U.S. v. Automated Medical Laboratories, Inc.

• Decision Date: 15 August 1985
• Docket Number: No. 84-5152,84-5152
• Citation: 770 F.2d 399
• Parties: UNITED STATES of America, Appellee, v. AUTOMATED MEDICAL LABORATORIES, INC., Appellant. (L).
• Court: U.S. Court of Appeals — Fourth Circuit

Page 399

770 F.2d 399

UNITED STATES of America, Appellee, v. AUTOMATED MEDICAL LABORATORIES, INC., Appellant.

No. 84-5152(L).

United States Court of Appeals Fourth Circuit.

Argued Feb. 5, 1985.

Decided Aug. 15, 1985.

Benton L. Becker, Coral Gables, Fla. (Joseph Ryland Winston, Richmond, Va., Peter A. Collins, on brief) for appellant.

J. Patrick Glynn, Washington, D.C. (Thomas Scarlett, Chief Counsel, Eric M. Blumberg, Associate Chief Counsel, Rockville, Md., for Enforcement, Food & Drug Admin.

Richard K. Willard, Acting Asst. Atty. Gen., Washington, D.C., Elsie L. Munsell, U.S. Atty., Alexandria, Va., Randy S. Chartash, Washington, D.C., Gregory Welsh, Asst. U.S. Atty., Richmond, Va., on brief) for appellee.

Before ERVIN, CHAPMAN, and SNEEDEN, Circuit Judges.

SNEEDEN, Circuit Judge:

The defendant, Automated Medical Laboratories, Inc. ("AML"), appeals its conviction of one count of conspiracy, in violation of 18 U.S.C. Sec. 371, and three counts of making and using false documents in a matter within the jurisdiction of a federal agency, in violation of 18 U.S.C. Sec. 1001. AML was convicted of these four counts following a jury trial in March 1984 in the United States District Court for the Eastern District of Virginia. AML was fined $250.00 for each count, for a total fine of $1000.00. AML argues that its convictions should be reversed because several instances of prosecutorial misconduct denied it a fundamentally fair trial and because the evidence adduced at trial was insufficient to sustain its convictions. We disagree with these contentions and consequently affirm AML's conviction on all counts.

I.

On December 12, 1983, a grand jury indicted AML, along with one of its wholly-owned subsidiaries, Richmond Plasma Corporation ("RPC"), and three individuals, Hugo Partucci, Noberto Queris, and Pedro Ramos, for engaging in a conspiracy that included falsification of logbooks and records required to be maintained in connection with the commercial enterprise of producing blood plasma. ¹ The indictment alleged that the falsification of logbooks and records was engaged in to conceal from the Food and Drug Administration ("FDA") various violations of federal regulations governing the plasmapheresis process and facilities. The remainder of the eight-count indictment alleged specific violations of the false statements statute, 18 U.S.C. Sec. 1001, with regard to particular logbooks or records at the RPC facility. AML was named as a defendant in six of the seven substantive counts plus the conspiracy count. RPC was found guilty on all counts.

The three individuals indicted--Partucci, Queris, and Ramos--were all involved, at various times, in the management or oversight of RPC. Queris was the manager of RPC from 1979 to 1980. In 1980, Ramos succeeded Queris as manager of RPC. Hugo Partucci was a regional manager and "Responsible Head" for several of AML's plasmapheresis facilities between 1972 and 1979. Queris pleaded guilty to one substantive count prior to trial. Ramos was found guilty of one substantive count. Partucci was not present at trial, having apparently left for his native country, Argentina, about six months before the indictment was returned.

AML, a Florida corporation with its main office in Miami, owns and operates several medically-related businesses, such as kidney dialysis centers, facilities for the manufacture and sale of the cancer drug Interferon, and plasmapheresis facilities. AML's primary line of business, however, is the collection and sale of plasma through its eight commercial plasmapheresis centers. Each center, including RPC, is separately incorporated and wholly-owned by AML.

AML had experienced difficulties with RPC dating back to 1977. The FDA closed RPC twice, once in 1977 and again in late 1978, because of problems with overbleeding of donors (removing more blood from a given donor than is allowed by federal regulations) and incomplete recordkeeping. Following the first closing, the manager and responsible head for RPC were changed. Partucci became responsible head for RPC and was charged with assuring compliance with FDA regulations. Partucci, although technically employed by the Orlando Plasma Center, another AML subsidiary, operated as a regional manager for AML and was responsible for assuring compliance with FDA regulations. Partucci was responsible for assuring compliance at RPC and at least two other plasma centers.

At some point, apparently in 1978, Partucci and Edgar Nugent, an Executive Vice President at AML, established a special office for the specific purpose of assuring compliance with federal regulations at AML plasma centers. The compliance office, headed by Partucci, operated from the Orlando Center. By late 1978, the compliance office included Partucci, Claudia Hayes, and Mary Jo Lawton. Another AML employee, Robert Curry, sometimes accompanied them on inspection trips. The members of the compliance "team" conducted periodic inspection at various AML centers to discover and correct any deficiencies in compliance with FDA regulations. Contrary to AML's later characterizations of their responsibilities, the members of the compliance team clearly drew their authority from AML, not from the Orlando Center where their office was located. Thus, they functioned as agents of AML.

The compliance team often conducted inspections in advance of FDA inspections. Some of the deficiencies, particularly at RPC, were severe enough, however, that the compliance team members began to instruct plasma center employees to falsify and fabricate records to conceal these deficiencies--a practice apparently engaged in on the basis of Partucci's instructions. During the time that RPC was closed in late 1978 and early 1979, the compliance team, sometimes with Queris and Curry, visited RPC to prepare for the FDA inspection prior to its reopening. Faced with numerous problems, the compliance team, Queris, and Curry instructed RPC employees to falsify various records or falsified the records themselves.

Partucci left AML in December of 1979; but, even after his departure, the practice of falsifying records continued. Several RPC employees testified at trial that they were instructed by the compliance team, Queris, or Curry to falsify various records, including whole blood weight logs (in which false entries regarding the number of overbleeds in a given day were recorded); quality control logs (in which false entries for quality control tests of equipment were made when such test had not been conducted); autoclave logs (in which false entries were made showing sterilization of materials and destruction of infectious plasma by autoclaving when such autoclaving had not occurred); and various other records including donor records and plasma storage freezer temperature charts.

After Partucci's departure, members of the compliance team began to report to Mili Lamas, a vice-president at AML. Sometime in March or April of 1980, Queris informed Lamas of the entire history of unlawful practices at RPC. ² In mid-March 1980, Lois Keith, an AML employee, travelled from the Miami office to the RPC offices, where she discovered a whole blood weight log that had been falsified. Keith telephoned Lamas to inform Lamas of her discovery. Several days later, Lamas met with Keith, Lawton, and Hayes to discuss the falsification of the weight log. Lamas informed them that AML's attorney would notify the FDA of the problem. Unbeknownst to Lamas, however, or anyone else at AML or RPC, several RPC employees had gone to the FDA in mid-March 1980 to report the long-standing and pervasive falsification practices at RPC.

The FDA began an inspection of RPC in March of 1980. By the end of that March, an initial FDA inspection report had been prepared. The investigation was concluded by June of 1980 and a final report prepared by October 1980. From that point until March 1982, various levels of the FDA reviewed what had been recommended. In March of 1982, the FDA referred the matter to the Department of Justice recommending criminal prosecution. The Department of Justice referred it to the U.S. Attorney's office in Richmond in mid-March 1982. An indictment was returned by the grand jury on December 12, 1983. An eight-day jury trial was held in March 1984 resulting in the conviction of AML on four of seven counts.

II.

AML alleges that the following instances of prosecutorial misconduct denied AML a fundamentally fair trial:

(1) that pre-indictment delay by the Government substantially prejudiced AML's ability to present a defense;

(2) that the Government did not fully respond to AML's request for a bill of particulars; and

(3) that Government counsel engaged in improper questioning of witnesses at trial.

We shall briefly address each of these allegations of prosecutorial misconduct.

A. Pre-indictment Delay and Prejudice

AML emphasizes that approximately 45 months elapsed from the time the FDA completed its initial investigative report in March 1980 to the time that the grand jury indicted AML in December 1983. During that period of time, Partucci left for Argentina. AML claims that it has been substantially prejudiced in presenting a defense because of the loss of Partucci's testimony. AML asserts that Partucci would have testified that no officer or director of AML participated in, had knowledge of, or directed the unlawful practices at RPC; that Partucci intentionally concealed such practices from AML; and that Partucci engaged in these practices for his benefit.

The district court, although indicating that it thought the delay was unreasonable and prejudicial, decided not to rule prior to trial on AML's motion to dismiss the indictment. App.Vol. III at 931. Following the trial, the district court declined to overturn the jury's verdict, apparently concluding, among other things, that AML had not been denied its right to a fair trial. App.Vol. VI at 2502-03 and 2510. We agree that AML has not been...