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United States v. Schulte

United States Court of Appeals, Tenth Circuit

January 21, 2014

UNITED STATES of America, Plaintiff-Appellee,
v.
George John SCHULTE, a/k/a John Schulte, Defendant-Appellant.

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[Copyrighted Material Omitted]

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Thomas L. Kirsch, II, (Steffen N. Johnson, Washington, DC; Michael A. Skokna, Andrew J. Yahkind, Benjamin L. Ellison, Chicago, IL, with him on the brief) of Winston & Strawn LLP, Chicago, IL, for Defendant-Appellant.

James C. Murphy, Assistant U.S. Attorney, (John F. Walsh, United States Attorney, Jaime A. Pena, Tim R. Neff, Assistant

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U.S. Attorneys, with him on the brief) U.S. Attorney's Office, District of Colorado, Denver, CO, for Plaintiff-Appellee.

Before KELLY, McKAY, and O'BRIEN, Circuit Judges.

O'BRIEN, Circuit Judge.

John Schulte appeals from his conviction on one charge of making a false statement to the government. See 18 U.S.C. § 1001(a). The charge alleged he made five false statements during a voluntary interview with a United States Food and Drug Administration (FDA) agent while a search warrant was being executed at the offices of Schulte's employer, Spectranetics. Schulte claims two of the charged statements were not false, and therefore, cannot support the verdict as a matter of law. As to all five statements, he contends the government failed to prove both his intent to supply false information and the materiality of the statements to the government's investigation. We find no error and affirm.

BACKGROUND

Because the jury found Schulte guilty, we draw the facts from the evidence presented at trial in the light most favorable to the government. United States v. Rufai, 732 F.3d 1175, 1188 (10th Cir.2013). Schulte was the Chief Executive Officer of Spectranetics, located in Colorado Springs, Colorado. The company primarily developed, manufactured, and marketed laser-based medical devices for use in procedures to remove blockage in coronary (heart) arteries and peripheral arteries (usually located in the patient's leg). Schulte was CEO from January 2003 through October 2008. During this time, Spectranetics sought to expand its product line to include devices made by other manufacturers which would provide a good fit with Spectranetics' products. To that end, Schulte and various other Spectranetics employees engaged in discussions with manufacturing companies in the United States and abroad.

Schulte's statements concerned two potential product expansions. The first was a guidewire designed to puncture through a severe artery blockage known as chronic total occlusion.[1] The guidewire was designed and manufactured by a Japanese company, Future Medical Design, Ltd. (FMD). The second product was a balloon angioplasty catheter which was placed into an artery to expand its circumference to remove blockage. This product was designed and manufactured by Bavarian Medizin Technologie (BMT) in Germany.

A. FMD Guidewire

The negotiations between Spectranetics and FMD began in early 2005 and continued through the end of 2007. On at least three occasions, Schulte travelled to Japan to meet with FMD President, Tsuyoshi Terashi, and was given guidewire samples to bring back to the United States. The first visit occurred in July 2005, when Schulte received a prototype coronary wire. In late September/early October 2005, FMD shipped 50 guidewires of various specifications to Spectranetics. Although FMD's facilities and products were approved by Japanese authorities, they had not been approved by the FDA. Spectranetics planned to file the necessary information for such approval. Prior to filing for approval, however, Schulte asked Dr. Bruce Murphy, one of Spectranetics' advising physicians, to evaluate the guidewires

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after he had used them in patients. Spectranetics received a second shipment of ten peripheral guidewires in November 2005. These wires were also sent to Dr. Murphy for evaluation. It is undisputed Murphy placed FMD's wires in five patients in November 2005, although the parties dispute whether he knew the product was not FDA-approved at that time. As reported to Schulte, the evaluation of the guidewire was very positive.

Schulte again visited FMD in August 2006. At that time, he was given samples of new peripheral guidewires to bring back with him for bench evaluation. Schulte's third visit to FMD's facilities occurred in the summer of 2007; he returned with samples of the newest design. Disagreements over pricing stalled negotiations, but even so, Spectranetics submitted a 510(k) request for approval of the guidewires with the FDA under the market name " Quick-Cross" guidewires.[2] (Appellant's App'x. Vol. V at 1920-21.) The FDA requested additional information to complete the approval process. When Spectranetics did not respond, the FDA considered the 510(k) application withdrawn. In October 2007, Spectranetics notified FMD it was cancelling further business dealings as of January 1, 2008.

B. BMT Balloon Catheter

BMT manufactured medical devices for customers worldwide. Each device was made to the customer's specifications and then distributed under the customer's label. In 2007, Schulte began negotiations with Knut Sauerteig, BMT's managing director, regarding a line of BMT balloon catheters. These catheters were not distributed in the United States and the balloons under discussion were not approved in Europe or by the FDA. In October 2007, BMT sent Spectranetics a shipment to be used in clinical studies (used on human patients) prior to FDA approval. A Spectranetics employee developed a one-page form entitled " BMT PTA Catheter Product Evaluation" to record the physician's comments. (Appellant's App'x Vol. VIII at 3290.) By e-mail, Schulte approved the form stating, " [O]n the money. I look forward to the results." (Appellant's App'x Vol. III at 1282.)

At the end of October, Schulte and others met with Sauerteig in Washington D.C. They discussed the positive clinical evaluations from two physicians, Dr. Craig Walker and Dr. Robert Gallino. Again, there was contradicting testimony as to whether the doctors knew the devices were not approved in the United States. Negotiations between the two companies continued into 2008, but were formally terminated in January 2009.

C. Internal Investigation

On April 1, 2008, a former employee contacted the Spectranetics' employee hotline.

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He complained of unethical practices, including the use of unapproved German and Japanese devices in patients. Emile Geisenheimer, chairman of Spectranetics Board of Directors, telephoned Schulte and told him about the allegations. Schulte denied any use of the devices in humans and stated he had ordered the devices only for bench testing in the United States. Spectranetics' Board hired an outside law firm to conduct an internal investigation to determine the truth of the allegations. Lawyers from the firm interviewed Schulte and other Spectranetics employees over the next few months and Schulte and Geisenheimer spoke frequently during the investigation. Schulte steadfastly maintained the devices had not been used in human patients. In August 2008, Spectranetics' general counsel ended the Board's investigation.

D. FDA Search Warrant

In July 2008, three former employees and one current employee brought their allegations to the FDA. The employees provided internal company e-mails and the BMT evaluation forms as proof of Spectranetics' illegal conduct under Schulte's direction. FDA investigator Dan Burke was assigned to lead the investigation. The employees' information led to a search warrant which FDA executed on September 8, 2008.

Burke, along with 30-40 officers from the FDA and other federal agents, arrived unannounced at Spectranetics offices at approximately 9:15 a.m. The first hour was " chaotic." (Appellant's App'x Vol. V at 2257.) After immediate business concerns were addressed, Schulte and other key employees agreed to be interviewed. Burke conducted Schulte's interview in the presence of Special Agent Rob Cruz and Spectranetics' corporate counsel. Although Cruz and general counsel were both called out of the interview at certain times, they were present for much of the questioning. According to Burke's testimony, Schulte said: he was never supplied FMD guidewires while in Japan and did not physically carry guidewires with him when he returned to the United States; he was not aware his staff or consultants provided FMD guidewires to Bruce Murphy for use in human patients; he never physically provided BMT balloons to Dr. Robert Gallino or Dr. Craig Walker for use in human patients; and when asked if " this testing [was] done by rogue employees," Schulte said, " I don't know." (Appellant's App'x Vol. V at 2221, 2223-24, 2225, 2227.) When shown the BMT evaluation forms with the testing results, Schulte said " he had never seen the forms before." ( Id. at 2225-26.)

Because Burke did not feel Schulte was being truthful, he provided Schulte an advisement form containing the language of 18 U.S.C. § 1001(a) which states, in relevant part:

[W]hoever, in any matter within the jurisdiction of the executive, legislative, or judicial branch of the Government of the United States, knowingly and willfully— .... makes any materially false, fictitious, or fraudulent statement or representation.... shall be fined under this title [and] imprisoned not more than 5 years....

This was followed by a sentence reading: " I have read and understand the provisions and penalties of this law." (Appellant's App'x Vol. VIII at 3281.) Schulte read the form and signed it. He told Burke he did not want to change any of his statements.

Later that day, Schulte called Chairman Geisenheimer. Schulte was " distraught" and said he had been reviewing his e-mails and realized his statements to the FDA agents were not accurate. (Appellant's

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App'x Vol. VI at 2341.) Geisenheimer told him to immediately contact the federal agents to correct the record and to get his own lawyer. Geisenheimer testified " it was incredible to me that one needs to review their e-mails to know whether they were knowledgeable of facts." ( Id. at 2341.) According to Geisenheimer:

Schulte's statements about those balloons and wires changed from not having any knowledge of it to certainly believing that they were never used in humans, to acknowledging that they were imported, and if anything, this was a misdemeanor, that the doctors knew about it, that ... senior colleagues, executives of the company knew about it, and it's common in the industry because these were low technology devices, et cetera.

( Id. at 2358-59.) Geisenheimer, however, said the use of unapproved devices was not common in the industry; he had " never encountered it before in [his] 40 years in the medical device industry." ( Id. at 2359.)

E. Schulte's Corrections

Schulte, through his attorneys, provided three letters correcting his interview statements. On September 9, 2008, his attorneys faxed a letter to Burke. It said, in part: " In thinking about the questions you asked concerning guidewires, Mr. Schulte promptly went back to check his records. This further review has refreshed Mr. Schulte's recollection that in early July [ ] 2005, Mr. Schulte returned from FMD with a single demonstration sample." (Appellant's App'x Vol. VIII at 3304.) The second letter, sent on September 22, 2008, attached an e-mail chain showing Schulte's knowledge of the proposed BMT evaluation form. The letter said:

Mr. Schulte believes Special Agent Burke showed Mr. Schulte the same or similar versions of this form, which had handwriting as though the forms had been filled out in whole or in part.
To clarify, Mr. Schulte still does not believe he had ever seen the completed forms before the interview.... Based on Mr. Schulte's subsequent review of this matter, however, it appears he had seen an earlier version of the form which did not bear the handwriting on the forms Special Agent Burke displayed.

( Id. at 3305-06.) The third letter, dated January 16, 2009, was sent to the Assistant United States Attorney. It explained Schulte's files " suggest[ed] that Mr. Schulte brought a small number of FMD guidewires into the United States on two additional ...


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