Opinion ID: 460360
Heading Depth: 2
Heading Rank: 2

Heading: Naprosyn

Text: 27 The second study examined the long-term toxicity effects of Naprosyn, a drug used for the treatment of arthritis. That study was conducted by IBT for Syntex in 1971 and 1972. The government identified two problem areas in the reports from that study: 1) alleged fabrication of blood and urine data, and 2) alleged fabrication of much of the gross pathology data appearing in Appendix II of the report. 28 In testing the evidence to determine its sufficiency, we focus first on the blood and urine data reported, which the government charged was never actually collected. The government presented evidence that the study was extended beyond 18 months, and as a result of the final sacrifice was postponed and the blood and urine tests scheduled to occur just before the sacrifice were canceled and never thereafter rescheduled. There was testimony that if blood and urine tests were canceled, they would not be performed later unless specifically rescheduled. At the 22-month point, when the final sacrifice did take place, the defendants for various reasons were under pressure to end the study quickly. The blood and urine tests were not rescheduled. 29 The government contends that these tests were never conducted, which explains why the raw data for them could not be located. Technician Smith testified that he could not find raw blood and urine data to include in his draft of the Naprosyn report and that he brought this to Wright's attention along with his surmise that the work had not been performed. Wright did not take issue with this conclusion. 30 Technician Garrett testified that his responsibilities included setting up the rats for the blood and urine tests but that he had not done so, implying that the tests had not been performed. Yet ultimately, the final report contained blood and urine data for animals long dead at the time the blood and urine analysis would have been made. 31 Defendants argue that the government's proof rests solely on the absence of the raw data. In particular they contend that the inability to locate data is circumstantial evidence insufficient to establish that the data did not exist and was fabricated. Besides attacking the credibility of technician Garrett, the defendants maintain that any apparent errors in the reported blood and urine data indicate mere negligent recording of the actual data, not falsification of it. Proof of absence of records that would ordinarily exist if a particular event had occurred is properly admitted to show that the event did not occur. See, e.g., Federal Rule of Evidence 803(7); United States v. Zeidman, 540 F.2d 314, 319 (7th Cir.1976). Despite the defendants' arguments, the jury had ample evidence to support a finding of falsification. 32 Appendix II was a report which contained allegedly fabricated gross pathology data for animals examined post-mortem. The government presented evidence to show that the relevant log completely contradicted or left unsubstantiated findings authored by Plank in Appendix II. Technicians Smith, Garrett and Penner, among others, identified their records for specific animals and reported those animals that died during the study and were discarded without findings of any kind because they were too badly decomposed (TBD). Yet Plank included various gross pathology findings about these animals in Appendix II. The necropsy log frequently conflicted with results as reported in Appendix II in other respects as well. Presumably, if Plank's conclusions had been based on actual gross observations, they would have been confirmed by the necropsy log. 33 In order to justify Plank's Appendix II, defendants attempt to persuade us that Garrett performed necropsies that yielded the data reported by Plank. Yet Garrett and other technicians denied performing necropsies. Defendants also argue that several technicians never worked on the Naprosyn project, and therefore could not say whether or not necropsies were performed on TBD animals or whether or not results of gross examinations of these animals were recorded on the backs of cage cards. Dr. Gordon testified that cage cards were not considered raw data and were not kept after a project was completed. Therefore, defendants assert it was unreasonable for the prosecution to contend, or for the jury to conclude, that, five years after the Naprosyn study was finished, IBT's failure to produce cage cards supports the inference that the cards contained no gross pathology data. But these matters, in light of all the other evidence, presented jury questions and there was sufficient evidence to support the jury's conclusions. 34 The government argues that Keplinger had knowledge of the falsifications of the blood and urine data and Appendix II because he never looked into the matter of missing data when given reason to do so. The defendants contend that there is insufficient evidence that Keplinger failed to do so, and, alternatively, even if he did not look into missing data, it is unreasonable to infer that he had knowledge of the falsification. Although failure to investigate the question of the missing data, considered in isolation, may not be sufficient to demonstrate Keplinger's participation in the scheme to defraud, in combination with other evidence, it entitled the jury to infer that Keplinger knew of the falsifications. We conclude the evidence on the blood and urine data and on Appendix II was sufficient.