United States v. Kaplan

Dr. Michael Kaplan (defendant) owned and operated two for-profit urology clinics in Nevada. Doctors in Kaplan’s clinics regularly performed prostate needle biopsies (i.e., surgical procedures that removed and examined prostate tissue). During biopsies, a needle guide stabilized the collection needle while tissue was collected and removed from the prostate through the patient’s rectal wall. Until late 2010, one of Kaplan’s clinics used a reusable stainless-steel needle guide, whereas the other clinic used single-use plastic needle guides that were packaged with literature clearly stating that the guides should be used only once. However, due to equipment issues in late 2010, Kaplan began directing medical assistants at both clinics to reuse the single-use plastic guides. Although the medical assistants notified Kaplan that the plastic-guide packaging clearly stated that the products were for single use, Kaplan and Kaplan’s office manager insisted that the guides be reused. The medical assistants noticed that the pipe cleaners used to clean the plastic guides did not fit all the way into the guides, resulting in leftover blood and fecal matter. Nevertheless, the medical assistants continued reusing the plastic guides at Kaplan’s direction until March 2011, when the medical assistants reported Kaplan to the Nevada State Medical Board (the board). The board reported Kaplan to federal investigators, and the United States government (plaintiff) ultimately charged Kaplan with conspiracy to commit adulteration under 21 U.S.C. § 331(k), part of the Federal Food, Drug, and Cosmetic Act (FDCA). That section prohibited any act that adulterated a drug or device while the drug or device was “held for sale.” Kaplan argued that using a device like the needle guides in treating patients was not covered by the ”held for sale” language, but the district court disagreed. A jury convicted Kaplan, and Kaplan appealed.