United States v. Schulte

741 F.3d 1141, 2014 WL 211833, 2014 U.S. App. LEXIS 1079
CourtCourt of Appeals for the Tenth Circuit
DecidedJanuary 21, 2014
Docket12-1239
StatusPublished
Cited by10 cases

This text of 741 F.3d 1141 (United States v. Schulte) is published on Counsel Stack Legal Research, covering Court of Appeals for the Tenth 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. Schulte, 741 F.3d 1141, 2014 WL 211833, 2014 U.S. App. LEXIS 1079 (10th Cir. 2014).

Opinion

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, Spectranet-ics. 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. Spec-tranetics 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 guide- *1145 wires 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 guide-wires with the FDA under the market name “Quick-Cross” guidewires. 2 (Appellant’s App’x. Yol. V at 1920-21.) The FDA requested additional information to complete the approval process. When Spec-tranetics 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, “[0]n the money. I look forward to the results.” (Appellant’s App’x Vol. Ill 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 hot *1146 line. He complained of unethical practices, including the use of unapproved German and Japanese devices in patients. Emile Geisenheimer, chairman of Spec-tranetics 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. Speetranetics’ 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 Speetranetics 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, Speetranetics’ 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 Spec-tranetics’ 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.

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Bluebook (online)
741 F.3d 1141, 2014 WL 211833, 2014 U.S. App. LEXIS 1079, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-v-schulte-ca10-2014.