Searchable Amended Complaint Usdc Sdtx

AMENDED COMPLAINT

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COMES NOW the Plaintiffs, Robert Michael Davidson and Vanessa Elaine Komar, husband and wife, representing themselves, pro se, state and allege as follows: I.

JURISDICTION AND VENUE

1. This Court has jurisdiction of the claim herein pursuant to 18 U.S.C.A. Section 1964 (c), 28 U.S.C.A. Section 1331, 28 U.S.C.A. Section 1367, and 28 U.S.C.A. Section 1332. This civil action arises under the laws

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of the United States. Plaintiffs’ rights have been violated under Title IX of the Organized Crime Control Act of 1970, as amended, 18 U.S.C.A. Subsection 1961 et seq. The amount in controversy requirement is exceeded, by Plaintiffs (Robert M. Davidson and Vanessa E. Komar, husband and wife) jointly having sustained actual

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damages (injury) to their business and property that exceeds, exclusive of interest and costs, the sum of $5,000,000.00. 2. Venue herein is proper under 18 U.S.C.A. Section 1965(a), 18 U.S.C.A. Section 1965(b), 18 U.S.C.A.

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Section 1965(d), 28 U.S.C.A. Section 1391 (b), 28 U.S.C.A. Section 1391 (c), and the Texas Long-arm statute. Venue herein is proper under 18 U.S.C.A. Section 1965(a) for at least one defendant. Venue is proper in this Court for all “other” RICO defendants under 18 U.S.C.A. Section 1965(b), because the “ends of justice”

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require it. The “ends of justice” apply because there is no other forum which is proper as to all Defendants

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under 18 U.S.C. Section 1965(a). In this case, 18 U.S.C. Section 1965(b) is applicable because venue is not improper as to all the Defendants under 18 U.S.C. Section 1965(a). Defendant Gambro Healthcare Inc is

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regularly conducting business of substantial and continuous character within the district under the names DVA Renal Healthcare Inc. and DVA Healthcare Renal Inc. Defendant DVA Renal Healthcare Inc (a corporation existing under and by virtue of the laws of the State of Tennessee) is a wholly-owned subsidiary of Davita Inc.

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Defendant DVA Renal Healthcare Inc is regularly conducting business of substantial and continuous character within the district. Davita Inc is a corporation existing under and by virtue of the laws of the State of Delaware. Defendant Davita Inc is regularly conducting business of substantial and continuous character within the

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district. Nationwide service under 18 U.S.C.A. Section 1965(b) may be imposed on Defendant Jay Grossman, Defendant Eudice Grossman, Defendant Gayle F. Petrillo, Defendant Charles W. Ott, Defendant Joanne C. Wray, Defendant Kent W. Thiry, Defendant Joseph C. Mello, Defendant Anthony P. Tartaglia, Defendant Michael J. Meehan, Defendant Bruce R. Heurlin, Defendant Albany Medical College, Defendant Vivra Holdings Inc, and Defendant Sepracor Inc, because this Court has personal jurisdiction over Defendant Gambro Healthcare Inc, Defendant DVA Renal Healthcare Inc, Defendant Davita Inc, and Defendant Sepracor Inc, under 18 U.S.C.A. Section 1965(a), and the “ends of justice” require nationwide service of process over

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nonresident defendants. The ends of justice require nationwide service in this lawsuit because there is a nationwide (literally coast to coast) conspiracy to “conceal on-going, parallel schemes of serial related clinical research frauds and insurance frauds” that can only be challenged in one suit in which all defendants are

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present. By the very nature of their business (contract clinical research and specialty medical practice), Defendants have willfully injected themselves, their business, and their conduct, into the stream of interstate commerce. Defendants have “nationwide contacts” and Defendants have conspired to defraud the United

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

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States. Fifth Amendment due process is not violated by nationwide service of process over these nonresident Defendants. Plaintiffs have stated a claim under civil RICO and the ends of justice require nationwide service. Plaintiffs have established in their pleadings, affidavit, and exhibits to this Amended Complaint, that a substantial part of the events or omissions giving rise to their claims occurred in the forum State of Texas. Plaintiffs have established in their pleadings, affidavit, and exhibits to this Amended Complaint, that Gambro Healthcare Inc, DVA Renal Healthcare Inc, Davita Inc, and Sepracor Inc, are regularly conducting business

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of substantial and continuous character within the District. II.

PARTIES

3. Plaintiffs, Robert Michael Davidson and Vanessa Elaine Komar, husband and wife, are citizens of the 7 8

United States, and residents of the State of Texas. 4. Defendant Jay Grossman, is a citizen of the United States, and is a resident of the State of Arizona. Defendant Eudice Grossman, is a citizen of the United States, and is a resident of the State of Arizona.

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Defendant Gayle F. Petrillo (“Petrillo”), is a citizen of the United States, and is a resident of the State of Arizona. Defendant Charles W. Ott (“Ott”), is a citizen of the United States, and is a resident of the State of California. Defendant Joanne C. Wray (formerly known as Joanne C. Siegel), is a citizen of the United States,

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and is a resident of the State of California. Defendant Anthony P. Tartaglia (“Tartaglia”), is a citizen of the

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United States, and is a resident of the State of New York. Defendant Kent J. Thiry (“Thiry”), is a citizen of the United States, and is a resident of the State of California. Defendant Joseph C. Mello (“Mello”), is a citizen of

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the United States, and is a resident of the State of California. Defendant Michael J. Meehan (“Meehan”), is a citizen of the United States, and is a resident of the State of Arizona. Defendant Bruce R. Heurlin, (“Heurlin”) is a citizen of the United States, and is a resident of the State of Arizona. Defendant Vivra Holdings Inc, is a

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corporation existing under and by virtue of the laws of the State of Delaware with its office and principal place of business located at 1350 Old Bayshore Hwy, Ste 777, Burlingame, CA 94010. Defendant Gambro Healthcare Inc (“Gambro”), is a corporation existing under and by virtue of the laws of the State of Tennessee

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with its office and principal place of business located at 1919 Charlotte Avenue, Nashville, TN 37203. Defendant Gambro Healthcare Inc is regularly conducting business of substantial and continuous character within the district under the name DVA Renal Healthcare Inc. and DVA Healthcare Renal Inc. Defendant DVA Renal Healthcare Inc (“DVA Renal”), is a corporation existing under and by virtue of the laws of the State of Tennessee with its office and principal place of business located at 10810 W. Collins Avenue, Lakewood, CO 80215. Defendant DVA Renal Healthcare Inc is regularly conducting business of substantial and continuous character within the district and maintains a registered agent authorized to accept service at

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701 Brazos Street, Suite 1050, Austin, TX. 78701. Defendant DVA Renal Healthcare Inc is a wholly-owned subsidiary of Davita Inc. Defendant Davita Inc (“Davita”) is a corporation existing under and by virtue of the laws of the State of Delaware with its office and principal place of business located at 601 Hawaii Street, El

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Segundo, CA 90245. Defendant Davita Inc is regularly conducting business of substantial and continuous character within the district. Defendant Albany Medical College (“AMC”), is a corporation existing under and by virtue of the laws of the State of New York with its office and principal place of business located in 43 New

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

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Scotland Ave, Albany, NY 12208. Defendant Sepracor Inc (“Sepracor”) is a corporation existing under and by virtue of the laws of the State of Delaware with its principal place of business located in 84 Waterford Drive, Marlborough, MA 01752. Defendant Sepracor Inc is regularly conducting business of substantial and continuous character within the district and maintains a registered agent authorized to accept service at 350 North St. Paul Street, Dallas, TX 75201. III.

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5. 5.1

CLAIM FOR RELIEF The “VIVRA” association-in-fact enterprise is set forth in the following subparagraphs: “Vivra” is an enterprise that is engaged in and the activities of which affected interstate commerce. “Vivra” is an association-in-fact enterprise whose common purpose is to employ both legitimate and

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illegitimate business practices: (a) to defraud Medicare, Medicaid, (and other 3rd party insurance payers) in multiple states including Arizona, California, New York, and Texas, (b) to defraud the

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Food and Drug Administration in multiple states, (c) to defraud clinical research subjects in multiple 9

states, (d) to defraud specialty practice patients in multiple states, (e) to defraud clinical research

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subinvestigators in multiple states (including Plaintiff Robert M. Davidson, M.D., in Arizona and Texas), (f) to defraud clinical research coordinators in multiple states, and (g) to defraud the United

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States. 5.2

These illegitimate business practices included an enterprise-wide pattern of (a) fraudulent omissions and misrepresentations in the hiring and retention of key “Vivra” employees (including Plaintiff

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Robert M. Davidson, M.D.), (b) fraudulent omissions and misrepresentations to prospective and current clinical research subjects, (c) fraudulent omissions and misrepresentations to specialty

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practice patients, (d) fraudulent omissions and misrepresentations to federal regulators [acting in their 15

“official” capacities], (e) fraudulent omissions and misrepresentations to 3rd party insurance payors

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[both commercial and federal], (f) obstructions of justice, (g) Hobbs Act (extortion under RICO statute) violations, (h) Travel Act violations, (i) intentional endangerments, and (j) deaths.

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5.3

These illegitimate business practices deprived certain “Vivra” employees (including Plaintiff Robert M. Davidson, M.D.) of their right to the good and honest services of Defendants, and deprived

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certain “Vivra” employees (including Robert M. Davidson, M.D.) of their right freely to conduct

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one’s lawful business. These illegitimate business practices deprived certain “Vivra” employees

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(including Robert M. Davidson, M.D.) of property (inappropriate study subject enrollments), with their consent, induced by Defendant Jay Grossman’s wrongful use of actual or threatened force,

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violence, or fear, or under color of official right. These illegitimate business practices were a regular 22

part of the “Vivra” enterprise’s regular way of doing business. While the “Vivra” association-in-fact enterprise had the appearance of legitimacy (and indeed may have had some legitimate functions and

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some legitimate business practices), illegitimate business practices were a regular part of the “Vivra” 24 25

enterprise’s regular way of doing business. 5.4

Defendant Vivra Holdings Inc, Defendant Gambro Healthcare Inc, and Defendant DVA Renal Healthcare Inc have serially abused the corporate form, by means of signing and filing, or causing to

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

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be signed and filed, fraudulent Annual Reports, Certificates of Disclosure, and Corporate Integrity

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Agreements, that made willful use of the U.S. mail and wire facilities to perpetrate, perpetuate, and

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conceal fraud, between 1998 and the present. 5.5

Plaintiffs have firmly established a nexus between misconduct of Albany Medical College, Sepracor Inc, and the forum state of Texas. On March 23, 2000, the FDA issued a Warning Letter to Sepracor

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Inc regarding a Sepracor sales representative who made oral statements promoting Xopenex 0.63 mg 5

(levalbuterol HCl) Inhalation Solution for an unapproved dosage regimen (“every four hours, similarly to albuterol”), thereby misrepresenting the dose response of the product to health care

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professionals in Dallas, TX. See the affidavit and exhibits to this Amended Complaint. See ¶ 8.987

8.104, and ¶ 19 to this Amended Complaint. In 2004, Sepracor Inc entered into four leases for office space that serve as regional sales offices. These offices include a regional sales office in Flower

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Mound, TX. As recent as April 7, 2007, Sepracor Inc advertised to fill the position of Sr. Regional 9

Admin Assistant/Flower Mound, TX. As recent as March 30, 2007, Sepracor Inc advertised to fill the position of Respiratory Sales Specialist/Houston, TX. By information and belief, Sepracor Inc

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maintains a U.S.-based, 1,250-person primary care and specialty-oriented sales force to further its 11

commercialization efforts. As recent as January 23, 2007, Xopenex (levalbuterol) Inhalation Solution

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was listed on the Health and Human Services Commission Texas Medicaid Preferred Drug List (PDL) and Prior Authorization (PA) Criteria. The Comptroller of Public Accounts of the State of

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Texas certified that on March 21, 2007, Sepracor Inc (Taxpayer # 12225365878) was in good standing. Sepracor Inc is authorized to do business in Texas with the Secretary of State of Texas.

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Plaintiffs have firmly established a nexus between misconduct of Gambro Healthcare Inc and the forum state of Texas. See the “Settlement Agreement and Release” in the case known to the Texas Attorney General’s Office as “Gambro Healthcare Inc” MF 052976-01-7, GBL 1204 040. Pages 3 to 7 of 20 of the “Settlement Agreement and Release” detail the allegations of the State of Texas with

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respect to conduct of Gambro Healthcare Inc in the forum state of Texas. See the federal docket for U.S. District Court Eastern District of Missouri Case # 4:01-CV-00553-DDN captioned “Bander v. Gambro Healthcare U.S., Inc”. See the Order (Document 47) filed 12/02/2004, of David D. Noce, U.S. Magistrate Judge, the U.S. District Court Case # 4:01CV00553DDN, captioned “Bander v. Gambro Healthcare U.S., Inc”. Gambro and Davita provide for-profit out-patient in-facility hemodialysis for Medicare recipients in the forum State of Texas. Gambro and Davita paid 2006 property taxes on business personal property and real property within Harris County, TX. Gambro

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has been a contracted provider for hemodialysis services to Texas residents since at least as early as 2000. Gambro and Davita have been certified by the U.S. Department of Health & Human Services as hemodialysis facilities. Gambro and Davita currently own for-profit in center hemodialysis

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facilities in Arlington, TX, Dallas, TX, Houston, TX, and Katy, TX. As of December 31, 2006, Davita owns 111 out-patient dialysis centers in the State of Texas. As of December 31, 2006, 58% of Davita revenues were from Medicare and Medicare assigned HMO plans, 4% from Medicaid, and

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

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3% from other government-based programs. The Comptroller of Public Accounts of the State of

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Texas certified that on March 21, 2007, DVA Renal Healthcare Inc (Taxpayer # 16213230903) and

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DVA Healthcare Renal Inc (Taxpayer # 19529779167) were in good standing. DVA Renal

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Healthcare Inc and DVA Healthcare Renal Inc are authorized to do business in Texas with the Secretary of State of Texas. As recent as April 6, 2007, Davita Inc advertised in the Texas Job Bank

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for 56 jobs in Texas, including 9 jobs in Houston, TX. 5

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Each Defendant listed in paragraph 4 was an owner of, was employed by, or was associated with an enterprise [that is “Vivra”, an association-in-fact enterprise] engaged in, or the activities of which

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affected interstate commerce, within the meaning of 18 U.S.C.A. Section 1962 (b), (c), and (d). 7

5.8

At the time that they acted illegally, Kent J. Thiry, Joseph C. Mello, Anthony P. Tartaglia, Charles W. Ott, and others to be determined at trial, were acting within the scope of their duties and their

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illegal acts were intended, at least in part, to benefit the respective corporation. 9

5.9

Vivra Holdings Inc, Gambro Healthcare Inc, Davita Inc, DVA Renal Healthcare Inc, and Albany Medical College, recklessly tolerated, commanded, and ratified, the willful misconduct of Kent J.

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Thiry, Joseph C. Mello, Leanne M. Zumwalt, Timothy G. Wighton, Anthony P. Tartaglia, Charles 11

W. Ott, and others to be determined at trial. Plaintiffs allege a pattern of reckless corporate behavior.

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Plaintiffs have linked that behavior to specific culpable individuals. See ¶ 8.18, ¶ 8.20, and ¶ 8.22 to this Amended Complaint.

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5.10

Kent J. Thiry, Joseph C. Mello, Leanne M. Zumwalt, Timothy G. Wighton, Anthony P. Tartaglia, Charles W. Ott, and others to be determined at trial, either individually or severally, possessed the requisite culpable state of mind upon which to base liability of the corporate parties (Vivra Holdings

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Inc, Gambro Healthcare Inc, Davita Inc, DVA Renal Healthcare Inc, Sepracor Inc, and Albany Medical College) to this lawsuit. They all had actual knowledge that Jay Grossman had been accused of violence. They all had actual knowledge that Jay Grossman had been accused of clinical

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research fraud and violence, in both Albany, NY and in Tucson, AZ. They all had actual knowledge of the lawsuit in Albany, NY (Albany County Case # 2960-91) and the sworn affidavit by Richard Ball, M.D., et al. in Albany County Case # 2960-91. Charles W. Ott had actual knowledge that Joanne C. Wray (Siegel), R.N., was William H. Ziering’s former research nurse in Fresno, CA prior to becoming Jay Grossman’s research nurse in Tucson, AZ. Charles W. Ott had actual knowledge of William H. Ziering’s criminal mail fraud conviction in connection with his clinical research practice in Fresno, CA. Albany Medical College, Anthony P. Tartaglia, and Sepracor Inc, had actual

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knowledge that Jay Grossman had been accused of clinical research fraud and violence, and actual knowledge that Thomas B. Edwards had been disqualified for clinical research fraud at Albany Medical College by the FDA. Albany Medical College and Anthony P. Tartaglia knew that Albany

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Medical College’s considerable revenue from clinical research studies conducted at Albany Medical College would potentially suffer if Jay Grossman and Thomas B. Edwards were to continue their clinical research practices at Albany Medical College, after allegations of Jay Grossman’s research

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

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fraud and violence, and Thomas B. Edwards’ disqualification for research fraud. Albany Medical

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College, Anthony P. Tartaglia, Sepracor Inc, and others, had actual knowledge that the FDA’s

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approval for marketing of NDA # 20-837, levoalbuterol HCl inhalational solution, that gained FDA

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approval on 3/25/99 (review was posted on 6/20/01), was at least in part, based upon fraudulent clinical research by Thomas B. Edwards conducted at Albany Medical College. Jay Grossman is

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known to have been involved in at least one clinical research study in support of a New Drug 5

Application for levoalbuterol HCl inhalational solution, sponsored by Sepracor Inc, from 1998 until 1999, at the “Vivra” Tucson, AZ facility. The lives of millions of citizens of the United States,

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including citizens of Texas, have been intentionally endangered under color of the Prescription Drug 7

User Fee Act (“PDUFA”). As applied to the Plaintiffs, the PDUFA is repugnant to the U.S. Constitution under the Equal Protection clause of the Fifth Amendment. See ¶s 8.64 - 8.67 and ¶s

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8.80 - 8.89, to this Amended Complaint. Application of the PDUFA to the Plaintiffs was motivated 9

by invidiously discriminatory animus (so as to conceal clinical research fraud by Jay Grossman, Albany Medical College, Thomas B. Edwards, and Sepracor Inc). See ¶s 8.94 - 8.104 to this

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Amended Complaint. 11

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Kent J. Thiry, Joseph C. Mello, Leanne M. Zumwalt, Timothy G. Wighton, Anthony P. Tartaglia, Charles W. Ott, and others to be determined at trial, acted either individually or in concert with

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others, made or caused to be made certain misrepresentations or omissions, when they knew the 13

information was false or had a duty to disclose the information. See ¶ 8.18, ¶ 8.20, and ¶ 8.22 to this Amended Complaint.

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“Vivra” was doing business in nearly every state in the country, as part of a conglomerate of corporate entities, the senior management of which was located in San Mateo, CA, Plantation, FL, Norcross, GA, Louisville, KY, Marlborough, MA, and several other locations, prior to the Chapter

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11 bankruptcy filing of the “Magellan defendants” that stayed the Plaintiffs’ original federal RICO 17

action in Tucson, Arizona (Robert M. Davidson, et al v. Vivra Inc, et al, in U.S. District Court Arizona, Case # CV-03-110-TUC-FRZ, filed on February 19, 2003) .

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5.13

The acts and events out of which this cause of action arises occurred in Albany, NY, Tucson, AZ, Longview, TX, Kilgore, TX, Tyler, TX, Dallas, TX, Arlington, TX, Houston, TX, Katy, TX, Fort

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Worth, TX, San Antonio, TX, Austin, TX, El Segundo, CA, Norcross, GA, Louisville, KY, Fresno, CA, San Mateo, CA, Torrance, CA, Deland, FL, Fort Lauderdale, FL, Plantation, FL, Lakewood,

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CO, Nashville, TN, Brentwood, TN, Denver, CO, Marlborough, MA, Rockville, MD, and other 22 23

locations presently unknown to the Plaintiffs. 5.14

Defendants’ dealings with the FDA are prompted by the FDCA (Food Drug and Cosmetic Act) and by the PDUFA (Prescription Drug User Fee Act). The fruit of Defendants’ misconduct has resulted in

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approvals by the FDA of numerous New Drug Applications for their corporate pharmaceutical sponsors, and personal and corporate financial gain for the enterprise. NDA # 20-837, levoalbuterol HCl inhalational solution, gained FDA approval on 3/25/99 (review was posted on 6/20/01).

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

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Application of the PDUFA to the Plaintiffs was motivated by invidiously discriminatory animus (so

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as to conceal clinical research fraud by Jay Grossman, Albany Medical College, Thomas B.

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Edwards, and Sepracor Inc). See ¶s 8.94 - 8.104 to this Amended Complaint. 5.15

Concerted action gave the “Vivra” association-in-fact enterprise a peculiar power of coercion over the Plaintiffs, enabling them to bring about results different in kind from what any of them could

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achieve individually. By information and belief, the “relocation” of Jay Grossman’s “research” 5

practice from Albany, NY to Tucson, AZ in the early 1990’s, involved an agreement (to conceal clinical research fraud at Albany Medical College) and concerted action, between Albany Medical

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College, Anthony P. Tartaglia, Jay Grossman, Thomas B. Edwards, Sepracor Inc, and others, to be 7

determined at trial. Similarly, and not coincidentally, the “relocation” of Thomas B. Edwards’ “research” practice from Albany, NY to Pittsfield, MA in the late 1990’s, by information and belief,

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involved an agreement (to conceal clinical research fraud at Albany Medical College) and concerted 9

action, between Albany Medical College, Anthony P. Tartaglia, Thomas B. Edwards, Sepracor Inc, and others, to be determined at trial. Plaintiffs have jointly suffered direct (“by reason of”)

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enterprise injury, conspiracy injury, predicate act injury, and substantive RICO injury, to their 11

business and property. Plaintiffs allege direct enterprise injury to their business and property due to

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the conspirators adoption of a practice and pattern of fraudulent inducement and retention of contracts as a regular part of the usual way in which the enterprise conducted its affairs. The

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“Vivra” association-in-fact enterprise adopted, as a regular way of doing the enterprise’s business, the routine use of fraudulent hiring and retention inducements in order that they might induce the

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employment of highly qualified individuals (including Robert M. Davidson, M.D.) to fill certain key 15

positions. Plaintiffs allege that they have suffered distinct RICO injuries, i.e. that Plaintiffs’ injuries derive from the pattern of racketeering activity which violates 18 U.S.C. Section 1962.

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Defendants to this lawsuit have demonstrated a pattern of placing or causing to be placed “defective products” into the stream of interstate commerce. By information and belief, Albany Medical College, Anthony P. Tartaglia, Sepracor Inc, and others to be determined at trial, acting in concert and by agreement to conceal fraud, “exported” Jay Grossman from Albany, NY to Tucson, AZ in the early 1990’s. By information and belief, Albany Medical College, Anthony P. Tartaglia, Sepracor Inc, and others to be determined at trial, acting in concert and by agreement to conceal fraud, “exported” Thomas B. Edwards from Albany, NY to Pittsfield, MA in the late 1990’s. By information and belief, William H. Ziering, Jay Grossman, and others to be determined at trial,

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acting in concert and by agreement to conceal fraud, “exported” Joanne C. Wray (formerly known as Joanne C. Siegel) from Fresno, CA to Tucson, AZ in the late 1990’s. Albany Medical College, Anthony P. Tartaglia, Sepracor Inc, and others to be determined at trial, had actual knowledge that

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the FDA’s approval (expedited under color of the PDUFA) for marketing of NDA #20-837, levoalbuterol HCl inhalational solution, that gained FDA approval on 3/25/99 (review was posted on 6/20/01), was at least in part, based upon fraudulent clinical research by Thomas B. Edwards,

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

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conducted at Albany Medical College on behalf of Sepracor Inc. By information and belief, Gambro

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Healthcare Inc has a history of deaths and injuries associated with the production of faulty products.

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In this country, the FDA now says nine deaths and 11 serious injuries have been linked to the Prisma

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System. 5.17

The “Vivra” enterprise exists separate and apart from the pattern of racketeering activity in which it engages. Each of the RICO “persons” who commit the predicate acts is distinct from the enterprise.

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Company officers and employees were associated other than through the activities of the companies. Kent J. Thiry (presently CEO of Davita Inc), Joseph C. Mello (presently COO of Davita Inc), and Leanne M. Zumwalt (presently Vice President of Davita Inc) have remained associates, long after the

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dissolution of Vivra Inc and Vivra Asthma Allergy Inc. Leanne M. Zumwalt was formerly Chief Financial Officer and Treasurer of Vivra Inc, from 1991 to 1997, and was Chief Financial Officer of Vivra Specialty Partners Inc from 1997 through 1999. After a multitude of corporate mergers,

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divestitures, acquisitions, dissolutions, and Chapter 11 filings, Kent J. Thiry, Joseph C. Mello, Charles W. Ott, and Leanne M. Zumwalt, remain associated-in-fact. This longstanding association is not coincidental, it is willful.

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COUNT ONE 6. Defendants, Jay Grossman, Eudice Grossman, Kent J. Thiry, Joseph C. Mello, Vivra Holdings Inc, DVA Renal Healthcare Inc, Gambro Healthcare Inc, and Davita Inc, as persons within the meaning of 18 U.S.C.A.

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Section 1961(3), through a pattern of racketeering activity, acquired and/or maintained, directly or indirectly, an interest in and control of said “Vivra” enterprise in violation of 18 U.S.C.A. Section 1962(b). Plaintiffs’ injury under COUNT ONE traces directly to the Physician Employment Agreement

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entered into as of April 22, 1997, by and between Vivra Specialty Partners of Arizona P.C. and Jay Grossman, M.D. Plaintiffs’ injury under COUNT ONE also traces directly to SEC filings for Vivra Inc, that include SC 14 D1, filed on 05/09/1997, that details the Proposed Merger between Vivra Inc and Gambro Healthcare Inc, that

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took place on or about June 1997. Page 31 of SC 14 D1 describes Conduct of Specialty Business under the Merger Agreement. A summary of the Specialty Merger Agreement is found at pages 36 and 37. Page 319 provides details of the Specialty Merger Agreement. Employee Stock Options are described at pages 33 and 34 of SC 14 D1. By information and belief, Kent J. Thiry and Joseph C. Mello are thought to currently possess substantial stock ownership in Davita Inc. The question of whether Vivra Holdings Inc actually did “spin off” its asthma/allergy business to its shareholders in the form of a stock dividend on December 1, 1998, as was sworn to by Michael P. McQuillen, is moot relative to the question of Plaintiffs’ injury under COUNT ONE.

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Plaintiffs incorporate here by reference ¶ 8.14 and ¶ 8.28 below. COUNT TWO

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7. Defendants, Jay Grossman, Eudice Grossman, Gayle F. Petrillo, Charles W. Ott, Kent J. Thiry, Joseph C. 24 25

Mello, Joanne C. Wray, Anthony P. Tartaglia, Michael J. Meehan, Bruce R. Heurlin, Vivra Holdings Inc, Gambro Healthcare Inc, DVA Renal Healthcare Inc, Davita Inc, Albany Medical College, and Sepracor Inc, as persons within the meaning of 18 U.S.C.A. Section 1961(3), and as persons employed by or associated with

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

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said “Vivra” enterprise, conducted and participated, directly and indirectly, in the conduct of the affairs of said “Vivra” enterprise through a pattern of racketeering activity in violation of 18 U.S.C.A. Section 1962 (c). Plaintiffs repeat here the allegations found in Paragraphs 1-6 above, and incorporate here by reference the allegations found in Paragraphs 9-90 below. 8. The predicate acts that constitute this pattern of racketeering activity are set out in the following subparagraphs:

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8.1.

Gayle F. Petrillo wrote the “stay home” note at Jay Grossman’s express request and faxed same to Robert Davidson on April 27, 1999, at 1609 hours with the “Vivra” date and time stamp.

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The Tucson FDA EIR report of 5/5-6/28/99, Page 13, Paragraph 11 provides the mens rea for this act. “Also included…is a handwritten memo by Gayle Petrillo, Office Manager. When I ask Ms. Petrillo where this came from she stated that Dr. Grossman had asked her to write this and present it to Dr.

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Davidson. The memo states that Dr. Davidson can take two days off beginning April 28, 1999. I asked 9

why to which she stated so Dr. Davidson would not be around during the scheduled inspection of 4/28-30/99.”

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Neither Gayle F. Petrillo nor Jay Grossman wanted Robert Davidson to be present at the Vivra

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Tucson facility during the scheduled inspection of 4/28-30/99 for fear he would “blow the whistle on

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them”. 8.4.

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Gayle F. Petrillo and Jay Grossman agreed to a scheme by which they would insure that Robert Davidson, M.D. was not present at the Vivra Tucson facility. They agreed to give him two days off beginning on April 28, 1999.

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Charles W. Ott, acting by agreement and in concert with others, bribed Joanne C. Wray, R.N. by directly or indirectly providing her with pro bono legal “services” in “defense” of her nursing license after Jay Grossman was terminated “for cause” by Vivra Inc on July 30, 1999. Joanne C. Wray, R.N.

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accepted the bribe from Charles W. Ott and others to be determined at trial. Both Charles W. Ott and 17

Joanne C. Wray, R.N. wished to conceal Jay Grossman’s serial insurance and research frauds, so as not to risk discovery by federal regulators of their own complicity in Jay Grossman’s serial insurance

18

and research frauds at the “Vivra” Tucson, AZ facility between on or about April 22, 1997, to on or

19

about May 12, 1999. Charles W. Ott, Joanne C. Wray, Gayle F. Petrillo, Kent J. Thiry, Joseph C.

20

Mello, Leanne M. Zumwalt, Timothy G. Wighton, Eudice Grossman, and Jay Grossman, had a “meeting of the minds”, wherein they all agreed to commit overt acts to conceal serial related

21

insurance and research frauds and obstruct justice at the “Vivra” Tucson, AZ facility, motivated by 22 23 24 25

personal and corporate financial gain. 8.6.

Joanne C. Wray, R.N. admitted to her actual involvement in serial upcoding and serial unnecessary procedures by Jay Grossman, billed or caused to be billed by “Vivra” to 3rd party insurance payers, that made readily foreseeable and necessary use of interstate mail and wire facilities to facilitate their scheme to defraud, at the “Vivra” Tucson, AZ location between on or about April 22, 1997, to on or about October 1, 1999. By information and belief, “Vivra” is thought to have continued to bill 3rd

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

9

party insurance payors, even after Jay Grossman was placed on administrative leave and subsequently

1

terminated for cause, under the “locum tenens rule”. The serial upcoding and serial unnecessary

2

procedures admitted to by Defendant Joanne C. Wray is related and posed a definite threat of

3 4

repetition (open-ended continuity). Plaintiffs incorporate here by reference ¶ 8.40. 8.7.

After Jay Grossman was terminated “for cause” by Vivra Inc on or about July 30, 1999, Jay Grossman attacked Joanne C. Wray’s nursing license by filing a complaint with the Arizona State

5

Board of Nursing, claiming that she “exceeded the scope of her practice”, presumably often. His motive was to shift blame for insurance and research fraud from Jay Grossman to Joanne C. Wray.

6 8.8. 7

The conditional pro bono legal “representation” of Joanne C. Wray, by Charles W. Ott and others acting in concert, was conditioned upon her remaining an employee of “Vivra”. The object was to exert control over Joanne C. Wray and thereby conceal insurance and research fraud.

8 8.9. 9

Charles W. Ott’s inducement of Joanne Christa Wray [formerly known as Joanne Christa Siegel] with pro bono legal representation was intended and actually succeeded in keeping Joanne C. Wray from independently seeking her own legal redress, until much later.

10 8.10.

Joanne C. Wray, R.N. could otherwise have readily “blown the whistle” on serial related insurance

11

frauds and research frauds perpetrated by Jay Grossman at the “Vivra” Tucson, AZ facility between

12

on or about April 22, 1997, to on or about May 12, 1999. These serial insurance frauds and research frauds were related and posed a definite threat of repetition (open-ended continuity). A “study buddy”

13

is typically a former specialty practice patient who is enrolled serially by Jay Grossman in one clinical research study after another. Between studies they became specialty practice patients again.

14

Cross-over was commonplace. 15

8.11.

Charles W. Ott was always very much aware of the reason why Jay Grossman attacked Joanne C. Wray’s nursing license. Charles W. Ott knew that the reason was to shift blame for insurance and

16

research fraud from Jay Grossman to Joanne C. Wray. 17

8.12.

on or about October 1, 1999, of her nursing license were calculated overt acts in furtherance of a

18

conspiracy to conceal on-going, parallel schemes of serial related clinical research frauds and

19

insurance frauds. The object was to shift blame for insurance and research fraud from Jay Grossman

20

to Joanne C. Wray. The object was to exert control over Joanne C. Wray and thereby conceal insurance and research fraud.

21 8.13. 22 23

Both Jay Grossman’s attack upon Joanne C. Wray’s nursing license and Charles W. Ott’s “defense”

Jay Grossman, Charles W. Ott, Gayle F. Petrillo, Eudice Grossman, and Timothy G. Wighton, agreed that Jay Grossman would assault Robert Davidson in the workplace on May 11, 1999.

8.14.

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

24 25

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

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

10

Grossman to sue Robert Davidson (and his wife Vanessa Komar) for alleged defamation after

1

Davidson reported the incident to the Tucson Police Department. Davidson was advised to make a

2

police report on May 11, 1999, by Gayle F. Petrillo (the “Vivra” Tucson Office Manager). Their

3

contingency plan called for Grossman to use his stock ownership and stock options in “Vivra” as a measure of alleged damages against the Davidson, should Grossman ultimately prevail in his

4

defamation suit. “Vivra” knew in advance of the assault and battery in the workplace on May 11, 5

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

6

purchase and sale” that took place between Vivra Specialty Partners of Arizona, P.C. (“VSP”) and 7

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

8

in the “Vivra” enterprise. Jay Grossman is known to have been involved in many lawsuits. See Albany 9 10

County Case #2960-91. See ¶ 6 above. 8.15.

These overt acts (assault and battery) by Jay Grossman represent a physical “attack [upon] the messenger” (Robert Davidson). These overt acts were intended to provoke and induce fear in Robert

11 12

Davidson. These acts succeeded in inducing fear in Robert Davidson. 8.16.

Jay Grossman, Charles W. Ott, Gayle F. Petrillo, Eudice Grossman, and Timothy G. Wighton, agreed that Jay Grossman would attack [file a complaint against Joanne C. Wray (formerly Siegel) with

13

Arizona state board of nursing] Joanne C. Wray’s nursing license. The object was to thereby economically cripple Ms Wray, and thereby increase her dependency upon “Vivra” for her

14

professional livelihood. The object was to conceal insurance and research fraud. The object was to 15 16

shift blame for insurance and research fraud from Jay Grossman to Joanne C. Wray. 8.17.

Jay Grossman, Charles W. Ott, Gayle F. Petrillo, Eudice Grossman, and Timothy G. Wighton, agreed that Charles W. Ott would bribe Joanne C. Wray, by providing her with “free” legal representation as

17 18 19 20 21

long as she remained an employee of “Vivra”. The object was to prevent Ms. Wray from seeking a legal remedy against Jay Grossman and “Vivra”. The object was also to prevent Ms Wray from “blowing the whistle” on Jay Grossman’s serial extortions, insurance frauds, and research frauds, at the “Vivra” Tucson, AZ, facility, from on or about April 22, 1997, to on or about May 12, 1999. Charles W. Ott, Jay Grossman, Eudice Grossman, Gayle F. Petrillo, Timothy G. Wighton, and others, knew that Joanne C. Wray, R.N., was Dr William H. Ziering’s former research nurse in Fresno, CA prior to becoming Jay Grossman’s research nurse in Tucson, AZ. Defendants to this lawsuit are

22 23

collaterally estopped from denying the criminal conviction, and prison sentence for clinical research fraud, specifically mail fraud and aiding and abetting, of William H. Ziering, M.D., on June 3, 2002. It was not coincidental that Joanne C. Wray, R.N. was Dr Ziering’s research nurse in

24 25

Fresno, CA, prior to her becoming Jay Grossman’s research nurse in Tucson, AZ. Charles W. Ott, Jay Grossman, Eudice Grossman, Gayle F. Petrillo, Timothy G. Wighton, and others, used their

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

11

knowledge of Dr Ziering’s criminal indictment, mail fraud and aiding and abetting conviction, to

1 2

control Joanne C. Wray, thereby concealing fraud and obstructing justice in Tucson, AZ. 8.18.

3

Charles W. Ott’s letter to Robert Davidson of May 28, 1999, is categorically false when it states, “Contrary to allegations in your May 17 letter to Joe Mello, you did not communicate any concerns to Vivra management until Pamela Gaard conducted the audit of the Practice. It is unfortunate that, if

4

you had concerns prior to such date, you did not bring them to our attention.” The letter of May 19, 5

1999, from Joseph C. Mello, President of Vivra Asthma & Allergy Inc, to Robert Davidson, M.D., represents an additional “lulling” inducement that was a product of the concerted acts and agreement

6

between Joseph C. Mello, Kent J. Thiry, and Charles W. Ott, willfully and maliciously directed at 7

Robert Davidson, M.D., to conceal on-going parallel, schemes of serial related clinical research frauds and insurance frauds in Tucson, AZ. Use of interstate mails or wire facilities to achieve the object of

8

their schemes to defraud was reasonably foreseeable and necessary. Intentional overt acts and 9

omissions were committed by Joseph C. Mello, Kent J. Thiry, and Charles W. Ott, in furtherance of

10

their agreement to conceal on-going, parallel, schemes of serial related clinical research frauds and insurance frauds in Tucson, AZ. They were motivated by personal and corporate financial gain. These

11

“lulling” inducements were willfully and wantonly directed at Robert M. Davidson, M.D. by Kent J.

12

Thiry, Joseph C. Mello, and Charles W. Ott, acting by agreement and in concert, to improperly lessen Plaintiffs’ apprehension and delay Plaintiffs’ seeking a legal remedy. By information and belief,

13

Charles W. Ott was the General Counsel of Vivra Inc and Vivra Asthma & Allergy Inc, from June 1997 through December 1999. By information and belief, Joseph C. Mello served as president and

14

chief executive officer of Vivra Asthma & Allergy Inc, from April 1998 until June 2000. In June 15

2000, he became Chief Operating Officer of Davita Inc. These officers had motive (personal and corporate financial gain), means, and opportunity to commit these frauds. These individuals had

16

access to information concerning Jay Grossman’s long history of malfeasance and these individuals 17 18 19 20 21

knew that Jay Grossman was engaged in wrongdoing. 8.19.

Robert Davidson affirms that he brought his concerns to the attention of “Vivra” management on at least three separate occasions prior to Ms. Gaard’s audit.

8.20.

Charles W. Ott, and others, perjured themselves by signing “NO” to the Certificate of Disclosure, question re: any >10% shareholder having been subject to sanctions by regulatory or federal body for fraud, misrepresentation within seven year period (see Arizona Corporations Commission Annual Report filings for 1999 and 2000, for Vivra Asthma Allergy Care America of Arizona, P.C.). Officers

22 23

of Gambro Healthcare Inc and DVA Renal Healthcare Inc, including Larry C. Buckelew, the current President of DVA Renal Healthcare Inc (formerly known as Gambro Healthcare Inc), perjured themselves by signing “NO” to the Certificate of Disclosure, question re: any >10% shareholder

24 25

having been subject to sanctions by regulatory or federal body for fraud or misrepresentation within seven year period (see Arizona Corporations Commission Annual Report filings for 1999-2006, for Gambro Healthcare Inc and DVA Renal Healthcare Inc). See Larry C. Buckelew’s signature on the

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

12

amended Corporate Integrity Agreement of March 27, 2002, between Gambro Healthcare Inc and the

1

Office of the Inspector General of the U.S. Department of Health and Human Services. See Judith A.

2

Waltz’s signature (counsel for Gambro Healthcare Inc) on the Corporate Integrity Agreement of

3

November 29, 2004, between Gambro Healthcare Inc and the Office of the Inspector General of the U.S. Department of Health and Human Services. See the U.S. District Court-Massachusetts (Boston)

4

Civil Docket filings for USA, et al v. Quest Diagnostics, et al, Case No. 97-CV-10400, filed on 5

02/21/97 under the False Claims Act and closed on 12/12/02. See the federal docket filings for U.S. District Court Eastern District of Missouri Case # 4:01-CV-00553-DDN captioned “Bander v.

6

Gambro Healthcare U.S., Inc”. These “lulling” inducements (Arizona Corporations Commission 7

Certificates of Disclosure and Corporate Integrity Agreements) by Gambro Healthcare Inc and DVA Renal Healthcare Inc, between 1999 and 2006, all made willful, wanton, and readily foreseeable and

8

necessary use of interstate mailings and wire facilities, to accomplish their fraudulent scheme to 9

conceal fraud. See the “Settlement Agreement and Release” in the case known to the Texas Attorney General’s Office as “Gambro Healthcare Inc” MF 052976-01-7, GBL 1204 040. Pages 3 to 7 of 20 of

10

the “Settlement Agreement and Release” detail the allegations of the State of Texas with respect to 11 12

conduct of Gambro Healthcare Inc in the forum state of Texas. 8.21.

Jay Grossman, Eudice Grossman, and Gayle Petrillo each agreed to perform overt acts that made willful, wanton, and readily foreseeable and necessary use of interstate mailings, to libel Robert

13

Davidson, M.D. [and Arnold Funckes, M.D.] on or about August 20, 1999, in Tucson, AZ when, according to an email from Eric Johansen on August 20, 1999, “Dr Grossman had sent letters to all

14

the drug companies and insurance companies that Vivra bills printing a grey picture of you [Robert 15

Davidson] and Dr Funckes. Trying to put the blame on you two and how you walked out of the office and left patients that were waiting to be seen…a copy of these letters were put in the regulatory

16

binders [at the Vivra Tucson facility of VAACAA].” The object of these defendants’ fraudulent 17

scheme (Jay Grossman’s, Eudice Grossman’s, and Gayle F. Petrillo’s fraudulent scheme) was to conceal fraud by blaming their problems on their staff.

18 19 20 21

8.22.

“Vivra” willfully directed frauds at the Plaintiffs in the inducement and retention of Robert Davidson’s employment with Vivra. See the Classified advertisement of July 15, 1998, from the Tucson Citizen, titled “Physician, Pharmaceutical Research”. See the “ZERO TOLERANCE POLICY” memorandum (addressed to All Vivra Employees) on “Vivra” Norcross, GA letterhead and both editions of the Vivra Employee’s Handbook for Vivra’s avowed policy regarding violence in

22 23

the workplace and Vivra’s averments as to legitimacy of its business operations. At the direction of Kent J. Thiry and Joseph C. Mello, acting by agreement and in concert, the October 1998 revision of the Employee Handbook was sent by both interstate mail and wire facilities to the employees,

24 25

including Robert M. Davidson, M.D., at the Vivra Tucson 698 E. Wetmore Road location, on or about November 19, 1998, at 1410 hours from fax # 954-723-1217. The mailings directed specifically at Robert M. Davidson, M.D. of the initial Employees Handbook (December 12, 1995 revision) and

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

13

Zero Tolerance Policy memorandum on or about September 1, 1998, and the mailings and fax

1

transmissions on or about November 19, 1998, of the October 1998 revision of the Employees

2

Handbook, that further detailed Vivra’s avowed aversion to violence in the workplace and further

3

detailed Vivra’s averments as to legitimacy of Vivra’s business operations, took place within 10 years of the commission of a prior act of racketeering activity (one of which occurred after October 15,

4

1970), and represent a pattern of racketeering activity (related and continuous activity) by Gambro 5

Healthcare Inc, Vivra Holdings Inc, Kent J. Thiry, and Joseph C. Mello, that was a direct cause of injury to Plaintiffs’ business and property. Both Kent J. Thiry and Joseph C. Mello knew that the

6

Zero Tolerance Policy was false. They both knew that Jay Grossman was violent. They both knew 7

that the averments as to legitimacy of Vivra’s business operations were false. They both knew that Jay Grossman was commiting clinical research fraud and insurance fraud at the Vivra Tucson, AZ

8

facility. These officers had motive (personal and corporate financial gain), means, and opportunity to 9

commit fraud. These individuals had access to information concerning Jay Grossman’s long history of malfeasance and these individuals knew that Jay Grossman was engaged in wrongdoing. By their

10

willful actions and omissions, Kent J. Thiry and Joseph C. Mello both sought to mislead Robert 11

Davidson, M.D. and Vanessa E. Komar, and thereby induce Plaintiffs’ decision for Robert Davidson,

12

M.D. to accept and continue employment with Vivra. Acting by agreement and in concert, they both used the mails or wire facilities to commit fraud. Plaintiffs relied on the misrepresentations. Plaintiffs

13

have shown injury to Plaintiffs’ business and property that was directly (“by reason of”) caused by the racketeering activities, i.e., the predicate acts. Plaintiffs have shown enterprise injury to their business

14

and property that was directly (“by reason of”) caused by the concerted acts of Kent J. Thiry and 15

Joseph C. Mello. At the time of these fraudulent hiring and retention inducements, Kent J. Thiry was chairman of the board and chief executive officer of Vivra Holdings Inc. Vivra Holdings Inc is

16

liable to Plaintiffs for the willful, wanton misconduct of its chairman of the board and chief 17

executive officer. These fraudulent hiring and retention inducements preceded the alleged “spin-off” on December 1, 1998, by Vivra Holding Inc of its asthma/allergy business to its shareholders in the

18

form of a stock dividend. The question of whether Vivra Holdings Inc actually did “spin off” its

19

asthma/allergy business on December 1, 1998, as was sworn to by Michael P. McQuillen, is therefore

20

moot relative to Plaintiffs’ allegation of injury to business and property by reason of the aforementioned fraudulent hiring and retention inducements.

21 8.23. 22 23

Jay Grossman serially upcoded all E&M claims and coded for unnecessary procedures on every specialty practice patient. Reimbursement claims for these upcoded office visits and unnecessary procedures were submitted or caused to be submitted to 3rd party payers, including Medicare, by “Vivra”, at the “Vivra” Tucson, AZ facility between April 22, 1997, and May 12, 1999, by willful,

24 25

wanton use of interstate mail and wire facilities to accomplish the fraudulent scheme, for personal and corporate financial gain. See ¶ 8.62 to this Amended Complaint.

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

14

1

8.24.

performed testified in Albany, NY, that the studies were performed properly and that there were no

2

protocol violations committed by Dr Grossman. See documents received from the Albany County

3 4

By information and belief, representatives from the drug companies for whom the studies were

Clerk from Albany County Case #2960-91. 8.25.

By information and belief, Jay Grossman is thought to have received payments from Big Pharma corporations for “consulting” between April 22, 1997, and May 12, 1999.

5

8.26.

Jay Grossman asserted to the FDA that he does not have to solicit corporate research sponsors…they come to him. Page 3 of FDA Albany, NY EIR of 1990, states, “[Jay Grossman] as President of the

6

corporation, is responsible for its overall operation. Dr Grossman indicated he does not attempt to 7

recruit drug manufacturers, since he is well known in the industry as a clinical researcher, and the manufacturers take the initiative to contact him.”

8 8.27. 9

Per telephone conversation between Robert Davidson and FDA [Carolanne Currier], “corporate pharma sponsors usually tell Contract Research Organizations which clinical investigators they may and may not use for the conduct of research studies.”

10 8.28.

Stock options and stock ownership in the “Vivra” enterprise are two of the methods employed by Jay

11

Grossman, Eudice Grossman, Kent J. Thiry, Joseph C. Mello, Vivra Holdings Inc, Vivra Specialty

12

Partners of Arizona P.C., Vivra Asthma Allergy Care America of Arizona, P.C., Gambro Healthcare Inc, DVA Renal Healthcare Inc, Gambro Inc, Davita Inc, and others, to acquire or maintain, directly

13

or indirectly, through a pattern of racketeering activity, an interest in or control of an enterprise [that is, “Vivra”] that is engaged in, or the activities of which affect, interstate commerce, in violation of 18

14

U.S.C.A. Section 1962 (b). See page 1 of the Physician Employment Agreement (the “Agreement”) 15

on April 22, 1997, between Jay Grossman, M.D. and Vivra Specialty Partners of Arizona, P.C., and that certain Stock Purchase and Sale Agreement (the “Purchase Agreement”). See paragraphs 4.1, 4.2,

16

6.3, and 6.4, of the “Agreement”. See SEC filings for Vivra Inc, especially those that detail the merger 17

on or about June 1997, between Gambro Healthcare Inc and Vivra Inc, and the Employee Stock Option Plans related to the merger.

18 19

8.29.

An unrelenting, pervasive pattern of intimidation and harassment of the clinical research staff by Jay Grossman under color of official right, engendered an atmosphere of “don’t ask, don’t tell” and

20

“psychic blindness” to certain objective clinical facts, including patient safety, out of fear of retribution, at the Vivra Tucson facility, between April 22, 1997, and May 12, 1999.

21 8.30. 22

According to the Tucson FDA EIR of 5/5-6/28/99, it states, “Included in the records provided by Andrea York was a handwritten letter dated 4/17/99, Exhibit 7.03-7.05 and signed by the majority of the staff describing their concerns about their work environment ranging from theft…prescreens done

23

by front office, patients with questionable qualifying criteria being randomized anyway.” 24 25

8.31.

Page 3, Paragraph 5 of the FDA Tucson EIR of 5/5-6/28/99 states, “He [former Vivra Tucson Supervisory Clinical Research Coordinator, Eric Johansen] has seen Dr JG argue with Dr RD regarding Dr RD informing patient (and documenting in the clinic notes) of the possible side effects

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

15

of a study. EJ stated that Dr JG has been heard to say that type of comment would scare patients

1 2

away. Dr JG would tell patients of the benefits of the study and downplay the risks.” 8.32.

3

Jay Grossman intentionally created an atmosphere of unquestioned obedience by the clinical research staff, inspired by fear, under color of official right. His intent was to further a plan or purpose to obtain property (inappropriate study subject enrollments) from Robert Davidson and the Vivra clinical

4

research study coordinators, with their consent, induced by Jay Grossman’s wrongful use of actual or 5 6

threatened force, violence, or fear, or under color of official right. 8.33.

Former “Vivra” Tucson, AZ clinical research coordinator, Linda Buer [formerly LeBlanc] was a victim of Jay Grossman’s Hobbs Act (extortion) violations at the “Vivra” Tucson, AZ facility.

7

8.34.

In an email of November 13, 2000, from Linda Buer to Robert Davidson, she states, “It was nice to hear from you. I’m sorry it is for this reason however. Sometimes bad pennies don’t want to go away.

8

I think it is terrible that Dr. Grossman just won’t owe up to his personal responsibility and ethical 9

conduct—but must continue to find scapegoats for his misconduct, my deepest empathies.” “I just remember feeling ethically compromised and not sleeping well there at the end of my employment.”

10 8.35.

In a letter to Robert Davidson on November 28, 2000 [as an email attachment], former Vivra Tucson,

11

AZ, clinical research study coordinator, Linda Buer [formerly Linda LeBlanc] wrote: “However, my

12

professional relationship with Dr Grossman during my employ contributed greatly to my decision to leave Vivra. Over a period of several months, I found my professional ethics concerning the health

13

and welfare of the study patient increasingly violated by Dr Grossman’s reversals in the approval of study patients’ entry into a particular trial.” “As coordinator, I only facilitate his [Jay Grossman’s]

14

decision by collecting the needed information. Dr Davidson, as a sub-investigator, also must defer to 15

the decisions of the Principal Investigator.” “Dr Grossman may say to the Sponsor that a patient’s asthma is stable, but he would neglect to tell the Sponsor that the patient had had a number of

16

prednisone bursts during the previous year.” “Dr Grossman routinely pushed the envelope of 17

acceptable criteria for entry into a study.” “I found Dr Grossman to be more concerned with patient accrual and subsequent paid patient visits than with the highest and best for the patient. The health

18

interests of the patient were secondary to Dr Grossman. Dr Grossman continually berated Dr

19

Davidson and myself for making any decisions concerning the entry or early withdrawal of a study

20

patient from a study no matter how appropriate the basis of our decision. Dr Grossman would verbally “assault” us within earshot of others. Dr Grossman would continually tell us that only he

21

had the ability to admit a patient or not.” 22

8.36.

In an email on or about October 1, 1999, from Joanne C. Wray to Robert Davidson, she states, “Jay [Grossman] managed to fuck me over…he filed a complaint against my nursing license: exceeding

23

the scope of my nursing practice. Now I have to mount a defense. I have the Vivra attorneys working 24 25

on my behalf, but it still sucks.” 8.37.

In an email of April 22, 2000, from Joanne C. Wray to Robert Davidson, she states, “I am packed to move, have lost my job, am facing a move to a place I don’t want to be [Fresno]. Forgive me for

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

16

being self-absorbed.” “I have no interest in pursing litigation against Jay [Grossman]. I want this

1

mess to go away. One month ago, my attorney was using words like “criminal…obstruction of

2

justice…” I want to go on with my life, not continue to wallow in Jay’s “fleas”…”. “You may win a

3 4

fight with a skunk, but you still smell.” 8.38.

In an email of October 11, 2000, from Joanne C. Wray to Robert Davidson, she states, “Yes, Jay is continuing to haunt me. The complaint he lodged against my AZ license is still pending.”

5

8.39.

In an email of December 12, 2000, from Joanne C. Wray to Robert Davidson, she states, “Jay is actually taking you to trial? I’d be happy to depose in your favor. Just tell what I have to do.”

6 8.40. 7

In an email of January 18, 2003, from Joanne C. Wray to Robert Davidson, she states, “I am sorry to inform you, but after further consideration, and after discussion with the man who is important in my life, I am rescinding my agreement to participate as co-plaintiff in your suit against Grossman.” “My

8

stint at Vivra is just a memory now. Whatever atrocities Grossman may or may not have committed 9

involves me only in the periphery, and having said that, I don’t wish to waken a sleeping giant (Grossman) against me. Grossman has money, time and influence. I have neither.” “I wish you well in

10

this suit, but do not want to participate in what appears to me to be a vendetta.” 11

8.41.

“Vivra” enterprise between on or about April 22, 1997, and on or about October 1, 1999.

12 8.42. 13 14

By information and belief, Jay Grossman and Charles W. Ott regularly traveled interstate in aid of the

Paragraph 1, Page 5 of FDA Exhibit 1.05 states, “After checking my calendar for 1998, I confirmed that I was at the Vivra site in Tucson for approximately 214 days of that year.”

8.43.

Paragraph 4, Page 3 of FDA Exhibit 1.03 states “in addition to my work at the research site, I have worked with several drug companies in the development of research protocols, and as a consultant.”

15

Please also reference the Monthly Operations Meeting Agenda of January 15, 1999, at the “Vivra” Tucson facility.

16 8.44. 17

interstate wire facilities, in interstate commerce, between on or about April 22, 1997, and on or about October 1, 1999, was with intent to aid the “Vivra” enterprise, and they thereby serially performed or

18

attempted to perform related related predicate acts proscribed by 18 U.S.C.A. Section 1952,

19

Subsection (a)(3), in a pattern of racketeering activity, with open-ended continuity, for personal and

20 21

Jay Grossman’s and Charles W. Ott’s frequent interstate travel, and frequent use of interstate mail and

corporate financial gain. 8.45.

During an on-going FDA inspection of Jay Grossman’s regulated conduct in Albany, NY, Jay Grossman took all of the Case Report Forms for a study plus the study binder and some copies of the

22

patient files when he abruptly moved from Albany, NY to Tucson, AZ (reference page 3 of Albany, NY FDA EIR of 1993). This relocation is thought to have occurred in either 1992 or 1993.

23 8.46. 24 25

Carolanne Currier of the FDA, gave permission to omit coverage required by the Compliance Program 7348.811 and was told to check only the 7 Case Report Forms received as supporting documents to the assignment (reference page 4 of Albany, NY FDA EIR of 1993).

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

17

1

8.47.

Jay Grossman serially and intentionally (and/or recklessly) endangered clinical research subject MHJ [DOB 5-23-53] by not informing her of her abnormal EKG’s, motivated by personal financial gain.

2

This subject’s prior EKG of 5/30/98 shows the computer-generated “T ABNORMALITY IN

3

INFERIOR LEADS” to have been crossed-out by Jay Grossman and WNL (within normal limits) written and initialed by Jay Grossman on 5-30-98. Jay Grossman had actual knowledge that this

4

subject’s EKG’s were abnormal. Jay Grossman had actual knowledge that this subject’s EKG’s were 5

NOT within normal limits when he crossed-out the computer-generated interpretation, wrote “WNL”, and initialed the EKG, on May 30, 1998, in Tucson, AZ, motivated by personal financial gain. Jay

6

Grossman knew that MHJ had multiple risk factors for coronary artery disease, including 7

hypertension, hyperlipidemia, and positive family history of myocardial infarction. His intent was to qualify MHJ for study participation, despite EKG abnormality (T-wave inversion in the inferior

8

leads), and without informing MHJ of her EKG abnormality. 9

8.48.

Jay Grossman continued to screen MHJ at several subsequent visits even after this subject’s EKG abnormalities (both present and prior EKG’s) were brought to Jay Grossman’s attention and despite

10

safety concerns having been expressed to Jay Grossman by Robert Davidson. Jay Grossman knew that 11

MHJ had multiple risk factors for coronary artery disease, including hypertension, hyperlipidemia,

12

and positive family history of myocardial infarction. Jay Grossman willfully, wantonly, and repeatedly endangered MHJ for personal financial gain. Jay Grossman’s motive, method, and victim

13

for these frauds were similar, in fact, they were identical. Jay Grossman had motive (personal financial gain), means, and opportunity to commit these frauds.

14 8.49. 15

Jay Grossman employed this scheme or artifice to defraud to enroll MHJ in the Glaxo-Wellcome FLTA 4039 study on or about 2-10-99, and again when Jay Grossman enrolled her in the Pfizer 264101 study on or about 3-26-99 at the “Vivra” 698 E. Wetmore Road, Suite 100, Tucson, AZ facility.

16

Thus, Jay Grossman’s motive, methods, and type of victim were similar [in fact, they were identical] 17

for these two frauds. MHJ was a so-called “study buddy” of Jay Grossman’s. A “study buddy” is typically a former specialty practice patient who is enrolled serially by Jay Grossman in one clinical

18

research study after another. Between studies they became specialty practice patients again. Cross-

19 20 21

over was commonplace. 8.50.

It was routine, customary, necessary, and entirely foreseeable, that EKG data, such as that obtained on 5-30-98 and on 3-15-99 would be placed, or caused to be placed, directly or indirectly, into the U.S. mail and interstate wire communications, by Jay Grossman, to corporate pharmaceutical sponsors, in

22 23

support of New Drug Applications. The EKG of 3-15-99 for MHJ was transmitted on or about 3-1599 by Jay Grossman or caused to be transmitted by Jay Grossman either by interstate mail or wire facility to the corporate sponsor (Pfizer) in behalf of a New Drug Application to the FDA. See the

24 25

Affidavit and Exhibits attached to this Amended Complaint. Included in these exhibits are copies of the EKG data obtained on 5-30-98 and 3-15-99 for MHJ. Also included in these exhibits is the EKG of study subject CKC from study visit #1 in the Novartis E25 research study at the “Vivra” Tucson

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

18

facility. The computer-generated “ST & T ABNORMALITY, CONSIDER INFEROLATERAL

1

ISCHEMIA OR LEFT VENTRICULAR STRAIN” was crossed-out by Jay Grossman and WNL

2

(within normal limits) written and initialed by Jay Grossman on 12-18-98. He knew the EKG was not

3

WNL. To a virtual certainty, this EKG was also transmitted or caused to be transmitted on or about 12-18-98 by Jay Grossman either by interstate mail or wire facility to the corporate sponsor in behalf

4

of a New Drug Application to the FDA. Page 2, paragraph 20, of the Tucson FDA-483 report of 5/55

6/28/99, states “Subject [JML redacted] in [Forest Labs 01 redacted] study had a ECG which was listed as normal while the ECG strip listed, “Leftward Axis QRS(T) CONTOUR ABNORMALITY

6

CONSISTENT WITH ANTEROSEPTAL INFARCT”. PI signed “WNL”. Jay Grossman knew the 7

EKG was not WNL. To a virtual certainty, this EKG was also transmitted or caused to be transmitted by Jay Grossman either by interstate mail or wire facility to the corporate sponsor in behalf of a New

8

Drug Application to the FDA. Jay Grossman had motive (personal financial gain), means, and 9 10

opportunity to commit these frauds. 8.51.

Jay Grossman, Eudice Grossman, Gayle Petrillo, and others, acting in concert and by agreement to commit or cause to be committed serial overt acts of fraud that willfully and wantonly made routine,

11

necessary, and readily foreseeable use of the United States mail or interstate wire facilities or caused

12

use of the United States mail or interstate wire facilities in furtherance of a scheme or artifice to defraud, and Jay Grossman, Eudice Grossman, and Gayle F. Petrillo, did so with the specific intent to

13 14

deceive or defraud, for personal and corporate financial gain. The scheme or artifice to defraud involved submitting or causing to be submitted fraudulently upcoded reimbursement claims and fraudulent reimbursement claims for medically-unnecessary PFTs (pulmonary function tests) to

15

Medicare and other commercial 3rd party payers, from the “Vivra” Tucson, AZ facility, between on or

16

about April 22, 1997, and on or about October 1, 1999, for every specialty practice seen at the “Vivra” Tucson, AZ facility. Particularity in the allegation of these frauds is found at ¶ 8.62 below, and

17 18 19 20 21

incorporated here by reference. The scheme or artifice to defraud specifically involved submitting or causing to be submitted falsified clinical research data (Case Report Forms and clinical source documents) in support of New Drug Applications, to the FDA and to clinical research sponsors, from Albany, NY and from the “Vivra” Tucson, AZ facility, between on or about April 22, 1997, and on or about May 12, 1999. Particularity in the allegation of these frauds is found at ¶ 8.47-8.50 and ¶ 8.538.61, and incorporated here by reference. Jay Grossman, Eudice Grossman, and Gayle Petrillo, had motive (personal and corporate financial gain), means, and opportunity to commit these frauds. The

22 23

scheme or artifice to defraud involved “study buddies”. A “study buddy” is typically a former specialty practice patient who is enrolled serially by Jay Grossman [or Thomas B. Edwards] in one clinical research study after another. Between studies they became specialty practice patients again.

24

Cross-over was commonplace. Plaintiffs incorporate here by reference ¶s 8.30, 8.68, and 8.69.

25

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

19

1

8.52.

the U.S. mails and interstate wire communications for the purpose of the alleged crimes, at the

2 3

Jay Grossman and others, acting in concert, knowingly and willfully made use of or caused the use of

“Vivra” Tucson, AZ facility, between on or about April 22, 1997, and on or about October 1, 1999. 8.53.

Jay Grossman serially and intentionally (and/or recklessly) endangered clinical research subject MMD [DOB 1-8-44] by enrolling her in multiple research studies despite this subject having history of

4

multiple prior abnormal EKG’s loud heart murmur, history of RBBB (right bundle branch block) and 5 6

rheumatic fever. 8.54.

Study subject MMD was enrolled by Jay Grossman in the Forest Labs 01 study for personal financial gain, despite this study subject having a very clear study exclusion criterion, history of rheumatic

7

fever. MMD was again enrolled by Jay Grossman in the Novartis E25 asthma study on 10/6/98, for personal financial gain.

8 8.55. 9

out and Jay Grossman’s assertion on 11/25/98 that subject now states that she did have rheumatic fever as a child.

10 8.56. 11 12

Subject MMD’s medical history questionnaire shows subject history of rheumatic fever to be crossed-

Subject MMD was intentionally (and/or recklessly) endangered by Jay Grossman, motivated by personal financial gain.

8.57.

Jay Grossman had [apparently] crossed-out this subject’s history of rheumatic fever, realizing that rheumatic fever was an exclusion criteria for nearly all asthma studies.

13

8.58.

Jay Grossman did not make the written assertion that “subject now states that she did have rheumatic fever as a child” until after Jay Grossman had learned that Robert Davidson had become aware of this

14

research subject’s loud heart murmur, abnormal EKG’s, and her history of rheumatic fever. 15

8.59.

Subject MMD was improperly enrolled by Jay Grossman into the Novartis E25 asthma study on 10/6/98. Not only did this subject have history of rheumatic fever (a clear study exclusion for nearly

16

any asthma study), but she also had a history of pulmonary embolism (another clear study exclusion 17

for nearly any asthma study). Thus, Jay Grossman’s motive, methods, and type of victim were similar [in fact, they were identical] for these two frauds. This study subject (MMD) was thus serially

18

intentionally (and/or recklessly) endangered by Jay Grossman, for personal financial gain. MMD was

19

a so-called “study buddy” of Jay Grossman’s. Jay Grossman had motive (personal financial gain),

20 21

means, and opportunity to commit these frauds. 8.60.

Jay Grossman enrolled subject SML [DOB 5-7-44] into the Hoechst Marion Roussel 3647A/3005 acute sinusitis study despite subject having a clear study exclusion (maintenance inhaled

22 23

corticosteroid therapy). Subject SML subsequently experienced a Serious Adverse Event: hospitalization, while in study. Moreover, this subject had recently participated in a prior asthma study [Zeneca 088] during which she required multiple prednisone bursts and multiple courses of

24 25

antibiotic therapy for several bouts of acute sinusitis with asthma exacerbation. This clinical research subject was, thus, intentionally (and/or recklessly) endangered by Jay Grossman, motivated by personal financial gain. Subject SML was another so-called “study buddy” of Jay Grossman’s.

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

20

1

8.61.

Study Coordinator Laura Hulse stated that subject BJD [redacted] called to say she could not participate in a 12-hour a day study due to her schedule. Jay Grossman called the subject’s estranged

2

husband to say that they had to get the disease under control. Coordinator says Jay Grossman then

3

called subject BJD [redacted] who agreed to complete the screening visit. Jay Grosman’s intent was not to “get the disease under control” as Jay Grossman indicated to her estranged husband. Jay

4

Grossman’s intent was to enroll clinical study subject BJD in a clinical research study for Jay 5 6

Grossman’s personal financial gain. 8.62.

In an email from Joanne C. Wray, R.N. to Robert Davidson on December 15, 2000, she states, “As for the upcoding, it’s a fact for anyone to see. All office visits were billed exactly the same, without

7

exception.” “As for unnecessary procedures…did I think that every person needed a PFT [pulmonary function test] every visit? No.” The upcoding and unnecessary procedures admitted to by Defendant

8

Joanne C. Wray is related and posed a definite threat of repetition (open-ended continuity). 9

8.63.

There is striking similarity between the allegations of violence, unethical, and probably illegal conduct in the Affidavit filed by Richard Ball, M.D. in Albany County Case # 2960-91 on December 6, 1994,

10

and the allegations of violence, unethical, and probably illegal conduct found in the letter from Robert 11

Davidson to Dr Antoine El Hage of FDA on April 14, 1999, and the Affidavit filed by Robert

12

Davidson with FDA investigator, Armando Chavez, on May 21, 1999. 8.64.

13

There is a recurring pattern of expedited marketing approvals of New Drug Applications by the FDA while both routine and “for cause” investigations of clinical research establishments are often selectively “delayed” [intentionally “stone-walled”] under the auspices of the PDUFA I, II, III, and

14

IV. 15

8.65.

Numerous expedited marketing approvals by FDA, often based upon seriously flawed clinical research, have occurred from 1992 (upon initial enactment by Congress of the PDUFA) until the

16

present and have a very real threat of continuing into the future under the PDUFA IV. Millions of 17

U.S. citizens have been and continue to be intentionally endangered under color of the PDUFA. There have been many hospitalizations and deaths. The PDUFA is repugnant to the U.S. Constitution,

18

violative of Fifth Amendment Due Process and Equal Protection. Obstruction of justice under color of

19

the PDUFA by Federal Action, has been alleged in the case at bar. Direct injury to Plaintiffs’

20

business and property by reason of obstruction of justice under color of the PDUFA, has been alleged in the case at bar. A recurring pattern of misconduct [obstructions of justice, fraudulent

21

concealment, fraudulent misrepresentation (acts and omissions), Hobbs Act extortion, Travel Act 22

violations, intentional endangerments, and deaths] under color of the PDUFA to gain expedited review and marketing approvals of New Drug Applications, and personal and corporate financial gain

23

for the enterprise, has been alleged in the case at bar. 24 25

8.66.

These “expedited” marketing approvals of New Drug Applications, intentional endangerments, hospitalizations, and deaths, while both routine and “for cause” investigations of potential clinical research misconduct are often “delayed” [intentionally “stone-walled”] represent a pattern of serial

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

21

corporate bribery of FDA officials acting in their personal capacity in violation of 18 U.S.C.A.

1 2

Section 201. 8.67.

3

This pattern of serial corporate bribery of FDA officials (acting in their personal capacities) by corporate pharmaceutical research sponsors, and intentionally delayed “for cause” FDA inspections [the FDA Tucson, AZ EIR of 5/5-6/28/99 (Jay Grossman, M.D.) and the FDA Albany, NY EIR of

4

10/22-12/23/97 (Thomas B. Edwards, M.D.)], under color of the PDUFA, caused direct (“by reason 5

of”) predicate act injury, enterprise injury, and conspiracy injury to Plaintiffs’ business and property, and arises out of the pattern of racketeering activity. By information and belief, “expedited” marketing

6

approvals for New Drug Applications, based in part upon seriously-flawed (fraudulent) clinical 7

research, were granted by the FDA during the “delay” of these “for cause” FDA inspections, under color of the PDUFA. See the NDA # 20-837 for Xopenex Inhalation Solution, that gained FDA

8

approval on 3/25/99 (review was posted on 6/20/01). 9

8.68.

Paragraph 4, Page 3 of Tucson FDA EIR of 5/5-6/28/99 states: “All three affiants stated that they have seen [Jay Grossman] postdate records.”

10 8.69.

Paragraph 5, Page 3 of Tucson FDA EIR of 5/5-6/28/99 states: “EJ [Eric Johansen, Vivra Tucson

11

supervisory clinical research coordinator] stated that Dr JG [Jay Grossman] asked him to bring all

12

Case Report Forms and records for this study into his office and recreated past medical histories into the clinic notes from information taken from source document medical questionnaires. EJ stated he

13 14

has seen Dr JG tear up clinic notes and redo them because of the information on them.” 8.70.

By information and belief, SEC filings of Vivra Inc (then the successor in interest to Vivra Specialty Partners Inc), Gambro Inc (then the successor in interest to Gambro Healthcare Inc), and Davita Inc

15

(now the successor in interest to Gambro Healthcare Inc), describe employee stock option plans for specialty practice physicians. By information and belief, Jay Grossman is alleged to have been a

16

recipient of stock and stock options from “Vivra”. By information and belief, Kent J. Thiry and 17 18 19

Joseph C. Mello are recipients of stock and stock options from “Vivra”. 8.71.

the Monthly Operations Meeting at the Vivra Tucson facility on January 15, 1999. 8.72.

20

Jay Grossman’s Physician Employment Agreement (the “Agreement”) strictly reserved the setting of fees, billings, and collections to Vivra Specialty Partners of Arizona, P.C. See page 17, at ¶ 11.4 and ¶ 11.5 of the “Agreement”.

21 8.73. 22 23

The bonus compensation for Vivra specialty practice physicians is referred to in an Agenda item for

A longstanding, ongoing conspiracy to conceal fraud exists from which Plaintiffs have suffered injury to Plaintiffs’ business and property prior to May 23, 2006.

8.74.

Plaintiffs continue to suffer ongoing injury to Plaintiffs’ business and property by reason of this ongoing conspiracy to conceal fraud.

24 25

8.75.

The conspiracy to conceal fraud, the “Vivra” association-in-fact enterprise, the pattern of racketeering activity, and the predicate acts, are still ongoing to the present day, and Plaintiffs continue to suffer direct injury to Plaintiffs’ business and property by reason of the conspiracy, the racketeering

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

22

enterprise, the pattern of racketeering activity, the substantive RICO statute violations, and the

1 2 3

predicate acts. 8.76.

Defendants took, and continue to take, affirmative steps to conceal the existence of the conspiracy.

8.77.

Plaintiffs did not know of the existence of the conspiracy and could not have discovered it by the exercise of due diligence.

4 8.78. 5

Without the predicate act violations, in a pattern of racketeering activity, and overt acts of conspiracy found in the FDA Tucson, AZ EIR [Establishment Inspection Report] of 5/5-6/28/99, a substantially delayed and heavily redacted copy of which was finally obtained by Robert Davidson on or about

6

February 20, 2001, by means of an FOI request, Robert Davidson did not know that a RICO violation 7 8

had occurred. 8.79.

Page 13, Paragraph 11, of the FDA Tucson, AZ EIR of 5/5-6/28/99 documents an agreement to obstruct justice, overt acts of conspiracy to obstruct justice, and provides the mens rea for obstruction

9 10

of justice, attempt to obstruct justice, and conspiracy to obstruct justice. 8.80.

Because Defendants took affirmative steps to conceal the existence of the conspiracy, Robert Davidson did not then [prior to February 20, 2001] know of the existence of the conspiracy much less

11

know the identity of the co-conspirators or the extent of the conspiracy. Plaintiffs allege direct injury

12

to their business and property by reason of obstruction of justice under color of the PDUFA in the case at bar. See paragraphs 8.64 - 8.67 and paragraphs 8.81 - 8.89, to this Amended Complaint.

13

8.81.

Robert Davidson did not obtain heavily redacted copies of the FDA Albany, NY EIR of 4/29-5/2 & 8/96 (Thomas B. Edwards, M.D.) and FDA Albany, NY EIR of 10/22-12/23/97 (Thomas B. Edwards,

14

M.D.) until on or about November 13, 2003, despite having originally requested these reports through 15 16

FOI on or about 12/20/2000. 8.82.

Paragraph 2, Page 1 of the FDA Tucson, AZ EIR of 5/5-6/28/99 states “This inspection report was delayed due to a PDUFA report.” This delay was willful and directly targeted at the Plaintiffs. See ¶

17

8.84 to this Amended Complaint. As applied to the Plaintiffs, the PDUFA is repugnant to the U.S. Constitution under the Equal Protection clause of the Fifth Amendment.

18 19

8.83.

studies inspected by the FDA at the “Vivra” Tucson, AZ facility in 1999, was a very substantial cause

20 21

The PDUFA [Prescription Drug User Fee Act] status of at least one of the index clinical research

of injury to Plaintiffs. 8.84.

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

22 23

“delay” was intentional and directly targeted at the Plaintiffs. This “delay” inured greatly to the benefit of Defendants, Big Pharma corporations [including Sepracor Inc], the “Vivra” enterprise, and the FDA [employees acting in their official capacity], while inuring greatly to the detriment of

24 25

Plaintiffs. 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

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

23

support of the NDA # 20-837 for Xopenex Inhalation Solution, that gained FDA approval on

1 2

3/25/99 (review was posted on 6/20/01). See paragraphs 8.94 - 8.104 to this Amended Complaint. 8.85.

3

“Expedited” market approvals of New Drug Applications by the FDA took place during this “delay” and during the pendency of the ostensibly ongoing criminal investigation of Jay Grossman’s conduct by the Criminal Division of the FDA. See the NDA # 20-837 for Xopenex Inhalation Solution, that

4

gained FDA approval on 3/25/99 (review was posted on 6/20/01). This FDA approval was based in 5

part upon fraudulent (seriously flawed) clinical research by Thomas B. Edwards in Albany, NY at Albany Medical College.

6 8.86. 7

while both routine and “for cause” investigations of clinical research establishments are selectively “delayed” [intentionally “stone-walled”] under color of PDUFA I, II, III, and soon the PDUFA IV.

8 8.87. 9 10

There is a recurring pattern of expedited market “approvals” of New Drug Applications by the FDA,

The Principal Investigator [Jay Grossman] was terminated for cause on July 30, 1999, by Vivra Inc, yet the FDA report on 7/10/2000 states, “Review of the records found no deviations…”

8.88.

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-

11

Approval Study-Oriented Clinical Investigator Data Validation Inspection assigned by HFD-46 to

12

audit…under CP 7348.811. Review of the records found no deviations and no FD-483 was issued.” 8.89.

13

The FDA Tucson AZ EIRs of 5/5-6/28/99 and 7/6-10/2000 made no findings that in any way deterred Big Pharma corporations (including Sepracor Inc) from proceeding under the PDUFA II [now under the PDUFA III] to gain expedited FDA “review” and market approval of their products. See

14

paragraphs 8.94 - 8.104 to this Amended Complaint. 15

8.90.

According to the U.S. Department of Justice, on December 2, 2004, “Gambro Healthcare will pay more than $350 million in criminal fines and civil penalties to settle allegations of healthcare fraud in

16

the Medicare, Medicaid and TRICARE programs…” “Gambro Healthcare will also pay in excess of 17

$310 million to resolve civil liabilities stemming from alleged kickbacks paid to physicians, false statements made to procure payment for unnecessary tests and services, and payments made to

18

Gambro Supply.” “The settlement also requires Gambro to allocate an additional $15 million to

19

resolve potential liability for the conduct resolved under the federal agreement pursuant to a

20

preliminary understanding reached with representatives of various state Medicaid programs.” [boldface, italics, and underline are added for emphasis].

21 8.91. 22 23

According to the Texas Attorney General’s Office, on or about September 22, 2005, “Texas Attorney General Greg Abbott [today] announced the recovery of $1.86 million for the Texas Medicaid program following a multi-state investigation of Gambro Healthcare Inc and its subsidiary, Gambro Supply Corp.” “The total recovery [$1.86 million for the Texas Medicaid program] reflects the

24 25

amount defrauded from the program, which comprises the state’s partnership with the federal government for managing this program.” “The states were wrongly billed for these medically unnecessary tests. The total nationwide restitution to Medicaid, with penalties and interest, is $37.5

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

24

million and relates to similar schemes to defraud 40 other states from January 1991 through

1 2

September 2004.” [boldface, italics, and underline are added for emphasis]. 8.92.

3

Defendants to this lawsuit are collaterally estopped from denying the allegations of the State of Texas with respect to the conduct of Gambro Healthcare Inc in the forum state of Texas, found at pages 3 to 7 of 20 of the “Settlement Agreement and Release” signed by Barry R. McBee, First Assistant

4

Attorney General for the State of Texas, and by Scott T. Larson, Senior Vice President and General 5

Counsel for Gambro Healthcare Inc, on August 12, 2005. These allegations include the State of Texas’s allegations that (a) Gambro Healthcare Inc, from January 1, 1991 to December 1, 2004,

6

submitted, or caused to be submitted, false claims to its [the State of Texas’s] Medicaid program, 7

seeking reimbursement for certain medications and tests that lacked medical necessity and/or lacked the documentation to support medical necessity; (b) Gambro Healthcare Inc knowingly and willfully

8

offered to pay and/or paid to physicians illegal remuneration intended to induce physicians to refer 9

their patients to dialysis clinics owned and/or operated by Gambro Healthcare Inc, in violation of the Anti-Kickback Statute, 42 U.S.C. Section 1320a-7b(b), and applicable State anti-kickback statutes

10

and/or regulations, if any, (c ) Gambro Healthcare Inc submitted false claims to the State’s Medicaid 11

program for reimbursement, because Gambro Healthcare Inc certified on cost reports submitted to

12

Medicare fiscal intermediaries that services identified or summarized in each cost report were not provided or procured through the payment directly or indirectly of a kickback or billed in violation of

13

law, and that Gambro Healthcare Inc submitted such claims for reimbursement to the State’s Medicaid program despite and notwithstanding Gambro Healthcare Inc’s knowledge that the claims

14

were false, (d) Gambro Healthcare Inc knowingly and willfully offered to pay and/or paid to its Joint 15

Ventures in the form of distributions of income from the Joint Ventures, reduction or elimination of losses incurred by the Joint Ventures, and the accumulation of equity interest in the Joint Ventures, (e)

16

the illegal remuneration paid by Gambro Healthcare Inc was intended to induce the Joint Venture 17

Partners to refer their ESRD patients to dialysis clinics owned by the Joint Ventures in which Gambro Healthcare Inc had a significant financial interest, and (f) Gambro Healthcare Inc submitted such

18

claims for reimbursement to the State’s Medicaid program despite and notwithstanding Gambro

19

Healthcare Inc’s knowledge that the claims were false because the Joint Ventures forfeited their right

20

to bill the State’s Medicaid program for such services by paying remuneration intended to induce referrals in violation of the Anti-Kickback Statute, 42 U.S.C. Section 1320a-7b(b), and applicable

21

State anti-kickback statutes and/or regulations, if any, and the Joint Ventures were required to and did 22

certify on cost reports submitted to Medicare fiscal intermediaries that services identified or summarized in each of the cost reports were not provided or procured through the payment directly or

23

indirectly of a kickback or billed in violation of law. 24 25

8.93.

Davita Inc, Vivra Holdings Inc, Gambro Healthcare Inc, and DVA Renal Healthcare, have recklessly tolerated, commanded, and ratified, the willful misconduct of Jay Grossman, Kent J. Thiry, Joseph C. Mello, Charles W. Ott, and others acting in concert, in the hiring, retention, and “lulling”

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

25

inducements, willfully and wantonly directed at Plaintiffs and employed the U.S. mail and wire

1

facilities to accomplish these frauds, whose object was to conceal serial clinical research frauds and

2

insurance frauds at the “Vivra” Tucson, AZ facility between on or about April 22, 1997, and on or

3 4

about October 1, 1999. 8.94.

Albany Medical College, Anthony P. Tartaglia, M.D., who was then the Dean of Albany Medical College, Sepracor Inc, and others to be determined at trial, agreed with each other to commit

5

intentional acts and omissions to conceal the clinical research fraud and violence of Jay Grossman, M.D., and Thomas B. Edwards, M.D., so as to provide both personal and financial gain for the

6

enterprise. 7

8.95.

Albany Medical College recklessly tolerated, commanded, and ratified, the willful misconduct of Anthony P. Tartaglia, M.D., Jay Grossman, M.D., Thomas B. Edwards, M.D., and others, so as to

8

conceal clinical research fraud, insurance fraud, and violence of Jay Grossman, M.D., and Thomas B. 9

Edwards, M.D., at Albany Medical College, so as to provide both personal and corporate financial gain for the enterprise.

10 8.96.

Albany Medical College, Anthony P. Tartaglia, Sepracor Inc, and others, agreed with each other to

11

commit two or more overt acts and omissions to facilitate the relocation of Jay Grossman, M.D. from

12

Albany, NY to Tucson, AZ in the early 1990’s, and to facilitate the relocation of Thomas B. Edwards, M.D. from Albany, NY to Pittsfield, MA in the late 1990’s, in order to obstruct justice, conceal

13

clinical research fraud and violence of Jay Grossman, M.D., and Thomas B. Edwards, M.D., and provide ongoing personal and corporate financial gain for the enterprise.

14 8.97. 15

Thomas B. Edwards, M.D., Albany Medical College, Anthony P. Tartaglia, and Sepracor Inc, are collaterally estopped from denying the specific allegations of clinical research fraud found on Page 1, Paragraph 2, of the Agreement with Respect to Use of Investigational New Drugs, signed by Thomas

16

B. Edwards, M.D. on January 22, 1998. This research fraud included allegation of failure to 17

“personally conduct or supervise the clinical investigation”, use of falsified “chest x-ray radiology reports, which were used to qualify subjects” and falsified “EKG tracings” in Albany, NY, between

18

October 22 and December 23, 1997, for research that was conducted by Dr. Thomas B. Edwards. Dr

19

Edwards did not contest the above allegations. The falsified “EKG tracings” in Albany NY, between

20

October 22 and December 23, 1997, for research that was conducted by Dr Thomas B. Edwards, is related (same motive, similar method, and similar victims) to the use of falsified EKG tracings in

21

Tucson, AZ for research that was conducted by Dr Jay Grossman, and posed a very real threat of 22

repetition (open-ended continuity). A “study buddy” is typically a former specialty practice patient who is enrolled serially by Jay Grossman [or Thomas B. Edwards] in one clinical research study

23

after another. Between studies they became specialty practice patients again. Cross-over was 24 25

commonplace. See ¶ 8.44-8.51. 8.98.

By information and belief, Thomas B. Edwards and Jay Grossman are both thought to have been involved in clinical research studies in support of NDA # 20-837, levoalbuterol HCl inhalational

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

26

solution, that gained FDA approval on 3/25/99 (review was posted on 6/20/01). They are also thought

1

to have been involved in clinical research studies in support of Supplemental New Drug Applications

2 3

for levoalbuterol HCl inhalational solution on behalf of Sepracor Inc. 8.99.

FOI Services, Inc on 11/13/2003 (despite being originally requested on 12/20/2000), provided Plaintiffs with the FDA “Endorsement” of January 22, 1998, FDA Establishment Inspection Report,

4

and FDA 483 Report, for the FDA inspection of 10/22-12/23/97, Thomas B. Edwards, M.D. at 215 5

Washington Avenue Extension, Albany, NY states, in part, “This was a clinical investigator/data audit inspection assigned by CDER as a high priority user fee bimo assignment (T3 98-36). The EI

6

was performed in accordance with CP 7348.811. The assignment requested coverage of Dr. [Thomas 7

B.] Edwards relative to his conduct of a Sepracor (sponsor) study for NDA 20837, test article Levalbuterol HC Inhalation solution. The EI revealed evidence of fraud, after which DSI requested

8

the EI be expanded to include additional studies, and provided a DSI Medical Officer to assist. 7 9

studies were covered.” “Coverage of the Sepracor study found source documents had been fabricated

10

and/or altered in order to qualify patients who would otherwise have been excluded from the study. 2 original subject records which reported the administration of Biaxin, an exclusion criteria, had been

11

removed from a clinic file, and a different clinical record which did not show the biaxin usage, had

12

been substituted; for four study subjects, the chest x-ray radiology reports used to qualify them for the study, were not supported by x-ray films; chest x-ray radiology reports used to qualify three other

13

patients had date alterations which were not supported by x-ray films; EKG tracings for 8 of the 23 study subjects had unauthorized alterations; and test article accountability appears to have been

14

manipulated. Deficiencies regarding EKG records and test article accountability were also found for 15

two other studies.” By information and belief, 215 Washington Ave Extension is the physical address of the Division of Allergy and Asthma at Albany Medical Center. See the affidavit and Exhibits to

16

this Amended Complaint. 17

8.100.

states, “The inspection revealed source document fabrication and alteration to qualify patients for

18

study Zopen participation; clinic file record substitution for one patient to continue study Zopen

19

participation; source EKG record alterations; inadequate drug accountability; and protocol

20 21

Page 1, titled Summary of Findings for the 10/22-12/23/97 FDA Establishment Inspection Report,

violations.” 8.101.

Albany Medical College (“AMC”), Anthony P. Tartaglia (“Tartaglia”), Jay Grossman, Thomas B. Edwards (“Edwards”), Sepracor Inc (“Sepracor”) and others presently unknown to Plaintiffs, agreed

22 23

to obstruct justice, by the commission of overt acts to conceal the fraudulent clinical research and insurance frauds 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

24 25

on 3/25/99 (review was posted on 6/20/01). A “study buddy” is typically a former specialty practice patient who is enrolled serially by Jay Grossman in one clinical research study after another. Between studies they became specialty practice patients again. Cross-over was commonplace.

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

27

Defendant Joanne C. Wray’s admission of upcoding and unnecessary procedures by Jay Grossman is

1 2

related and posed a definite threat of repetition (open-ended continuity). See ¶ 8.49, 8.62, and 8.68. 8.102.

3

AMC, Tartaglia, and others acting in concert, agreed to bribe Jay Grossman into leaving Albany, NY, during an on-going FDA inspection of Jay Grossman’s regulated conduct, by offering him the position of Chief, Allergy Division, at Albany Medical College. The object of the agreement was to

4

conceal fraudulent clinical research and insurance fraud of Jay Grossman at Albany Medical College, 5

on behalf of corporate research sponsors presently unknown to Plaintiffs. AMC, Tartaglia, and others acting in concert, offered Jay Grossman the bribe. Jay Grossman accepted the bribe and abruptly left

6

Albany, NY and relocated to Tucson, AZ. Plaintiffs were directly injured in their business and 7

property by reason of this misconduct (bribery, obstruction of justice, Travel Act violations), because Plaintiffs subsequently became victims (in Tucson, AZ, Kilgore, TX, and Longview, TX) of Jay

8

Grossman’s substantive RICO act violations (see Counts One, Two, and Three), fraudulent hiring and 9

retention inducements, and violence (extortion, assault, and battery), pendant state law violations (Count Four), and ongoing Constitutional tort (Count Seven). See ¶ 8.44-8.46. See also the Affidavit

10

and Exhibits to this Amended Complaint. 11

8.103.

Jay Grossman, acting in concert with others presently unknown to Plaintiffs, employed a scheme or artifice to defraud Robert M. Davidson, which made use of the U.S. mail to accomplish the fraud,

12

when he ran the classified advertisement in the July 15, 1998, edition of the Tucson Citizen, classified 13

section, entitled “Physician, Pharmaceutical Research”, in which he [they] sought to hire a key, highly-qualified individual, with Davidsons’ credentials, for employment with “Vivra” in Tucson, AZ.

14

Plaintiffs detrimentally-relied upon the representations of legitimate employment found in the 15

advertisement. Plaintiffs sustained direct by reason of injury to their business and property due to this fraudulent hiring inducement. This fraudulent hiring inducement was related (similar method, motive,

16

and victims) to the fraudulent hiring, retention, and “lulling” inducements of Kent J. Thiry and Joseph 17

C. Mello, which also made use of the U.S. mail to accomplish the fraud, which were directly targeted at Robert M. Davidson. These fraudulent hiring, retention, and “lulling” inducements posed a definite

18

threat of repetition (open-ended continuity). Jay Grossman, Kent J. Thiry, and Joseph C. Mello,

19

intended the consequences of their fraudulent acts. The consequences of their fraudulent acts were

20

readily foreseeable. These fraudulent acts (and omissions) were intended to provide personal and corporate financial gain for the enterprise.

21 8.104. 22 23

By information and belief, Timothy G. Wighton (former Vice President, Clinical Research, for “Vivra”) can be placed in Albany, NY (10 Madison Place, Albany, NY) during the same time that Jay Grossman and Eudice Grossman lived in Albany, NY. By information and belief, Gayle F. Petrillo (former Practice Manager for “Vivra”) can be placed in New York (10 Biscayne Drive, Latham, NY)

24 25

during the same time that Jay Grossman and Eudice Grossman lived in Albany, NY. By information and belief, Petrillo’s sister (Lisa M. Petrillo) lived in Albany, NY (178 Brevator Street, Albany, NY 12206). Timothy G. Wighton actually lived in Albany, NY (10 Madison Place, Albany, NY) and was

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

28

1 2 3 4

affiliated with Albany Medical College. By information and belief, Timothy G. Wighton and Joseph C. Mello are the “Vivra” executives who made the decision to hire Jay Grossman. William H. Ziering, M.D. had to surrender his New York medical license (#080678) on November 5, 2001, after his criminal mail fraud indictment (May 25, 2000, in U.S. District Court Eastern District of Claifornia Case # 1:00-cr-05212-OWW-1), conviction, and prison sentence (beginning July 1, 2002) for clinical research fraud in Fresno, CA.

5 6

COUNT THREE 9. Plaintiffs here repeat the allegations in paragraphs 1-8 of this Amended Complaint, and incorporate here by reference the allegations found in paragraphs 16-90.

7 8

10. Defendant Jay Grossman, Defendant Eudice Grossman, Defendant Gayle F. Petrillo, Defendant Charles W. Ott, Defendant Joanne C. Wray, Defendant Kent J. Thiry, Defendant Joseph C. Mello, Defendant Anthony P. Tartaglia, Defendant Michael J. Meehan, Defendant Bruce R. Heurlin, Defendant Vivra Holdings Inc,

9

Defendant Gambro Healthcare Inc, Defendant DVA Renal Healthcare Inc, Defendant Davita Inc, Defendant

10

Sepracor Inc, and Defendant Albany Medical College, as persons within the meaning of 18 U.S.C.A. Section 1961(3), and as persons employed by or associated with said “Vivra” enterprise, agreed with each other to

11

conduct or participate in the violation of the substantive RICO statute, specifically 18 U.S.C.A. Section

12

1962(b) and 18 U.S.C.A. Section 1962(c), in violation of 18 U.S.C.A. Section 1962(d). These Defendants agreed with each other to conceal fraud by means of bribery, provision of stock ownership, stock options, mail

13 14

fraud, wire fraud, Travel Act violations, Hobbs Act violations, and obstructions of justice. See ¶ 8.5, 8.66, 8.67, 6, 8.14, 8.28, 8.70, 8.18, 8.20, 8.93, 8.41-8.44, 8.29, 8.67, 8.79, 8.94–8.104 of this Amended Complaint. 11. Through the commission of two or more of the enumerated predicate acts that constitute a pattern of

15 16

racketeering activity, Defendants directly or indirectly participated in the conduct of said “Vivra” enterprise the activities of which affect interstate commerce. 12. Plaintiffs (Robert M. Davidson, M.D. and Vanessa E. Komar R.N., husband and wife), were jointly injured

17 18 19 20 21

in their business and property by reason of such conduct by Defendants that was violative of the substantive RICO statute. Defendants are jointly and severally liable to Plaintiffs. 13. These acts of racketeering, occurring within ten years of one another, constitute a pattern of racketeering activity within the meaning of 18 U.S.C.A. Section 1961(5). 14. Plaintiffs were jointly injured in their business or property by reason of these violations of 18 U.S.C.A. Section 1962, in that, as a direct and proximate result of Defendant’s complained of acts, Plaintiffs jointly suffered actual damages to Plaintiffs’ business and property in excess of $5,000,000.00, including and not

22 23

limited to: damage to Plaintiffs’ professional reputations through association with “Vivra’s” fraudulent Medicare, Medicaid, and clinical research practices. By reason of the fraudulent representations to Davidson in the ZERO TOLERANCE POLICY MEMO and Employees Handbook as to legitimacy and freedom from

24 25

violence of its operations, Davidson would not have accepted and continued employment with Vivra in Tucson, AZ, Plaintiffs would not have been delayed and hindered in their business and occupations, would not have lost a great deal of time from it, would not have been deprived of gains and profits which they would

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

29

1 2 3 4

have acquired, had they not been injured as stated, Davidson would not have missed out on numerous legitimate employment opportunities, Davidson would not have been unemployed for a substantial length of time after his employment with Vivra was constructively terminated on May 11, 1999, Plaintiffs would not have lost substantial income over the last 8 years, including a fully executed employment contract in 2001, in Bentonville, AR, Plaintiffs would not have sustained damage to presently-enjoyed business relationships, damage to prospective business relationships, inability to readily obtain liability insurance, inability to readily

5 6

obtain new state medical licensures, loss of investments, loss of investment income, loss of liberty, loss of Plaintiffs’ intangible right to the good and honest services of the Defendants, and loss of Plaintiffs intangible right to freely conduct one’s lawful business, Plaintiffs would not have incurred substantial legal expenses

7 8

(including attorney’s fees and costs and Westlaw charges), Plaintiffs would not have incurred substantial debt, and Plaintiffs would not have been forced to file for Chapter 7 relief in the Bankruptcy Court. See the letter of December 19, 2000, from the Arkansas State Medical Board to Robert Michael Davidson, M.D., the letter of

9

January 22, 2001, from Robert Davidson, M.D. to Mark Bever, CEO of Bates Medical Center, Bentonville,

10

AR, and the letter of February 23, 2005, from Micole Matyas of National City Mortgage to Robert Davidson and Vanessa Komar, Re: Inquiry for Lot Land Refinance. See the federal PACER docket filings for Plaintiffs’

11

Chapter 7 Bankruptcy filing, on October 5, 2005, in the U.S. Bankruptcy Court, Eastern District of Texas,

12

Tyler Division, (05-62258). See the true and correct copies of Plaintiffs’ checks for payment of attorney’s fees and costs to attorney Michael Markley, attorney Michael J. Meehan, attorney Kenneth Haber, and the law firm

13 14

Quarles Brady Streich & Lang. See the statement of fees paid by Plaintiffs to Westlaw. Defendants’ tortuous conduct was a “substantial factor in the sequence of responsible causation.” The fraudulent representations as to legitimacy and freedom from violence of its operations found in the ZERO TOLERANCE POLICY

15 16

MEMO and the December 12, 1995 revision of the Employees Handbook as to legitimacy and freedom from violence of Vivra’s operations were targeted directly at Robert M. Davidson, on or about September 1, 1998. See the FEDEX Airbill from September 3, 1998, from Aaron Risen of Vivra Physicians Services, 1941 Bishop

17 18 19 20 21

Ln, Ste. 501, Louisville, KY 40218, addressed to Robert Davidson, M.D. at 2427 East 1st Street, Tucson, AZ 85719. See the letter of August 21, 1998, from Maylene R. Nafrada of Vivra Specialty Partners, 1850 Gateway Drive, Suite 500, San Mateo, CA 94404, addressed to Robert Davidson, M.D. at 2427 East 1st Street, Tucson, AZ 85719, sent VIA FEDERAL EXPRESS. See the letter of August 14, 1998, from Maylene R. Nafrada of Vivra Specialty Partners, 1850 Gateway Drive, Suite 500, San Mateo, CA 94404, addressed to Robert Davidson, M.D. at 2427 East 1st Street, Tucson, AZ 85719, Sent VIA FEDERAL EXPRESS. See the Employee Receipt & Acknowledgement Form signed by Robert M. Davidson on September 1, 1998. See the

22 23

“To New Employees” letter of Kent J. Thiry of Vivra at 1850 Gateway Drive, Suite 500, San Mateo, CA 94404, included in the October 1998 revision of the Vivra Employee Handbook. See the “To New Employees” letter of Joseph C. Mello of Vivra Asthma & Allergy, 150 South Pine Island Road, Suite 520, Plantation, FL

24 25

33324, included in the October 1998 revision of the Vivra Employee Handbook. See the “Welcome to Vivra” letter of Kent J. Thiry, President and Chief Executive Officer, included in the December 12, 1995 revision of

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

30

1 2 3 4

the Vivra Employee Handbook which was part of the “Vivra” New Employee Packet Information Checklist, addressed to Robert Davidson, M.D. on or about September 1, 1998. 15. By reason of Defendants’ violations of 18 U.S.C.A. Section 1962, Plaintiffs (Robert M. Davidson and Vanessa E. Komar, husband and wife) are jointly entitled, pursuant to 18 U.S.C.A. Section 1964(c), to threefold the damages sustained or $15,000,000.00, with interest thereof at 10% per annum, and a reasonable attorney’s fee and costs in connection herewith. Defendants are jointly and severally liable to Plaintiffs for this

5

sum. COUNT FOUR

6

PENDANT STATE LAW CLAIMS FOR FRAUDULENT MISREPRESENTATION, 7 8

BREACH OF FIDUCIARY DUTY, AND CIVIL CONSPIRACY 16. Plaintiffs here repeat the allegations found in paragraphs 1-15 of this Amended Complaint and incorporate here by reference the allegations found in paragraphs 22 - 90 below.

9

17. Charles W. Ott, Jay Grossman, Eudice Grossman, Gayle F. Petrillo, Joanne C. Wray, Kent J. Thiry, Joseph

10

C. Mello, Michael J. Meehan, Bruce R. Heurlin, Vivra Holding Inc, Gambro Healthcare Inc, Albany Medical College, and Sepracor Inc, acting by agreement (to conceal fraud and/or to obstruct justice) and in concert with

11

each other and with others, made or caused to be made misrepresentations or omissions (including fraudulent

12

hiring and retention inducements) with fraudulent intent or scienter. These fraudulent hiring and retention inducements were directed at Robert M. Davidson, M.D. The misrepresentations or omissions were material

13 14

to Plaintiffs’ decision for Robert M. Davidson, M.D. to accept or continue employment at the 698 E. Wetmore Road, Tucson, AZ clinical research facility, from on or about September 1,1998, until on or about May 11, 1999. Plaintiffs reasonably relied on the misrepresentations or omissions. Plaintiffs jointly suffered injury as a

15 16

result of Plaintiffs’ reliance on the misrepresentations or omissions. Plaintiffs detrimentally relied on “Vivra’s” misrepresentations or omissions as to legitimacy and freedom from violence of its operations, and damage to Plaintiffs’ professional reputations was foreseeable result of various racketeering acts of wire

17 18 19 20 21

and mail fraud. “Vivra” fraudulently induced Robert M. Davidson, M.D. to accept and continue employment via mail and wire fraud, thereby damaging Plaintiffs’ reputations through association with “Vivra’s” fraudulent Medicare, Medicaid, and clinical research practices. Plaintiffs allege a combination of two or more persons acting with a common purpose to do an unlawful act or do a lawful act in an unlawful means or for an unlawful purpose; an overt act done in pursuant of the common purpose; and actual legal damage. Plaintiffs incorporate here by reference ¶s 8.94-8.104, and ¶s 14, 54, 58-62, 69, 86, 87, of this Amended Complaint.

22 23

18. Albany Medical College, Anthony P. Tartaglia, M.D., then the Dean of Albany Medical College, Sepracor Inc, and others, had an ethical, moral, and legal duty to report Jay Grossman’s misconduct in Albany, NY to appropriate state and/or federal regulators. By information and belief, Jay Grossman, M.D., and Thomas B.

24 25

Edwards, M.D., are thought to have been employees of Albany Medical College Allergy Division in conducting certain clinical research studies in support of New Drug Applications by Big Pharma corporations (including Sepracor Inc) in Albany, NY. See the Affidavit and Exhibits to this Amended Complaint.

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

31

1 2 3 4

19. By information and belief, Albany Medical College, Sepracor Inc, Anthony P. Tartaglia, Thomas B. Edwards, William H. Ziering, Joanne C. Wray, Timothy G. Wighton, Gayle F. Petrillo, Charles W. Ott, and Joseph C. Mello, are thought to have had actual knowledge of the allegations of violence and clinical research fraud at Albany Medical College leveled against Jay Grossman by Richard Ball, M.D., David Shulan, M.D., and Scott Osur, M.D., in a sworn affidavit in Albany County Case # 2960-91, on December 6, 1994. By information and belief, Albany Medical College, Sepracor Inc, Anthony P. Tartaglia, Timothy G. Wighton,

5 6

Gayle F. Petrillo, and Charles W. Ott, are thought to have had actual knowledge of the FDA Disqualification of Thomas B. Edwards for clinical research fraud at Albany Medical College. By information and belief, Albany Medical College, Anthony P. Tartaglia, Thomas B. Edwards, Sepracor Inc, William H. Ziering, Joanne C.

7 8

Wray, Timothy G. Wighton, and Joseph C. Mello, acting by agreement to conceal fraud, in concert with each other and with others to be determined at trial, committed overt acts or omissions that: (a) facilitated the relocation of Jay Grossman’s “research” practice from Albany, NY to Tucson, AZ, (b) facilitated the

9

relocation of Thomas B. Edwards’ “research” practice from Albany, NY to Pittsfield, MA, and (c ) facilitated

10

the relocation of Joanne C. Wray’s (formerly known as Joanne C. Siegel) “research” practice from Fresno, CA to Tucson, AZ.

11

20. Because Plaintiffs were jointly injured by Defendants’ violations, detailed above, and because the intent

12

was knowing, or willing, or reckless, or malicious, or with improper motive (personal and/or corporate financial gain), Plaintiffs seek actual damages (including damages for personal injury and economic injury),

13 14

punitive damages, interest, court costs and attorney fees from Defendants, and any other relief as this Court may deem appropriate. Defendants are jointly and severally liable to Plaintiffs. 21. Defendants made representations or omissions (including fraudulent hiring and retention inducements) to

15 16

Plaintiffs; the representations or omissions were material; the representations or omissions were false; when Defendants made the representations or omissions, they knew the representations or omissions were false, or made them recklessly, as positive assertions, and without knowledge of their truth; Defendants made the

17 18 19 20 21

representations or omissions with the intent that Plaintiffs act on them; Plaintiffs relied on the representations or omissions; and the representations caused Plaintiffs injury. Defendants’ fraudulent misrepresentations or omissions consisted of nondisclosure of material facts when there was a duty to do so. Defendants had a duty to speak and deliberately remained silent. There was a special relationship that required disclosure. There was a fiduciary relationship between Plaintiff (Robert M. Davidson, M.D.) and Defendants, that required Defendants to disclose material facts. Defendants made representations or omissions to Plaintiffs knowing that they were false. Defendants intended for Plaintiffs to rely on the representations or omissions. Defendants

22 23

desired to cause the consequences of their acts or omissions. Plaintiffs actually relied upon the representations or omissions, that is, plaintiffs knew of the representations or omissions and acted upon them. Plaintiffs believed the false representations or omissions when they acted on them. Plaintiffs did not have a duty to use

24 25

due diligence to discover whether the representations or omissions were fraudulent. Plaintiffs changed their position for the worse. The representations and omissions caused injury. Plaintiffs (Robert M. Davidson and Vanessa E. Komar, husband and wife) jointly seek both direct and consequential damages. The frauds

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

32

1 2 3 4

proximately caused the damages. The frauds were a substantial factor in bringing about the damages, without which the damages would not have occurred, and a person of ordinary intelligence would have foreseen that the damages might result from the frauds. Plaintiffs suffered [and continue to suffer] injury, both pecuniary and physical (mental anguish). Plaintiffs (Robert M. Davidson and Vanessa E. Komar, husband and wife) jointly seek actual damages (including damages for economic injury and personal injury), punitive damages, interest, court costs, and attorney’s fees, and any other relief as this Court may deem appropriate. Defendants are jointly

5

and severally liable to Plaintiffs. COUNT FIVE

6

MOTION FOR DECLARATORY RELIEF UNDER 28 U.S.C. SECTION 2201 AND 2202 7 8

22. Plaintiffs repeat here paragraphs 1-21 to this Amended Complaint, and incorporate here by reference the allegations found in paragraphs 36 - 90 below. 23. This Court has jurisdiction over a general constitutional challenge to the Prescription Drug User Fee Act (a

9

renewable Act of Congress, in which the harms enabled by federal action under color of the PDUFA are

10

capable of repetition, yet evade review) that does not require a review of a final state court decision in a particular case. The declaratory relief requested by this Count (Count Five) is supplemental to the coercive

11

relief prayed for in Counts One, Two, Three, Four, and Seven.

12

24. The Plaintiffs to this Count (Count Five) are Robert M. Davidson and Vanessa E. Komar (collectively “the Davidsons”), husband and wife. The Defendants to this Count (Count Five) are Defendant Jay Grossman,

13 14

Defendant Eudice Grossman, Defendant Gayle F. Petrillo, Defendant Charles W. Ott, Defendant Joanne C. Wray, Defendant Anthony P. Tartaglia, Defendant Kent J. Thiry, Defendant Joseph C. Mello, Defendant Michael J. Meehan, Defendant Bruce R. Heurlin, Defendant Vivra Holdings Inc, Defendant Gambro

15 16

Healthcare Inc, Defendant DVA Renal Healthcare Inc, Defendant Davita Inc, Defendant Albany Medical College, and Defendant Sepracor Inc. 25. As applied to the Plaintiffs, the Prescription Drug User Fee Act is repugnant to the U.S. Constitution under

17 18 19 20 21

the Equal Protection Clause of the Fifth Amendment. 26. Plaintiffs incorporate here by reference paragraphs 8.64 - 8.67, paragraphs 8.80 - 8.89, and paragraphs 8.94 - 8.104, to this Amended Complaint. 27. Plaintiffs’ federal Constitutional injury can be fairly traced to the challenged action and is likely to be redressed by a favorable decision by this Court. Plaintiffs’ have suffered injury in fact. Defendants conduct, acting by agreement, and in concert with others to be determined at trial, caused Plaintiffs’ injury. 28. Plaintiffs have Article III standing to make this motion for declaratory relief. Plaintiffs were adversely

22 23

affected by application of the PDUFA to Plaintiffs. Plaintiffs have suffered palpable economic injury to their business and property by reason of an invidiously discriminatory application of the PDUFA to the Plaintiffs. The PDUFA has the effect of encouraging physicians acting as either principal investigators or

24 25

subinvestigators in clinical research studies, to violate the Oath of Hippocrates by not “blowing the whistle” whenever the PDUFA is applied (selectively enforced) to conceal clinical research fraud and obstruct justice, in order to gain expedited FDA review and market approval for the FDA’s Big Pharma corporate clients. Clinical

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

33

1 2 3 4

research subjects have been endangered, injured, and died, by reason of the PDUFA (in its various enactments I, II, III, IV, etc). U.S. citizens who have been exposed to certain unsafe FDA-approved drugs have been intentionally endangered, injured, and died, by reason of application (selective enforcement) of the PDUFA to the review and approval for marketing of certain unsafe drugs by the FDA, e.g. vioxx-associated deaths and injuries, rezulin-associated deaths and injuries, lotronex-associated deaths and injuries, and others. This is a case of actual controversy wherein the threat of continuing violations and future injuries are capable of

5 6

repetition, yet has evaded constitutional review. By reason of the misconduct of the Defendants to this lawsuit, Plaintiffs have suffered direct injury to their business and property. Plaintiffs allege direct conspiracy injury to their business and property by reason of an agreement between the Defendants and others to conceal fraud and

7 8

obstruct justice. Plaintiffs have alleged in this Amended Complaint overt acts by or caused by the Defendants acting in concert with each other and in concert with others who are presently unknown to the Plaintiffs, knowingly intended to achieve the object of expedited review and marketing approvals by FDA, under color of

9 10

the PDUFA, for personal and/or corporate financial gain. 29. Paragraph 2, Page 1 of the FDA Tucson, AZ EIR of 5/5-6/28/99 states “This inspection report was delayed due to a PDUFA report.” This delay was willful and directly targeted at the Plaintiffs. As applied to the

11

Plaintiffs, the PDUFA is repugnant to the U.S. Constitution under the Equal Protection clause of the Fifth

12

Amendment. 30. By delaying the publication of the FDA Tucson, AZ EIR of 5/5-6/28/99, the PDUFA II substantially

13 14

delayed the time at which Plaintiffs could begin to seek a legal remedy against Defendants. This “delay” was intentional and directly targeted at the Plaintiffs. This “delay” inured greatly to the benefit of Defendants, Big Pharma corporations [including Sepracor Inc], the “Vivra” enterprise [including Sepracor Inc], and the FDA

15 16

[employees acting in their official capacity], while inuring greatly to the detriment of Plaintiffs. 31. 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

17 18 19 20 21

Grossman, Thomas B. Edwards, Albany Medical College, and Sepracor Inc, in support of the NDA # 20837 for Xopenex Inhalation Solution, that gained FDA approval on 3/25/99 (review was posted on 6/20/01). 32. “Expedited” market approvals of New Drug Applications by the FDA took place during this “delay” and during the pendency of the ostensibly ongoing criminal investigation of Jay Grossman’s conduct by the Criminal Division of the FDA. The FDA approval of the NDA # 20-837 for Xopenex Inhalational Solution, was based in part upon fraudulent (seriously flawed) clinical research by Thomas B. Edwards in Albany, NY at Albany Medical College.

22 23

33. There is a recurring pattern of expedited market “approvals” of New Drug Applications by the FDA, while both routine and “for cause” investigations of clinical research establishments are selectively “delayed” [intentionally “stone-walled”] under color of PDUFA I, II, III, and soon the PDUFA IV.

24 25

34. The Principal Investigator [Jay Grossman] was terminated for cause on July 30, 1999, by Vivra Inc, yet the FDA report on 7/10/2000 states, “Review of the records found no deviations…”

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

34

1 2 3 4

35. The FDA Tucson AZ EIRs of 5/5-6/28/99 and 7/6-10/2000 made no findings that in any way deterred Big Pharma corporations (including Sepracor Inc) from proceeding under the PDUFA II [now under the PDUFA III] to gain expedited FDA “review” and market approval of their products. See paragraphs 8.94 - 8.104 to this Amended Complaint. 36. The relief Plaintiffs seek by this Count (Count Five) is a holding by this Court that the Prescription Drug User Fee Act, as applied to the Davidsons, is violative of the Equal Protection Clause of the Fifth Amendment

5

of the U.S. Constitution, and therefore held by this Court to be unconstitutional.

6 COUNT SIX 7 8

MOTION FOR DECLARATORY RELIEF UNDER 28 U.S.C. SECTION 2201 AND SECTION 2202 37. Plaintiffs repeat here paragraphs 1-36 to this Amended Complaint, and incorporate here by reference the allegations found in paragraphs 43 - 90 below.

9 10

38. This Court has jurisdiction over a general constitutional challenge to Arizona Rules of Civil Procedure Rule 5.1 that does not require a review of a final state court decision in a particular case. The declaratory relief requested by this Count (Count Six) is supplemental to the coercive relief prayed for in Counts One, Two,

11

Three, Four, and Seven.

12

39. The Plaintiffs to this Count (Count Six) are Robert M. Davidson and Vanessa E. Komar (collectively “the Davidsons”), husband and wife. The Defendants to this Count (Count Six) are Defendant Jay Grossman,

13 14

Defendant Eudice Grossman, Defendant Bruce R. Heurlin (counsel of record for Jay Grossman and Eudice Grossman in the Arizona state court proceedings), and Defendant Michael J. Meehan (former retained counsel of record for Robert M. Davidson and Vanessa E. Komar in the Arizona state court proceedings).

15 16

40. Arizona Rule of Civil Procedure 5.1 is repugnant to the U.S. Constitution. There is no ongoing Arizona state court proceeding. Division II Arizona Court of Appeals has affirmed the final judgments of the Arizona trial court. The Arizona Supreme denied Petition for Review. The U.S. Supreme Court has denied certiorari.

17 18 19 20 21

41. Plaintiffs allege an ongoing actual case or controversy. 42. Plaintiffs’ federal Constitutional injury in the State Action can be fairly traced to the challenged action and is likely to be redressed by a favorable decision. Plaintiffs are suffering continuing present adverse effects (continuous constitutional tort and continuous jeopardy) by reason of decisions in the State Action. 43. Arizona Rules of Civil Procedure 5.1 is flagrantly and patently violative of express constitutional provisions. Arizona Rules of Civil Procedure Rule 5.1 is facially unconstitutional. Arizona Rules of Civil Procedure Rule 5.1 is unconstitutional as applied to the Davidsons in the Arizona state court proceedings.

22 23

44. The relief Plaintiffs seek by this Count (Count Six) is a holding by this Court that Arizona Rules of Civil Procedure, Rule 5.1 is repugnant to the U.S. Constitution and therefore held by this Court to be unconstitutional.

24 25

DAVIDSON, et al v. GROSSMAN, et al

AMENDED COMPLAINT

35

COUNT SEVEN

1 2 3 4

SUPPLEMENTAL CLAIM FOR VIOLATION OF 42 U.S.C. SECTION 1983 AND SECTION 1985 45. Plaintiffs repeat here by reference paragraphs 1 – 44, and incorporate here by reference the allegations found in paragraphs 87 - 90 below. 46. Plaintiffs do not seek vacatur or review of the “final judgments” in the State court proceeding. Plaintiffs to this Count (Count Seven) are Robert M. Davidson and Vanessa E. Komar (collectively “the Davidsons”),

5 6

husband and wife. Defendants to this Count (Count Seven) are Defendant Jay Grossman, Defendant Eudice Grossman, Defendant Bruce R. Heurlin, and Defendant Michael J. Meehan. 47. Robert M. Davidson and Vanessa E. Komar were prevented from raising their federal damages claim in the

7 8

state court proceedings. 48. Plaintiffs were denied a full and fair opportunity to litigate their constitutional challenge to Arizona Rule of Civil Procedure 5.1.

9 10

49. There was never actual consideration of and a decision on the issues presented in the state court proceedings. 50. Plaintiffs have suffered actual injury as a result of the illegal conduct of Jay Grossman, Eudice Grossman,

11

Bruce R. Heurlin (“BRH”), Michael J. Meehan (“MJM”), and Jane L. Eikleberry (“JLE”, the Arizona trial

12

court judge) in the Arizona state court proceedings (“the State Action”). Plaintiffs were the specificallytargeted victims of this illegal conduct.

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51. Jay Grossman, Eudice Grossman, Quarles Brady Streich & Lang (MJM’s new law firm, “QBSL”), BRH, MJM, and JLE, were willful participants in joint activity with the State of Arizona or its agents. 52. Jay Grossman, Eudice Grossman, QBSL, BRH, and MJM, conspired with Arizona trial court judge JLE to

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deprive Plaintiffs of Constitutional rights under color of Arizona Rule of Civil Procedure 5.1 and there was State Action. 53. The State Actors (Jay Grossman, Eudice Grossman, QBSL, BRH, MJM, and JLE) deprived Plaintiffs of

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federally-protected rights under color of Arizona Rule of Civil Procedure 5.1. 54. Jay Grossman, Eudice Grossman, QBSL, BRH, MJM, and JLE, agreed with each other to conceal fraud by knowingly committing overt acts in furtherance of this objective for personal, political, and corporate financial gain. By reason of this corrupt conspiracy, Davidsons suffered direct injury to their business and property. 55. Jay Grossman, Eudice Grossman, QBSL, BRH, MJM, and JLE, were State Actors in the Arizona state court proceedings. Plaintiffs allege the state involvement necessary to transform the private acts of Jay Grossman, Eudice Grossman, QBSL, BRH, MJM, and JLE, into State Action covered by 42 U.S.C. Section

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1983 and Section 1985. 56. After MJM changed law firms (he joined the law firm of Quarles Brady Streich Lang (“QBSL”) during his representation of the Davidsons in State court proceedings), he stated in writing in a letter of January 15, 2001,

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from MJM to the Davidsons, “I do not expect this [his change in law firm] to affect or impair in any way my ability to continue effective representation for you.”.

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57. MJM and QBSL abandoned their clients (the Davidsons) with their Motion to Withdraw, just four months before the scheduled trial date, under color of Arizona Rules of Civil Procedure 5.1. 58. In retrospect, it is a reasonable inference to postulate that both MJM’s employment with the law firm QBSL and MJM’s candidacy for positions on the Arizona bench, were bribes and that these bribes (and MJM’s acceptance of these bribes) were overt acts to conceal a racketeering conspiracy which has been ongoing for nearly two decades, in both New York and Arizona.

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59. MJM’s and QBSL’s Motion to Withdraw as counsel of record (December 17, 2001), when viewed against the backdrop of the Prosecution Memorandum (November 20, 2000) provides prima facie evidence of actual malice and willful misconduct by the attorney (MJM) and his law firm (QBSL) towards his clients

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(Davidsons). There was not “good cause appearing therefore” upon which to base the Trial Judge’s (JLE’s) Order of January 11, 2002. The reasons given for attorney withdrawal are false. MJM and QBSL have defrauded the Trial Court by alleging that ethical considerations motivated their Motion to Withdraw. MJM

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and QBSL actually slandered their then clients (the Davidsons) in their Motion to Withdraw, by maliciously characterizing their clients’ objectives as being unprofessional, imprudent, unethical, and repugnant. This intentional misrepresentation inflicted irreparable harm upon the Davidsons once the motion was filed. By

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information and belief, MJM and QBSL knew the substance and content of the Prosecution Memorandum,

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prior to filing their Motion to Withdraw as counsel of record. Yet, QBSL and MJM agreed with each other to continue to refuse to bring Arizona fraud, Arizona RICO, and federal RICO actions, on behalf of their then

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clients, the Davidsons, despite repeated requests by the Davidsons to bring such actions. Davidsons did not realize at the time that the object of the aforementioned repeated refusals to bring fraud and racketeering actions on behalf of their clients, and the object of their Motion to Withdraw, was not solely to permanently

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deprive the Davidsons of a legal remedy for the injuries wrought upon them by the Grossmans and others acting in concert, and avoid their contractual and professional responsibility to the Davidsons, just four months before the scheduled trial date, but was also intended to conceal the racketeering conspiracy which had been

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ongoing for nearly two decades, in both New York and Arizona, and facilitate MJM’s candidacy for anticipated vacancies in the Arizona Supreme Court and Division II Arizona Court of Appeals. 60. Davidsons allege extrinsic fraud in the procurement of final judgement in the Arizona court proceedings. 61. Davidsons allege a corrupt conspiracy in the Arizona State court proceedings (“the State Action”) between MJM, BRH, Jay Grossman, Eudice Grossman, and JLE to deprive Davidsons of Constitutionally-protected fundamental rights in property (their retained legal counsel in civil lawsuit) and liberty (a bargained-for benefit of entering into a retainer agreement with MJM).

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62. JLE was a joint participant in the corrupt conspiracy to defraud the whistle blower (Davidson) and deprive Davidsons of constitutional rights. JLE had actual knowledge that there was not “good cause appearing therefore” upon which to base the Order of January 11, 2002. So too did certain named Division II Judges and

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Arizona Supreme Court justices have personal, extrajudicially acquired knowledge of disputed evidentiary facts concerning Davidsons’ attorney (MJM). These judges had actual knowledge that MJM’s and QBSL’s Motion to Withdraw was in no way motivated by “good cause”. To the contrary, the trial judge and named

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Division II Judges and Supreme Court Justices, had personal, extrajudicially-acquired knowledge that the Motion to Withdraw as Counsel of Record was a willful, malicious violation of Davidsons’ civil rights, motivated by bad faith (evil intent), an improper motive (personal political and financial gain), and with deliberate reckless indifference to the federally-protected rights of the Davidsons. 63. The State trial court’s signed Order of January 11, 2002, denied the Davidsons important Constitutional rights including the right to Due Process, right to Equal Protection, right to Contract, right to freedom from

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arbitrary Takings, and the presently-enjoyed right to retained legal counsel in a civil proceeding. 64. MJM’s candidacy for the Arizona bench while Davidsons’ interlocutory appeal was pending gives rise to estoppel as a matter of law.

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65. Intentional discrimination in the dismissal of Davidsons’ retained counsel is a grave constitutional trespass, possible only under color of state authority, and wholly within the power of the state to prevent. 66. The coerced dismissal of Davidsons’ retained counsel by fiat of the trial court vitiates the judgment

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because it violates the Due Process Clause of the Fourteenth Amendment. 67. Arizona Rules of Civil Procedure 5.1 is flagrantly and patently violative of express constitutional provisions. Davidsons were denied federal constitutional rights by State Action under color of Ariz. R. Civ. P.

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Rule 5.1(A)(2)(B) and (C ) in the State court proceeding.

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68. A civil litigant has a Constitutional right to retain hired counsel. There is a Constitutionally-guaranteed right to retain hired counsel in civil matters under the due process clause of Fourteenth Amendment. Subject to

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certain limitations, right to counsel expressly guaranteed by the Sixth Amendment in criminal cases, is no less fundamental in civil cases and springs from both statutory authority and from the constitutional right to due process of law.

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69. Davidsons were deprived of the presently-enjoyed benefit of retained counsel in an ongoing civil proceeding without procedural due process. The process that was due is, at minimum, a hearing. There was no such hearing afforded the Davidsons. The opposing legal counsel (MJM, QBSL, and BRH) simply agreed

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between themselves and with the Court (JLE) under color of Ariz. R. Civ. P., rule 5.1, and there was State Action. 70. To say that there is generally no constitutional right to retained counsel in civil cases is a statement of such broad scope and sweep that it would undermine many, if not all, of the basic foundations upon which our legal system rests. 71. Ariz. R. Civ. P., rule 5.1 (A)(2)(B) and (C ), subrogates client’s rights to those of their attorney’s based upon a conclusive presumption of the trial judge. It creates a constitutionally-impermissible unequal

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classification of clients and attorneys. It provides none of the citizens of the State of Arizona with constitutionally-guaranteed protections of presently-enjoyed property and liberty interests in their retained legal counsel.

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72. Every Arizona citizen is vulnerable to the same federal constitutional deprivation, because clause (ii) of Ariz. R. Civ. P. Rule 5.1(A)(2)(C ) is written as a disjunctive condition, that is it reads, [in pertinent part], “…, or (ii) unless the court is satisfied for good cause shown that the attorney should be permitted to withdraw.”

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This statutory construction renders Ariz. R. Civ. P. Rule 5.1 to be “flagrantly and patently” violative of express Constitutional protections. There is no hearing or certification process afforded to clients to protect client’s rights. There is no protection against the risk of error by the state. The consequence of error is substantial. Ariz. R. Civ. P. rule 5.1 is not reasonably susceptible of a limiting construction that would avoid the constitutional question posed in this case, because its language is plain and its meaning unambiguous. It nowhere makes a hearing or certification process mandatory to protect client’s rights from wrongful deprivation.

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73. The Trial Court in the State court proceeding summarily absolved MJM and QBSL of their contractual and professional responsibility to their clients at the precise moment of their clients’ greatest need, i.e., just before trial, under Ariz. R. Civ. P. Rule 5.1(A)(2)(B) and (C ).

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74. There is a Constitutionally-protected property and liberty interest in retained legal counsel in civil lawsuits. 75. The State Court system of Arizona created a constitutionally-impermissible unequal “classification” of clients vis a vis their attorneys, when Ariz. R. Civ. P. rule 5.1(A)(2)(B) and (C ) was enacted.

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76. Ariz. R. Civ. P. rule 5.1 and the state action complained of had a disproportionate or discriminatory impact,

10

and also the action was taken with intent to discriminate, so as to permanently deny their clients a legal remedy for the crimes alleged in the federal court proceedings and avoid their contractual and professional

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responsibility to their clients, just 4 months before the scheduled trial date.

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77. MJM’s and QBSL’s conduct, under color of Ariz. R. Civ. P. Rule 5.1, was intentionally harmful to Davidsons, or otherwise deliberately inconsistent with their obligations to Davidsons, so as to be a voluntary

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excursion outside the scope of their duties. Liability attaches to MJM, QBSL, JLE, and BRH, under 42 U.S.C. Section 1983 and 1985, since the acts complained of were done outside the scope of their duty. 78. Coerced dismissal of Davidsons’ retained legal counsel by fiat of the trial court under color of Arizona

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Rule of Civil Procedure 5.1 may be viewed a punitive sanction. 79. The Arizona trial court judge JLE actually refused to litigate Davidsons’ Amended Answer to First Amended Complaint and Counterclaims, filed on or about February 26, 2004, in the Arizona state court

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proceedings. Davidsons aggressively pursued all available means to secure state-court decision of federal issues presented to the state court, including interlocutory appeal to Division II from the State trial court’s Order of January 1, 2002, which coerced the dismissal of Davidsons’ retained counsel of record, by fiat of the trial court just 4 months before the scheduled trial date, under color of Ariz. R. Civ. P. Rule 5.1. 80. The Arizona state court remedy for redressing the wrong was woefully inadequate, both in form and in substance. 81. Plaintiffs have suffered an intentional deprivation of property and liberty without Due Process.

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82. There was a meeting of the minds concerning unconstitutional conduct, and an express agreement between the purported conspirators (Jay Grossman, Eudice Grossman, BRH, JLE, QBSL, and MJM). 83. A genuine actual issue of concerted activity toward an unlawful objective is alleged.

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84. Substantial direct injury to Plaintiffs’ business and property occurred by reason of the State Action and “final judgments” in the Arizona state court proceeding.

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85. By reason of violations of 42 U.S.C. Section 1983 and Section 1985, by Jay Grossman, Eudice Grossman, Bruce R. Heurlin, Michael J. Meehan, Jane L. Eikleberry, Quarles Brady Streich & Lang, and others, in the State Action, Davidsons would not have been subjected to sanctions (including the striking of Plaintiffs’ Counterclaims) and a default judgment in the State court proceeding (“the State Action”) for $7.8 million. 86. By reason of constitutional errors, corrupt conspiracy, extrinsic fraud and collusion in the procurement of final judgment, lack of Due Process, agreement to conceal fraud, and concerted acts to conceal fraud of Jay

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Grossman, Eudice Grossman, Bruce R. Heurlin, Michael J. Meehan, Jane L. Eikleberry, and others, in the State Action, Davidsons would not have been subjected to sanctions (including the striking of Plaintiffs’ Counterclaims) and a default judgment in the State court proceeding (“the State Action”) for $7.8 million. See

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Issue #1 and #2 of Davidsons’ Petition for Writ of Mandamus (U.S. Supreme Court Docket # 06-397, mandamus denied on November 27, 2006). 87. By reason of deprivation of Davidsons’ Constitutional right to Due Process and Equal Protection under the

9

Fourteenth Amendment in the State Action, Davidsons would not have suffered injury to their business and

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property, additional injury (injury which is additional to the injury to Plaintiffs alleged in Counts One, Two, Three, Four, and Seven of the Amended Complaint) for which the Defendants in the Case at bar are jointly and

11

severally liable toPlaintiffs. See Issues # 1, #2, and #3, of Davidsons’ Petition for Writ of Certiorari (U.S.

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Supreme Court Docket # 06-398, certiorari denied on November 6, 2006). See Davidsons’ Supplemental Brief and Davidsons’ Petition for Rehearing (U.S.Supreme Court Docket # 04-1687). See signed Court order of May

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5, 2006, for distribution of surplus funds to applicants Jay and Eudice Grossman, in the sum of $226,469.90, from the nonjudicial foreclosure sale of Davidsons’ real property, in Tucson, AZ. See file-stamped copy of the Order of May 5, 2006, signed by Judge John Davis. See the Application for Turnover Order and the

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Application for the Appointment of a receiver for Davidsons’ medical practice (Dominion Health Services, P.A., a Texas Professional Association) with the clerk of the 188th District Court in Gregg County, Texas, Cause No. 2005-93-A. See the Notice of Constable Sale (personal property), signed on July 24, 2006, by

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Constable Bill Echart, Gregg County Texas, that states, “The above property is levied on as the property of Robert Michael Davidson and Vanessa Komar Davidson”. See the Arizona Corporation Commission corporate inquiry on 12/19/2006, re: Tranquility Ventures LLC. See the recent Pima County Assessor’s Office download for the entity, Tranquility Ventures LLC. 88. Davidsons seek coercive relief (compensatory and punitive damages) in this Count (Count Seven) which is supplemental to the coercive relief sought in Counts One, Two, Three, and Four, to this Amended Complaint. See the Prayer for Relief below.

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TOLLING THE STATUTE OF LIMITATIONS 89. Plaintiffs filed their initial RICO action in Arizona on February 19, 2003. The statute of limitations is tolled, for all of the counts to this Amended Complaint, under the doctrine of fraudulent concealment, the

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doctrine of continuing tort, the doctrine of concerted action (conspiracy), the doctrine of equitable tolling, the doctrine of regulatory estoppel, and the doctrine of constitutional regulatory estoppel. Plaintiffs incorporate here by reference ¶ 8.78 - ¶ 8.85.

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90. Defendants are estopped from asserting the statute of limitations as a defense to this Amended Complaint, for the reasons found in paragraph 89 above. PRAYER FOR RELIEF WHEREFORE, Plaintiff pray for judgment against Defendant Jay Grossman, Defendant Eudice Grossman, Defendant Gayle F. Petrillo, Defendant Charles W. Ott, Defendant Joanne C. Wray, Defendant Kent J. Thiry, Defendant Joseph C. Mello, Defendant Anthony P. Tartaglia, Defendant Michael J. Meehan, Defendant Bruce

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R. Heurlin, Defendant Vivra Holdings Inc, Defendant Gambro Healthcare Inc, Defendant DVA Renal Healthcare Inc, Defendant Davita Inc, Defendant Albany Medical College, Defendant Sepracor Inc, and each of them, jointly and severally, as follows:

7

1.

For threefold the damages actually sustained and the costs of suit, in a sum not less than $15,000,000.00, including a reasonable attorney’s fee and costs, pursuant to 18 U.S.C.A. Section

8

1964(c), with interest thereon at the rate of 10% per annum; 9

2.

the rate of 10% per annum;

10 3. 11 12

For punitive (exemplary) damages in the sum of not less than $75,000,000.00, with interest thereon at

Plaintiffs join the above stated Prayer for (coercive) Relief with the above-stated Prayer for declaratory relief (stated in Count Five and Count Six above).

4.

For such other and further relief as the Court may deem appropriate pursuant to 18 U.S.C.A. Section 1964, 28 U.S.C.A. Section 2202, 42 U.S.C.A. Section 1983, and 42 U.S.C.A. Section 1985.

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5.

For such other and further relief as the Court may deem proper and just in the premises.

6.

For trial by jury on all issues so triable.

RESPECTFULLY SUBMITTED, this 16th Day of April, 2007, by

16 ____________________________ and ____________________________ 17 18

ROBERT MICHAEL DAVIDSON

VANESSA ELAINE KOMAR

Representing themselves, Pro Se.

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