Health Law Checkup
Ninth Circuit Upholds Felony Conviction of Urologist, Under FDCA, for Reusing Single-Use Needle Guides During Prostate Biopsies (September 9, 2016)
The background of the case began in 2010 when Dr. Kaplan’s office ran out of reusable needle guides for prostate biopsies. The needle guide is a housing that stabilizes the needle throughout the biopsy procedure. During the procedure, the needle is contaminated with tissue, blood, and fecal material. Patients take antibiotics to prevent infection.
Needle guides come in single-use and reusable forms. Reusable guides are made of stainless steel and can be disinfected after every use. Single-use guides are made of plastic and are not to be reused. The plastic guides are prone to scratching by the needle, which may create crevices that can trap debris.
After Dr. Kaplan needed to purchase a new ultrasound machine, he could no longer use his reusable stainless steel guide as it did not fit. Therefore, he requested a new stainless steel guide, but a new one was not available. When the office also ran out of single-use plastic guides, the office began, as directed by Dr. Kaplan, cleaning the plastic guides for multiple use. There was conflicting testimony on the protocol used to clean the guides, how often they were reused, and when the office stopped using them. At trial, the government estimated that Dr. Kaplan used 67 guides for 94 procedures. Both sides offered evidence regarding whether the guides were adulterated, and whether they may have become contaminated.
On appeal, the primary issue was whether the use of the guide in the course of treating a patient was a “sale” under the statute (“the device is adulterated if it is ‘held under insanitary conditions whereby it may have been contaminated …’”) The Court noted that the medical practice was operated for a profit, and patients paid for both services and products used in the course of treatment. Therefore, the Court concluded that the plastic guides were covered by the “held for sale” provision of the statute. The Court also held that there was sufficient evidence to support the conviction that Dr. Kaplan conspired to commit adulteration in violation of Section 331(k) and to support the special finding that he intended to defraud his patients, the public, and the government.
The Court then rejected Dr. Kaplan’s contentions that the trial judge erred in refusing proposed jury instructions on his defenses that “off label use” of an unadulterated device is not unlawful, and that the “practice of medicine” allows the use of adulterated devices. Finally, the Court expressed its opinion about Dr. Kaplan in its conclusion:
At one point, Kaplan bragged that the volume of the successful medical practice made him the “McDonald’s of Urology”. But the evidence showed that, instead of protecting the safety of his patients, Kaplan took shortcuts to keep pumping patients through his clinic. Greed overcame his concern for patient care. And his practice of reusing single-use plastic guides on prostate biopsy patients bought them into contact with dangerous products, threatened public health, and breached Section 331(k) of the FDCA.
See U.S. vs. Michael Stanley Kaplan, M.D., No. 15-10241, D.C. No. 2:13-cr-00377-GMN-CWH-1 (Ninth Circuit, 09/09/2016), http://cdn.ca9.uscourts.gov/datastore/opinions/2016/09/09/15-10241.pdf
