Second Motion For Declaratory Judgment

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

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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 10591067, 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

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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

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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). 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

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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

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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 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

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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

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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 (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

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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 (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

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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

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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. 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-

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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 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

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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 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 “whistleblower” 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

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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 highenrollers 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

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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 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 7/610/2000, a redacted copy of which was obtained through FOI by Plaintiffs, states, “This was a High Priority CDER User Fee NDA PreApproval 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,

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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 775780. 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 fullbodied 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

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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 (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

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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 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

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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 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

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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 all of 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 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

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