Monday, September 12, 2016
Panel Upholds Doctor’s Conviction for Reusing Equipment
By KENNETH OFGANG, Staff Writer
A physician who repeatedly reused single-use plastic needle guides during prostate biopsy exams was properly convicted of conspiracy to violate the Federal Food, Drug, and Cosmetic Act with intent to defraud, the Ninth U.S. Circuit Court of Appeals ruled Friday.
The panel affirmed the conviction of Michael Stanley Kaplan, a Henderson, Nev. urologist. Kaplan was sentenced by Chief U.S. District Judge Gloria M. Navarro of the District of Nevada to four years in prison last year.
U.S. Attorney Daniel Bogden said at the time of sentencing that Kaplan “re-used the needle guides for the purpose of personal enrichment and with an intent to defraud or mislead.” Prosecutors, he said, “will hold accountable those medical professionals who endanger patients for their own personal profit.”
Health officials reportedly sent letters to 101 of his patients, advising them to get tested for HIV and hepatitis B and C. The local health district did not report a positive case among the patients.
Records of the Nevada medical board show that Kaplan has an active license, but is facing disciplinary charges of conduct placing the profession in disrepute, commission of an offense involving moral turpitude, and commission of a felony involving the practice of medicine.
Witnesses testified that the packaging on each needle guide clearly warned against reuse, but Kaplan instructed his staff to reuse them three to five times prior to disposal. Between about Dec. 15, 2010, and March 11, 2011, Kaplan performed approximately 120 procedures requiring a needle guide but used less than 10 guides during that period, according to the testimony.
The evidence established that Kaplan used a reusable stainless-steel guide for the procedures until his ultrasound machine broke in 2010. Because a new reusable guide was not available for, and the old one didn’t work with, the new machine, a sales representative agreed to send single-use plastic guides to the office.
The sales representative testified that he never advised Kaplan’s office manager to reuse the guides, was not qualified to give such advice, and never told her how to sterilize the guides. Staff members claimed that Kaplan and the office manager insisted on reusing the guides even after it was pointed out that the packaging clearly said they were for single use only.
Eventually, Kaplan’s medical assistants tipped off regulators. Investigations were conducted by both the Nevada State Board of Medical Examiners and the Food and Drug Administration’s Office of Criminal Investigations before Kaplan was charged.
Jurors convicted him of conspiracy, with a special finding of intent to defraud, but acquitted him of lying to an FDA agent. Navarro sentenced him to 48 months in custody, rather than the 33 to 41 months called for by the Sentencing Guidelines.
On appeal, Kaplan argued that he could not be convicted under 21 U.S.C. §331(k), which prohibits the adulteration of an “article held for sale…after shipment in interstate commerce,” because a doctor’s use of a device in the course of treatment is not a “sale.” But several courts have held otherwise, Judge Richard Tallman wrote.
The correct inquiry, the judge elaborated, is not whether “a sale in the strict sense” has occurred, but whether the defendant was “a commercial actor in a commercial setting, using a commercial product.”
‘Held for Sale’
Because the single-use needle guide, once used, “no longer possesses a functional purpose in the medical practice” and is disposed of, “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,” Tallman wrote.
This interpretation is consistent with congressional intent that the act be interpreted broadly, and that §331(k) “protect the ultimate consumer, the patient, from dangerous products,” the judge said.
Tallman’s opinion in United States v. Kaplan, 15-10241, was joined by Judge Susan P. Graber and Senior District Judge Nancy G. Edmunds, of the Eastern District of Michigan, sitting by designation.
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