United States v. Barry Garfinkel, United States of America v. Barry Garfinkel

29 F.3d 1253, 1994 U.S. App. LEXIS 17093
CourtCourt of Appeals for the Eighth Circuit
DecidedJuly 13, 1994
Docket93-3873, 93-4001
StatusPublished
Cited by43 cases

This text of 29 F.3d 1253 (United States v. Barry Garfinkel, United States of America v. Barry Garfinkel) is published on Counsel Stack Legal Research, covering Court of Appeals for the Eighth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States v. Barry Garfinkel, United States of America v. Barry Garfinkel, 29 F.3d 1253, 1994 U.S. App. LEXIS 17093 (8th Cir. 1994).

Opinion

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. § 1001 (1988) and mail fraud in violation of 18 U.S.C. § 1341 (Supp. IV 1992) and § 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, Gar-finkel 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 *1255 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 Garfink-el’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. § 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. § 1341 and § 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 repre *1256 senting, 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).

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Bluebook (online)
29 F.3d 1253, 1994 U.S. App. LEXIS 17093, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-v-barry-garfinkel-united-states-of-america-v-barry-ca8-1994.