U.S. v. Garfinkel, s. 93-3873

Decision Date13 July 1994
Docket Number93-4001,Nos. 93-3873,s. 93-3873
Citation29 F.3d 1253
PartiesUNITED STATES of America, Appellee, v. Barry GARFINKEL, Appellant. UNITED STATES of America, Appellant, v. Barry GARFINKEL, Appellee.
CourtU.S. Court of Appeals — Eighth Circuit

Lawrence S. Robbins, Washington, DC, argued (Laurie R. Rubenstein, DC, Douglas Kelley and Steven Wolter, Minneapolis, MN, on the brief), for appellant.

Andrew Mark Luger, Asst. U.S. Atty., Minneapolis, MN, argued, for appellee.

Before MAGILL, Circuit Judge, HEANEY, Senior Circuit Judge, and HANSEN, Circuit Judge.

MAGILL, Circuit Judge.

Barry Garfinkel appeals from the district court's 1 judgment entered after a jury found him guilty of making false statements to the government in violation of 18 U.S.C. Sec. 1001 (1988) and mail fraud in violation of 18 U.S.C. Sec. 1341 (Supp. IV 1992) and Sec. 1346 (1988). The government cross-appeals the district court's denial of a sentencing enhancement. We affirm.

I. BACKGROUND

Garfinkel, a psychiatrist and director of child and adolescent psychiatry at the University of Minnesota, was engaged by CIBA-GEIGY 2 in 1986 to participate in a research study involving the investigational drug, Anafranil. Such research studies are required by the Food and Drug Administration (FDA) pursuant to authority granted by the Food, Drug, and Cosmetic Act. Prior to approval of a drug for mass marketing, a pharmaceutical company is required to submit its plan, or protocol, for investigating the safety and effectiveness of the drug to FDA for approval. Research investigators then compile, through procedures mandated by the protocol, the data that will be used by FDA to determine whether the drug is safe and effective.

Between 1986 and 1989, Garfinkel participated, as the principal investigator, 3 in several research studies involving Anafranil. CIBA-GEIGY had proposed to FDA to study Anafranil because it believed Anafranil had potential therapeutic effects for individuals suffering from obsessive-compulsive disorder (OCD). 4

At the University of Minnesota site, Garfinkel enrolled in the study of children and adolescents suffering from OCD. Protocol 64, the initial study in which Garfinkel participated, was a ten-week double-blind study. 5 Data intended to indicate the safety and effectiveness of the drug were then collected through weekly patient visits. The data included, among other data, the completion of psychiatric rating scales and physical exams. After the initial ten-week period, Protocol 64 was extended to a one-year open-label study 6 to investigate further Anafranil therapy in patients who were enrolled in Protocol 64. After the completion of Protocol 64, CIBA-GEIGY then enlarged the scope of its investigation of Anafranil by conducting a larger open-label study entitled Protocol 62.

Prior to beginning the study of Anafranil, CIBA-GEIGY held an investigator's meeting in Toronto. During that meeting, the investigators received pharmaceutical information regarding Anafranil, instruction on the study protocol and required methodology, and training in the specific psychiatric review techniques required by the protocol. In Toronto, as part of the pre-study training, the investigators received specific instruction regarding the completion of the patient record forms (PRFs) that each patient enrolled in the study was assigned. PRFs are multi-page booklets intended for patient data collection and constructed by CIBA-GEIGY so that the investigator is aware from the PRF specifically what data must be collected for each patient visit. 7

In February 1989, Michelle Rennie, the study coordinator at the University of Minnesota site, filed a complaint with the University of Minnesota against Garfinkel. This complaint led to investigations by CIBA-GEIGY and FDA and, eventually, to Garfinkel's indictment. Rennie complained that Garfinkel ordered her to conduct entire study visits, including the accumulation of psychiatric and medical data; ordered her to enter false data on PRFs for visits that never occurred or for patients that did not fit the protocol requirements; and prescribed prohibited medications for patients during the study and ordered her to conceal their use. Rennie, although college educated, has no health care background.

In February 1993, a grand jury returned a twenty-five-count indictment against Garfinkel. After a jury trial, Garfinkel was convicted of three of the false statements counts and two of the mail fraud counts. Garfinkel timely appealed.

II. GARFINKEL'S APPEAL

Garfinkel argues on appeal that his conviction should be reversed because his signature on the PRFs was not a false statement in violation on 18 U.S.C. Sec. 1001, nor, according to Garfinkel, was his signature on the PRFs in furtherance of a scheme to defraud in violation of 18 U.S.C. Sec. 1341 and Sec. 1346. Garfinkel alleges further defects in both the mail fraud counts and evidentiary error.

A. The False Statements Counts

At Garfinkel's trial, he was tried on nineteen counts of violating the False Statements Act. The False Statements Act prohibits the intentional making of a false statement in a matter within the jurisdiction of the government. 8 The jury found Garfinkel guilty of counts five, twenty-one, and twenty-three.

Count five charged Garfinkel with falsely representing, through his signatures on the relevant PRF pages, that he had personally conducted Eve G.'s initial visit in Protocol 62. Count twenty-one charged Garfinkel with representing, through his signatures on the relevant PRF pages, that he had conducted Tom B.'s visit 17 in Protocol 64. And, count twenty-three charged Garfinkel with representing through his signatures on the relevant PRF pages, that he had conducted Stephanie M.'s visit 21 in Protocol 64. The evidence indicated that Garfinkel performed none of these visits, and that, in fact, no clinical investigator conducted the visits. Eve G. testified that Garfinkel did not conduct, nor did any individual conduct, her first visit in Protocol 62. The evidence indicated that Tom B. and Stephanie M. were seen by Rennie.

Garfinkel argues that his signature on the PRF did not constitute a false statement. Relying on Williams v. United States, 458 U.S. 279, 102 S.Ct. 3088, 73 L.Ed.2d 767 (1982), Garfinkel contends that his signature on the PRF simply is not a statement, false or otherwise. We do not review this claim. Because Garfinkel's trial defense and this argument are mutually exclusive, "he cannot now be heard to complain about his strategic choices." 9 United States v. Auman, 920 F.2d 495, 497 n. 5 (8th Cir.1990). In the alternative, Garfinkel alleges that his signature on the PRF is an ambiguous statement and the government " 'failed to clarify the facial ambiguities' in the underlying statement." Appellant's Br. at 25 (quoting United States v. Anderson, 579 F.2d 455, 460 (8th Cir.), cert. denied, 439 U.S. 980, 99 S.Ct. 567, 58 L.Ed.2d 651 (1978)). The government counters that its reliance at trial was not simply on the signature but on testimony about what Garfinkel was told the signature meant.

Garfinkel's defense at trial was quite specific: He alleged his signature at the bottom of each PRF page certified that he had reviewed the data, i.e., assessed the data on the form, irrespective of who performed the actual evaluation, or assessment, of the patient. 10 The government claimed that Garfinkel's signature on the PRF certified that he had personally performed the patient visit. 11 We agree that, standing alone, the statement related by Garfinkel's signature on the PRF is ambiguous; however, we also agree with the government that evidence offered at trial could potentially resolve any ambiguity on the face of the document. See Anderson, 579 F.2d at 459-60; United States v. Lanier, 578 F.2d 1246, 1252 (8th Cir.), cert. denied, 439 U.S. 856, 99 S.Ct. 169, 58 L.Ed.2d 163 (1978). 12

"[T]he government ha[s] the burden of negativing any reasonable interpretation that would make the statements true." United States v. Adler, 623 F.2d 1287, 1289 (8th Cir.1980). The parties explicitly limited the jury's interpretations of the representation made by the PRF signature. The jury was faced squarely with the question whether Garfinkel's signature on the PRF pages represents a statement that Garfinkel had personally conducted the patient visit or if the signature represents a statement that Garfinkel examined and analyzed the data. As a result, despite Garfinkel's characterization of his arguments on appeal, we believe he has raised a challenge to the sufficiency of the evidence supporting his conviction. That is, Garfinkel alleges that the evidence does not support the jury's verdict adopting the government's characterization of the PRF representation, as opposed to his characterization.

When reviewing the sufficiency of the evidence, or "the denial of a motion for judgment of acquittal, we examine the evidence in the light most favorable to the government." 13 United States v. Patterson, 886 F.2d 217, 218 (8th Cir.1989). "[T]he government is given the benefit of any reasonable inferences drawn from the evidence." Id. We reverse a jury verdict only if "the evidence viewed in the light most favorable to the [g]overnment is such that a reasonably minded jury must have reasonable doubt." Id. (internal quotations and citation omitted).

In support of their opposing views of the statement intended by the PRF signature line, the parties offered written materials that were given to the clinical investigators by CIBA-GEIGY. They also offered the testimony of witnesses regarding instructions given to Garfinkel for completing the PRFs and the understanding of other investigators or officials connected to the study.

The clinical investigators were given two different written instructions regarding the PRF signature line. The CIBA-GEIGY Clinical Investigator Reference Manual (the Manual) stated:

Regarding PRF...

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