United States v. Michael Kaplan

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. Kap-lan worked at the clinic in Henderson, while his associate Dr. Brian Golden worked out of the Las Vegas clinic.…