Doctor Michael Kaplan was a urologist who owned and operated two urology clinics in Henderson and Las Vegas, Nevada. Both clinics regularly performed prostate needle biopsies. The procedure is used to collect prostate tissue sample to examine for disease. While Kaplan owned both clinics, the Las Vegas clinic was run by Dr. Brian Golden and Kaplan managed the Henderson clinic. To complete the prostate needle biopsy, an ultrasound probe is inserted into a patient’s rectum to locate the prostate, after which a hollow needle is used to penetrate the rectal wall and gather the needed tissue sample. To help stabilize the needle, an enclosure which houses it, called a needle guide, is used. Due to the nature of the biopsy, blood, tissue, fecal matter, viruses, and bacteria can contaminate the needle guide. Thus, needle guides come in reusable stainless steel, which must be sterilized, or in single-use disposable plastic forms. Kaplan’s clinics had used a stainless steel needle guide with a corresponding sterilizing machine until December 2010, when the machine broke. Kaplan ordered a refurbished machine, but a stainless steel needle guide that would fit the machine was not available at the time. Because of time constraints, the sales representative Kaplan worked with, Timothy Brandt, arranged to send disposable plastic guides to the clinics. By January 2011, both clinics were low on plastic needle guides and additional shipments were on backorder. Kaplan instructed his medical assistant supervisor at the Henderson clinic to tell the medical assistants to sterilize the plastic needle guides using the same protocol they had previously used for the stainless steel needle guide. The Las Vegas clinic did not reuse the plastic needle guides.
Medical assistants noticed blood and pinkish water left in the plastic needle guides after the sterilization process. Assistants also noticed brown scratches that would not come clean and noted that they could tell a used plastic needle guide from a new one due to its discoloration. In March 2011, Kaplan’s medical assistants reported him to the Nevada State Medical Board. The FDA’s Office of Criminal Investigations subsequently interviewed Kaplan and other staff at the clinics. Following the investigation, a grand jury indicted Kaplan in October 2013 on two counts. The relevant count charged Kaplan with 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) of the FDCA. In September 2014, a jury found Kaplan guilty of conspiring to commit adulteration and a final judgment for a 48-month prison sentence was entered in May 2015. Kaplan appealed, contending that he could not be criminally prosecuted under the FDCA.
CIRCUIT JUDGE TALLMA To interpret a statute, “we look first to the plain meaning of the text.” When words in a statute are not defined, they “will be interpreted as taking their ordinary, contemporary, common meaning.” Courts examine “not only the specific provision at issue, but also the structure of the statute as a whole, including its object and policy.” The FDCA is to be interpreted broadly in order to protect public health.
The FDCA’s overall purpose is to protect consumers from dangerous products. Congress’s specific intent in enacting § 331(k) was “to extend the Act’s coverage to every article” in interstate commerce until it reaches “the ultimate consumer,” the patient. In construing the meaning of “held for sale” under §
331(k), several courts have held that the phrase extends to physicians using both drugs and devices in the treatment of patients. The statements made in these cases, however, are quite conclusory and offer little guidance.
In the only case from our circuit addressing the “held for sale” provision, we concluded that “held for sale” does not reach homemade products distributed in a noncommercial setting at no cost to the recipients. Geborde, who was not a physician, made his own recreational drugs and distributed them free of charge. The government charged Geborde under § 331(k), alleging that “held for sale” included this type of distribution because it covered any conduct in which a drug is not held for personal consumption. In rejecting that argument, we emphasized “that the phrase ‘held for sale’ plainly contemplates a sale.” Notably, in construing the term “held for sale” we focused on “commercial transactions, commercial actors, and commercial products” but did not define the term more specifically.
Geborde’s conduct was not a sale under this definition because Geborde was a noncommercial actor, in a noncommercial setting, distributing homemade drugs completely free of charge.
In applying § 331(k) to Kaplan’s conduct, Kaplan argues that the phrase “held for sale” must be interpreted narrowly and cannot be read to mean “held for use.” Because title and possession of the guides were not transferred to patients, Kaplan argues that there was no sale and thus that his use of the guides during prostate biopsies falls outside the scope of the statute. Such an argument, however, is in direct contravention to out-of-circuit caselaw stating that a physician’s use of a device on a patient is covered by the statutory phrase “held for sale.”
Kaplan’s reliance on Geborde to distinguish these cases is misplaced. We did not hold that a sale in the strict sense must occur. Rather, we focused more generally on the commercial nature of the transaction, actors, and products. The district court in this case, therefore, properly focused on the commercial nature of Kaplan’s business, a medical practice operated for profit, reasoning 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, and that the patients were therefore the ultimate consumers of the guides. Kaplan is a physician engaged in the business of providing medical services in exchange for payment: a commercial actor in a commercial setting, using a commercial product. We hold that his use of the plastic guides is covered by the “held for sale” provision of § 331(k).
The single-use nature of the guides is particularly critical to our decision. A single-use device is meant to be “consumed” in the course of treating a patient-just like a drug. 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 disposable 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. This interpretation of “held for sale” comports with Congress’s intent that the FDCA be interpreted broadly, and the intent of § 331(k) to protect the ultimate consumer, the patient, from dangerous products. Even a physician can make a product dangerous for a patient if the product is utilized improperly.
The argument that defining “held for sale” in this manner impermissibly interferes with a physician’s ability to treat patients is foreclosed by United States v.
Regenerative Scis., LLC. There, physicians removed stem cells from patients, cultured them in a mixture with antibiotics, and then reinjected them into the patients to treat orthopedic conditions. In the suit alleging that the stem cell mixture was misbranded and adulterated under the FDCA, the physicians argued that the FDA was improperly attempting to regulate the practice of medicine by regulating the stem cell procedure. The court noted, however, that “the FDA does not claim that the procedures used to administer the Mixture are unsafe; it claims that the Mixture itself is unsafe.” Similarly, in Kaplan’s case the government is not alleging that the biopsy procedure is unsafe, but rather that the guides themselves are unsafe. Kaplan’s “arguments about the practice-of-medicine exemption are therefore wide of the mark.”
Finally, Kaplan’s claim that his reuse of the single-use guides is merely off-label use is similarly unavailing. Off-label use allows a physician to use drugs or devices regulated by the FDCA for a purpose not approved by the FDA. The purpose of this exception is to allow physicians the freedom to manage the care of their patients.
Kaplan’s argument that his reuse of the single-use guides was merely a permissible off-label use that cannot be criminally prosecuted fails for two reasons: the allegations of adulteration and the purpose of the off-label use. First, off-label use does not immunize a physician who uses adulterated products. Though offlabel use “allow[s] physicians to prescribe …lawful drugs for unapproved uses,” off-label use of adulterated products is beyond the scope of the privilege. While a physician may exercise professional judgment in the off-label use of unadulterated products, nothing in the FDCA or caselaw suggests that the use of adulterated products is ever permissible.
Second, Kaplan’s stated purpose for reusing the guides was “cost-effective medicine,” and there is no evidence in the record to suggest that this cost savings was passed on to the patients or that the practice in any way benefitted the patients. The 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 argument that Kaplan used professional judgment for some legitimate off-label purpose fails.
Therefore, we hold that a physician’s use of a consumable, single-use device on a paying patient satisfies the “held for sale” element under 21 U.S.C. §
331(k). The district court did not err in denying the motion to dismiss the indictment.
At one point, Kaplan bragged that the volume of his 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 needle guides on prostate biopsy patients brought them into contact with dangerous products, threatened public health, and breached § 331(k) of the FDCA. A physician’s use of a consumable device on a patient is covered by the “held for sale” provision of 21 U.S.C. §
331(k), and there was sufficient evidence to support the jury’s verdict that Kaplan engaged in a conspiracy to violate § 331(k). The district court did not err in denying Kaplan’s proposed jury instructions or in holding that the indictment sufficiently charged him with a felony. Finally, Kaplan waived any objection to how the jury instruction and special verdict form distinguished between a misdemeanor and felony conviction.
CRITICAL THINKING:
According to the court, “When words in a statute are not defined, they ‘will be interpreted as taking their ordinary, contemporary, common meaning.’” Your friend reads this and states that if the court’s statement is true, the meaning of statutes would change as time went by. What assumption is your friend making?
ETHICAL DECISION MAKING:
Brandt testified that he “had heard from a physician in California that, with appropriate sterilization, the single-use guides could be used two to three times before the guides disintegrate.” Brandt also testified he never advised Kaplan’s office manager to reuse the guides. Dr. Golden, who ran the Las Vegas clinic, advised Kaplan to stop reusing the plastic guides as soon as he became aware of the problem but did not follow up to see if Kaplan had stopped. Do you think either of the two can be held accountable for the plastic needle reuse at the Henderson clinic? How would you allocate blame?