Second Motion for Declaratory Judgment

8/14/2019 Second Motion for Declaratory Judgment

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

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. Tartaglias 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


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

Sepracor Incs 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

5 Amendment equal protection grounds found in the U.S. Constitution. Appellantsth

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


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andthere 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-motivatedFDA 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. SeeDeMuria v. Hawkes , 328 F.3d 704, 705 (2d

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

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


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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). SeeMach 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 5 Circuit U.S.th

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 concludeat 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 3 party reliance See Summit Propertiesrd

Inc. v. Hoechst Celanese Corp., 214 F.3d 556 (5 Cir. 2000); Procterth


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and Gamble Co. v. Amway Corp., 242 F.3d 539 (5 Cir. 2001);th

Sandwich Chef of Texas, Inc. v. Reliance Natl. Indemnity, 202 F.R.D.

484 (5 Cir. 2001). Justice Thomas dissenting opinion in the Anza caseth

appears to lend considerable support for target wing types of injured

Plaintiffs, maintaining their standing to bring civil RICO complaints. Itshould 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 theAnza 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.

SeePreveza 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. SeeLittle 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


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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

Davidsons 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 ones right to

equality of treatment before the law (fair legal procedures). FDAs 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.


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Davidsons have alleged and provided proof that FDAs act were motivated by

improper considerations to prevent Davidsons exercise of his fundamental right to

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

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

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 FDAs 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,


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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 (6 Cir. 1997).th

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


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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

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

FDAs 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


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rational basis for the difference in treatment. FDAs 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. SeeBryan v. City of Madison, 213 F.3d 267

(5 cir. 2000);Allreds Produce v. U.S. Dept of Agric., 178 F.3d 743, 748 (5 Cir.th th

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

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

FDAs 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 FDAs 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


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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.

SeeBlacks 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

receivers 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-


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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 Sepracors 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. SeeHeckler 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


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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 FDAs acts were motivated by impermissible

considerations (bribery) and their desire to prevent Davidsons 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

Davidsons 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 ofimproper 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


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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 FDAs motive in selectively enforcing the

PDUFA was to prevent or paralyze [the] exercise of [Davidsons] 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.


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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 Grossmanfor 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 Davidsons 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 ValidationInspection 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,


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this Court is referred to Sepracors 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, captionedDavidson et al v. Vivra Inc et al) and page 25,


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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 (1 Cir. 1979). Appellants continue tost

seek a legal remedy forsignificantinjuries 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), citingAssociated Gen.

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

Defendants misconduct.

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


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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 Grossmans

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 isknown 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


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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 Grossmans medical practice and the

stock purchase and sale of Vivra stock,... and Plaintiffs are alsoawarded the sum of $2,493,921.00 for the losses in connection with the

sale of Dr Grossmans 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, Grossmans stock

options and stock ownership in Vivra was used [as] a measure ofGrossmans 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 andOrder, 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


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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 allof the defendants/appellees.


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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 appliedto 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 7 Day of November, 2007, byth

________________________ and ______________________________

ROBERT M. DAVIDSON VANESSA E. KOMAR

Documents

Second Motion for Declaratory Judgment