United States v. Michael Kaplan

Rule of Law:

A physician's use of a consumable, single-use medical device on a paying patient satisfies the 'held for sale' element under 21 U.S.C. § 331(k) of the Federal Food, Drug, and Cosmetic Act (FDCA), allowing for prosecution if the device becomes adulterated.

Facts:

• Michael Kaplan, MD, owned and operated urology clinics in Henderson and Las Vegas, Nevada, regularly performing prostate needle biopsies.
• During biopsies, physicians used needle guides, which came in both single-use plastic and reusable stainless-steel forms; the plastic guides were explicitly labeled for single use only and prone to scratching, creating crevices that could trap debris.
• In December 2010, Kaplan's office received single-use plastic guides after a reusable stainless-steel guide was unavailable for a new ultrasound machine.
• Beginning in January 2011, Kaplan instructed his office manager, Mary Taylor, and medical assistant supervisor, Martha Cortez, to have medical assistants reuse the single-use plastic guides, cleaning them with the same Cidex protocol used for reusable stainless-steel guides, despite protests and clear single-use labels.
• Medical assistants observed blood, pinkish water, and fecal matter remaining in the reused plastic guides after cleaning, trapped in scratches, and noted the used guides were discolored.
• Kaplan and his staff did not inform patients that the single-use guides were being reused.
• After his associate, Dr. Brian Golden, discovered the reuse in February 2011 and instructed Taylor to stop, and Kaplan's wife, Michelle Darquea Kaplan, similarly told Kaplan to cease the practice after her own research, the reuse continued.
• In March 2011, Kaplan's own medical assistants reported him to the Nevada State Medical Board due to concerns over the continued reuse of the plastic guides.

Procedural Posture:

• On October 2, 2013, a grand jury in Nevada returned a two-count indictment against Michael Kaplan, MD, including one count for conspiracy under 18 U.S.C. § 371 to commit adulteration in violation of 21 U.S.C. §§ 331(k), 333(a)(2), and 351(a)(2)(A).
• Before trial, Kaplan moved to dismiss the indictment in the United States District Court for the District of Nevada, arguing his use of guides was not covered by the 'held for sale' provision of § 331(k).
• The district court (Judge Philip M. Pro) denied Kaplan's motion to dismiss, adopting the magistrate judge's recommendation that 'held for sale' included a physician's use of a device in treating patients.
• After a nine-day jury trial in the district court, Kaplan was found guilty of conspiring to commit adulteration on September 25, 2014, with a special finding that he acted with the intent to defraud or mislead, leading to a felony conviction.
• On May 5, 2015, Chief District Judge Gloria Navarro sentenced Kaplan to 48 months' imprisonment, upwardly varying from the advisory guidelines, and final judgment was entered on May 7, 2015.
• Kaplan, as Defendant-Appellant, appealed his felony conviction to the United States Court of Appeals for the Ninth Circuit, challenging various aspects including the statute's applicability, sufficiency of the evidence, denial of jury instructions, sufficiency of the indictment, and his enhanced sentence.