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United States v. Hofstetter

United States District Court, E.D. Tennessee, Knoxville

August 28, 2019



          Debra C. Poplin United States Magistrate Judge

         All pretrial motions in this case have been referred to the undersigned pursuant to 28 U.S.C. § 636(b) for disposition or report and recommendation regarding disposition by the District Court as may be appropriate. Defendants Hofstetter, Newman, and Clemons ask [Doc. 444] the Court to exclude or limit the expert testimony of the Government's four medical experts, arguing that their proposed testimony is not reliable or relevant. They also ask the Court to exclude or limit the use of the Government's DOMEX report, contending that the methodology used in compiling the data contained therein is deficient on its face. The Government responds [Doc. 477');">477] that a hearing to test the methodology of its medical experts is unnecessary because the Defendants do not raise a Daubert issue, its medical experts may properly testify about their opinions on patient files that they have reviewed, and its DOMEX report is admissible as a summary of other admissible evidence.

         For the reasons discussed herein, the Court finds the parties agree that the Government's medical experts cannot extrapolate to the treatment of patients at the pain clinics as a whole, based solely upon their review of a limited number of patient files selected by the Government. Thus, a “Daubert hearing, ” at which the Government's experts must defend their methodology, is not necessary. The Court also finds that the DOMEX report is not subject to a Daubert analysis, because it is not an expert report.


         On March 10, 2015, law enforcement officers executed search warrants at two pain clinics associated with this case and seized approximately 6, 300 patient files.[1] In preparation for trial, the Government retained the following medical experts: Dr. James Wilke, an anesthesiologist and the medical director of a pain management clinic; Dr. John Blake, a medical doctor, president and medical director of a pain management clinic, and assistant professor at the University of Tennessee Department of Medicine; Dr. Michael Carter, a retired professor at the University of Tennessee Health Science Center, with a doctorate in nursing practice; and Mr. Gary Tooley, a physician assistant and associate professor at Christian Brothers University [Doc. 477');">477, pp.5-7]. The Government selected and provided a number of patient files, seized from the pain clinics in this case, for each of these experts to review: Dr. Wilke reviewed 55 files; Dr. Blake reviewed 79 files; Dr. Carter reviewed 77 files; and Mr. Tooley reviewed 13 files [Doc. 477');">477, pp.5-6]. The Government also provided these experts with “related prescription data” from the Tennessee Controlled Substance Monitoring Database, which is maintained by the Tennessee Department of Health [Doc. 477');">477, p.7]. The experts created written opinions on the files they reviewed, and the Government disclosed these reports to the Defendants [Doc. 477');">477, p.7].

         The Government also used the Drug Enforcement Agency's National Drug Intelligence Center, Document and Media Exploitation Branch (“DOMEX”) to extract certain data from patient files seized from the Lenoir City and Knoxville pain clinics in this case and to quantify and summarize the data from these files [Doc. 477');">477, p.7]. The Government selected 444 patient files based upon its own criteria, such as whether the patient had died, claimed disability, had been indicted in a related case, was an undercover agent, or had been discharged from one clinic and sent to an associated clinic [Doc. 477');">477, p.8]. An additional 256 patient files were randomly selected [Doc. 477');">477, p.8]. Analysts from DOMEX manually entered the data from these 700 patient files and then provided summaries of specific data points requested by the Government: Summary of Weight by Drug, Summary of Drug Weights by Provider, Location and Demographics of Patients, Provider Summary Tables, Payments and Referrals, and Drugs Prescribed by Provider [Doc. 477');">477, p.8]. Logan Lake and Jon West, the analysts who oversaw the creation of the “DOMEX report” in this case, do not hold a medical degree or have any medical training or experience [Doc. 477');">477, p.8].

         Relying on Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993), the Defendants argue [Doc. 444] that the Government's medical experts should be excluded because the methodology used in selecting the patient files they reviewed is flawed and the sample pool of patient files is unrepresentative. They maintain that because the Government “cherry picked” the patient files reviewed by the medical experts, the experts' opinions are skewed to support the Government's theory of the case and any extrapolation to the case as a whole from their review of this flawed sample will mislead or confuse the jury. They also argue that the medical experts' opinions are not relevant to whether the Defendants acted like conventional drug dealers in this case. Accordingly, the Defendants assert that the Government's medical experts must be excluded or, at least, limited to the files they each individually examined.

         With regard to the DOMEX report, the Defendants also argue that the unrepresentative selection of patient files analyzed renders the report unreliable. They ask the Court to exclude the report or to order the Government not to extrapolate to the whole patient population and to instruct the jury that it may not extrapolate from the report to all of the patients in the clinic.

         The Government admits [Doc. 477');">477] that it selected all of the patient files reviewed by its experts and most of the files analyzed in the DOMEX report, but it contends that this does not create a Daubert issue. It argues that the manner in which the files were selected does not affect the reliability of the experts' opinions about the files that each expert has reviewed. The Government argues that in addition to providing their expert medical opinion about the files that they have each personally reviewed, its medical experts may properly give an opinion on the examination and prescribing practices of the clinic medical staff in light of the overall clinic environment. It maintains that its medical experts may also properly testify about the generally acceptable standards for issuing prescriptions.

         The Government also argues that the DOMEX report is not an expert report subject to Daubert analysis but, instead, is a summary pursuant to Federal Rule of Evidence 1006. It asserts that the DOMEX report is admissible, because it summarizes a large volume of patient files, which cannot be conveniently introduced at trial. The Government maintains that the patient files have all been provided in discovery and that each patient file would be individually admissible. It also contends that the summaries contained within the report are accurate and not prejudicial and that the report will be introduced by an analyst, who supervised its preparation. Thus, the Government argues that the DOMEX report is admissible under Rule 1006. It asserts that if the Defendants object to the method used to create the report, their remedy is to cross-examine the analysts about the sample selection and size at trial.

         The Court heard argument on these issues at a motion hearing on May 10, 2019. Assistant United States Attorneys Tracy L. Stone and Kelly Kathleen Pearson appeared on behalf of the Government. Attorneys Charles C. Burks, Jr., and Loretta G. Cravens represented Defendant Hofstetter. Attorneys Christopher J. Oldham and Mark E. Brown represented Defendant Newman. Attorneys Randall E. Reagan and Cullen Michael Wojcik represented Defendant Clemons.[2] The Defendants were excused from appearing at the hearing.

         Mr. Brown argued on behalf of the Defendants that the testimony of the Government's experts is neither reliable, nor relevant. He asserted that the Government's theory of the case is that the medical providers working at the clinics at issue were essentially drug dealers with prescription pads and that not one patient received care that was within the scope of professional practice or for a legitimate medical purpose. Mr. Brown maintained that the opinions of the Government's medical experts are not reliable, because they reviewed a small percentage of patient files, all of which were chosen by the Government. He agreed that the Government's medical experts could properly give an expert opinion about the care of a specific patient whose file the expert reviewed. However, he argued that the Government's theory in this case is that the entire clinics are run illegally, and that due to the statistical unreliability of the method of choosing the patient files, the Government's experts cannot give a valid expert opinion about the patient care at the clinics as a whole.

         Mr. Oldham argued that there are two problems with the Government's proposed medical experts. One issue is that the expert reports disclosed by the Government do not provide the standards upon which Dr. Blake and Dr. Wilke based their opinions and provide only a brief statement of the standard used by Mr. Carter. Mr. Oldham argued that defense counsel need a Daubert hearing in order to question the Government's experts about the standards that form the basis of their opinions. However, he acknowledged that the Defendants are not challenging the credibility or the qualifications of the Government's medical experts. Mr. Oldham asserted that if the experts are limited to testifying about the specific patient files that they reviewed, then defense counsel can cross-examine them about those files.

         Mr. Oldham argued that the more important issue is whether the Government's medical experts should be allowed to extrapolate to the clinics as a whole, based upon their review of an invalid statistical sample. He stated that a truly random sample is necessary in order to extrapolate to the entire group. He noted that the files selected by the Government for the experts to review were almost exclusively those of patients who were indicted. Thus, he contends that the sample was weighted to yield the conclusion that the Government wants. Mr. Oldham contended that the Court, as the gatekeeper, must make a threshold ruling that this data is not reliable in this case. He argued that the average juror does not understand statistics and, thus, it would be very difficult for defense counsel to expose the flaws in the expert's extrapolation through cross-examination. Mr. Oldham agreed that a Daubert hearing would not be relevant to the issue of the reliability of the sample, because the Government admits that it selected the patient files. He asked the Court to rule that while the Government's medical experts can testify on their opinions about the individual charts that they reviewed, they cannot extrapolate to all the patients or to the clinic as a whole.

         Mr. Brown argued that the DOMEX report is also inadmissible, even as a summary, because the manner in which the patient files included in the summary were selected is flawed. He argued ...

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