa
Komar was never a nurse at “Vivra”.”

This lawsuit (Case 4:07-cv-00471) was timely-filed under the Texas tolling

Second M otion for Declaratory Judgment 07-20650 Davidson v. Grossman 19

rule as well as the power in the federal courts to toll limitations when a potentially

valid federal interest is to be protected.

Conclusions and Relief Sought

Denial of Appellants’ Ninth Amendment fundamental right to equality of

treatment before the law, has been alleged. Selective enforcement has been alleged.

Invidious discrimination has been alleged. As applied to the Appellants, the PDUFA

is repugnant to the U.S. Constitution under Fifth Amendment Equal Protection.

Because Davidsons’ claims involve a fundamental right (equality of treatment before

the law), their federal equal protection claims are subject to de novo review.

Davidsons’ Notice of Appeal was timely-filed under Rule 4(a) of the Federal

Rules of Appellate Procedure. Jurisdiction on appeal is proper based upon 28 U.S.C.

§1291. “Any court of the United States” may render a declaratory judgment based

upon 28 U.S.C. § 2201 (a). The constitutionality of the PDUFA has already been

thoroughly briefed and is ripe for adjudication by this Court. Granting the relief

requested likely would redress Appellants’ injury. Bribery is a predicate act of

racketeering under the RICO statute. The User Fees under the PDUFA are bribes.

Appellants have stated claims under RICO as to all of the defendants/appellees.

Second M otion for Declaratory Judgment 07-20650 Davidson v. Grossman 20

 WHEREFORE, based upon all of the aforementioned arguments, points, and

authorities, Appellants pro se, pray for this Court to remedy ongoing violations of

constitutional law by declaring that the PDUFA is repugnant to the U.S. Constitution

as applied to the Davidsons and therefore held by this Court to be unconstitutional,

and order such “further necessary or proper relief” to aid enforcement of the

judgment.

RESPECTFULLY signed, on this 7th Day of November, 2007, by

________________________ and ______________________________

ROBERT M. DAVIDSON VANESSA E. KOMAR

Second M otion for Declaratory Judgment 07-20650 Davidson v. Grossman 21