United States v. Kaplan

• Citation: 836 F.3d 1199
• Decision Date: 09 September 2016
• Docket Number: No. 15–10241,15–10241
• Parties: United States of America, Plaintiff–Appellee, v. Michael Stanley Kaplan, MD, Defendant–Appellant.
• Court: U.S. Court of Appeals — Ninth Circuit

836 F.3d 1199

United States of America, Plaintiff–Appellee,

v.Michael Stanley Kaplan, MD, Defendant–Appellant.

No. 15–10241

United States Court of Appeals, Ninth Circuit.

Argued and Submitted July 19, 2016 San Francisco, California

Filed September 9, 2016

Dennis P. Riordan (argued) and Donald M. Horgan, Riordan & Horgan, San Francisco, California, for Defendant–Appellant.

Elizabeth O. White (argued), Appellate Chief and Assistant United States Attorney; Daniel G. Bogden, United States Attorney; United States Attorney's Office, Reno, Nevada; for Plaintiff–Appellee.

Before: Susan P. Graber and Richard C. Tallman, Circuit Judges, and Nancy G. Edmunds,^** Senior District Judge.

OPINION

TALLMAN, Circuit Judge:

It is axiomatic that physicians are expected to do no harm. When a physician breaches that duty and puts his own interests above those of his patients, great harm can occur. Though the regulation of the practice of medicine is delegated to the states, when a physician misuses medical devices and threatens public health, the physician may run afoul of the Federal Food, Drug, and Cosmetic Act (“FDCA”). Doctor Michael Kaplan, a Nevada urologist, entered that domain when he decided to start reusing single-use plastic needle guides

during prostate biopsy exams.

Kaplan appeals his felony conviction for conspiracy to commit adulteration in violation of 21 U.S.C. § 331(k) with the intent to defraud or mislead. Kaplan challenges the statute under which he was charged, the sufficiency of the evidence, the denial of his proposed jury instructions, the sufficiency of the indictment, and his enhanced sentence. For all the reasons set forth below, we affirm.

I

In December 2010, Kaplan owned and operated two urology clinics located in Henderson and Las Vegas, Nevada. Kaplan worked at the clinic in Henderson, while his associate Dr. Brian Golden worked out of the Las Vegas clinic. At both offices the physicians regularly performed prostate needle biopsies

, a surgical procedure in which prostate tissue is removed and examined for disease.

During a prostate biopsy, an ultrasound probe is inserted into the patient's rectum to locate the prostate. A hollow needle is then injected through the rectal wall into the prostate to gather the tissue sample. A needle guide

, housing the collection needle, stabilizes the needle throughout the biopsy procedure. During the biopsy procedure, both the inside and outside of the needle are contaminated with various biological debris, including tissue, blood, and fecal matter, along with any bacteria and viruses. When the procedure is complete, the needle is pulled back into the channel of the needle guide, bringing debris with it. Because the procedure is bloody and dirty, patients take antibiotics at the time of the biopsy to prevent infection.

Needle guides

come in both single-use and reusable forms. Reusable guides are made of stainless steel and can be disinfected after every use. Single-use guides, however, are made of plastic, which is prone to scratching by the needle, creating crevices that can trap debris. The plastic guides come in distinctive packaging and are accompanied by a booklet clearly stating that they are sterile only for a single use and are not to be reused. Before the conduct at issue, Kaplan's office used a reusable stainless-steel guide and Golden's office used single-use plastic guides.

Circumstances changed in December 2010, when Kaplan's ultrasound machine broke and a new one was ordered. Kaplan was in a “tight crunch” and quickly ordered a refurbished machine and requested another reusable stainless-steel guide. Because a reusable stainless-steel guide was not available for the new machine and the old stainless-steel guide did not fit, sales representative Timothy Brandt arranged to send single-use plastic guides to Kaplan's office.

Office manager Mary Taylor called Brandt after the Kaplan office received the plastic guides, because she was concerned and upset that the guides were not reusable. Brandt told Taylor he had heard from a physician in California that, with appropriate sterilization, the single-use guides could be used two to three times before the guides disintegrate. Brandt, however, testified that he was relying only on the California physician's information because he was a lay person and “naive.” Brandt further testified that he never advised Taylor to reuse the single-use guides, he did not believe he was qualified to give such advice, and he never instructed her on how to sterilize the guides.

By January 2011, because both clinics were using the plastic guides, supplies were running short and additional plastic guides were on backorder with the manufacturer. Kaplan told Taylor and the medical assistant supervisor, Martha Cortez, to tell the medical assistants to reuse the plastic guides by cleaning them in the same manner as the reusable stainless-steel guides. Taylor told a medical assistant, in Kaplan's presence, that because the single-use guides were expensive, it would be “ridiculous” not to reuse them. Kaplan and Taylor insisted on reusing the guides even after the medical assistants pointed out that the packaging for the plastic guides clearly stated that they were for single use only.

No formal procedures for cleaning the single-use plastic guides were ever provided, other than Kaplan's instruction to clean them with the same Cidex¹ cleaning protocol used to clean the stainless-steel guide. Using that protocol, the medical assistants would first hold a guide under the sink to rinse it with water and then use a wire with bristles, like a pipe cleaner, or thin needle to clean the inside of the guide. The guides were then submerged in Cidex for a period of time. After transferring the guides to sterile water for some time, the guides were placed on a sterile tray, ready to use in the next biopsy.

There were many inconsistencies and safety issues surrounding the Cidex cleaning protocol as implemented in Kaplan's office. The temperature of the water and the length of time a guide spent in the initial rinse varied from medical assistant to medical assistant. The amount of time the guides spent in the Cidex also varied. Though Cortez, the supervisor, testified that the Cidex was refreshed and replaced “religiously,” the medical assistants did not know how often the Cidex was replaced or whether the logs were updated; they had never replaced the Cidex and had never checked the Cidex with test strips or checked the temperature. Cortez herself testified that she did not know that Cidex came with test strips. The sterile water in which the guides were placed at the end of the protocol was not changed frequently enough to maintain sterility.

Finally, Kaplan's office kept no record of how many times a particular guide was reused. But all employees estimated that the guides were reused three to five times. Neither Kaplan, Taylor, Cortez, nor the medical assistants informed patients that the guides were being reused.

During the time the medical assistants were instructed to reuse the plastic guides, they observed blood and pinkish water left in the guides. The pipe cleaner that the assistants used to clean the stainless-steel guide was not designed to clean the plastic guides and therefore did not reach fully inside the plastic guides. Additionally, the pipe cleaner could not reach into the scratches in the plastic created by the needle during the biopsy procedure, and blood and fecal matter became trapped in the guides. Assistants observed brown scratches that did not come clean during the disinfecting process. Cortez testified that she could tell the difference between a new and used plastic guide because the used guides were discolored.²

A month after Kaplan began reusing the single-use plastic guides, Dr. Golden discovered the reuse. Golden immediately contacted Taylor to tell her to stop the practice. Taylor informed Golden that “if this was ever happening at this office it's not happening anymore.” Golden assumed that the practice stopped. And Golden himself, who had always used the plastic guides, never reused them.

At this time, Kaplan's wife, Michelle Darquea Kaplan, an attorney and the office administrator, learned that the plastic guides were being reused. Mrs. Kaplan spoke to her husband, who told her they reused the plastic needle guides

just like any other medical equipment in the office. After doing some research and calling the company that made the disposable guides, Mrs. Kaplan again spoke to Kaplan because she was still confused as to whether the guides were reusable and why Golden had contacted Taylor. Kaplan replied that he didn't know and that Golden was “always mad at me for something.... He's probably just trying to give me a hard time or whatever.” Mrs. Kaplan then told her husband that they should stop reusing the plastic guides, he agreed, and Mrs. Kaplan told Taylor, the office manager, to instruct everyone to stop using the guides. As of January 6, 2011, Mrs. Kaplan believed that reuse had stopped.

The practice of reusing the needle guides

, however, did not stop. The medical assistants all testified that they were never told by Kaplan or Taylor to stop reusing the plastic guides. Reuse continued until March 2011, when Kaplan's own medical assistants reported him to the Nevada State Medical Board (“Medical Board”). The Medical Board immediately notified federal investigators and commenced its own inquiry in response.

When Food and Drug Administration (“FDA”) Office of Criminal Investigations special agents arrived on March 11, 2011, Kaplan readily admitted to reusing the guides. However, Kaplan inconsistently claimed to the agents how long reuse had lasted. First he insisted that reuse had ended as early as January, when Dr. Golden called, then later stated that it had lasted not beyond late February. When asked why he reused the devices, Kaplan would say only that “he was practicing cost-effective medicine and good patient care.” The agents...