Last week, the Ninth Circuit affirmed a physician’s conviction for conspiracy to distribute an adulterated device with intent to defraud or mislead in violation of Section 331(k) of the federal Food, Drug and Cosmetic Act (FDCA). The physician – who dubbed his own practice “The McDonald’s of Urology” because of the high volume of patients he treated – reused plastic needle guides meant for single-use to conduct prostate biopsies on his patients over a period of several months.
Prostate biopsies involve inserting an ultrasound probe into the patient’s rectum to locate the patient’s prostrate and then using a hallow needle to collect a tissue sample from the prostate wall, which can be biopsied for disease. The needle is inserted through a needle guide, which comes in a reusable stainless steel version or a single-use plastic version. The physician in this case – Dr. Michael Stanley Kaplan – originally used a stainless steel needle guide, which was sterilized after each use. After his ultrasound machine broke, he switched to the single-use plastic needle guides, but, instead of disposing of them as directed by the manufacturer, he sterilized and reused them. Despite being warned by another physician, members of his staff, and his own wife to stop reusing the plastic needle guides, Dr. Kaplan continued the practice for several months until a staff member reported him to the Nevada State Medical Board.
At trial, Dr. Kaplan was found guilty of conspiracy to commit adulteration in violation of Section 331(k) of the FDCA. Section 331(k) prohibits “the doing of any . . . act with respect to . . . [a] drug [or] device . . . if such act is done while such article is held for sale . . . after shipment in interstate commerce and results in such article being adulterated.” 21 U.S.C. § 331(k). A device is adulterated if it is “held under insanitary conditions whereby it may have been contaminated with filth, or . . . rendered injurious to health.” Id. § 351(a)(2)(A).
On appeal, Dr. Kaplan argued that Section 331(k) of the FDCA did not apply to his conduct because he never offered the needle guides for sale, but simply used them as equipment in a manner he believed was safe. The Ninth Circuit rejected this argument, agreeing with the district court that a physician’s use of a consumable device on a patient is covered by the “held for sale” provision of Section 331(k) of the FDCA. The Ninth Circuit explained that Section 331(k) of the FDCA covered Dr. Kaplan’s conduct because he used the needle guides in a commercial nature, stating that “patients who paid Kaplan for the medical services he performed were also paying for the cost of products used in the course of treatment, including biopsies. . . the patients were therefore the ultimate consumers of the guides.”
The Ninth Circuit similarly rejected Dr. Kaplan’s claim that his reuse of the single-use guides constituted a permissible, “off-label” use of the product. According to the Ninth Circuit, this argument failed for two reasons. First, off-label uses do not protect a physician who uses an adulterated product; rather, off-label uses allow physicians to prescribe lawful drugs for unapproved uses. Second, the so-called “off-label use” provided no benefit to the patients. As the Court stated, “[t]he benefits, if any, of reusing the single-use guides seem to be confined to cost savings for Kaplan and had nothing to do with Kaplan’s management of patient care.”
The Court further emphasized that the “single-use nature” of the needle guides was critical to the decision. As the Court explained, a single-use device is meant to be “consumed” in the course of treating a patient—just like a drug; “[o]nce the single-use device is used or consumed there is nothing left to be done with the device.” This could be interpreted to mean that re-using a product labeled for single-use is, by definition, transforming the device into an adulterated state.
However, the Ninth’s Circuit opinion does not appear to go that far, as it recognizes that “[t]his is a closer question [and that]. . .an agreement to intend to reuse the devices is not the same as an agreement to intend to hold the devices in an adulterated state.” With respect to Dr. Kaplan, the Court found that he both ignored the manufacturer’s warnings against re-using the device and relied on a cleaning protocol that was ineffective for cleaning the device. The Court pointed out that the cleaning protocol specifically warned that it was “not to be used to clean disposable devices.” Thus, it was not only that Dr. Kaplan re-used a single-use device, but also that he used a cleaning protocol for which “he possessed no evidence [that it] would actually work” to sanitize the device, which made him guilty of violating Section 331(K) of the FDCA.
This an important point, as the FDCA does not specifically prohibit re-processing and then re-using single-use devices. While the FDA has expressed concern about the growing trend of reusing single-use devices, it has not out-right banned the practice. To address safety concerns associated with re-using single-use devices, the FDA requires hospitals and other providers that re-use single-use devices to meet the same manufacturing standards used by the original manufacturer. In other words, hospitals and providers re-using these device must show these devices are as safe and as effective as when the device was originally manufactured. The Kaplan decision suggests that a hospital or other provider may risk violating the FDCA by using a cleaning protocol to re-process a single-use device, which is not approved or proven effective for cleaning such devices.
The case is United States. v. Michael Stanley Kaplan MD, case number 15-10241, in the U.S. Court of Appeals for the Ninth Circuit.