A Nevada urologist was properly convicted for conspiracy under the federal Food, Drug, and Cosmetic Act for the reuse of plastic needle guides during prostate biopsy procedures, an appellate court has ruled.
As described in the published opinion, U.S. v. Michael Stanley Kaplan, MD, 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 a tissue sample. During the procedure, both the inside and outside of the needle are contaminated with biological debris, including tissue, blood, and fecal matter. The needle guide houses and stabilizes the collection needle.
According to the opinion from the Ninth U.S. Circuit Court of Appeals, Dr. Kaplan began using plastic needle guides labeled as "for single-use only" for such procedures after the urology office’s ultrasound machine broke down and reusable stainless-steel guides were not available for the new machine. The next month, supplies of the plastic guides were running short and Dr. Kaplan told the office manager and the supervisor of the office’s medical assistants to reuse the plastic guides by cleaning them in the same manner as the stainless-steel guides. The office used running water, bristle wire, thin needles, Cidex, and sterile water to clean the plastic guides. No record was kept on Cidex replacement schedules or how many times a particular guide was reused. Patients were not told that the needle 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 and brown scratches that did not come clean during the disinfecting process. Three months later, Dr. Kaplan’s medical assistants reported him to the Nevada State Medical Board, which commenced an inquiry and immediately notified federal investigators.
When federal agents arrived at the office, Dr. Kaplan admitted his office reused the guides but insisted that the practice had stopped. According to the opinion by the Ninth Circuit, when asked why the office reused the devices, the urologist said only that he was practicing cost-effective medicine and good patient care.
In 2013, a Nevada grand jury indicted Dr. Kaplan for conspiracy to commit adulteration of a drug or device that is “held for sale.” Under the Food, Drug, and Cosmetic Act (FDCA), a device is adulterated if it is “held under unsanitary conditions whereby it may have been contaminated with filth, or . . . rendered injurious to health.”
At trial, a defense witness offered that the risk of infection to Dr. Kaplan’s patients was between one in one trillion and one in one hundred trillion. The expert admitted, however, that he was the primary author of an article that advised “do not reuse items labeled for single use” and had conducted no experiments to determine if the plastic guides could safely be reused. After a nine-day jury trial, Dr. Kaplan was found guilty of conspiring to commit adulteration and that he had acted with the intent to defraud or mislead.
On appeal, Dr. Kaplan’s attorneys contended that the plastic guides were not “held for sale” because title and possession of the guides were not transferred to the patients.
In upholding Dr. Kaplan’s conviction, however, the Court of Appeals “focused more generally on the commercial nature of the transaction, actors, and products.”
“A single-use device is meant to be ‘consumed’ in the course of treating a patient – just like a drug,” the three-judge panel wrote. “Once the single-use device is used or consumed, there is nothing left to be done with the device. It no longer possesses a functional purpose in the medical practice and, rather than giving the used device to the patient, the doctor disposes of it. Therefore, when a physician uses a disposal device on a patient, the device is ‘held for sale’ within the meaning of the FDCA provided that there is a commercial relationship between the doctor and the patient and that the device is one that is meant to be ‘consumed’ in the process.”
Gordon Ownby is CAP’s General Counsel. Comments on Case of the Month may be directed to gownby@CAPphysicians.com.