US v. Jackson: Jackson was an ear/nose/throat doctor in North Carolina who built a specialty performing ballon sinusplasty surgery (to treat chronic sinusitis). The procedure required a particular device that was “designed for single use and is labeled by the Food and Drug Administration as being approved only for single use.” Jackson and her staff used the devices repeatedly and created intense incentives for office staff to attract new patients/customers. Jackson was eventually charged with numerous offenses related to fraud, as well as “holding for resale adulterated medical devices” – the device used to perform the sinusplasty surgery. She was convicted on all charges and sentenced to 300 months in prison and $5.7 million dollars in restitution.
On appeal, the Fourth Circuit affirmed Jackson’s convictions and sentence. Of primary interest was Jackson’s challenge to her adulterated medical device count, on which Jackson made several arguments, most of which “are raised here for the first time on appeal.” Particularly, Jackson argued that, at most, she held the devices for use, but not for sale. Applying plain error because none of the argument presented below “challenge any aspect of the ‘held for sale’ element,” the court concluded that any error could not be plain. The only Circuit Court to have dealt with the issue rejected Jackson’s argument. Even if that decision was incorrect it means Jackson could not show an error that was “clear or obvious.” As the court noted, it had previously held that a district court does not plainly err when it follows the decision of another Circuit Court on an issue where the Fourth Circuit has not yet ruled.
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