Doctor’s Conviction for Reusing Medical Devices Upheld

A Nevada urologist who reused single-use needle guides in prostate biopsies to save money for an ultrasound machine had his conspiracy conviction and four-year sentence upheld by a federal appeals court Friday.

Dr. Michael Kaplan (photo Nev.Review Journal)

Dr. Michael Kaplan (photo Las Vegas Review Journal)

Dr. Michael Kaplan, who operated two urology clinics in Henderson and Las Vegas, Nevada in 2010, was convicted of conspiracy to adulterate medical equipment and intent to defraud his patients. He was accused of using single-use plastic needle guards during needle biopsies, a surgical procedure in which prostate tissue is removed and examined.

The 9th U.S. Circuit Court of Appeals upheld his convictions, rejecting defense claims that there was insufficient evidence to support a criminal conviction that he intended to defraud patients, the public or the U.S. Food and Drug Administration.

The panel also rejected Kaplan’s argument that the trial judge should have given a requested jury instruction that off-label use of the device was not unlawful.

Needle biopsies require both an ultrasound probe inserted in a patient’s rectum to locate the prostate and a needle guide, which houses the needle, to insert through the rectal wall into the prostate to collect tissue.  During the biopsy, both the inside and outside of the needle are contaminated with tissue, blood and fecal matter, along with any bacteria and viruses, according to the court.

Needle guides come in single-use and reusable styles.  Reusable ones are made of stainless steel and may be disinfected after every use. Single-use guides are plastic and prone to scratching, which can trap debris. They cannot be sanitized and are not meant for reuse.

In 2010, Kaplan’s ultrasound machine broke and he was placed in a “tight crunch” financially in order to replace the machine, the court said. Kaplan received single-use needle guides, which it was found the reusable stainless steel guide was not available for the new machine.

By 2011, supplies of the plastic guides ran short and Kaplan began to reuse the plastic ones. Kaplan insisted on reusing the guides even after the medical assistants pointed out the packages were clearly marked for single use.

Although Kaplan’s partner in the clinic told Kaplan to stop the reuse once he discovered it, he reuse continued. The practice was reported to the Nevada Medical board and federal investigators for the FDA.

By 2013, a federal grand jury in Nevada returned a two-count indictment against Kaplan. He was convicted following a nine-day jury trial and sentenced to four years in prison.

Case: U.S. v. Kaplan, No. 15-10241

 

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